Excipients Market Analysis and Segement Forecasts To 2025

MARKET ESTIMATES & TREND ANALYSIS
Excipients Market
Market, by Product (Polymers {MCC, HPMC, Ethyl Cellulose, Methyl Cellulose,
Carboxymethyl Cellulose, Croscarmellose Sodium, Povidone, Pregelatinized Starch,
Sodium Starch Glycolate, Polyethylene Glycol, Acrylic Polymers}, Alcohols {Glycerin,
Propylene Glycol, Sorbitol, Mannitol, Others}, Minerals {Calcium Phosphate, Calcium
Carbonate, Clay, Silicon Dioxide, Titanium Dioxide, Others}, Sugar & Others, {Lactose,
Sucrose, Others}, and Gelatin)
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Excipients market analysis and segment forecasts to 2025
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2
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Table of Contents
Chapter 1 Research Methodology ................................................... 11

1.1 Information Procurement ........................................................................................... 13
1.2 Data Analysis ............................................................................................................. 16
Chapter 2 Executive Summary ........................................................ 20
Chapter 3 Market Variables, Trends& Scope .................................. 22

3.1 Market Segmentation &Scope .................................................................................... 23
3.1.1 Market driver analysis ...................................................................................... 25
3.1.1.1 Growing pharmaceutical market .................................. 26
3.1.1.2 Rising demand for novel excipients .............................. 26
3.1.1.3 Patent cliffs driving the growth of excipients in the
generics market ........................................................ 27
3.1.2 Market restraint analysis .................................................................................. 30
3.1.2.1 Stringent rules by regulatory bodies ............................. 31
3.2 Penetration &Growth Prospect Mapping for Products, 2016........................................ 32
3.3 Excipients Market-Swot Analysis, By Factor (Political & Legal, Economic And
Technological) ............................................................................................................ 33
3.4 Industry Analysis – Porter’s ........................................................................................ 34
Chapter 4 Market Categorization: Product Estimates & Trend

Analysis ........................................................................... 35
4.1 Global Excipients Market: Product Movement Analysis ............................................... 36
4.2 Polymers .................................................................................................................... 38
4.2.1 Global polymers market, 2012 – 2025 (USD Million)........................................... 38
4.2.2 Methyl Crystalline Cellulose (MCC) .................................................................... 39
4.2.2.1 Global MCC market, 2012 – 2025 (USD Million) ............. 39
4.2.3 Hydroxy Propyl Methyl Cellulose (HPMC) .......................................................... 40
4.2.3.1 Global HPMC market, 2012 – 2025 (USD Million)............ 40
4.2.4 Ethyl cellulose .................................................................................................. 41
4.2.4.1 Global ethyl cellulose market, 2012 – 2025 (USD
Million) .................................................................... 41
4.2.5 Methyl cellulose ............................................................................................... 41
4.2.5.1 Global methyl cellulose market, 2012 – 2025 (USD
Million) .................................................................... 42

3
4.2.6 Carboxy Methyl Cellulose (CMC) ....................................................................... 42

4.2.6.1 Global CMC market, 2012 – 2025 (USD Million) ............. 43
4.2.7 Croscarmellose sodium ..................................................................................... 43
4.2.7.1 Global croscarmellose sodium market, 2012 – 2025
(USD Million) ............................................................ 44
4.2.8 Povidone .......................................................................................................... 44
4.2.8.1 Global povidone market, 2012 – 2025 (USD Million) ....... 45
4.2.9 Pregelatinized starch ........................................................................................ 45
4.2.9.1 Global pregelatinized starch market, 2012 – 2025
(USD Million) ............................................................ 46
4.2.10 Sodium starch glycolate .................................................................................... 46
4.2.10.1 Global sodium starch glycolate market, 2012 – 2025
(USD Million) ............................................................ 47
4.2.11 Polyethylene glycol ........................................................................................... 47
4.2.11.1 Global polyethylene glycol market, 2012 – 2025
(USD Million) ............................................................ 48
4.2.12 Acrylic polymers ............................................................................................... 48
4.2.12.1 Global acrylic polymers market, 2012 – 2025 (USD
Million) .................................................................... 49
4.3 Alcohol ...................................................................................................................... 49
4.3.1 Global alcohol market, 2012 – 2025 (USD Million).............................................. 50
4.3.2 Glycerin............................................................................................................ 50
4.3.2.1 Global glycerin market, 2012 – 2025 (USD Million) ......... 51
4.3.3 Propylene glycol ............................................................................................... 51
4.3.3.1 Global propylene glycol market, 2012 – 2025 (USD
Million) .................................................................... 52
4.3.4 Sorbitol ............................................................................................................ 52
4.3.4.1 Global sorbitol market, 2012 – 2025 (USD Million) ......... 53
4.3.5 Mannitol .......................................................................................................... 53
4.3.5.1 Global mannitol market, 2012 – 2025 (USD Million) ....... 54
4.3.6 Others .............................................................................................................. 54
4.3.6.1 Global other alcohol market, 2012 – 2025 (USD
Million) .................................................................... 55
4.4 Minerals..................................................................................................................... 55
4.4.1 Global minerals market, 2012 – 2025 (USD Million)............................................ 56
4.4.2 Calcium phosphate ........................................................................................... 56
4.4.2.1 Global calcium phosphate market, 2012 – 2025
(USD Million) ............................................................ 57

4
4.4.3 Calcium carbonate ............................................................................................ 57

4.4.3.1 Global calcium carbonate market, 2012 – 2025 (USD
Million) .................................................................... 58
4.4.4 Clay .................................................................................................................. 58
4.4.4.1 Global clay market, 2012 – 2025 (USD Million) .............. 59
4.4.5 Silicon dioxide .................................................................................................. 59
4.4.5.1 Global silicon dioxide market, 2012 – 2025 (USD
Million) .................................................................... 60
4.4.6 Titanium dioxide .............................................................................................. 60
4.4.6.1 Global titanium dioxide market, 2012 – 2025 (USD
Million) .................................................................... 61
4.4.7 Others .............................................................................................................. 62
4.4.7.1 Global other minerals market, 2012 – 2025 (USD
Million) .................................................................... 62
4.5 Sugar ......................................................................................................................... 63
4.5.1 Global sugar market, 2012 – 2025 (USD Million) ................................................ 63
4.5.2 Lactose............................................................................................................. 64
4.5.2.1 Global lactose market, 2012 – 2025 (USD Million) .......... 64
4.5.3 Sucrose ............................................................................................................ 65
4.5.3.1 Global sucrose market, 2012 – 2025 (USD Million) ......... 65
4.5.4 Others .............................................................................................................. 66
4.5.4.1 Global other excipients market, 2012 – 2025 (USD
Million) .................................................................... 66
4.6 Gelatin ....................................................................................................................... 66
4.6.1 Global gelatin market, 2012 – 2025 (USD Million) .............................................. 67
Chapter 5 Market Categorization: Regional Estimates &

Trend Analysis, by Product ............................................ 68
5.1 Global Excipients Market: Region Movement Analysis ................................................. 69
5.2 North America............................................................................................................ 71
5.2.1 North America excipients market, 2012 – 2025 (USD Million) ............................. 71
5.2.2 U.S. .................................................................................................................. 72
5.2.2.1 U.S. excipients market, 2012 – 2025 (USD Million) ........ 73
5.2.3 Canada ............................................................................................................. 73
5.2.3.1 Canada excipients market, 2012 – 2025 (USD
Million) .................................................................... 74
5.3 Europe ....................................................................................................................... 74
5.3.1 Europe excipients market, 2012 – 2025 (USD Million) ........................................ 76

5
5.3.2 Germany .......................................................................................................... 77

5.3.2.1 Germany excipients market, 2012 – 2025 (USD
Million) .................................................................... 77
5.4 Asia Pacific ................................................................................................................. 77
5.4.1 Asia Pacific excipients market, 2012 – 2025 (USD Million) .................................. 79
5.4.2 Japan ............................................................................................................... 79
5.4.2.1 Japan excipients market, 2012 – 2025 (USD Million) ...... 79
5.5 Latin America ............................................................................................................. 80
5.5.1 Latin America excipients market, 2012 – 2025 (USD Million) .............................. 81
5.5.2 Brazil ................................................................................................................ 81
5.5.2.1 Brazil excipients market, 2012 – 2025 (USD Million) ....... 82
5.6 Middle East & Africa (MEA) ........................................................................................ 82
5.6.1 Middle East & Africa excipients market, 2012 – 2025 (USD Million) .................... 83
5.6.2 South Africa ..................................................................................................... 83
5.6.2.1 South Africa excipients market, 2012 – 2025 (USD
Million) .................................................................... 84
Chapter 6 Competitive Landscape .................................................. 85

6.1 Strategy Framework ................................................................................................... 85
6.2 Market Participation Categorization ........................................................................... 86
6.3 Company Profiles ....................................................................................................... 87
6.3.1 Eastman Chemical Corporation ......................................................................... 87
6.3.1.1 Company overview .................................................... 87
6.3.1.2 Financial performance ................................................ 87
6.3.1.3 Product benchmarking................................................ 88
6.3.2 P & G................................................................................................................ 89
6.3.3 Avantor Performance Materials, LLC ................................................................. 91
6.3.3.2 Financial Performance ................................................ 91
6.3.3.4 Strategic initiatives .................................................... 92
6.3.4 Huntsman Corporation ..................................................................................... 93

6

6.3.5 BASF SE ............................................................................................................ 95
6.3.6 Ashland Inc,...................................................................................................... 97
6.3.7 FMC Corporation .............................................................................................. 99
6.3.7.3 Product benchmarking.............................................. 100
6.3.7.4 Strategic initiatives .................................................. 100
6.3.8 Roquette ........................................................................................................ 101
6.3.8.1 Company overview .................................................. 101
6.3.8.2 Financial performance .............................................. 101
6.3.9 Colorcon Inc., ................................................................................................. 103
6.3.10 Lubrizol Corporation ....................................................................................... 105
6.3.11 Valeant .......................................................................................................... 107
6.3.11.1.1 The Dow Chemical Company (Dow Pharma
Solutions) ..................................................... 107

7
6.3.11.2.1 Financial performance ..................................... 108

6.3.12 JRS PHARMA .................................................................................................. 110
6.3.13 Shin-Etsu Chemical Co., Ltd ............................................................................. 113
6.3.13.1.1 SE Pharma & Food Materials Distribution
GmbH .......................................................... 113
6.3.14 DFE pharma .................................................................................................... 116
6.3.15 FINAR LIMITED ............................................................................................... 119

8
List of Tables
TABLE 1 Major drugs going off patent in 2017 29
List of Figures
FIG. 1 Market research process 12

FIG. 2 Information Procurement 13
FIG. 3 Primary research pattern 15
FIG. 4 Market research approaches 17
FIG. 5 Value chain based sizing & forecasting 17
FIG. 6 QFD modelling for market share assessment 19
FIG. 7 Market summary 21
FIG. 8 Market trends & outlook 22
FIG. 9 Market segmentation & scope 23
FIG. 10 Market driver relevance analysis (Current & future impact) 25
FIG. 11 Major drugs that lost patent protection in 2016 (Revenue in USD million) 28
FIG. 12 Market restraint relevance analysis (Current & future impact) 30
FIG. 13 Penetration & growth prospect mapping for Products, 2016 32
FIG. 14 SWOT Analysis, By Factor (political & legal, economic and technological) 33
FIG. 15 Porter’s Five Forces Analysis 34
FIG. 16 Global excipients market: Product outlook key takeaways 35
FIG. 17 Global excipients market: Product movement analysis 37
FIG. 18 Global polymers market, 2012 – 2025 (USD Million) 38
FIG. 19 Global MCC market, 2012 – 2025 (USD Million) 39
FIG. 20 Global HPMC market, 2012 – 2025 (USD Million) 40
FIG. 21 Global ethyl cellulose market, 2012 – 2025 (USD Million) 41
FIG. 22 Global methyl cellulose market, 2012 – 2025 (USD Million) 42
FIG. 23 Global CMC market, 2012 – 2025 (USD Million) 43
FIG. 24 Global croscarmellose sodium market, 2012 – 2025 (USD Million) 44
FIG. 25 Global povidone market, 2012 – 2025 (USD Million) 45
FIG. 26 Global pregelatinized starch market, 2012 – 2025 (USD Million) 46
FIG. 27 Global sodium starch glycolate market, 2012 – 2025 (USD Million) 47
FIG. 28 Global polyethylene glycol market, 2012 – 2025 (USD Million) 48
FIG. 29 Global acrylic polymers market, 2012 – 2025 (USD Million) 49
FIG. 30 Global alcohol market, 2012 – 2025 (USD Million) 50
FIG. 31 Global glycerine market, 2012 – 2025 (USD Million) 51
FIG. 32 Global propylene glycol market, 2012 – 2025 (USD Million) 52
FIG. 33 Global sorbitol market, 2012 – 2025 (USD Million) 53

9
FIG. 34 Global mannitol market, 2012 – 2025 (USD Million) 54

FIG. 35 Global other alcohol market, 2012 – 2025 (USD Million) 55
FIG. 36 Global minerals market, 2012 – 2025 (USD Million) 56
FIG. 37 Global calcium phosphate market, 2012 – 2025 (USD Million) 57
FIG. 38 Global calcium carbonate market, 2012 – 2025 (USD Million) 58
FIG. 39 Global clay market, 2012 – 2025 (USD Million) 59
FIG. 40 Global silicon dioxide market, 2012 – 2025 (USD Million) 60
FIG. 41 Global titanium dioxide market, 2012 – 2025 (USD Million) 61
FIG. 42 Global other minerals market, 2012 – 2025 (USD Million) 62
FIG. 43 Global sugar market, 2012 – 2025 (USD Million) 63
FIG. 44 Global lactose market, 2012 – 2025 (USD Million) 64
FIG. 45 Global sucrose market, 2012 – 2025 (USD Million) 65
FIG. 46 Global other excipients market, 2012 – 2025 (USD Million) 66
FIG. 47 Global gelatin market, 2012 – 2025 (USD Million) 67
FIG. 48 Regional market place: Key takeaway 68
FIG. 49 Excipients regional outlook, 2016 & 2025 70
FIG. 50 North America excipients market, 2012 – 2025 (USD Million) 71
FIG. 51 U.S. excipients market, 2012 – 2025 (USD Million) 73
FIG. 52 Canada excipients market, 2012 – 2025 (USD Million) 74
FIG. 53 Europe excipients market, 2012 – 2025 (USD Million) 76
FIG. 54 Germany excipients market, 2012 – 2025 (USD Million) 77
FIG. 55 Asia Pacific excipients market, 2012 – 2025 (USD Million) 79
FIG. 56 Japan excipients market, 2012 – 2025 (USD Million) 79
FIG. 57 Latin America excipients market, 2012 – 2025 (USD Million) 81
FIG. 58 Brazil excipients market, 2012 – 2025 (USD Million) 82
FIG. 59 Middle East & Africa excipients market, 2012 – 2025 (USD Million) 83
FIG. 60 South Africa excipients market, 2012 – 2025 (USD Million) 84
FIG. 61 Strategy framework 85
FIG. 62 Participant categorization 86

10
Chapter 1 Research Methodology

Our research methodology entails an ideal mixture of primary and secondary initiatives. Key
steps involves in the process are listed below:
 Information Procurement
The stage involves the procurement of market data or related information via different
sources & methodologies.
 Information Analysis
This step involves the analysis & mapping of all the information procured from the
previous step. It also encompasses the analysis of data discrepancies observed across
various data sources.
 Market Formulation
The final step entails the placement of data points at appropriate market spaces in an
attempt to deduce viable conclusions. Analyst perspective & subject matter expert based
heuristic form of market sizing also plays an integral role in this step.
 Validation &Publishing
Validation is the most important step in the process. Validation & re-validation via an
intricately designed process helps us finalize data-points to be used for final calculations.
The movement from step – 1 and step – 2 is bi-directional in nature. The process follows a to &
fro from both the ends. This is an integral data filtration technique used by GVR. The validation
& market formulation steps are also reversible in nature. They are run parallel to ensure data
accuracy and process flexibility.
The process of market sizing & data point identification runs throughout the report schedule.
The process moves from Step 1&2 to Step 3&4, while keeping the steps 1&2 and 3&4
reversible. The cycle of market sizing & variable identification also keeps repeating until every
data point is duly validated and is fit for publishing.

11
FIG. 1 Market research process
Information procurement Information analysis Market formulation

Validation & publishing
The stage involves the This step involves the The final step entails the
Validation is the most
procurement of market analysis & mapping of all placement of data points
important step in the
data or related the information procured at appropriate market
process. Validation & re-
information via different from the previous step. It spaces in an attempt to
validation via an
sources & methodologies. also encompasses the deduce viable conclusions.
intricately designed
analysis of data Analyst perspective &
process helps us finalize
discrepancies observed subject matter expert
data-points to be used for
across various data based heuristic form of
final calculations.
sources. market sizing also plays an
integral role in this step.
The movement from step – 1 and step – 2 is bi-directional in The validation & market formulation steps are also reversible in
nature. The process follows a to & fro from both the ends. This is nature. They are run parallel to ensure data accuracy and process
an integral data filtration technique used by GVR. flexibility.
The process of market sizing & data point identification runs throughout the report schedule. The process moves from Step 1&2
to Step 3&4, while keeping the steps 1&2 and 3&4 reversible. The cycle of market sizing & variable identification also keeps
repeating until every data point is duly validated and is fit for publishing.
12

1.1 Information Procurement
FIG. 2 Information Procurement
Purchased Database GVR’s Internal Database

We buy access to paid Includes historic market
databases such as Hoover’s & databases, pertinent studies,
Factiva to gain access to internal audit reports &
company financials, industry archives. Pertinent data such
information, white papers, as prevalence rates,
industry journals, SME journals prescription rates, treatment
etc. rates, usage rates etc. We have
a dedicated team of analysts
updating & maintaining these
databases.
Primary Research
Primary interviews with in-
Information Procurement house industry experts,
freelance consultants,
manufacturers, users &
distributors. Interviews are
largely based on
The stage involves the brainstorming, tele-interviews,
procurement of market data or online surveys etc.
related information via different
sources & methodologies.
Third Party Perspective Secondary Sources
Analysis of investor analyst Includes government statistics
reports, broker reports, published by organizations like
academic commentary, WHO, NGOs, World Bank etc.,
government quotes & wealth KoL publications, Company
management publications. filings, Investor documents etc.
13

Information procurement is one of the most extensive stages in our research process. As
illustrated in the figure above, the techniques can broadly be categorized into five sections, as
stated below:
Purchased database:
 Includes company databases such as Hoover’s: This helps us identify financial

information, industry competitive landscape, and structure of the market participants. Also,
it serves as an important step in market sizing, especially, in case of commodity-flow
techniques.
 Industry databases, e.g. Factiva. Helps us gain access to industry statistics, and KoL
opinions & formulate conclusions.
 Other sources include SME journals, pertinent databases from third-party vendors to gain
insights into:
o Treatment rates
o Prescription/usage rates
o Line of treatment/procedure statistics
o Potential market related statistics
o Information on unmet needs
o Regional expenditure pattern
o Investment information or opportunity based statistics
GVR’s Internal Database
 Includes our internal database of data points, collected as a result of previous research &
studies and information made available via our database management team
 Also includes internal audit reports & archives
Secondary sources:
 A list of secondary sources along with the information extracted from them will be available
in the final deliverable
 Notable examples include white papers, government statistics published by organizations
like WHO, NGOs, World Bank etc., KoL publications, company filings, investor documents
etc.
14

Third Party Perspective:
 This section includes market derivation through investor analyst reports, broker reports,
academic commentary, government quotes & wealth management publications.
Primary Research:
FIG. 3 Primary research pattern
The primary interviews and surveys derive directions from extensive secondary
research. Secondary research is a continuous process and is conducted at each
level along the value chain.
Interviews with
Interviews with
manufacturers,
Interviews with raw healthcare
distributors,
material suppliers and practitioners, industry
researchers and
manufacturers experts & independent
representatives of
consultants
regulatory bodies
Interview Scope:
• Research tools: Questionnaire based research and telephonic discussions
• Database: Paid vendors, LinkedIn, Hoover’s, Factiva, Sources extracted from
previous pertinent studies
• Regional scope: All countries within the scope of the study. Interviews of KoLs
from non-English speaking countries are conducted via our vendors and
questionnaires
Sample size for the study on Excipients Market:
 Manufacturers & Raw material suppliers- Colorcon Inc., BASF SE, ELIX polymers,
S.L

15
1.2 Data Analysis
Information procured from secondary and primary initiatives are then, analyzed by using
the following tools/models: (a partial list)
 Identifying variables and establishing market impact

 Establishing market trends
 Analyzing future opportunities and market penetration rates by understanding
product commercialization, regional expansion etc.
 Analyzing reimbursement trends and changes in healthcare dynamics to establish
future growth
 Analyzing sustainability strategies adhered by market participants in an attempt to
determine future course of the market
 Analyzing historical market trends and super-imposing them on the current and
future variables to determine year-on-year trend
 Understanding disease prevalence, procedure trends and reimbursement framework
 Keeping a track of technological advancements in individual segments
 Base numbers are established by analyzing the following:
- Company revenues and market share (this list generally includes the analysis of
revenue published by publicly listed manufacturers)
- Derivation of market estimates via analyzing parent and ancillary markets
However, it is difficult for us to currently state the methodology or model that we would follow
while, catering to the client requirements, we propose the use of the following models (a partial
list):
 Model selection: demand based bottom up approach, epidemiology and treatment rates
based approach and mixed approach (top down and bottom up)

16
FIG. 4 Market research approaches
Bottom-up demand approach

Total • Demand estimation of each product across countries/regions summed
market to form the total market
Product • Variable analysis for demand forecasting
Product
• Demand estimation via analyzing paid databases, company financials
A B1
Product B either via annual reports or paid databases
Product • Primary interviews for data revalidation and insight collection
Product B B2
Top-down approach • Used extensively for new product forecasting or analyzing penetration
Prev alence levels
lev els • Tools used involve patient flow and prevalence-based models
Line of
Diagnosis therapy • Use of regression and multi-variate analyses for forecasting
Treatment
rate rate
• Involves extensive use of paid and public databases
Prescription • Primary interviews and vendor based primary research for the
Treatme rates
identification of treatment rates, prescription rates, user preferences
nt rate etc.
Combined approach
Total Prev alence
lev els
market Line of
Product Diagnosis Treatment
therapy
Product
rate rate
A Product A1 Prescription
Treatme rates
A Product
Product B A2 nt rate
FIG. 5 Value chain based sizing & forecasting
Demand side estimates

Supply side estimates
• Identifying parent
• Company revenue
markets and ancillary
estimation via
markets
referring to annual
• Segment penetration
reports, investor
analysis to obtain
presentations and
pertinent
Hoover’s
revenue/volume
• Segment revenue
• Procedure
determination via Market sizing and volumes, diagnosis
variable analysis and forecasting rates and treatment
penetration modeling simplified rates to derive market
• Competitive
size
benchmarking to
• Heuristic forecasting
identify market leaders
with the help of
and their collective
subject matter experts
revenue shares
• Forecasting via
• Forecasting via
variable
analyzing
analysis, expected
commercialization
change in diagnosis
rates, pipeline, market
and treatment rates
initiatives, distribution
and reimbursement
networks etc.
etc.

17
 Penetration modeling for products

o Determining and forecasting penetration via analyzing product features,
proposed pricing, availability of internal and external substitutes etc.
o Heuristic estimation of year-on-year sales by conducting primary interviews with:
 Healthcare practitioners
 Industry experts & KoLs
 Distributors
o Product sizing and forecasting by following a diffusion model based on S-curve
growth
Analysis of current usage rates and dosage/regimen patterns to determine substitution rates
 Regression and variable analysis
o Identifying variables and assigning impact to determine growth)
o QFD modeling for market share assessment (an example cited in the figure
below)
o Referring to historic data to establish base estimates
o Using exponential smoothing for forecasting
 Epidemiology or user size based penetration
o Analyzing current needs and determining penetration to estimate market size or
sales
o Using unmet needs and capitalization rates to determine growth
 Trend analysis (based on year on year trending models)

18
FIG. 6 QFD modelling for market share assessment
Scores derived via QFD Price Efficacy rates Current penetration Future prospects Consumer preference index
Product A 10 9 7 9 6
Product B 8 9 4 6 5
Product C 10 7 1 7 9
Product D 4 8 10 9 4
Product E 8 6 6 3 1
Weightage in terms of % Market shares as calculated for initial research purposes

Avg. score Relative market share
Price 25% Product A 8.3 24.48%
Efficacy rates 25% Product B 6.6 19.47%
Current penetration 25% Product C 6.6 19.32%
Future prospects 10% Product D 7.0 20.65%
Consumer preference index 15% Product E 5.5 16.08%
100% 33.9
NOTE: THE ABOVE ILLUSTRATED FIGURE IS FOR REPRESENTATION PURPOSES ONLY. ATTRIBUTE SELECTION AND SCORE RENDERING
IS AN EXTENSIVE PROCESS INVOLVING RIGOROUS PRIMARY AND SECONDARY RESEARCH
Note in case of upcoming reports only: The above mentioned proposed techniques will
enable us with the ability to estimate and revalidate all our market estimates while
reducing error margins.

19
Chapter 2 Executive Summary

The global excipient market was valued at USD 4,128.5 million in
Rising demand for 2016 and is expected to grow at a CAGR of 6.0% over the forecast
biologics due to their
period to reach an estimated value of USD 6,986.0 million by 2025.
improved efficacy
and instantaneous In recent years, pharmaceutical excipients have made a remarkable
effect is anticipated progress in quantities used and revenue captured. Gradual
to drive the market
recognition of excipients in providing better functionality and
growth in the coming
years competitive advantage in drug formulations have contributed to the
increased usage of these products by the pharmaceutical firms in the
recent years.
In addition, presence of stringent regulations and guidelines that

ensure the proper and safe use of excipients in drug development is
expected to dramatically impact the future growth of this market.
Europe captured the largest share with respect to revenue generation

Europe excipients
market is expected to
in 2016 excipients market. This market share was attributed to
reach $ 2,179.2 mn presence of regulatory agencies which are involved in enacting new
by 2025. MEA
policies in order to prevent drug adulteration in excipients.
market of excipients
is expected to emerge Europe excipients market was valued at USD 1,336.4 million in 2016
as the fastest
and is anticipated to register 5.6% CAGR over the forecast period.
growing region
However, Middle East & Africa is expected to experience the fastest
growth in the coming years as this region is receiving support from
WHO in the form of training services for local personnel. These
training services are intended to allow the local firms to comply with
the GMP standards for pharmaceutical excipients.
Currently, investigations are going on for optimization of the excipients

functioning in drug formulations and delivery. Moreover,
pharmaceutical firms are engaged in development of more
sophisticated excipients with enhanced role. These factors are
expected to have major impact on development and marketing of
excipients in the near future.
20

FIG. 7 Market summary
Segment Key facts
Rising adoption in different formulations

Product: Sugars(fastest) expected to fuel growth.
Market CAGR of 6.9%
High usage of polymers and sugars

Region: Europe (largest)
attributive for dominance
1,870.24
Market led by Roquette Frères, Lubrizol
Competitive landscape
Corporation, FMC Corporation
4128.55
550.49
Drivers Restraints
1,242.55 • Growing pharmaceutical market • Stringent rules by regulatory bodies
• Rising demand for novel excipients
• Patent Cliffs Driving the Growth of
175.61 Excipients in the Generics Market
289.66
Global Polymers Alcohols Sugars Minerals Gelatin
Source: WHO, U.S. CDC, FDA, Investor Presentations, Primary Interviews, Grand View Research
21

Chapter 3 Market Variables, Trends& Scope
FIG. 8 Market trends & outlook
Ever growing pharmaceutical market demands the need for continuous supply of
Growing pharmaceutical market excipients to process newer formulations and meet the demand for quality
medication in developing regions
Growth factor.
(Impact low to Need for newer drug delivery systems fuels the innovations in excipient technology
high along the Rising demand for novel like the nanoparticles for oncological drug delivery systems. Multifunctional
arrow
excipients excipients which can serve for more than one purpose is marketable owing to the
market scenario
Many multinational companies are on a verge of crisis due to the expiring patents of
Patent cliffs driving the growth of many blockbuster drugs they possess. This led the need for patent protection by
excipients in the generics market adding functional excipients to the drugs that can modify and make the drug more
effective such as modifying the route of administration or delayed release of drug
Restraining factor.
(Impact low to Strict regulations such as maintaining the GMP protocols, licensing of new
high along the Stringent rules by regulatory manufacturers of excipients, sign of agreement and regulations by suppliers make it
arrow bodies difficult to obtain approval of R & D sites can cause a shortage of US-FDA approved
manufacturing sites
22

3.1 Market Segmentation &Scope
FIG. 9 Market segmentation & scope
Excipients Market
Product Type Regional
 Polymers  Sorbitol  North America

 MCC  Mannitol  U.S.
 HPMC  Others  Canada
 Ethyl Cellulose  Minerals  Europe
 Methyl Cellulose  Calcium Phosphate  Germany
 Carboxymethyl Cellulose  Calcium Carbonate  UK
 Croscarmellose Sodium  Clay  Asia Pacific
 Povidone  Silicon Dioxide  China
 Pregelatinized starch  Titanium Dioxide  Japan
 Sodium starch glycolate  Others  Latin America
 Polyethylene Glycol  Sugars  Brazil
 Acrylic Polymers  Lactose  MEA
 Alcohols  Sucrose  South Africa
 Glycerin  Others
 Propylene Glycol  Gelatin
Attribute Details
Base year used for market estimation 2016
Historic analysis Actual data from 2012 to 2015
Forecast 2017 to 2025

Excipients play a pivotal role in drug formulations and are expected to witness significant growth
in the coming years. Growth of excipients market is significantly driven by the the growing
demand for all-round excipients. Moreover, ongoing developments in the various categories of
excipients is expected to have positive impact on the progress of this market.
On the basis of product classes offered by this market, the overall excipients market is
segmented into polymers, alcohols, sugar & others, minerals, and gelatin. Out of which,
23

polymers as excipient accounted for the largest share in terms in both volume and revenue
owing to the presence of broader array of products falling into this category. In addition,
polymers are recognized to act as multifunctional excipients in drug development process,
which in turn, has attributed to the high usage rate as excipients in drug development.
On the other hand, sugar-based excipients are estimated to be the fastest growing segment.
Continuous introduction of new products in this category is the major factor driving the growth of
this segment. Moreover, ongoing studies on the use and stability effect of sugars as
pharmaceutical excipients are expected to enhance the progress of this segment.

24
3.1.1 Market driver analys is
FIG. 10 Market driver relevance analysis (Current & future impact)
Growing
High
pharmaceutic
al market
Rising
Medium
demand for
novel
excipients
Patent cliffs
driving the
growth of
Low
excipients in
the generics
market
Current impact Short-term impact Long-term impact

25

3.1.1.1 Growing pharmaceutical market
Pharmaceuticals market is being flooded with generic medicine that can be used as OTC
product to a prescribed medicine for critical illnesses. Generic medicine offers high treatment
opportunity at considerably lower prices than the branded drugs. Generic medicine market has
seen an exponential growth in recent years owing to the involvement of bigger pharmaceutical
companies in the production of generic medicines. Generic medicines are manufactured at a
higher rate than the branded drugs and to meet this demand the production of excipients has
increased in the recent years to close the demand supply gap of excipients.
Moreover, the drug formulators are relying on the blend of selected and sophisticated excipients
in order to defend against available excipient competition. Preparation of special excipient
blends that provide manufacturers with ready-made combinations of fillers, binders, disintegrant,
lubricants and other products, reducing manufacturing time and standardizing materials to be
combined with active ingredients This trend is expected to continue and prosper in the forecast
period owing to the growing generic market in the emerging regions such as Asia Pacific and
Latin America where there is a need for cheaper and effective pharmaceuticals.
3.1.1.2 Rising demand for novel excipients
As pharmaceutical industry constantly needs novel and multifunctional products to improve the
available pharmaceuticals, there exists the need for novel excipients that are multifunctional and
can aid in improvement of absorption and solubility, increase the stability of biologics and
parental formulations, enhance disintegration.
There has been a high demand for the development of novel excipients for novel drug delivery
formulations, such as liposomal and nanotechnology-enabled delivery systems. Other
requirements such as multifunctional or excipients that can co-exist and provide better excipient
functions. Market is about witness faster market approvals for the multifunctional or combined
excipients, in which two or more excipients co-exist in a specific product.
Furthermore, regulatory transition driven by rising need of high-quality excipients and rising
demand for new excipients coupled with emphasis on co-processed excipients is anticipated to
bolster growth in the global market through to 2025. Application of the functional excipients for
solving the formulation problems and contribute to simpler, more cost effective and robust drug
26

product manufacture, is becoming a critical component of quality-by-design projects within the

pharmaceutical industry.
Demand for an all-round excipient that enables direct compression is expected to drive market
with potential avenues. Attempts for development of a single excipient that incorporates binding,
disintegrating and lubricating properties is expected to fuel research in the sector thereby
resulting to industrial growth.
Development of nanoparticle excipients and drug delivery systems involving nanoparticles is

expected to gain popularity in the forecast years owing to increased efforts for the development
of oncological pharmaceuticals.
3.1.1.3 Patent cliffs driving the growth of excipients in the generics

market
The recent years have seen an increase in number of companies losing patents for many of
their propriety drug molecules. Companies have employed a different approach on extending
their patents on the drug molecules by including a wholly different functional excipient mixture or
composition for the drug delivery. This had worked out for many of the bigger pharmaceutical
companies in extending the patents for their molecules.
For instance, excipients help pharmaceutical companies in extending the patent life for a
molecule with innovations such as sustained release in the drug delivery. This trend is expected
to continue in the forecast period as many of the big pharmaceutical companies are in a verge
of losing patents of molecules that form a major revenue role for the companies.
Increased competition in the United States has been observed as several major drugs such as
Lipitor (atorvastatin), Plavix (clopidogrel), and Singulair (montelukast) faced patent expirations.
Patent expirations are one of the high impact rendering factors for the progress of biologics
arena as it offers ample opportunities for the pharmaceutical firms to step into this market.

27
FIG. 11 Major drugs that lost patent protection in 2016 (Revenue in USD million)
$7,000
$6,000
$5,000
$4,000
$3,000
$2,000
$1,000
$0
High revenue generating drugs going off patent in 2016
Figure 4 represents the highly profitable drugs that are expected to lose respective patent
protection in 2016.

28
TABLE 1 Major drugs going off patent in 2017
Drug Company Indication

Azilect Teva
Neurological disorders
Fanapt Vanda
Mepron GSK
Invanz
Cancidas Merck Infections
Cubicin
Tamiflu Roche
Treximet GSK
Relpax Pfizer Pain
Butrans Purdue Pharma
Vytorin Merck Blood pressure/ cholesterol/
heart diseases
Sandostatin LAR Novartis
Carbeglu Orphan Europe
Endocrine disorders
Somavert Pfizer
Acthar Gel Questcor
Omnaris Altana
Reyataz Bristol-Myers Squibb
Axiron
Eli Lilly
Strattera Others
Arranon GSK
Sabril Lundbeck
Macugen Valeant
Source: Industry Journals, Annual Reports, Investor Presentations, Primary Interviews, Grand View Research
Patent expiration is observed to heat up the competition amongst the pharmaceutical firms for
capitalizing the avenues present in the market space of biologics. Drugs patent expiration and
growing demand for robust biologics are anticipated to have major ramifications on the
development and marketing of biologics and thereby influencing the growth of biologics in future
market.

29
3.1.2 Market res tra int analysis
FIG. 12
High
Medium Market restraint relevance analysis (Current & future impact)
Stringent
rules by
regulatory
bodies
Low
Current impact Short-term impact Long-term impact

30

3.1.2.1 Stringent rules by regulatory bodies
Recent years have seen many adverse reactions caused by excipients added to the API’s. Due
to this the U.S.-FDA and European regulatory bodies have imposed strict regulations for the
approval of new R&D sites for excipient manufacturing.
Excipients production has been affected mainly in 3 ways; manufacturing bodies of these
excipients must comply to the standards for quality control pharmaceutical excipients which
once was just used as a reference standard. New set of rules have been laid stating that the
manufacturer must obtain pharmaceutical manufacturing license as well as pharmaceutical
excipient registration to manufacture new excipients that are considered to have a high safety
risk.
These rules are set to enhance the quality and streaming the manufacturing process right from
the selection of excipients and their use in various critical molecules. These factors led to a
shortage of FDA-approved excipient production sites, which might hamper the growth of the
market to a certain extent.
31

3.2 Penetration &Growth Prospect Mapping for Products, 2016
FIG. 13 Penetration & growth prospect mapping for Products, 2016
Uncharted territories Segment spearhead

Expected adoption rate (Low to High along the axis)
Polymers
Alcohols
Sugar & Others
Minerals
Gelatin
Nascent platforms Mature platforms
Penetration (Low to High along the axis)
Penetration is defined as the maturity of the segment.
Growth rate is considered as the future projected CAGR till year 2025. These growth rates are comparative in nature, with the
overall market growth rate as being the benchmark.
Polymer-based excipients held the largest share in the 2016 market and are expected to
register significant growth rate due to its high usage rate in drug formulations. This high usage
rate is mainly attributed to the wide range of polymer functionalities as excipients which is
attained with polymer chemistries and molecular weights. Sugar-based pharmaceutical
excipients are expected to gain significant ground in the future market of excipients over its
counterpart segment. This segment is expected to emerge as fastest growing segment due to
the investments made by the companies for expansion of their manufacturing facilities for
development of sugar based excipients. Moreover, researchers continue to investigate the
effectiveness of sugar based pharmaceutical excipients in drug development, thereby driving
growth of this segment. Mineral-based excipients are estimated to have lowest market share in
the 2016 market and are expected to grow with considerable CAGR over the forecast period as
this segment is at nascent stage in current excipient landscape.

32
3.3 Excipients Market-Swot Analysis, By Factor (Political & Legal, Economic And Technological)
FIG. 14 SWOT Analysis, By Factor (political & legal, economic and technological)
Strengths: Governments from the developed countries have devised strong GMP regulations to enhance the quality of excipients
used in the formulations
Weaknesses: The regulations laid have become a hurdle for the development of approved new R&D sites for newer technologies
and delivery systems
Political & Legal Opportunities: Political pressure had presented companies to come up with quality enhancements to their excipient offerings right
from selection of material to processing of final formulation
Threats: The regulations laid by the government bodies might hamper the production levels of excipients due to the closure of
manufacturing sites following a small error might lead to demand-supply gap
Strengths: Collaborations between a well established excipient manufacturer and a well-known distributor network in a particular
region is expected to increase the market penetration
Weaknesses: Pharmaceutical excipient suppliers in the emerging countries are often affected by the lack of appropriate
infrastructure for the effective transportation of the material
Economic Opportunities: Presence of well versed supplier chain and their reach to developing regions might boost the market in the forecast
period. Rising pharmaceutical manufacturing outsourcing in developing economies is expected to drive demand.
Threats: Developing regions where the technological advancements in the processing of newer excipients have to depend on
imports which is associated with high costs. This might hamper the market’s growth
Strengths : Development of newer technologies and newer excipients like the nanoparticles in the delivery of oncological drugs can
promote the market
Weaknesses: Reducing investments in excipient manufacture owing to the strict regulations and lack of resources from local players
to compete with bigger MNC’s might hamper the market in the developing regions
Technological Opportunities: Companies with newer technologies and adequate funding to expand their manufacturing capacity might help
boost the market and have an opportunity to grab major market share
Threats: Entry of newer technological might replace the existing technologies although, high costs and adoption rate might hamper
the market in the initial phase of adoption
33

3.4 Industry Analysis – Porter’s
FIG. 15 Porter’s Five Forces Analysis
Threat of new entrants: Moderate
Threat of new companies into the market is low as

a consequence of expensive infrastructure and
GMP compliant facilities required for the
manufacture of these products.
Bargaining power of suppliers: High Competitive rivalry: High Bargaining power of buyers: Moderate
Bargaining power of suppliers is high due to the Competitive rivalry between the companies very Buyers bargaining is power is expected to remain
presence of few GMP compliant laboratories and high owing to the highly fragmented nature of high due to the large number of manufacturers for
presence of stringent regulations. This leads to market and high demand for the excipients in the the pharmaceutical molecules. Moreover,
increase in the bargaining power of suppliers formulation of API’s. Presence of established presence of regulations for the manufacturing of
players in the chemical market space drives the excipients reduces the bargaining power, bringing
rivalry level it to moderate.
Threat of substitutes: Low

Threat of substitutes is expected to stay low in
case of excipients, as these are mandatory to
make an ideal molecule for the administration with
high acceptability from the consumer side.
34

Chapter 4 Market Categorization: Product Estimates & Trend Analysis
FIG. 16 Global excipients market: Product outlook key takeaways
Key product segments Key segment trends
3,500.0
•Largest Market 3,000.0
•Market growth from $ 1,870 Mn in
Polymers 2016 to $3,062 Mn in 2025 2,500.0
•CAGR 5.6% from 2017 - 2025
2,000.0
1,500.0
•Revenue estimates at $1,242.6 Mn in 1,000.0

2016
Sugars 500.0
•Highest contributor in terms of CAGR
with 6.9% from 2017-2025 0.0
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Polymers Alcohols Sugars Minerals Gelatin

•Market was valued at $ 550.5 Mn in
Alcohols 2016
•CAGR 5.6% from 2017-2025
Number of times used in the Top 200
Excipient
prescription tablets
•Market was valued at $ 175.6 Mn in Polymers 269

2016
Minerals •CAGR 5.0% from 2017-2025 Alcohols 112
Sugars & Others 151
•Market was valued at $ 289.7Mn in Minerals 70

2016
Gelatin •CAGR 6.0% from 2017-2025 Gelatin 81
Source: Industry Journals, Annual Reports, Investor Presentations, Primary Interviews, Modern Medicine Journals, Grand View Research
35

4.1 Global Excipients Market: Product Movement Analysis
There are various types of excipients used in the pharmaceutical formulations such as solid
oral, liquid oral and other formulations administered by different routes. Amongst these,
polymers emerged as market leaders attributed to their wide usage in the formulation of tablets,
capsules and other oral formulations.
Alcohols also found their way as pharmaceutical excipients from a long time for various
enhancements such as sweeteners by sugar alcohols and are used widely in water sensitive
API’s. It had a significant share in the usage of pharmaceutical formulations in 2016.
However, sugars, gelatin are expected to have a stable market over the course of forecast
owing to the uses like capsule shell preparation and taste masking.
The quest for newer excipients has begun in the recent years which can add value to the
formulations for the delivery of oncological drugs and other critical molecules. Initiatives like
development of novel excipients that enhance drug delivery and bioavailability is expected to
drive the market in the forecast period.
36

FIG. 17 Global excipients market: Product movement analysis
High
Sugars: Share growth by 2.28%
272.18
2025 3,062.13 901.73 2,261.55 488.43
Medium
Low
Low
175.61
2016 1,870.24 550.49 1,242.55 289.66
Polymers: Share decline by Alcohols: Share decline by
1.47% 0.43%
Medium
0% 20% 40% 60% 80% 100%
Minerals: Share decline by

Gelatin: Share decline by 0.02%
Polymers Alcohols Sugars Minerals Gelatin 0.36%
High
Source: WHO, U.S. CDC, FDA, NIH Journals, Investor Presentations, Primary Interviews, Grand View Research
37

4.2 Polymers
Polymers have most of the ideal properties so that they can be used as an excipient in solid
pharmaceutical formulations. Polymers offer strength and improved shelf life when compared to
the other types of excipients used in the pharmaceutical preparations.
Over the past decade, pharmaceutical polymers have evolved from being used in the
preparation of simple gelatin shells to strengthen capsule to an excipient that has ideal
formulation features that include controlled/sustained release and also in delivering the drug to
specific target sites of action.
Polymers are used in higher proportions than any other excipients in pharmaceutical
preparations. In 2016, polymers occupied the largest market share in usage of over 45% of
which microcrystalline cellulose has been valued as the most used polymer type.
4.2.1 Global polyme rs ma rket, 2012 – 2025 (USD M illion)
FIG. 18 Global polymers market, 2012 – 2025 (USD Million)
3,500.0
3,000.0
3,062.1
2,899.7
2,500.0 2,745.8
2,600.1
2,462.0
2,335.2
2,000.0
2,208.3
2,088.4
1,976.1
1,870.2
1,770.8
1,500.0
1,677.0
1,588.2
1,505.0
1,000.0
500.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global polymers market was valued at USD 1,870.2 million in 2016 and is expected to grow at a
CAGR of 5.6% during the forecast period, to reach an expected value of USD 3,062.01 million
in 2025.
38

4.2.2 Methyl Crysta lline Cellu lose (MCC)
Microcrystalline Cellulose is a form of cellulosic polymer chain that is partially depolymerized,

purified, with shorter and crystalline chains. MCC is one of the most used fillers or binders for
drug formulations, along with Lactose due to its outstanding binding property allowing the
manufacture of tablets by direct compression method.
MCC can be used in various pharmaceutical processes like wet and dry granulation or direct
compression. MCC owing to its low moisture-content is specially used for the filling of tablets
that contain moisture sensitive API’s. MCC was valued as the most used polymer type in 2016
owing to its outstanding binding property along with low moisture content and its ability to help
disintegrate the formulation when administered. This trend is expected to continue in the
forecast period owing to the ease of usage and the abundance in supply in the preparation of
formulations.
4.2.2.1 Global MCC market, 2012 – 2025 (USD Million)
FIG. 19 Global MCC market, 2012 – 2025 (USD Million)
900.0
800.0
786.2
700.0
747.5
710.8
676.1
600.0
643.3
612.2
582.3
554.9
500.0
528.1
503.0
478.8
456.5
400.0
435.0
414.6
300.0
200.0
100.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global MCC market was valued at USD 503.0 million in 2016 and is expected to grow at a
CAGR of 5.1% during the forecast period, to reach an expected value of USD 786.2 million in
2025.

39
4.2.3 H ydrox y Prop yl M eth yl Cellulose (HPMC)
Hydroxy Propyl Methyl Cellulose(HPMC) is used in solid oral dosage forms for controlled or
sustained release owing to its strong hydrophilic property. HPMC is an odorless and tasteless
polymer that can be used in fibrous or granular forms and is a free-flowing powder. However,
kinetics of the HPMC gel layer formation largely depends on the external factors like molecular
weight of the polymer, temperature, and pH of the solution.
HPMC is expected to grow at steady pace owing to the valuable combination of properties that
HPMC offers which cannot be found in any other water soluble excipients. Superiority to gelatin
as this provides better disintegrating and dissolution rates coupled with its usage in vegetative
formulations and over the counter products, might help boost the market in the forecast years.
4.2.3.1 Global HPMC market, 2012 – 2025 (USD Million)
FIG. 20 Global HPMC market, 2012 – 2025 (USD Million)
400.0
350.0
363.1
347.7
332.8
300.0
318.4
304.5
291.9
278.3
250.0
265.5
253.3
241.4
230.3
200.0
219.8
209.5
200.0
150.0
100.0
50.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global HPMC market was valued at USD 241.4 million in 2016 and is expected to grow at a
2025.

40
4.2.4 Eth yl ce llulose
Ethyl Cellulose is used for hydrophobic film coating on the oral dosage forms. EC has a varied
range of chemical properties when added to various mixtures of biodegradable coatings such as
maltodextrin, dextrins, pregelatinized and hydroxypropylated starch and this could be used to
“tailor-make” based on the requirements of a particular API for the specific subject.
EC is one of the bigger markets in terms of usage mainly due to the wide usage for the varying
applications such as filler, binder, suspending agents for both oral solid and liquid formulations
and this trend is expected to continue in the forecast years with a steady CAGR.
However, other polymers like MCC, HPMC are likely to grab a larger market share and this
might hinder the market in terms of usage.
4.2.4.1 Global ethyl cellulose market, 2012 – 2025 (USD Million)
FIG. 21 Global ethyl cellulose market, 2012 – 2025 (USD Million)
400.0
350.0
340.2
327.8
300.0
315.6
303.7
292.2
281.6
250.0
270.2
259.3
248.9
238.8
229.2
200.0
219.9
211.1
202.6
150.0
100.0
50.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global ethyl cellulose market was valued at USD 238.8 million in 2016 and is expected to grow
at a CAGR of 4.0% during the forecast period, to reach an expected value of USD 340.2 million
in 2025.
4.2.5 Methyl cellu lose
Methylcellulose is generally used as a disintegrant for tablets and capsules and can be used as
tablet binder, and a viscosity-increasing agent. It is being used in the vegetarian formulations as

41
an alternative to gelatin in the development of capsule shells. Properties such as non-allergic,

inexpensive, vegetarian, non-digestible, soluble in cold water, capsule disintegrant, nontoxic
tablet filler make methyl cellulose a go to option in most of the applications. MC market is set to
grow at significant pace in the forecast years owing to the increased adoption for the
preparation of oral suspensions and artificial tears. It is one of widely used pharmaceutical
excipient and is set to replace ethyl cellulose usage.
4.2.5.1 Global methyl cellulose market, 2012 – 2025 (USD Million)
FIG. 22 Global methyl cellulose market, 2012 – 2025 (USD Million)
35.0
30.0
29.8
28.2
25.0
26.7
25.3
23.9
22.6
20.0
21.4
20.2
19.0
18.0
15.0
17.0
16.0
15.2
14.4
10.0
5.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global methyl cellulose market was valued at USD 18.0 million in 2016 and is expected to grow
in 2025.
4.2.6 Carboxy M eth yl Cellulose (CM C)
CMC is used in pharmaceuticals as a, viscosity control, thickening agent and water absorption
or water retention; for example, used as a lubricant in eye drops. In pharmaceutical
preparations, CMC is used in the preparation of oral liquid and solid preparations and also in
topical formulations such as liquid, gel, emulsion. In emulsions, CMC is used as a stabilizer.
Properties such as easy moisture absorption, dissolution in hot water as a colloidal solution and
easy dissolution in cold water make it more preferable than methyl cellulose in the drug delivery
formulations. However, CMC cannot be used for all kinds of API’S and all environments as it

42
cannot dissolve in organic solvents such as ethanol, methanol, acetone, benzene, chloroform
etc and is not compatible with salts of iron and some metals like aluminum, mercury, etc.
4.2.6.1 Global CMC market, 2012 – 2025 (USD Million)
FIG. 23 Global CMC market, 2012 – 2025 (USD Million)
140.0
120.0
123.8
118.9
114.2
109.7
100.0
105.3
101.2
97.0
92.9
89.1
80.0
85.3
81.8
78.4
75.2
72.0
60.0
40.0
20.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global CMC market was valued at USD 85.3 million in 2016 and is expected to grow at a CAGR
of 4.2% during the forecast period, to reach an expected value of USD 123.8 million in 2025.
4.2.7 Croscarmellose sodium
Croscarmellose sodium is one of the commonly used pharmaceutical additives that can be used
in injectable as a suspending agent that promotes solubility of various compounds that have
poor water solubility. It is also added to tablets as a glidant, binder, and an antiadherent.
Croscarmellose Sodium is also known as one of the superdisintegrants that allows the tablet to
disintegrate rapidly without the intervention of water.
This excipient is preferred over other superdisintegrants as many studies confirm that this had
given the fastest disintegration time along with the maximum amount of drug released.
Croscarmellose sodium has occupied a significant share in the market for 2016 owing to the
advantages of wide usage and faster time of action and this trend is expected to continue in the
forecast years owing to the higher adoption rates of fast release and chewable tablets.

43
4.2.7.1 Global croscarmellose sodium market, 2012 – 2025 (USD Million)
FIG. 24 Global croscarmellose sodium market, 2012 – 2025 (USD Million)
120.0
100.0
100.6
95.7
91.1
80.0
86.6
82.4
78.6
74.8
70.6
67.2
60.0
64.0
61.0
58.1
54.9
52.4
40.0
20.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global croscarmellose sodium market was valued at USD 64.0 million in 2016 and is expected
to grow at a CAGR of 5.2% during the forecast period, to reach an expected value of USD 100.6
million in 2025.
4.2.8 Povidone
Povidone formulations are widely used in the pharmaceutical industry due to their ability to
dissolve in both water and oil solvents. Povidone (Polyvinylpyrrolidone, PVP) is used in the
pharmaceutical industry as a synthetic polymer vehicle for dispersing and suspending drugs. It
also acts as a disintegrant and tablet binder. Although povidone is used in a variety of
pharmaceutical formulations, it is primarily used in solid-dosage forms. In tableting, povidone
solutions are used as binders in wet-granulation processes. PVP exhibited superior bonding
properties as compared to other binders incorporated into sodium diclofenac tablets prepared
using wet granulation method. Although, Povidone market is set to grow at a significant rate
owing to superior binding and suspending properties, the market size of povidone in 2016 is
minimal when compared to other binding agents.

44
4.2.8.1 Global povidone market, 2012 – 2025 (USD Million)
FIG. 25 Global povidone market, 2012 – 2025 (USD Million)
25.0
23.2
21.7
20.0
20.2
18.9
17.6
15.0
16.4
15.4
14.2
13.4
12.3
11.6
10.0
10.7
10.0
9.4
5.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global povidone market was valued at USD 12.3 million in 2016 and is expected to grow at a
2025.
4.2.9 Pregelatinized starc h
Pregelatinized Starch is used for various applications such as excipient, diluent, disintegrant, a
glidant, and as a binder in the pharmaceutical industry. Advantages associated with the use of
pregelatinized starch is include lowest porosity, largest density, particle size, and best flow when
compared to other pharmaceutical grade starches available. On adding this starch to the tablet,
tablet showed very high resistance to crushing when applied different compression forces while
offering a very fast disintegration time in water. It is expected to witness fastest growth amongst
the polymers.
Most common form of modified starch is the pre-gelatinized starch with the market name as
“starch 1500.” It is the most preferred compressible excipient in pharmaceutical industry. This
has been rated as the one of the top ten used excipients in the pharmaceutical industry by the
International Joint Conference.

45
4.2.9.1 Global pregelatinized starch market, 2012 – 2025 (USD Million)
FIG. 26 Global pregelatinized starch market, 2012 – 2025 (USD Million)
700.0
660.0
600.0
616.5
575.8
500.0
537.7
502.0
469.7
400.0
437.4
407.6
379.7
354.0
300.0
330.1
307.6
286.9
267.6
200.0
100.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global pregelatinized starch market was valued at USD 354.0 million in 2016 and is expected to
grow at a CAGR of 7.2% during the forecast period, to reach an expected value of USD 660.0
million in 2025.
4.2.10 Sodium starch glyco late
Sodium starch glycolate is generally used as a pharmaceutical dissolution and disintegration

excipient for capsules and tablets. It is mostly used to prepare tablets by wet-granulation or
direct-compression processes. Sodium starch glycolate helps disintegration by absorbing water
rapidly, which results in swelling of the excipient that aids the rapid disintegration of granules
and tablets. It also doubles as a suspending agent and a gelling agent as well. This helps in
effective distribution of active ingredient by developing strong disintegrating force by taking up
more water than many other products in the market.

46
4.2.10.1 Global sodium starch glycolate market, 2012 – 2025 (USD

Million)
FIG. 27 Global sodium starch glycolate market, 2012 – 2025 (USD Million)
500.0
450.0
472.8
442.5
400.0
414.0
387.3
350.0
362.2
339.6
300.0
316.8
295.4
250.0
275.8
257.3
240.4
200.0
224.6
209.7
195.9
150.0
100.0
50.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global sodium starch glycolate market was valued at USD 257.3 million in 2016 and is expected
to grow at a CAGR of 7.0% during the forecast period, to reach an expected value of USD 472.8
million in 2025.
4.2.11 Polye th ylene g lycol
Polyethylene glycol, referred to as PEG, is used as an inactive ingredient in many

pharmaceutical applications such as plasticizer, solvent, surfactant, suppository base,
ointments, and lubricant. It is also said that PEG’s have a very low toxicity as the systemic
absorption is less than 0.5%. All these applications and advantages attribute to the high usage
of PEG is various pharmaceutical formulations.
In 2016, PEG grabbed a major share in the excipient market and is expected to grow at a
significant rate though out the forecast period owing to the flexibility in its applications. However,
polyethylene glycols market growth might get hampered due to many disadvantages such as
faster reactivity to chemicals than fats, higher the molecular weight which reduces the release of
water-soluble medications. Furthermore, PEG is said to be more irritating to mucous
membranes when compared to fats.

47
4.2.11.1 Global polyethylene glycol market, 2012 – 2025 (USD Million)
FIG. 28 Global polyethylene glycol market, 2012 – 2025 (USD Million)
90.0
80.0
82.0
77.1
70.0
72.5
68.2
60.0
64.1
60.4
56.8
50.0
53.2
50.1
47.1
40.0
44.3
41.6
39.2
36.9
30.0
20.0
10.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global polyethylene glycol market was valued at USD 47.1 million in 2016 and is expected to
million in 2025.
4.2.12 Ac rylic polyme rs
Acrylic polymers are used in the film coating of solid dosage formulations and can also be used
for the transdermal delivery systems as a drug–polymer matrix films along with plasticizers.
Acrylics are used widely in the market as a binder for tablet coatings owing to its outstanding
properties like the transparency, color stability, as well as added resistance to wearing and
aging. Acrylic polymers mostly comprise of acrylic esters and methacrylic acid which are
polymerized with the aid of a free radical technique.
However, due to the toxic nature and environmental hazards, these are being replaced by
water-based coatings for the solid drug formulations. In 2016, acrylic polymers occupied a major
share in the excipients market owing to the benefits acrylics offer such as increased strength
and stability along with the privilege of extended shelf life for the solid coated formulations.

48
4.2.12.1 Global acrylic polymers market, 2012 – 2025 (USD Million)
FIG. 29 Global acrylic polymers market, 2012 – 2025 (USD Million)
90.0
80.0
80.4
76.0
70.0
71.9
68.1
60.0
64.4
61.0
57.8
50.0
54.5
51.6
48.9
46.3
40.0
43.7
41.5
39.3
30.0
20.0
10.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global acrylic polymers market was valued at USD 48.9 million in 2016 and is expected to grow
in 2025.
4.3 Alcohol
Alcohols are used widely in pharmaceuticals as an active ingredient for the preparation of oral,
parenteral, and topical along with inhalation medicaments. Although primary use of alcohols is
to increase the solubility of many water insoluble drugs. Added to those alcohols possess many
pharmacological uses such as carminative, sedative, cooling, rubefacient, antiseptic, and
cleansing properties.
Alcohols are used for the preparations that involve water sensitive API’s. Ethanol has varying
pharmaceutical uses such as it acts as a universal solvent for both lipophilic and hydrophilic
substances. Many a times they can be used as a replacement for stabilizers and preservatives.
In 2016, alcohol usage as excipients remained significant owing to the multiple uses, inertness
in most of the conditions.

49
4.3.1 Global a lcohol ma rk et, 2012 – 2025 (USD M illion )
FIG. 30 Global alcohol market, 2012 – 2025 (USD Million)
1,000.0
900.0
901.7
800.0
854.2
809.1
766.3
700.0
725.6
687.9
600.0
650.5
615.3
581.9
500.0
550.5
520.8
492.8
466.3
400.0
441.3
300.0
200.0
100.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global alcohol market was valued at USD 550.5 million in 2016 and is expected to grow at a
2025.
4.3.2 Glycerin
Glycerin, also known as glycerine or glycerol is one of the excipient that is used extensively in
pharmaceutical preparations, as a humectant, taste masking agent in lozenges and syrups for
its sweet taste, as an excipient in eye wash solutions owing to its low volatility, and as an
expectorant for congestion.
In 2016, glycerin had occupied a substantial share owing to its varied range of applications such
as osmotic diuretic, hyperosmotic, and ophthalmic agent. It is also used as excipients in topical
solutions and medical creams for its moisturizing properties. Added to the above features the
overall toxicity of glycerin used is very low when compared to other products used in
pharmaceutical formulations.

50
4.3.2.1 Global glycerin market, 2012 – 2025 (USD Million)
FIG. 31 Global glycerine market, 2012 – 2025 (USD Million)
90.0
80.0
84.9
79.5
70.0
74.5
69.7
60.0
65.2
61.1
57.1
50.0
53.4
49.9
46.7
40.0
43.6
40.8
38.1
35.6
30.0
20.0
10.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global glycerin market was valued at USD 46.7 million in 2016 and is expected to grow at a
2025.
4.3.3 Prop ylene glyco l
Propylene glycol is one of the commonly used alcoholic excipient that acts as a solubilizer in
oral, topical, and injectable formulations. It is also used as a water-soluble co-solvent and in
vitamin medications. Propylene glycol is being used largely in pharmaceutical preparations from
over 50 years owing to its low toxicity and wide variety of applications.
However, recent studies have opined that high concentrations of propylene glycol in many of the
pharmaceutical preparations is being harmful especially for the pediatric population. This might
hamper the extensive growth of propylene glycol. Increasing production of propylene glycol
might act as a driver for the growth of the market in Asia-Pacific region driving market in the
forecast period.

51
4.3.3.1 Global propylene glycol market, 2012 – 2025 (USD Million)
FIG. 32 Global propylene glycol market, 2012 – 2025 (USD Million)
300.0
250.0
258.7
243.6
229.4
200.0
215.9
203.3
191.6
180.1
169.4
150.0
159.4
149.9
141.1
132.7
124.9
100.0
117.5
50.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global propylene glycol market was valued at USD 149.9 million in 2016 and is expected to
million in 2025.
4.3.4 Sorbitol
Sorbitol is a sugar alcohol used in the pharmaceutical industry as a sweetener in syrups and in
some chewable solid dosage formulations for taste masking or as humectant in topical
preparations. It is synthetically manufactured by hydrogenating glucose and can be made
available in crystalline and liquid form.
Sorbitol is used extensively in many of the forms owing to its inertness and excellent taste
masking attribute without increasing the sugar content in the particular medicament. For
instance, sorbitol when compared to glucose is only two-thirds sweet. These benefits of sorbitol
pushes its usage in pharmaceutical preparations. The small quantities used in pharmaceutical
manufacturing is generally considered safe however, excessive usage of sorbitol can have
laxative effects.

52
4.3.4.1 Global sorbitol market, 2012 – 2025 (USD Million)
FIG. 33 Global sorbitol market, 2012 – 2025 (USD Million)
180.0
160.0
158.3
152.5
140.0
147.0
141.6
136.4
131.4
120.0
126.5
121.7
117.2
112.8
100.0
108.5
104.5
100.5
96.8
80.0
60.0
40.0
20.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global sorbitol market was valued at USD 112.8 million in 2016 and is expected to grow at a
2025.
4.3.5 Mannitol
Mannitol is an isomer of sorbitol which appears to be white in color, odorless, and sweet tasting
powder that can be applied for pharmaceutical preparations as sweetening agent, excipient in
the preparation of chewable tablets, diluent, a tonicity agent, and as a bulking agent for
lyophilized preparations.
It is superior in many ways for pharmaceutical usage owing to its qualities of being non-
hygroscopic and can be used for moisture sensitive API”S formulation. Moreover, its fast drying
capacity aids in the spray dried direct compression of tablets, it is also used in liquid dosage
forms as it helps in rapid dispersing of medicament.
Other advantages of mannitol include its non-cariogenic nature, low calorie content, and taste
masking ability. These all advantages make mannitol an ideal excipient with wide range of
applications over the forecast period.

53
4.3.5.1 Global mannitol market, 2012 – 2025 (USD Million)
FIG. 34 Global mannitol market, 2012 – 2025 (USD Million)
350.0
300.0
315.1
299.1
283.8
250.0
269.3
255.3
242.6
229.5
200.0
217.0
205.2
194.1
183.6
173.7
150.0
164.3
155.4
100.0
50.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global mannitol market was valued at USD 194.1 million in 2016 and is expected to grow at a
2025.
4.3.6 Others
There are many types of alcohols that can be used in pharmaceutical preparations, some of the
examples of alcohols used are isopropranol, benzyl alcohol, lactitol, methanol, butyl alcohol,
and various glycols can be used as active and inactive ingredients in solid and liquid dosage
preparations.
Benzyl alcohol is mostly used as a preservative and a solubilizer in many injectable solutions
and drugs. However, high quantities of benzyl alcohol might affect the efficacy of the product by
increasing the rate of adverse reactions after the administration. Other commonly used alcoholic
excipient is Lactitol which is generally used as a sweetening agent owing to its low sugar
content.

54
Usage of other types of alcohols for pharmaceutical preparations is on rise owing to the
availability of technological modifications that can eliminate adverse reactions and reactivity of
existing excipients.
4.3.6.1 Global other alcohol market, 2012 – 2025 (USD Million)
FIG. 35 Global other alcohol market, 2012 – 2025 (USD Million)
90.0
80.0
84.8
79.5
70.0
74.5
69.8
65.4
60.0
61.3
57.4
50.0
53.7
50.3
47.1
40.0
44.0
41.2
38.5
36.1
30.0
20.0
10.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global other alcohol market was valued at USD 47.1 million in 2016 and is expected to grow at
a CAGR of 6.8% during the forecast period, to reach an expected value of USD 84.8 million in
2025.
4.4 Minerals
Minerals are an important class of excipients owing to the properties such as reactivity to acids,
swelling capacity, specific surface area, and high absorption capacity. They also possess other
properties like thixotropic nature, unctuosity, hygroscopicity, color, opacity, slightly alkaline
reaction (pH), plasticity, water solubility and dispersivity. Owing to these properties of minerals
they find important applications as excipients and supplements but they are used in small
quantities which are attributive to their smallest contribution to the market. Huge number of
formulations are available for generic market due to patent expiry thereby, anticipating an
increase in demand for minerals. The minerals used as excipients are calcium phosphate,
calcium carbonate, clay, silicon dioxide, titanium dioxide and others.

55
4.4.1 Global minera ls ma rket, 2012 – 2025 (USD M illion)
FIG. 36 Global minerals market, 2012 – 2025 (USD Million)
300.0
272.2
250.0
259.2
246.8
235.1
223.9
200.0
213.4
203.2
193.5
184.3
175.6
150.0 167.3
159.5
152.0
144.9
100.0
50.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global minerals market was valued at USD 175.6 million in 2016 and is expected to grow at a
2025.
4.4.2 Calcium phosphate
Anhydrous dibasic calcium phosphate is non-hygroscopic, stable at room temperature and does
not hydrate to form dehydrate as a result of which calcium phosphate is estimated to have the
significant contribution in revenue generation in minerals segment. Calcium phosphate finds a
wide range of adoption as an excipient in direct compression, wet granulation and tableting,
anti-caking agent and as a source of calcium mineral in nutritional supplements.
Moreover, the final formulations with calcium phosphate exhibit high friability and low breaking
force though it has high porosity, good flow characteristics and hydrophilic behavior that allows
it to disintegrate fast. With a high number of formulations in the pipeline and facing clinical trials
and the aforementioned properties of calcium phosphate, the market for calcium phosphate is
expected to witness the lucrative growth through to the forecast period.

56
Its simplicity of preparation and non-toxic nature is expected to maintain its dominance in in vitro
transfection. This along with the lower rate of intestinal absorption compared to sodium salts is
expected to grow demand for calcium phosphate through to the forecast period.
4.4.2.1 Global calcium phosphate market, 2012 – 2025 (USD Million)
FIG. 37 Global calcium phosphate market, 2012 – 2025 (USD Million)
180.0
160.0
161.4
153.2
140.0
145.3
137.9
130.8
120.0
124.2
117.8
111.7
100.0
106.0
100.5
95.4
80.0
90.6
85.9
81.6
60.0
40.0
20.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global calcium phosphate market was valued at USD 100.5 million in 2016 and is expected to
million in 2025.
4.4.3 Calcium ca rbonate
Calcium carbonate is estimated to be the second highest contributor to minerals revenue

generation. Pharmaceutical manufacturers use Functionalized Calcium Carbonate (FCC) to
produce Orally Disintegrating Tablets (ODTs) with higher mechanical strength and disintegration
twice as fast as the comparable tablet.
High purity calcium carbonate undergoes recrystallization process for creation of a structured
mineral (FCC) that provides porosity of about 60%, the specific surface area between a range of
30 to 180 sq.m /g and median particle distribution of 2-30 µm. Moreover, it also provides the
advantage of being highly biocompatible. The basic composition of FCC is calcium carbonate

57
and hydroxyapatite. Higher efficacy and availability of calcium carbonate in specific desired
forms is expected to boost the market growth
4.4.3.1 Global calcium carbonate market, 2012 – 2025 (USD Million)
FIG. 38 Global calcium carbonate market, 2012 – 2025 (USD Million)
40.0
35.0
36.0
34.7
33.4
30.0
32.1
30.9
29.8
28.7
27.6
25.0
26.6
25.6
24.7
23.7
22.9
20.0
22.0
15.0
10.0
5.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global calcium carbonate market was valued at USD 25.6 million in 2016 and is expected to
million in 2025.
4.4.4 Cla y
Pharmaceutical formulations use clay minerals to enhance their organoleptic characteristics.

These characteristics include addition of colour (pigments) and flavour and improvement of
physicochemical properties. It aids in increasing the viscosity of ingredients by acting as
thickening, emulsifying, and anticaking agent. In addition to this, it facilitates in formulation by
acting as diluents, isotonic agents, binder and lubricants.
Pharmaceutical formulations and cosmetics use clays like smectites, palygorskite, talc and
kaolinite as excipients. The anticipated rise in demand for novel formulations of drugs coupled
with the increase in demand for cosmetics is expected to drive the demand for clays.

58
Furthermore, bentonite nanotubes can be applicable for introduction of non-injectable drug

formulations like cosmetics, oral and topical dosage forms to enhance therapeutic effects as a
composite material. These applications include dentist resins, bone cement and tissue scaffolds
with sustained release of antimicrobial and cell growth-promoting medicines, that include DNA
and protein, and other compound formulations for antiseptic treatment. This, in addition to the
properties of clays to act as viscosity-increasing agent, suspending agent, stabilizing agent, and
adsorbent is expected to drive growth of segment.
4.4.4.1 Global clay market, 2012 – 2025 (USD Million)
FIG. 39 Global clay market, 2012 – 2025 (USD Million)
6.0
5.0
5.0
4.9
4.7
4.6
4.5
4.0
4.3
4.2
4.1
3.9
3.8
3.7
3.6
3.5
3.4
3.0
2.0
1.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global clay market was valued at USD 3.8 million in 2016 and is expected to grow at a CAGR of
3.2% during the forecast period, to reach an expected value of USD 5.0 million in 2025.
4.4.5 Silicon diox ide
Amorphous silicon dioxide is widely used in powder formulations as a glidant. It is also used as
companion excipient with starch and chitin. It finds major demand in pharmaceutical
formulations followed by cosmetics and food products.
Pharmaceutical applications mainly include oral-dose products as it is essentially a non-irritant

and non-toxic excipient. Silicon dioxide absorbs water readily from its surrounding without itself
liquefying, allowing its application in solid dosage forms as anti-static agent and glidant to

59
provide better flow properties of granulations in high-speed capsule and tableting machines.
Such properties are anticipated to increase its adoption resulting to market growth.
Silicon dioxide exhibits functional properties such as viscosity increasing agent, a thermal
stabilizer, glidant, suspending agent, anti-caking agent, adsorbent, emulsion stabilizer, and
tablet disintegrant. Owing to the aforementioned properties. It is useful in capsule filling,
tableting, and inhalation formulations. Also, colloidal silicon dioxide is used as an excipient in
suppository formulations, preparation of wax microspheres, topical preparations, and nano-
capsules.
4.4.5.1 Global silicon dioxide market, 2012 – 2025 (USD Million)
FIG. 40 Global silicon dioxide market, 2012 – 2025 (USD Million)
20.0
18.0
18.8
18.0
17.3
16.0
16.5
14.0 15.8
15.2
14.5
13.9
13.3
12.0
12.7
12.2
11.7
11.2
10.0
10.7
8.0
6.0
4.0
2.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global silicon dioxide market was valued at USD 12.7 million in 2016 and is expected to grow at
2025.
4.4.6 Titanium diox ide
Titanium dioxide is estimated to be the second highest contributor for the revenue generated by
minerals. It is used as a pigment to provide opacity and whiteness to tablets, pills and topical
pharmaceutical formulations. Titanium oxide has light scattering properties, owing to its high
refractive index. The range of this light scattering can be altered by varying the particle size of

60
titanium dioxide powder. For example, titanium dioxide with an average particle size of 230 nm
scatters visible light, while titanium dioxide with an average particle size of 60 nm scatters
ultraviolet light and reflects visible light. Thus, the adoption of titanium dioxide in film coating
suspensions, gelatin capsules and sugar coated tablets with formulations that are light sensitive
is expected to grow over the coming years.
In addition to this, it has excellent ultraviolet resistant qualities and also acts as UV absorbent.
This leads to its higher use in dermatological preparations and cosmetics, such as sunscreen
products. Rising awareness and demand for skincare products is expected to drive segment
growth significantly. Use of titanium dioxide in pharmaceutical industry is significant to block
UVA and UVB rays and as pigment in various formulations.
4.4.6.1 Global titanium dioxide market, 2012 – 2025 (USD Million)
FIG. 41 Global titanium dioxide market, 2012 – 2025 (USD Million)
50.0
45.0
43.4
40.0
41.2
39.1
35.0
37.1
35.2
33.4
30.0
31.7
30.1
28.5
25.0
27.1
25.7
24.4
23.1
20.0
22.0
15.0
10.0
5.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global titanium dioxide market was valued at USD 27.1 million in 2016 and is expected to grow
in 2025.

61
4.4.7 Others
Other minerals that are used as excipients include magnesium oxide, magnesium carbonate,
potassium citrate, sodium benzoate, magnesium trisilicate and others. These minerals provide
similar properties of lubrication, glidants, anti-caking, carrier for tablet and capsules, and
antimicrobial preservative.
The market is small due to its limited demand as other cheap alternatives exist.
Owing to demand in specific applications where substitutes cannot be used along with presence
of allergies or non-acceptance of certain minerals the demand for these other minerals is
expected to witness slight growth over the forecast period.
4.4.7.1 Global other minerals market, 2012 – 2025 (USD Million)
FIG. 42 Global other minerals market, 2012 – 2025 (USD Million)
8.0
7.0
7.4
7.2
7.0
6.9
6.7
6.5
6.0
6.3
6.2
6.0
5.8
5.7
5.5
5.0
5.4
5.2
4.0
3.0
2.0
1.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global other minerals market was valued at USD 5.8 million in 2016 and is expected to grow at
2025.

62
4.5 Sugar
Sugar is currently second highest in terms of revenue share after polymers. Also, it is the third
largest contributor to excipients market in terms of volumes. The higher contribution of sugar is
attributive to its properties such as spherical shape and porous nature that provides flow ability,
low friability thereby, making sugar as the choice of excipient for a wide range of
pharmaceuticals. Sugar is also applicable as a drug delivery agent in the pulmonary route
based formulations is anticipated to fuel growth. Moreover, rise in adoption of co-processed
excipients for better solubility, dissolution, and bioavailability of novel APIs is anticipated to
bolster demand of excipients.
4.5.1 Global sugar marke t, 2012 – 2025 (USD M illion)
FIG. 43 Global sugar market, 2012 – 2025 (USD Million)
2,500.0
2,261.5
2,000.0
2,115.5
1,979.1
1,851.7
1,732.6
1,500.0
1,623.3
1,517.6
1,419.3
1,327.8
1,242.6
1,163.2
1,000.0
1,089.3
1,020.4
956.2
500.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global sugar market was valued at USD 1,242.6 million in 2016 and is expected to grow at a
CAGR of 6.9% during the forecast period, to reach an expected value of USD 2,261.5 million in
2025.

63
4.5.2 Lactose
Lactose is estimated to have the highest share in revenue generation in sugar. This is attributive
to its selection as excipient majorly owing to its general properties such as compatibility with
active ingredients and other excipients, availability, cost effectiveness, water solubility, low
hygroscopicity, and bland taste.
Lactose is available for use as excipient in various forms such as lactose monohydrate,
anhydrous lactose, and as co-processed excipient. Spray dried lactose, anhydrous lactose,
agglomerate, blended and co-processed lactose prove to have key properties like compaction
ability under compression. Aforementioned features are expected to drive demand for lactose
excipients.
4.5.2.1 Global lactose market, 2012 – 2025 (USD Million)
FIG. 44 Global lactose market, 2012 – 2025 (USD Million)
2,500.0
2,000.0
1,941.1
1,810.7
1,500.0 1,689.1
1,575.6
1,469.8
1,373.1
1,279.4
1,192.5
1,000.0
1,111.7
1,036.7
966.9
902.2
842.0
786.1
500.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global lactose market was valued at USD 1,036.7 million in 2016 and is expected to grow at a
CAGR of 7.2% during the forecast period, to reach an expected value of USD 1,941.1 million in
2025.

64
4.5.3 Sucrose
Sucrose is majorly used to mask unpleasant taste or smell. Syrups constitute of sucrose as a
major component as it provides dental care, assists weight loss, and is available at lower cost. It
plays a dual role as it prevents oxidation and acts as binder for iron tablets containing ferrous
sulphate. Sucrose is chosen in tablets which require slow release as it provides long
disintegration time. This is expected to boost its demand for the sustained release formulations.
In December 2016, team from Coriolis Pharma and Leiden University Academic Centre for Drug
Research (LACDR) found the use of sugar as a stabilizer in different formulations. It prevents
the development of nanoparticle impurities in the formulations. These impurities are one of the
major reason for failure in approval of formulation though having a promising API. Improving the
safety levels of formulations by using appropriate sugar based excipients provides a drug with a
second chance for approval. This is anticipated propel the demand for sugar and other
sweeteners including sucrose.
4.5.3.1 Global sucrose market, 2012 – 2025 (USD Million)
FIG. 45 Global sucrose market, 2012 – 2025 (USD Million)
160.0
150.2
140.0
141.5
120.0 133.3
125.6
118.4
111.7
100.0
105.1
99.0
93.2
80.0
87.9
82.9
78.1
73.6
60.0
69.4
40.0
20.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global sucrose market was valued at USD 87.9 million in 2016 and is expected to grow at a
2025.

65
4.5.4 Others
The other sweetners used as excipients inclued sacharin sodium, aspartame, sodium cyclamate
and sorbitol. With a wide population base suffering from lactose intolerance and rise in diabetic
patient base the use of other sweetners is anticipated to witness growth. The use of other
sweetners is limited due to its possible side-effects for example the above metnioned artificial
surrogates may induce hypersensitive reactions which cause angioedema, pruritus and urticaria
thereby impeding YoY growth of the segment.
4.5.4.1 Global other excipients market, 2012 – 2025 (USD Million)
FIG. 46 Global other excipients market, 2012 – 2025 (USD Million)
180.0
160.0
170.2
163.3
156.7
140.0
150.4
144.4
138.6
133.1
120.0
127.8
122.8
118.0
113.4
100.0
109.0
104.8
100.7
80.0
60.0
40.0
20.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global other excipients market was valued at USD 118.0 million in 2016 and is expected to
million in 2025.
4.6 Gelatin
Gelatin is estimated to hold the lowest share in revenue generation currently. Soft gel capsules
allow release of content in a range of about 5 to 15 minutes. About 90% of the pharmaceutical
gelatin is for capsule production. Capsules are a more preferred form of dosage for various
reasons like ease to swallow, higher compatibility with most ingredients, non-allergic and easy
to digest protein composition. Moreover, it offers protection to sensitive ingredients from air,
light, oxygen and microbial contamination. Applicability in delivering powder, liquid, oil-based

66
pastes i.e. solids, semi-solids and liquid forms of formulations is expected to drive segment
growth followed by sugars.
The use of gelatin was restricted with extreme storage conditions such as high temperature and
or humidity and reactivity with certain fillings. Recent developments in technology like reducing
the crosslinking of gelatin and other provides solutions for the limited use. In addition, increased
concern for dosage control, convenience, and consumer acceptance for gelatins is anticipated
to witness a rise in demand through to the forecast period.
4.6.1 Global gela tin mark et, 2012 – 2025 (USD M illion )
FIG. 47 Global gelatin market, 2012 – 2025 (USD Million)
600.0
500.0
488.4
461.0
400.0
435.1
410.7
387.6
366.3
345.3
300.0
325.6
307.1
289.7
273.3
257.9
243.4
200.0
229.8
100.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Global gelatin market was valued at USD 298.7 million in 2016 and is expected to grow at a
2025.

67
Chapter 5 Market Categorization: Regional Estimates & Trend Analysis, by

Product
FIG. 48 Regional market place: Key takeaway
Europe
Revenue in 2016: $1,336.4 Mn
Revenue in 2025: $2,179.2 Mn
CAGR (2017-2025): 5.6%
Notable markets: Germany, UK
Asia Pacific
Revenue in 2016: $1,169.2
Mn
North America Revenue in 2025: $2,082.5
Mn
Revenue in 2016 : $1,270.8 Mn CAGR (2017-2025): 6.6%
Revenue in 2025 : $2,115.9 Mn Notable markets: China,
CAGR (2017-2025): 5.8% Japan
Notable markets : U.S., Canada
Latin America MEA

Revenue in 2016: $227.1 Mn Revenue in 2016: $125.1 Mn
Revenue in 2025: $385.4 Mn Revenue in 2025: $223.1 Mn
CAGR (2017-2025): 6.1% CAGR (2017-2025): 6.6%
Notable markets: Brazil Notable markets: South Africa
68

5.1 Global Excipients Market: Region Movement Analysis

Owing to the fact that excipients are useful for achieving better functionality and competitive
advantage of the active pharmaceutical ingredients, these products are gaining substantial
importance. The revolution from viewing excipients as inert agents to treating them as functional
active components has infused vigorous energy into this industry.
Pharma companies in the developed markets of North America and Europe prefer high-quality
excipients, however the emerging markets such as China and India in the Asia-Pacific region
tend to use cheaper alternatives that may not have been as rigorously tested as their Western
counterparts.
Europe was observed to be the dominant region for excipient industry accounting for 32.4% of
global revenue in 2016 as a consequence of presence of a large number of pharmaceutical
manufacturers, high demand for medicine products due to rising geriatric population base in
western European countries. However, saturation in these regions is expected to result in
decline of industry growth.
Asia Pacific market for excipients is expected to grow at lucrative rate with the highest CAGR of
approximately 6.6% from 2017 to 2025 and its revenue is estimated to reach over USD 2,082.5
million in 2025. Presence of low cost manufacturing options and high unmet medical needs in
countries of this region are factors that are anticipated to attribute towards growth of this
industry in the given region through to 2025.
69

FIG. 49 Excipients regional outlook, 2016 & 2025
High
AsiaPacific: Share growth by
1.49%
Latin America: Share growth by
385.4
223.1
2025 2,115.9 2,179.2 2,082.5 MEA: Share Growth by 0.16%
Medium 0.02%
Low
Low
227.1
125.1
2016 1,270.8 1,336.4 1,169.2 North America: Share decline by
Europe: Share decline by 1.18%
0.49%
Medium
0% 20% 40% 60% 80% 100%
North America Europe Asia Pacific Latin America MEA
High
70

5.2 North America
Presence of organizations such as International Pharmaceutical Excipients Council of the

Americas in Virginia and Pharmaceutical Research and Manufacturers of America in
Washington are attributive for the larger revenue share of the region. These organizations and
associations are engaged in the formulation of regulatory frameworks pertaining to manufacture
of these products.
Moreover, ExcipientFest carried out in America has been the leading educational conference
and expo that is devoted to scientific, regulatory and sourcing developments in pharmaceutical
excipients for over 16 years. Such initiatives taken up by the government is expected to drive
growth in the excipients market in the coming years.
In addition to this, International Pharmaceutical Excipients Council of the Americas (IPEC),

which operates by uniting the excipients makers and users network is expected to drive
industrial growth of this region over the forecast period. Scientists at the American Association
of Pharmaceutical Scientists are also engaged in the development of novel techniques for the
manufacture of excipients.
5.2.1 North Ame rica exc ipients marke t, 2012 – 2025 (USD M illion)
FIG. 50 North America excipients market, 2012 – 2025 (USD Million)
2,500.0
2,000.0
2,115.9
1,999.4
1,889.5
1,785.6
1,687.6
1,500.0
1,597.1
1,508.0
1,423.7
1,345.1
1,270.8
1,201.3
1,000.0
1,135.7
1,074.1
1,016.0
500.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
71

North America excipients market was valued at USD 1,270.8 million in 2016 and is expected to
grow at a CAGR of 5.8% during the forecast period, to reach an expected value of USD 2,115.9
million in 2025.
5.2.2 U.S.
The United States is in an established position with respect to revenue share in excipients
market. Factors attributing for the larger share of the country include presence of significant
market entities operating herein. The countries include Avantor Performance Materials Inc.,
P&G, Huntsman Corporation, Ashland Inc., FMC Corporation, and Colorcon Inc.
Significant share of the U.S market of excipients in global market of excipients is mainly
attributed to the presence of the US Food and Drug Administration Safety and Innovation Act
(FDASIA). FDASIA was introduced to prevent drug adulterations by conducting physical audits
of all excipient developers.
These acts ensure the compliant manufacturing of excipients thus propelling revenue share of
the country. Moreover, in 2015, NSF/IPEC/ ANSI 363-2014 was launched as the first American
national standard for GMP of pharmaceutical excipients –which ensures safe use of excipients
for medicine development in order to improve patient’s outcome in the country.
Excipient market of the U.S is also expected to witness growth due to ongoing case studies and
research activities in the country on drug-excipient interactions. For instance, in 2016, a
research project was conducted to provide a comprehensive analysis of excipients impact on
the drug stability and their role during the drug development. This research was affiliated with
the New Jersey-based Novel Laboratories Inc.

72
5.2.2.1 U.S. excipients market, 2012 – 2025 (USD Million)
FIG. 51 U.S. excipients market, 2012 – 2025 (USD Million)
2,000.0
1,800.0
1,816.8
1,600.0
1,717.2
1,623.2
1,400.0
1,534.3
1,450.3
1,372.9
1,200.0
1,296.6
1,224.4
1,157.1
1,000.0
1,093.4
1,033.9
977.6
800.0
924.8
874.9
600.0
400.0
200.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
The U.S. excipients market was valued at USD 1,093.4 million in 2016 and is expected to grow
at a CAGR of 5.8% during the forecast period, to reach an expected value of USD 1,816.8
million in 2025.
5.2.3 Canada
Canada excipients market is driven as a consequence of incorporation of novel features in

already existing excipients in order to improve efficacy as well as potential utility in drug
development. For instance, in 2014, co-processed excipients were developed using acacia and
calcium carbonate for designing and evaluation of atorvastatin calcium tablets. The paper
elaborating this development is published in PubMed Canada. Moreover, companies, such as
Chemroy, which is involved in providing Canadian pharmaceutical industry with GMP compliant
excipients is expected to boost revenue generation in Canadian market of excipients.

73
5.2.3.1 Canada excipients market, 2012 – 2025 (USD Million)
FIG. 52 Canada excipients market, 2012 – 2025 (USD Million)
350.0
300.0
299.2
282.3
250.0
266.4
251.4
237.3
200.0
224.2
211.4
199.3
188.0
177.4
150.0 167.5
158.1
149.3
141.0
100.0
50.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Canada excipients market was valued at USD 177.4 million in 2016 and is expected to grow at
a CAGR of 5.98% during the forecast period, to reach an expected value of USD 299.2 million
in 2025.
5.3 Europe
Europe accounted for the largest market share with respect to both revenue generation and
volume. The major factor driving growth in this region is presence of European Medicines
Agency’s scientific guidelines on excipients which facilitates pharmaceutical entities to prepare
marketing authorization applications for human medicines.
The regulatory agencies are involved in enacting new regulations such as EU Falsified
Medicines Directive (FMD or Directive 2011/62/EU) for prevention of drug adulteration in
excipients as well as API. As per these laws, medicine developers are expected to perform
physical audits at the site of excipient developer and distributors in order to ensure a secure
supply chain.
Moreover, in 2015, the European Union Commission issued final guidelines on GMP for
excipients of pharmaceutical candidate for human use to ensure proper and safe use of
excipients. These factors are expected to significantly accelerate the growth of excipients
market in this region. The European Pediatric Formulation Initiative (EuPFI) is involved in raising

74
awareness about pediatric formulation challenges which covers pharmaceutical excipients along
with other aspects of pharmaceutical development.
Recently, EuPFI conducted its 8th conference in Lisbon, Portugal that discussed
issues/challenges with respect to development of age appropriate dosage forms as well as use
and development of pharmaceutical excipients. Such conferences are expected to significantly
impact the growth of the future excipients market of Europe.
In addition, companies are involved in obtaining EXCiPACT certifications as an approved

supplier for pharmaceutical excipients in this region. For instance, in August 2014, Croda
International Plc received EXCiPACT certifications for its Spain based excipients manufacturing
site.
Germany market of excipients is expected to register significant YoY growth over the forecast
period due to the presence of stringent guidelines for maintaining the GMP standards of
excipients used in the medicine development. Seminars conducted in the country on the
particularities of pharmaceutical excipients development and marketing and offer an overview of
appropriate GMP and GDP guidelines for excipients usage is expected to drive the growth of
market in the country over the forecast period. In May 2015, W. R. Grace & Co’s Germany-
based manufacturing facility received GMP certifications from EXCiPACT for its SYLOID FP
silica gel. Such certifications allow Germany-based excipients manufacturers to minimize overall
supply chain costs by ensuring product safety and quality verification, thereby influencing overall
market of excipients in the country.
Furthermore, Germany-based companies are engaged in expansion of their excipients portfolio

through strategic partnerships with other firms, which in turn, is expected to aid in revenue
generation in German excipients market. For instance, in July 2016, Merck underwent
partnership with PCAS S.A, a France-based company, for expansion of its excipients product
portfolio by addition of PCAS S. A’s expansorb line of biocompatible and biodegradable
polymers to its product portfolio. In addition, continuous introduction of new excipients in the
market by companies, such as Merck, is expected to drive the future German market of
excipients by enhancing revenue generation. UK market of excipients is expected to witness
significant growth over the forecast period owing to the fact that major global pharmaceutical
R&D projects are performed in UK laboratories. UK based Pharmaceutical Quality Group (PQG)

75
in collaboration with International Pharmaceutical Excipients Council (IPEC), and European

Association of Chemical Distributors (FECC) established EXCiPACT as a certification scheme
for pharmaceutical excipient suppliers.
This encourages the local drug manufacturers to work with third-party auditors in order to
maintain the cGMPs standards of excipients used in the drug development, thereby expanding
the excipients market in this region. This country operates as a member of Pharmaceutical
Inspection Co-operation Scheme and International Coalition of Medicines Regulatory Authorities
which is involved in monitoring entire drug development process. This fact is expected to drive
market growth in the country by ensuring the safe use of excipients for drug development. UK
based companies such as Surfachem Group Ltd, SGS United Kingdom Ltd, and Safic-Alcan
which are involved in development of pharmaceutical excipients are expected to boost revenue
generation in UK market of excipients.
5.3.1 Europe excipients market, 2012 – 2025 (USD M illion)
FIG. 53 Europe excipients market, 2012 – 2025 (USD Million)
2,500.0
2,179.2
2,000.0
2,064.1
1,955.3
1,852.1
1,754.5
1,664.5
1,500.0
1,575.0
1,490.6
1,411.2
1,336.4
1,266.0
1,200.0
1,000.0
1,136.9
1,078.2
500.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Europe excipients market was valued at USD 4.66 million in 2016 and is expected to grow at a
2025.

76
5.3.2 German y
5.3.2.1 Germany excipients market, 2012 – 2025 (USD Million)
FIG. 54 Germany excipients market, 2012 – 2025 (USD Million)
500.0
450.0
439.9
400.0
415.8
393.0
350.0
371.5
351.2
300.0
332.5
314.0
296.5
250.0
280.1
264.7
250.2
200.0
236.7
223.8
211.8
150.0
100.0
50.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Germany excipients market was valued at USD 264.7 million in 2016 and is expected to grow at
2025.
5.4 Asia Pacific
Major factor driving the excipients market in Asia Pacific region is constant improvement in
economic health of countries such as China and India coupled with increase in excipients
volume in these countries. Expanding excipients volumes from emerging markets of China and
India are anticipated to soon outpace output volumes from North America and Europe.
Moreover, Asian countries such as India are known for its quick adaptability to new excipients,
thereby enhancing growth of the Asian market of excipients. Advancements in novel drug
delivery system are driving the demand for innovative excipients in this region.
Growing pharmaceutical market in this region has fomented several international firms to shift
their excipients business to Asian countries such as India. For instance, in April 2014, Colorcon
opened an excipient manufacturing facility in Goa to serve drug manufacturers in South Asia.
Workshops and events conducted in the region to showcase excipients usage in drug products
as well as regulations associated with the safe use of these excipients are expected to
significantly accelerate the growth of excipients market in the region over the forecast period.

77
For instance, in July 2016, ExcipientFest was conducted in the Asia which discussed the
requirements on excipients used in drug products in China and other aspects of excipients
usage & development.
Presence of Japan Pharmaceutical Excipients Council (JPEC) has significantly contributed in

revenue generation in the Japan market of excipients. JPEC aimed at better health outcome in
the country through advancements in the effectiveness and properties of pharmaceutical
excipients. Recently, Japan Pharmaceutical Manufacturers Association (JPMA) collaborated
with government for expansion of domestic pharmaceutical companies.
This collaboration mainly aimed at reducing soaring R&D costs and complicated drug review
processes. This collaboration is expected to positively influence the improved usage of
excipients. The JPMA also monitors the labeling requirements of excipients of non-prescription
drugs as well as prescription drugs. Japan-based companies which are involved in excipients
development are observed to meet stringent ISO 14001 and ISO 9001-HACCP quality
standards for certification of Japanese pharmaceutical excipients GMP standards. This factor is
expected to greatly influence the expansion of excipients market in this country.
In addition, international companies are engaged in expansion of their manufacturing facilities

for pharmaceutical excipients in this country. For instance, in October 2015, Evonik, a Germany-
based company, opened its plants in Ako, Japan for production of SIPERNAT and CARPLEX
lines of specialty silica.
China Food and Drug Administration (CFDA) formed a new licensing system for higher risk
excipients based on toxicity and dosage data, thereby influencing the use of excipients by the
Chinese pharmaceutical entities. Moreover, China has developed U.S. FDA style DMF system
as a database to track excipients usage and its composition. These factors are anticipated to
positively influence the use of excipients in this country. Remarkable economic growth of this
country which is no more threatened by the western dominance is the major factor driving the
market growth in this country.
Moreover, China is witnessing investments from foreign companies such as Croquette, Meggle,
Colorcon, and Degussa in this market, thereby accelerating growth of the excipients market in

78
this country. Presence of substantial number of players in this region is supportive for the
estimated revenue share.
5.4.1 As ia Pacific exc ipie nts marke t , 2012 – 2 025 (USD M illion)
FIG. 55 Asia Pacific excipients market, 2012 – 2025 (USD Million)
2,500.0
2,000.0
2,082.5
1,953.4
1,832.3
1,718.8
1,500.0
1,612.2
1,514.5
1,418.9
1,329.9
1,246.6
1,000.0
1,169.2
1,096.6
1,028.7
965.5
906.2
500.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Asia Pacific excipients market was valued at USD 8.09 million in 2016 and is expected to grow
at a CAGR of 16.18% during the forecast period, to reach an expected value of USD39.76
million in 2025.
5.4.2 Japan
5.4.2.1 Japan excipients market, 2012 – 2025 (USD Million)
FIG. 56 Japan excipients market, 2012 – 2025 (USD Million)
800.0
700.0
708.8
669.2
600.0
631.8
596.5
563.2
500.0
532.4
502.0
473.5
400.0
446.6
421.5
397.8
375.5
300.0
354.6
334.8
200.0
100.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025

79
Japan excipients market was valued at USD 421.5 million in 2016 and is expected to grow at a
2025.
5.5 Latin America
With improving GDP growth and presence of untapped market potential in the region, Latin
American countries, in particular Brazil, are expected to emerge as a promising market for the
progress of excipients market.
Growth of local pharmaceutical industries is observed to bolster the need for improvement in
excipients use in order to maintain the quality of drugs offered to the local markets, thereby
driving market growth in this region.
Furthermore, presence of IPEC in this region is expected to positively impact the growth of
market in the region. This council is involved in safe & effective production and use of excipients
for drug manufacturing. IPEC underwent partnership with Sindusfarma (Brazil) and SaFybi
(Argentina) for expansion of IPEC’s reach into Latin America that would allow the local drug
manufacturing companies to participate in IPEC’s activities and to implement IPEC guidelines
for improvement in use of excipients for better patient outcome.

80
5.5.1 Latin America excip ients marke t , 2012 – 2025 (USD M illion)
FIG. 57 Latin America excipients market, 2012 – 2025 (USD Million)
450.0
400.0
385.4
350.0
363.4
342.7
300.0
323.2
304.8
287.9
250.0
271.2
255.5
240.9
227.1
200.0
214.2
202.1
190.7
180.0
150.0
100.0
50.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Latin America excipients market was valued at USD 227.1 million in 2016 and is expected to
million in 2025.
5.5.2 Brazil
Brazilian market of excipients is expected to experience substantial growth over the forecast
period owing to factors such as demographic changes, a changing consumer profile, rising
pharmaceutical contract manufacturing market and the need for advanced healthcare in the
country.
ANVISA, Brazil’s national regulatory agency, is involved in regulations for the certificate of good
manufacturing practices for pharmaceutical excipients. Presence of such regulatory bodies in
the countries is expected to positively impact the progress of excipients market in the country.
In addition, international firms are engaged in strategic partnership with local vendors for the
distribution of drug excipients in the country. For instance, Grupo MCassab, a Brazilian API and
excipient distributor, underwent partnership with Gattefossé, a France-based pharmaceutical
excipients manufacturer, for distribution of pharmaceutical products including excipients to the

81
pharmaceutical companies in the country. Such collaborations aimed at obtaining enhanced and
safe formulations for applications in d development of novel pharmaceuticals.
5.5.2.1 Brazil excipients market, 2012 – 2025 (USD Million)
FIG. 58 Brazil excipients market, 2012 – 2025 (USD Million)
140.0
120.0
124.6
117.5
100.0
110.7
104.4
98.4
92.9
80.0
87.5
82.4
77.7
73.2
60.0
69.0
65.1
61.4
57.9
40.0
20.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Brazil excipients market was valued at USD 73.2 million in 2016 and is expected to grow at a
2025.
5.6 Middle East & Africa (MEA)
MEA excipients market is estimated to have lowest market penetration owing to low volumes of
the domestic market and the lack of real competitive advantages in the region. However,
presence of international excipients developing company’s distribution network in this region is
expected to positively influence the growth of the market in MEA region in the near future.
In addition, presence of target population and need for the robust medicine as a consequence of
disease epidemic in the region is expected to fuel the demand for growth of excipients market in
the region.

82
5.6.1 M iddle East & Africa excip ients marke t, 2012 – 2025 (USD M illion)
FIG. 59 Middle East & Africa excipients market, 2012 – 2025 (USD Million)
250.0
223.1
200.0
209.2
196.2
184.0
172.6
150.0
162.1
151.9
142.3
133.4
125.1
117.3
100.0
110.0
103.3
96.9
50.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Middle East & Africa excipients market was valued at USD 125.1 million in 2016 and is
expected to grow at a CAGR of 6.6% during the forecast period, to reach an expected value of
USD 223.1 million in 2025.
5.6.2 South Africa
South Africa market of excipients is expected to witness considerable growth over the forecast
period as a support from WHO to train local personnel in achieving compliance with stringent
GMP standards for pharmaceutical excipients. Moreover, organizations, such as SGS SA,
which is involved in growing awareness amongst the pharmaceutical entities about good
manufacturing practices is expected to drive the growth of the excipients market in this country.
Tax and tariff policies for local drug manufacturing have attributed for the slow growth of
excipients market in this country by slowing down the entire process of drug development.
Moreover, medicine production facilities established in sub-Saharan Africa tend to have higher
manufacturing costs when compared with other regions, which in turn, is expected to impede
the market growth in the country to some extent.

83
5.6.2.1 So ut h Af rica excipien ts market , 2012 – 2025 ( U SD M illion )
FIG. 60 South Africa excipients market, 2012 – 2025 (USD Million)
35.0
30.0
29.0
25.0
27.1
25.3
23.6
20.0
22.1
20.6
19.3
18.0
15.0
16.8
15.7
14.6
13.7
12.8
10.0
11.9
5.0
-
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
South Africa excipients market was valued at USD 15.7 million in 2016 and is expected to grow
in 2025.

84
Chapter 6 Competitive Landscape

6.1 Strategy Framework
FIG. 61 Strategy framework
Research Initiatives
Partnerships
Mergers & Acquisitions
New Product Development
Low Medium High
Strategy Spearheads
Research Initiatives Avantor Performance Materials, Inc. Colorcon, Inc.
Partnerships Colorcon, Inc., Eastman Chemical Corporation
M&A Colorcon, Inc., BASF SE
New product development FMC corporation, BASF SE, Roquette Frères
85

6.2 Market Participation Categorization
FIG. 62 Participant categorization
Operating strategies Competitive Edge Weaknesses
 These players are involved in  Presence of highly qualified personnel Presence of stringent framework
development of new products in house. Availability of funds from the parallel Expensive infrastructure requirement
 High valued in partnerships and business for keeping up the pace.
Mature players
BASF SE, Colorcon, collaborations with other established

Inc., Roquette distribution networks and different chemical
Frères, JRS Pharma manufacturers.
 Collaborations with the established Strong technology platforms Unavailability of sufficient funds for the
companies for development of novel  Strong pipeline. development and continuation of pipeline
excipients development
Technology platform sharing fro molecule Absence of experts in the field of
Emerging players
Finar Limited,
designing nanotechnology and multifunctional
Avantor
Outsourcing clinical testing excipients.
Performance
Materials, Inc.
Source: WHO, U.S. CDC, FDA, NIH Journals, Invest Company Profiles

86
6.3 Company Profiles
6.3.1 Eastman Chemica l C orporation
6.3.1.1 Company overview

Key Statistics
Eastman is a chemical company which is involved
in manufacturing of products for daily use. Establishment year: 1920
Company has a product portfolio ranging from Headquarters: Tennessee, U.S.

medical formulation fillers to materials used in
Employee strength: 14,000
construction business. Company operates in over
Market relevance: Pharmaceutical
100 countries along with 40 manufacturing sites in
Excipients
over 16 countries.
6.3.1.2 Financial performance
Financial 2014 2015 2016
Revenue 9,527.00 9,648.00 9,008.00
Operating Income 1,162.00 1,384.00 1,383.00
Net Income 757.00 854.00 859.00
12,000.00
10,000.00
8,000.00
6,000.00
4,000.00
2,000.00
-
2014 2015 2016
Revenue Operating Income Net Income
Note: Net revenue of Eastman Chemical Corporation. Reported in Millions
87

6.3.1.3 Product benchmarking
Product Application/ Features

Eastman C-A-P pH sensitive enteric coating material derived from cellulose that
Cellulose Ester NF is designed for coating pharmaceutical tablets, capsules or
(Pellets) granules
Eastman C-A-P pH sensitive enteric coating material derived from cellulose that
Cellulose Ester NF is designed for coating pharmaceutical tablets, capsules or
(Powder) granules
Eastman Cellulose A taste-masking and an osmotic drug delivery agent with low
Acetate (CA-320S acetyl content
NF/EP)
Eastman Cellulose A coating material that can be used as a semi-permeable
Acetate Butyrate (CAB- membrane for osmotic drug delivery.
171-15NF)
Eastman Cellulose A solution grade low viscosity cellulose acetate that can be used
Acetate (CA-398- for taste masking, tablet coating for sustained release, osmotic
10NF/EP) drug delivery
Eastman Ethyl Acetate, A colorless, fragrant, low boiling solvent that can be used a bulk
NF/EP pharmaceutical excipient
Eastman Ethyl Acetate, A colorless, fragrant, low boiling solvent that can be used a bulk
NF/EP, Kosher pharmaceutical excipient

88
6.3.2 P & G
P&G has its business operations in over 70 countries

and is involved in providing various services ranging
Key Statistics
from cosmetics to pharmaceutical ingredients and
other FMCG goods. Establishment year: 1837
Headquarters: Cincinnati, Ohio,

P & G chemicals deliver solutions to various
U.S.
manufacturers both internally and externally to P & G
and other manufacturers. Company has a history of Employee strength: 105,000 (June
2016)
operations in the oleo chemical industry, in the 1800s;
P&G used stearic acid in their candles and since 1837 Market relevance: Diagnostics &
Pharmaceuticals
company has been operating in the chemical business
by focusing on delivering high quality chemicals to various fields of industry.
Financial 2014 2015 2016
74.4 70.7 65.3

Revenue
13.9 11.0 13.4

Operating Income
11.6 7.0 10.5

Net Income
80.0
70.0
60.0
50.0
40.0
30.0
20.0
10.0
0.0
2014 2015 2016
Note: Net revenue of P&G. Reported in USD Billions

89

Fatty Acids  C-670, Caproic/Caprylic Acid (Hexanoic/Octanoic Acid)
 C-698S, Caproic Acid (Hexanoic Acid)
 C-810, Caprylic/Capric Acid (Octanoic/Decanoic Acid)
 C-895, Caprylic Acid (Octanoic Acid)
 C-1095, Capric Acid (Decanoic Acid)
 C-810L, Caprylic/Capric Acid (Octanoic/Decanoic Acid)
 C-1098, Capric Acid (Decanoic Acid)
Glycerin  Superol KPO Kosher Glycerin, USP/FCC/EP
 MOON OU KOSHER GLYCERIN, USP/FCC
 Superol NK Glycerin, USP/FCC
 MOON K KOSHER GLYCERIN, USP/FCC
 SUPEROL K KOSHER GLYCERIN, USP/FCC

90
6.3.3 Avantor Performanc e M aterials , LLC
Avantor Performance Materials, LLC is engaged in

development and marketing of chemicals and
other materials to serve life science, biomaterial,
pharmaceutical, and diagnostic markets. It offers Key Statistics
acids, amino acids, biological buffers, aqueous Establishment year: 1867
solutions, chromatography medias, biological
Headquarters: Central Valley,
reagents, and consumables, diagnostic solutions,
Pennsylvania, U.S
denaturants, excipients, solvents for gas
Employees Strength: 35
chromatography and reagents, LC/MS solvents
and reagents, high-purity low endotoxin sugars, Market relevance: Pharmaceutical
ingredients
molecular biology products, ultra-high pressure
liquid chromatography solvents, and vitamins and
minerals.
6.3.3.2 Financial Performance
2014 2015
N/A USD 10.7 Million
Note: Net revenue of Avantor Performance Materials. Reported from Owler.com

Excipients It includes:
 PanExcea MHC300G: Excipients for immediate release
 PanExcea MC200G: Used for orally disintegrating tablets
 Ascorbic acid as antioxidant
 Anhydrous citric acid as antioxidant
 Monohydrate citric acid as antioxidant
 Glycine-Bulking agent
 Mannitol-Bulking agent

91
6.3.3.4 Strategic initiatives
 In January 2014, Avantor Performance Materials signed agreement with VWR

International, LLC for the distribution of pharmaceutical production and chemicals
portfolio in the regions of Asia, Europe and the Middle East. With this agreement,
company aimed at expansion of its market reach in these regions.

92
6.3.4 Huntsman Corporation
Huntsman Corporation is a global manufacturer of

over 1000 differentiated chemicals and over 30,000 Key Statistics
products that are being used in various fields such
Establishment year: 1982
as automotive, food, pharmaceuticals etc.
Company’s products are sold worldwide serving a Headquarters: Hercules, California,
the U.S.
diverse range of industrial and consumer end
markets. Company has its business operations in Employee strength: 15,000 (2015)
nearly 30 countries with more than 100 R&D Market relevance: Pharmaceutical
facilities and manufacturing sites. additives
Financial 2013 2014 2015
Revenue 11,079 11,578 10,168
Gross Profit 1,753 1,919 1,848
Operating Income 510 633 405
Net Income 128 323 93
14,000
12,000
10,000
8,000
6,000
4,000
2,000
-
2013 2014 2015
Revenue Gross Profit Operating Income Net Income
Note: Net revenue of Huntsman Corporation. Reported in USD millions

Titanium Dioxide / Purity control pigment used as an additive to maintain the purity and
HOMBITAN AFDC protects from the effects of light
Propylene Glycol USP Used as a humectants and emulsifier

93
 In February 2017, Huntsman Corporation announced increase in global prices for

its titanium dioxide pigments. This price increase is expected to aid in revenue
generation in the market through this company.
 In June 2012, Huntsman Corporation received GMP certification for its Texas-
based manufacturing facility which is involved in the production and manufacturing
of Propylene Glycol.

94
6.3.5 B ASF SE
BASF is engaged in the development of chemical

compounds to serve various applications such as Key Statistics
pharmaceuticals, food, chemical, additives,
textiles and others. Company operates its Establishment year: 1865
business through five segments: performance Headquarters: Ludwigshafen,
products, chemicals, agricultural solutions, Germany
functional materials & solutions, and oil & gas. Employee Strength: 113,830 (As of
Company has its worldwide operations in more March 2016)
than 80 countries. It has more than 390
Market relevance: Excipients for
production sites and plants. Pharmaceuticals
Financial 2013 2014 2015
Revenue 78,785.6 74,675.9 61,003.0
Net Income 5,464.3 4,226.2 4,299.4
90,000.0
80,000.0
70,000.0
60,000.0
50,000.0
40,000.0
30,000.0
20,000.0
10,000.0
-
2013 2014 2015
Revenue Operating Expenses Net Income
Note: Net sales of BASF. Reported in millions (Conversion rate: 1 Euro = 1.06 USD)

95

Novata For suppository masses or solid compositions
Kollicream 3C Mild solubilizer and skin penetration enhancer for dermal
pharmaceuticals
Kollicream CP15 It is a high viscosity emollient for dermal applications
Kollicream DO An emollient and solubilizer for lipophilic API’s
Kollicream IPM An emollient with penetration enhancement properties for lipophilic
API’s
Kollicream OA A medium spreading emollient with penetration enhancement
properties, and a potential solvent for lipophilic solvents
Kollidon 25 Can be used as a binder, stabilizer, pore former, thickener,
solubilizing agent, and crystallization inhibitor
Kolliphor CS 12 A non-ionic emulsifier; which can be stable with acidic, basic and
ionic excipients
Kolliphor CS 20 A non-ionic emulsifier with good sensory properties
Kolliphor CSA A self-bodying cream base
 In September 2016, Company announced the opening of its new PVP production
facility in Shanghai. Through this initiative, company aimed at enhancing its
presence in Asia Pacific region.
 In May 2016, BASF and Colorcon, Inc. signed an agreement to co-develop
pharmaceutical film coatings. This will enhance the company’s position as a lead
position in supplying fully formulated film coating components.
 In April 2016, BASF has introduced Kollicoat MAE 100-55, a functional excipient
that can be used in enteric coatings. This helped strengthen the company’s
portfolio of tablet coating excipients.
 In January 2015, BASF invested up to €56 million in the expansion of its PVP value
chain along with the expansion of manufacturing plant in LudwigShafen. This
helped company to manufacture and distribute high-quality PVP across Europe.

96
6.3.6 Ash land Inc,.
Ashland develops advanced drug delivery with latest

equipment. Company’s line of products combined Key Statistics
capabilities can help deliver drugs. Company has Establishment year: 1924
wide product ranges for oral solid-dosage forms.
Headquarters: Kentucky, U.S
Ashland built its products on its foundation of
formulation and excipients solutions. Company has a Employee strength: 11,000
global footprint of over 100 countries with Market relevance: Pharmaceutical

manufacturing sites that operate in cGMP standards excipients
in various countries.
Financial 2014 2015 2016
Revenue 6121.0 5387.0 4948.0
Operating Income 46.0 458.0 327.0
Net Income 233.0 309.0 -29.0
Segment Revenue 2498.0 2263.0 2089.0
7000.0
6000.0
5000.0
4000.0
3000.0
2000.0
1000.0
0.0
-1000.0 2014 2015 2016
Revenue Operating Income Net Income Segment Revenue
Note: Net product revenue of Ashland Inc, Reported in Millions,
 Oral Solid  AquaSolve hypromellose acetate succinate

 Aqualon ethylcellulose
Dosage
 Aqualon sodium carboxymethylcellulose
Form
 Aquarius film coating systems

97
excipients  Benecel methylcellulose and hypromellose

 Blanose sodium carboxymethylcellulose
 CAVAMAX native cyclodextrins
 Klucel hydroxypropylcellulose
 Natrosol hydroxyethylcellulose
 Pharmasolve N-methyl-2-pyrrolidone
 Plasdone S-630 copovidone
 Plasdone povidone
 Polyplasdone crospovidone
 Oral Liquid
Dosage
 Cavamax native cyclodextrins
Form
excipients
Other Dosage forms  Cavitron and CAVASOL* HPBCD and HPGCD
excipients  Ferronyl iron supplement
 In October 2016, company had opened its pharmaceutical production facility in

Nanjing, China. This led the company to produce and expand its market in Asian
region

98
6.3.7 FM C Corporation
FMC is into the supply of raw materials to the

Key Statistics
various healthcare firms. Company also operates in
solving supply chain, and processing, and Establishment year: 1883
formulation challenges. Company operates in Headquarters: Pennsylvania, U.S.
different regions in the world market for
Employee strength: 6,000
pharmaceutical excipients with over30
manufacturing facilities in 18 countries. Market relevance: Diagnostics &
Testing
Financial 2013 2014 2015
Revenue 3,130.7 3,258.7 3,276.5
Operating Income 371.6 307.6 -177.9
Net Income 308.0 322.1 495.5
Segment Revenue 762.0 828.2 785.5
3,500.0
3,000.0
2,500.0
2,000.0
1,500.0
1,000.0
500.0
0.0
-500.0 2013 2014 2015
Revenue Operating Income Net Income Segement Revenue
Note: Net revenue of FMC Corporation. Reported in Millions

99

Avicel Tablet Binder
Avicel Suspension Aid
Ac- Di –Sol Super Disintegrant
Aquacoat Controlled release coatings
Anti-reflux active ingredient, controlled release matrix formers,

Alginates
dental impression materials
Viscarin, Gelcarin, and

Controlled release matrix formers, suspension aids
SeaSpen
Alginate Capsule,
Non-animal Soft Capsules
Seagel Capsule
AlubraTM PG100 Soluble Lubricant
 In July 2014, FMC Corporation opened an innovation centre in Shanghai for Asian
region. This helped company to increase their research and production of
healthcare and nutrition products
 In December 2016, FMC Health launched AquatericN100 enteric coating, a ready-
to-use, clean label solution is a new innovation in nutraceuticals which helps deliver
simple manufacturing process at a lower cost

100
6.3.8 Roquette
Croquette group is a family-owned company serving

as a specialty firm in the supply of various additives in Key Statistics
the manufacture of pharmaceutical excipients and food Establishment year: 1933
ingredients. Croquette offers various raw materials that
Headquarters: Lestrem, France
are produced from plant-based materials such as
Employee strength: 8000
wheat, corn, peas and potatoes.
Croquette has its operations in over 100 countries, Excipients
with more than 20 manufacturing sites around the
world.
2014 2015
N/A USD 3.3 billion
Note: Net revenue of FMC Corporation. Reported from company website

Pyrogen free In Large Volume Parenteral (LVP) and Total Parenteral
nutrients and osmotic Nutrition (TPN)
agents  LYCADEX PF pyrogen free monohydrate dextrose
 PEARLITOL PF pyrogen free mannitol
 INEOSORB PF pyrogen free sorbitol
 In Dialysis
 LYCADEX PF pyrogen free monohydrate dextrose
High quality pyrogen  SODIUM GLUCONATE PHARMA
free excipients for Rx
 Modified Cyclodextrins parenteral grade
injectable
KLEPTOSE
 Pyrogen-free mannitol PEARLITOL PF
 Pyrogen-free sorbitol NEOSORB PF

101
 Pyrogen-free Dextrose LYCADEX PF

Bulk sweeteners  NEOSORB liquid sorbitol
 LYCASIN liquid maltitol
stability improvement  Native betacyclodextrins
and taste masking
 Methyl betacyclodextrin
 Pea maltodextrin
 Hydroxypropyl betacyclodextrins
fillers, diluents,  PEARLITOL FLASH mannitol-starch compound
binders
 StarLac lactose-starch compound
 LYCATAB C multifunctional starch excipient
 PEARLITOL SD mannitol
 PEARLITOL DC mannitol
Superdisintegrants  GLYCOLYS LV, for wet granulation
 GLYCOLYS Low pH
 GLYCOLYS
Film Coating Sugarfree
 SweetPearl maltitol powder
 LYCOAT, film forming polymer
 In March 2017, company announced the introduction of three new products under
the names of Lycadex, Pearlitol and Neosorb that can be used in biological drug
formulations. This helped the company to expand its excipient offerings for various
pharmaceutical companies

102
6.3.9 Colorcon Inc.,
Colorcon is one of the leading companies in the

development tablet film coating systems, modified
release mechanisms, and functional excipients for the Key Statistics
pharmaceutical industries. Company’s products and Establishment year: 1961
technologies support all phases of solid oral dose
Headquarters: Pennsylvania, U.S
designing, its development and manufacture.
Colorcon operates in more than 100 countries with coating and modifications
over 19 service laboratories that offer support and
services to the customers.
2014 2015
N/A USD 560.30 million
Note: Net revenue of Colorcon Inc., Reported from Hoovers.com

 Surelease
 ETHOCEL
Film Coatings  ETHOCEL HP
(Sustained)
 Opadry CA
 Opadry EC
 Opadry
 Opadry II
Immediate Release film  Opadry QX

coating  Opadry amb II
 Opadry fx
 Opalux
 ETHOCEL ethylcellulose polymers
Polymers for Controlled
 METHOCEL cellulose ethers CR (hypromellose or
release
HPMC)

103
 POLYOX water-soluble resins.

 AFFINISOL Solubility Enhancing Polymers
 AMBERLITE
 DUOLITE Ion Exchange Resins
 ENTERACT HPMCAS Polymers
 Acryl-EZE
 Acryl-EZE II
 ENTERACT
Enteric film coatings
 Opadry Enteric
 Nutrateric
 Sureteric
 StarCap 1500
Tablet Binders
 Starch 1500
Drug Layer Substrates  Suglets
 In January 2016, Colorcon acquired pharmaceutical sugar spheres from Paulaur

Corporation. This helped company to improve the product range in sugar spheres
supply.
 In May 2016, company had announced new film coating manufacturing plant in Sao
Paulo, Brazil. This helps the company to maintain its position in the region of South
America
 In May 2016, Colorcon, Inc. and BASF announced an agreement to co-develop
pharmaceutical film coatings. This will enhance the company’s position as a lead
position in supplying fully formulated film coating components.

104
6.3.10 Lubrizol Corporatio n
Lubrizol LifeSciences is a provider of raw materials

ingredients, drug formulation development for Key Statistics
medical and pharmaceutical manufacturers. Lubrizol
Establishment Year: 1928
along with Particle Sciences and Vesta are the only
Headquarter: Ohio, U.S
companies that offer polymer customization, complex
drug formulation. Employee Strength: 9000
Company has its operations in over 100 countries Market Relevance: Molecular
with more than 17 manufacturing and processing diagnostic assays and kits.
plants in various countries
2014 2015
N/A USD 6,094.57 Million
Note: Net revenue of Lubrizol Corporation. Reported from Hoovers.com

 Pathway excipients
Drug Delivery
 Topical and Transdermal Drug Delivery
 Carbopol polymers
Oral Care  Oral Liquids
 Oral Solid Dose
 Carbopol Polymers
 Carbothane TPU
 Isoplast ETPU
 Noveon AA-1 Polycarbophil
 Pathway TPU Excipients
Thermoplastic
 Pellethane TPU
Polyurethanes
 Pemulen Polymeric Emulsifiers
 Tecoflex TPU
 Tecophilic TPU
 Tecoplast TPU
 Tecothane TPU

105
 In September 2015, Lubrizol acquired Particle Sciences, a leading drug development

and manufacturing organization. This led the company to expand its pharmaceutical
development capabilities
 In April 2016, company had invested USD 15 million for expanding the manufacturing
capacity of sterile and non-sterile space for the development of complete lyophilization
and filling operations

106
6.3.11 Valeant
Valeant Pharmaceuticals International, Inc. is a

pharmaceutical and medical device company.
Key Statistics
Company develops and manufactures generic
pharmaceuticals, medical devices and several
over-the-counter (OTC) products. This company Headquarters: Laval, Canada
has its worldwide operation in North America, Employee strength: 22000+
Europe, Asia Pacific, Latin America, and Middle
Market relevance:
East. Pharmaceuticals
Valeant is focused on developing new treatments
and innovations with its wide and innovative R&D.
In January 2009, this company The Dow Chemical Company and it started operating as wholly
owned subsidiary of Valeant Pharmaceuticals International, Inc.
6.3.11.1.1 The Dow Chemical

Company (Dow
Pharma Solutions) Key Statistics
Dow Pharma Solutions is engaged in designing Establishment year: 2011
solutions to facilitate drug delivery. It is involved in
Headquarters: Incheon, South
development and distribution of APIs and Korea
functional excipients. It offers excipients for
Market relevance: APIs &
delivery of drugs in various dosage forms excipients
including capsules, tablets, oral liquid dosage,
topical applications, suppositories, gums, and
mucosal bio adhesives. It provides solutions for range of pharmaceutical formulation
technologies including spray-dried dispersion, hot melt extrusion, dry processes, and
granulation technologies. It has its worldwide operations.

107
Financial 2013 2014 2015
Revenue 8,206 10,447 9,674
Operating Income 2,001 1,527 -566
Net Income 881 -292 -2,409
12,000
10,000
8,000
6,000
4,000
2,000
0
-2,000 2014 2015 2016
-4,000
Note: Net revenue of Valeant. Reported in millions
6.3.11.2.1 Financial performance
Financial 2013 2014 2015
Revenue 57,080 58,167 48,778
Net Income 4,816 3,839 7,783
Segment Revenue 4,591 4,639 4,379
70,000
60,000
50,000
40,000
30,000
20,000
10,000
0
2013 2014 2015
Revenue Net Income Segment Revenue
Note: Net revenue of The Dow Chemical Company. Reported in millions

108

Methocel It is a water-soluble polymers suitable for controlled or modified
release formulations, dry processes, granulation and binding,
tablet coating, capsules, liquid solutions
Ethocel It is an ethyl cellulose polymer. These are film-forming, release
rate-modifying and water-insoluble polymers that are used in
pharmaceutical applications
Polyox These are non-ionic, high molecular weight, water-soluble poly
(ethylene oxide) resins. These are hydrating water soluble
polymers available for the pharmaceutical market
Affinisol It is a polymers that are used for solubilization performance
requirements of a wide variety of poorly soluble APIs including
solutions designed for spray drying and hot melt extrusion
Carbowax Sentry It is used for a number of applications including intestinal health,
tablet coating, solubility enhancement and API stability
Amberlite It is an ion exchange resin used as an API in hyperkalemia
solutions and as a formulation excipient in a variety of pharma
applications
Duolite It is a flexible ion exchange resin used as an API in
hypercholesterolemia solutions and as a formulation excipient in a
variety of pharma applications
Enteract HPMCAS polymers that provide flexible coatings for enteric
delivery
Walocel C It is sodium carboxymethyl cellulose excipients that helps in
controlling the rheological (flow) properties in a variety of liquid
and semi-solid dosage forms

109
6.3.12 JRS PH ARM A
JRS PHARMA is an excipients manufacturer that

offers complete portfolio of solutions for health
science industries. The company serves Key Statistics
pharmaceutical, nutraceuticals, contract pharma, and Establishment year: 1878
animal health.
Headquarters: Rosenberg,
Germany
The products manufactured by the company include
Market relevance:
binders, lubricants, fillers, thickeners, stabilizers,
Pharmaceuticals
carriers, and coatings. The company is engaged in
meeting the IPEC guidelines for GMP standards in
the Good Manufacturing Guide for Bulk Pharmaceutical Excipients. It is also certified with ISO
9001 certification.
It offers a portfolio of excipients for solid dosage forms, including calcium sulfate dehydrate,
microcrystalline cellulose, powdered cellulose, calcium hydrogen phosphate, soy
polysaccharides, calcium hydrogen phosphate dehydrate, dextrates, hydrogenated vegetable
oil, sugar spheres, sodium stearyl fumarate, sodium starch glycolate, croscarmellose sodium,
and hypromellose. It also provides a co-processing technology for development of active
pharmaceutical ingredients.
The company serves the market by providing biopharma services through Celonic and ProJect
Pharmaceuticals. It has global sales offices in Austria, Benelux, China, Czech & Slovak
Republic, Finland, France, India, Italy, Japan, Latin America, Malaysia, Mexico, Poland, Russia,
Sweden, Switzerland, Spain, and UK. Its R&D facilities are located in North America, Europe,
and Asia.
2014 2015
NA USD 7.92 Million
Note: Financials obtained from Hoover

110

High Functionality PROSOLV SMCC: Silicified Microcrystalline Cellulose
Excipients PROSOLV EASYtab SP: This is an all-in-one composite
containing binder-filler, glidant, super disintegrant, and
lubricant microcrystalline cellulose, colloidal silicon
dioxide, sodium starch glycolate, sodium stearyl fumarate
PROSOLV EASYtab Nutra: This is an all in one all-in-one,
ready-to-use excipient composite containing binder,
glidant, superdisintegrant, lubricant, microcrystalline
cellulose, colloidal silicon dioxide, croscarmellose, palm
kernel oil saturated, DATEM
PROSOLV ODT G2: This is an orally disintegrating tablet
excipient matrix containing microcrystalline cellulose,
colloidal silicon dioxide, mannitol, fructose, crospovidone.
Binders Binders used for the solid dosage formulations include:
 VIVAPUR & EMCOCEL in the form of microcrystalline
cellulose
 EMCOMPRESS is calcium phosphate, water insoluble
functional fillers. It is available in three different grades:
o Anhydrous Calcium Hydrogen Phosphate (DCP
anhydrous)
o Calcium Hydrogen Phosphate Dihydrate (DCP
dihydrate)
o Calcium phosphate (TCP)
EMDEX is a directly compressible, 100% water soluble, and
lactose-free tablet binder
COMPACTROL is a specially processed Calcium Sulfate
Dihydrate for use as a filler in tablets made by direct
compression or for use as a binder in wet granulation
Super disintegrants It includes:
VIVASTAR & EXPLOTAB: Made up of sodium starch
glycolate
VIVASOL: It is a sodium carmellose containing disintegrant
for tablets and capsules
EMCOSOY: It is a genetically unmodified disintegrant
manufactured from soy
Lubricants It includes:
PRUV: Made up of sodium stearyl fumarate. It is a tablet
lubricant designed for formulations in which other
lubricants lead to formulation and/or manufacturing
challenges

111
LUBRITAB: Hydrogenated vegetable oil lubricant for tablet

and capsule formulations
Functional Filler ARBOCELL is a powdered cellulose plant based filler
Thickeners & VIVAPUR MCG contains microcrystalline cellulose and
Stabilizers, Carriers carboxymethylcellulose sodium
Povidone products These include:
VIVAPHARM PVP K30 (Povidone), the classic wet binder
with optimal balance between adhesive strength and
ease of handling.
VIVAPHARM PVP/VA 64 (Copovidone), the ultimate tablet
binder for all processing technologies.
VIVAPHARM PVPP (Crospovidone), offering unsurpassed
disintegration performance and versatility.
Carriers: VIVAPUR MCC Spheres containing microcrystalline
cellulose
 In February 2017, JRS PHARMA added Povidone Family product line to its product
portfolio. The products are VIVAPHARM PVP, VIVAPHARM PVP/VA 64, and
VIVAPHARM PVPP. This product addition was aimed at expansion of its excipients
product portfolio.
 In August 2016, JRS PHARMA announced for direct selling of products in India.
Company has transferred its business to its wholly owned subsidiary Rettenmaier India
Pvt. Ltd. from S. Zhaveri Pharmakem Pvt. Ltd. Through this initiative, this company
would operate as an international microcrystalline cellulose distributor with its own
distribution network in India.
 In July 2016, JRS PHARMA underwent partnership with SSP, a China-based company,
for marketing of povidone products. This alliance is expected to broaden the product
portfolio of JRS Pharma.
 In March 2016, the company announced completion of its Dextrates facility construction
in Cedar Rapids, IA. This completion of the construction facility is anticipated to enhance
the geographic presence of the company.

112
6.3.13 Shin-Etsu Chemica l Co., L td
It was established as Shin-Etsu Nitrogen Fertilizer

Co., Ltd and in 2003, SE Tylose GmbH&Co. KG Key Statistics
was established. Its operates its business through
PVC division, silicone division, electronics
materials division, advanced materials division, Headquarters: Tokyo, Japan
semiconductor materials division, organic Employee strength: 18,407 (as of
chemicals division, new functional materials dept., 2016)
special functional products dept., and international Market relevance: Excipients
division.
It has worldwide network in North America, South
America, Europe, and Asia-Oceania.
6.3.13.1.1 SE Pharma & Food

Materials Distribution
GmbH
Key Statistics
SE Pharma & Food Materials Distribution GmbH Headquarters: Wiesbaden,
(SE PFMD) operates as a distribution organization Germany
of Japan-based Shin-Etsu Chemical Co., Ltd. and Market relevance: Excipients

Germany based SE-Tylose. Its service portfolio
includes technical service and customer service.
Its technical services provide support for all
aspects of tablet & capsule formulation, coating
formulation, and process optimization. It offers excipients for manufacturing of tablet, pellet,
liquid, and others. Company’s products are approved with FDA and USP/NF.

113
Financial 2013 2014 2015
Revenue 10,142.63 10,923.22 11,134.32
Gross Profit 2,539.87 2,744.09 1,814.17
Net Income 988.47 1,118.87 1,294.91
12,000.00
10,000.00
8,000.00
6,000.00
4,000.00
2,000.00
0.00
2014 2015 2016
Revenue Gross Profit Oprating Income Net Income
Note: Revenue of Shin-Etsu Chemical Co. Ltd. Reported in millions (Conversion rate 1 Yen=0.0087 USD)

Pharmacoat It is developed from hydroxypropyl methylcellulose to be used as a
film coating material and gives an excellent finish
Metolose It is a water soluble cellulose ethers to be used as a binder for
solid dosage forms such as tablets and granules
Metolose SR It is suitable for hydrophilic matrix systems which is designed with
(Hypromellose) water-soluble polymers
L-HPC (Low- It is used to resolve capping in the tableting process
Substituted
Hydroxypropyl
Cellulose)
Hypromellose It is used as an enteric coating agent by the pharmaceutical
Phthalate (HPMCP) industry
Shin-Etsu AQOAT It is an enteric coating agent is used to protect drugs from
degradation by gastric acid or to protect gastric mucosa from
irritating drugs

114
Tylopur It is a low viscosity Hypromellose which is used in the design film-

coated tablet formulations
SmartEx It is a co-processed excipient containing three pharmaceutical
excipients, is suitable for direct compression manufacturing orally
disintegrating tablets and immediate release tablets
 In February 2017, SE PFMD’s Low-Substituted Hydroxypropyl Cellulose (L-HPC) met

the guidelines of European Pharmacopoeia (EP) ver. 8.7 which is based on international
harmonization of pharmacopoeia among United States Pharmacopeia, Europe
Pharmacopeia, and Japan Pharmacopeia. This initiative is expected to enhance the
company’s presence in this market by complying with Pharmacopoeia for its excipient
product.
 In February 2014, SE PFMD launched SmartEx as a co-processed excipient that
incorporate three excipients. This product launch aimed at expansion of company’s
excipients product portfolio.

115
6.3.14 DFE pharma
DFE pharma is a privately held company which is

involved in manufacturing excipients for
pharmaceutical companies. The company is
engaged in partnership with pharmaceutical firms to Key Statistics
provide them with excipients. This company is jointly Establishment year: 2005
owned by Royal FrieslandCampina and Fonterra. It
Headquarters: Goch, Germany
has production locations in Germany, India, New
Employee strength: 360
Zealand, and the Netherlands. Its sales offices are
located in the United States, Japan, Brazil, China, Market relevance: Excipients
Germany, Singapore, and India. It offers products
for direct compression, dry granulation, wet
granulation, capsule filling, inhalants, and extrusion spheronization.
2014 2015
NA USD 54.40 Million
Note: Financials obtained from Hoover

Microcrystalline It offers MCC-based product which includes:
Cellulose (MCC)  Pharmacel 101: Component for wet granulation
formulations
 Pharmacel 102: Used for direct compression
formulations
 Pharmacel 112: It is a directly compressible
microcrystalline cellulose with a low moisture content
Starch Used in oral solid dosage forms such as tablets, capsules or
sachets
Lactose It offers specialty, key, and customised range of lactose. It
includes sieved lactose, milled lactose, spray-dried lactose,
granulated lactose, and anhydrous lactose

116
Inhalation grade DFE Pharma Inhalation develops pharmaceutical lactose that

lactose facilitates delivery of your active ingredient to the lung of patients.
It includes:
 Lactohale 100: It is crystalline lactose with Tomahawk-
shaped particles with a smooth surface where the particle
size profile has been controlled by sieving as the primary
process
 Lactohale 200: It is milled lactose which enables the mean
particle size to be tightly controlled
 Lactohale 210: It is hard milled lactose which enables the
mean particle size to be tightly controlled below 50
microns
microns
microns
 Lactohale 300: Micronised lactose with a D50 below 5
microns
 Respitose ML001: Milled inhalation grade lactose
 Respitose ML003: Fine milled inhalation grade lactose
 Respitose SV003: Fine sieved inhalation grade lactose
 Respitose SV010: Coarse sieved inhalation grade lactose
Superdisintegrants It includes:
 Primojel: Sodium starch glycolate
 Primellose: Croscarmellose sodium
 In August 2015, DFE Pharma launched Pharmacel 112 as directly compressible MCC
for formulation of APIs. With addition of this product to its product line, company aimed
at expansion of its excipients product portfolio.

117
 In October 2014, DFE Pharma announced opening of new sales office in Shanghai,
China. This initiative was intended to allow the company to meet the growing demand
excipient products in China, thereby enhancing its geographic presence.
 In April 2013, DFE Pharma opened new MCC manufacturing facility in India. The new
facility is equipped with new warehouse for finished goods that meets the highest
international standards.

118
6.3.15 FIN AR LIM ITED
FINAR LIMITED is engaged in development of

novel products for pharmaceutical industry. Its
product portfolio includes solutions for excipients,
Fin SQ food grade additives, high purity laboratory Key Statistics
chemicals, certified reference materials, product Establishment year: 1998
packaging, new product development, label
Headquarters: Gujarat, India
identification guide, and grade selection guide. It
technical center offers periodic table, conversion Market relevance:
Pharmaceuticals
tables, chemical compatibility & plastic suitability,
and chemical standard information. This company is
certified with OHSAS 18001:2007, ISO 9001:2008,
& ISO 14001:2004, GMP, NABL, and FSSAI. In
August 2012, it changed it named to FINAR LIMITED. Previously it was known as Finar
Chemicals Limited.
2014 2015
NA USD 14.39 Million
Note: Financials obtained from Hoovers.com

Excipients for These excipients which are used for injectable formulations
Injectable Formulations maintain low level of endotoxins with the bioburden limits
(BET/MLT etc) controlled as a part of specifications
DMF Filed Excipients Offers excipients with Type IV DMF filing for use in various drug
formulations. It includes:
Acetonitrile
Benzene sulphonic acid
Cyclohexane
N, N-Dimethyl acetamide
Monosodium glycine carbonate
Tert – Butanol
N-Heptane
Di - Sodium succinate hexahydrate
Lauryl lactate

119
Levulinic acid
Methane sulfonic acid
Excipients for Specific It includes:
Formulations tert-Butanol HP
Acetonitrile HP
Acetone
tert-Butanol HP
N, N-Dimethyl acetamide HP
PEG 400
Benzene sulphonic acid HP
n-Heptane
Di - Sodium succinate hexahydrate
meta-Cresol
Diethylene triamine pentaacetic acid (Pentetic acid)
Sodium caprate
Hydroxylamine hydrochloride
Monosodium glycine carbonate
Fumaric acid
Excipients for Solid / Company offers excipients for solid and semi-solid dosage
Semi-Solid Dosage formulations for drug development
Forms

120
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Chapter 1 Research Methodology ................................................... 11

Chapter 2 Executive Summary ........................................................ 20

Chapter 3 Market Variables, Trends& Scope .................................. 22

Chapter 4 Market Categorization: Product Estimates & Trend

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4.2.6 Carboxy Methyl Cellulose (CMC) ....................................................................... 42

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4.4.3 Calcium carbonate ............................................................................................ 57

Chapter 5 Market Categorization: Regional Estimates &

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5.3.2 Germany .......................................................................................................... 77

Chapter 6 Competitive Landscape .................................................. 85

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6.3.4.3 Product benchmarking................................................ 93

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6.3.11.2.1 Financial performance ..................................... 108

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TABLE 1 Major drugs going off patent in 2017 29

FIG. 1 Market research process 12

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FIG. 34 Global mannitol market, 2012 – 2025 (USD Million) 54

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Chapter 1 Research Methodology

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FIG. 1 Market research process

Information procurement Information analysis Market formulation

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1.1 Information Procurement

FIG. 2 Information Procurement

Purchased Database GVR’s Internal Database

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 Includes company databases such as Hoover’s: This helps us identify financial

GVR’s Internal Database

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Third Party Perspective:

FIG. 3 Primary research pattern

Sample size for the study on Excipients Market:

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1.2 Data Analysis

 Identifying variables and establishing market impact

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FIG. 4 Market research approaches

Bottom-up demand approach

FIG. 5 Value chain based sizing & forecasting

Demand side estimates