Pharmaceutical excipients Global Market

–Forecast to 2025

Pharmaceutical Excipients Global Market estimated to be worth $9.9 billion by

2025

IQ4I Research & Consultancy published a new report on “Pharmaceutical Excipients

Global Market – Forecast To 2025” This report analyzes and studies the overall market,
major Drivers & Opportunities, Restraints & Threats in North America, Europe, Asia-Pacific
and Rest of the World.

IQ4I’s Report Contains 231 market data tables and 136 figures spread through 648
pages and an exhaustive TOC on “Pharmaceutical Excipients Global Market”, [Source
(Plant, Animal, Mineral and Synthetic Based Excipients), Product (Inorganic Chemicals,
Organic Chemicals and Pharma/USP Water), Process (Granulation and Direct Compression
Methods), Functionality (Fillers & Diluents, Binders & Adhesives, Suspension & Viscosity
Agents, Coatings, Flavoring Agents & Sweeteners, Disintegrants, Colorants, Lubricants &
Glidants, And Others), Dosage forms (Solid, Injectables and Semi-Solid, Liquid and
Gaseous Dosage Forms), Finished Products (Prescription and OTC drugs), Region (North
America, Europe, Asia-Pacific and Rest of the World)]

Pharmaceutical Excipients are non-active substances combined with active pharmaceutical

ingredient (API) during formulation to form a desired finished drug product, which helps in
modulating solubility, bioavailability, stability and perform a wide range of functions.
Pharmaceutical excipients are naturally derived or manufactured through semi-synthetic or
synthetic modes. They are classified based on their physio-chemical characteristics in
formulating different dosage forms based on nature of active ingredient and intended route
of administration. Pharmaceutical excipients may aid in lubricity, disintegration, taste,
flowability and may confer some form of antimicrobial function. Choosing the appropriate
excipient to support the design of formulation is an important step in drug manufacturing. A
carefully chosen excipient may reduce the manufacturing costs by being multifunctional or it
may enhance the patient experience by offering taste masking properties. Few decades ago,
excipients were not considered as important component due to their inactive nature, but now
they are considered as one of the essential components in the production of tablets,
injectables, semi-solids and parenteral as excipients impact the stabilization of drug product
in various conditions such as change in pressure, temperature and pH.

As estimated by IQ4I Research, the global pharmaceutical excipients market is expected to

grow at a CAGR of 6.3% to reach $9,911.2 million by 2025. Some of the factors driving the
market are increased demand for OSDF (oral solid dosage form) excipients, increasing
demand for multifunctional excipients, growth in generics and biosimilar drugs, increasing
demand for solubility enhancing excipients, rising demand for sustained release

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formulations, novel excipients for biologic drugs, drug coated medical devices and increase
in prevalence of chronic diseases. However, there are several obstacles like adverse
reactions of excipients, contaminations, pricing pressure, high market fragmentation with
low-profit margin and stringent regulations may hinder the growth of the Pharmaceutical
excipients market.

The pharmaceutical excipients market is mainly classified into source, product,

manufacturing process, functionality, dosage forms, finished products, and geography. In
pharmaceutical excipient by source, plant-based excipients held the largest share in 2018
and expected to grow at a high single digit CAGR from 2018 to 2025. In pharmaceutical
excipient by-product, organic chemical excipients held the largest share in 2018 and
expected to grow at a mid single digit CAGR from 2018 to 2025 due to their increased
efficacy in oral delivery and increased compressibility and flowability properties. In
pharmaceutical excipients by manufacturing process, granulation held the largest share in
2018 and direct compression is the fastest growing, it is expected to grow a high single digit
CAGR from 2018 to 2025. In pharmaceutical excipient by functionality, binders & adhesives
held the largest share in 2018 and expected to grow at a high single digit CAGR from 2018
to 2025.

In pharmaceutical excipients by the dosage form, solid dosage form held the largest share in
2018 and expected to grow at a high single digit CAGR from 2018 to 2025 as solid
formulations are the most preferred dosages for their ease of administration, dosage
accuracy, stability, and cost-effectiveness.

In finished products, prescription drugs held the largest share in 2018 and expected to grow
at a mid single digit CAGR from 2018 to 2025, due to the high cost of drugs, as
pharmaceutical companies spent a huge amount of money in research and development of
the drugs.

Geographically, Pharmaceutical excipients market is segmented into North America, Europe,

Asia-Pacific and Rest of the world regions. North America region dominated the global
excipients market and is expected to grow at a mid single digit CAGR from 2018 to 2025 due
to the increasing demand for functional excipients, implementation of new novelties like
nanotechnology, increasing usage of oral solid dosage forms, increasing incidence of
chronic disorders, elderly population and favorable reimbursement scenario for drugs. Also,
technological innovations in manufacturing procedures of excipients have also propelled the
market growth in North America. In North America, United States accounted for the highest

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revenue in 2018. The factors driving the market are increasing usage of generics,
personalized dosage forms, rise in generic drug manufacturers, and hefty investments by the
pharmaceutical companies in the development of medicines and increasing usage of oral
solid dosage forms.

The Asia-Pacific region is the fastest growing region with a high single digit CAGR from 2018
to 2025. The market is driven by an increasing excipients outsourcing, low manufacturing
and labor costs, growing generics market owing to patent cliffs, rising healthcare demand,
rising investments, increasing demand for multifunctional excipients, better infrastructure,
lower capital overhead costs and tax advantages. Excipients manufacturers in developing
countries face major challenges to develop product with quality at an affordable price, due to
lower price of excipients and large number of producers, which creates a price sensitive
market.

Pharmaceutical drugs are of two types, small molecule and large molecule, where excipients
are used in both of these drugs. According to IQ4I analysis, small and large molecule
accounts for xx% and xx% share respectively in the market. Some of the most commonly
used excipients in small molecules are carbohydrates, oleochemicals, petrochemicals,
metallic oxides, silicates, calcium salts, proteins, halites and generally in combinations.
Compared to a small molecule, biologics have different requirements with respect to
excipient performance in order to prevent aggregation and degradation during the
manufacturing process. Hence, choosing appropriate excipient with desired stabilization is
not an easy task as it can have a positive or negative impact on therapeutic effect. Some of
the most commonly used in excipients in biological drugs include sodium salts, solvents,
emulsifiers, amino acids, saccharides, acids, calcium salts, and others.

In 2018, the FDA approved 59 drugs, of that 42 were small molecules and 17 were biologics
which accounts to about 28.8% of total approvals which has risen from 26.1% from the year
2017. Biologics continue to expand in the marketplace with a growing number of protein
therapeutics and vaccines in development. The group of functional excipients for biologic
drugs is limited in comparison to those used in small molecule oral drug delivery. So, novel
excipients are required to stabilize biologics and vaccines during processing and storage. In
2018, Dupont developed a new surfactant excipient, FM1000, which is able to better
stabilize biologics to interfacial stresses than conventional excipients.

Currently, there is an increasing demand for the development of novel excipients with
advanced technologies like new chemically modified grade excipients, multifunctional

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excipients, new chemical entity excipients, controlled release excipients, existing excipients
with the various route of administration and co-processed excipients. For instance, in
January 2019, Dr. Reddy’s Laboratories Ltd. and its subsidiary, Promius Pharma, LLC
announced the approval of TOSYMRA by the U.S. Food and Drug Administration (FDA).
TOSYMRA is used for the acute treatment of migraine and it is a nasal spray, formulated
using proprietary novel excipients known as “Intravail”, a permeation enhancing
alkylglycoside to achieve blood levels similar to a 4-mg sumatiptan subcutaneous injection,
resulting in the rapid onset of action. These novel excipients increase the scope for the
development of drug delivery system and new drug formulation which is a major gain for the
industry, but the lengthy developmental process and high cost along with the safety and
quality issues are delaying the excipients approval.

Multifunctional excipients are the class of excipients which are preferred by the
manufacturers as the single excipients do not meet all the functional requirements such as
high solubility, stability, and bioavailability. As approval of new excipient is time-consuming
and often linked to the approval of new drugs, the suppliers are focused on developing
multifunctional excipients. By using multifunctional excipients the developmental cost
associated formulation will be reduced as excipients demand toxicity study, the risk of
product quality is reduced and productivity is improved. For instance, in April 2019, Lubrizol
Corporation launched multifunctional, 2-in-1 rheology modifier, Carbopol Style 2.0 polymer.
This novel technology not only provides rheology modification but also offers light to medium
styling hold, reducing or eliminating the need for Polyvinylpyrrolidone (PVP) or fixatives.

The global Pharmaceutical excipients production in 2018 was estimated to be xx kilotons

(Kt) of which Organic chemical excipients production is xx kilotons, Inorganic chemical
excipients production is xx Kt and USP/Pharma water production is xx Kt. Organic chemicals
is the fastest growing segment with the high single digit CAGR from 2018 to 2025 to reach
xx kilo tons by 2025.

Global top 100 selling drugs based on revenue were considered and analyzed for most
common excipients found and categorized into segments such as source, product,
functionality and dosage form. According to IQ4I analysis, some of the commonly used
excipients in global top 100 selling drugs by revenue are Magnesium Stearate, Titanium
Dioxide, Microcrystalline Cellulose, Croscarmellose Sodium, Lactose Monohydrate,
Polysorbate 80, Talc, Mannitol, Sodium Hydroxide, Yellow Iron Oxide, Sodium Chloride,

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Hypromellose, Polysorbate 20, Hydrochloric Acid, Iron Oxide Red, Gelatin, Iron Oxide Black,
Shellac, Sucrose, Glycerol, Macrogol 3350 and Polyvinyl Alcohol.

The pharmaceutical excipients global market is a fragmented with the top ten players
occupying major share of the market. The existing players in the pharmaceutical excipients
market are involved in developing new and advanced products to maintain their market
shares. Pharmaceutical excipient manufacturers have also relied on long terms strategical
initiatives such as acquisition, partnership, investments, product launch and expansions to
gain access to new manufacturing technologies and for improving their market size among
its competitors. For instance, in June 2019, Peptidream and poharma Inc. entered into a
strategic partnership to use PGC (protected graft co-polymer), which utilizes a PEG
(Polyethylene glycol) based excipient that reversibly binds the therapeutic peptides and does
not require the peptide to be modified to enable delivery, the excipient also has the ability to
protect the peptide from degradataion and provide a longer circulation half-life. Additionally,
some of the companies are also applying for the EXCiPACT certification scheme, where it
provides detailed information about excipients by the professional for physical audit. For
instance, in May 2019 Colorcon Inc. received EXCiPACT good manufacturing practice
(GMP) certificate for its site in Stoughton, Wisconsin, U.S. from SGS (EXCIPACT’s
internationally recognised certification body). The Certificate demonstrates that the site
manufactures pharmaceutical excipients according to the EXCiPACT GMP Standard.

Some of the key players of the pharmaceutical excipient market are Dow DuPont (U.S.),
Ashland, Inc. (U.S.), BASF SE (Germany), DFE Pharma (Germany), Evonik Industries AG
(Germany), Associated British Foods Plc (U.K.), Merck KGAA (U.S.), Roquette (France),
Colorcon (U.S.), JRS Pharma (Germany), Lubrizol Corporation (U.S.), Avantor Performance
Materials (U.S.), Croda International Plc (U.K.), and Asahi Kasei (Japan).

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Reasons for buying this report:

 The pharmaceutical excipients global market is expected to reach $9,911.2 million by

2025 and is expected to grow at a CAGR of 6.3%.

 Analysis of the pharmaceutical excipients market structure by identifying various

segments and sub-segments of the market.
 Revenue forecast and strategic analysis with respect to industrial trends and
contribution to overall pharmaceutical excipients market.
 Revenue forecast of pharmaceutical excipients market with respect to North America,
Europe, Asia-Pacific and Rest of the world.
 Analysis of top selling excipients, novel excipients and excipient classification by
molecule type.
 Production volume, Excipients used in top 100 selling drugs, Drug Master Filing
(DMF), Product matrix.
 Identification of major market trends, factors driving, restraining, threatening and
providing opportunities for the pharmaceutical excipients market growth.
 Analyzing opportunities by identification of high-growth segments/revenue pockets in
pharmaceutical excipients market.
 Major players’ profiles in pharmaceutical excipients market and analysis of their
business strategies and market shares.
 Analyzing competitive developments such as joint ventures, alliances, mergers and
acquisitions, and new product launches in pharmaceutical excipients market.

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FIGURE 1

PHARMACEUTICAL EXCIPIENTS GLOBAL MARKET SEGMENTATION

Pharmaceutical Excipients Global Market

Dosage Finished
Source Product Process Functionality
Form Product

Plant Organic Granula Fillers & Binders & Prescrip

Solid tion
tion Dilutents Adhesives

Animal Inorganic D. Compre Injectables OTC

Suspending
ssion Coatings
Agents
Mineral USP water Semi-solid,
Lubricants Disinte Liquid, Gas
& Glidants grants
Synthetic
Colorants &
Solvents
Flavoring

Preserva
Solubilizers
tives

Others

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