Active Pharmaceutical Ingredients (API) Global Market

–Forecast to 2025

Active Pharmaceutical Ingredients (API) Global Market estimated to be worth

$307.2 billion by 2025

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

Ingredients (API) 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 181 market data tables and 151 figures spread through 626
pages and an exhaustive TOC on “Active Pharmaceutical Ingredients Global Market”,
[Synthesis {Synthetic API (By customer base [Branded and Generic]), Biotech API (By
product type [Monoclonal antibodies, Recombinant proteins, Vaccines and Others], By
customer base [Biologics and Biosimilar]) HPAPI (By customer base [Branded and
Generic]}; Business type {Captive (By customer type [Branded captive and Generic
captive]) Merchant (By customer type [Branded merchant API and Generic merchant
API])}; Therapeutic application (Infectious diseases, Oncology, Cardiovascular diseases,
CNS, Pulmonary disorders, Gastrointestinal, Endocrine diseases, Metabolic disorders,
Genitourinary diseases, Musculoskeletal diseases and Others); REGION (North America,
Europe, Asia-Pacific and Rest of the World)]

Active pharmaceutical ingredient (API) is any substance or combination of substances used

in a finished pharmaceutical product (FPP), with pharmacological activity and has direct
effect in the cure, mitigation, treatment of the disease, or to have direct effect in restoring,
correcting or modifying physiological functions in human beings. API manufacturing involves
conversion of raw materials like fine chemicals and intermediates into active ingredient,
which will be used for formulating drug product.

According to IQ4I analysis, Active pharmaceutical ingredients global market is expected to

grow at a CAGR of 7.7% to reach $307.2 billion by 2025. Adoption of biologics in disease
management and increasing regulatory approvals in the last few years, increasing scope of
HPAPI market, patent expiration of major drugs, increasing trend of outsourcing and
increase in geriatric population are some of the factors driving the market growth. Whereas
contamination of API, fierce competition between API players, high cost for the
manufacturing of APIs, requirement of highly skilled technicians, stringent regulatory policies
and rising environmental concerns are the factors that are hindering API market growth.

The global API market is segmented based on synthesis, business type, therapeutic
applications and geography. Depending on synthesis, the market is classified into synthetic
API, biotech API and HPAPI (High Potent Active Pharmaceutical Ingredient). Synthetic API
holds the maximum share in 2018 and expected to grow at a high single digit CAGR from

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2018 to 2025. The major factors driving the synthetic chemical API market are patent
expiration of synthetic drugs (small molecule drugs), increasing number of small molecules
in clinical trials, increasing outsourcing by the pharmaceutical companies, CMOs investment
to expand manufacturing facilities, rise in incidence of chronic and age-related diseases,
rapid growth in oncology market, technological advancement like cryogenic and continuous
flow manufacturing. Biotech API holds the second largest share in 2018 and expected to
grow at a high single digit CAGR from 2018 to 2025. Biotech API is further segmented into
monoclonal antibodies, recombinant proteins, vaccines and others. Monoclonal antibodies
accounted for the largest share in 2018, growing at double digit CAGR from 2018 to 2025.
Increased investment in R&D by pharmaceutical companies for developing biologic drugs,
adoption of biological therapies in disease management, increasing outsourcing are few
factors driving the biotech API market. HPAPI segment is expected to grow at a high single
digit CAGR from 2018 to 2025. Rapid growth in oncology market, low toxicity and lower side
effects, technological advancements in HPAPI, increasing outsourcing, increasing incidence
of chronic and age related diseases are few factors driving the HPAPI market growth.

API market based on business type is segmented into captive and merchant. Captive market
accounted for the largest revenue in 2018 and is expected to grow at a mid single digit
CAGR from 2018 to 2025. Merchant market is expected to grow at a high single digit CAGR
from 2018 to 2025, due to increasing outsourcing, advanced manufacturing facilities, lack of
in-house manufacturing capability, high capital investment and cost of API manufacturing.

Among applications, oncology market accounted for the largest share in 2018 and is
expected to grow at a high single digit CAGR from 2018 to 2025. Infectious diseases
segment is the second largest segment and expected to grow at a high single digit CAGR
from 2018 to 2025. Patent expiration of major drugs, increased generic drug sales, high
uptake of biologics, increase in chronic and infectious diseases are the factors driving API
application market whereas stringent regulations are hindering the market growth.

According to IQ4I analysis, during 2017-2018 majority of the ANDA approvals received by
generic API manufacturers were focused on therapeutic areas like infectious diseases,
musculoskeletal disorder, cardiovascular disorders, endocrinology and oncology. Some of
the high demand API based on ANDA approvals are Efavirenz (Atripla), Epinephrine
(Epipen) for infectious diseases, Dexmedetomidine (Brecedex), Azelaic acid (Finacea) for
musculoskeletal disorder, Dorzolamide (Cosopt), Buprenorphine (Suboxone) for
cardiovascular disorders, Abiraterone (Zytiga), Arsenic trioxide (Trisenox ) for oncology.

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Similarly, our analysis of patent expiration data indicates that during 2019-2021 some of the
key drugs going off patent are Pramlintide, Erlotinib, Rivastigmine, Ipratropium,
Dexlansoprazole, Axitinib, Asenapine, Dasatinib, Nebivolol, Indinavir, Hydrocodone,
Fluticasone furoate, Rivaroxaban and others, which creates opportunity for generic API
manufacturers.

Geographically, API market is segmented into North America, Europe, Asia-Pacific and Rest
of the world regions. North American region dominated the global API market and is
expected to grow at a high single digit CAGR from 2018 to 2025. Patent expiration of the
major drugs, rising demand for biotech APIs from government and private companies,
market entry of biosimilars, increasing scope of high potent drugs and increase in the
prevalence of chronic diseases such as cancer, musculoskeletal disorder, cardiac disease
are some of the major factors that are driving the market growth. Asia pacific market is
expected to grow at a double digit CAGR from 2018 to 2025. Low labor cost, abundance
availability of raw materials, infrastructure facility, rise in generic drugs demand, increased
production capabilities, the presence of large number of domestic and international players,
and concentration of CMO companies are some of the factors that are driving the market
growth.

In 2018, 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. Few biologic drugs approved in 2018 are Trogarzo, Ilumya, Crysvita, Aimovig,
Poteligeo, Emgality, Libtayo and Takyzyro. Due to increased demand for biotech API
manufacturers are expanding their manufacturing capacity in order to maintain their
leadership. For instance, in April 2018, Lonza opened the world’s largest dedicated cell and
gene therapy manufacturing facility in Pearland, Greater Houston, TX (USA), with 300,000
square feet area. In the last few years, though there is an increase in the growth of biologics
market, small molecules continue to dominate the global therapeutics market. Many small
molecules are going off-patent, paving way for generics into the market through ANDA
approval. In 2018, 23 new drugs received ANDA approval, creating a favorable opportunity
for API manufacturers.

API manufacturers with advanced manufacturing technologies like continuous flow

manufacturing, cryogenic process, high containment facility and capability to produce
controlled substances, HPAPI and opioids will attract the pharmaceutical companies to
outsource API manufacturing. For instance, in August 2018, Nemus Bioscience, Inc. signed

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an agreement with AMRI for the development and manufacturing of Nemus’ proprietary
cannabinoid-based active pharmaceutical ingredients (API) which is a controlled substance.

The global small molecules manufacturing installed capacity is estimated to be xx million

Litres in 2018. Total small molecule utilization volume is xx million litres at x.x% capacity
utilization rate and is expected to grow at a CAGR of x.x% from 2018 to 2025 to reach xx
million litres volume by 2025, at x.x% capacity utilization rate. The global biologics
manufacturing installed capacity is estimated to be xx million Litres in the year 2018 at x.x%
capacity utilization and is expected to grow at a CAGR of x.x% from 2018 to 2025 to reach
xx million litres volume by 2025, at x.x% capacity utilization rate. The global API production
in 2018 was estimated to be xx Metric tons of which small molecules API production is xx
Metric tons and biologics API production is xx Metric tons.

Even though, the Active pharmaceutical ingredients global market witnessed some of the
strategic acquisition and mergers by API manufactures to expand their respective service
portfolios, the market remained fragmented with the major players in the sector occupying
mid single digit market share and the remaining player’s occupied major share in this
market. Some of the contract API manufacturing organizations (CMOs) are transforming into
Contract development and manufacturing organization (CDMO) by offering end to end
services, ranging from development activities including clinical trials to commercial scale
production and regulatory filings.

Major players in the API market include AMRI (U.S.), Aurobindo pharma (India), Boehringer
Ingelheim GmbH (Germany), Cambrex Corporation (U.S.), Divis Laboratories (India), Olon
S.p.A (Italy), Lonza group (Switzerland), Pfizer Inc. (U.S.), Sanofi SA (France), Seigfried
Holdings AG (Switzerland), Thermo Fisher Scientific (Patheon N.V.) (U.S.) and Teva
Pharmaceutical Industries Limited (Israel).

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Reasons for buying this report:

 Global Active Pharmaceutical Ingredient market is expected to grow at a CAGR of

7.7% from 2018 to 2025 to reach $307.2 billion by 2025.
 Identification and analysis of the Global active pharmaceutical ingredient market by
identifying various segments by synthesis (by customer base), by business type,
application, and geography.
 Revenue forecast of the Global active pharmaceutical ingredient market and strategic
analysis of each sub-segment with respect to segmental growth trends.
 Identification of major market trends, Porter’s model, supply chain and factors driving,
restraining, threatening and providing opportunities for the active pharmaceutical
ingredient market growth.
 API average selling price (ASP) by therapeutic application, overall market share,
company capabilities, acquisitions, collaborations, expansions, ANDA approvals,
patent expiry, API manufacturing units, and company matrix.
 Global pharmaceutical API production and utilization volume of small molecule and
biologics (In-house, contract manufacturing).
 Global active pharmaceutical ingredients market share analysis of major players.
 Revenue forecast of the active pharmaceutical ingredient market with respect
to North America (U.S., Rest of North America), Europe (Italy, Germany, France, and
Rest of Europe), Asia-pacific (China, Japan, India and Rest of Asia-Pacific) and Rest
of the World (Brazil, Rest of Latin America, Middle East and Others).
 Analysis of the opportunities for stakeholders by identifying the high-growth
segments of the market.
 Profiles of major players in active pharmaceutical ingredient manufacturing market
and analysis of their financial revenue, business strategies, SWOTs and market
shares.

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FIGURE 1

ACTIVE PHARMACEUTICAL INGREDIENTS (API) GLOBAL MARKET

SEGMENTATION

API Global Market

Synthesis type Business type Application Region

Synthetic API Biotech API HPAPI Captive API Infectious disease NA EU APAC RoW
Synthetic API by HPAPI by
By product type Branded
customer base Customer base Oncology
Captive U.S. Italy China Brazil
Monoclonal
Branded API Branded API Generic
antibodies CVD Rest of
Captive Others Germany Japan
Recombinant LATAM
Generic API Generic API
proteins Middle East
Merchant API CNS
France India and Others
Vaccines
Branded Pulmonary
Merchant disorder Others Others
Others Generic
GI disorder
Merchant
Biotech API by
customer base Endocrine
disorder
Biologics
Metabolic
disorder
Biosimilar
Genitourinary
disorder

MSD

Others

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