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–Forecast to 2025
IQ4I’s Report Contains 88 market data tables and 93 figures spread through 429 pages
and an exhaustive TOC on “Pharmaceutical Contract Manufacturing Global Market”,
[Product {Active Pharmaceutical Ingredient Manufacturing (Branded and Generics),
Finished Dosage Formulation Manufacturing (Solid Dosage Form, Injectable Dosage Form,
Semi-Solids, Liquids and Gaseous Dosage Form), Phase (Clinical Manufacturing and
Commercial Manufacturing), Application (Oncology, Central Nervous Systems,
Cardiovascular Disorders, Infectious Diseases, Pulmonary Disorders, Metabolic Disorders,
Gastrointestinal Disorders, Musculoskeletal Disorders, Genitourinary Disorders,
Endocrinology and Other Applications), Region (North America, Europe, Asia-Pacific and
Rest of the World)].
Small molecule drugs are organic compounds with defined chemical structures and
molecular weights typically ranging from 500 to 900 Daltons. Unlike biologics, these
compounds can easily diffuse across cell membranes to reach intracellular sites and are
designed to modulate a specific target that controls the biological processes associated with
a specific disease.
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. In 2018, FDA approved 59
drugs, of that 42 were small molecules and only 17 were biologics. Similarly, many small
molecules are going off-patent, paving way for generics into the market through ANDA
approval, 23 drugs received ANDA approval in 2018, creating a favorable opportunity for the
Pharmaceutical contract manufacturers. During the period 2017-2018 475 companies filed
type II DMFs and these filings indicate that majority of the companies are focusing in
therapeutic areas like metabolic disorders (Type 2 diabetes), Musculoskeletal disorders
(Psoriatic arthritis), Cancer (breast cancer), CNS (Major depressive disorder) and multiple
fibrosis.
The global expenses for small molecule manufacturing is $xx billion, of that contract
manufacturing occupies x.x% growing at a high single digit CAGR from 2018 to 2025 and
expected to increase share during the forecast period. As estimated by IQ4I Research and
–Forecast to 2025
Even though, the CMO market witnessed some of the strategic acquisition and mergers by
contract manufactures to expand their respective service portfolios, the market remained
fragmented with the top-15 players in the sector only occupying ~10%-15% market share.
Some of the contract 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. The pharmaceutical CMO’s estimated capacity is 43.3% of total
pharmaceutical manufacturing volume. The capacity utilization of total CMO manufacturing
volume during 2018 was estimated to be 65% and expected to grow at a mid single digit
CAGR from 2018 to 2025 to reach 72% capacity utilization by 2025. In 2018, Global small
molecule API production was estimated to be 350kt of which CMO production accounted for
more than half.
–Forecast to 2025
form, and injectable dosage forms. Among these solid dosage form holds the maximum
share in 2018 and expected to grow at a mid single digit CAGR from 2018 to 2025, due to
increase in oral solid dosage form as it is more convenient to patients than other dosage
forms. However, the injectables are expected to grow at a double digit CAGR from 2018 to
2025, due to growth in use of generic injectables, increase use of injectable in chronic
diseases and cancer.
Among the applications, Infectious diseases hold the highest revenue in 2018 and expected
to grow at a high single digit CAGR from 2018 to 2025, due to increase in incidence of
infectious diseases like hepatitis A, B and C and human immunodeficiency virus (HIV),
increasing awareness about the infectious disease and newly emerging diseases like
dengue fever, ebola virus, yellow fever, swine flu and avian flu, and chikungunya. Oncology
is expected to grow at a strong single digit CAGR from 2018 to 2025, due to increase in the
incidence of breast and lung cancer, increase in the usage of synthetic HPAPIs for cancer
treatment, investment in new drug development and increasing regulatory approvals of
oncology drugs. Some of the oncology drugs approved in 2018 are Venclexta (Venetoclax),
Daurismo (glasdegib), Lorbrena (lorlatinib), duvelisib (Copiktra), apalutamide (Erleada).
Geographically, the North American region held the largest market share in 2018 wherein,
the United States accounted for the highest revenue. This growth is driven by the high
investments in cardiovascular and cancer research, growing demand for cancer API’s,
constructive government reforms, availability of highest number of FDA approved
manufacturing facilities and demand for generic drugs and adaptation of novel
manufacturing technologies. Europe held the second largest share in 2018 where, Italy and
–Forecast to 2025
Germany dominates the market, as Italy is the leader in API manufacturing mainly driven by
exports, which represents 74% of the turnover and Germany is the leader in Finished dose
formulation market.
Asia Pacific region is expected to grow with a high single digit CAGR from 2018 to 2025, due
to the increase in the number of generic API production companies, rising affordability,
enhanced life expectancy, improved standard of living and increase in population are driving
the market. China and India are the low cost hubs for pharmaceutical contract manufacturing
due to lower labor costs and capital expenditures. India has established itself as a significant
player, especially in solid dosage form manufacturing for the large-scale production of
generics for global markets. Availability of skilled workforce and lower labor cost are some of
the factors propelling the rapid growth of the Asia-Pacific market.
The Pharmaceutical Contract Manufacturing global market is evolving with the increase in
the number of API manufacturers. Many of the pharmaceutical companies without
manufacturing and advanced capabilities of API and FDF tend to outsource manufacturing to
CMOs. In pharma contract manufactuirng market CMOs are strategically enhansing their
service capabilities by acquisition, investment, an expansion for providing access to new API
and FDF manufacturing capacity and technologies. For instance, in January 2019, Cambrex
Corporation has acquired Avista Pharma, a contract development, manufacturing, and
testing organization (CDMO) for about $252 million, the facility adds pre-formulation,
formulation, process development.
Small molecules still dominate the early and late stage pipeline development. In order to tap
the opportunity several CMOs are investing in expansion. For instance, in September, 2018,
Evonik Industries AG invested €36 million ($42 million) to expand its CMO capability in API
manufacturing in U.S. and Europe. The company is enhancing the advanced technologies
like high-potency API (HPAPI), and continuous processing at multiple manufacturing sites.
–Forecast to 2025
Major players in the Pharmaceutical Contact Manufacturing global market include Aenova
Holding GMBH (Germany), Cambrex Corporation (U.S.), Abbvie Contract Manufacturing
(U.S.), Patheon N.V. (Thermo Fisher Scientific) (Netherlands), Albany Molecular Research
Inc. (U.S.), Famar S. A. (Greece), Lonza Group Ltd. (Switzerland), GlaxoSmithKline (U.K.),
Pfizer CentreOne (U.S.), Wuxi STA pharmaceutical Co., Ltd. (China), Almac (U.K.) and
Recipharm AB (Sweden).
–Forecast to 2025
FIGURE 1