Pharmaceutical Contract Manufacturing Global Market

–Forecast to 2025

Pharmaceutical Contract Manufacturing Global Market estimated to be worth

$96 billion by 2025

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

Manufacturing 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 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

IQ4I Research & Consultancy Pvt. Ltd. Page 1

Pharmaceutical Contract Manufacturing Global Market

–Forecast to 2025

Consultancy, the Pharmaceutical Contract Manufacturing Global Market is expected to grow

at a high single digit CAGR to reach $95,904.9 million by 2025. The major factors driving the
market includes patent expiration of small molecule drugs, increasing number of small
molecules in clinical trials, increasing outsourcing by the pharmaceutical companies, CMOs
investments 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. However, contamination during manufacturing, side effects
associated with small molecules, increasing shift towards biologics and stringent regulations
are hindering the growth of the Pharmaceutical Contract Manufacturing market.

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.

The Pharmaceutical Contract Manufacturing global market is segmented based on the

Product, Customer base, dosage forms, phase, and applications. Among Product, API
Manufacturing holds the maximum revenue in 2018 and FDF Manufacturing is expected to
grow at a strong single digit CAGR from 2018 to 2025, due to rising demand for FDF
manufacturing, increase in controlled release dosage forms, oral dosage forms for the
treatment of oncology and rise in generic injectables. Generics are the key driver of the
contract manufacturing of API and FDF due to their cost advantage over branded drugs. API
Manufacturing by customer base is further sub-segmented into Branded and Generic.
Generic API manufacturing holds the maximum share in 2018 and expected to grow at a
high single digit CAGR from 2018 to 2025, due to patent expirations of drugs, increase in
government initiatives to use generic drugs, increasing ANDA approvals and expansion of
generic API manufacturing facilities to meet global demand. FDF Manufacturing by customer
base is further sub-segmented into a solid dosage form, semi-solid, liquid, gaseous dosage

IQ4I Research & Consultancy Pvt. Ltd. Page 2

Pharmaceutical Contract Manufacturing Global Market

–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.

Pharmaceutical contract manufacturing by phase is segmented into commercial

manufacturing and clinical manufacturing. Commercial manufacturing holds the highest
revenue in 2018 and expected to grow at a single digit CAGR from 2018 to 2025, due to
huge demand for commercial API production, patent expiry increases commercial
manufacturing of API and FDF and increase in outsourcing of generic APIs. Whereas,
clinical manufacturing is expected to grow at a high single digit CAGR from 2018 to 2025,
due to increase in the number of pipeline drugs where 55-60% of the APIs are synthetic API
clinical phase 2 and 3 projects requiring cGMP facilities and increase in outsourcing by
innovator pharma companies due to low cost manufacturing and shorter timelines. Also,
clinical manufacturing play a significant role in securing client relationships that can lead to
commercial scale manufacturing contracts.

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

IQ4I Research & Consultancy Pvt. Ltd. Page 3

Pharmaceutical Contract Manufacturing Global Market

–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.

CMOs with advanced manufacturing technologies like continuous flow manufacturing,

cryogenic process, high containment facility and capabilities to produce controlled
substances and HPAPI drugs will attract the pharmaceutical companies to outsource API
and FDF manufacturing. For instance, in August 2018, Nemus Bioscience, Inc. signed an
agreement with AMRI for the development and manufacturing of Nemus’ proprietary
cannabinoid-based active pharmaceutical ingredients (API) which is a controlled substance.

IQ4I Research & Consultancy Pvt. Ltd. Page 4

Pharmaceutical Contract Manufacturing Global Market

–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).

Reasons for buying this report:

 Pharmaceutical contract manufacturing global market is expected grow at a CAGR of
6.7% from 2018 to 2025 to reach $95,904.9 million by 2025.
 Identification and analysis of the pharmaceutical contract manufacturing market by
identifying various segments by product (customer base and dosage form), phase,
application, and geography.
 Revenue forecast of the pharmaceutical contract manufacturing 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
and restraining pharmaceutical contract manufacturing market growth.
 API average selling price (ASP), overall market share, company capabilities,
acquisitions, collaboration, expansion, ANDA approval, patent expiry, API pricing,
FDA approved manufacturing facility, drug master filing and company matrix tables.
 Global pharmaceutical API production volume (In-house, contract manufacturing),
cost of manufacturing facility and India v/s China pharmaceutical contract
manufacturing market.
 Global pharmaceutical contract manufacturing, API contract manufacturing and FDF
contract manufacturing market share analysis of major players.
 Revenue forecast of the pharmaceutical contract manufacturing market with respect
to North America (U.S., Rest of North America), Europe (Germany, France, Italy and
Rest of Europe), Asia-pacific (China, India, Japan 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.
 Identification of key technology developments and innovations driving the market.
 Profiles of major players in the pharmaceutical contract manufacturing market and
analysis of their service offerings, financial revenue, business strategies, SWOTs and
market shares.

IQ4I Research & Consultancy Pvt. Ltd. Page 5

Pharmaceutical Contract Manufacturing Global Market

–Forecast to 2025

FIGURE 1

PHARMACEUTICAL CONTRACT MANUFACTURING GLOBAL MARKET

SEGMENTATION

IQ4I Research & Consultancy Pvt. Ltd. Page 6