IQ4I Research published a new report on "Pharmaceutical Contract Manufacturing Global Market-2025"

BOSTON - March 20, 2019 - PRLog -- 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.

As estimated by IQ4I Research and 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 manufacturers 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. 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.

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, Whereas, clinical manufacturing is expected to grow at a high single digit CAGR from 2018 to 2025. 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, Oncology is expected to grow at a strong single digit CAGR from 2018 to 2025.

Geographically, the North American region held the largest market share in 2018 wherein, the United States accounted for the highest revenue. Europe held the second largest share in 2018 where, Italy and 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.

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 manufacturing market CMOs are strategically enhancing their service capabilities by acquisition, investment, an expansion for providing access to new API and FDF manufacturing capacity and technologies.

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.

Major players in the Pharmaceutical Contract 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).

For further information and queries please visit our website: https://www.iq4i.com/reports-category/pharmaceuticals/r/185 or write to us: bd@iq4i.com