Pharmaceutical companies are now pushing hard to reduce overall manufacturing and research costs by outsourcing various processes related to research, development and manufacturing. Furthermore, patent expiration and generic drug competition, continue to fuel demand for pharmaceutical contract manufacturing organizations in the market.
Rising number of food and drug administration (FDA) approvals and clinical trials are supporting growth of biopharmaceutical industry, which in turn is fueling growth of the contract pharmaceutical manufacturing market growth. For instance, according to ClinicalTrials.gov, on 26 July 2022, there were around 422,923 clinical trial studies registered in US and non US. In addition, according to the percentage of Registered Studies by Location and Percentage of Recruiting Studies by Location, U.S. alone contributed for 32% and 33% respectively in the clinical trials study.
Furthermore, stringent regulatory policies for clinical research studies and manufacturing make entire drug manufacturing process more complex, as it requires more resources to develop new drugs and biologics. These processes require expertise in broad scientific disciplines of preclinical, clinical, ancillary clinical in chemistry, packaging, manufacturing, project management, and regulatory affairs, which are provided by the CROs and CMOs. This is considered as a major reason for pharmaceutical companies to outsource clinical trials and manufacturing processes.
Market Dynamics
Contract manufacturing organizations (CMOs) provide wide range of manufacturing services, which include contract packaging, quality testing, and development service to pharmaceutical and biotechnology industries. Biopharmaceutical companies prefer CMOs due to the complexity involved in manufacturing process of biomolecules, as it consists of different shape, size, and behavior with significantly complex process than pharmaceutical drugs. Furthermore, by outsourcing manufacturing capabilities from contract manufacturing organization, allows recruiter firms to focus more on the research and development (R&D), product development, and marketing aspects.
Pharmaceutical market is increasingly concentered with generic products and is highly competitive with various companies located in Asia Pacific, which are entering into the developed markets such as the U.S., Germany, France, and the U.K. Rising number of patents expiring in the near future serves to be a major opportunity for generic drugs manufacturers to prosper in the market.
Furthermore, mergers and acquisitions between generic drug manufacturers, with major players focusing on enhancing their product portfolio through inorganic strategies, will support the addition of generic drug portfolio into company’s offering and thus, generating demand for CMOs to fulfil it.
For instance, in December 2021, Moderna, Inc., an American pharmaceutical and biotechnology company, and RECIPHARM, a pharmaceutical contract development and manufacturing organizations, announced an agreement to support formulation and fill-finish a part of the Moderna COVID-19 Vaccine supply outside of the U.S. The activity was performed in Recipharm’s drug product manufacturing facility located in France.
Key features of the study:
Detailed Segmentation:
“*” marked represents similar segmentation in other categories in the respective section.
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