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US Pharmaceutical Contract Manufacturing Organization Market Analysis

The US pharmaceutical contract manufacturing organization (CMO) market is expected to reach a CAGR of 5 % during the forecast period of 2021 to 2026. The stricter regulation in the country ensures the superior quality of the manufacturing and the end-product that is being adhered to by the CMOs. As of 2019, more than 800 active Investigational New Drugs (IND) are waiting for approval with the FDA in the United States. This approval and drug-developing pipelines are expected to promise more opportunities to CMOs in the future.

• The growing emphasis on drug discovery and outsourcing of manufacturing drives the market. The adoption of scientific exploration of disease mechanisms progressing to the discovery and development of agents is increasing in the country. The pre-clinical analysis is a critical phase in pharmaceutical research. Several tests are conducted at this stage to determine if a drug is ready for clinical trials.
• According to a recent report of Biopharmaceutical Industry-sponsored Clinical Trials published by the Pharmaceutical Research and Manufacturers of America (PhRMA), in April 2019, a total of 4,516 active clinical trials and 920,173 are estimated for the overall US enrollment. Further, players are increasingly outsourcing their manufacturing to improve their comprehensive services from drug development.
• In February 2019, Thermo Fisher Scientific announced that the company is focused on supplying critical raw materials to manufacture precise immunotherapy vaccines. Under the agreement, Thermo Fisher announced to supply nucleotides, enzymes, and other critical raw materials to support BioNTech's messenger RNA (mRNA) manufacturing platform.
• Also, the increasing investment in capacity expansion significantly assists the market growth. For instance, in January 2019, Catalent announced that it had made a USD 200 million capital investment in the biologics business, for expanding the drug substance manufacturing capacity with drug product fill/finish capacity due to major projected growth among its existing and future customers.
• Further, as the economies around the world are suffering from the impact of Covid-19, and many businesses are experiencing losses, pharmaceutical companies are taking center stage in the Covid-19 fight in countries, such as India and China. In the United States, FDA stated that as Indian imports accounted for 24% of medicines and 31% of medicine ingredients in 2018, but with COVID-19-related shortage, the US manufacturers are affected by COVID-19 that produces an API. The trade group Association for Accessible Medicines sought to reassure the US public with a message that pharmaceutical manufacturers are planning for potential supply disruptions.
• However, players in the country are seeking to grow the business through their clinical trial of the current pandemic. In May 2020, Ajinomoto Bio-Pharma Services (CMO player) announced it has entered into the manufacturing services agreement with CytoDyn Inc. for supplying of the investigational new drug known as leronlimab (PRO 140), which is currently being observed in clinical trial protocols for mild-to-moderately ill and severely ill COVID-19 patients.

US Pharmaceutical Contract Manufacturing Organization Industry Segmentation

The US pharmaceutical contract manufacturing organization (CMO) Market comprises services provided through solutions, such as Active Pharmaceutical Ingredient (API) Manufacturing, Finished Dosage Formulation (FDF) Development and Manufacturing, and Secondary Packaging, which serves the other companies in the pharmaceutical industry on a contract basis.