The US pharmaceutical contract manufacturing organization (CMO) market is expected to reach a CAGR of 5.5 % during the forecast period of 2020 to 2025. 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.
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– 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.
Key Market Trends
Increasing Demand of API to Witness Significant Market Growth
– The demand for API manufacturing witnessed a sustained rise in the past few years, and it is expected to continue growing steadily. As of August 2019, 28% of the manufacturing facilities making APIs for the US markets are based in the United States.
– Further, the increasing prevalence of infectious diseases, cardiovascular conditions, and other chronic and genetic disorders are driving the market of API. For instance, The Alzheimer’s Association stated that an estimated 5.8 million Americans aging 65 and older have Alzheimer’s dementia in 2020. 80% are age 75 or older, and this number is predicted to reach approx 14 million, worsening the situation over the forecast period. Also, by 2050, a new case of the disease is expected to develop every 33 seconds. This significantly demands more API facility prevailing high stock.