DUBLIN--(BUSINESS WIRE)--The "United States Pharmaceutical Contract Manufacturing Organization (CMO) Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)" report has been added to ResearchAndMarkets.com's offering.
The US pharmaceutical contract manufacturing organization (CMO) market is expected to reach a CAGR of 5 % during the forecast period of 2022 to 2027.
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.
Key Highlights
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.
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.
Furthermore, according to Hemp Business Journal, till 2022, the estimated sales of hemp-based cannabidiol (CBD) products in the United States is USD 522 million (human) and USD 125 million (pet/animal). The Wall Street investment firm estimated that in 2018, Americans spent about USD 2 billion on CBD API mostly for treating anxiety, pain, or sleep issues. By 2025, Wall Street predicts that the market value will rise to USD 16 billion. With the increasing rate of chronic pain, anxiety, inflammation, and insomnia in the United States people, this significantly supports the market growth.
Injectable Dose to Witness Significant Market Share
The increasing demand for generic drugs in the country tends to increase the market of Finished Dosage Formulation (FDF) Development. With increasing approval of Abbreviated New Drug Application (ANDA), Generics will continue to dominate prescription drug usage in the United States, rising to 92% by 2020, the source stated by IMS Institute for Healthcare Informatics. Also, an additional 146 Tentative Approvals for new drugs were also granted during the calendar year 2019 through the Food and Drug Administration (FDA).
The rise in a number of chronic illnesses, like diabetes and cancer (with roughly 1.8 million people diagnosed with cancer in 2019 and 34 million diabetic people in the United States), has increased the requirement for injectable drug delivery. Injectable dose formulations are sterile preparations, including small- and large-volume parenterals. Small-volume parenterals are of two types: cytotoxic and non-cytotoxic.
Owing to the robust demand for oncology and other high-potency drugs (such as antibody conjugates, steroids, and IV fluids that require quick onset of action), cytotoxic drugs (drugs used to destroy cancer cell) are expected to be the key growth driver for the injectable dose formulation segment. According to the American Cancer Society, in 2020, there will be an estimated 1.8 million new cancer cases diagnosed and 606,520 cancer deaths in the United States.
Companies Mentioned
- Catalent Inc.
- Recipharm AB
- Jubilant Life Sciences Ltd
- Thermo Fisher Scientific Inc. (Patheon Inc.)
- Boehringer Ingelheim Group
- Pfizer CentreSource (Pfizer Inc.)
- Aenova Group
- AbbVie Contract Manufacturing
- Baxter Biopharma Solutions (Baxter International Inc.)
- Lonza Group AG
- Siegfried AG
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