Market Size of US Pharmaceutical CMO Industry
| Study Period | 2019 - 2029 |
| Base Year For Estimation | 2023 |
| Forecast Data Period | 2024 - 2029 |
| Historical Data Period | 2019 - 2022 |
| CAGR | 5.00 % |
| Market Concentration | Low |
Major Players
*Disclaimer: Major Players sorted in no particular order |
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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.
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US Pharmaceutical CMO Market Size Summary
The US pharmaceutical contract manufacturing organization (CMO) market is poised for growth, driven by the increasing emphasis on drug discovery and the outsourcing of manufacturing processes. The stringent regulatory environment in the United States ensures high-quality manufacturing standards, which is a significant factor in the market's expansion. The presence of a substantial number of active Investigational New Drugs awaiting FDA approval highlights the potential opportunities for CMOs. The market is further bolstered by advancements in scientific exploration and pre-clinical analysis, which are crucial phases in pharmaceutical research. The trend of outsourcing manufacturing to enhance comprehensive services in drug development is gaining momentum, with companies like Thermo Fisher Scientific and Catalent making significant investments to expand their capabilities.
The demand for active pharmaceutical ingredients (APIs) and finished dosage formulations is on the rise, fueled by the increasing prevalence of chronic diseases and the growing need for generic drugs. The market for injectable drug delivery systems is expected to grow, driven by the robust demand for oncology and high-potency drugs. The US pharmaceutical industry is also witnessing a surge in the development of CBD-based products, reflecting the rising consumer interest in alternative therapies. The competitive landscape is characterized by the presence of major players such as Catalent Inc. and Recipharm AB, who are continuously expanding their facilities and capabilities to meet the evolving market demands. The market's growth is supported by strategic collaborations and investments aimed at enhancing manufacturing capacities and ensuring a stable supply of critical medications.
US Pharmaceutical CMO Market Size - Table of Contents
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1. MARKET DYNAMICS
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1.1 Market Overview
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1.2 Industry Attractiveness - Porter's Five Forces Analysis
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1.2.1 Bargaining Power of Suppliers
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1.2.2 Bargaining Power of Consumers
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1.2.3 Threat of New Entrants
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1.2.4 Threat of Substitute Products
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1.2.5 Intensity of Competitive Rivalry
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1.3 Industry Value Chain Analysis
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1.4 Industry Policies
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1.5 Market Drivers
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1.5.1 Increasing Emphasis on Drug Discovery and Outsourcing of Manufacturing
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1.5.2 Strong R&D Investments
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1.6 Market Challenges
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1.6.1 Presence of Low-Cost Alternatives For Outsourcing
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1.6.2 Regulatory and Operational Concerns Due to the Move Toward Serialization
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1.7 Key considerations involved in the selection of a CMO in the United States
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1.8 Impact of COVID-19 on CMOs and Analysis on the Short and Medium-Term Impact on Manufacturing Output
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2. MARKET SEGMENTATION
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2.1 By Service Type
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2.1.1 Active Pharmaceutical Ingredient (API) Manufacturing
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2.1.1.1 Small Molecule
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2.1.1.2 Large Molecule
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2.1.1.3 High Potency API (HPAPI)
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2.1.2 Finished Dosage Formulation (FDF) Development and Manufacturing
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2.1.2.1 Solid Dose Formulation
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2.1.2.2 Liquid Dose Formulation
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2.1.2.3 Injectable Dose Formulation
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2.1.3 Secondary Packaging
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US Pharmaceutical CMO Market Size FAQs
What is the current US Pharmaceutical CMO Market size?
The US Pharmaceutical CMO Market is projected to register a CAGR of 5% during the forecast period (2024-2029)
Who are the key players in US Pharmaceutical CMO Market?
Catalent Inc., Recipharm AB, Jubilant Life Sciences Ltd, Thermo Fisher Scientific Inc. (Patheon Inc.) and Boehringer Ingelheim Group are the major companies operating in the US Pharmaceutical CMO Market.
