United States Pharmaceutical Contract Manufacturing Organization Report (2026-2031) - Rising Pharmaceutical Manufacturing Outsourcing Drives Market Growth
Dublin, Aug. 20, 2026 (GLOBE NEWSWIRE) -- The "United States Pharmaceutical CMO - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)" report has been added to ResearchAndMarkets.com's offering.
United States Pharmaceutical CMO Market to Reach USD 77.56 Billion by 2031
The United States pharmaceutical contract manufacturing organization (CMO) market was valued at USD 55.91 billion in 2025 and is projected to grow from USD 59.20 billion in 2026 to USD 77.56 billion by 2031. The market is expected to register a compound annual growth rate of 5.55% between 2026 and 2031, supported by rising demand for injectable drugs, biologics, advanced therapies, and specialized manufacturing services.
Pharmaceutical companies are increasingly outsourcing production to reduce capital expenditure, improve operational flexibility, and gain access to advanced technologies. This trend is strengthening demand for active pharmaceutical ingredient manufacturing, finished-dose development and manufacturing, secondary packaging, and both clinical- and commercial-scale production.
GLP-1 Demand Accelerates Investment in Fill-Finish Capacity
Rapid growth in prescriptions for GLP-1 treatments, including semaglutide and tirzepatide, is placing significant pressure on syringe and autoinjector manufacturing capacity. Weekly prescriptions tripled between 2023 and 2025, creating longer production queues and higher costs for expedited injectable projects.
The acquisition of three Catalent facilities by Novo Nordisk in 2024 reduced the number of injectable manufacturing slots available to other pharmaceutical sponsors. Although Eli Lilly's USD 9 billion expansion in Lebanon, Indiana, is expected to add four aseptic manufacturing suites by 2027, near-term capacity constraints remain. In response, CMOs are adopting single-use filling systems, automated visual inspection, and real-time release testing to increase throughput and shorten batch cycles.
Domestic Pharmaceutical Manufacturing Gains Momentum
Federal sourcing policies and supply chain security initiatives are encouraging pharmaceutical companies to move more manufacturing work to the United States and allied markets. The BioSecure Act, effective May 2024, has contributed to a shift in biologics production away from suppliers with significant Chinese ties. Domestic mammalian cell-culture capacity is now experiencing booking windows of approximately nine to 15 months.
Major investments reflect this expansion. Samsung Biologics has announced a USD 2.2 billion, 256,000-liter facility in Texas that is scheduled to begin operations in late 2027. Lonza is also investing USD 1 billion in a Pearland expansion focused on CHO cell-line production, while National Resilience has raised USD 800 million for a California gene therapy hub. At the same time, greater regulatory scrutiny of quality systems and electronic records is increasing compliance requirements across the United States pharmaceutical CMO market.
International Cost Competition Pressures Domestic CMOs
Lower-cost manufacturers in Asia-Pacific and South America continue to challenge U.S. pharmaceutical CMOs. Indian and Chinese suppliers offer active pharmaceutical ingredient pricing that can be 30% to 40% below U.S. levels, while Brazilian companies added approximately USD 400 million in sterile injectable capacity during 2025.
Despite ongoing regulatory concerns involving overseas manufacturing facilities, dual-sourcing remains common, particularly in the generics sector. Domestic CMOs are responding by emphasizing faster turnaround times, quality performance, high-containment manufacturing, and specialized services that are more difficult for low-cost competitors to replicate. Pricing pressure is especially pronounced in commodity oral solid-dose manufacturing.
High-Potency APIs and Advanced Therapies Lead Segment Growth
High-potency active pharmaceutical ingredient manufacturing is forecast to expand at an annual rate of 6.21% through 2031, making it one of the fastest-growing service areas. U.S. API manufacturing services generated USD 26.17 billion in 2025, with high-potency projects producing attractive margins due to stringent containment requirements. Investments such as Cambrex's USD 120 million reactor expansion in Iowa demonstrate growing industry interest in cytotoxic and other specialized manufacturing capabilities.
Small molecules accounted for 58.24% of market revenue in 2025 and remain the largest molecule category. However, advanced therapies are projected to grow at a 6.52% CAGR through 2031. Capacity shortages for viral vectors and plasmid DNA have extended booking periods to between 12 and 18 months, encouraging further investment in gene therapy infrastructure.
Biologics manufacturing is also expected to maintain steady growth as established production platforms support expanding drug pipelines and biosimilar opportunities. Meanwhile, demand for injectable finished-dose products is rising rapidly due to GLP-1 therapies and biologic medicines. These trends are prompting large CMOs to build integrated manufacturing networks, while specialized providers focus on high-potency APIs, radiolabeling, lipid nanoparticle formulations, and other technically demanding services.
Continued outsourcing, domestic capacity investment, and the growth of complex drug modalities are expected to support sustained expansion of the United States pharmaceutical CMO market through 2031. Providers that combine regulatory compliance, manufacturing speed, advanced technology, and specialized capabilities will be best positioned to capture emerging opportunities.
Key Topics Covered:
1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET LANDSCAPE
4.1 Market Overview
4.2 Market Drivers
4.2.1 Shift Toward Outsourcing to Reduce CapEx
4.2.2 Growing Pipeline of Biologics and Advanced Therapies
4.2.3 Capacity Shortages Among U.S. Sterile Facilities
4.2.4 Rising Demand for High-Potency API Suites
4.2.5 Surge in GLP-1 Demand Straining Fill-Finish Capacity
4.2.6 BioSecure Act and Domestic Sourcing Incentives
4.3 Market Restraints
4.3.1 Lower-Cost CDMOs in Asia-Pacific and Latin America
4.3.2 Regulatory Complexities and Serialization Mandates
4.3.3 Acute Scarcity of Skilled Radiopharmaceutical Workforce
4.3.4 Cybersecurity Insurance Premiums Post-Ransomware Incidents
4.4 Industry Value-Chain Analysis
4.5 Regulatory Landscape
4.6 Impact of Macroeconomic Factors on the Market
4.7 Technological Outlook
4.8 Porter's Five Forces Analysis
4.8.1 Bargaining Power of Suppliers
4.8.2 Bargaining Power of Buyers
4.8.3 Threat of New Entrants
4.8.4 Threat of Substitutes
4.8.5 Intensity of Competitive Rivalry
5 MARKET SIZE AND GROWTH FORECASTS (VALUE)
5.1 By Service Type
5.1.1 API Manufacturing
5.1.1.1 Small Molecule
5.1.1.2 Large Molecule
5.1.1.3 High-Potency API (HPAPI)
5.1.2 FDF Development and Manufacturing
5.1.2.1 Solid Dose
5.1.2.2 Liquid Dose
5.1.2.3 Injectable Dose
5.1.3 Secondary Packaging
5.2 By Drug Molecule Type
5.2.1 Small Molecule
5.2.2 Biologics
5.2.3 Advanced Therapies (Cell and Gene)
5.3 By Scale of Operation
5.3.1 Clinical-Phase Manufacturing
5.3.2 Commercial-Scale Manufacturing
5.4 By End User
5.4.1 Big Pharma
5.4.2 Generic Pharma
5.4.3 Emerging / Virtual Biotech
5.4.4 Specialty Pharma
5.5 By Therapeutic Area
5.5.1 Oncology
5.5.2 Cardiovascular
5.5.3 Central Nervous System (CNS)
5.5.4 Infectious Disease
5.5.5 Other Therapeutic Areas
6 COMPETITIVE LANDSCAPE
6.1 Market Concentration
6.2 Strategic Moves
6.3 Relative Positioning Analysis
6.4 Market Share Analysis
6.5 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
6.5.1 Catalent Inc.
6.5.2 Thermo Fisher Scientific Inc. (Patheon)
6.5.3 Lonza Group AG
6.5.4 Pfizer CentreOne (Pfizer Inc.)
6.5.5 Baxter International Inc. (BioPharma Solutions)
6.5.6 AbbVie Contract Manufacturing (AbbVie Inc.)
6.5.7 Recipharm AB
6.5.8 Jubilant Pharmova Limited
6.5.9 Boehringer Ingelheim BioXcellence
6.5.10 Aenova Group GmbH
6.5.11 Siegfried Holding AG
6.5.12 Samsung Biologics Co., Ltd.
6.5.13 FUJIFILM Diosynth Biotechnologies USA Inc.
6.5.14 Cambrex Corporation
6.5.15 Alcami Corporation Inc.
6.5.16 PCI Pharma Services
6.5.17 Ajinomoto Bio-Pharma Services
6.5.18 Emergent BioSolutions Inc.
6.5.19 Vetter Pharma-Fertigung GmbH & Co. KG
6.5.20 Grand River Aseptic Manufacturing Inc.
6.5.21 Curia Global Inc.
6.5.22 National Resilience Inc.
6.5.23 Avid Bioservices Inc.
6.5.24 KBI Biopharma Inc.
7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK
7.1 White-Space and Unmet-Need Assessment
For more information about this report visit https://www.researchandmarkets.com/r/b2gybg
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