미국의 의약품 CMO 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the United States pharmaceutical CMO market size was valued at USD 55.91 billion in 2025 and estimated to grow from USD 59.2 billion in 2026 to reach USD 77.56 billion by 2031, at a CAGR of 5.55% during the forecast period (2026-2031).

This report is Segmented by Service Type (API Manufacturing, FDF Development and Manufacturing, and Secondary Packaging), Drug Molecule Type (Small Molecule, Biologics, and Advanced Therapies), Scale of Operation (Clinical-Phase, and Commercial-Scale), End User (Big Pharma, and More), Therapeutic Area (Oncology, and More), and Geography. Market Forecasts are Provided in Terms of Value (USD).

United States Pharmaceutical CMO Market Trends and Insights

Surge In GLP-1 Demand Straining Fill-Finish Capacity

Weekly semaglutide and tirzepatide prescriptions tripled between 2023 and 2025, overwhelming syringe and autoinjector lines originally sized for insulin volumes. The 2024 acquisition of three Catalent plants by Novo Nordisk removed roughly one-quarter of open-market injectable slots, forcing smaller sponsors to accept 18-month queues or premium surcharges. Eli Lilly's USD 9 billion Lebanon, Indiana, build-out will add four aseptic suites by 2027, yet interim shortages persist. CDMOs now charge 30%-40% more than 2024 rates for expedited GLP-1 projects, spurring rapid adoption of single-use filling systems and automated vision inspection. The FDA's Quality Management Maturity pilot, launched in 2024, rewards real-time release testing that trims two to three weeks from batch cycles.

BioSecure Act And Domestic Sourcing Incentives

Effective May 2024, the BioSecure Act bars federal contractors from sourcing drug substance from suppliers with significant Chinese ties, redirecting an estimated USD 3 billion in biologics work to domestic and allied CDMOs within a year. Mammalian cell-culture bookings now run 9-15 months, prompting Samsung Biologics to break ground on a USD 2.2 billion, 256,000-liter Texas plant slated for late 2027 start-up. Lonza followed with a USD 1 billion Pearland expansion focused on CHO cell lines. National Resilience raised USD 800 million for a California gene-therapy hub aimed at biodefense contracts. Federal auditors now scrutinize ISO 13485 and 21 CFR Part 11 compliance in unprecedented depth, raising the bar for smaller competitors.

Lower-Cost CDMOs In Asia-Pacific and South America

Indian and Chinese suppliers undercut U.S. API pricing by 30%-40%, and Brazilian operators added USD 400 million in sterile-injectable capacity during 2025. Biocon Biologics and Dr. Reddy's have scaled biosimilars for trastuzumab and adalimumab, positioning to capture share when U.S. patents expire in 2027-2028. Although the FDA issued 14 warning letters to Indian API plants in 2024 for data-integrity failures, dual-sourcing remains common because generic margins cannot absorb U.S. cost structures. Consequently, domestic CDMOs must compete on speed, quality metrics, or high-containment niches that low-cost rivals cannot mimic. Margin compression is most acute in commodity oral solids, where price sensitivity is highest.

Other drivers and restraints analyzed in the detailed report include:

1. Growing Pipeline of Biologics and Advanced Therapies
2. Shift Toward Outsourcing to Reduce CapEx
3. Regulatory Complexities and Serialization Mandates

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

High-potency API work grew 6.21% annually through 2031, the quickest pace within the service mix. The United States pharmaceutical CMO market size for API services reached USD 26.17 billion in 2025, with HPAPI contributing the steepest margin because antibody-drug conjugate payloads require nanogram-level containment. Cambrex's USD 120 million Iowa reactors exemplify the shift toward cytotoxic specialization. Full-dose formulation, including solid, liquid, and injectable products, fills the remainder of revenue, yet injectable demand is expanding fastest due to GLP-1 and biologics pipelines. Continuous manufacturing in solid dose cuts cycle time 75% but fewer than 20 domestic lines use the technology.

Service providers are bifurcating scale players invest in integrated API-to-packaging chains, while niche firms target HPAPI, radiolabelling, or lipid-nanoparticle formulation. Sponsors pay 30%-70% premiums for SafeBridge-certified suites versus standard reactors, expanding the United States pharmaceutical CMO market by incentivizing brownfield retrofits. Commodity solid-dose producers, by contrast, compete on throughput and cost, especially as generic pricing pressure intensifies.

Small molecules still accounted for 58.24% revenue in 2025, yet advanced therapies are accelerating at a 6.52% CAGR to 2031. Viral-vector and plasmid-DNA capacity shortfalls elevate booking windows to 12-18 months. Thermo Fisher's Plainville site and FUJIFILM Diosynth's North Carolina campus illustrate the capital race toward large-scale gene-therapy production. Biologics occupy the middle trajectory, sustained by established CHO platforms and biosimilar opportunities as blockbuster antibodies lose exclusivity.

The United States pharmaceutical CMO market share for advanced therapies, while modest today, is set to widen as payers embrace one-time curative treatments. Simultaneously, small-molecule CDMOs hedge with HPAPI upgrades and abuse-deterrent formulation expertise to defend margins. Molecule diversity therefore anchors strategic flexibility for contractors.

Complete Report Scope:

• By Service Type
  • API Manufacturing
    • Small Molecule
    • Large Molecule
    • High-Potency API (HPAPI)
  • FDF Development and Manufacturing
    • Solid Dose
    • Liquid Dose
    • Injectable Dose
  • Secondary Packaging
• By Drug Molecule Type
  • Small Molecule
  • Biologics
  • Advanced Therapies (Cell and Gene)
• By Scale of Operation
  • Clinical-Phase Manufacturing
  • Commercial-Scale Manufacturing
• By End User
  • Big Pharma
  • Generic Pharma
  • Emerging / Virtual Biotech
  • Specialty Pharma
• By Therapeutic Area
  • Oncology
  • Cardiovascular
  • Central Nervous System (CNS)
  • Infectious Disease
  • Other Therapeutic Areas

List of Companies Covered in this Report:

1. Catalent Inc.
2. Thermo Fisher Scientific Inc. (Patheon)
3. Lonza Group AG
4. Pfizer CentreOne (Pfizer Inc.)
5. Baxter International Inc. (BioPharma Solutions)
6. AbbVie Contract Manufacturing (AbbVie Inc.)
7. Recipharm AB
8. Jubilant Pharmova Limited
9. Boehringer Ingelheim BioXcellence
10. Aenova Group GmbH
11. Siegfried Holding AG
12. Samsung Biologics Co., Ltd.
13. FUJIFILM Diosynth Biotechnologies USA Inc.
14. Cambrex Corporation
15. Alcami Corporation Inc.
16. PCI Pharma Services
17. Ajinomoto Bio-Pharma Services
18. Emergent BioSolutions Inc.
19. Vetter Pharma-Fertigung GmbH & Co. KG
20. Grand River Aseptic Manufacturing Inc.
21. Curia Global Inc.
22. National Resilience Inc.
23. Avid Bioservices Inc.
24. KBI Biopharma Inc.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

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