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

According to Mordor Intelligence, the biopharmaceutical cMO and cRO market size is projected to be USD 41.32 billion in 2025, USD 43.34 billion in 2026, and reach USD 58.64 billion by 2031, growing at a CAGR of 6.23% from 2026 to 2031.

This report is Segmented by Service Type (Contract Manufacturing Organisations, and More), Biologic Type (Monoclonal Antibodies, and More), Source System (Mammalian Expression, and More), Scale of Operation (Pre-Clinical & Clinical, and More), End User (Small & Mid-Size Biopharma, and More), and Geography (North America, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Biopharmaceutical CMO And CRO Market Trends and Insights

Expanding Biologics And Biosimilars Pipeline

The FDA cleared 59 novel drugs in 2024 and another 18 biosimilars in 2025 under streamlined interchangeability rules, pulling analytical and process-development work toward external partners. Monoclonal-antibody pipelines climbed 18% year-on-year, extending into rare-disease combinations that require co-formulation know-how. Cell and gene therapy programs surpassed 2,000 globally, with roughly 80% already contracting CDMOs for early process optimisation to secure late-stage slots. WHO now lists 34 national authorities at Maturity Level 3 or higher, broadening where pivotal biosimilar studies can run. India's vaccine self-sufficiency hit 99%, and China reached roughly 90%, enabling local CDMOs to compete on both cost and speed for biosimilar tech-transfer projects.

Outsourcing Shift From Small To Large Molecules

Small-molecule API outsourcing hit 87% in 2024, essentially topping out, whereas biologics API outsourcing lagged at 61%, pointing to a structural headroom sponsors are rushing to close. Finished-dose outsourcing reached 61% versus a decade average of 50% as innovators reuse in-house lines for high-margin modalities. Large biopharma pledged USD 370 billion in U.S. plants yet earmarked most of that spend for proprietary drug-substance assets, leaving drug-product and clinical supplies to external partners. Facilities such as Lilly's USD 3.5 billion Pennsylvania site and Novo Nordisk's USD 4.1 billion Clayton plant show innovators keeping high-volume commercial assets internal while outsourcing early and niche programs. Single-use technology now allows CDMOs to flip between products within days, making large-molecule contract production economical at sub-large-batch volumes.

Viral-Vector Capacity Bottlenecks

Lead times run 12-18 months for GMP AAV slots, forcing sponsors to pre-book during Phase I and absorb cancellation penalties if programs falter. EU GMP Annex 1, in force since 2023, mandates isolator-based aseptic processing and real-time particulate tracking, raising capex hurdles. Lotte Biologics' USD 3.3 billion Songdo antibody-drug conjugate site shows the capital shift, yet vector suites need bespoke air handling and waste neutralisation that cannot be retrofitted easily. More than 2,000 CGT programs were active in 2024, but only a handful of plants can scale autologous CAR-T therapies, creating a structural mismatch. FDA issued 561 Form 483s in 2024 and over 600 in 2025, many tied to aseptic deviations, underscoring quality barriers that slow capacity growth.

Other drivers and restraints analyzed in the detailed report include:

1. Cost & Time Pressure On Late-Stage Trials
2. Single-Use Bioprocessing Economics
3. Regulatory Harmonisation Gaps

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

Segment Analysis

CMOs captured 57.24% of 2025 turnover, underscoring sponsor preference to outsource asset-heavy drug-substance work instead of funding depreciating capacity in-house. The biopharmaceutical CMO and CRO market share advantage nevertheless shifts when growth is considered: CRO revenue is set to climb 10.42% through 2031 as late-phase protocol complexity drives decentralised-trial adoption. Over the same horizon, the biopharmaceutical CMO and CRO market size tied to manufacturing expands steadily but cedes relative growth to data-rich study services. ICON's USD 15.5 billion backlog, with half deliverable in 12 months, signals stable outsource budgets, while IQVIA's 2026 collaboration with Boehringer Ingelheim shows CROs moving into real-world evidence and regulatory strategy.

Sponsors still rely on CMOs for capacity insurance: global mammalian-cell capacity is forecast to rise from about 6,750 kL in 2024 to close to 9,000 kL by 2028, and CMO share climbs from 28% to roughly 40%. Single-site giants such as Samsung Biologics' 784 kL Incheon campus provide both drug-substance and fill-finish, reducing tech-transfer friction. Industry watchers expect CMOs to keep majority revenue, yet CROs will outpace them in percentage terms, driven by AI-enabled patient matching and real-time data capture that trims enrolment timelines by double digits.

Monoclonal antibodies held 44.57% of 2025 revenue as innovators expand into rare diseases and combination regimens needing co-formulation finesse. The segment's absolute expansion secures the biopharmaceutical CMO and CRO market size floor; however, cell and gene therapies clock the fastest 9.37% CAGR, buoyed by over 2,000 active programs and widespread CDMO engagement during preclinical optimisation. Vaccine volumes normalised post-pandemic, but oligopolistic share keeps margins attractive: the top 10 producers controlled 85% of 2023 value.

Recombinant proteins surge on the back of GLP-1 combinations such as CagriSema, forecast for USD 15 billion sales by 2029, pressuring fill-finish lines tailored to prefilled syringes. Antibody-drug conjugates grow near 20% CAGR, yet capacity shortages endure, prompting Samsung and Lotte to earmark over USD 4 billion for dedicated suites. Sponsors view CGT outsourcing as risk mitigation; lead times, regulatory scrutiny, and bespoke analytics challenge internal build-or-buy economics, handing CDMOs a durable growth lever.

Geography Analysis

North America held 37.81% of 2025 revenue, anchored by the United States' dense innovator pipelines and rapid IND processing. More than USD 370 billion in announced plant spend underlines the region's biomanufacturing primacy, from Lilly's USD 3.5 billion Pennsylvania build to Novo Nordisk's USD 4.1 billion GLP-1 facility. Samsung Biologics' USD 280 million acquisition of GSK's Rockville plant granted 60,000 L of capacity and 500 staff, exemplifying Asian CDMOs entering the U.S. for proximity to clients. Canada and Mexico contribute niche fill-finish and near-shore supply roles under free-trade frameworks.

Europe combines deep biosimilar know-how with mid-tier CDMOs specialising in ADCs and autologous cells. Annex 1 compliance raises cost bars but also forms a quality moat. Investments include Fujifilm Diosynth's USD 928 million Denmark expansion and BioNTech's EUR 1.8 billion Mainz mRNA hub. The biopharmaceutical CMO and CRO market size in Europe benefits from balanced demand across incumbent big pharma and specialty biotechs.

Asia-Pacific is the fastest-growing region at 8.33% CAGR through 2031. Samsung Biologics' 784 kL campus and WuXi Biologics' USD 1.4 billion Singapore site evidence technical parity with Western peers. China accounts for 40% of global clinical trials, yet data-integrity questions keep some pivotal studies abroad. India's 99% vaccine self-sufficiency and Aragen's 2025 Bangalore launch illustrate rising domestic capability. Australia and South Korea round out regional momentum with streamlined early-phase pathways.

Middle East & Africa and South America remain emerging. Africa imports over 70% of its medicines and runs production lines at 30-60% utilisation mainly due to fragmented regulation. Latin America scores 59% on research-climate metrics; Chile and Costa Rica lead but still trail Asian benchmarks by orders of magnitude. Near-term uplift hinges on harmonised regulation and targeted workforce development.

1. Abbvie
2. AGC Biologics
3. Baxter
4. Biocon Biologics Ltd.
5. Boehringer Ingelheim BioXcellence
6. Catalent
7. Charles River
8. Cytovance Biologics
9. Eurofins
10. FUJIFILM
11. ICON
12. IQVIA
13. Laboratory Corporation of America Holdings (Labcorp Drug Development)
14. Lonza Group
15. Merck
16. Parexel International
17. Porton Pharma Solutions
18. Recipharm
19. Samsung Bioepis
20. Samsung Biologics Co., Ltd.
21. SGS
22. Syneos Health
23. Thermo Fisher Scientific
24. Wuxi Biologics

Additional Benefits:

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

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & 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 Expanding Biologics and Biosimilars Pipeline
  • 4.2.2 Increasing Small-Molecule to Large-Molecule Outsourcing Shift
  • 4.2.3 Cost & Time Pressures on Late-Stage Clinical Programs
  • 4.2.4 Single-Use Bioprocessing Economics
  • 4.2.5 Demand for Rapid Surge Capacity (Pandemic Readiness)
  • 4.2.6 Venture-Backed "Virtual Biotech" Operating Model Growth
• 4.3 Market Restraints
  • 4.3.1 Capacity Bottlenecks for Viral-Vector Manufacturing
  • 4.3.2 Regulatory Harmonisation Gaps Across Regions
  • 4.3.3 Rising Energy-Input Costs for Large-Scale Biologics Plants
  • 4.3.4 Talent Scarcity in Advanced Therapy Manufacturing
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value in USD)

• 5.1 By Service Type
  • 5.1.1 Contract Manufacturing Organisations (CMO)
  • 5.1.2 Contract Research Organisations (CRO)
• 5.2 By Biologic Type
  • 5.2.1 Monoclonal Antibodies
  • 5.2.2 Vaccines
  • 5.2.3 Cell & Gene Therapies
  • 5.2.4 Recombinant Proteins
  • 5.2.5 Others
• 5.3 By Source System
  • 5.3.1 Mammalian Expression
  • 5.3.2 Microbial Expression
  • 5.3.3 Other Expression Systems
• 5.4 By Scale of Operation
  • 5.4.1 Pre-clinical & Clinical
  • 5.4.2 Commercial
• 5.5 By End User
  • 5.5.1 Small & Mid-size Biopharma
  • 5.5.2 Large Biopharma
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 France
    • 5.6.2.3 United Kingdom
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 South Korea
    • 5.6.3.5 Australia
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East & Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East & Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products and Services, and Recent Developments)
  • 6.3.1 AbbVie
  • 6.3.2 AGC Biologics
  • 6.3.3 Baxter
  • 6.3.4 Biocon Biologics Ltd.
  • 6.3.5 Boehringer Ingelheim BioXcellence
  • 6.3.6 Catalent Inc.
  • 6.3.7 Charles River Laboratories International Inc.
  • 6.3.8 Cytovance Biologics
  • 6.3.9 Eurofins Scientific SE
  • 6.3.10 Fujifilm Diosynth Biotechnologies
  • 6.3.11 ICON plc
  • 6.3.12 IQVIA Holdings Inc.
  • 6.3.13 Laboratory Corporation of America Holdings (Labcorp Drug Development)
  • 6.3.14 Lonza Group AG
  • 6.3.15 Merck KGaA
  • 6.3.16 Parexel International Corporation
  • 6.3.17 Porton Pharma Solutions
  • 6.3.18 Recipharm AB
  • 6.3.19 Samsung Bioepis
  • 6.3.20 Samsung Biologics Co., Ltd.
  • 6.3.21 SGS SA
  • 6.3.22 Syneos Health Inc.
  • 6.3.23 Thermo Fisher Scientific Inc.
  • 6.3.24 WuXi Biologics

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment