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

According to Mordor Intelligence, the biologics contract research organization market size is expected to increase from USD 35.25 billion in 2025 to USD 38.83 billion in 2026 and reach USD 60.34 billion by 2031, growing at a CAGR of 9.21% over 2026-2031.

This report is Segmented by Service Type (Pre-Clinical & Analytical Services, Clinical Trial Services and More), Phase (Pre-Clinical, Phase I, and More), Therapeutic Area (Oncology, Immunology & Inflammation, and More), End User (Biopharmaceutical & Biotech Firms, and More), and Geography (North America, Europe, and More). Market Forecasts are Provided in Terms of Value (USD).

Global Biologics Contract Research Organization (CRO) Market Trends and Insights

Surging Adoption of Novel Biologics & Biosimilars

The FDA cleared sixteen biosimilars across 2024 and 2025, including interchangeable adalimumab and ustekinumab versions that together replace reference sales of roughly USD 20 billion. Sponsors outsource comparability analytics because internal labs generally lack validated high-throughput assays, which is why the biologics contract research organization market posts stronger growth in Pre-clinical & Analytical Services than overall revenue. Eurofins and SGS have expanded LC-MS fleets by more than fifteen units each since 2024 to manage the influx . Interchangeability studies require multi-switch crossover designs that only experienced CROs can execute without protocol deviations, reinforcing the strategic value of seasoned providers.

Growing Complexity of Biomolecules Necessitating Specialized Analytics

Bispecific antibodies, ADCs, and fusion proteins demand orthogonal characterization hydrogen-deuterium exchange, analytical ultracentrifugation, and cryo-EM, which sits beyond most in-house quality-control budgets. FDA guidance issued in 2024 asks sponsors to use at least five analytic modalities to confirm lot-to-lot consistency for multispecific constructs. Charles River invested USD 80 million in 2025 for additional cryo-EM and HDX-MS capacity, reinforcing its leadership in the biologics contract research organization market. Glycosylation profiling has emerged as a gating factor for IND acceptance, pushing many sponsors to outsource glycan mapping to labs with validated LC-MS workflows.

Cyber-Security & Data-Integrity Risks in Distributed Biotesting

Ransomware incidents against CRO trial databases shot up 42 % in 2024, prompting FDA warning letters and higher cyber-insurance premiums. Implementation of zero-trust architectures and blockchain audit trails adds USD 2-5 million to annual IT budgets, costs that small labs struggle to absorb.

Other drivers and restraints analyzed in the detailed report include:

1. Cost Pressure & Need for Faster Time-to-Market Encouraging Outsourcing
2. Cell & Gene Therapy Pipeline Expansion Boosting Demand for Advanced Bio-Analytics
3. Scarcity of High-End Biologics Expertise in Emerging Regions

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

Segment Analysis

Clinical Trial Services generated 75.23 % of the biologics contract research organization market revenue in 2025, reflecting the sheer cost of patient enrollment, global site monitoring, and real-time safety oversight. Sponsors routinely spend USD 50 million or more on a single late-stage oncology trial, cementing the clinical category's dominance. However, Pre-clinical & Analytical Services are forecast to expand at 9.60 % CAGR as agencies demand orthogonal analytics, primary structure, higher-order structure, glycosylation, and bioactivity for biosimilar comparability packages. Pre-clinical clients value rapid turnaround on method validation and immunogenicity screening, so CROs with large LC-MS fleets and validated ELISA panels command premium fees. Quality & Regulatory Consulting remains a slim but profitable niche; top-tier providers bill USD 300-500 per hour for CMC dossier drafting and FDA pre-IND support.

Second-generation service lines are emerging as decentralized trials gain traction. Labcorp's 2024 remote-monitoring platform streams cytokine readouts from participants' homes, cutting site visits and speeding recruitment in immunology trials. Charles River booked a 25 % rise in non-human-primate toxicology studies in 2025, driven by bispecific and CAR-T programs. Parexel's Regulatory Intelligence portal flags global CMC gaps in real time, trimming submission readiness by three to six months. Altogether, the biologics contract research organization market benefits from sponsors eager to de-risk clinical programs through better analytics, data visualization, and proactive regulatory strategy.

Clinical Trial phase activities captured 75.10 % of 2025 revenue, with Phase III studies alone often costing USD 40-80 million due to extensive site networks and multi-year follow-up. Adaptive first-in-human designs are making Phase I work more data-rich and expensive, especially when pharmacodynamic biomarkers or basket-trial cohorts are involved. Medpace's 2025 hybrid design combines central infusion clinics with home pharmacokinetic sampling, trimming per-patient costs by 30 % while maintaining data quality. Meanwhile, Pre-clinical projects are accelerating at 9.30 % CAGR as sponsors invest in formulation optimization, developability screening, and immunogenicity risk assessment before filing an IND.

Discovery budgets also rise as AI tools flag aggregation or viscosity liabilities in silico, allowing chemists to prioritize high-probability candidates. NIH awarded USD 120 million in 2025 to university CRO consortia that bridge discovery and pre-clinical toxicology, feeding a pipeline of early-stage work to service providers. Regulatory pressure for long-term monitoring fifteen-year post-marketing follow-up for gene therapies, makes Phase IV an increasingly material revenue stream. Collectively, all stages contribute to the biologics contract research organization market, yet risk-conscious sponsors tilt funding toward early analytics to avoid costly late-phase failures.

Geography Analysis

North America captured 45.32 % of 2025 revenue thanks to a dense cluster of biopharma headquarters, high NIH funding, and FDA leadership in biosimilar and gene-therapy guidance. Nonetheless, the Asia-Pacific is projected to post a 9.90 % CAGR as streamlined regulations and cost arbitrage lure sponsors to China, India, Japan, and South Korea. China's NMPA green-lit 27 biosimilars across 2024-2025 after adopting ICH Q5E, shortening local timelines by eighteen months. India's CDSCO waiver of local trials for low-risk molecules, Japan's alignment of extrapolation, and South Korea's twelve-month fast-track review further solidify the region's appeal.

Europe remains vital, with Germany, the United Kingdom, and France combining for a significant share of 2025 turnover. Germany's Federal Ministry of Education and Research earmarked EUR 800 million in 2025 for translational biologics, often channeled through CRO-managed clinical networks. The Middle East & Africa and South America are smaller but growing, driven by fast-track pathways such as Brazil's fifteen-month biosimilar review. Australia and South Korea benefit from ICH alignment and R&D tax credits; Canada and Mexico gain from USMCA provisions that simplify cross-border sample flow. South Africa and GCC states attract infectious-disease trials where patient prevalence supports larger cohorts, and WHO-backed regulatory capacity building improves data portability to U.S. and EU submissions.

1. Altasciences
2. BioAgilytix Labs
3. Charles River
4. Eurofins
5. Frontage Laboratories
6. Genscript Biotech
7. ICON
8. IQVIA
9. Jubilant Biosys
10. KBI Biopharma
11. LabCorp
12. Lonza Bioscience Solutions
13. Medpace Holdings
14. Parexel International
15. PPD (Thermo Fisher Scientific)
16. Rentschler Biopharma
17. Samsung Biologics CRO Services
18. SGS
19. Syneos Health
20. WuXi App Tec

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 Surging Adoption of Novel Biologics & Biosimilars
  • 4.2.2 Growing Complexity of Biomolecules Necessitating Specialized Analytics
  • 4.2.3 Cost-Pressure & Need for Faster Time-To-Market, Encouraging Outsourcing
  • 4.2.4 Cell & Gene Therapy Pipeline Expansion Boosting Demand for Advanced Bio-Analytics
  • 4.2.5 AI/ML-Enabled In-Silico Biologics Design Services Offered by Cros
  • 4.2.6 Regulatory Harmonization in APAC Facilitating Offshore Biologics Trials
• 4.3 Market Restraints
  • 4.3.1 Stringent Global GMP/GLP Compliance Raising Operating Costs
  • 4.3.2 Scarcity Of High-End Biologics Expertise in Emerging Regions
  • 4.3.3 Shift Toward Integrated CDMO Models Cannibalizing Standalone CRO Revenue
  • 4.3.4 Cyber-Security & Data-Integrity Risks in Distributed Biotesting
• 4.4 Value Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Threat of Substitutes
  • 4.7.4 Threat of New Entrants
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Service Type
  • 5.1.1 Pre-clinical & Analytical Services
  • 5.1.2 Clinical Trial Services
  • 5.1.3 Quality & Regulatory Consulting
  • 5.1.4 Bio-informatics & Data Management
• 5.2 By Phase
  • 5.2.1 Pre-clinical
  • 5.2.2 Phase I
  • 5.2.3 Phase II
  • 5.2.4 Phase III
  • 5.2.5 Phase IV
• 5.3 By Therapeutic Area
  • 5.3.1 Oncology
  • 5.3.2 Immunology & Inflammation
  • 5.3.3 Infectious Diseases
  • 5.3.4 Rare Diseases
  • 5.3.5 Others (Cardio-metabolic, Neurology)
• 5.4 By End User
  • 5.4.1 Biopharmaceutical & Biotech Firms
  • 5.4.2 Academic & Research Institutes
  • 5.4.3 Government & Non-profit Organizations
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 India
    • 5.5.3.3 Japan
    • 5.5.3.4 South Korea
    • 5.5.3.5 Australia
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 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 & Services, and Recent Developments)
  • 6.3.1 Altasciences
  • 6.3.2 BioAgilytix Labs
  • 6.3.3 Charles River Laboratories
  • 6.3.4 Eurofins Scientific
  • 6.3.5 Frontage Laboratories
  • 6.3.6 Genscript Biotech
  • 6.3.7 ICON plc
  • 6.3.8 IQVIA
  • 6.3.9 Jubilant Biosys
  • 6.3.10 KBI Biopharma
  • 6.3.11 Labcorp Drug Development
  • 6.3.12 Lonza Bioscience Solutions
  • 6.3.13 Medpace Holdings
  • 6.3.14 Parexel International
  • 6.3.15 PPD (Thermo Fisher Scientific)
  • 6.3.16 Rentschler Biopharma
  • 6.3.17 Samsung Biologics CRO Services
  • 6.3.18 SGS SA
  • 6.3.19 Syneos Health
  • 6.3.20 WuXi AppTec

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment