생물제제 CRO(임상시험수탁기관) 시장 규모, 점유율, 동향, 성장 분석(2026-2034년)

The global biologics contract research organizations market size is expected to reach USD 90.46 Billion in 2034 from USD 38.02 Billion in 2025, growing at a CAGR of 10.11 during 2026-2034.This market is witnessing remarkable growth as pharmaceutical and biotechnology companies increasingly outsource biologics research, clinical development, and regulatory support to specialized contract research organizations. Outsourcing enables companies to accelerate drug development, reduce operational costs, and access advanced scientific expertise while maintaining high regulatory compliance standards. Rising demand for biologic therapies is significantly strengthening market expansion across global healthcare industries.

Increasing research activities involving monoclonal antibodies, vaccines, cell therapies, gene therapies, and biosimilars are major drivers supporting industry growth. Contract research organizations are investing in advanced laboratory technologies, digital clinical trial management, and specialized scientific capabilities to improve development efficiency. Expanding collaborations between biotechnology companies, academic institutions, and pharmaceutical manufacturers are creating substantial opportunities across the biologics research ecosystem.

The future outlook remains highly favorable as personalized medicine, precision therapeutics, and advanced biologic treatments continue gaining global importance. Artificial intelligence, automation, and data-driven clinical research will improve development timelines and regulatory success rates. Rising healthcare investments, expanding biologics pipelines, and increasing outsourcing strategies will support sustained long-term market growth worldwide.

Our reports are carefully developed to deliver comprehensive and actionable insights across a wide range of industries and markets. Each report includes several essential components designed to provide a complete understanding of the market environment:

Market Overview: This section provides a clear introduction to the market, including key definitions, classifications, and an overview of the current industry landscape.

Market Dynamics: A detailed evaluation of the primary drivers, restraints, opportunities, and challenges shaping market growth. It covers factors such as technological developments, regulatory frameworks, and evolving industry trends.

Segmentation Analysis: A structured breakdown of the market into key segments based on product type, application, end-user, and geographic region. This section highlights the performance, growth potential, and contribution of each segment.

Competitive Landscape: An in-depth assessment of leading market participants, including their market positioning, product portfolios, strategic initiatives, and financial performance. It provides valuable insights into competitive dynamics and the strategies adopted by key players.

Market Forecast: Data-driven projections of market size and growth patterns over a defined forecast period. This section incorporates historical trends, current market conditions, and quantitative analysis to illustrate expected future developments.

Regional Analysis: A comprehensive review of market performance across major geographic regions, identifying high-growth areas and regional trends to better understand localized market opportunities.

Emerging Trends and Opportunities: Identification of significant market trends, technological advancements, and new investment opportunities. This section highlights potential growth areas and future industry developments.

Customization Options: We offer flexible customization services to tailor reports according to specific client requirements. This may include additional segmentation, country-level analysis, competitor profiling, customized data points, or focused insights on particular market segments to better support strategic decision-making.

MARKET SEGMENTATION

By Service Type

• Pre-Clinical & Analytical Services
• Clinical Trial Services
• Quality & Regulatory Consulting
• Bioinformatics & Data Management

By Phase

• Pre-Clinical
• Phase I
• Phase II
• Phase III
• Phase IV

By Therapeutic Area

• Oncology
• Immunology & Inflammation
• Infectious Diseases
• Rare Diseases
• Others (Cardio-Metabolic, Neurology)

By End User

• Biopharmaceutical & Biotech Firms
• Academic & Research Institutes
• Government & Non-Profit Organizations

COMPANIES PROFILED

• Altasciences, BioAgilytix Labs, LLC, Charles River Laboratories, Eurofins Scientific SE, Frontage Laboratories Inc., GenScript Biotech Corporation, ICON plc, IQVIA Holdings Inc., Jubilant Biosys Limited, KBI Biopharma Inc., Labcorp Drug Development, Lonza Bioscience Solutions, Medpace Holdings Inc., Parexel International Corporation, PPD Inc. (Thermo Fisher), Rentschler Biopharma SE, Samsung Biologics Co. Ltd., SGS SA, Syneos Health Inc., WuXi AppTec Co. Ltd.

TABLE OF CONTENTS

Chapter 1. PREFACE

• 1.1. Market Segmentation & Scope
• 1.2. Market Definition
• 1.3. Information Procurement
  • 1.3.1 Information Analysis
  • 1.3.2 Market Formulation & Data Visualization
  • 1.3.3 Data Validation & Publishing
• 1.4. Research Scope and Assumptions
  • 1.4.1 List of Data Sources

Chapter 2. EXECUTIVE SUMMARY

• 2.1. Market Snapshot
• 2.2. Segmental Outlook
• 2.3. Competitive Outlook

Chapter 3. MARKET VARIABLES, TRENDS, FRAMEWORK

• 3.1. Market Lineage Outlook
• 3.2. Penetration & Growth Prospect Mapping
• 3.3. Value Chain Analysis
• 3.4. Regulatory Framework
  • 3.4.1 Standards & Compliance
  • 3.4.2 Regulatory Impact Analysis
• 3.5. Market Dynamics
  • 3.5.1 Market Drivers
  • 3.5.2 Market Restraints
  • 3.5.3 Market Opportunities
  • 3.5.4 Market Challenges
• 3.6. Porter's Five Forces Analysis
• 3.7. PESTLE Analysis

Chapter 4. GLOBAL BIOLOGICS CONTRACT RESEARCH ORGANIZATIONS MARKET: BY SERVICE TYPE 2022-2034 (USD MN)

• 4.1. Market Analysis, Insights and Forecast Service Type
• 4.2. Pre-Clinical & Analytical Services Estimates and Forecasts By Regions 2022-2034 (USD MN)
• 4.3. Clinical Trial Services Estimates and Forecasts By Regions 2022-2034 (USD MN)
• 4.4. Quality & Regulatory Consulting Estimates and Forecasts By Regions 2022-2034 (USD MN)
• 4.5. Bioinformatics & Data Management Estimates and Forecasts By Regions 2022-2034 (USD MN)

Chapter 5. GLOBAL BIOLOGICS CONTRACT RESEARCH ORGANIZATIONS MARKET: BY PHASE 2022-2034 (USD MN)

• 5.1. Market Analysis, Insights and Forecast Phase
• 5.2. Pre-Clinical Estimates and Forecasts By Regions 2022-2034 (USD MN)
• 5.3. Phase I Estimates and Forecasts By Regions 2022-2034 (USD MN)
• 5.4. Phase II Estimates and Forecasts By Regions 2022-2034 (USD MN)
• 5.5. Phase III Estimates and Forecasts By Regions 2022-2034 (USD MN)
• 5.6. Phase IV Estimates and Forecasts By Regions 2022-2034 (USD MN)

Chapter 6. GLOBAL BIOLOGICS CONTRACT RESEARCH ORGANIZATIONS MARKET: BY THERAPEUTIC AREA 2022-2034 (USD MN)

• 6.1. Market Analysis, Insights and Forecast Therapeutic Area
• 6.2. Oncology Estimates and Forecasts By Regions 2022-2034 (USD MN)
• 6.3. Immunology & Inflammation Estimates and Forecasts By Regions 2022-2034 (USD MN)
• 6.4. Infectious Diseases Estimates and Forecasts By Regions 2022-2034 (USD MN)
• 6.5. Rare Diseases Estimates and Forecasts By Regions 2022-2034 (USD MN)
• 6.6. Others (Cardio-Metabolic, Neurology) Estimates and Forecasts By Regions 2022-2034 (USD MN)

Chapter 7. GLOBAL BIOLOGICS CONTRACT RESEARCH ORGANIZATIONS MARKET: BY END USER 2022-2034 (USD MN)

• 7.1. Market Analysis, Insights and Forecast End User
• 7.2. Biopharmaceutical & Biotech Firms Estimates and Forecasts By Regions 2022-2034 (USD MN)
• 7.3. Academic & Research Institutes Estimates and Forecasts By Regions 2022-2034 (USD MN)
• 7.4. Government & Non-Profit Organizations Estimates and Forecasts By Regions 2022-2034 (USD MN)

Chapter 8. GLOBAL BIOLOGICS CONTRACT RESEARCH ORGANIZATIONS MARKET: BY REGION 2022-2034 (USD MN)

• 8.1. Regional Outlook
• 8.2. North America Market Analysis, Insights and Forecast, 2022-2034 (USD MN)
  • 8.2.1 By Service Type
  • 8.2.2 By Phase
  • 8.2.3 By Therapeutic Area
  • 8.2.4 By End User
  • 8.2.5 United States
  • 8.2.6 Canada
  • 8.2.7 Mexico
• 8.3. Europe Market Analysis, Insights and Forecast, 2022-2034 (USD MN)
  • 8.3.1 By Service Type
  • 8.3.2 By Phase
  • 8.3.3 By Therapeutic Area
  • 8.3.4 By End User
  • 8.3.5 United Kingdom
  • 8.3.6 France
  • 8.3.7 Germany
  • 8.3.8 Italy
  • 8.3.9 Russia
  • 8.3.10 Rest Of Europe
• 8.4. Asia-Pacific Market Analysis, Insights and Forecast, 2022-2034 (USD MN)
  • 8.4.1 By Service Type
  • 8.4.2 By Phase
  • 8.4.3 By Therapeutic Area
  • 8.4.4 By End User
  • 8.4.5 India
  • 8.4.6 Japan
  • 8.4.7 South Korea
  • 8.4.8 Australia
  • 8.4.9 South East Asia
  • 8.4.10 Rest Of Asia Pacific
• 8.5. Latin America Market Analysis, Insights and Forecast, 2022-2034 (USD MN)
  • 8.5.1 By Service Type
  • 8.5.2 By Phase
  • 8.5.3 By Therapeutic Area
  • 8.5.4 By End User
  • 8.5.5 Brazil
  • 8.5.6 Argentina
  • 8.5.7 Peru
  • 8.5.8 Chile
  • 8.5.9 Rest of Latin America
• 8.6. Middle East & Africa Market Analysis, Insights and Forecast, 2022-2034 (USD MN)
  • 8.6.1 By Service Type
  • 8.6.2 By Phase
  • 8.6.3 By Therapeutic Area
  • 8.6.4 By End User
  • 8.6.5 Saudi Arabia
  • 8.6.6 UAE
  • 8.6.7 Israel
  • 8.6.8 South Africa
  • 8.6.9 Rest of the Middle East And Africa

Chapter 9. COMPETITIVE LANDSCAPE

• 9.1. Recent Developments
• 9.2. Company Categorization
• 9.3. Supply Chain & Channel Partners (based on availability)
• 9.4. Market Share & Positioning Analysis (based on availability)
• 9.5. Vendor Landscape (based on availability)
• 9.6. Strategy Mapping

Chapter 10. COMPANY PROFILES OF GLOBAL BIOLOGICS CONTRACT RESEARCH ORGANIZATIONS INDUSTRY

• 10.1. Top Companies Market Share Analysis
• 10.2. Company Profiles
  • 10.2.1 Altasciences
  • 10.2.2 BioAgilytix Labs, LLC
  • 10.2.3 Charles River Laboratories
  • 10.2.4 Eurofins Scientific SE
  • 10.2.5 Frontage Laboratories Inc
  • 10.2.6 GenScript Biotech Corporation
  • 10.2.7 ICON Plc
  • 10.2.8 IQVIA Holdings Inc
  • 10.2.9 Jubilant Biosys Limited
  • 10.2.10 KBI Biopharma Inc
  • 10.2.11 Labcorp Drug Development
  • 10.2.12 Lonza Bioscience Solutions
  • 10.2.13 Medpace Holdings Inc
  • 10.2.14 Parexel International Corporation
  • 10.2.15 PPD Inc. (Thermo Fisher)
  • 10.2.16 Rentschler Biopharma SE
  • 10.2.17 Samsung Biologics Co. Ltd
  • 10.2.18 SGS SA
  • 10.2.19 Syneos Health Inc
  • 10.2.20 WuXi AppTec Co. Ltd