Summary

Cell & Gene Therapy Contract Research Organizations Market Summary

The global cell & gene therapy contract research organizations market size was estimated at USD 4.84 billion in 2024 and is projected to reach USD 11.26 million by 2033, growing at a CAGR of 9.89% from 2025 to 2033. The growth is due to the rising clinical trial volume in CGT, increased outsourcing by biotech firms, regulatory complexity, and global expansion, among others.

The growth of the cell & gene therapy contract research organizations industry is fueled by the rapid expansion of clinical pipelines, especially in oncology, hematologic, and rare genetic disorders. Sponsors are increasingly turning to CROs due to the high complexity, regulatory scrutiny, and cost intensity of CGT trials. These therapies demand specialized logistics, personalized manufacturing coordination, and sophisticated data handling capabilities that most small to mid-sized biotech firms prefer to outsource. Moreover, the global increase in Investigational New Drug (IND) applications for ATMPs has heightened demand for regulatory support, trial design, and long-term safety monitoring services.

Advancements in gene-editing platforms such as CRISPR and viral and non-viral delivery technologies are transforming CGT development, thereby intensifying the need for expert-led preclinical and clinical research support. CROs offering integrated solutions across discovery, preclinical validation, vector analytics, and GMP compliance are gaining a competitive edge. Additionally, increased funding, strategic partnerships, and industry consolidation have enhanced the CRO ecosystem’s capacity to scale with the innovation surge. This ecosystem shift has positioned specialized CROs as essential partners in accelerating CGT approvals and global trial execution.

Global Cell & Gene Therapy Contract Research Organizations Market Report Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global cell & gene therapy contract research organizations market report based on type, service, indication, modality, and region:

• Type Outlook (Revenue, USD Million, 2021 - 2033)
• Drug Discovery
o Target Validation
o Lead Identification
o Lead Optimization
• Preclinical
• Clinical
o Phase I
o Phase II
o Phase III
o Phase IV
• Service Outlook (Revenue, USD Million, 2021 - 2033)
• Project & Clinical Trial Management
• Regulatory Strategy
• Data Management & Medical Writing
• Clinical Monitoring
• Quality Management / GMP Compliance
• Biostatistics & Safety Monitoring
• Patient & Site Recruitment
• Technology Transfer
• Others
• Indication Outlook (Revenue, USD Million, 2021 - 2033)
• Oncology
• CNS Disorders
• Infectious Diseases
• Immunological Disorders
• Cardiovascular Diseases
• Respiratory Diseases
• Diabetes
• Ophthalmology
• Pain Management
• Others
• Modality Outlook (Revenue, USD Million, 2021 - 2033)
• Cell-Based Therapies
• Gene Therapies
• Gene-Modified Cell Therapies
• Regional Outlook (Revenue, USD Million, 2021 - 2033)
• North America
o U.S.
o Canada
o Mexico
• Europe
o UK
o Germany
o France
o Italy
o Spain
o Denmark
o Norway
o Sweden
• Asia Pacific
o Japan
o China
o India
o Australia
o South Korea
o Thailand
• Latin America
o Brazil
o Argentina
• Middle East and Africa (MEA)
o South Africa
o Saudi Arabia
o UAE
o Kuwait

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Table of Contents

Table of Contents

Chapter 1. Methodology and Scope
1.1. Market Segmentation and Scope
1.2. Market Definitions
1.3. Research Methodology
1.4. Information Procurement
1.4.1. Purchased database
1.4.2. GVR’s internal database
1.4.3. Secondary sources
1.4.4. Primary research
1.5. Information or Data Analysis
1.5.1. Data analysis models
1.6. Market Formulation & Validation
1.7. Model Details
1.7.1. Commodity flow analysis (Model 1)
1.7.2. Value chain based analysis (Model 2)
1.7.3. Multivariate Analysis (Model 3)
1.8. List of Secondary Sources
1.9. List of Primary Sources
1.10. Objectives
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Snapshot
2.3. Competitive Landscape Snapshot
Chapter 3. Cell & Gene Therapy Contract Research Organizations Market: Variables, Trends, & Scope
3.1. Market Lineage Outlook
3.1.1. Parent Market Outlook
3.1.2. Ancillary Market Outlook
3.2. Cell & Gene Therapy Contract Research Organizations Market Dynamics
3.2.1. Market Driver Impact Analysis
3.2.2. Market Restraint Analysis
3.3. Technological Landscape
3.4. Pricing Model Analysis
3.5. Cell & Gene Therapy Contract Research Organizations Market: Analysis Tools
3.5.1. Porter’s Five Forces Analysis
3.5.2. PESTEL Analysis
Chapter 4. Cell & Gene Therapy Contract Research Organizations Market: Type Estimates & Trend Analysis
4.1. Segment Dashboard
4.2. Global Cell & Gene Therapy Contract Research Organizations Market Type Movement Analysis
4.3. Global Cell & Gene Therapy Contract Research Organizations Market Size & Trend Analysis, by Type, 2021 to 2033 (USD Million)
4.4. Drug Discovery
4.4.1. Drug Discovery Market Estimates and Forecasts, 2021 - 2033 (USD million)
4.4.2. Target Validation
4.4.2.1. Target Validation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.3. Lead Identification
4.4.3.1. Lead Identification Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.4. Lead Optimization
4.4.4.1. Lead Optimization Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.5. Preclinical
4.5.1. Preclinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.6. Clinical
4.6.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.6.2. Phase I
4.6.2.1. Phase I Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.6.3. Phase II
4.6.3.1. Phase II Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.6.4. Phase III
4.6.4.1. Phase III Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.6.5. Phase IV
4.6.5.1. Phase IV Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 5. Cell & Gene Therapy Contract Research Organizations Market: Service Estimates & Trend Analysis
5.1. Segment Dashboard
5.2. Global Cell & Gene Therapy Contract Research Organizations Market Service Movement Analysis
5.3. Global Cell & Gene Therapy Contract Research Organizations Market Size & Trend Analysis, by Service, 2021 to 2033 (USD Million)
5.4. Project & Clinical Trial Management
5.4.1. Project & Clinical Trial Management Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.5. Regulatory Strategy
5.5.1. Regulatory Strategy Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.6. Data Management & Medical Writing
5.6.1. Data Management & Medical Writing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.7. Clinical Monitoring
5.7.1. Clinical Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.8. Quality Management / GMP Compliance
5.8.1. Quality Management / GMP Compliance Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.9. Biostatistics & Safety Monitoring
5.9.1. Biostatistics & Safety Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.10. Patient & Site Recruitment
5.10.1. Patient & Site Recruitment Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.11. Technology Transfer
5.11.1. Technology Transfer Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.12. Others
5.12.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 6. Cell & Gene Therapy Contract Research Organizations Market: Indication Estimates & Trend Analysis
6.1. Segment Dashboard
6.2. Global Cell & Gene Therapy Contract Research Organizations Market Indication Movement Analysis
6.3. Global Cell & Gene Therapy Contract Research Organizations Market Size & Trend Analysis, by Indication, 2021 to 2033 (USD Million)
6.4. Oncology
6.4.1. Oncology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.5. CNS Disorders
6.5.1. CNS Disorders Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.6. Infectious Diseases
6.6.1. Infectious Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.7. Immunological Disorders
6.7.1. Immunological Disorders Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.8. Cardiovascular Diseases
6.8.1. Cardiovascular Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.9. Respiratory Diseases
6.9.1. Respiratory Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.10. Diabetes
6.10.1. Diabetes Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.11. Ophthalmology
6.11.1. Ophthalmology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.12. Pain Management
6.12.1. Pain Management Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.13. Others
6.13.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 7. Cell & Gene Therapy Contract Research Organizations Market: Modality Estimates & Trend Analysis
7.1. Segment Dashboard
7.2. Global Cell & Gene Therapy Contract Research Organizations Market Modality Movement Analysis
7.3. Global Cell & Gene Therapy Contract Research Organizations Market Size & Trend Analysis, by Modality, 2021 to 2033 (USD Million)
7.4. Cell-Based Therapies
7.4.1. Cell-Based Therapies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
7.5. Gene Therapies
7.5.1. Gene Therapies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
7.6. Gene-Modified Cell Therapies
7.6.1. Gene-Modified Cell Therapies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 8. Cell & Gene Therapy Contract Research Organizations Market: Regional Estimates & Trend Analysis by Type, Product, Test, Sample, End Use
8.1. Regional Market Dashboard
8.2. Global Regional Market Snapshot
8.3. Market Size, & Forecasts Trend Analysis, 2021 to 2033:
8.4. North America
8.4.1. North America Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.4.2. U.S.
8.4.2.1. Key Country Dynamics
8.4.2.2. Competitive Scenario
8.4.2.3. Regulatory Framework
8.4.2.4. U.S. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.4.3. Canada
8.4.3.1. Key Country Dynamics
8.4.3.2. Competitive Scenario
8.4.3.3. Regulatory Framework
8.4.3.4. Canada Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.4.4. Mexico
8.4.4.1. Key Country Dynamics
8.4.4.2. Competitive Scenario
8.4.4.3. Regulatory Framework
8.4.4.4. Mexico Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.5. Europe
8.5.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.5.2. UK
8.5.2.1. Key Country Dynamics
8.5.2.2. Competitive Scenario
8.5.2.3. Regulatory Framework
8.5.2.4. Europe Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.5.3. Germany
8.5.3.1. Key Country Dynamics
8.5.3.2. Competitive Scenario
8.5.3.3. Regulatory Framework
8.5.3.4. Germany Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.5.4. France
8.5.4.1. Key Country Dynamics
8.5.4.2. Competitive Scenario
8.5.4.3. Regulatory Framework
8.5.4.4. France Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.5.5. Italy
8.5.5.1. Key Country Dynamics
8.5.5.2. Competitive Scenario
8.5.5.3. Regulatory Framework
8.5.5.4. Italy Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.5.6. Spain
8.5.6.1. Key Country Dynamics
8.5.6.2. Competitive Scenario
8.5.6.3. Regulatory Framework
8.5.6.4. Spain Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.5.7. Denmark
8.5.7.1. Key Country Dynamics
8.5.7.2. Competitive Scenario
8.5.7.3. Regulatory Framework
8.5.7.4. Denmark Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.5.8. Sweden
8.5.8.1. Key Country Dynamics
8.5.8.2. Competitive Scenario
8.5.8.3. Regulatory Framework
8.5.8.4. Sweden Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.5.9. Norway
8.5.9.1. Key Country Dynamics
8.5.9.2. Competitive Scenario
8.5.9.3. Regulatory Framework
8.5.9.4. Norway Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.6. Asia Pacific
8.6.1. Asia Pacific Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.6.2. Japan
8.6.2.1. Key Country Dynamics
8.6.2.2. Competitive Scenario
8.6.2.3. Regulatory Framework
8.6.2.4. Japan Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.6.3. China
8.6.3.1. Key Country Dynamics
8.6.3.2. Competitive Scenario
8.6.3.3. Regulatory Framework
8.6.3.4. China Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.6.4. India
8.6.4.1. Key Country Dynamics
8.6.4.2. Competitive Scenario
8.6.4.3. Regulatory Framework
8.6.4.4. India Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.6.5. Australia
8.6.5.1. Key Country Dynamics
8.6.5.2. Competitive Scenario
8.6.5.3. Regulatory Framework
8.6.5.4. Australia Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.6.6. South Korea
8.6.6.1. Key Country Dynamics
8.6.6.2. Competitive Scenario
8.6.6.3. Regulatory Framework
8.6.6.4. South Korea Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.6.7. Thailand
8.6.7.1. Key Country Dynamics
8.6.7.2. Competitive Scenario
8.6.7.3. Regulatory Framework
8.6.7.4. Thailand Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.7. Latin America
8.7.1. Latin America Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.7.2. Brazil
8.7.2.1. Key Country Dynamics
8.7.2.2. Competitive Scenario
8.7.2.3. Regulatory Framework
8.7.2.4. Brazil Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.7.3. Argentina
8.7.3.1. Key Country Dynamics
8.7.3.2. Competitive Scenario
8.7.3.3. Regulatory Framework
8.7.3.4. Argentina Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.8. MEA
8.8.1. MEA Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.8.2. South Africa
8.8.2.1. Key Country Dynamics
8.8.2.2. Competitive Scenario
8.8.2.3. Regulatory Framework
8.8.2.4. South Africa Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.8.3. Saudi Arabia
8.8.3.1. Key Country Dynamics
8.8.3.2. Competitive Scenario
8.8.3.3. Regulatory Framework
8.8.3.4. Saudi Arabia Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.8.4. UAE
8.8.4.1. Key Country Dynamics
8.8.4.2. Competitive Scenario
8.8.4.3. Regulatory Framework
8.8.4.4. UAE Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.8.5. Kuwait
8.8.5.1. Key Country Dynamics
8.8.5.2. Competitive Scenario
8.8.5.3. Regulatory Framework
8.8.5.4. Kuwait Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 9. Competitive Landscape
9.1. Company Categorization
9.2. Cell & Gene Therapy Contract Research Organizations Market Share Analysis, 2024
9.3. Company Profiles
9.3.1. Altasciences
9.3.1.1. Company overview
9.3.1.2. Financial performance
9.3.1.3. Product benchmarking
9.3.1.4. Strategic initiatives
9.3.2. Allucent
9.3.2.1. Company overview
9.3.2.2. Financial performance
9.3.2.3. Product benchmarking
9.3.2.4. Strategic initiatives
9.3.3. Labcorp
9.3.3.1. Company overview
9.3.3.2. Financial performance
9.3.3.3. Product benchmarking
9.3.3.4. Strategic initiatives
9.3.4. Linical
9.3.4.1. Company overview
9.3.4.2. Financial performance
9.3.4.3. Product benchmarking
9.3.4.4. Strategic initiatives
9.3.5. Medpace
9.3.5.1. Company overview
9.3.5.2. Financial performance
9.3.5.3. Product benchmarking
9.3.5.4. Strategic initiatives
9.3.6. Thermo Fisher Scientific Inc.
9.3.6.1. Company overview
9.3.6.2. Financial performance
9.3.6.3. Product benchmarking
9.3.6.4. Strategic initiatives
9.3.7. Precision Medicine Group, LLC.
9.3.7.1. Company overview
9.3.7.2. Financial performance
9.3.7.3. Product benchmarking
9.3.7.4. Strategic initiatives
9.3.8. QPS Holdings
9.3.8.1. Company overview
9.3.8.2. Financial performance
9.3.8.3. Product benchmarking
9.3.8.4. Strategic initiatives
9.3.9. Syneos Health
9.3.9.1. Company overview
9.3.9.2. Financial performance
9.3.9.3. Product benchmarking
9.3.9.4. Strategic initiatives
9.3.10. ICON plc
9.3.10.1. Company overview
9.3.10.2. Financial performance
9.3.10.3. Product benchmarking
9.3.10.4. Strategic initiatives