Summary

Market Size & Trends

The U.S. cell & gene therapy contract research organizations market size was estimated at USD 2.09 billion in 2024 and is projected to reach USD 4.86 billion by 2033, growing at a CAGR of 9.91% from 2025 to 2033. The growth of the market is due to growing complexity of cell- and gene-based therapeutics, rising clinical trial volume in CGT, increased outsourcing by biotech firms, regulatory complexity, among others.

The market is being driven by growing collaboration among scientific innovation, regulatory changes, and evolving sponsor needs. A growing number of advanced therapies-including autologous cell therapies, gene editing interventions, and in vivo viral vector-based treatments-are reaching investigational and clinical stages, often requiring highly tailored preclinical and clinical development programs. Most small-to-midsize biotech firms lack the internal infrastructure to navigate the complex clinical, regulatory, and bioanalytical demands of such therapies, especially those targeting rare or ultra-rare conditions. This gap fuels demand for CROs with niche expertise in translational biology, GMP-compliant sample management, and immunogenicity testing.

Furthermore, an increase in strategic outsourcing models, where sponsors form integrated partnerships with CROs to reduce fixed operational costs and increase scalability, is also one of the factors driving the market growth. The high logistical and patient-specific complexity of therapies such as CAR-T or AAV-based interventions necessitates deep coordination between trial sponsors, clinical sites, and regulatory bodies, prompting sponsors to engage CROs that bring both scientific depth and operational agility. The expansion of academic-industry partnerships, government initiatives supporting rare disease trials, and growing venture capital inflows into cell and gene therapy startups further amplify CRO demand.

U.S. Cell & Gene Therapy Contract Research Organizations Market Report Segmentation

This report forecasts revenue growth at country level 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 U.S. cell & gene therapy contract research organizations market report based on type, phase, service, indication, and modality:

• 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

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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. U.S. 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. U.S. 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. U.S. Cell & Gene Therapy Contract Research Organizations Market: Analysis Tools
3.5.1. Porter’s Five Forces Analysis
3.5.2. PESTEL Analysis
Chapter 4. U.S. Cell & Gene Therapy Contract Research Organizations Market: Type Estimates & Trend Analysis
4.1. Segment Dashboard
4.2. U.S. Cell & Gene Therapy Contract Research Organizations Market Type Movement Analysis
4.3. U.S. 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. U.S. Cell & Gene Therapy Contract Research Organizations Market: Service Estimates & Trend Analysis
5.1. Segment Dashboard
5.2. U.S. Cell & Gene Therapy Contract Research Organizations Market Service Movement Analysis
5.3. U.S. 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. U.S. Cell & Gene Therapy Contract Research Organizations Market: Indication Estimates & Trend Analysis
6.1. Segment Dashboard
6.2. U.S. Cell & Gene Therapy Contract Research Organizations Market Indication Movement Analysis
6.3. U.S. 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. Clinical Monitoring
6.7.1. Clinical Monitoring Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.8. Immunological Disorders
6.8.1. Immunological Disorders Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.9. Cardiovascular Diseases
6.9.1. Cardiovascular Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.10. Respiratory Diseases
6.10.1. Respiratory Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.11. Diabetes
6.11.1. Diabetes Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.12. Ophthalmology
6.12.1. Ophthalmology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.13. Pain Management
6.13.1. Pain Management Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.14. Others
6.14.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 7. U.S. Cell & Gene Therapy Contract Research Organizations Market: Modality Estimates & Trend Analysis
7.1. Segment Dashboard
7.2. U.S. Cell & Gene Therapy Contract Research Organizations Market Modality Movement Analysis
7.3. U.S. 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. Competitive Landscape
8.1. Company Categorization
8.1.1. Market Leaders
8.1.2. Emerging Players
8.2. Company Market Share/Assessment Analysis, 2024
8.3. Company Profiles
8.3.1. Altasciences
8.3.1.1. Company overview
8.3.1.2. Financial performance
8.3.1.3. Service benchmarking
8.3.1.4. Strategic initiatives
8.3.2. Allucent
8.3.2.1. Company overview
8.3.2.2. Financial performance
8.3.2.3. Service benchmarking
8.3.2.4. Strategic initiatives
8.3.3. LabCorp
8.3.3.1. Company overview
8.3.3.2. Financial performance
8.3.3.3. Service benchmarking
8.3.3.4. Strategic initiatives
8.3.4. Linical
8.3.4.1. Company overview
8.3.4.2. Financial performance
8.3.4.3. Service benchmarking
8.3.4.4. Strategic initiatives
8.3.5. Medpace
8.3.5.1. Company overview
8.3.5.2. Financial performance
8.3.5.3. Service benchmarking
8.3.5.4. Strategic initiatives
8.3.6. Thermo Fisher Scientific Inc.
8.3.6.1. Company overview
8.3.6.2. Financial performance
8.3.6.3. Service benchmarking
8.3.6.4. Strategic initiatives
8.3.7. Precision Medicine Group, LLC.
8.3.7.1. Company overview
8.3.7.2. Financial performance
8.3.7.3. Service benchmarking
8.3.7.4. Strategic initiatives
8.3.8. QPS Holdings
8.3.8.1. Company overview
8.3.8.2. Financial performance
8.3.8.3. Service benchmarking
8.3.8.4. Strategic initiatives
8.3.9. Syneos Health
8.3.9.1. Company overview
8.3.9.2. Financial performance
8.3.9.3. Service benchmarking
8.3.9.4. Strategic initiatives
8.3.10. ICON plc
8.3.10.1. Company overview
8.3.10.2. Financial performance
8.3.10.3. Service benchmarking
8.3.10.4. Strategic initiatives