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.
This product will be delivered within 2 business days.
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, the analyst 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
- Target Validation
- Lead Identification
- Lead Optimization
- Preclinical
- Clinical
- Phase I
- Phase II
- Phase III
- 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
Why should you buy this report?
- Comprehensive Market Analysis: Gain detailed insights into the global market across major regions and segments.
- Competitive Landscape: Explore the market presence of key players worldwide.
- Future Trends: Discover the pivotal trends and drivers shaping the future of the global market.
- Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.
This report addresses:
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segment and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
- Product innovation listing for you to stay ahead of the curve
- COVID-19's impact and how to sustain in these fast-evolving markets
This product will be delivered within 2 business days.
Table of Contents
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. U.S. Cell & Gene Therapy Contract Research Organizations Market: Variables, Trends, & Scope
Chapter 4. U.S. Cell & Gene Therapy Contract Research Organizations Market: Type Estimates & Trend Analysis
Chapter 5. U.S. Cell & Gene Therapy Contract Research Organizations Market: Service Estimates & Trend Analysis
Chapter 6. U.S. Cell & Gene Therapy Contract Research Organizations Market: Indication Estimates & Trend Analysis
Chapter 7. U.S. Cell & Gene Therapy Contract Research Organizations Market: Modality Estimates & Trend Analysis
Chapter 8. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
- Altasciences
- Allucent
- Labcorp
- Linical
- Medpace
- Thermo Fisher Scientific Inc.
- Precision Medicine Group, LLC.
- QPS Holdings
- Syneos Health
- ICON plc
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 150 |
| Published | July 2025 |
| Forecast Period | 2024 - 2033 |
| Estimated Market Value ( USD | $ 2.09 Billion |
| Forecasted Market Value ( USD | $ 4.86 Billion |
| Compound Annual Growth Rate | 9.9% |
| Regions Covered | United States |
| No. of Companies Mentioned | 10 |
