Dublin, Sept. 18, 2025 (GLOBE NEWSWIRE) — The “U.S. Cell & Gene Therapy Contract Research Organizations Market Size, Share & Trends Analysis Report By Type (Drug Discovery, Preclinical, Clinical), By Service, By Indication, By Modality, And Segment Forecasts, 2025 – 2033” report has been added to ResearchAndMarkets.com’s offering.
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, the analyst has segmented the U.S. cell & gene therapy contract research organizations market report based on type, phase, service, indication, and modality.
Key Attributes:
| Report Attribute | Details |
| No. of Pages | 150 |
| Forecast Period | 2024 – 2033 |
| Estimated Market Value (USD) in 2024 | $2.09 Billion |
| Forecasted Market Value (USD) by 2033 | $4.86 Billion |
| Compound Annual Growth Rate | 9.9% |
| Regions Covered | United States |
Key Topics Covered:
Chapter 1. Methodology and Scope
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
3.2. U.S. Cell & Gene Therapy Contract Research Organizations Market Dynamics
3.3. Technological Landscape
3.4. Pricing Model Analysis
3.5. U.S. Cell & Gene Therapy Contract Research Organizations Market: Analysis Tools
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
4.4.3. Lead Identification
4.4.4. Lead Optimization
4.5. Preclinical
4.6. Clinical
4.6.2. Phase I
4.6.3. Phase II
4.6.4. Phase III
4.6.5. Phase IV
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
5.5. Regulatory Strategy
5.6. Data Management & Medical Writing
5.7. Clinical Monitoring
5.8. Quality Management / GMP Compliance
5.9. Biostatistics & Safety Monitoring
5.10. Patient & Site Recruitment
5.11. Technology Transfer
5.12. Others
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
6.5. CNS Disorders
6.6. Infectious Diseases
6.7. Clinical Monitoring
6.8. Immunological Disorders
6.9. Cardiovascular Diseases
6.10. Respiratory Diseases
6.11. Diabetes
6.12. Ophthalmology
6.13. Pain Management
6.14. Others
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
7.5. Gene Therapies
7.6. Gene-Modified Cell Therapies
Chapter 8. Competitive Landscape
8.1. Company Categorization
8.2. Company Market Share/Assessment Analysis, 2024
8.3. Company Profiles
- Altasciences
- Allucent
- Labcorp
- Linical
- Medpace
- Thermo Fisher Scientific Inc.
- Precision Medicine Group, LLC.
- QPS Holdings
- Syneos Health
- ICON plc
For more information about this report visit https://www.researchandmarkets.com/r/wbr1i
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
- U.S. Cell & Gene Therapy Contract Research Organizations Market
