(MENAFN- GlobeNewsWire - Nasdaq) The U.S. cell and gene therapy clinical trial market is poised for significant growth driven by increased R&D funding, a favorable regulatory environment, and a surge in pipeline candidates. Opportunities include expansion in oncology, personalized therapies, and advanced platform developments, backed by strategic investments.

Dublin, Oct. 03, 2025 (GLOBE NEWSWIRE) -- The "U.S. Cell And Gene Therapy Clinical Trials Market Size, Share & Trends Analysis Report By Phase (Phase I, II, III, IV), By Indication (Oncology, Cardiology, CNS, Musculoskeletal, Infectious Diseases), And Segment Forecasts, 2025 - 2033" report has been added to ResearchAndMarkets's offering.
The U.S. cell and gene therapy clinical trials market size was estimated at USD 4.64 billion in 2024 and is projected to reach USD 17.03 billion by 2033, growing at a CAGR of 15.60% from 2025 to 2033.

The market is driven by an increase in R&D funding, increasing disease burden in oncology, rare genetic disorders, and neurodegenerative conditions, growing interest in cell and gene therapies for cancer treatment, and a favorable regulatory environment.

Besides, the surge in pipeline candidates with over 2,000 CGT assets is currently in development at various preclinical and clinical stages. It has benefited from substantial R&D funding provided by biopharma companies, startups, and government entities. In addition, regulatory advancements, including the FDA's accelerated approval pathways, RMAT designations, and INTERACT meetings, support the need for cell and gene therapy initiation and development of trials.
Moreover, increased investments and M&A activities from large pharmaceutical companies are propelling the expansion of CGT trials, particularly in autologous CAR-T therapies, AAV-based gene therapies, and allogeneic platforms. Service providers and CDMOs are enhancing their CGT-specific capabilities, such as GMP vector production, viral delivery systems, and decentralized trial logistics.
U.S. Cell And Gene Therapy Clinical Trials 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 and gene therapy clinical trials market report based on phase and indication.
Phase Outlook (Revenue, USD Million, 2021 - 2033)

• Phase I
• Phase II
• Phase III
• Phase IV

Indication Outlook (Revenue, USD Million, 2021 - 2033)

• Oncology
• Cardiology
• CNS
• Musculoskeletal
• Infectious diseases
• Dermatology
• Endocrine, metabolic, genetic
• Immunology & inflammation
• Ophthalmology
• Hematology
• Gastroenterology
• Others

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

Key Attributes:

Report Attribute	Details
No. of Pages	150
Forecast Period	2024 - 2033
Estimated Market Value (USD) in 2024	$4.64 Billion
Forecasted Market Value (USD) by 2033	$17.03 Billion
Compound Annual Growth Rate	15.6%
Regions Covered	United States

Key Topics Covered:
Chapter 1. Research Methodology and Scope
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.3. Competitive Insights
Chapter 3. U.S. Cell and Gene Therapy Clinical Trials Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.2. Market Dynamics
3.2.1. Market Driver Analysis
3.2.1.1. Growing Interest in Cell and Gene Therapy
3.2.1.2. Adoption of New Technology in Clinical Research
3.2.1.3. Increasing Investments and R&D Funding
3.2.1.4. Rising Prevalence of Rare and Genetic Disorders
3.2.2. Market Restraint Analysis
3.2.2.1. Recruitment Obstacles
3.3. Pricing Model Analysis
3.4. Technology Landscape
3.5. Market Analysis Tools
3.5.1. Porter's Five Force Analysis
3.5.2. PESTEL by SWOT Analysis
3.5.3. COVID-19 Impact Analysis
Chapter 4. U.S. Cell and Gene Therapy Clinical Trials Market: Phase Estimates & Trend Analysis
4.1. U.S. Cell and Gene Therapy Clinical Trials Market, By Phase: Segment Dashboard
4.2. U.S. Cell and Gene Therapy Clinical Trials Market, By Phase: Movement Analysis
4.3. U.S. Cell and Gene Therapy Clinical Trials Market Estimates & Forecasts, By Phase, 2021 - 2033
4.4. Phase I
4.5. Phase II
4.6. Phase III
4.7. Phase IV
Chapter 5. U.S. Cell and Gene Therapy Clinical Trials Market: Indication Estimates & Trend Analysis
5.1. U.S. Cell and Gene Therapy Clinical Trials Market, By Indication: Segment Dashboard
5.2. U.S. Cell and Gene Therapy Clinical Trials Market, By Indication: Movement Analysis
5.3. U.S. Cell and Gene Therapy Clinical Trials Market Estimates & Forecasts, By Indication, 2021 - 2033
5.4. Oncology
5.5. Cardiology
5.6. CNS
5.7. Musculoskeletal
5.8. Infectious diseases
5.9. Dermatology
5.10. Endocrine, metabolic, genetic
5.11. Immunology & inflammation
5.12. Ophthalmology
5.13. Hematology
5.14. Gastroenterology
5.15. Others
Chapter 6. Competitive Landscape
6.1. Market Participant Categorization
6.2. Company Market Share/Assessment Analysis, 2024
6.3. Company Profiles

• IQVIA
• ICON Plc
• LabCorp
• Charles River Laboratories
• PAREXEL International Corp.
• Syneos Health
• Medpace
• Thermo Fisher Scientific, Inc.
• Novotech
• Veristat, LLC

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• U.S. Cell And Gene Therapy Clinical Trials Market

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