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

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

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

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

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Chapter 1. Research Methodology and Scope

1.1. Market Segmentation & Scope
1.2. Segment Definitions
1.2.1. Phase
1.2.2. Indication
1.3. Research Methodology
1.4. Information Procurement
1.4.1. Purchased Database
1.4.2. 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 Abbreviations
1.10. Objectives

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
3.1.1. Parent Market Outlook
3.1.2. Related/Ancillary Market 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 (USD Million)
4.4. Phase I
4.4.1. Phase I Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.5. Phase II
4.5.1. Phase II Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.6. Phase III
4.6.1. Phase III Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.7. Phase IV
4.7.1. Phase IV Market Estimates and Forecasts, 2021 - 2033 (USD Million)

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 (USD Million)
5.4. Oncology
5.4.1. Oncology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.5. Cardiology
5.5.1. Cardiology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.6. CNS
5.6.1. CNS Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.7. Musculoskeletal
5.7.1. Musculoskeletal Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.8. Infectious diseases
5.8.1. Infectious diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.9. Dermatology
5.9.1. Dermatology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.10. Endocrine, metabolic, genetic
5.10.1. Endocrine, metabolic, genetic Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.11. Immunology & inflammation
5.11.1. Immunology & inflammation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.12. Ophthalmology
5.12.1. Ophthalmology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.13. Hematology
5.13.1. Hematology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.14. Gastroenterology
5.14.1. Gastroenterology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.15. Others
5.15.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. Competitive Landscape

6.1. Market Participant Categorization
6.2. Company Market Share/Assessment Analysis, 2024
6.3. Company Profiles
6.3.1. IQVIA
6.3.1.1. Company Overview
6.3.1.2. Financial Performance
6.3.1.3. Service Benchmarking
6.3.1.4. Strategic Initiatives
6.3.2. ICON Plc
6.3.2.1. Company Overview
6.3.2.2. Financial Performance
6.3.2.3. Service Benchmarking
6.3.2.4. Strategic Initiatives
6.3.3. LabCorp
6.3.3.1. Company Overview
6.3.3.2. Financial Performance
6.3.3.3. Service Benchmarking
6.3.3.4. Strategic Initiatives
6.3.4. Charles River Laboratories
6.3.4.1. Company Overview
6.3.4.2. Financial Performance
6.3.4.3. Service Benchmarking
6.3.4.4. Strategic Initiatives
6.3.5. PAREXEL International Corp.
6.3.5.1. Company Overview
6.3.5.2. Financial Performance
6.3.5.3. Service Benchmarking
6.3.5.4. Strategic Initiatives
6.3.6. Syneos Health
6.3.6.1. Company Overview
6.3.6.2. Financial Performance
6.3.6.3. Service Benchmarking
6.3.6.4. Strategic Initiatives
6.3.7. Medpace
6.3.7.1. Company Overview
6.3.7.2. Financial Performance
6.3.7.3. Service Benchmarking
6.3.7.4. Strategic Initiatives
6.3.8. Thermo Fisher Scientific, Inc.
6.3.8.1. Company Overview
6.3.8.2. Financial Performance
6.3.8.3. Service Benchmarking
6.3.8.4. Strategic Initiatives
6.3.9. Novotech
6.3.9.1. Company Overview
6.3.9.2. Financial Performance
6.3.9.3. Service Benchmarking
6.3.9.4. Strategic Initiatives
6.3.10. Veristat, LLC
6.3.10.1. Company Overview
6.3.10.2. Financial Performance
6.3.10.3. Service Benchmarking
6.3.10.4. Strategic Initiatives

Chapter 7. Key Recommendations

List of Tables

Table 1 List of Tables
Table 2 List of Secondary Sources
Table 3 List of Abbreviations
Table 4 U.S. Cell And Gene Therapy Clinical Trials Market Estimates and Forecasts, By Phase, 2021 - 2033 (USD Million)
Table 5 U.S. Cell And Gene Therapy Clinical Trials Market Estimates and Forecasts, By Indication, 2021 - 2033 (USD Million)

List of Figures

Fig. 1 Market research process
Fig. 2 Information procurement
Fig. 3 Primary research pattern
Fig. 4 Market research approaches
Fig. 5 Market formulation & validation
Fig. 6 Commodity flow analysis
Fig. 7 Value-chain-based sizing & forecasting
Fig. 8 QFD model sizing & forecasting
Fig. 9 Bottom-up approach
Fig. 10 Market snapshot
Fig. 11 Segment snapshot 1
Fig. 12 Segment snapshot 2
Fig. 13 Competitive landscape snapshot
Fig. 14 Parent market outlook, 2024 (USD Billion)
Fig. 15 Ancillary market outlook, 2024 (USD Billion)
Fig. 16 U.S. Cell and Gene Therapy Clinical Trials Market Dynamics
Fig. 17 Porter’s five forces analysis
Fig. 18 PESTEL analysis
Fig. 19 U.S. Cell and Gene Therapy Clinical Trials Market: Phase outlook and key takeaways
Fig. 20 U.S. Cell and Gene Therapy Clinical Trials Market: Phase movement analysis
Fig. 21 Phase I Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 22 Phase II Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 23 Phase III Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 24 Phase IV Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 25 U.S. Cell and Gene Therapy Clinical Trials Market: Indication outlook and key takeaways
Fig. 26 U.S. Cell and Gene Therapy Clinical Trials Market: Indication movement analysis
Fig. 27 Oncology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 28 Cardiology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 29 CNS Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 30 Musculoskeletal Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 31 Infectious Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 32 Dermatology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 33 Endocrine, metabolic, genetic Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 34 Immunology & Inflammation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 35 Ophthalmology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 36 Hematology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 37 Gastroenterology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 38 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 39 Key company categorization
Fig. 40 Service heat map analysis
Fig. 41 Strategic framework

Companies Mentioned

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

Table Information

Report Attribute	Details
No. of Pages	150
Published	July 2025
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
No. of Companies Mentioned	10

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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

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

U.S. Cell And Gene Therapy Clinical Trials Market Report Segmentation

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

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

Why should you buy this report?

This report addresses:

Table of Contents

Companies Mentioned

Table Information

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

U.S. Cell And Gene Therapy Clinical Trials Market Report Segmentation

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

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

Why should you buy this report?

This report addresses:

Table of Contents

Companies Mentioned

Table Information

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