Cell and Gene Therapy Clinical Trials Market Size, Share, Trends, Industry Analysis Report By Phase (Phase I, Phase II, Phase III, Phase IV), By Indication, By Region

Description

List of Tables

The cell and gene therapy clinical trials market size is expected to reach USD 44.83 billion by 2034, according to a new study by Polaris Market Research. The report "Cell and Gene Therapy Clinical Trials Market Size, Share, Trends, Industry Analysis Report By Phase (Phase I, Phase II, Phase III, Phase IV), By Indication, By Region - Market Forecast, 2025-2034" gives a detailed insight into current market dynamics and provides analysis on future market growth.

The cell and gene therapy clinical trials market refers to the ecosystem where investigational therapies using genetically modified cells or direct gene-editing techniques undergo structured testing to assess safety, efficacy, and therapeutic impact in humans. This market is expanding rapidly due to the rising demand for curative treatments across a range of chronic and rare conditions. The push for precision medicine and targeted intervention is increasing investments in early-stage research, leading to a sharp rise in the number of active trials. Investors and market players are focusing on novel platforms such as CRISPR-based gene editing, autologous cell therapies, and in vivo delivery systems to improve therapeutic outcomes. Increased regulatory support through expedited pathways and orphan drug designations is accelerating trial timelines and reducing developmental risks. Industry trends are moving toward decentralized and adaptive trial designs to improve recruitment, enhance data capture, and increase access for diverse patient populations.

Innovation in manufacturing scalability and cold chain logistics is also improving trial feasibility for complex products. Opportunities are expanding due to rising partnerships between biotech firms, academic institutions, and contract research organizations, which help streamline trial design and execution. Integration of advanced data analytics and remote monitoring tools is further transforming the way these trials are conducted, offering real-time insights and enhancing protocol compliance. Market players are also leveraging digital biomarkers and artificial intelligence to better identify patient subgroups and optimize enrollment strategies. The competitive focus remains on accelerating development while ensuring trial integrity, patient safety, and alignment with evolving regulatory expectations.

Cell and Gene Therapy Clinical Trials Market Report Highlights

By phase, the phase III segment dominated the market in 2024 with ~55% of the revenue share due to the growing number of advanced-stage cell and gene therapy candidates entering pivotal testing stages.

Based on indication, the oncology segment held the largest revenue share in 2024 due to the high number of active cell and gene therapy trials targeting various cancer types

The North America cell and gene therapy clinical trials market accounted for ~50% of the revenue share in 2024 due to the region's strong research infrastructure, high clinical trial density, and access to skilled professionals.

The market in Asia Pacific is expected to register the highest CAGR from 2025 to 2034 due to the rapid expansion of clinical research infrastructure and increased government support for biotech innovation.

A few global key players include Charles River Laboratories; ICON Plc; IQVIA; LabCorp; Medpace; Novotech; PAREXEL International Corp.; Syneos Health; Thermo Fisher Scientific, Inc.; Veristat, LLC.

Polaris Market Research has segmented the cell and gene therapy clinical trials market report on the basis of phase, indication, and region:

By Phase Outlook (Revenue, USD Billion, 2020-2034)

Phase I

Phase II

Phase III

Phase IV

By Indication Outlook (Revenue, USD Billion, 2020-2034)

Oncology

Cardiology

CNS

Musculoskeletal

Infectious Diseases

Dermatology

Endocrine, Metabolic, Genetic

Immunology & Inflammation

Ophthalmology

Hematology

Gastroenterology

Others

By Regional Outlook (Revenue, USD Billion, 2020-2034)

North America

U.S.

Canada

Europe

Germany

France

Italy

Spain

Russia

Netherlands

Rest of Europe

Asia Pacific

China

India

Japan

South Korea

Indonesia

Malaysia

Vietnam

Australia

Rest of Asia Pacific

Latin America

Argentina

Brazil

Mexico

Rest of Latin America

Middle East & Africa

UAE

Saudi Arabia

Israel

South Africa

Rest of Middle East & Africa

Product Code: PM6185

1. Introduction

1.1. Report Description
- 1.1.1. Objectives of the Study
- 1.1.2. Market Scope
- 1.1.3. Assumptions
1.2. Stakeholders

2. Executive Summary

2.1. Market Highlights

3. Research Methodology

3.1. Overview
- 3.1.1. Data Mining
3.2. Data Sources
- 3.2.1. Primary Sources
- 3.2.2. Secondary Sources

4. Global Cell and Gene Therapy Clinical Trials Market Insights

4.1. Cell and Gene Therapy Clinical Trials Market - Market Snapshot
4.2. Cell and Gene Therapy Clinical Trials Market Dynamics
- 4.2.1. Drivers and Opportunities
  - 4.2.1.1. High Prevalence of Rare and Genetic Disorders
  - 4.2.1.2. Rising R&D Investment in Advanced Therapies
- 4.2.2. Restraints and Challenges
  - 4.2.2.1. High Initial Investment
4.3. Porter's Five Forces Analysis
- 4.3.1. Bargaining Power of Suppliers (Moderate)
- 4.3.2. Threats of New Entrants: (Low)
- 4.3.3. Bargaining Power of Buyers (Moderate)
- 4.3.4. Threat of Substitute (Moderate)
- 4.3.5. Rivalry among existing firms (High)
4.4. PESTEL Analysis
4.5. Cell and Gene Therapy Clinical Trials Market Indication Trends
4.6. Value Chain Analysis

5. Global Cell and Gene Therapy Clinical Trials Market, by Phase

5.1. Key Findings
5.2. Introduction
- 5.2.1. Global Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
5.3. Phase I
- 5.3.1. Global Cell and Gene Therapy Clinical Trials Market, by Phase I, by Region, 2020-2034 (USD Billion)
5.4. Phase II
- 5.4.1. Global Cell and Gene Therapy Clinical Trials Market, by Phase II, by Region, 2020-2034 (USD Billion)
5.5. Phase III
- 5.5.1. Global Cell and Gene Therapy Clinical Trials Market, by Phase III, by Region, 2020-2034 (USD Billion)
5.6. Phase IV
- 5.6.1. Global Cell and Gene Therapy Clinical Trials Market, by Phase IV, by Region, 2020-2034 (USD Billion)

6. Global Cell and Gene Therapy Clinical Trials Market, by Indication

6.1. Key Findings
6.2. Introduction
- 6.2.1. Global Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
6.3. Oncology
- 6.3.1. Global Cell and Gene Therapy Clinical Trials Market, by Oncology, by Region, 2020-2034 (USD Billion)
6.4. Cardiology
- 6.4.1. Global Cell and Gene Therapy Clinical Trials Market, by Cardiology, by Region, 2020-2034 (USD Billion)
6.5. CNS
- 6.5.1. Global Cell and Gene Therapy Clinical Trials Market, by CNS, by Region, 2020-2034 (USD Billion)
6.6. Musculoskeletal
- 6.6.1. Global Cell and Gene Therapy Clinical Trials Market, by Musculoskeletal, by Region, 2020-2034 (USD Billion)
6.7. Infectious diseases
- 6.7.1. Global Cell and Gene Therapy Clinical Trials Market, by Infectious diseases, by Region, 2020-2034 (USD Billion)
6.8. Dermatology
- 6.8.1. Global Cell and Gene Therapy Clinical Trials Market, by Dermatology, by Region, 2020-2034 (USD Billion)
6.9. Endocrine, metabolic, genetic
- 6.9.1. Global Cell and Gene Therapy Clinical Trials Market, by Endocrine, metabolic, genetic, by Region, 2020-2034 (USD Billion)
6.10. Immunology & inflammation
- 6.10.1. Global Cell and Gene Therapy Clinical Trials Market, by Immunology & inflammation, by Region, 2020-2034 (USD Billion)
6.11. Ophthalmology
- 6.11.1. Global Cell and Gene Therapy Clinical Trials Market, by Ophthalmology, by Region, 2020-2034 (USD Billion)
6.12. Hematology
- 6.12.1. Global Cell and Gene Therapy Clinical Trials Market, by Hematology, by Region, 2020-2034 (USD Billion)
6.13. Gastroenterology
- 6.13.1. Global Cell and Gene Therapy Clinical Trials Market, by Gastroenterology, by Region, 2020-2034 (USD Billion)
6.14. Others
- 6.14.1. Global Cell and Gene Therapy Clinical Trials Market, by Others, by Region, 2020-2034 (USD Billion)

7. Global Cell and Gene Therapy Clinical Trials Market, by Geography

7.1. Key Findings
7.2. Introduction
- 7.2.1. Cell and Gene Therapy Clinical Trials Market Assessment, By Geography, 2020-2034 (USD Billion)
7.3. Cell and Gene Therapy Clinical Trials Market - North America
- 7.3.1. North America: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
- 7.3.2. North America: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.3.3. Cell and Gene Therapy Clinical Trials Market - U.S.
  - 7.3.3.1. U.S.: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.3.3.2. U.S.: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.3.4. Cell and Gene Therapy Clinical Trials Market - Canada
  - 7.3.4.1. Canada: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.3.4.2. Canada: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.3.5. Cell and Gene Therapy Clinical Trials Market - Mexico
  - 7.3.5.1. Mexico: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.3.5.2. Mexico: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
7.4. Cell and Gene Therapy Clinical Trials Market - Europe
- 7.4.1. Europe: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
- 7.4.2. Europe: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.4.3. Cell and Gene Therapy Clinical Trials Market - UK
  - 7.4.3.1. UK: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.4.3.2. UK: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.4.4. Cell and Gene Therapy Clinical Trials Market - France
  - 7.4.4.1. France: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.4.4.2. France: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.4.5. Cell and Gene Therapy Clinical Trials Market - Germany
  - 7.4.5.1. Germany: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.4.5.2. Germany: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.4.6. Cell and Gene Therapy Clinical Trials Market - Italy
  - 7.4.6.1. Italy: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.4.6.2. Italy: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.4.7. Cell and Gene Therapy Clinical Trials Market - Spain
  - 7.4.7.1. Spain: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.4.7.2. Spain: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.4.8. Cell and Gene Therapy Clinical Trials Market - Netherlands
  - 7.4.8.1. Netherlands: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.4.8.2. Netherlands: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.4.9. Cell and Gene Therapy Clinical Trials Market - Russia
  - 7.4.9.1. Russia: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.4.9.2. Russia: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.4.10. Cell and Gene Therapy Clinical Trials Market - Rest of Europe
  - 7.4.10.1. Rest of Europe: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.4.10.2. Rest of Europe: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
7.5. Cell and Gene Therapy Clinical Trials Market - Asia Pacific
- 7.5.1. Asia Pacific: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
- 7.5.2. Asia Pacific: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.5.3. Cell and Gene Therapy Clinical Trials Market - China
  - 7.5.3.1. China: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.5.3.2. China: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.5.4. Cell and Gene Therapy Clinical Trials Market - India
  - 7.5.4.1. India: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.5.4.2. India: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.5.5. Cell and Gene Therapy Clinical Trials Market - Malaysia
  - 7.5.5.1. Malaysia: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.5.5.2. Malaysia: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.5.6. Cell and Gene Therapy Clinical Trials Market - Japan
  - 7.5.6.1. Japan: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.5.6.2. Japan: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.5.7. Cell and Gene Therapy Clinical Trials Market - Indonesia
  - 7.5.7.1. Indonesia: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.5.7.2. Indonesia: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.5.8. Cell and Gene Therapy Clinical Trials Market - South Korea
  - 7.5.8.1. South Korea: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.5.8.2. South Korea: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.5.9. Cell and Gene Therapy Clinical Trials Market - Australia
  - 7.5.9.1. Australia: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.5.9.2. Australia: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.5.10. Cell and Gene Therapy Clinical Trials Market - Rest of Asia Pacific
  - 7.5.10.1. Rest of Asia Pacific: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.5.10.2. Rest of Asia Pacific: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
7.6. Cell and Gene Therapy Clinical Trials Market - Middle East & Africa
- 7.6.1. Middle East & Africa: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
- 7.6.2. Middle East & Africa: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.6.3. Cell and Gene Therapy Clinical Trials Market - Saudi Arabia
  - 7.6.3.1. Saudi Arabia: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.6.3.2. Saudi Arabia: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.6.4. Cell and Gene Therapy Clinical Trials Market - UAE
  - 7.6.4.1. UAE: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.6.4.2. UAE: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.6.5. Cell and Gene Therapy Clinical Trials Market - Israel
  - 7.6.5.1. Israel: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.6.5.2. Israel: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.6.6. Cell and Gene Therapy Clinical Trials Market - South Africa
  - 7.6.6.1. South Africa: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.6.6.2. South Africa: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.6.7. Cell and Gene Therapy Clinical Trials Market - Rest of Middle East & Africa
  - 7.6.7.1. Rest of Middle East & Africa: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.6.7.2. Rest of Middle East & Africa: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
7.7. Cell and Gene Therapy Clinical Trials Market - Latin America
- 7.7.1. Latin America: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
- 7.7.2. Latin America: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.7.3. Cell and Gene Therapy Clinical Trials Market - Brazil
  - 7.7.3.1. Brazil: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.7.3.2. Brazil: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.7.4. Cell and Gene Therapy Clinical Trials Market - Argentina
  - 7.7.4.1. Argentina: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.7.4.2. Argentina: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)
- 7.7.5. Cell and Gene Therapy Clinical Trials Market - Rest of Latin America
  - 7.7.5.1. Rest of Latin America: Cell and Gene Therapy Clinical Trials Market, by Phase, 2020-2034 (USD Billion)
  - 7.7.5.2. Rest of Latin America: Cell and Gene Therapy Clinical Trials Market, by Indication, 2020-2034 (USD Billion)

8. Competitive Landscape

8.1. Expansion and Acquisition Analysis
- 8.1.1. Expansion
- 8.1.2. Acquisitions
8.2. Partnerships/Collaborations/Agreements/Exhibitions

9. Company Profiles

9.1. Charles River Laboratories
- 9.1.1. Company Overview
- 9.1.2. Financial Performance
- 9.1.3. Product Benchmarking
- 9.1.4. Recent Development
9.2. ICON Plc
- 9.2.1. Company Overview
- 9.2.2. Financial Performance
- 9.2.3. Product Benchmarking
- 9.2.4. Recent Development
9.3. IQVIA
- 9.3.1. Company Overview
- 9.3.2. Financial Performance
- 9.3.3. Product Benchmarking
- 9.3.4. Recent Development
9.4. LabCorp
- 9.4.1. Company Overview
- 9.4.2. Financial Performance
- 9.4.3. Product Benchmarking
- 9.4.4. Recent Development
9.5. Medpace
- 9.5.1. Company Overview
- 9.5.2. Financial Performance
- 9.5.3. Product Benchmarking
- 9.5.4. Recent Development
9.6. Novotech
- 9.6.1. Company Overview
- 9.6.2. Financial Performance
- 9.6.3. Product Benchmarking
- 9.6.4. Recent Development
9.7. PAREXEL International Corp.
- 9.7.1. Company Overview
- 9.7.2. Financial Performance
- 9.7.3. Product Benchmarking
- 9.7.4. Recent Development
9.8. Syneos Health
- 9.8.1. Company Overview
- 9.8.2. Financial Performance
- 9.8.3. Product Benchmarking
- 9.8.4. Recent Development
9.9. Thermo Fisher Scientific, Inc.
- 9.9.1. Company Overview
- 9.9.2. Financial Performance
- 9.9.3. Product Benchmarking
- 9.9.4. Recent Development
9.10. Veristat, LLC
- 9.10.1. Company Overview
- 9.10.2. Financial Performance
- 9.10.3. Product Benchmarking
- 9.10.4. Recent Development