Cell and Gene Therapy Clinical Trials Market Size Worth USD 44.83 Billion by 2034 | CAGR: 15.4%

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.

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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.

Top of FormCell 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
  • UK
  • 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