Global Cell and Gene Therapy Clinical Trials Market Overview

The global cell and gene therapy (CGT) clinical trials market was valued at USD 10.75 billion in 2024 and is projected to reach USD 39.41 billion by 2033, growing at a CAGR of 15.58% from 2025 to 2033. The market growth is primarily driven by increasing R&D investments, rising patient demand for innovative therapies, expanding applications of cell and gene therapies in cancer treatment, and a supportive regulatory landscape across key regions.

The acceleration of innovation in genetic medicine, coupled with growing regulatory support for advanced therapies, has significantly boosted the CGT clinical trials market. Cutting-edge technologies such as CRISPR genome editing and advances in viral and non-viral vector delivery systems have enabled researchers to design highly precise therapeutic candidates for rare genetic disorders, oncology, and autoimmune diseases.

Regulatory agencies, including the U.S. FDA and the European Medicines Agency (EMA), have implemented accelerated approval pathways, orphan drug designations, and Regenerative Medicine Advanced Therapy (RMAT) designations to expedite the development and approval of CGT products. These initiatives have helped lower development costs and timelines, motivating more companies to initiate early-phase clinical trials and expand their research pipelines.

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Market Drivers and Developments

The influx of funding and strategic collaborations between biotechnology firms, pharmaceutical companies, and academic institutions has further stimulated the growth of CGT clinical trials. Increased venture capital investment and public–private partnerships have provided the financial strength required for sponsors to scale up from pilot studies to multi-site international trials.

Leading companies such as Bluebird Bio, CRISPR Therapeutics, and Beam Therapeutics are actively advancing multiple Phase I/II trials in areas including sickle cell disease, CAR-T therapies, and gene editing-based oncology. The growing need to assess long-term efficacy, dosing, and safety of these advanced therapies has also heightened demand for specialized contract research organizations (CROs) and dedicated clinical trial infrastructure tailored for CGT studies.

Key Market Trends & Insights

• North America dominated the global market in 2024, accounting for 50.90% of total revenue.
• The U.S. CGT clinical trials market is expected to exhibit strong growth throughout the forecast period.
• By phase, the Phase III segment led the market, holding the largest revenue share of 54.3% in 2024.
• By indication, the oncology segment accounted for the highest market share in 2024.
• Asia-Pacific is anticipated to be the fastest-growing region over the forecast period.

Market Size & Forecast

• 2024 Market Size: USD 10.75 Billion
• 2033 Projected Market Size: USD 39.41 Billion
• CAGR (2025–2033): 15.58%
• Largest Market (2024): North America
• Fastest Growing Market: Asia-Pacific

Competitive Landscape

The global cell and gene therapy clinical trials market is characterized by the presence of several key players focusing on expansion, strategic partnerships, and service enhancement to strengthen their market presence. Companies are actively working to broaden their expertise in managing complex CGT trials and improve patient recruitment and data collection efficiency through advanced technologies.

Key Cell and Gene Therapy Clinical Trials Companies:

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

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Conclusion

The global cell and gene therapy clinical trials market is undergoing a transformative phase, fueled by technological breakthroughs, regulatory incentives, and robust financial support from both public and private sectors. The convergence of genomic innovation, precision medicine, and biotechnology investment is accelerating the pace of clinical trial activity across major therapeutic areas such as oncology, hematology, and rare genetic diseases.

As governments and regulatory agencies continue to facilitate faster approval pathways and encourage innovation through favorable frameworks, the industry is poised for substantial expansion. The increasing collaboration between CROs, biotech firms, and academic institutions will further enhance clinical efficiency, scalability, and global reach.

By 2033, with the market projected to reach USD 39.41 billion, the CGT clinical trials sector is set to play a pivotal role in advancing next-generation therapies—bringing transformative, potentially curative treatments closer to widespread clinical reality.