Cell And Gene Therapy Clinical Trial Market Size, Share, and Industry Analysis, By Phase (Phase I, Phase II, Phase III, and Phase IV), By Product (Cell Therapy and Gene Therapy), By Indication (Oncology, Cardiovascular, Autoimmune Diseases, Rare & Orphan Diseases, and Others), and Regional Forecast, 2026-2034

The global cell and gene therapy clinical trials market size was valued at USD 12.62 billion in 2025. The market is projected to grow from USD 14.61 billion in 2026 to USD 47.16 billion by 2034, exhibiting a CAGR of 15.77% during the forecast period.

The global cell and gene therapy clinical trial market is witnessing significant growth due to the rise in the cell and gene therapies attributed to several key factors that reflect the advancements in medical science, increased investments to expand their use in clinical applications, and the growing recognition of these therapies for providing potential benefits.

• For instance, in March 2024, IQVIA Inc. published its institute report that stated the spending on cell and gene therapies is increasing rapidly and reached USD 5.9 billion in 2023.

Cell And Gene Therapy Clinical Trial Market Driver

Expanding Therapeutic Applications Boosts the Market Growth

In the recent years, cell and gene therapies have been developed to treat a wide array of conditions, including cancers, genetic disorders, and autoimmune diseases. These innovative treatments aim to modify or replace genetic material or cells to prevent or treat diseases, leading to their increasing adoption in clinical settings. Such a scenario is projected to boost the number of cell and gene therapy clinical trials, driving market growth in the coming years.

• For instance, in April 2023, Novotech reported that cell & gene therapies have emerged as revolutionary treatments for several diseases, including genetic disorders, cancer, and autoimmune conditions.
• For instance, an article published by the National Center for Biotechnology Information (NCBI) in October 2023 reported that the sector has seen significant growth, with over 5,000 gene therapy trials currently listed with the National Institutes of Health (NIH), up from approximately 1,800 a decade ago.

Download Free sample to learn more about this report.

According to the Q4 2023 Gene, Cell, + RNA Therapy Landscape Report by the American Society of Gene & Cell Therapy (ASGCT) and Citeline, around 2,111 gene therapy products (including genetically modified cell therapies such as CAR T-cell therapies) were in development, accounting for 53.0% of gene, cell, and RNA therapies

Cell And Gene Therapy Clinical Trial Market Restraint

Regulatory Challenges for Trial Initiation May Hinder Market Growth

The regulatory authorities, such as the U.S. FDA, have imposed stringent regulatory requirements for the cell and gene therapy trials. Sponsors must submit an Investigational New Drug (IND) application that includes comprehensive preclinical data and clinical protocols. This process can be lengthy and complex, leading to delays in the trial initiation. Moreover, the clinical trials for cell and gene therapies often face clinical holds due to the identified deficiencies during the review process, which is expected to hinder market growth.

• For instance, as of October 2023, the Molecular Therapy Journal stated that clinical trial holds are disproportionately high, with cell and gene therapies accounting for about 40% of all clinical holds despite representing less than 2% of all clinical trials.

Cell And Gene Therapy Clinical Trial Market Opportunity

Technological Advancements in Cell And Gene Therapy Clinical Trials

Advancements in the development of gene therapy technologies are facilitating the launches of new therapies. The ability to deliver genetic material effectively and the growing understanding of the underlying genetic and molecular contributors to diseases are essential for the development of such therapies. In consideration of such factors, several approved cell and gene therapies are being developed for various applications.

• For instance, as of early 2023, there are over 100 approved gene, cell, and RNA therapies worldwide, with thousands more in various stages of development.

Key Insights

The report covers the following key insights:

• Prevalence of Key Diseases, By Key Countries, 2023
• Key Industry Developments (Mergers, Acquisitions & Partnerships)
• Overview of Regulatory Scenario, By Key Countries/Region
• Overview: Technological Advancements in Cell and Gene Therapy Clinical Trials
• Impact of COVID 19 on the Market

Segmentation

Analysis by Phase

Based on phase, the market is segmented into Phase I, Phase II, Phase III, and Phase IV.

The Phase II segment is expected to hold a substantial share of the global market. Cell and gene therapies are significantly studied in early phase trials such as Phase II to thoroughly evaluate safety and feasibility before advancing to larger, later Phase III trials to confirm efficacy. As a result, the majority of cell and gene therapy clinical trials are currently in Phase II, which is expected to boost the segment growth.

• For instance, as of July 2024, Oliver Wyman, LLC, stated that more than 280 cell and gene therapy commercial assets are in Phase II, and several approvals for these pipeline candidates are anticipated by 2032.

Analysis by Product

By form, the market is divided into cell therapy and gene therapy.

The gene therapy segment accounts for a significant share of the cell and gene therapy clinical trial market. Gene therapy currently has a greater number of products in clinical trials as it involves the process of modifying or manipulating the genes to treat or prevent diseases, particularly the genetic disorders and certain other conditions. Such a scenario is expected to propel the segment growth in the forthcoming years.

• For instance, according to the Q2 2023 Gene, Cell, + RNA Therapy Landscape Report by the American Society of Gene & Cell Therapy (ASGCT) and Citeline, there were 260 gene therapies in Phase II development as of the end of Q2 2023, a 5.0% increase from 247 at the end of Q1 2023.

Analysis by Indication

By indication, the market for cell and gene therapy clinical trials is categorized into oncology, autoimmune diseases, cardiovascular, rare & orphan diseases, and others.

The oncology segment accounts for a major share of the cell and gene therapy market in 2023. The growth can be attributed to the greater significance of cell and gene therapies in cancers. This is inspiring the key players to conduct more trials to expand the applications of these products in cancer, which is expected to boost the segment growth.

• For instance, as per the Gene, Cell, + RNA Therapy Landscape Q2 Report published by the American Society of Gene & Cell Therapy (ASGCT) in 2023, oncology remained a primary focus, comprising 27.0% of the late-stage clinical pipeline, with CAR-T therapies leading the charge.

Regional Analysis

To gain extensive insights into the market, Download for Customization

Based on region, the market has been studied across Europe, Asia Pacific, North America, Latin America, and the Middle East & Africa.

North America accounted for the largest share of the global cell and gene therapy clinical trial market in 2023. The growth of the market in the region is attributed to the well-established healthcare infrastructure and the presence of prominent players contributing to the large number of cell and gene therapy trials in the region.

• For instance, in June 2024, Stanford Medicine helped conduct clinical trials for a new gene therapy for a devastating pediatric neurologic disease.

Europe is the second-largest market based on the demand for clinical trials of cell and gene therapy. The growth of the region can be attributed to the key focus of companies to offer potential cures for serious and often rare diseases that previously lacked effective treatments. Such a scenario is expected to boost the clinical trials for cell and gene therapy in Europe.

The Asia Pacific market is expected to grow substantially over the forthcoming years. The large patient pool of cancer and genetic disorders in the region is anticipated to fuel the need for cell and gene therapy clinical trials, thereby driving the Asia Pacific market growth during the projection period.

Key Players Covered

The global market is fragmented, with a large number of companies offering various types of services and products for cell and gene therapy clinical trials.

The report includes the profiles of the following key players:

• IQVIA Inc (U.S.)
• Laboratory Corporation of America Holdings (U.S.)
• ICON plc (Ireland)
• Charles River Laboratories (U.S.)
• Parexel International (MA) Corporation (U.S.)
• Syneos Health (U.S.)
• Medpace (U.S.)
• Novotech (Australia)

Key Industry Developments

• In November 2023, AstraZeneca announced a collaboration and investment agreement with Cellectis to accelerate the development of cell therapy and genomic medicine in areas of high unmet need, including oncology, immunology, and rare diseases.
• In April 2022, Labcorp collaborated with Xcell Biosciences Inc. to enhance the development of cell and gene therapy and help clients effectively bring innovative cell and gene therapies to market.