Gene Therapy Clinical Trial Services Market Report 2025

The gene therapy clinical trial services market size has grown rapidly in recent years. It will grow from $1.53 billion in 2024 to $1.82 billion in 2025 at a compound annual growth rate (CAGR) of 19.6%. The growth in the historic period can be attributed to rising investments in research and development, increasing prevalence of rare genetic disorders, growing adoption of precision medicine strategies, enhanced regulatory support via accelerated approval pathways, and a growing pipeline of gene therapy candidates.

The gene therapy clinical trial services market size is expected to see rapid growth in the next few years. It will grow to $3.69 billion in 2029 at a compound annual growth rate (CAGR) of 19.2%. The growth in the forecast period can be attributed to ongoing technological advancements in gene-editing tools, an increasing number of clinical trials, rising demand for personalized treatments, growing investments in manufacturing infrastructure for cell and gene therapies, and enhanced patient recruitment efforts. Major trends in the forecast period include innovations in gene-editing technologies, improvements in vector manufacturing capabilities, optimization of patient recruitment strategies, integration of real-world evidence, and adoption of decentralized clinical trial models.

The growing demand for personalized medicine is expected to drive the expansion of the gene therapy clinical trial services market in the coming years. Personalized medicine involves tailoring medical treatments to individual characteristics, including genetic, biomarker, and lifestyle factors. This demand is increasing due to advancements in genomics and biotechnology, which enable more precise targeting of therapies. Gene therapy clinical trial services support personalized medicine by analyzing patient-specific genetic profiles and customizing treatments using biomarker analysis and companion diagnostics, optimizing therapy for each patient while enhancing safety and effectiveness. For example, in February 2024, the Personalized Medicine Coalition, a US-based hospital and healthcare organization, reported that the FDA approved 16 new personalized treatments for rare disease patients in 2023, up from six in 2022. As a result, the rising demand for personalized medicine is fueling growth in the gene therapy clinical trial services market.

Key players in the gene therapy clinical trial services market are developing innovative solutions, such as long-term follow-up (LTFU) models for cell and gene therapy (CGT) trials, to accelerate trial processes while maintaining regulatory compliance and safety standards. An LTFU model for CGT trials is a structured framework designed to monitor patients over an extended period, often up to 15 years after receiving treatment. For instance, in May 2025, Medable Inc., a US-based SaaS company, launched a digital-first LTFU model specifically for CGT trials. This model supports gene therapy trials by reducing patient and site burdens while maintaining scientific rigor throughout the FDA-required 15-year monitoring period. It enhances patient access, retention, and data continuity through remote and hybrid follow-up methods, improving long-term safety and efficacy monitoring.

In January 2024, Kyowa Kirin Co., Ltd., a Japan-based pharmaceutical company, acquired Orchard Therapeutics plc for an undisclosed amount. Through this acquisition, Kyowa Kirin aims to strengthen its gene therapy capabilities and expand its presence in the advanced therapies sector, with a particular focus on rare diseases and genetic disorders. Orchard Therapeutics plc, a UK-based biotechnology company, provides gene therapy clinical trial services.

Major players in the gene therapy clinical trial services market are Thermo Fisher Scientific Inc., Sharp Services LLC, Labcorp, Pharmaceutical Product Development LLC, ICON plc, Syneos Health Inc., WuXi AppTec, Franklin Biolabs, Catalent Inc., Charles River Laboratories International Inc., Parexel International (MA) Corporation, Medpace Holdings Inc., Precision Medicine Group LLC, Worldwide Clinical Trials, IQVIA Holdings Inc., TFS HealthScience, Poseida Therapeutics Inc., Veristat LLC, Genprex Inc., Novotech Health Holdings Pte Limited, bluebird bio Inc.

North America was the largest region in the gene therapy clinical trial services market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in gene therapy clinical trial services market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the gene therapy clinical trial services market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.

Gene therapy clinical trial services encompass the specialized support, infrastructure, and expertise required to design, manage, and conduct clinical trials evaluating gene therapy products in humans. These services cover a broad range of activities aimed at ensuring investigational gene therapies are tested safely, ethically, and efficiently, while generating robust clinical evidence to support regulatory approval and potential commercialization.

The primary types of gene therapy clinical trial services include clinical trial design and planning, supply and logistics services, regulatory support, data management and biostatistics, site management and monitoring, and others. Clinical trial design and planning involves outlining the study’s objectives, methodologies, timelines, and analytical strategies to ensure scientific validity and regulatory compliance. These services are applied across diverse therapeutic areas, including oncology, hematology, endocrine and metabolic disorders, musculoskeletal diseases, cardiovascular conditions, neurological disorders, infectious diseases, ophthalmology, immunology, and more. Key end users include pharmaceutical companies, biotechnology firms, academic institutions, government research institutes, and contract research organizations.

The gene therapy clinical trial services market research report is one of a series of new reports that provides gene therapy clinical trial services market statistics, including gene therapy clinical trial services industry global market size, regional shares, competitors with a gene therapy clinical trial services market share, detailed gene therapy clinical trial services market segments, market trends and opportunities, and any further data you may need to thrive in the gene therapy clinical trial services industry. This gene therapy clinical trial services market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The gene therapy clinical trial services market includes revenues earned by entities by providing services such as patient recruitment and enrollment, clinical trial site selection and setup, pharmacovigilance and safety monitoring, biomarker analysis and companion diagnostics, and training and support for clinical staff. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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