Cell and Gene Therapy Clinical Trial Services Market Report 2025

This Cell and Gene Therapy Clinical Trial Services market report provides a comprehensive analysis of the market’s characteristics, size, and growth, including segmentation, regional and country-level breakdowns, competitive landscape, market shares, trends, and strategies. It also tracks historical and forecasted market growth across various geographies.

The cell and gene therapy clinical trial services market size has grown rapidly in recent years. It will grow from $3.79 billion in 2024 to $4.2 billion in 2025 at a compound annual growth rate (CAGR) of 10.7%. The growth in the historic period can be attributed to the increased prevalence of chronic diseases, increased demand for effective treatments for rare genetic disorders, increased government funding for research in regenerative medicine, increased understanding of molecular mechanisms underlying various diseases, and increased awareness of the potential of personalized medicine.

The cell and gene therapy clinical trial services market size is expected to see rapid growth in the next few years. It will grow to $6.22 billion in 2029 at a compound annual growth rate (CAGR) of 10.3%. The growth in the forecast period can be attributed to increasing global incidence of genetic and auto-immune diseases, rising public and private sector funding for gene therapy research, growing adoption of novel technologies, and a rise in the number of genetic defects. Major trends in the forecast period include the adoption of AI, the adoption of machine learning, the adoption of personalized medicine, technological advancements, and gene therapies.

The increasing prevalence of genetic diseases is expected to drive the expansion of the cell and gene therapy clinical trial services market in the future. Genetic diseases result from variations in an individual's DNA or genetic makeup and are becoming more common due to factors such as increased accessibility to genetic testing, occurrences of genetic mutations, and the prevalence of consanguineous marriages. Cell and gene therapy clinical trial services play a crucial role in addressing the growing incidence of genetic diseases by fostering the development of innovative treatments, customizing therapies for individual patients, accelerating the translation of research into clinical applications, and broadening the treatment options available to patients with genetic disorders. For instance, according to the Cystic Fibrosis (CF) Foundation's July 2022 report, there has been a notable increase in the number of individuals diagnosed with cystic fibrosis, affecting nearly 40,000 children and adults in the United States alone, and over 105,000 people worldwide. Consequently, the rising prevalence of genetic diseases is a key driver behind the growth of the cell and gene therapy clinical trial services market.

Leading companies in the cell and gene therapy clinical trial services market are concentrating their efforts on introducing advanced technology, including customer relationship management (CRM) system technology, to enhance operational efficiency and gain a competitive advantage. CRM systems utilized by cell and gene therapy clinical trial services streamline and manage interactions with trial participants, healthcare providers, and other stakeholders throughout the clinical trial process. For instance, in April 2023, AmerisourceBergen Corporation unveiled the Cell and Gene Therapy (CGT) Integration Hub, a platform designed to enhance connectivity and streamline processes across the cell and gene therapy treatment pathway. Supported by AmerisourceBergen's CRM system, this platform aims to simplify care coordination by providing physicians and patient services teams with better visibility throughout the therapy development and delivery process. The CGT Integration Hub includes features such as expedited benefits investigation, real-time status tracking, and proactive alerts, all aimed at simplifying care coordination and improving the overall patient and provider experience in delivering cell and gene therapies.

In January 2024, Kyowa Kirin Co. Ltd. acquired Orchard Therapeutics Limited to strengthen its focus on addressing unmet medical needs in genetic and severe diseases by leveraging Orchard's expertise in developing and commercializing gene therapies for rare diseases. Orchard Therapeutics Limited, a UK-based biotechnology company, is dedicated to researching, developing, and commercializing gene therapies for rare diseases.

Major companies operating in the cell and gene therapy clinical trial services market are Thermo Fisher Scientific Inc., Sharp Services LLC, IQVIA, Laboratory Corporation of America Holdings, ICON plc, Syneos Health Inc., Catalent Pharma Solutions Inc., Charles River Laboratories International Inc., Parexel International Corporation, PRA Health Sciences Inc., Covance Inc., Medpace Holdings Inc., BioClinica Inc., Precision Medicine Group LLC, Worldwide Clinical Trials LLC, Clinigen Group plc, Evidera Inc., Advarra LLC, Veristat LLC, Clinipace Inc., Celonic AG, Cromsource Inc., Novotech Pty Ltd., MedSource Holdings Inc., Frontage Laboratories Inc.

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

Cell and gene therapy clinical trial services are specialized offerings provided by contract research organizations (CROs) or clinical trial management firms to support the design, implementation, and oversight of clinical trials for cell and gene therapies. These services encompass various aspects such as protocol design, patient recruitment, regulatory compliance, and data management, ensuring precision, efficacy, and adherence to rigorous standards throughout the trial process.

The primary types of cell and gene therapy clinical trial services include clinical trial design and planning, supply chain and logistics management, regulatory affairs and compliance, data management and biostatistics, site management and monitoring, among others. Clinical trial design and planning entail the development and organization of trial protocols, determining the objectives and methodologies of the trial. Various types of therapies, including gene therapy, cell therapy, and gene-modified cell therapy, are utilized for a range of indications such as oncology, hematology, metabolic disorders, infectious diseases, neurology, cardiovascular diseases, musculoskeletal disorders, among others. These services cater to a diverse range of end-users, including pharmaceutical and biotechnology companies, contract research organizations, academic and research institutions, among others.

The cell and gene therapy clinical trial services market research report is one of a series of new reports that provides cell and gene therapy clinical trial services market statistics, including cell and gene therapy clinical trial services industry global market size, regional shares, competitors with a cell and gene therapy clinical trial services market share, detailed cell and gene therapy clinical trial services market segments, market trends and opportunities, and any further data you may need to thrive in the cell and gene therapy clinical trial services industry. This cell and 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 cell and gene therapy clinical trial services market includes revenues earned by providing services, such as regulatory pathways navigation, logistics management, patient retention strategy management, and biomarker analysis services. 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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