Gene Therapy Clinical Trial Services Market - By Services (Clinical Trial Design & Planning, Supply & Logistics, Regulatory, Data Management & Biostatistics), Therapeutic Areas (Oncology, Musculoskeletal, CVD), End-user – Global Forecast (2024 – 2032)

Gene Therapy Clinical Trial Services Market - By Services (Clinical Trial Design & Planning, Supply & Logistics, Regulatory, Data Management & Biostatistics), Therapeutic Areas (Oncology, Musculoskeletal, CVD), End-user – Global Forecast (2024 – 2032)

Gene Therapy Clinical Trial Services Market Size

Gene Therapy Clinical Trial Services Market size was valued at USD 1.1 billion in 2023 and is estimated to grow at 9.2% CAGR from 2024 to 2032. The market has witnessed significant expansion attributed to the global rise in genetic disorders and chronic diseases.

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The growing focus on genetic mechanisms has intensified efforts toward developing gene-based therapies for previously non-curable conditions. This has prompted substantial investments in gene therapy clinical trials by pharmaceutical and biotech companies, and academic institutions, thereby spurring the demand for specialized services. For instance, by the end of 2023, there was a global launch of 76 cell and gene therapies, accounting more than double the number in 2013. This show an escalated research activities and clinical studies. Thus, widespread adoption of clinical trial services in gene therapy sector will foster the market growth.
 

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Gene therapy clinical trial services refer to a comprehensive range of specialized services provided throughout the various stages of clinical trials aimed at evaluating the safety, efficacy, and feasibility of gene therapy interventions. These services include trial design, patient recruitment, regulatory compliance, data management, monitoring, and manufacturing support tailored to meet the unique requirements of gene therapy research protocols.

Gene Therapy Clinical Trial Services Market Trends

The growing prevalence of genetic disorders and chronic diseases has led to a surge in the number of gene therapy clinical trial studies. This trend reflected the growing demand for clinical trial services to support the planning, execution, and oversight of studies. Therefore, to address the clinical trial service requirements, service-based companies are consistently expanding their networks to provide efficient services that would meet the clinical study demands, aiming to capitalize on market opportunities.

• For instance, in May 2023, Central Pharma collaborated with CSafe's, an extensive network of pharmaceutical service providers worldwide, to offer a complementary service network supporting cell and gene therapy products. This partnership sought to broaden supply chain offerings for cell and gene therapy products at the entire developmental stages.

Therefore, increasing research funding expediting research activities, growing advancements in gene therapy technologies, and expanding the clinical service network fosters the market demand for comprehensive solutions in the healthcare sector.

Gene Therapy Clinical Trial Services Market Analysis

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Based on services, the market is categorized into clinical trial design & planning, supply & logistics services, regulatory services, data management & biostatistics, site management & monitoring, and other services. The regulatory services segment is poised to lead the market, with projections to reach a value of USD 561.1 million by the end of 2032.

• Regulatory services are essential to ensure adherence to strict regulations overseeing gene therapy trials, including those established by the FDA and EMA among other regulatory bodies in their respective countries.
• These services involve the development of regulatory strategies, preparation of submissions, and coordination with regulatory bodies. Thus, to meet the complex regulatory landscape and the crucial role of compliance in obtaining approval, intends to surge the demand for regulatory services.

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Based on therapeutic area, the gene therapy clinical trial services market is classified into oncology, hematology, endocrine/ metabolic disorders, musculoskeletal diseases, cardiovascular diseases (CVD), neurology disorders, infectious diseases, ophthalmology, immunology, and other therapeutic areas. The oncology segment hold the largest market share of 38.8% in 2023 and is expected to maintain dominance throughout the analysis period.

• The oncology sector’s dominance stemmed from extensive research and development (R&D) endeavors aimed at addressing various cancer types through gene therapy methods. Oncology retains its prominence in gene therapy trials owing to the urgent demand for improved, precisely targeted cancer gene therapies.  As a result, to meet global requirements, a multitude of ongoing clinical trials and an increasing array of promising cancer gene therapy candidates drive the oncology segment's dominance in the market.

Based on the end-user, the gene therapy clinical trial services market is segmented into pharmaceutical and biotechnology companies, contract research organizations (CROS), academic and research institutes, and other end-users. The pharmaceutical & biotechnology companies segment accounted for the largest revenue share in the market expected to account for USD 1.1 billion by 2032.

• Pharmaceutical and biotechnology companies emerged as the dominant end-users due to their substantial R&D investments, coupled with their extensive networks and resources, positioning them as key players shaping the market landscape.
• These companies outsource clinical trials that drive demand for various services essential for trial conduct, including trial design, patient recruitment, regulatory services, data management, monitoring, and manufacturing support, emphasizing their pivotal role in advancing gene therapy

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The U.S. dominated the North American gene therapy clinical trial services market accounting for USD 494.5 million in 2023 and is anticipated to show significant growth over the analysis period.

• The rising investment in cell and gene therapy clinical trials in the U.S. is expected to expand the pipeline of studies, thereby increasing market opportunities. According to Center for Biologics Evaluation and Research (CBER) data, there are presently 18 cell and gene therapy products in the U.S. approved to treat 25 indications. The projection suggested the current therapy pipeline yielded 66 product-indication approvals by 2032. Thus, the growing focus on cell and gene therapy research and pipeline extensions expects to capitalize on market prospects, thereby driving increased demand for services in the U.S.

Germany exhibited a high growth potential in the European gene therapy clinical trial services market.

• Germany holds a prominent position in the European market, leveraging its advanced healthcare infrastructure, renowned research institutions, and skilled workforce. The country's supportive regulatory landscape and significant focus on cell and gene therapy research aimed to bolster the demand for clinical trial services, ensuring the smooth conduct of trials.
• Furthermore, Germany's focus on personalized medicine and biotechnology establishes it as a crucial hub for gene therapy trials, fostering collaboration among academics, industry, and healthcare providers, thus expanding demand for services.

The Asia Pacific gene therapy clinical trial services market is poised for rapid growth with a CAGR of 9.6% during the forecast period.

• The Asia-Pacific region is poised for significant growth in the cell and gene therapy market due to factors such as increasing healthcare expenditure, rising prevalence of genetic disorders, and supportive regulatory frameworks.
• Moreover, the region's large patient population, particularly in countries such as China, India, South Korea and Japan, offers substantial market opportunities. Also, collaborations between industry players and government initiatives further stimulate growth in this dynamic and evolving market.
• Furthermore, gradual shift of clinical trials from western countries to Asian countries owing to cost structure and patient recruitment will spur the regional market growth.

Gene Therapy Clinical Trial Services Market Share

The gene therapy clinical trial services industry is characterized by rapid growth and innovation, driven by increasing investment in R&D, rising prevalence of genetic disorders, and advancements in biotechnology. Major service providers focus on offering a range of services such as regulatory consulting, patient recruitment, and data management. Additionally, collaborations between industry and academia, along with supportive regulatory frameworks, contribute to a dynamic market landscape with significant opportunities for growth and advancement in gene therapy treatments.

Gene Therapy Clinical Trial Services Market Companies

Some of the prominent players operating in the gene therapy clinical trial services industry include

• Almac Group
• Catalent Biologics
• Charles River Laboratories International, Inc.
• ICON plc
• IQVIA Biotech
• Labcorp Drug Development
• Medpace Holdings, Inc.
• Novotech 
• Parexel International (MA) Corporation
• Precision Medicine Group LLC
• Sharp Services, LLC
• Thermo Fisher Scientific Inc.
• Worldwide Clinical Trials

Gene Therapy Clinical Trial Services Industry News

• In November 2023, TrakCel and The Quick Life Science Group entered into a partnership to provide an integrated IT logistics orchestration platform. This platform allowed the global cell and gene therapy industry to efficiently track products and streamline logistical processes from start to finish. This collaboration aimed to enhance efficiency and transparency in supply chain management for cell and gene therapies, thereby strengthening business relation.
• In January 2023, Catalent introduced its new Case Management Service, designed to address challenges in delivering advanced therapies like cell and gene therapies securely and promptly to patients. This service provides expert oversight of the supply chain, aiming to improve the efficiency and reliability of advanced therapy delivery, thereby strengthening product offerings.

The gene therapy clinical trial services market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments

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Market, By Services

• Clinical trial design & planning
• Supply & logistics services
• Regulatory services
• Data management & biostatistics
• Site management & monitoring
• Other services

Market, By Therapeutic Area

• Oncology
• Hematology
• Endocrine/ metabolic disorders
• Musculoskeletal diseases
• Cardiovascular diseases (CVD)
• Neurology disorders
• Infectious diseases
• Ophthalmology
• Immunology
• Other therapeutic areas

Market, By End-user

• Pharmaceutical and biotechnology companies
• Contract research organizations (CROs)
• Academic and research institutes
• Other end-users

The above information is provided for the following regions and countries

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of Middle East and Africa