Cell Therapy Clinical Trial Services Market Size

Cell Therapy Clinical Trial Services Market size was valued at USD 2.6 billion in 2023, growing at a CAGR of 10.6% between 2024 and 2032. The global market is experiencing dynamic growth driven by factors such as the growing prevalence of chronic diseases such as cancer, cardiovascular diseases, and autoimmune disorders that increase the demand for innovative treatments like cell therapy, leading to more clinical trials.

Moreover, continuous advancements in cell therapy technologies, such as CAR-T cell therapy and stem cell therapy, are expanding the scope of clinical trials services, thus, driving the market growth. For instance, in February 2024, BioNTech SE a next-generation immunotherapy company and Autolus Therapeutics plc a clinical-stage biopharmaceutical company developing next-generation programmed T-cell therapies, announced a strategic collaboration aimed at advancing both companies’ autologous CAR-T programs towards commercialization and pending regulatory authorizations. In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement. Thus, the collaboration with Autolus enables BioNTech SE to expand BNT211 program into trials for multiple cancer indications in a cost-efficient way. Thus, widespread usage of regulatory services will spur the market growth.

Cell therapy clinical trial services encompass a range of activities and support mechanisms provided by specialized organizations to facilitate the planning, execution, and management of clinical trials focused on cell-based therapies. These services are designed to assist pharmaceutical companies, biotechnology firms, academic institutions, and other stakeholders in navigating the complex process of conducting clinical trials for cell therapies.

Cell Therapy Clinical Trial Services Market Trends

The rise in the prevalence of chronic and genetic diseases has sparked a corresponding increase in the demand for cell therapy. Also, the increase in the number of research & development activities in the field of cell therapy has increased the demand for clinical trial services that is anticipated to boost the growth of the market.

• For instance, as per the report published in January 2024 reported that, the biopharma industry has its largest and most diverse clinical pipeline in the last few years. The total number of distinct drugs in development grew from 3,200 in 2012 to 6,100 in 2022. This pipeline is increasingly diverse with 14% of assets use modalities validated over the past five years (predominantly various forms of cell and gene therapy).
  
• Thus, the escalating prevalence of chronic and genetic diseases and rapid increase in R&D activities by biopharma industry for the development of advanced cell therapy products increases the demand for cell therapy clinical trial services that will boost the growth of the market.
  

Cell Therapy Clinical Trial Services Market Analysis

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Based on the service, the global market is classified into clinical trial design and planning, supply & logistics services, regulatory affairs & compliance, data management & biostatics, site management & monitoring, and other services. The regulatory affairs & compliance segment dominated the market with revenue of USD 662.4 million in 2023.

• Regulatory compliance is essential to demonstrate the safety and efficacy of these therapies in clinical trials. Robust regulatory affairs practices help ensure that appropriate safety measures are implemented and followed throughout the development process.
  
• Moreover, regulatory affairs professionals play a crucial role in identifying and mitigating various risks such as related to product variability, patient safety, and ethical considerations, through comprehensive risk management strategies. By ensuring compliance with regulatory requirements, companies can minimize risks associated with non-compliance and avoid delays in the development process. Such aforementioned factor is expected to spur the segmental growth.

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Based on the phase, the global cell therapy clinical trial services market is classified into phase I, phase II, phase III, and phase IV. The phase II segment dominated the market with market share of 35.2% in 2023.

• Phase II trials typically involve larger patient populations than Phase I trials, requiring efficient patient recruitment and retention strategies. Advances in patient engagement, site selection, and recruitment technologies contribute to the successful execution of Phase II trials.
  
• Moreover, promising results from Phase I clinical trials demonstrating the safety and preliminary efficacy of a cell therapy, often lead to the initiation of Phase II trials. Therefore, sponsors are encouraged to advance promising candidates into Phase II to further evaluate their therapeutic potential. Thus, usage of trial services in phase II will augment the segmental growth.
  

Based on the indication, the global cell therapy clinical trial services market is classified into oncology, hematology, neurology, cardiovascular diseases, musculoskeletal disorders, and other indications. The oncology segment is expected to reach USD 2.8 billion by end of 2032.

• Cancer remains a leading cause of morbidity and mortality worldwide, with many patients facing limited treatment options, especially in late stage of the disease. Therefore, cell therapies offer a promising avenue for addressing this unmet medical need by providing innovative and potentially curative treatment options.
  
• Moreover, rapid advancement in immunotherapy including chimeric antigen receptor (CAR) T-cell therapy and immune checkpoint inhibitors, have revolutionized cancer treatment by harnessing the body's immune system to target and eliminate cancer cells. This development of cell-based immunotherapies has propelled the usage of clinical trial services, thereby supplementing the growth of oncology-focused cell therapy clinical trials.
  

Based on end-use, the cell therapy clinical trial services market is classified into pharmaceutical & biotechnology companies, contract research organizations, academic & research institutes, and other end-users. The pharmaceutical & biotechnology companies’ segment is expected to exhibit 10.9% CAGR between 2024 - 2032.

• Pharmaceutical and biotechnology companies are investing heavily in research and development (R&D) efforts focused on cell therapies. The growing understanding of cellular biology, advancements in cell culture techniques, and innovative technologies such as gene editing have fueled interest in cell-based treatments. This increased investment drives the demand for clinical trial services to support the development and testing of cell therapies.
  
• Moreover, pharmaceutical and biotechnology companies are actively developing novel cell therapies to address unmet medical needs and capitalize on market opportunities. As the pipeline grows, the demand for clinical trial services, including clinical trial management, regulatory affairs support, and specialized laboratory services, increases accordingly, thereby fostering the market size. 

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In 2023, North America secured a substantial market share of 43.2% in the global cell therapy clinical trial services market and is expected to dominate throughout the forecast period.

• The presence of robust biopharmaceutical industry with numerous pharmaceutical and biotechnology companies actively engaged in cell therapy research and development activities in North America coupled with substantial investment in innovative technologies and therapies, drives the demand for cell therapy clinical trial services in this region.
  
• Moreover, regulatory agencies in North America, such as the Food and Drug Administration (FDA) in the U.S. and Health Canada, have established regulatory pathways and guidelines to facilitate the development and approval of cell therapies. Initiatives such as the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and expedited review programs accelerate the regulatory approval process for promising cell therapy products, thereby fostering growth in the market.
  

Germany to experience the highest growth rate in the market, outstripping other countries in Europe in the assessment period.

• Germany hosts leading academic and research institutions with expertise in cell biology, immunology, and regenerative medicine. Collaborations between industry sponsors and these institutions facilitate the design and conduct of innovative cell therapy clinical trials. Therefore, access to leading researchers, specialized facilities, and patient populations contributes to the growth of the market in Germany.
  

The Asia Pacific cell therapy clinical trial services market is expected to grow with a significant CAGR during the forecast period.

• The region's abundant patient base, notably in nations such as China, India, South Korea, and Japan, presents significant market prospects. Furthermore, partnerships between industry stakeholders and governmental efforts serve to bolster growth in this vibrant and evolving market.
  
• Moreover, the gradual migration of clinical trials from Western nations to Asian countries, driven by cost considerations and patient recruitment advantages, will further fuel growth in the regional market.
  
• Further, the Asia-Pacific region is posed for substantial expansion within the cell and gene therapy market, propelled by factors such as escalating healthcare spending, a growing incidence of genetic disorders, and favorable regulatory environments.
  

Cell Therapy Clinical Trial Services Market Share

The competitive landscape of the cell therapy clinical trial services industry is characterized by the presence of established pharmaceutical & biotechnology companies along with CROs that collaborates to provide cell therapy clinical trial services vying for market share. Key players are engaging in strategic initiatives such as collaboration, investment, and partnerships to strengthen their service portfolio. The companies are actively adopting a multi-pronged approaches to address the rising demand for cell therapy clinical trial services.

Cell Therapy Clinical Trial Services Market Companies

Prominent players operating in the market are as mentioned below:

• ICON PLC
• IQVIA
• Medpace, Inc.
• LabCorp
• Parexel International
• Worldwide Clinical Trials
• Charles River Laboratories International, Inc.
• Syneos Health
• Thermo Fisher Scientific Inc.
• Novotech
• Catalent Pharma
• Precision Medicine Group, LLC
  

Cell Therapy Clinical Trial Services Industry News:

• In November 2022, Coeptis Therapeutics Holdings, Inc. a biopharmaceutical company developing innovative cell therapy platforms for cancer, announced an agreement with IQVIA, a leading global provider of advanced analytics, technology solutions and contract services to the life sciences industry, to support the development of SNAP-CAR, a multi-antigen chimeric antigen receptor T cell (CAR T) technology. SNAP-CAR is designed as a "universal" CAR T cell therapy platform that can be adapted to different cancer indications, including hematologic and solid tumours. This strategy enabled company to enhance their business relations.
  
• In August 2022, Worldwide Clinical Trials, Inc. the industry’s leading global, midsize, full-service contract research organization (CRO), has expanded its early phase large molecule capabilities and services with a new 15,000 square foot dedicated lab at its Bioanalytical Center of Excellence in Austin, Texas. Thus, with this added capacity, Worldwide Clinical Trials, Inc. provide its sponsors with optimized sample processing and analysis workflows for minimal turnaround times, as well as the flexibility to continuously scale additional capabilities into preexisting workflows, thereby strengthening its market position.
  

The cell 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 Service

• Clinical trial design & planning
• Supply & logistics services
• Regulatory affairs & compliance
• Data management & biostatics
• Site management & monitoring
• Other services

Market, By Phase

• Phase I
• Phase II
• Phase III
• Phase IV

Market, By Indication

• Oncology
• Hematology
• Neurology
• Cardiovascular diseases
• Musculoskeletal disorders
• Other indications

Market, By End-use

• Pharmaceutical & biotechnology companies
• Contract research organizations
• Academic & 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
  • Italy
  • Spain
  • 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
  • South Africa
  • Saudia Arabia
  • UAE
  • Rest of Middle East and Africa