In-Depth Insights into the Cell And Gene Therapy Clinical Trial Services Market: Growth, Trends, and Opportunities for 2025-2034
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How has the cell and gene therapy clinical trial services market grown in recent years?
The cell and gene therapy clinical trial services market has seen rapid growth in recent years. It will grow from $3.79 billion in 2024 to $4.2 billion in 2025, with a compound annual growth rate (CAGR) of 10.7%. This growth is driven by the rising prevalence of chronic diseases, the demand for treatments for rare genetic disorders, increased funding for regenerative medicine research, better understanding of molecular disease mechanisms, and the increasing recognition of personalized medicine.
How is the cell and gene therapy clinical trial services market size expected to evolve during the forecast period?
The cell and gene therapy clinical trial services market is expected to reach $6.22 billion by 2029 with a CAGR of 10.3%. Growth is driven by the rise in genetic and autoimmune diseases, increased funding for gene therapy, the adoption of novel technologies, and growing genetic defects. Trends include AI and machine learning adoption, personalized medicine, and advancements in gene therapies.
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Which key drivers are propelling the cell and gene therapy clinical trial services market’s growth?
The rising incidence of genetic diseases is expected to drive the growth of the cell and gene therapy clinical trial services market. Genetic diseases are caused by variations in DNA or genetic composition, and their prevalence is rising due to factors like increased genetic testing and consanguineous marriages. Clinical trial services for cell and gene therapies are key in developing new treatments for genetic disorders. For example, in July 2022, the Cystic Fibrosis Foundation reported that cystic fibrosis affects nearly 40,000 people in the U.S., and over 105,000 people globally. The growing incidence of genetic diseases is propelling the market forward.
What are the market segments in the cell and gene therapy clinical trial services industry?
The cell and gene therapy clinical trial services market covered in this report is segmented –
1) By Service: Clinical Trial Design And Planning, Supply And Logistic Services, Regulatory Affairs And Compliance, Data Management And Biostatics, Site Management And Monitoring, Other Services
2) By Therapy Type: Gene Therapy, Cell Therapy, Gene Modified Cell Therapy
3) By Indication: Oncology, Hematology, Metabolic Disorders, Infectious Diseases, Neurology, Cardiovascular Diseases, Musculoskeletal Disorders, Other Indications
4) By End-Use: Pharmaceutical And Biotechnology Companies, Contract Research Organizations, Academic And Research Institutes, Other End-Users
Subsegments:
1) By Clinical Trial Design And Planning: Protocol Development, Trial Feasibility Studies, Trial Design Consultation, Patient Recruitment And Enrollment Strategy, Risk-Based Monitoring Plans
2) By Supply And Logistic Services: Clinical Trial Supply Chain Management, Cold Chain Logistics, Packaging And Labeling Services, Transportation And Distribution Of Biological Samples, Customs And Import/Export Services
3) By Regulatory Affairs And Compliance: Regulatory Strategy And Consulting, Regulatory Submission And Documentation, Compliance With GMP (Good Manufacturing Practices), Regulatory Pathway Consultation, Clinical Trial Applications (CTAs)
4) By Data Management And Biostatistics: Clinical Data Management (CDM), Statistical Analysis And Reporting, Clinical Data Monitoring, Data Integration And Validation, Electronic Data Capture (EDC) Solutions
5) By Site Management And Monitoring: Site Selection And Initiation, Clinical Monitoring And Site Visits, Patient Recruitment And Retention, Site Training And Support, Site Performance Monitoring
6) By Other Services: Patient Advocacy And Engagement, Real-World Evidence (RWE) Studies, Post-Trial Services, Medical Writing And Documentation, Clinical Trial Auditing And Inspection
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Which leading companies are shaping the growth of the cell and gene therapy clinical trial services market?
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.
What key trends are currently impacting the cell and gene therapy clinical trial services market’s development?
In the cell and gene therapy clinical trial services market, companies are implementing advanced technologies, such as customer relationship management (CRM) systems, to streamline processes and improve efficiency. For example, in April 2023, AmerisourceBergen Corporation, a US-based healthcare company, launched the Cell and Gene Therapy (CGT) Integration Hub, which leverages CRM technology to enhance connectivity and simplify the therapy development process. The platform aims to improve patient and provider experiences by offering real-time tracking, expedited benefits investigation, and proactive alerts.
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Which geographic areas are influencing the growth of the cell and gene therapy clinical trial services market?
North America was the largest region in the cell and gene therapy clinical trial services market in 2023. 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.
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