Key Influencer in the Cell And Gene Therapy Clinical Trial Services Market 2025: Role Of Cell And Gene Therapy Trials In Tackling Genetic Diseases Driver

What industry-specific factors are fueling the growth of the cell and gene therapy clinical trial services market?
The increasing prevalence of genetic disorders is anticipated to drive the expansion of the cell and gene therapy clinical trial services market. Genetic conditions, which are caused by changes in an individual's DNA or genetic make-up, are becoming more prevalent due to numerous factors such as greater access to genetic testing, the occurrence of genetic mutations, and the prevalence of consanguinity. Cell and gene therapy clinical trial services are responding to the mounting prevalence of genetic diseases by initiating the development of new treatments, customizing therapy to specific patients, expediting the application of research into clinical procedures, and offering more alternatives to patients afflicted with genetic conditions. For example, the Cystic Fibrosis (CF) Foundation, a not-for-profit organization based in the US, reported in July 2022 an increase in the number of cystic fibrosis patients. In 2022, cystic fibrosis impacted nearly 40,000 children and adults in the United States, and over 105,000 people globally have been diagnosed. Thus, the escalating prevalence of genetic diseases is spurring the growth of the cell and gene therapy clinical trial services market.

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What Is the projected market size and growth rate for the cell and gene therapy clinical trial services market?
Over the last few years, the market size for clinical trial services in cell and gene therapy has experienced swift expansion. The market is predicted to rise from $3.79 billion in 2024 to $4.2 billion in 2025, with a compound annual growth rate (CAGR) of 10.7%. The surge in the historical period is a result of the rising occurrence of chronic illnesses, heightened demand for effective treatments for rare genetic conditions, increased government contributions towards regenerative medicine studies, improved knowledge on the molecular processes inherent in various diseases, and growing consciousness about the potential of individualized medicine.

In the coming years, the market size for clinical trial services in cell and gene therapy is predicted to experience a rapid expansion. It is projected to reach a valuation of $6.22 billion by 2029, progressing at a compound annual growth rate (CAGR) of 10.3%. The anticipated growth during the forecast period can be credited to the escalating worldwide prevalence of genetic and auto-immune disorders, increased funding from private and public sectors for gene therapy research, broader acceptance of innovative technologies, and surge in the amount of genetic defects. The forecast period will likely see major trends such as AI incorporation, the integration of machine learning, the application of personalized medicine, advancements in technology, and gene therapies.

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What new trends are reshaping the cell and gene therapy clinical trial services market and its opportunities?
Major organizations in the cell and gene therapy clinical trial services market are concentrating on applying advanced technology coupled with a customer relationship management system (CRM) to enhance efficiency and secure a competitive advantage. The CRM system in use facilitates the management and synchronization of interactions with trial participants, healthcare providers, and other stakeholders throughout the clinical trial process. For example, in April 2023, AmerisourceBergen Corporation, a healthcare firm based in the US, introduced the Cell and Gene Therapy (CGT) Integration Hub. This platform seeks to enhance connectivity and simplify procedures across the cell and gene therapy treatment pathway. It leverages AmerisourceBergen's CRM system, intending to facilitate the path-to-care process by providing physicians and patient services teams with improved visibility into the therapy development and delivery process. The CGT Integration Hub incorporates features like expedited benefits investigation, real-time status tracking, and proactive alerts. Its objective is to ease care coordination, reduce obstacles, and enhance the overall patient and provider experience during the delivery of cell and gene therapies.

What major market segments define the scope and growth of the cell and gene therapy clinical trial services market?
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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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.

Which key market leaders are driving the cell and gene therapy clinical trial services industry growth?
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.

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What Is Covered In The Cell And Gene Therapy Clinical Trial Services Global Market Report?

•Market Size Forecast: Examine the cell and gene therapy clinical trial services market size across key regions, countries, product categories, and applications.
•Segmentation Insights: Identify and classify subsegments within the cell and gene therapy clinical trial services market for a structured understanding.
•Key Players Overview: Analyze major players in the cell and gene therapy clinical trial services market, including their market value, share, and competitive positioning.
•Growth Trends Exploration: Assess individual growth patterns and future opportunities in the cell and gene therapy clinical trial services market.
•Segment Contributions: Evaluate how different segments drive overall growth in the cell and gene therapy clinical trial services market.
•Growth Factors: Highlight key drivers and opportunities influencing the expansion of the cell and gene therapy clinical trial services market.
•Industry Challenges: Identify potential risks and obstacles affecting the cell and gene therapy clinical trial services market.
•Competitive Landscape: Review strategic developments in the cell and gene therapy clinical trial services market, including expansions, agreements, and new product launches.

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