Cell And Gene Therapy Clinical Trial Services Market Forecast and Analysis: Key Insights into Growth, Trends, and Emerging Opportunities
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How Will the Growth Rate of the Cell And Gene Therapy Clinical Trial Services Market Shape Industry Trends by 2034?
There has been impressive growth in recent years in the market size of clinical trial services for cell and gene therapy. The market, which will expand from $3.79 billion in 2024 to $4.2 billion in 2025, is expected to witness a compound annual growth rate (CAGR) of 10.7%. This growth during the historic period can be traced back to an elevated incidence of chronic diseases, a heightened demand for successful treatments for rare genetic conditions, an increase in government funding towards regenerative medical research, an expanded comprehension of the molecular mechanisms of various diseases, and enhanced awareness in personalized medicine’s potential.
The market size of clinical trial services for cell and gene therapy is projected to undergo significant expansion in the coming years, anticipated to reach $6.22 billion by 2029, with a compound annual growth rate (CAGR) of 10.3%. This predicted growth during the projection period is due to the surge in worldwide cases of genetic and autoimmune diseases, increasing funds from the public and private sectors towards gene therapy research, the uptake of groundbreaking technologies, and an increase in genetic defects. Emerging trends within the forecast period consist of the integration of Artificial Intelligence, the employment of machine learning, the adoption of personalized medication, technological progressions, and gene therapies.
What Are the Primary Drivers Supporting the Growth of the Cell And Gene Therapy Clinical Trial Services Market?
The cell and gene therapy clinical trial services market growth is set to be spurred on by the escalating incidence of genetic diseases. These diseases are triggered by alterations in an individual’s DNA or genetic makeup. Various factors, such as increased genetic testing availability, the frequency of genetic mutations, and commonality of consanguineous marriages, are behind the rising prevalence of these diseases. The market for cell and gene therapy clinical trial services responds to this surge by fostering the creation of innovative treatments, personalizing therapies to each patient, hastening the conversion of research into clinical application, and widening the choices for patients plagued by genetic disorders. For instance, the Cystic Fibrosis (CF) Foundation, a not-for-profit organization based in the USA, reported a significant rise in cystic fibrosis cases in July of 2022. The disease affected close to 40,000 children and adults in the United States in 2022, with the global count exceeding 105,000 diagnosed cases. Therefore, the escalating incidence of genetic diseases is fueling the expansion of the cell and gene therapy clinical trial services market.
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Who Are the Key Market Players Influencing the Growth of the Cell And Gene Therapy Clinical Trial Services Industry?
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
What Key Market Trends Are Shaping the Future of the Cell And Gene Therapy Clinical Trial Services Industry?
Noteworthy corporations within the cell and gene therapy clinical trial services market are directing their resources towards implementing sophisticated technology inclusive of customer relationship management system technology. This strategy aims to boost efficiency and secure a competitive edge in the market. The customer relationship management system adopted by these services optimizes and orchestrates communications with trial participants, healthcare providers, and other stakeholders throughout the clinical trial course. For example, AmerisourceBergen Corporation, a healthcare firm based in the US, unveiled the Cell and Gene Therapy (CGT) Integration Hub in April 2023. This platform seeks to enhance connectivity and expedite processes across the treatment pathway of cell and gene therapy. It is supported by AmerisourceBergen’s customer relationship management (CRM) system and aims to streamline the path-to-care process by extending superior visibility to doctors and patient services teams over the therapy development and delivery process. The CGT Integration Hub, equipped with features like accelerated benefits investigation, real-time status tracking, and proactive alerts, aspires to simplify care coordination, reduce hurdles, and enhance the overall patient and provider experience in delivering cell and gene therapies.
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How Are Key Segments Defining the Competitive Landscape 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
Which Regions Are Emerging as Leaders in 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.
What Defines the Scope of the Cell And Gene Therapy Clinical Trial Services Market?
Cell and gene therapy clinical trial services refer to specialized services offered by contract research organizations (CROs) or clinical trial management corporations to facilitate the design, implementation, and management of clinical trials for cell and gene therapies. These services, which range from protocol design and patient recruiting to regulatory compliance and data administration, serve as the foundation for trials to progress smoothly, ensuring precision, efficacy, and adherence to high standards.
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