What are the recent trends in market size and growth for the cell and gene therapy clinical trial services market?
The cell and gene therapy clinical trial services market size has grown rapidly in recent years. It will grow from $3.79 billion in 2024 to $4.2 billion in 2025 at a compound annual growth rate (CAGR) of 10.7%. The growth in the historic period can be attributed to the increased prevalence of chronic diseases, increased demand for effective treatments for rare genetic disorders, increased government funding for research in regenerative medicine, increased understanding of molecular mechanisms underlying various diseases, and increased awareness of the potential of personalized medicine.
The cell and gene therapy clinical trial services market size is expected to see rapid growth in the next few years. It will grow to $6.22 billion in 2029 at a compound annual growth rate (CAGR) of 10.3%. The growth in the forecast period can be attributed to increasing global incidence of genetic and auto-immune diseases, rising public and private sector funding for gene therapy research, growing adoption of novel technologies, and a rise in the number of genetic defects. Major trends in the forecast period include the adoption of AI, the adoption of machine learning, the adoption of personalized medicine, technological advancements, and gene therapies.
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How have varous drivers impacted the growth of the cell and gene therapy clinical trial services market?
The rising incidence of genetic disease is expected to propel the growth of the cell and gene therapy clinical trial services market going forward. Genetic diseases are ailments caused by variations in a person’s DNA or genetic composition. The incidence of genetic diseases is on the rise due to numerous factors, including the increased availability of genetic testing, the occurrence of genetic mutations, and the prevalence of consanguineous marriage. Cell and gene therapy clinical trial services address the rising incidence of genetic diseases by encouraging the development of novel treatments, tailoring therapies to individual patients, accelerating the translation of research into clinical practice, and expanding the options available to patients suffering from genetic disorders. For instance, in July 2022, according to the Cystic Fibrosis (CF) Foundation, a US-based non-profit organization, there had been an upsurge in the number of people with cystic fibrosis. In 2022, cystic fibrosis affected almost 40,000 children and adults in the United States, and over 105,000 people worldwide have been diagnosed. Therefore, the rising incidence of genetic disease is driving the growth of the cell and gene therapy clinical trial services market.
What are the primary segments 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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Which firms are leading 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.
How will industry trends affect the trajectory of the cell and gene therapy clinical trial services market?
Major companies operating in the cell and gene therapy clinical trial services market are focusing their efforts on introducing advanced technology with customer relationship management system technology, to improve efficiency, and gain a competitive edge in the market. The customer relationship management system utilized by cell and gene therapy clinical trial services streamlines and coordinates interactions with trial participants, healthcare providers, and other stakeholders throughout the clinical trial process. For instance, in April 2023, AmerisourceBergen Corporation, a US-based healthcare company, launched the Cell and Gene Therapy (CGT) Integration Hub, a platform that aims to increase connectivity and streamline processes throughout the cell and gene therapy treatment pathway. This platform is backed by AmerisourceBergen’s customer relationship management (CRM) system and attempts to streamline the path-to-care process, in part by giving physicians and patient services teams better visibility across the therapy development and delivery process. The CGT Integration Hub, which includes features such as expedited benefits investigation, real-time status tracking, and proactive alerts, aims to simplify care coordination, minimize barriers, and improve the entire patient and provider experience when delivering cell and gene therapies.
Which geographic trends are shaping the cell and gene therapy clinical trial services market, and which region has the highest market share?
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 Does The Cell And Gene Therapy Clinical Trial Services Market Report 2025 Offer?
The cell and gene therapy clinical trial services market research report from The Business Research Company offers global market size, growth rate, regional shares, competitor analysis, detailed segments, trends, and opportunities.
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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