The Cell and Gene Therapy (CGT) Bioanalytical Testing Services market is experiencing significant growth, driven by advancements in biotechnology and the increasing adoption of personalized medicine. These services are essential for ensuring the safety, efficacy, and quality of innovative therapies.
Market Overview
In 2023, the global CGT bioanalytical testing services market was valued at approximately USD 503.91 million. Projections indicate a compound annual growth rate (CAGR) of 7.3%, anticipating the market to reach around USD 950.06 million by 2032.
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Major Players Operating in Global Cell & Gene Therapy Bioanalytical Testing Services Market
- BioAgilytix Labs
- Charles River Laboratories
- Intertek Group Plc.
- IQVIA, Inc.
- KCAS Bioanalytical Services
- Laboratory Corporation of America Holdings
- Pharmaron
- Pharmaceutical Product Development, Inc.
- Prolytix
- SGS SA
- Syneos Health
Growth Drivers
- Advancements in Biotechnology: Innovations in gene editing tools, such as CRISPR, have expanded the development of cell and gene therapies, necessitating comprehensive bioanalytical testing services.
- Personalized Medicine: The shift towards treatments tailored to individual genetic profiles has increased the demand for precise bioanalytical testing to support personalized therapeutic approaches.
- Regulatory Requirements: Stringent guidelines from health authorities mandate thorough testing of CGT products, boosting the need for specialized bioanalytical services.
- Investment in R&D: Substantial funding in CGT research and development has accelerated clinical trials and product approvals, thereby driving the market for associated testing services.
Key Trends
- Outsourcing of Testing Services: Pharmaceutical and biotechnology companies are increasingly outsourcing bioanalytical testing to specialized contract research organizations to enhance efficiency and focus on core competencies.
- Technological Innovations: The integration of automation and high-throughput screening methods is improving the accuracy and speed of bioanalytical testing processes.
- Focus on Biopharmaceuticals: The rise in development and approval of biopharmaceuticals has created a demand for specialized bioanalytical testing services tailored to biologics.
Cell & Gene Therapy Bioanalytical Testing Services Market Report Segmentation
The research report categorizes the market into various segments and sub-segments. The primary segments covered in the study include type, application, end use and region. The splitting of the market into various groups enables businesses to understand market preferences and trends better.
Cell & Gene Therapy Bioanalytical Testing Services Market, Test Type Outlook (Revenue – USD Million, 2019-2032)
- Bioavailability & Bioequivalence Studies
- Pharmacokinetics
- Pharmacodynamics
- Others
Cell & Gene Therapy Bioanalytical Testing Services Market, Product Type Outlook (Revenue – USD Million, 2019-2032)
- Gene Therapy
- Gene-Modified Cell Therapy
- Cell Therapy
Cell & Gene Therapy Bioanalytical Testing Services Market, Stage of Development Outlook (Revenue – USD Million, 2019-2032)
- Nonclinical
- Clinical
Cell & Gene Therapy Bioanalytical Testing Services Market, Indication Outlook (Revenue – USD Million, 2019-2032)
- Infectious Diseases
- Neurological disorders
- Oncology
- Rare Diseases
- Others
Research Scope
The research scope encompasses the development of novel assays, validation of testing methodologies, and the establishment of standardized protocols to ensure the reliability and reproducibility of test results. Collaborations between academic institutions, industry players, and regulatory bodies are pivotal in advancing the field.
Future Outlook
The CGT bioanalytical testing services market is poised for robust growth, propelled by continuous advancements in therapeutic modalities and supportive regulatory frameworks. The increasing prevalence of chronic and genetic disorders is expected to sustain the demand for these services. Moreover, emerging markets, particularly in the Asia-Pacific region, are anticipated to offer lucrative opportunities due to rising healthcare investments and expanding biotechnology sectors.
Recent Developments in Cell & Gene Therapy Bioanalytical Testing Services
April 2024: The National Institutes of Health (NIH) awarded a $6.2 million grant to researchers at Washington University School of Medicine in St. Louis. This funding supports the development of a gene therapy aimed at modifying B cells to produce broadly neutralizing antibodies against HIV, potentially controlling or eliminating the infection without ongoing antiretroviral therapy.
May 2024: Merck KGaA, Darmstadt, Germany, announced a definitive agreement to acquire Mirus Bio for $600 million. Mirus Bio specializes in transfection reagents essential for introducing genetic material into cells, a critical component in viral vector production for cell and gene therapies. This acquisition enhances Merck’s capabilities in viral vector manufacturing, reinforcing its position in the biotechnology sector.
These developments underscore the ongoing commitment within the industry to advance cell and gene therapy research and manufacturing capabilities.