The global cell and gene therapy bioanalytical testing services market size is expected to reach USD 828.7 million by 2030, registering a CAGR of 7.40% from 2025 to 2030, according to a new report by Grand View Research, Inc. Increasing R&D activities related to cell and gene therapy, growth in investments by public organizations for cell and gene therapy research and high potential of gene and cell therapy in treating rare diseases are the key factors driving the growth of the market.
Cell and gene therapies have popularly been adopted in the treatment of cancer, autoimmune diseases, and rare diseases. These therapies have shown a significant improvement in patients' clinical conditions, owing to which a significant number of cell and gene therapy drug candidates are in the pipeline. For instance, according to the American Society of Cell and Gene Therapy, over 2,053 gene therapies and 827 non-genetically modified cell therapies were in the pipeline as of January 2023. High number of cell and gene therapy drug candidates in pipeline is promoting the demand for bioanalytical testing services.
Public and private organizations are actively investing in cell and gene therapy-based research. For instance, in April 2023, the California Institute for Regenerative Medicine invested USD 89.0 million in stem cell and gene therapy research. This funding was planned for the development of therapy in the treatment of persistent corneal epithelial defects. Similar fundings in the future is expected to boost the demand for bioanalytical testing services in the forecasted period.
The COVID-19 pandemic had a negative impact on the market for cell & gene therapy bioanalytical testing services. The majority of the cell and gene therapy-based trials were postponed in the pandemic. However, in the post COVID-19 era, the scenario is changing, and many trials are resumed. This is expected to support market growth in the post-COVID-19 period.
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The bioavailability & bioequivalence studies dominated with a market share of 35.44% in 2024 and are also expected to witness the fastest growth over the forecast period.
The non-clinical segment dominated the market in 2024. The stage of development segment has been further classified based on the product type, which includes gene therapy, gene-modified cell therapy, and cell therapy.
The cell therapy segment dominated the product segment in 2024. Cell therapy is the transplantation of human cells to repair or replace damaged tissue or cells. The gene-modified cell therapy segment is expected to register the fastest growth during the forecast period.
The oncology segment dominated the market and accounted for the largest revenue share in 2024. The rare diseases segment is expected to register the fastest CAGR during the forecast period.
North America dominated the cell and gene therapy bioanalytical testing services market and accounted for the largest revenue share of 41.57% in 2024. Asia Pacific cell and gene therapy bioanalytical testing services are anticipated to witness the fastest CAGR over the forecast period.
Grand View Research has segmented global cell and gene therapy bioanalytical testing services market on the basis of test type, product type, stage of development by product type, indication and region:
Cell & Gene Therapy Bioanalytical Testing Services Test Type Outlook (Revenue, USD Million, 2018 - 2030)
Bioavailability & Cell & Gene Therapy Bioanalytical Testing Services
Pharmacokinetics
Pharmacodynamics
Other Test Type
Cell & Gene Therapy Bioanalytical Testing Services Product Type Outlook (Revenue, USD Million, 2018 - 2030)
Gene Therapy
Ex-vivo
In-vivo
Gene-Modified Cell Therapy
CAR T-cell therapies
CAR-NK cell therapy
TCR-T cell therapy
Other
Cell Therapy
Cell & Gene Therapy Bioanalytical Testing Services Stage of Development by Product Type Outlook (Revenue, USD Million, 2018 - 2030)
Non-Clinical
Gene Therapy
Gene-Modified Cell Therapy
Cell Therapy
Clinical
Gene Therapy
Gene-Modified Cell Therapy
Cell Therapy
Cell & Gene Therapy Bioanalytical Testing Services Indication Outlook (Revenue, USD Million, 2018 - 2030)
Oncology
Infectious Diseases
Neurological disorders
Rare Diseases
Others
Cell & Gene Therapy Bioanalytical Testing Services Regional Outlook (Revenue, USD Million, 2018 - 2030)
North America
U.S.
Canada
Mexico
Europe
UK
Germany
France
Italy
Spain
Denmark
Sweden
Norway
Asia Pacific
Japan
China
India
Australia
South Korea
Thailand
Latin America
Brazil
Argentina
Middle East & Africa
South Africa
Saudi Arabia
UAE
Kuwait
List of Key Players in the Cell & Gene Therapy Bioanalytical Testing Services Market
BioAgilytix Labs
KCAS Bioanalytical Services
IQVIA, Inc.
Laboratory Corporation of America Holdings
Pharmaceutical Product Development, Inc. (Thermo Fisher Scientific Inc.)
Prolytix
Pharmaron
Charles River Laboratories
Syneos Health
SGS SA
Intertek Group Plc
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