Cell & Gene Therapy Bioanalytical Testing Services Market To Reach $828.7 Million By 2030

Cell & Gene Therapy Bioanalytical Testing Services Market Growth & Trends

The global cell & gene therapy bioanalytical testing services market size is expected to reach USD 828.7 million by 2030, growing at a CAGR of 7.3% from 2024 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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Cell & Gene Therapy Bioanalytical Testing Services Market Report Highlights

• Based on test type, the bioavailability & bioequivalence studies segment accounted for the largest revenue share of around 35.4% in 2023. Bioavailability & bioequivalence studies primarily focus on the R&D of pharmaceutical & biotechnological products such as cell and gene therapies. In cell & gene therapies, bioavailability refers to the proportion of the administered dose of a therapeutic agent that reaches the systemic circulation.

• Based on product type, cell therapy accounted for the largest revenue share of 42.1% in 2023. Cell therapies have great potential in treating autoimmune diseases, cancers, and other conditions. This is improving the clinical research in cell therapy, thus boosting the demand for bioanalytical services for cell therapy.

• Based on the stage of development by product type, the non-clinical segment held a share of 66.2% in 2023. Bioanalytical testing for non-clinical stage is essential for obtaining IND approval. The high demand among researchers for transitioning the therapy into the clinical stage is supporting the market growth of the segment.

• Based on indication, the oncology segment held the maximum revenue share of 49.0% in 2023. The high potential of gene and cell therapy to treat cancer cells effectively is the prime reason for the segment market growth.

• Asia Pacific is anticipated to witness the highest CAGR of 7.7% during the forecast time frame. Funding for cell and gene therapy-based research by public organizations and the low cost associated with outsourcing bioanalytical services in the region is supporting the segment market growth.

Cell & Gene Therapy Bioanalytical Testing Services Market Segmentation

Grand View Research has segmented the global cell & gene therapy bioanalytical testing services market based on test type, product type, stage of development, 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

• Europe

  • UK

  • Germany

  • France

  • Italy

  • Spain

  • Denmark

  • Sweden

  • Norway

• Asia Pacific

  • Japan

  • China

  • India

  • Australia

  • South Korea

  • Thailand

• Latin America

  • Brazil

  • Mexico

  • 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