According to a recent report published by Grand View Research, Inc., the global cell and gene therapy bioanalytical testing services market is projected to reach a valuation of USD 828.7 million by the year 2030. The market is expected to grow at a compound annual growth rate (CAGR) of 7.3% from 2024 to 2030. This growth is being driven primarily by several key factors, including a steady increase in research and development (R&D) activities centered around cell and gene therapies, growing levels of financial support from public institutions for research in this area, and the remarkable therapeutic potential of these advanced treatments, particularly in addressing rare and previously untreatable diseases.

Cell and gene therapies are being increasingly embraced in the medical field for their efficacy in treating a range of conditions, such as various types of cancer, autoimmune disorders, and rare genetic diseases. These therapies have demonstrated substantial improvements in patient outcomes, thereby increasing interest and investment in their development. As a result, there is a growing pipeline of drug candidates based on cell and gene therapy. For instance, data from the American Society of Cell and Gene Therapy indicates that as of January 2023, more than 2,053 gene therapy candidates and 827 non-genetically modified cell therapies were under development. The large number of therapies in the pipeline is driving significant demand for bioanalytical testing services, which are essential for assessing the safety, efficacy, and pharmacokinetics of these therapies.

Moreover, there has been a notable rise in investments from both public and private entities to support research and development in this field. For example, in April 2023, the California Institute for Regenerative Medicine allocated USD 89.0 million towards research focused on stem cell and gene therapies. This funding was specifically aimed at supporting the development of treatments for persistent corneal epithelial defects. It is anticipated that similar funding initiatives in the future will continue to stimulate demand for bioanalytical testing services, as these services are critical throughout various stages of therapy development and regulatory approval.

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Cell & Gene Therapy Bioanalytical Testing Services Market Report Highlights:

• By Test Type:

In 2023, the bioavailability and bioequivalence studies segment accounted for the largest share of market revenue, representing approximately 35.4%. These studies are critical in the research and development of pharmaceutical and biotechnology products, including cell and gene therapies. Specifically, in the context of cell and gene therapy, bioavailability refers to the proportion of a therapeutic agent that successfully enters systemic circulation and becomes available at the site of action.

• By Product Type:

The cell therapy segment held the largest revenue share in 2023, contributing 42.1% to the overall market. Cell therapies have demonstrated strong potential in treating autoimmune disorders, various forms of cancer, and other severe conditions. The growing body of clinical research in this space is consequently increasing the demand for specialized bioanalytical services to support the safe and effective development of these therapies.

• By Stage of Development (Product Type):

In 2023, the non-clinical development stage segment captured a market share of 66.2%. Bioanalytical testing during the non-clinical stage plays a vital role in acquiring Investigational New Drug (IND) approval, which is a prerequisite for entering clinical trials. The increasing emphasis on transitioning experimental therapies from the preclinical to clinical stage is contributing to the growth of this segment.

• By Indication:

The oncology segment emerged as the leading application area in 2023, accounting for 49.0% of the total market revenue. This dominance is largely due to the high effectiveness of gene and cell therapies in targeting and destroying cancer cells, positioning them as a transformative option in cancer treatment.

• By Region:

The Asia Pacific region is projected to experience the fastest growth during the forecast period, with an expected CAGR of 7.7%. The region’s market expansion is being supported by increased public funding for research in cell and gene therapies and the cost-effective nature of outsourcing bioanalytical testing services to countries within the region.

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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

o Ex-vivo

o In-vivo

• Gene-Modified Cell Therapy

o CAR T-cell therapies

o CAR-NK cell therapy

o TCR-T cell therapy

o Other

• Cell Therapy

Cell & Gene Therapy Bioanalytical Testing Services Stage of Development by Product Type Outlook (Revenue, USD Million, 2018 - 2030)

• Non-Clinical

o Gene Therapy

o Gene-Modified Cell Therapy

o Cell Therapy

• Clinical

o Gene Therapy

o Gene-Modified Cell Therapy

o 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

o U.S.

o Canada

• Europe

o UK

o Germany

o France

o Italy

o Spain

o Denmark

o Sweden

o Norway

• Asia Pacific

o Japan

o China

o India

o Australia

o South Korea

o Thailand

• Latin America

o Brazil

o Mexico

o Argentina

• Middle East & Africa

o South Africa

o Saudi Arabia

o UAE

o 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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