December 2, 2023

Cell & Gene Therapy Bioanalytical Testing Services Market Analysis 2023-2030

The global cell & gene therapy bioanalytical testing services market is poised for remarkable growth, with a projected Compound Annual Growth Rate (CAGR) of 8% anticipated during the period from 2023 to 2030. By the end of 2030, the market is expected to reach an approximate valuation of US$0.8 billion.

Market Analysis in Brief:

Cell and gene therapy bioanalytical testing services are specialized laboratory services vital for analyzing the cellular and genetic components of therapeutic products. These innovative medical treatments involve the manipulation or modification of a patient’s cells or genes to treat or prevent diseases. Bioanalytical testing services ensure the safety, efficacy, and quality of these therapies by conducting rigorous tests and analyses on therapeutic products.

Key Report Findings:

  1. Massive Revenue Expansion: The market for cell & gene therapy bioanalytical testing services is poised for substantial revenue growth between 2023 and 2030.
  2. Demand for Bioavailability & Bioequivalence Studies: Bioavailability and bioequivalence studies continue to drive demand in the cell & gene therapy bioanalytical testing services market, providing critical insights into therapy pharmacokinetics and effectiveness.
  3. Non-Clinical Products in Demand: Non-clinical products remain in high demand within the cell & gene therapy bioanalytical testing services market, supporting research and development efforts.
  4. Cell Therapy Dominates: In 2022, cell therapy held the highest market share within the cell & gene therapy bioanalytical testing services market.
  5. North America Leads: North America is expected to maintain its leadership position, while the Asia Pacific market is projected to experience the strongest growth through 2030.

Growth Drivers:

  1. Rapid Advancements in Cell & Gene Therapies: The continuous evolution of cell and gene therapies drives the demand for rigorous and comprehensive bioanalytical testing services. As these therapies become more sophisticated, specialized testing services are essential to ensure safety, efficacy, and quality.
  2. Regulatory Requirements: Stringent standards and guidelines set by regulatory agencies, such as the FDA and EMA, require comprehensive and specialized bioanalytical testing services to ensure the safety and quality of cell and gene therapies.
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  1. Lack of Standardisation in Testing Protocols: The complexity of cell and gene therapies often leads to challenges in developing accurate and standardized testing methodologies.

Overview of Key Segments:

  1. Bioavailability and Bioequivalence Studies: These studies play a pivotal role in understanding therapy pharmacokinetics, safety, and effectiveness, supporting development, regulatory approval, and clinical implementation.
  2. Oncology-Focused Testing: Bioanalytical testing services tailored to oncology research and treatments provide essential insights for developing targeted therapies and optimizing treatment regimens.

Growth Opportunities Across Regions:

  1. North America: North America, particularly the United States, remains a leader in the cell & gene therapy bioanalytical testing services market, driven by a well-established biotechnology industry and regulatory support.
  2. Asia Pacific: This region is experiencing significant growth in cell and gene therapy, driven by economic development, increased investment in healthcare infrastructure, and regulatory advancements.

Competitive Landscape:

Key players in the cell & gene therapy bioanalytical testing services market include BioAgilytix Labs, KCAS Bioanalytical Services, Laboratory Corporation of America Holdings, Pharmaceutical Product Development, Inc., Prolytix, Pharmaron, Charles River Laboratories, Syneos Health, SGS SA, and CD BioSciences.

Recent Notable Developments:

  • In February 2023, KCAS Bioanalytical and Biomarker Services announced the acquisition of FlowMetric, LLC, strengthening its position as a preferred clinical research organization for outsourced cell and gene therapy initiatives.
  • In March 2021, Charles River completed the acquisition of Cognate BioServices, enhancing its capabilities in cell and gene therapy development and manufacturing.

Global Cell & Gene Therapy Bioanalytical Testing Services Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2023-2030 – (By Test Type Coverage, By Therapy Type Coverage, By End User Coverage, By Indication Coverage, By Geographic Coverage and Leading Companies)

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This press release first seen on Brilad