Cell & Gene Therapy Bioanalytical Testing Services Market Forecast Report to 2030 | CRISPR-Cas9 and Single-Cell Analysis Revolutionizing Bioanalytical Testing in Cell Therapies

Dublin, June 02, 2025 (GLOBE NEWSWIRE) -- The "Cell & Gene Therapy Bioanalytical Testing Services Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2020-2030F" has been added to ResearchAndMarkets.com's offering.

The Cell & Gene Therapy Bioanalytical Testing Services Market was valued at USD 523.26 Million in 2024 and is expected to reach USD 870.29 Million by 2030, rising at a CAGR of 8.85%.

The expanding field of cell and gene therapy is revolutionizing treatment approaches for genetic and chronic diseases by offering personalized, targeted therapies. As these therapies progress from research to commercialization, the demand for precise and compliant bioanalytical testing services is growing significantly. These services are critical for ensuring safety, efficacy, and quality in line with evolving regulatory expectations.

Supportive funding, technological innovations, and the expanding therapeutic pipeline are accelerating market development, while growing industry emphasis on tailored treatment solutions continues to elevate the role of bioanalytical testing in the cell and gene therapy lifecycle.

Key Market Drivers: Increasing Investment in Cell and Gene Therapy Research and Development

Recent breakthroughs in cell and gene therapy have opened new possibilities for treating diseases previously deemed untreatable. These treatments work by altering patients' own cells or genes to address conditions such as cancer, autoimmune disorders, and genetic abnormalities.

As the clinical potential of these therapies becomes more evident, global investment in research and development has increased rapidly. Bioanalytical testing services play an essential role in this growth by ensuring product safety, efficacy, and consistency.

Key Market Challenges: Regulatory Challenges

Navigating regulatory frameworks remains one of the most pressing challenges in the cell and gene therapy bioanalytical testing market. Regulatory agencies are continuously updating standards to ensure patient safety while accommodating rapid technological advances. This dynamic landscape makes compliance a complex and time-consuming process.

Companies often face delays and increased costs when attempting to align with these evolving guidelines, which can hinder the pace of therapy development and market entry. Meeting global regulatory expectations while innovating at speed demands significant investment and specialized expertise.

Key Market Trends: Technological Advancements

As cell and gene therapies reshape modern medicine, the bioanalytical testing segment is advancing rapidly to meet new analytical demands. A major trend is the integration of single-cell analysis technologies, including single-cell RNA sequencing and proteomics, which allow deeper insights into cellular responses and therapeutic outcomes. These methods address the limitations of traditional bulk analysis by revealing intercellular variability.

Another transformative trend is the adoption of CRISPR-Cas9, a powerful gene-editing tool that demands specialized testing protocols to evaluate gene function and detect potential off-target effects.

Furthermore, the deployment of state-of-the-art instrumentation has enhanced the precision and speed of testing processes, enabling faster and more accurate evaluation of complex therapies and supporting the broader growth of the market.

Key Market Players:

• BioAgilytix Labs Inc.
• KCAS Bioanalytical & Biomarker Services
• IQVIA, Inc.
• Laboratory Corporation of America Holdings
• Thermo Fisher Scientific Inc.
• Prolytix
• Pharmaron Biologics (UK) Ltd
• Charles River Laboratories International, Inc.
• Syneos Health Ltd
• Intertek Group

Key Attributes:

Report Scope:

In this report, the Global Cell & Gene Therapy Bioanalytical Testing Services Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Cell & Gene Therapy Bioanalytical Testing Services Market, By Test Type:

• Bioavailability & Bioequivalence Studies
• Pharmacokinetics
• Pharmacodynamics
• Other test type

Cell & Gene Therapy Bioanalytical Testing Services Market, By Product Type:

• Gene Therapy
• Gene-Modified Cell Therapy
• Cell Therapy

Cell & Gene Therapy Bioanalytical Testing Services Market, By Stage of Development:

• Non-Clinical
• Clinical

Cell & Gene Therapy Bioanalytical Testing Services Market, By Indication:

• Oncology
• Infectious Diseases
• Neurological disorders
• Rare Diseases
• Others

Cell & Gene Therapy Bioanalytical Testing Services Market, By Region:

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

For more information about this report visit https://www.researchandmarkets.com/r/tu811k

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• Cell & Gene Therapy Bioanalytical Testing Services Market