Cell & Gene Therapy Bioanalytical Testing Services Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2020-2030F

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. Notably, in April 2023, the California Institute for Regenerative Medicine committed USD 89.0 million toward advancing gene and stem cell research, exemplifying the growing commitment to innovation in this space.

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 pvt ltd
Pharmaron Biologics (UK) Ltd
Charles River Laboratories International, Inc.
Syneos Health Ltd
Intertek Group Plc

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

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Cell & Gene Therapy Bioanalytical Testing Services Market.

Available Customizations:

With the given market data, the publisher offers customizations according to a company's specific needs. The following customization options are available for the report.

Company Information

Detailed analysis and profiling of additional market players (up to five).

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1. Product Overview

1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations

2. Research Methodology

2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations

3. Executive Summary4. Voice of Customer

5. Global Cell & Gene Therapy Bioanalytical Testing Services Market Outlook

5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Test Type (Bioavailability & Bioequivalence Studies, Pharmacokinetics, Pharmacodynamics, Other test Type)
5.2.2. By Product Type (Gene Therapy, Gene-Modified Cell Therapy, Cell Therapy)
5.2.3. By Stage of Development (Non-Clinical, Clinical)
5.2.4. By Indication (Oncology, Infectious Diseases, Neurological disorders, Rare Diseases, Others)
5.2.5. By Region
5.2.6. By Company (2024)
5.3. Market Map

6. North America Cell & Gene Therapy Bioanalytical Testing Services Market Outlook

6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Test Type
6.2.2. By Product Type
6.2.3. By Stage of Development
6.2.4. By Indication
6.2.5. By Country
6.3. North America: Country Analysis
6.3.1. United States Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
6.3.1.1. Market Size & Forecast
6.3.1.1.1. By Value
6.3.1.2. Market Share & Forecast
6.3.1.2.1. By Test Type
6.3.1.2.2. By Product Type
6.3.1.2.3. By Stage of Development
6.3.1.2.4. By Indication
6.3.2. Canada Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
6.3.2.1. Market Size & Forecast
6.3.2.1.1. By Value
6.3.2.2. Market Share & Forecast
6.3.2.2.1. By Test Type
6.3.2.2.2. By Product Type
6.3.2.2.3. By Stage of Development
6.3.2.2.4. By Indication
6.3.3. Mexico Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
6.3.3.1. Market Size & Forecast
6.3.3.1.1. By Value
6.3.3.2. Market Share & Forecast
6.3.3.2.1. By Test Type
6.3.3.2.2. By Product Type
6.3.3.2.3. By Stage of Development
6.3.3.2.4. By Indication

7. Europe Cell & Gene Therapy Bioanalytical Testing Services Market Outlook

7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Test Type
7.2.2. By Product Type
7.2.3. By Stage of Development
7.2.4. By Indication
7.2.5. By Country
7.3. Europe: Country Analysis
7.3.1. Germany Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
7.3.1.1. Market Size & Forecast
7.3.1.1.1. By Value
7.3.1.2. Market Share & Forecast
7.3.1.2.1. By Test Type
7.3.1.2.2. By Product Type
7.3.1.2.3. By Stage of Development
7.3.1.2.4. By Indication
7.3.2. United Kingdom Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
7.3.2.1. Market Size & Forecast
7.3.2.1.1. By Value
7.3.2.2. Market Share & Forecast
7.3.2.2.1. By Test Type
7.3.2.2.2. By Product Type
7.3.2.2.3. By Stage of Development
7.3.2.2.4. By Indication
7.3.3. Italy Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
7.3.3.1. Market Size & Forecast
7.3.3.1.1. By Value
7.3.3.2. Market Share & Forecasty
7.3.3.2.1. By Test Type
7.3.3.2.2. By Product Type
7.3.3.2.3. By Stage of Development
7.3.3.2.4. By Indication
7.3.4. France Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
7.3.4.1. Market Size & Forecast
7.3.4.1.1. By Value
7.3.4.2. Market Share & Forecast
7.3.4.2.1. By Test Type
7.3.4.2.2. By Product Type
7.3.4.2.3. By Stage of Development
7.3.4.2.4. By Indication
7.3.5. Spain Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
7.3.5.1. Market Size & Forecast
7.3.5.1.1. By Value
7.3.5.2. Market Share & Forecast
7.3.5.2.1. By Test Type
7.3.5.2.2. By Product Type
7.3.5.2.3. By Stage of Development
7.3.5.2.4. By Indication

8. Asia-Pacific Cell & Gene Therapy Bioanalytical Testing Services Market Outlook

8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Test Type
8.2.2. By Product Type
8.2.3. By Stage of Development
8.2.4. By Indication
8.2.5. By Country
8.3. Asia-Pacific: Country Analysis
8.3.1. China Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
8.3.1.1. Market Size & Forecast
8.3.1.1.1. By Value
8.3.1.2. Market Share & Forecast
8.3.1.2.1. By Test Type
8.3.1.2.2. By Product Type
8.3.1.2.3. By Stage of Development
8.3.1.2.4. By Indication
8.3.2. India Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
8.3.2.1. Market Size & Forecast
8.3.2.1.1. By Value
8.3.2.2. Market Share & Forecast
8.3.2.2.1. By Test Type
8.3.2.2.2. By Product Type
8.3.2.2.3. By Stage of Development
8.3.2.2.4. By Indication
8.3.3. Japan Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
8.3.3.1. Market Size & Forecast
8.3.3.1.1. By Value
8.3.3.2. Market Share & Forecast
8.3.3.2.1. By Test Type
8.3.3.2.2. By Product Type
8.3.3.2.3. By Stage of Development
8.3.3.2.4. By Indication
8.3.4. South Korea Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
8.3.4.1. Market Size & Forecast
8.3.4.1.1. By Value
8.3.4.2. Market Share & Forecast
8.3.4.2.1. By Test Type
8.3.4.2.2. By Product Type
8.3.4.2.3. By Stage of Development
8.3.4.2.4. By Indication
8.3.5. Australia Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
8.3.5.1. Market Size & Forecast
8.3.5.1.1. By Value
8.3.5.2. Market Share & Forecast
8.3.5.2.1. By Test Type
8.3.5.2.2. By Product Type
8.3.5.2.3. By Stage of Development
8.3.5.2.4. By Indication

9. South America Cell & Gene Therapy Bioanalytical Testing Services Market Outlook

9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Test Type
9.2.2. By Product Type
9.2.3. By Stage of Development
9.2.4. By Indication
9.2.5. By Country
9.3. South America: Country Analysis
9.3.1. Brazil Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
9.3.1.1. Market Size & Forecast
9.3.1.1.1. By Value
9.3.1.2. Market Share & Forecast
9.3.1.2.1. By Test Type
9.3.1.2.2. By Product Type
9.3.1.2.3. By Stage of Development
9.3.1.2.4. By Indication
9.3.2. Argentina Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
9.3.2.1. Market Size & Forecast
9.3.2.1.1. By Value
9.3.2.2. Market Share & Forecast
9.3.2.2.1. By Test Type
9.3.2.2.2. By Product Type
9.3.2.2.3. By Stage of Development
9.3.2.2.4. By Indication
9.3.3. Colombia Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
9.3.3.1. Market Size & Forecast
9.3.3.1.1. By Value
9.3.3.2. Market Share & Forecast
9.3.3.2.1. By Test Type
9.3.3.2.2. By Product Type
9.3.3.2.3. By Stage of Development
9.3.3.2.4. By Indication

10. Middle East and Africa Cell & Gene Therapy Bioanalytical Testing Services Market Outlook

10.1. Market Size & Forecast
10.1.1. By Value
10.2. Market Share & Forecast
10.2.1. By Test Type
10.2.2. By Product Type
10.2.3. By Stage of Development
10.2.4. By Indication
10.2.5. By Country
10.3. MEA: Country Analysis
10.3.1. South Africa Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
10.3.1.1. Market Size & Forecast
10.3.1.1.1. By Value
10.3.1.2. Market Share & Forecast
10.3.1.2.1. By Test Type
10.3.1.2.2. By Product Type
10.3.1.2.3. By Stage of Development
10.3.1.2.4. By Indication
10.3.2. Saudi Arabia Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
10.3.2.1. Market Size & Forecast
10.3.2.1.1. By Value
10.3.2.2. Market Share & Forecast
10.3.2.2.1. By Test Type
10.3.2.2.2. By Product Type
10.3.2.2.3. By Stage of Development
10.3.2.2.4. By Indication
10.3.3. UAE Cell & Gene Therapy Bioanalytical Testing Services Market Outlook
10.3.3.1. Market Size & Forecast
10.3.3.1.1. By Value
10.3.3.2. Market Share & Forecast
10.3.3.2.1. By Test Type
10.3.3.2.2. By Product Type
10.3.3.2.3. By Stage of Development
10.3.3.2.4. By Indication

11. Market Dynamics

11.1. Drivers
11.2. Challenges

12. Market Trends & Developments

12.1. Merger & Acquisition
12.2. Product Development
12.3. Recent Developments

13. Global Cell & Gene Therapy Bioanalytical Testing Services Market: SWOT Analysis

14. Competitive Landscape

14.1. BioAgilytix Labs Inc.
14.1.1. Business Overview
14.1.2. Company Snapshot
14.1.3. Products & Services
14.1.4. Financials (As Reported)
14.1.5. Recent Developments
14.1.6. Key Personnel Details
14.1.7. SWOT Analysis
14.2. KCAS Bioanalytical & Biomarker Services
14.3. IQVIA, Inc.
14.4. Laboratory Corporation of America Holdings
14.5. Thermo Fisher Scientific Inc.
14.6. Prolytix pvt ltd
14.7. Pharmaron Biologics (UK) Ltd
14.8. Charles River Laboratories International, Inc.
14.9. Syneos Health Ltd
14.10. Intertek Group Plc

15. Strategic Recommendations16. About the Publisher & Disclaimer

Companies Mentioned

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

Table Information

Report Attribute	Details
No. of Pages	182
Published	May 2025
Forecast Period	2024 - 2030
Estimated Market Value ( USD ) in 2024	$ 523.26 Million
Forecasted Market Value ( USD ) by 2030	$ 870.29 Million
Compound Annual Growth Rate	8.8%
Regions Covered	Global
No. of Companies Mentioned	10

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