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Cell & Gene Therapy Bioanalytical Testing Services Market, By Product Type, By Test Type, By Technology, By Indication Coverage, By End User, By Country, and By Region - Global Industry Analysis, Market Size, Market Share & Forecast from 2025-2032
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REPORT HIGHLIGHT

Cell & Gene Therapy Bioanalytical Testing Services Market size was valued at US$ 560.90 Million in 2024, expanding at a CAGR of 7.90% from 2025 to 2032.

The Cell & Gene Therapy Bioanalytical Testing Services Market encompasses specialized analytical services that support the development, characterization, and regulatory approval of cell and gene therapy products. Growth in this market is propelled by the rising number of clinical trials in regenerative medicine and personalized therapeutics. For instance, as of early 2024, the FDA had over 2,000 active Investigational New Drug applications for gene and cell therapy products. Increasing investments from public health bodies, like the NIH's $500 million commitment to advance gene therapy for rare diseases, further bolster demand. However, the complexity of assay development and high operational costs remain key restraints. Opportunities lie in expanding testing capabilities for viral vectors, potency assays, and biodistribution studies, especially as global regulatory agencies tighten guidelines for cell-based therapies. Additionally, partnerships between biopharma and CROs are streamlining bioanalytical workflows to enhance speed-to-market for next-gen therapies.

Cell & Gene Therapy Bioanalytical Testing Services Market- Market Dynamics

Rising Clinical Trial Volume and Regulatory Scrutiny to Accelerate Market Expansion

The surge in clinical trial activity and growing regulatory focus on advanced therapies have significantly intensified the demand for cell and gene therapy bioanalytical testing services. In 2023, the U.S. FDA approved over 25 Investigational New Drug (IND) applications for gene therapies, reflecting the robust pipeline of therapies under evaluation. Furthermore, regulatory bodies like the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan are increasingly mandating comprehensive bioanalytical validation for safety and efficacy assurance. Organizations such as the NIH and CIRM (California Institute for Regenerative Medicine) have increased funding for gene and cell-based trials, indirectly fueling demand for specialized testing services. These trends emphasize the critical role of high-precision analytical platforms in ensuring data integrity, which is vital for therapeutic success and market authorization, particularly in a landscape that is becoming more regulated and innovation-driven.

Cell & Gene Therapy Bioanalytical Testing Services Market- Key Insights

As per the analysis shared by our research analyst, the global market is estimated to grow annually at a CAGR of around 7.90% over the forecast period (2025-2032)

Based on product type segmentation, Cell therapy was predicted to show maximum market share in the year 2024

Based on Test Type segmentation, Bioavailability & bioequivalence was the leading Test Type in 2024

Based on Technology segmentation, Next-Generation Sequencing (NGS) was the leading Technology in 2024

Based on Indication Coverage segmentation, Oncology Cancer was the leading Indication Coverage in 2024

Based on end user segmentation, Biotechnology & Pharmaceutical Companies were the leading end user in 2024

On the basis of region, North America was the leading revenue generator in 2024

Cell & Gene Therapy Bioanalytical Testing Services Market- Segmentation Analysis:

The Global Cell & Gene Therapy Bioanalytical Testing Services Market is segmented on the basis of Product Type, Test Type, Technology, Indication Coverage, End User, and Region.

The market is divided into three categories based on product type: Cell Therapy, Gene Therapy (Ex-vivo, and In-vivo), and Gene-Modified Cell Therapy (CAR T-cell therapies, CAR-NK cell therapy, TCR-T cell therapy). Cell therapy services focus on potency, identity, and safety testing for stem and immune cells. Gene therapy is segmented into ex-vivo and in-vivo modalities, requiring viral vector and transduction efficiency assays. Gene-modified cell therapies like CAR T, CAR-NK, and TCR-T emphasize bioanalytical validation for engineered immune responses.

The market is divided into eight categories based on Test Type: Bioavailability & Bioequivalence Studies, Pharmacokinetic Testing, Pharmacodynamic Testing, Biomarker Testing, Non-clinical, Tissue Bioanalysis, Miscellaneous, and Others. Bioavailability & bioequivalence studies ensure therapeutic consistency, while pharmacokinetic and pharmacodynamic testing assess absorption and drug action. Biomarker testing supports efficacy tracking, and non-clinical and tissue bioanalysis aid preclinical insights. Miscellaneous and other tests provide supportive, case-specific analytical data.

Cell & Gene Therapy Bioanalytical Testing Services Market- Geographical Insights

The Cell & Gene Therapy Bioanalytical Testing Services Market shows significant geographical variation, driven by the pace of therapy development, regulatory frameworks, and R&D funding across regions. North America leads in market share due to the presence of advanced biotechnology hubs, strong government support, and early adoption of innovative therapies. The U.S., in particular, has a dense network of gene and cell therapy developers and regulatory frameworks such as the FDA's accelerated pathways, encouraging clinical expansion. Europe follows closely, with countries like Germany, the UK, and the Netherlands investing in GMP-certified labs and national cell therapy initiatives. Asia-Pacific is rapidly emerging as a strong contender, especially in China, South Korea, and Japan, where government-backed biotech parks and expanding clinical infrastructure support growth. Increasing outsourcing trends in India and Singapore are also reshaping the regional service landscape, making Asia a strategic hub for cost-effective bioanalytical testing services.

Cell & Gene Therapy Bioanalytical Testing Services Market- Competitive Landscape:

The competitive landscape of the Cell & Gene Therapy Bioanalytical Testing Services Market is marked by the presence of global contract research organizations (CROs), specialized testing labs, and emerging biotech service providers focused on advancing analytical capabilities for complex biologics. Key players are investing in state-of-the-art facilities, GLP/GMP-certified labs, and proprietary assay platforms to meet growing regulatory and scientific demands. Collaborations between therapy developers and CROs are increasing, aiming to streamline timelines and ensure regulatory compliance from preclinical stages through clinical development. Companies are expanding service portfolios to include customized potency assays, biodistribution studies, vector characterization, and next-generation sequencing-based analytics. Moreover, academic and hospital-affiliated labs are contributing to early-stage method development and standardization. Competition is also intensifying in regions like Asia-Pacific, where local firms are scaling up offerings for global trials, making flexibility, regulatory expertise, and turnaround time key differentiators in this evolving landscape.

Recent Developments:

In August 2024, SGS launched specialized bioanalytical testing services for cell and gene therapy in North America, offering comprehensive solutions from discovery to phase 3 clinical trials at its Hudson, New Hampshire lab, expanding global capabilities for advanced therapeutic development and regulatory compliance.

In March 2025, Bharat Biotech launched its first cell and gene therapy facility in Telangana, investing $75 million. The company aims to introduce novel cell and gene therapies for oncology and rare diseases by 2028, focusing on affordability and expanding beyond vaccines.

In April 2025, Cell Therapies and Xellera Therapeutics partnered to accelerate cell and gene therapy access across Asia-Pacific, focusing on GMP manufacturing, regulatory solutions, and collaborative innovation in Australia and Hong Kong, aiming to enhance patient care and streamline market access.

SCOPE OF THE REPORT

The scope of this report covers the market by its major segments, which include as follows:

GLOBAL CELL & GENE THERAPY BIOANALYTICAL TESTING SERVICES MARKET KEY PLAYERS- DETAILED COMPETITIVE INSIGHTS

GLOBAL CELL & GENE THERAPY BIOANALYTICAL TESTING SERVICES MARKET, BY PRODUCT TYPE- MARKET ANALYSIS, 2019 - 2032

GLOBAL CELL & GENE THERAPY BIOANALYTICAL TESTING SERVICES MARKET, BY TEST TYPE- MARKET ANALYSIS, 2019 - 2032

GLOBAL CELL & GENE THERAPY BIOANALYTICAL TESTING SERVICES MARKET, BY TECHNOLOGY- MARKET ANALYSIS, 2019 - 2032

GLOBAL CELL & GENE THERAPY BIOANALYTICAL TESTING SERVICES MARKET, BY INDICATION COVERAGE- MARKET ANALYSIS, 2019 - 2032

GLOBAL CELL & GENE THERAPY BIOANALYTICAL TESTING SERVICES MARKET, BY END USER- MARKET ANALYSIS, 2019 - 2032

GLOBAL CELL & GENE THERAPY BIOANALYTICAL TESTING SERVICES MARKET, BY REGION- MARKET ANALYSIS, 2019 - 2032

Table of Contents

1. Cell & Gene Therapy Bioanalytical Testing Services Market Overview

2. Executive Summary

3. Cell & Gene Therapy Bioanalytical Testing Services Key Market Trends

4. Cell & Gene Therapy Bioanalytical Testing Services Industry Study

5. Cell & Gene Therapy Bioanalytical Testing Services Market: Impact of Escalating Geopolitical Tensions

6. Cell & Gene Therapy Bioanalytical Testing Services Market Landscape

7. Cell & Gene Therapy Bioanalytical Testing Services Market - By Product Type

8. Cell & Gene Therapy Bioanalytical Testing Services Market - By Test Type

9. Cell & Gene Therapy Bioanalytical Testing Services Market - By Technology

10. Cell & Gene Therapy Bioanalytical Testing Services Market - By Indication Coverage

11. Cell & Gene Therapy Bioanalytical Testing Services Market - By End User

12. Cell & Gene Therapy Bioanalytical Testing Services Market- By Geography

13. Key Vendor Analysis- Cell & Gene Therapy Bioanalytical Testing Services Industry

14. 360 Degree Analyst View

15. Appendix

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