Global Trends Overview: The Rapid Evolution of the Release Testing Market for Gene Therapy

The release testing sector for gene therapy is positioned for substantial expansion as the demand for advanced testing solutions grows alongside the gene therapy market itself. This report explores the anticipated market size, key players, prevailing trends, and segmentation of this rapidly evolving industry, providing a clear picture of where the market is headed by 2030.

Anticipated Growth and Size of the Release Testing for Gene Therapy Market
The release testing for gene therapy market is projected to grow significantly, reaching a value of $3.08 billion by 2030. This growth corresponds to a compound annual growth rate (CAGR) of 16.5%. Several factors are expected to fuel this expansion throughout the forecast period, including the rising number of commercial gene therapies, increased need for rapid release testing procedures, the broadening scope of contract testing services, heightened regulatory scrutiny, and the adoption of automated quality control platforms. Emerging trends set to influence this market include highly sensitive potency assays, rapid sterility testing technologies, automated batch release analytics, multiparameter quality control panels, and advanced techniques for vector identity testing.

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Leading Organizations Driving the Release Testing for Gene Therapy Market
The market is shaped by a range of influential companies, such as Thermo Fisher Scientific Inc., Boehringer Ingelheim BioXcellence GmbH, Fujifilm Diosynth Biotechnologies Inc., AGC Biologics Inc., SGS SA, Lonza Group AG, Eurofins Scientific SE, WuXi AppTec Co. Ltd., Charles River Laboratories International Inc., Sartorius AG, Samsung Biologics Co. Ltd., Bio-Rad Laboratories Inc., Pace Analytical Services LLC, KBI Biopharma Inc., BioAgilytix Labs LLC, Viralgen Vector S.L., GenScript ProBio LLC, KCAS Bioanalytical Services, Creative Biolabs LLC, and Cellipont Bioservices Inc. A notable industry development occurred in January 2026 when France's bioMérieux S.A. acquired US-based Accellix Inc. for approximately $41 million (€35 million). This acquisition was aimed at strengthening bioMérieux's pharmaceutical quality control offerings by enhancing rapid, automated flow cytometry testing solutions tailored for cell and gene therapy manufacturing, supporting the evolving needs of advanced therapies and improving testing capabilities throughout the therapy development lifecycle. Accellix specializes in rapid flow cytometry-based release testing, focusing on important parameters like cell purity and viability.

Innovations Shaping the Future of Release Testing for Gene Therapy
Key players in the release testing market are investing heavily in innovative solutions to meet the increasing demand for precise, sensitive, and standardized testing methods that guarantee the safety, potency, and regulatory compliance of complex gene therapy products. One significant technological advancement is the development of digital PCR-based analytical testing platforms. These platforms provide highly accurate quantification of DNA or RNA by dividing samples into thousands of separate reactions, allowing for extremely sensitive and absolute measurement of nucleic acid targets. For example, in April 2025, Germany-based QIAGEN N.V. expanded its QIAcuity digital PCR portfolio with new lentivirus-specific solutions designed to improve quality control procedures in cell and gene therapy manufacturing. The additions include tools for viral vector genome quantification, vector copy number assessment, and detection of replication-competent lentivirus. This platform supports singleplex and multiplex assays with high repeatability and specialized kits for critical gene therapy vectors, offering more reliable and reproducible results compared to traditional methods.

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Detailed Segmentation and Market Share Outlook for Release Testing in Gene Therapy
The release testing for gene therapy market is categorized into several segments to provide a comprehensive understanding of its scope:
1) By Test Type: Potency Testing, Purity Testing, Identity Testing, Safety Testing, Sterility Testing, and Other Test Types.
2) By Product Type: Assay Kits, Reagents, Instruments, and Services.
3) By Therapy Type: In Vivo Gene Therapy and Ex Vivo Gene Therapy.
4) By Application: Clinical Diagnostics, Research, Quality Control, Process Development, and Other Applications.
5) By End-User: Pharmaceutical and Biotechnology Companies, Academic and Research Institutes, Contract Research Organizations, and Other End-Users.

Further breakdowns detail specific subcategories such as:
- Potency Testing includes functional activity assays, gene expression measurements, biological activity evaluations, and dose response assessments.
- Purity Testing covers residual host cell protein analysis, residual DNA quantification, and testing for process- and product-related impurities.
- Identity Testing involves genetic sequence confirmation, vector identity verification, transgene identity analysis, and cell line authentication.
- Safety Testing encompasses adventitious agent testing, replication competent virus detection, endotoxin level evaluation, and toxicity assessments.
- Sterility Testing involves bacterial and fungal contamination testing, mycoplasma detection, and environmental monitoring validation.
- Other Test Types include stability testing, packaging integrity checks, shelf life determination, and transport and storage condition testing.

This segmentation helps provide a nuanced view of the market's structure and highlights growth opportunities across various testing types, products, therapy approaches, and applications within the gene therapy release testing landscape.

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This release was published on openPR.