(MENAFN- GlobeNewsWire - Nasdaq) Boost ROI with automated rapid-release analytics, digital PCR and sensitive assays; expand contract testing and localize sourcing to reduce tariff costs and delays.Dublin, Nov. 09, 2026 (GLOBE NEWSWIRE) -- "Release Testing for Gene Therapy Market Report 2026" has been added to ResearchAndMarkets.com's offering.
The global release testing for gene therapy market is experiencing rapid growth as gene therapy development accelerates and regulatory authorities increase their focus on product quality, consistency, and patient safety. The market is projected to grow from $1.43 billion in 2025 to $1.67 billion in 2026, representing a compound annual growth rate (CAGR) of 16.3%.
Growth during the historical period has been supported by an increase in gene therapy clinical trials, stringent regulatory quality standards, expanding viral vector production, greater availability of biologics testing laboratories, and a rising number of advanced therapy approvals. These factors have increased demand for reliable batch release testing across clinical development and commercial manufacturing.
The release testing for gene therapy market is forecast to reach $3.08 billion by 2030, expanding at a CAGR of 16.5%. Key growth drivers include the commercialization of gene therapies, demand for faster release testing, expansion of contract testing services, increasing regulatory scrutiny, and adoption of automated quality control platforms. High-sensitivity potency assays, rapid sterility testing, automated batch release analytics, multiparameter quality control panels, and advanced vector identity testing are expected to shape market development.
The growing number of gene therapy approvals worldwide is strengthening demand for release testing services and technologies. Scientific progress, greater regulatory acceptance, and the need for treatments targeting previously difficult-to-treat genetic disorders are contributing to a robust development pipeline. According to the National Center for Biotechnology Information, more than 100 gene, cell, and RNA therapies had received approval globally as of early 2023, while over 3,700 therapies were in clinical or preclinical development. This expanding pipeline is expected to increase requirements for potency, purity, identity, sterility, and safety testing before products can be released for clinical or commercial use.
Technology providers are investing in digital PCR-based analytical testing platforms to improve accuracy, sensitivity, standardization, and regulatory compliance. In April 2025, QIAGEN expanded its QIAcuity digital PCR portfolio with lentivirus-focused solutions for quality control in cell and gene therapy manufacturing. The expanded platform supports viral vector genome titration, vector copy number determination, and replication-competent lentivirus detection. These capabilities enable precise analytics for process development, batch release, and regulatory submissions while supporting repeatable singleplex and multiplex applications.
Strategic acquisitions are also strengthening the gene therapy quality control market. In January 2026, bioMerieux acquired Accellix for approximately $41 million (€35 million). The transaction expanded bioMerieux's pharmaceutical quality control portfolio, particularly in rapid and automated flow cytometry for cell and gene therapy manufacturing. The acquired technology supports critical batch release parameters, including cell purity and viability, and enhances testing capabilities across the advanced therapy development lifecycle.
Tariffs are creating additional challenges by increasing the cost of imported assay kits, specialized reagents, and analytical instruments used in gene therapy release testing. Contract research organizations, biotechnology companies, and testing laboratories that rely on international laboratory supply chains are particularly exposed to higher procurement costs and potential delivery delays. In response, testing providers are adopting localized sourcing strategies, working with regional suppliers, and supporting domestic production of analytical tools and testing kits. These measures may strengthen local laboratory supply ecosystems and improve long-term testing capacity.
The market is segmented by test type into potency, purity, identity, safety, sterility, and other testing categories. Product and service segments include assay kits, reagents, instruments, and testing services. Release testing supports in vivo and ex vivo gene therapies across clinical diagnostics, research, quality control, and process development. Major end users include pharmaceutical and biotechnology companies, academic and research institutions, contract research organizations, and specialist testing providers.
Market revenue includes quality control and analytical testing services, stability assessments, method validation, regulatory compliance testing, and batch release support. As gene therapy pipelines move from research into commercial production, scalable testing capacity, validated analytical methods, automation, and faster turnaround times will remain central to market growth.
Markets Covered:
1) By Test Type: Potency Testing; Purity Testing; Identity Testing; Safety Testing; Sterility Testing; Other Test Types
2) By Product Type: Assay Kits; Reagents; Instruments; Services
3) By Therapy Type: In Vivo Gene Therapy; Ex Vivo Gene Therapy
4) By Application: Clinical Diagnostics; Research; Quality Control; Process Development; Other Applications
5) By End-User: Pharmaceutical and Biotechnology Companies; Academic and Research Institutes; Contract Research Organizations; Other End-Users
Subsegments:
1) By Potency Testing: Functional Activity Assays; Gene Expression Level Measurement; Biological Activity Evaluation; Dose Response Assessment
2) By Purity Testing: Residual Host Cell Protein Analysis; Residual Deoxyribonucleic Acid Quantification; Process Related Impurity Testing; Product Related Impurity Assessment
3) By Identity Testing: Genetic Sequence Confirmation; Vector Identity Verification; Transgene Identity Analysis; Cell Line Authentication
4) By Safety Testing: Adventitious Agent Testing; Replication Competent Virus Detection; Endotoxin Level Evaluation; Toxicity Assessment
5) By Sterility Testing: Bacterial Contamination Testing; Fungal Contamination Testing; Mycoplasma Detection; Environmental Monitoring Validation
6) By Other Test Types: Stability Testing; Packaging Integrity Testing; Shelf Life Determination; Transport and Storage Condition Testing
Time Series:
Five years historic and ten years forecast.
Data:
Ratios of market size and growth to related markets, GDP proportions, expenditure per capita.
Data Segmentation:
Country and regional historic and forecast data, market share of competitors, market segments.
Key Attributes:
CONTACT:
CONTACT: ResearchAndMarkets.com
Laura Wood,Senior Press Manager...
For E.S.T Office Hours Call 1-917-300-0470
For U.S./ CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Comments
No comment