The global cell & gene therapy quality control market is on a rapid growth trajectory, expected to rise from USD 2.28 billion in 2024 to around USD 22.81 billion by 2034, reflecting a robust CAGR of 25.74% during the forecast period (2025–2034). This surge is driven by increasing approvals of cell and gene therapies, stringent regulatory requirements, and the rising demand for advanced testing processes.
In this article, we explore the market size, growth drivers, and provide a brief overview of the top companies shaping the cell & gene therapy quality control landscape.
Market Size (2024): USD 2.28 billion
Market Size (2025): USD 2.87 billion
Projected Size (2034): USD 22.81 billion
CAGR (2025–2034): 25.74%
North America dominates with a 40–45% share in 2024 due to strong R&D infrastructure and government support.
Asia Pacific is the fastest-growing region, driven by rising healthcare investments and increased awareness.
Sterility Testing accounted for the largest revenue share in 2024 (20–25%).
Potency Testing is expected to be the fastest-growing segment through 2035.
Rising Approvals of Advanced Therapies: Increased FDA and EMA approvals for gene and cell therapies.
Stringent Regulatory Norms: Need for rigorous testing to ensure safety and efficacy.
Innovation in QC Technologies: Automation and AI-driven testing platforms gaining traction.
Here’s a snapshot of the leading players shaping this dynamic industry:
About: A global leader in laboratory services supporting drug discovery and development.
Products: Endotoxin testing, sterility assurance, viral clearance studies.
Market Cap: Approx. USD 12 billion.
About: Specializes in analytical testing for genomics, pharmaceuticals, and environment.
Products: Cell-based assays, microbiology QC services, analytical support for CGT.
Market Cap: Approx. USD 17 billion.
About: A multinational providing innovative solutions for scientific research and diagnostics.
Products: PCR reagents, sterility testing kits, QC instrumentation.
Market Cap: Approx. USD 200 billion.
About: Known for life science tools and solutions under MilliporeSigma in the U.S.
Products: Sterility testing systems, viral filtration solutions, analytics platforms.
Market Cap: Approx. USD 85 billion.
About: German-based company focused on laboratory and bioprocess solutions.
Products: QC systems for gene therapy, bioanalytics tools, bioprocess control systems.
Market Cap: Approx. USD 25 billion.
About: Provides life science research and clinical diagnostic products worldwide.
Products: PCR instruments, QC assays for gene therapy validation.
Market Cap: Approx. USD 12 billion.
About: Dutch-German provider of sample and assay technologies.
Products: Viral vector QC, nucleic acid purification kits, PCR reagents.
Market Cap: Approx. USD 10 billion.
About: Through Cytiva, Danaher delivers bioprocess solutions for cell & gene therapies.
Products: QC testing platforms, viral clearance services, analytics solutions.
Market Cap: Approx. USD 185 billion.
About: Privately held company offering genomic and proteomic solutions.
Products: Luminescent assay kits, QC reagents for gene therapies.
Market Cap: Estimated revenue over USD 750 million annually.
About: Leading China-based CRO offering comprehensive cell & gene therapy services.
Products: GMP QC testing, viral safety testing, analytical development services.
Market Cap: Approx. USD 22 billion.
About: Swiss biotech giant providing end-to-end manufacturing for CGT.
Products: QC analytics, sterility testing, viral vector services.
Market Cap: Approx. USD 40 billion.
About: Develops instruments and software for laboratories globally.
Products: Analytical instruments for QC, bioanalyzers.
Market Cap: Approx. USD 35 billion.
About: Genomics pioneer, providing sequencing solutions.
Products: NGS platforms for QC in gene therapy, sequencing reagents.
Market Cap: Approx. USD 30 billion.
About: Supplies life sciences tools, particularly for CGT applications.
Products: QC reagents, analytical assays for cell characterization.
Market Cap: Approx. USD 12 billion.
About: South Korea’s leading CDMO with QC capabilities for advanced therapies.
Products: Sterility testing, viral vector analytics, manufacturing QC support.
Market Cap: Approx. USD 55 billion.
About: Formerly Covance, provides comprehensive QC solutions for clinical trials.
Products: Bioanalytical testing, viral clearance studies, sterility assurance.
Market Cap: Approx. USD 17 billion.
About: Specialized in gene therapy development with integrated QC labs.
Products: Potency testing, viral vector quality assessments.
Market Cap: Approx. USD 500 million.
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The growth is driven by increased approvals of CGTs, regulatory compliance needs, and innovations in QC technologies.
North America leads due to robust infrastructure and high R&D investments.
Sterility testing currently holds the largest share, while potency testing is the fastest-growing segment.
Top players include Thermo Fisher Scientific, Charles River Laboratories, Merck KGaA, Lonza Group, and WuXi AppTec.
The market is projected to grow at a CAGR of 25.74% during this period.
Source : https://www.towardshealthcare.com/insights/cell-and-gene-therapy-quality-control-market-sizing
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