Cell and Gene Therapy Testing and Quality Control Markets 2027–2031

Cell and Gene Therapy Testing and Quality Control Markets: Market Forecast, Competitive Landscape, Company Revenue Estimates, Technology and World Metropolitan Area Market Sizes, 2027–2031

Global forecasts of cell and gene therapy testing and QC revenue by test type, technology, therapy type, product and service, and customer, for 14 countries and regions and 237 metropolitan areas, with 38 company profiles. Safety, identity and purity, titer, potency and genomic-integrity testing: instruments, kits and reagents, software and outsourced testing services.

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Our Take

Every dose of a cell or gene therapy is tested before a patient receives it, and much of that testing is harder than the manufacturing it checks. Testing follows doses, batches and filings more than investor sentiment, so the market grows through a difficult period for therapy developers. Release testing is going molecular, with sequencing and digital PCR replacing slower culture and cell-based methods, and the work is moving to CDMOs and contract laboratories. The market grows from $2,000.0 million in 2026 to $3,450.0 million in 2031, at 11.5% a year.

Market Size 2026: USD $2,000.0M Market Size 2031: USD $3,450.0M CAGR: 11.5%

Situation Analysis: what is really happening

• Safety testing is the base. Sterility, mycoplasma, endotoxin and adventitious agent testing is the largest test type at 34.0% of the market in 2026, growing 9.5% a year to 31.0% by 2031 as rapid methods replace culture.
• Potency is the hardest problem. Potency & Functional Assays is the fastest-growing test type at 14.9% a year, rising from 15.0% to 17.4% of the market, and Characterisation & Genomic Integrity grows 12.9%.
• Release testing goes molecular. Next-Generation Sequencing grows 17.5% a year and qPCR & Digital PCR 13.5%, while Microbiological & Rapid Micro Methods falls from 22.0% to 19.0% of the market.
• Gene editing grows fastest. Gene Editing grows 18.9% a year, from 8.0% to 11.0% of the market. CAR-T & Engineered Cell Therapy is the largest therapy type at 34.0%.
• Testing moves to the CDMO. CDMOs and Contract Testing Labs & CROs each grow 14.3% a year, and Outsourced Testing Services reach 38.5% of the market by 2031, while therapy developers fall from 55.0% to 52.0%.
• New rules and new owners. FDA finalised flexibilities for cell and gene therapy manufacturing controls, Eurofins completed its purchase of Element’s North American life sciences testing business, Altaris formed Minaris Advanced Therapies and Merck KGaA agreed to acquire Bio-Techne. China is the second-largest country market at $214.9 million in 2026, growing 18.3% a year.

Company Analysis: who is positioned, who is exposed

• Agilent Technologies, Bio-Rad Laboratories, Bio-Techne, Danaher (Beckman Coulter, Cytiva, SCIEX, IDT), Merck KGaA (MilliporeSigma, BioReliance), QIAGEN, Revvity, Sartorius, Thermo Fisher Scientific and Waters: Instrument, kit and reagent suppliers, with HSR’s estimates of each company’s CGT testing revenue and ranges.
• Charles River Laboratories, Eurofins Scientific, Element Materials Technology, Labcorp, Nelson Labs (Sotera Health), SGS and WuXi AppTec: Contract testing laboratories and CROs.
• AGC Biologics, Andelyn Biosciences, Catalent, Cellares, GenScript ProBio, Lonza and Minaris Advanced Therapies: CDMOs that test what they make.
• Azenta (GENEWIZ), Illumina, KromaTiD, Oxford Nanopore Technologies and Pacific Biosciences: Sequencing and genomic integrity.
• Associates of Cape Cod, bioMérieux, ChemoMetec, Cygnus Technologies (Maravai), Dotmatics (Siemens), Miltenyi Biotec, Promega, Rapid Micro Biosystems and Takara Bio: Rapid microbiology, cell analysis, assay and software specialists.

In all, 38 company profiles, each one to two pages with a fact box covering website, headquarters, ownership, revenue, employees and key products or services.

Inside the report: HSR’s revenue estimate for every named company, with low–high ranges, and a growth and share-change map of every test type and therapy type. Names and values are in the full report.

Questions this report answers

• How large is the cell and gene therapy testing and QC market, and how fast will it grow?
• How much CGT testing revenue do the instrument makers, kit suppliers, contract laboratories and CDMOs each earn?
• How fast are sequencing and digital PCR replacing culture and cell-based release methods?
• Which test types and therapy types grow fastest, and where is potency testing heading?
• What do FDA, EU and China rules mean for testing suppliers and laboratories?
• How large is each country market, and which metropolitan areas lead?

What's inside

• 410 pages, 23 chapters, 141 tables and 60 figures
• Forecasts for 2027–2031 from a 2026 base year, by test type, technology, therapy type, product and service, and customer, for 14 countries and regions
• Market sizes for 237 world metropolitan areas in 2026 and 2031, with the top 30 and fastest-growing metros
• How CGT testing works; test types, technologies, therapy types, products and services, and customers; technology trends; IVD – The Big Picture
• Regulation and quality; 10 market-moving developments; competitive landscape with company revenue estimates, SWOT, Porter's Five Forces and strategic recommendations
• 38 company profiles
• Download the Table of Contents (PDF)

Who buys this report

• Instrument, kit and reagent suppliers: size target segments by test type, technology and customer, and benchmark competitors.
• Contract testing laboratories and CDMOs: plan capacity and services as developers outsource release testing.
• Therapy developers: understand the tools and providers for safety, potency and genomic-integrity testing.
• Investors: assess consolidation, new owners and growth.

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ABOUT THE LEAD AUTHOR

Mr. Greg Powell, B.SC., M.B.A is the President of Howe Sound Research. His education includes:

Finance for Senior Executives - Harvard Business School

Market Research - Burke Institute

M.B.A. (Finance and Policy) - University of British Columbia

B.Sc. (Chemistry) - University of British Columbia

He is an experienced business and clinical professional. He is co-author of the paper "The Radioimmunoassay of Angiotensinogen by Antibody Trapping." He has worked in laboratory testing and management for over 20 years.