{"product_id":"cell-and-gene-therapy-testing-and-quality-control-markets","title":"Cell and Gene Therapy Testing and Quality Control Markets 2027–2031","description":"\u003cp\u003e\u003cstrong\u003eCell and Gene Therapy Testing and Quality Control Markets: Market Forecast, Competitive Landscape, Company Revenue Estimates, Technology and World Metropolitan Area Market Sizes, 2027–2031\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eGlobal 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.\u003c\/p\u003e\n\u003cp\u003eSee the \u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0249\/8082\/files\/TECHCGTQC_1126_Table_of_Contents.pdf?v=1793912517\" title=\"Cell and Gene Therapy Testing and Quality Control Markets Table of Contents\" target=\"_blank\" rel=\"noopener\"\u003eTable of Contents\u003c\/a\u003e. GET the \u003ca href=\"https:\/\/www.howesoundresearch.com\/pages\/get-a-detailed-table-of-contents-and-sample-pages-for-any-report\" title=\"Free sample\"\u003eFree Sample of this Report\u003c\/a\u003e.\u003c\/p\u003e\n\u003cp\u003eMany organizations subscribe to all or some of our reports. You may already have free access to this report. FIND out \u003ca href=\"https:\/\/www.howesoundresearch.com\/pages\/get-a-detailed-table-of-contents-and-sample-pages-for-any-report\" title=\"Contact Us\"\u003eHere\u003c\/a\u003e.\u003c\/p\u003e\n\u003ch3\u003eOur Take\u003c\/h3\u003e\n\u003cp\u003eEvery 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.\u003c\/p\u003e\n\u003cp\u003e\u003cimg src=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0249\/8082\/files\/TECHCGTQC_Key_Graphic.png?v=1793912517\" alt=\"Release testing goes molecular: cell and gene therapy testing market by technology, 2026 vs 2031\" width=\"100%\"\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eMarket Size 2026:\u003c\/strong\u003e USD $2,000.0M   \u003cstrong\u003eMarket Size 2031:\u003c\/strong\u003e USD $3,450.0M   \u003cstrong\u003eCAGR:\u003c\/strong\u003e 11.5%\u003c\/p\u003e\n\u003ch3\u003eSituation Analysis: what is really happening\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eSafety testing is the base. \u003c\/strong\u003eSterility, 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.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePotency is the hardest problem. \u003c\/strong\u003ePotency \u0026amp; 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 \u0026amp; Genomic Integrity grows 12.9%.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRelease testing goes molecular. \u003c\/strong\u003eNext-Generation Sequencing grows 17.5% a year and qPCR \u0026amp; Digital PCR 13.5%, while Microbiological \u0026amp; Rapid Micro Methods falls from 22.0% to 19.0% of the market.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eGene editing grows fastest. \u003c\/strong\u003eGene Editing grows 18.9% a year, from 8.0% to 11.0% of the market. CAR-T \u0026amp; Engineered Cell Therapy is the largest therapy type at 34.0%.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTesting moves to the CDMO. \u003c\/strong\u003eCDMOs and Contract Testing Labs \u0026amp; 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%.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eNew rules and new owners. \u003c\/strong\u003eFDA 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.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg src=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0249\/8082\/files\/TECHCGTQC_Customer_Shift.png?v=1793912517\" alt=\"Testing moves to the CDMO: cell and gene therapy testing market by customer, 2026 vs 2031\" width=\"100%\"\u003e\u003c\/p\u003e\n\u003ch3\u003eCompany Analysis: who is positioned, who is exposed\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eAgilent Technologies, Bio-Rad Laboratories, Bio-Techne, Danaher (Beckman Coulter, Cytiva, SCIEX, IDT), Merck KGaA (MilliporeSigma, BioReliance), QIAGEN, Revvity, Sartorius, Thermo Fisher Scientific and Waters: \u003c\/strong\u003eInstrument, kit and reagent suppliers, with HSR’s estimates of each company’s CGT testing revenue and ranges.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCharles River Laboratories, Eurofins Scientific, Element Materials Technology, Labcorp, Nelson Labs (Sotera Health), SGS and WuXi AppTec: \u003c\/strong\u003eContract testing laboratories and CROs.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAGC Biologics, Andelyn Biosciences, Catalent, Cellares, GenScript ProBio, Lonza and Minaris Advanced Therapies: \u003c\/strong\u003eCDMOs that test what they make.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAzenta (GENEWIZ), Illumina, KromaTiD, Oxford Nanopore Technologies and Pacific Biosciences: \u003c\/strong\u003eSequencing and genomic integrity.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAssociates of Cape Cod, bioMérieux, ChemoMetec, Cygnus Technologies (Maravai), Dotmatics (Siemens), Miltenyi Biotec, Promega, Rapid Micro Biosystems and Takara Bio: \u003c\/strong\u003eRapid microbiology, cell analysis, assay and software specialists.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eIn all, 38 company profiles, each one to two pages with a fact box covering website, headquarters, ownership, revenue, employees and key products or services.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eInside the report:\u003c\/strong\u003e 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.\u003c\/p\u003e\n\u003cp\u003e\u003cimg src=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0249\/8082\/files\/TECHCGTQC_Teaser_Company_Revenue.png?v=1793912518\" alt=\"Company revenue estimates, anonymised preview: names and values in the full report\" width=\"100%\"\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cimg src=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0249\/8082\/files\/TECHCGTQC_Teaser_Segment_Map.png?v=1793912517\" alt=\"Growth and share-change map, anonymised preview: labels in the full report\" width=\"100%\"\u003e\u003c\/p\u003e\n\u003ch3\u003eQuestions this report answers\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eHow large is the cell and gene therapy testing and QC market, and how fast will it grow?\u003c\/li\u003e\n\u003cli\u003eHow much CGT testing revenue do the instrument makers, kit suppliers, contract laboratories and CDMOs each earn?\u003c\/li\u003e\n\u003cli\u003eHow fast are sequencing and digital PCR replacing culture and cell-based release methods?\u003c\/li\u003e\n\u003cli\u003eWhich test types and therapy types grow fastest, and where is potency testing heading?\u003c\/li\u003e\n\u003cli\u003eWhat do FDA, EU and China rules mean for testing suppliers and laboratories?\u003c\/li\u003e\n\u003cli\u003eHow large is each country market, and which metropolitan areas lead?\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3\u003eWhat's inside\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003e410 pages, 23 chapters, 141 tables and 60 figures\u003c\/li\u003e\n\u003cli\u003eForecasts for 2027–2031 from a 2026 base year, by test type, technology, therapy type, product and service, and customer, for 14 countries and regions\u003c\/li\u003e\n\u003cli\u003eMarket sizes for 237 world metropolitan areas in 2026 and 2031, with the top 30 and fastest-growing metros\u003c\/li\u003e\n\u003cli\u003eHow CGT testing works; test types, technologies, therapy types, products and services, and customers; technology trends; IVD – The Big Picture\u003c\/li\u003e\n\u003cli\u003eRegulation and quality; 10 market-moving developments; competitive landscape with company revenue estimates, SWOT, Porter's Five Forces and strategic recommendations\u003c\/li\u003e\n\u003cli\u003e38 company profiles\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0249\/8082\/files\/TECHCGTQC_1126_Table_of_Contents.pdf?v=1793912517\" target=\"_blank\" rel=\"noopener\"\u003eDownload the Table of Contents (PDF)\u003c\/a\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3\u003eWho buys this report\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eInstrument, kit and reagent suppliers: \u003c\/strong\u003esize target segments by test type, technology and customer, and benchmark competitors.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eContract testing laboratories and CDMOs: \u003c\/strong\u003eplan capacity and services as developers outsource release testing.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTherapy developers: \u003c\/strong\u003eunderstand the tools and providers for safety, potency and genomic-integrity testing.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eInvestors: \u003c\/strong\u003eassess consolidation, new owners and growth.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cb\u003eUse independent research that makes you the expert. Your credit card order sends the report to your inbox instantly. Check all your licensing options, but don't worry: your order is available as a credit if you wish to upgrade.\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003eSee the \u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0249\/8082\/files\/TECHCGTQC_1126_Table_of_Contents.pdf?v=1793912517\" title=\"Cell and Gene Therapy Testing and Quality Control Markets Table of Contents\" target=\"_blank\" rel=\"noopener\"\u003eTable of Contents\u003c\/a\u003e. GET the \u003ca href=\"https:\/\/www.howesoundresearch.com\/pages\/get-a-detailed-table-of-contents-and-sample-pages-for-any-report\" title=\"Free sample\"\u003eFree Sample of this Report\u003c\/a\u003e.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eABOUT THE LEAD AUTHOR\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cimg height=\"177\" width=\"142\" alt=\"Greg Powell\" src=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0249\/8082\/files\/Powellcopy_480x480.png?v=1709168834\"\u003e\u003c\/p\u003e\n\u003cp\u003eMr. Greg Powell, B.SC., M.B.A is the President of Howe Sound Research. His education includes:\u003c\/p\u003e\n\u003cp\u003eFinance for Senior Executives - \u003cstrong\u003eHarvard Business School\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eMarket Research - \u003cstrong\u003eBurke Institute\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eM.B.A. (Finance and Policy) - \u003cstrong\u003eUniversity of British Columbia\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eB.Sc. (Chemistry) - \u003cstrong\u003eUniversity of British Columbia\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eHe 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.\u003c\/p\u003e","brand":"Howe Sound Research","offers":[{"title":"Entire Report Single User","offer_id":68358545997937,"sku":null,"price":6995.0,"currency_code":"USD","in_stock":true},{"title":"Entire Report One to Five Users","offer_id":68358546030705,"sku":null,"price":9995.0,"currency_code":"USD","in_stock":true},{"title":"Entire Report Enterprise License","offer_id":68358546063473,"sku":null,"price":13995.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0249\/8082\/files\/TECHCGTQC_1126_covercap.png?v=1793912517","url":"https:\/\/www.howesoundresearch.com\/products\/cell-and-gene-therapy-testing-and-quality-control-markets","provider":"Howe Sound Research","version":"1.0","type":"link"}