Global Cell & Gene Therapy Manufacturing Market Report 2026-2036
Dublin, Aug. 31, 2026 (GLOBE NEWSWIRE) -- The "Global Cell & Gene Therapy Manufacturing Market Report 2026-2036" report has been added to ResearchAndMarkets.com's offering.
This report provides a comprehensive analysis of the global cell and gene therapy manufacturing market, including market size, growth drivers, competitive positioning, and revenue forecasts across therapy type, source of cells, scale of operation, type of manufacturer, and workflow segments.
The global cell and gene therapy manufacturing market is valued at US$13.7bn in 2026 and is forecast to reach US$63.0bn by 2036, at a CAGR of 16.5% over the forecast period.
This growth is driven by the expanding global clinical pipeline of cell and gene therapies, increasing commercial approvals, accelerating investment in dedicated manufacturing infrastructure, and advancing bioprocessing and automation technologies that are improving the scalability and commercial viability of advanced therapy production.
Technological Innovation Driving Market Expansion
Advances in bioprocessing technologies and manufacturing automation are significantly improving the efficiency, consistency, and scalability of cell and gene therapy production. The increasing adoption of automated manufacturing systems, closed-process platforms, and real-time digital monitoring is reducing manual intervention, lowering contamination risk, and enhancing batch-to-batch consistency. These capabilities are particularly important for autologous cell therapies, where maintaining chain-of-identity and chain-of-custody throughout manufacturing is essential to product quality and patient safety.
In May 2026, Thermo Fisher Scientific introduced an integrated platform designed to enable more scalable and standardised cell therapy manufacturing, reflecting the industry's broader transition toward automated and digitally enabled production environments. The growing implementation of Process Analytical Technology (PAT) is further strengthening manufacturing performance by enabling continuous process monitoring, tighter process control, and earlier identification of production deviations.
Innovations in both upstream and downstream bioprocessing are improving production throughput, increasing facility utilisation, and supporting more efficient technology transfer across manufacturing sites. As these technologies mature, manufacturers are expected to achieve higher productivity, improved product consistency, and lower production costs across the value chain.
Trade, Policy & Supply Chain Dynamics
- The cell and gene therapy manufacturing market is significantly affected by U.S. tariffs on imported bioprocessing equipment, single-use technologies, laboratory instruments, and cold-chain infrastructure. The sector relies extensively on globally sourced raw materials including bioreactors, filtration assemblies, cryopreservation technologies, plasmid DNA, viral vectors, and analytical instruments, many of which are manufactured or assembled in tariff-affected regions, particularly China and other parts of Asia. The financial impact has been most pronounced among emerging biotechnology companies and smaller CGT developers, which rely heavily on outsourced manufacturing and have less flexibility to absorb higher input costs. Larger pharmaceutical companies have been better positioned to mitigate tariff pressures through diversified supplier networks, long-term procurement agreements, and greater purchasing power. Trade-related pressures are accelerating a strategic shift toward regional manufacturing, with industry participants expanding capacity across North America and Europe, strengthening dual-source procurement for critical raw materials, and investing in closed-system and modular manufacturing platforms.
Commercial Impact
- Cost pressure: Tariffs on bioprocessing equipment, laboratory instruments, and advanced manufacturing technologies are increasing procurement costs for therapy developers and CDMOs across the manufacturing value chain Supply chain shifts: Manufacturers are accelerating regionalisation of production, strengthening dual-source procurement strategies, and investing in closed-system and modular facilities to reduce dependence on complex global supply chains Manufacturing localisation: Leading CDMOs including Lonza and Catalent are expanding manufacturing capacity across North America and Europe in response to tariff dynamics and growing demand for regionally anchored production Competitive positioning: Companies with diversified supply networks and established regional manufacturing footprints are better positioned to manage cost volatility and maintain programme delivery timelines
Company Intelligence
The cell and gene therapy manufacturing market is characterised by a mix of global CDMO leaders, specialist advanced therapy manufacturers, and large pharmaceutical companies competing across manufacturing capability, regulatory expertise, and technology platform breadth.
Leading companies including Lonza, Thermo Fisher Scientific, Catalent, Charles River Laboratories, and Fujifilm Diosynth Biotechnologies are strengthening their positions through capacity expansion, technology investment, and strategic partnerships across viral vector, cell therapy, and fill-finish manufacturing.
Competition is increasingly defined by:
- End-to-end CDMO capability across process development, vector production, fill and finish, and analytical testing Automation and closed-system manufacturing platform technology Viral vector production capacity and technical expertise across AAV, lentiviral, and adenoviral applications Ability to support both autologous and allogeneic manufacturing at clinical and commercial scale
This report analyses how competitive positioning is evolving across 16 leading companies, identifying where value is being created and how strategies are expected to shift over the forecast period.
Key Questions Answered
- What is the projected size of the cell and gene therapy manufacturing market through 2036? Which therapy types, workflows, and regions will drive growth? How will advances in bioprocessing automation and allogeneic platforms reshape the manufacturing landscape? What is the impact of U.S. trade tariffs on manufacturing costs and supply chain strategies? Who are the leading companies and how will their positions evolve?
Report Scope and Data Coverage
- Global cell and gene therapy manufacturing market analysis Revenue forecasts to 2036 Segment-level modelling across therapy type, source of cells, scale of operation, type of manufacturer, and workflow Regional and national market forecasts across five regions and 30+ leading national markets Competitive intelligence on 16 leading companies
Includes both quantitative forecasting and qualitative strategic analysis, covering technology, competition, policy, and supply chain dynamics.
Segmentation Framework
By Therapy Type
- Cell Therapy Immune Cell Therapy (CAR-T, TCR-T, TIL, NK Cell Therapy, Dendritic Cell Therapy, Others) Stem Cell Therapy (Hematopoietic Stem Cells, Mesenchymal Stromal Cells, iPSC-derived, ESC-derived, Others) Gene Therapy Viral Vector Gene Therapy (AAV, Lentiviral, Adenoviral, Retroviral, Other Viral Vectors) Non-Viral Gene Therapy (Plasmid DNA, mRNA, Gene Editing Systems and Components, Oligonucleotide-Based Therapies)
By Source of Cells
- Autologous Cells Allogeneic Cells Others
By Scale of Operation
- Clinical Scale Commercial Scale
By Type of Manufacturer
- In-house Manufacturers Contract Manufacturing Organisations
By Workflow
- Process Development Cell Processing Vector Production Fill & Finish Operations Cell Banking Analytical & Quality Testing Raw Material Testing Others
Geographic Coverage
North America
- U.S. Canada
Europe
- Germany UK France Italy Spain Russia Rest of Europe
Asia Pacific
- Japan China India Australia South Korea Rest of Asia Pacific
Latin America
- Brazil Mexico Argentina Rest of Latin America
MEA
- GCC South Africa Egypt Rest of MEA
Each profile includes:
- Business overview Financial and market positioning Product and technology capabilities Strategic outlook
Companies Featured
- Boehringer Ingelheim International GmbH Catalent, Inc. (Novo Holdings A/S) Charles River laboratories International, Inc. F. Hoffmann-La Roche Ltd. Fujifilm Biotechnologies (Fujifilm Holdings Corporation) Genetix Biotherapeutics Inc. Lonza Merck KGaA Miltenyi Biomedicine Minaris Advanced Therapies, LLC Novartis AG Oxford Biomedica PLC Resonac Corporation Samsung Epis Holdings Takara Bio Inc. Thermo Fisher Scientific Inc. AAVantgar Abbisko Therapeutics AimedBio Akadeum Life Sciences Akron Bio Altaris Capital Partners Anthos Therapeutics Autolus Therapeutics Avidity Biosciences, Inc. Axovia Therapeutics Ltd Bluebird Bio, Inc. Bristol Myers Squibb Broad Clinical Labs Cryoport Inc. Dyno Therapeutics Excellergy, Inc., Excellos Akadeum Life Sciences Galapagos NV Gen Sight Biologics Generate Biomedicines Genetix Biotherapeutics Inc. Healios Kate Therapeutics Mariana Oncology Modifi Biosciences, Inc. MorphoSys AG Nerio Therapeutics. Pioneer Group QUANTRO Therapeutics Regeneron Pharmaceuticals Regulus Therapeutics Siren Biotechnology Smart Cella Holding Sutro Biopharma Inc TG Therapeutics, Inc Variant Bio Verismo Therapeutics Verona Pharma plc Vertex Voyager Therapeutics Vyriad, Inc Biotechnology Industry Research Assistance Council (BIRAC) Brazilian Health Regulatory Agency (ANVISA) Central Drugs Standard Control Organization (CDSCO) Champalimaud Foundation Egyptian Drug Authority (EDA) European Medicines Agency (EMA) Indian Council of Medical Research (ICMR) Korea Research Institute of Bioscience and Biotechnology (KRIBB) National Administration of Drugs, Foods and Medical Devices (ANMAT) National Agency for the Safety of Medicines and Health Products (ANSM) National Medical Products Administration (NMPA) Parker Institute for Cancer Immunotherapy (PICI) Pharmaceuticals and Medical Devices Agency (PMDA) Skolkovo Foundation South African Health Products Regulatory Authority (SAHPRA) Spanish Agency of Medicines and Medical Devices (AEMPS) The Translational Health Science & Technology Institute (THSTI) Therapeutic Goods Administration (TGA) U.S. FDA World Health Organization (WHO)
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