Visiongain’s latest report, Cell & Gene Therapy Manufacturing Market Report 2026-2036, provides detailed forecasts and strategic analysis across therapy type, source of cells, scale of operation, type of manufacturer, and workflow segments, including technology trends, trade and supply chain dynamics, and competitive positioning.

The global cell and gene therapy manufacturing market is valued at US$13.7 billion in 2026 and is projected to reach US$63.0 billion by 2036, at a CAGR of 16.5% during the forecast period. 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.

Key Market Insights

• The global cell and gene therapy manufacturing market is valued at US$13.7 billion in 2026, growing at a CAGR of 16.5% to reach US$63.0 billion by 2036
• Growth is driven by expanding clinical pipelines, increasing commercial approvals, and rising investment in manufacturing capacity and automation
• Key regions: North America, Europe, Asia Pacific
• Leading companies: Lonza, Thermo Fisher Scientific, Catalent, Charles River Laboratories, Fujifilm Biotechnologies
• Key trend: Transition from clinical-scale to commercial-scale manufacturing as approved CGT products drive sustained demand for GMP-compliant production capacity

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Market Drivers

Rising Clinical Pipeline and Commercial Approvals of Cell & Gene Therapies

The expanding global pipeline of cell and gene therapies continues to be a fundamental driver of demand across the manufacturing market. According to the Alliance for Regenerative Medicine, around 400 oncology-focused CGT clinical trials and approximately 100 programmes targeting autoimmune diseases are currently underway worldwide. As programmes progress from early-stage development to pivotal studies and commercial production, manufacturing requirements increase considerably in both scale and complexity, driving demand for GMP-grade viral vectors, plasmid DNA, cell culture media, and single-use bioprocessing technologies.

In February 2026, Takara Bio announced that Fondazione Telethon ETS had received marketing authorisation from both the EMA and FDA for Waskyra, an ex vivo gene therapy, with Takara Bio supplying the commercial-use licence for RetroNectin, a key manufacturing technology. Cellares and Stanford Medicine also entered into a collaboration to develop automated manufacturing processes for gene-edited haematopoietic stem cell therapies, highlighting continued investment in next-generation manufacturing infrastructure.

Increasing Investment in Manufacturing Infrastructure and Capacity Expansion

Growing investment in dedicated CGT manufacturing infrastructure is a key driver of market expansion. Historically, shortages of GMP-compliant viral vector production capacity, specialised cell processing facilities, and aseptic fill-finish infrastructure have limited production scalability and extended manufacturing timelines. Leading contract manufacturers and technology providers are responding through strategic capacity expansion.

Lonza continues to strengthen its viral vector and cell therapy manufacturing capabilities, while Thermo Fisher Scientific is expanding its global biopharmaceutical manufacturing network, including bioprocess design centres in India, Singapore, and South Korea. Public initiatives including the U.S. National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and the UK Cell and Gene Therapy Catapult are also supporting infrastructure development, technology innovation, and workforce training to build a more resilient manufacturing ecosystem.

Technology & Innovation

Technological Advancements in Bioprocessing and Automation

The increasing adoption of automated manufacturing systems, closed-process platforms, and real-time digital monitoring is enabling manufacturers to enhance operational efficiency, improve product consistency, and reduce manufacturing risk across both cell therapy and viral vector production. These capabilities are especially important in autologous cell therapy manufacturing, where patient-specific production requires stringent chain-of-identity and chain-of-custody management.

In April 2026, Thermo Fisher Scientific launched the Gibco CTS DynaXS, a single-use bioreactor designed to help cell therapy developers scale manufacturing more efficiently. In November 2025, Novartis announced investment to expand its manufacturing hub in North Carolina, strengthening end-to-end production capabilities for advanced therapies. The growing adoption of Process Analytical Technology, real-time monitoring systems, and advanced digital analytics is further enhancing process control and enabling earlier detection of manufacturing deviations.

Trade & Supply Chain Dynamics

U.S. tariffs on imported bioprocessing equipment, single-use technologies, laboratory instruments, and cold-chain infrastructure have introduced additional cost and operational challenges across the global CGT manufacturing industry. The sector relies extensively on globally sourced components including bioreactors, filtration assemblies, cryopreservation technologies, plasmid DNA, viral vectors, and analytical instruments, many manufactured or assembled in tariff-affected regions, particularly China and other parts of Asia.

The financial impact is most pronounced among emerging biotechnology companies and smaller CGT developers, which rely heavily on outsourced manufacturing and have limited flexibility to absorb higher input costs. In response, manufacturers are accelerating regional production strategies, with leading CDMOs expanding capacity across North America and Europe and increasing investment in closed-system manufacturing and modular production facilities to reduce dependence on complex global supply chains.

Commercial Impact

• Cost pressure: Tariffs on bioprocessing equipment and laboratory instruments are increasing procurement costs for therapy developers and CDMOs, affecting programme budgets and manufacturing margins
• Supply chain shifts: Manufacturers are strengthening dual-source procurement strategies, expanding regional capacity, and investing in closed-system platforms to reduce reliance on tariff-sensitive imports
• Manufacturing localisation: Leading CDMOs including Lonza and Catalent are expanding North American and European manufacturing footprints, driven by both tariff dynamics and growing commercial demand
• Competitive positioning: Companies with diversified supply networks and regionally anchored manufacturing are better positioned to manage cost volatility and maintain delivery commitments

Market Opportunities

Allogeneic Cell Therapy Platforms Creating New Manufacturing Opportunities

The continued advancement of allogeneic cell therapy platforms presents a significant long-term opportunity for the CGT manufacturing market. Unlike autologous therapies manufactured individually from a patient’s own cells, allogeneic therapies are produced from healthy donor-derived cells in standardised, large-scale batches, offering the potential to improve production efficiency, lower cost per treatment, and expand patient access through off-the-shelf availability.

Large-scale cell expansion, master and working cell banking, cryopreservation technologies, and advanced gene-editing capabilities are becoming increasingly important as manufacturers prepare for higher-volume production. The growing clinical pipeline of allogeneic CAR-T, CAR-NK, and stem cell-based therapies is encouraging CDMOs and biopharmaceutical manufacturers to invest in infrastructure capable of supporting future commercial-scale production, creating substantial opportunities for capacity expansion and manufacturing innovation.

CDMOs Becoming the Backbone of Cell and Gene Therapy Manufacturing

As cell and gene therapies progress from clinical development to commercialisation, CDMOs are becoming increasingly central to the industry’s long-term growth. Manufacturing these advanced therapies requires highly specialised facilities, technical expertise, stringent regulatory compliance, and substantial capital investment. Consequently, many biotechnology companies are choosing to outsource manufacturing activities, enabling them to focus on research, clinical development, and commercialisation while avoiding the cost and complexity of establishing in-house production capabilities.

Leading CDMOs now offer comprehensive end-to-end services including process development, viral vector production, analytical testing, aseptic fill-finish, cryopreservation, and temperature-controlled global logistics. Companies including Samsung Biologics, Lonza, and Fujifilm Diosynth Biotechnologies continue to invest in manufacturing capacity and technology platforms, while National Resilience has strengthened its North American manufacturing network through strategic facility expansion.

Competitive Landscape

The major players operating in the cell and gene therapy manufacturing market include Boehringer Ingelheim International, Catalent (Novo Holdings), Charles River Laboratories, F. Hoffmann-La Roche, Fujifilm Biotechnologies, Genetix Biotherapeutics, Lonza, Merck KGaA, Miltenyi Biomedicine, Minaris Advanced Therapies, Novartis AG, Oxford Biomedica, Resonac Corporation, Samsung Epis Holdings, Takara Bio, and Thermo Fisher Scientific.

These companies are strengthening their market positions through M&A, R&D investment, strategic collaborations, capacity expansion, and development of next-generation manufacturing platforms for viral vector, cell therapy, and allogeneic production.

Recent Developments

• May 2026 – Thermo Fisher Scientific introduced an integrated platform to advance scalable and standardised cell therapy manufacturing, supporting the industry’s transition toward automated and digitally enabled production environments
• April 2026 – Thermo Fisher Scientific launched the Gibco CTS DynaXS single-use bioreactor, designed to help cell therapy developers scale manufacturing processes more efficiently and effectively
• March 2026 – Novartis announced the acquisition of Excellergy Inc., a private biotech firm developing next-generation anti-IgE treatments for IgE-mediated diseases, building out its allergy leadership pipeline
• February 2026 – Oxford Biomedica expanded its partnership with Bristol Myers Squibb to manufacture and supply lentiviral vectors supporting BMS’s CAR-T therapy programmes under a new multi-year commercial supply agreement

Frequently Asked Questions

What is driving growth in the cell and gene therapy manufacturing market?

Growth is driven by the expanding global pipeline of cell and gene therapies, increasing commercial approvals, accelerating investment in manufacturing infrastructure, and advancing bioprocessing and automation technologies that are improving the scalability and cost-effectiveness of advanced therapy production.

How are trade and supply chain dynamics affecting the market?

U.S. tariffs on bioprocessing equipment, laboratory instruments, and cold-chain infrastructure are increasing procurement costs across the manufacturing value chain, with the greatest impact on smaller developers and CDMOs reliant on imported inputs. This is accelerating manufacturing localisation, regional capacity expansion, and investment in closed-system production platforms.

Who are the leading companies in the market?

Key players include Lonza, Thermo Fisher Scientific, Catalent, Charles River Laboratories, Fujifilm Biotechnologies, Oxford Biomedica, and Novartis AG.

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About Visiongain

Established in 1998, Visiongain is an independent publisher of analyst-led market intelligence, delivering data-driven research, forecasts, and strategic insight across global industries and emerging markets. Visiongain supports evidence-based decision-making for investment, procurement, and long-term strategic planning.

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