Cell And Gene Therapy Bio-Manufacturing Global Market Report 2026

Cell and gene therapy bio-manufacturing refers to the industrial-scale production processes used to develop, expand, and manufacture advanced therapeutic products based on living cells and genetic material. It involves the controlled modification, cultivation, and processing of cells or genetic components to produce therapies intended to treat, prevent, or potentially cure diseases by targeting underlying biological mechanisms. These manufacturing processes require highly specialized facilities, precision engineering, and rigorous quality control measures to ensure product safety, effectiveness, and regulatory compliance.

The primary product types of cell and gene therapy bio-manufacturing include bioreactors and fermenters, cell processing systems, viral vector production systems, consumables and reagents, and software and automation platforms. Bioreactors and fermenters refer to controlled systems designed for the growth, expansion, and processing of cells and biological materials under regulated conditions. These systems are based on technologies including viral vector-based manufacturing, non-viral gene delivery systems, autologous cell therapy production, allogeneic cell therapy production, and stem cell-based manufacturing. The key applications include upstream processing, harvesting, and downstream processing, while the end users include pharmaceutical and biotechnology companies, contract development and manufacturing organizations, academic and research institutes, and hospitals and clinical centers.

Tariffs are influencing the cell and gene therapy bio-manufacturing market by increasing the cost of imported bioprocessing equipment, single-use consumables, and advanced laboratory instrumentation required for production. This is increasing operational expenses for pharmaceutical and biotechnology companies and slowing expansion of manufacturing capacity, particularly in import-dependent regions such as Asia-Pacific and Europe. Viral vector production systems and cell processing equipment segments are most affected due to their reliance on highly specialized global supply chains. However, tariffs are also encouraging regional manufacturing of bioprocessing components, localization of critical raw materials, and increased investment in domestic biotech infrastructure, ultimately supporting long-term supply chain resilience and reducing dependency on international suppliers.

The cell and gene therapy bio-manufacturing market size has grown rapidly in recent years. It will grow from $12.35 billion in 2025 to $13.83 billion in 2026 at a compound annual growth rate (CAGR) of 12.0%. The growth in the historic period can be attributed to rapid growth in monoclonal antibody and biologics development, increasing investment in early gene therapy research, expansion of biotechnology manufacturing infrastructure, rising prevalence of chronic and genetic diseases, development of regulatory frameworks for advanced therapies.

The cell and gene therapy bio-manufacturing market size is expected to see rapid growth in the next few years. It will grow to $21.46 billion in 2030 at a compound annual growth rate (CAGR) of 11.6%. The growth in the forecast period can be attributed to increasing commercialization of gene and cell therapies, rising demand for scalable viral vector production, expansion of personalized medicine adoption, growth in contract development and manufacturing organizations, increasing automation and digitalization of biomanufacturing facilities. Major trends in the forecast period include increasing adoption of single use bioprocessing systems in cell therapy manufacturing, growing demand for automated and closed system cell processing platforms, rising use of advanced viral vector production technologies, expansion of personalized and autologous therapy manufacturing pipelines, increasing integration of digital biomanufacturing and data driven quality control.

The increasing number of cell and gene therapy approvals is expected to propel the growth of the cell and gene therapy bio-manufacturing market going forward. Cell and gene therapies refer to advanced medical treatments that use modified cells or genetic material to treat, prevent, or potentially cure diseases, including cancer, rare genetic disorders, and chronic conditions. The increasing number of cell and gene therapy approvals is driven by rapid advancements in genetic engineering technologies such as CRISPR, a better understanding of disease biology, and improved delivery systems that enable safer and more effective targeted treatments. Cell and gene therapy approvals support cell and gene therapy bio-manufacturing by accelerating investment, expanding production infrastructure, and promoting the development of standardized, high-quality, and regulatory-compliant manufacturing processes required to consistently produce safe and effective therapies for clinical and commercial use. For instance, in January 2024, according to the American Society of Gene and Cell Therapy, a US-based organization for gene and cell therapy, in the fourth quarter of 2023, the number of gene therapies in Phase III increased by 10% compared to the previous quarter, marking the first increase since the third quarter of 2022. Therefore, the increasing number of cell and gene therapy approvals is driving the growth of the cell and gene therapy bio-manufacturing market.

Key companies operating in the cell and gene therapy bio-manufacturing market are focusing on developing innovative systems, such as modular lentiviral vector manufacturing systems, to enhance scalability, reduce development timelines, and improve consistency in clinical and commercial production of advanced therapies. Modular lentiviral vector manufacturing systems are standardized, scalable platforms that use predefined production modules to manufacture lentiviral vectors under GMP conditions, helping improve consistency, reduce variability, and accelerate development from research to clinical and commercial production. For example, in May 2026, Andelyn Biosciences, a US-based contract development and manufacturing organization (CDMO), launched its LVV Curator platform, a standardized lentiviral vector manufacturing system designed to streamline cell and gene therapy production. The platform leverages a modular and pre-validated framework built on proven Curator methodology that has supported over 100 adeno-associated virus (AAV) programs, enabling faster development and reduced process risk. It is designed to industrialize lentiviral vector processes from concept to clinic, improving scalability, productivity, and product purity while minimizing development complexity.

In January 2024, Oxford Biomedica plc, a UK-based healthcare and biotechnology company, acquired ABL Europe SAS for $17.35 million. Through this acquisition, Oxford Biomedica plc aimed to strengthen its position as a global leader in cell and gene therapy manufacturing by expanding its viral vector development and production capabilities, increasing its manufacturing footprint across Europe, and enhancing its capacity to serve biopharma clients with advanced gene therapy solutions. ABL Europe SAS is a France-based contract development and manufacturing organization (CDMO) that specializes in providing viral vector development, manufacturing, and testing services for gene therapies, vaccines, and oncolytic virus-based treatments.

Major companies operating in the cell and gene therapy bio-manufacturing market are Thermo Fisher Scientific Inc.; Merck KGaA; Lonza Group AG; Samsung Biologics Co. Ltd.; Danaher Corporation; FUJIFILM Corporation; Pfizer CentreOne; Charles River Laboratories International Inc.; Boehringer Ingelheim International GmbH; Sartorius AG; Miltenyi Biotec B.V. & Co. KG; AGC Biologics LLC; Oxford Biomedica plc; Takara Bio Inc.; KBI Biopharma Inc.; Rentschler Biopharma SE; Minaris Regenerative Medicine GmbH; ElevateBio LLC; Forge Biologics Holdings LLC; Porton Advanced Solutions Co. Ltd.; Cellares Corporation; Repligen Corporation; Asahi Kasei Medical; Thermo Fisher Scientific / Brammer Bio; WuXi Advanced Therapies; Catalent Inc.

North America was the largest region in the cell and gene therapy bio-manufacturing market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the cell and gene therapy bio-manufacturing market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the cell and gene therapy bio-manufacturing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The cell and gene therapy bio-manufacturing market consists of revenues earned by entities by providing services such as cell line development, aseptic fill-finish services, cryopreservation, and regulatory support services. The market value includes the value of related goods sold by the service provider or included within the service offering. The cell and gene therapy bio-manufacturing market also includes sales of engineered cell lines, gene editing reagents, single-use bioprocessing systems, cell processing kits, and analytical assay kits. Values in this market are 'factory gate' values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

The cell and gene therapy bio-manufacturing market research report is one of a series of new reports from The Business Research Company that provides cell and gene therapy bio-manufacturing market statistics, including cell and gene therapy bio-manufacturing industry global market size, regional shares, competitors with a cell and gene therapy bio-manufacturing market share, detailed cell and gene therapy bio-manufacturing market segments, market trends and opportunities, and any further data you may need to thrive in the cell and gene therapy bio-manufacturing industry. This cell and gene therapy bio-manufacturing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Cell And Gene Therapy Bio-Manufacturing Market Global Report 2026 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses cell and gene therapy bio-manufacturing market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

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Where is the largest and fastest growing market for cell and gene therapy bio-manufacturing ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The cell and gene therapy bio-manufacturing market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

• The market characteristics section of the report defines and explains the market. This section also examines key products and services offered in the market, evaluates brand-level differentiation, compares product features, and highlights major innovation and product development trends.
• The supply chain analysis section provides an overview of the entire value chain, including key raw materials, resources, and supplier analysis. It also provides a list competitor at each level of the supply chain.
• The updated trends and strategies section analyses the shape of the market as it evolves and highlights emerging technology trends such as digital transformation, automation, sustainability initiatives, and AI-driven innovation. It suggests how companies can leverage these advancements to strengthen their market position and achieve competitive differentiation.
• The regulatory and investment landscape section provides an overview of the key regulatory frameworks, regularity bodies, associations, and government policies influencing the market. It also examines major investment flows, incentives, and funding trends shaping industry growth and innovation.
• The market size section gives the market size ($b) covering both the historic growth of the market, and forecasting its development.
• The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.
• The total addressable market (TAM) analysis section defines and estimates the market potential compares it with the current market size, and provides strategic insights and growth opportunities based on this evaluation.
• The market attractiveness scoring section evaluates the market based on a quantitative scoring framework that considers growth potential, competitive dynamics, strategic fit, and risk profile. It also provides interpretive insights and strategic implications for decision-makers.
• Market segmentations break down the market into sub markets.
• The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth.
• Expanded geographical coverage includes Taiwan and Southeast Asia, reflecting recent supply chain realignments and manufacturing shifts in the region. This section analyzes how these markets are becoming increasingly important hubs in the global value chain.
• The competitive landscape chapter gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified.
• The company scoring matrix section evaluates and ranks leading companies based on a multi-parameter framework that includes market share or revenues, product innovation, and brand recognition.

Scope

• Markets Covered:1) By Product Type: Bioreactors And Fermenters; Cell Processing Systems; Viral Vector Production Systems; Consumables And Reagents; Software And Automation Platforms
• 2) By Technology: Viral Vector Based Manufacturing; Non Viral Gene Delivery Systems; Autologous Cell Therapy Production; Allogeneic Cell Therapy Production; Stem Cell Based Manufacturing
• 3) By Application: Upstream Processing; Harvesting; Downstream Processing
• 4) By End User: Pharmaceutical And Biotechnology Companies; Contract Development And Manufacturing Organizations; Academic And Research Institutes; Hospitals And Clinical Centers
• Subsegments:
• 1) By Bioreactors And Fermenters: Single Use Bioreactors; Stainless Steel Bioreactors; Stirred Tank Bioreactors; Wave Induced Bioreactors; Perfusion Bioreactors; Continuous Fermentation Systems
• 2) By Cell Processing Systems: Cell Isolation Systems; Cell Expansion Systems; Cell Washing Systems; Cell Separation Systems; Automated Cell Processing Platforms; Closed System Cell Processing Equipment
• 3) By Viral Vector Production Systems: Lentiviral Vector Production Systems; Adeno Associated Viral Vector Production Systems; Retroviral Vector Production Systems; Baculovirus Expression Systems; Transfection Systems; Viral Vector Purification Systems
• 4) By Consumables And Reagents: Cell Culture Media; Buffers And Solutions; Filtration Consumables; Chromatography Resins; Single Use Bags And Tubing; Assay And Detection Reagents
• 5) By Software And Automation Platforms: Manufacturing Execution Software; Laboratory Information Management Software; Process Monitoring Platforms; Data Analytics Platforms; Workflow Automation Systems; Quality Control Software
• Companies Mentioned: Thermo Fisher Scientific Inc.; Merck KGaA; Lonza Group AG; Samsung Biologics Co. Ltd.; Danaher Corporation; FUJIFILM Corporation; Pfizer CentreOne; Charles River Laboratories International Inc.; Boehringer Ingelheim International GmbH; Sartorius AG; Miltenyi Biotec B.V. & Co. KG; AGC Biologics LLC; Oxford Biomedica plc; Takara Bio Inc.; KBI Biopharma Inc.; Rentschler Biopharma SE; Minaris Regenerative Medicine GmbH; ElevateBio LLC; Forge Biologics Holdings LLC; Porton Advanced Solutions Co. Ltd.; Cellares Corporation; Repligen Corporation; Asahi Kasei Medical; Thermo Fisher Scientific / Brammer Bio; WuXi Advanced Therapies; Catalent Inc.
• Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Taiwan; Russia; South Korea; UK; USA; Canada; Italy; Spain
• Regions: Asia-Pacific; South East Asia; Western Europe; Eastern Europe; North America; South America; Middle East; Africa
• Time Series: Five years historic and ten years forecast.
• Data: Ratios of market size and growth to related markets, GDP proportions, expenditure per capita,
• Data Segmentations: country and regional historic and forecast data, market share of competitors, market segments.
• Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes.
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