Cell And Gene Therapy Bio-Manufacturing Market Report 2026

Cell And Gene Therapy Bio-Manufacturing Market Overview

• Cell And Gene Therapy Bio-Manufacturing market size has reached to $12.35 billion in 2025 • Expected to grow to $21.46 billion in 2030 at a compound annual growth rate (CAGR) of 11.6% • Growth Driver: Rapid Growth In Cell And Gene Therapy Approvals Fueling The Growth Of The Market Due To Increasing Adoption Of Advanced Precision Medicines • Market Trend: Technological Advancements In Standardized Viral Vector Manufacturing Platforms For Cell And Gene Therapy Production • North America was the largest region in 2025 and Asia-Pacific is the fastest growing region.

What Is Covered Under Cell And Gene Therapy Bio-Manufacturing Market?

Cell and gene therapy bio-manufacturing refers to the industrial production processes used to develop, scale, 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 create therapies designed to treat, prevent, or potentially cure diseases by addressing underlying biological mechanisms. These processes require highly specialized environments, precision engineering, and strict quality control to ensure safety, efficacy, and regulatory compliance. The main 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 used 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 of upstream processing, harvesting, and downstream processing, while the end-users includes pharmaceutical and biotechnology companies, contract development and manufacturing organizations, academic and research institutes, and hospitals and clinical centers.

What Is The Cell And Gene Therapy Bio-Manufacturing Market Growth Forecast?

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.

Global Cell And Gene Therapy Bio-Manufacturing Market Segmentation

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

What Is The Driver Of The Cell And Gene Therapy Bio-Manufacturing Market?

The rapid growth in 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 are 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. Cell and gene therapy approvals are rising mainly due to rapid advances in genetic engineering technologies such as CRISPR, better understanding of disease biology, and improved delivery systems that enable safer and more effective targeted treatments. Cell and gene therapy approvals drive cell and gene therapy bio-manufacturing by accelerating investment, scaling up production infrastructure, and driving the development of standardized, high-quality, and regulatory-compliant manufacturing processes needed 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 rapid growth in cell and gene therapy approvals is driving the growth of the cell and gene therapy market.

Key Players In The Global Cell And Gene Therapy Bio-Manufacturing Market

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.

Global Cell And Gene Therapy Bio-Manufacturing Market Trends and Insights

Major companies operating in the cell and gene therapy bio-manufacturing market are focusing on developing innovation 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 instance, 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.

What Are Latest Mergers And Acquisitions In The Cell And Gene Therapy Bio-Manufacturing Market?

In January 2024, Oxford Biomedica plc, a UK-based healthcare and biotechnology company, acquired ABL Europe SAS for $17.35 million. With 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 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.

Regional Outlook

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 this market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in this market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

What Defines the Cell And Gene Therapy Bio-Manufacturing Market?

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.

How is Market Value Defined and Measured?

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.

What Key Data and Analysis Are Included in the Cell And Gene Therapy Bio-Manufacturing Market Report 2026?

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 market statistics, including industry global market size, regional shares, competitors with the market share, detailed market segments, market trends and opportunities, and any further data you may need to thrive in the cell and gene therapy bio-manufacturing industry. The market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future state of the industry.