Cell and Gene Therapy Biomanufacturing Market - Size, Share, and Forecast, 2026-2031 | Automation, Viral Vectors, and CDMO Expansion Drive 11.7% CAGR to $8.7 Billion
Dublin, Oct. 05, 2026 (GLOBE NEWSWIRE) -- "Cell and Gene Therapy Biomanufacturing Market - Strategic Insights and Forecasts (2026-2031)" has been added to ResearchAndMarkets.com's offering.
The global cell and gene therapy biomanufacturing market is forecast to grow from USD 5.0 billion in 2026 to USD 8.7 billion by 2031, representing a compound annual growth rate of 11.7%. Market expansion is being supported by the accelerating transition of advanced therapies from clinical development to commercial production, alongside rising demand for scalable, compliant, and flexible manufacturing infrastructure.
Regulatory approvals for therapies targeting cancer, rare genetic disorders, and chronic diseases are increasing the need for specialized production capabilities. Biopharmaceutical companies and contract development and manufacturing organizations are responding through facility expansion, strategic partnerships, and investments in advanced manufacturing platforms. The continued shift toward personalized medicine is also increasing demand for flexible and small-batch manufacturing systems, particularly for autologous cell therapies.
Key Cell and Gene Therapy Biomanufacturing Market Drivers
A growing pipeline of cell and gene therapy products in clinical trials is creating substantial demand for manufacturing solutions that can manage complex biological processes while maintaining product consistency and regulatory compliance. Oncology and rare disease applications represent particularly important areas of development, generating requirements for viral vector production, cell expansion, purification, quality testing, and commercial-scale processing.
Technological innovation is improving both upstream and downstream processing. Advances in viral vector production, automated cell expansion, purification platforms, and closed-system technologies are helping manufacturers increase yields, reduce contamination risks, and strengthen quality control. Digitalization and automation are also enhancing process monitoring, operational efficiency, and manufacturing consistency.
Market Restraints and Operational Challenges
High production costs remain a significant barrier to broader market development. Cell and gene therapy manufacturing requires specialized facilities, sophisticated equipment, extensive quality controls, and highly trained personnel. These requirements can restrict scalability and place pressure on profitability, particularly for emerging biotechnology companies.
Regulatory complexity also affects commercialization timelines and market entry strategies. Strict compliance requirements and differences among regional regulatory frameworks can increase development costs and complicate global expansion. In addition, the limited availability of professionals with expertise in bioprocessing and advanced manufacturing continues to create workforce challenges across the industry.
Technology, Workflow, and End-user Insights
The market is segmented by type into consumables, equipment, and software solutions. Consumables account for a significant share because of their recurring use throughout production. Equipment and software solutions are expected to gain traction as manufacturers adopt automated, connected, and digitally controlled production systems.
Major workflow segments include upstream processing, downstream processing, vector production, fill and finish operations, and quality testing. Viral vector manufacturing remains a strategic priority due to its central role in gene delivery and the need for reliable, high-quality production capacity.
Primary end users include life sciences companies, contract development and manufacturing organizations, and research institutions. Outsourcing is increasing as smaller biotechnology companies seek access to specialized expertise, regulatory support, and production infrastructure without making substantial capital investments in internal facilities.
Competitive and Strategic Outlook
Competition in the cell and gene therapy biomanufacturing market is centered on capacity expansion, process innovation, quality assurance, and speed to market. Industry participants are developing new facilities, expanding viral vector capacity, and forming collaborations to address production constraints. Investments in modular manufacturing, automation, and digital systems are expected to improve flexibility, reduce operational risk, and support commercial-scale output.
The market is positioned for sustained growth through 2031 as more advanced therapies achieve regulatory approval and move into commercial production. Although cost, workforce, and compliance challenges remain, continued investment in manufacturing technologies and specialized capacity is expected to strengthen the industry's long-term outlook.
Key Benefits of the Report
Business Applications
Organizations can use the report for market opportunity assessment, product demand forecasting, market entry planning, geographical expansion, capital investment decisions, regulatory analysis, competitive intelligence, and new product development.
Report Coverage
Key Topics Covered
1. EXECUTIVE SUMMARY
2. MARKET SNAPSHOT
2.1. Market Overview
2.2. Market Definition
2.3. Scope of the Study
2.4. Market Segmentation
3. BUSINESS LANDSCAPE
3.1. Market Drivers
3.2. Market Restraints
3.3. Market Opportunities
3.4. Porter's Five Forces Analysis
3.5. Industry Value Chain Analysis
3.6. Policies and Regulations
3.7. Strategic Recommendations
4. TECHNOLOGICAL OUTLOOK
5. CELL AND GENE THERAPY BIOMANUFACTURING MARKET BY PRODUCT
5.1. Introduction
5.2. Reagents & Consumables
5.3. Instruments & Equipment
5.4. Software & Services
6. CELL AND GENE THERAPY BIOMANUFACTURING MARKET BY WORKFLOW
6.1. Introduction
6.2. Upstream Processing
6.3. Downstream Processing
6.4. Fill-Finish Operations
7. CELL AND GENE THERAPY BIOMANUFACTURING MARKET BY APPLICATION
7.1. Introduction
7.2. Oncology
7.3. Rare & Genetic Diseases
7.4. Cardiovascular Diseases
7.5. Neurological Disorders
7.6. Infectious Diseases
7.7. Others
8. CELL AND GENE THERAPY BIOMANUFACTURING MARKET BY GEOGRAPHY
8.1. Introduction
8.2. North America
8.2.1. USA
8.2.2. Canada
8.2.3. Mexico
8.3. South America
8.3.1. Brazil
8.3.2. Argentina
8.3.3. Others
8.4. Europe
8.4.1. United Kingdom
8.4.2. Germany
8.4.3. France
8.4.4. Spain
8.4.5. Others
8.5. Middle East and Africa
8.5.1. Saudi Arabia
8.5.2. UAE
8.5.3. Others
8.6. Asia Pacific
8.6.1. China
8.6.2. India
8.6.3. Japan
8.6.4. South Korea
8.6.5. Indonesia
8.6.6. Thailand
8.6.7. Others
9. COMPETITIVE ENVIRONMENT AND ANALYSIS
9.1. Major Players and Strategy Analysis
9.2. Market Share Analysis
9.3. Mergers, Acquisitions, Agreements, and Collaborations
9.4. Competitive Dashboard
10. COMPANY PROFILES
10.1. Lonza Group
10.2. Thermo Fisher Scientific
10.3. Merck KGaA
10.4. Danaher Corporation
10.5. WuXi AppTec
10.6. Catalent, Inc.
10.7. Samsung Biologics
10.8. Fujifilm Diosynth Biotechnologies
10.9. Charles River Laboratories
10.10. Cytiva
11. APPENDIX
11.1. Currency
11.2. Assumptions
11.3. Base and Forecast Years Timeline
11.4. Key Benefits for the Stakeholders
11.5. Research Methodology
11.6. Abbreviations
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