Expanding Clinical Pipelines, Contract Manufacturing Adoption, and Automation-Led Process Innovation Fuel Robust Market Growth Globally.
Austin, United States, Feb. 27, 2026 (GLOBE NEWSWIRE) — According to SNS Insider, The Cell & Gene Therapy Manufacturing Services Market size is estimated at USD 15.59 billion in 2025 and is expected to reach USD 74.41 billion by 2035, growing at a CAGR of 16.96% over 2026-2035. Growing demand for cutting-edge therapeutic manufacturing solutions, including viral vector production, cell processing platforms, and gene editing technologies, is driving the global market for cell & gene therapy manufacturing services.
Market Size and Forecast:
- Market Size in 2025: USD 15.59 billion
- Market Size by 2035: USD 74.41 billion
- CAGR: 16.96% from 2026 to 2035
- Base Year: 2025
- Forecast Period: 2026–2035
- Historical Data: 2022–2024
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The U.S. Cell & Gene Therapy Manufacturing Services Market is estimated at USD 6.54 billion in 2025 and is expected to reach USD 31.23 billion by 2035, growing at a CAGR of 17.08% during 2026-2035. Due in significant part to the country’s strong biotechnology sector, government backing for regenerative medicine, and sophisticated contract manufacturing infrastructure, the U.S. is the largest market for cell and gene therapy manufacturing services.
Increasing Regulatory Approvals and Clinical Pipeline Expansion to Boost Market Growth Globally
The implementation of expedited regulatory pathways, breakthrough therapy designations, and regenerative medicine advanced therapy standards for accelerated therapy development and commercial manufacturing readiness are the main factors driving the growth of the cell & gene therapy manufacturing services market share. These factors include an increase in regulatory approvals and the expansion of the clinical pipeline. The market’s foundation, the penetration of contract manufacturing and in-house markets, and the expansion of the market share globally are all being driven by these solutions for enhanced therapeutic manufacturing and quality assurance.
High Manufacturing Costs and Technical Complexity Hamper Market Growth Globally
Since many new biotechnology companies struggle to establish specialized manufacturing capabilities and uphold strict quality control standards, the market growth for cell and gene therapy manufacturing services is further constrained by the high manufacturing costs and technical complexity of cell and gene therapy production. Production bottlenecks, restricted therapy accessibility, and a worse return on investment for therapy developers could result from this. As a result, in areas with inadequate manufacturing infrastructure and specialized staff availability, market growth is slowed and therapeutic commercialization timelines suffer.
Major Players Listed in this Report:
- Lonza Group AG
- Thermo Fisher Scientific Inc.
- Catalent Biologics
- WuXi AppTec
- Samsung Biologics
- Fujifilm Diosynth Biotechnologies
- Charles River Laboratories
- MilliporeSigma
- AGC Biologics
- Oxford Biomedica
- Cobra Biologics
- Cognate BioServices
- MaxCyte Inc.
- Minaris Regenerative Medicine
- Cell and Gene Therapy Catapult
- Cytiva
- Waisman Biomanufacturing
- Paragon Bioservices
- RoosterBio Inc.
- Andelyn Biosciences
Segmentation Analysis:
By Therapy Type
The cell therapy manufacturing segment accounted for the highest revenue share of approximately 56.72% in 2025, owing to established manufacturing protocols for CAR-T cell therapies. The gene therapy manufacturing segment is anticipated to achieve the highest CAGR of nearly 18.34% during the 2026–2035 period, driven by the increasing number of gene therapy clinical trials and advancements in viral vector production technologies.
By Manufacturing Scale
By 2025, the commercial scale manufacturing segment contributed the largest revenue share of 58.16% due to increasing therapy commercialization. The pre-commercial/R&D scale manufacturing segment is projected to grow at the highest CAGR of about 17.45% between 2026 and 2035 due to the growing number of clinical trial initiations and demand for flexible manufacturing platforms.
By Manufacturing Mode
The contract manufacturing segment accounted for the largest share with about 64.89%, of the cell & gene therapy manufacturing services market and it is also expected to grow with the fastest CAGR or around 17.23% globally owing to capital efficiency advantages.
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Cell & Gene Therapy Manufacturing Services Market Segmentation
By Therapy Type
- Cell Therapy Manufacturing
- Stem Cell Therapy
- Non Stem Cell Therapy
- Gene Therapy Manufacturing
By Manufacturing Scale
- Pre-commercial/R&D Scale Manufacturing
- Commercial Scale Manufacturing
By Manufacturing Mode
- Contract Manufacturing
- In-house Manufacturing
By Workflow
- Cell Processing
- Cell Banking
- Process Development
- Fill & Finish Operations
- Analytical and Quality Testing
- Raw Material Testing
- Vector Production
- Others
Regional Insights:
With a compound annual growth rate (CAGR) of 19.27%, Asia Pacific is the market segment with the fastest rate of growth for cell and gene therapy manufacturing services. This growth is driven by the factors, such as government biotechnology development initiatives, increased awareness of the advantages of advanced therapy, and investments in manufacturing infrastructure in developing countries.
North America held the largest revenue share of over 41.94% in 2025 of the cell & gene therapy manufacturing services market due to an established biotechnology industry infrastructure, strong venture capital funding ecosystem, and increased pharmaceutical company investment in regenerative medicine.
Recent Developments:
- In February 2025, it expanded its cell & gene therapy manufacturing capacity with a new automated processing facility in Switzerland, aiming to improve viral vector production efficiency and autologous therapy manufacturing capabilities across its global client network.
- In May 2024, launched an enhanced cell processing platform featuring closed-system manufacturing and integrated quality analytics across global pharmaceutical markets, enhancing production consistency, regulatory compliance automation, and manufacturing throughput optimization.
Exclusive Sections of the Report (The USPs):
- MANUFACTURING CAPACITY & UTILIZATION METRICS – helps you understand global manufacturing capacity growth and expansion trends. Tracks average facility utilization rates by region and therapy type. Measures batch success rates, quality benchmarks, throughput levels, and turnaround time performance.
- TECHNOLOGICAL ADOPTION RATE – helps you assess adoption of closed systems and single-use technologies. Compares automated processing platforms versus manual operations. Tracks implementation of real-time analytics and AI-driven quality control systems.
- REGULATORY COMPLIANCE METRICS – helps you evaluate GMP compliance rates by geography. Analyzes regulatory inspection outcomes and observation trends. Reviews Chemistry Manufacturing Controls documentation standards and technology transfer success rates.
- CLINICAL MANUFACTURING & COMMERCIAL READINESS INDICATORS – helps you measure clinical trial manufacturing volumes and growth rates. Tracks therapy approval timelines and manufacturing readiness levels. Monitors commercialization success rates and market access progress.
- COST & THROUGHPUT BENCHMARKS – helps you analyze average manufacturing cost per treatment unit. Compares processing efficiency across therapy types. Supports margin optimization and scalability planning decisions.
- COMPETITIVE LANDSCAPE – helps you gauge the competitive strength of key service providers. Covers capacity expansions, regional footprint, technology capabilities, partnerships, and recent developments. Supports benchmarking of growth projections and strategic positioning.
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Table of Contents – Major Key Points
1. Introduction
2. Executive Summary
3. Market Overview
4. Statistical Insights & Trends Reporting
5. Cell & Gene Therapy Manufacturing Services Market Segmental Analysis & Forecast, By Therapy Type
6. Cell & Gene Therapy Manufacturing Services Market Segmental Analysis & Forecast, By Manufacturing Scale
7. Cell & Gene Therapy Manufacturing Services Market Segmental Analysis & Forecast, By Manufacturing Mode
8. Cell & Gene Therapy Manufacturing Services Market Segmental Analysis & Forecast, By Workflow
9. Cell & Gene Therapy Manufacturing Services Market Segmental Analysis & Forecast, By Region
10. Competitive Landscape
11. Analyst Recommendations
12. Assumptions
13. Disclaimer
14. Appendix
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