Pune, Sept. 17, 2024 (GLOBE NEWSWIRE) -- Cell & Gene Therapy Manufacturing Services Market Analysis:
“The Cell & Gene Therapy Manufacturing Services Market is experiencing rapid growth, with projections indicating a rise from USD 11.4 billion in 2023 to USD 70.7 billion by 2032. This impressive expansion, representing a Compound Annual Growth Rate (CAGR) of 22.4% from 2024 to 2032, is fueled by a surge in clinical trials, technological advancements, and an increasing demand for scalable manufacturing solutions.”
Market Overview
The Cell & Gene Therapy Manufacturing Services Market is witnessing dynamic evolution due to the escalating demand for cell and gene-based therapies. Currently, over 360 clinical trials are underway for CAR-T cell therapies alone, highlighting substantial investment in the development and scaling of production processes. The industry is rapidly adapting to meet this growing demand, with a focus on innovations in viral vector production, cell culture optimization, and bioprocessing technology to enhance yield and efficiency.
Strategic partnerships between biopharmaceutical companies and contract manufacturing organizations (CMOs) are addressing capacity constraints and technological complexities. Regulatory agencies are accelerating approvals, streamlining the commercialization process for therapies. This robust demand-supply dynamic is poised to drive significant market growth over the next decade.
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Major Players Analysis Listed in this Report are:
- Cellular Therapeutics
- Lonza
- Bluebird Bio Inc.
- Thermo Fisher Scientific
- Samsung Biologics
- Boehringer Ingelheim
- Hitachi Chemical Co., Ltd.
- Takara Bio Inc.
- Catalent Inc.
- Miltenyi Biotec
- F. Hoffmann-La Roche Ltd
- Novartis AG
- Merck KGaA
- Wuxi Advanced Therapies and others
Cell & Gene Therapy Manufacturing Services Market Report Scope:
| Report Attributes | Details |
| Market Size in 2023 | US$ 11.4 Billion |
| Market Size by 2032 | US$ 70.7 Billion |
| CAGR | CAGR of 22.4% From 2024 to 2032 |
| Base Year | 2023 |
| Forecast Period | 2024-2032 |
| Historical Data | 2020-2022 |
| Key Regional Coverage | North America (US, Canada, Mexico), Europe (Eastern Europe [Poland, Romania, Hungary, Turkey, Rest of Eastern Europe] Western Europe] Germany, France, UK, Italy, Spain, Netherlands, Switzerland, Austria, Rest of Western Europe]), Asia Pacific (China, India, Japan, South Korea, Vietnam, Singapore, Australia, Rest of Asia Pacific), Middle East & Africa (Middle East [UAE, Egypt, Saudi Arabia, Qatar, Rest of Middle East], Africa [Nigeria, South Africa, Rest of Africa], Latin America (Brazil, Argentina, Colombia, Rest of Latin America) |
| Key Growth Drivers | • Rising Demand for Cell and Gene Therapy Manufacturing Services |
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Segment Analysis
By Therapy Type: In 2023, the cell therapy manufacturing segment led the market with a significant revenue share of 59.9%. This dominance is attributed to the introduction of new products and the extensive number of clinical trials, particularly for CAR-T cell therapies and other cell-based treatments. The gene therapy segment, however, is anticipated to exhibit the fastest CAGR during the forecast period, driven by the increasing number of clinical trials and substantial investments in enhancing production processes.
By Manufacturing Scale: The pre-commercial/R&D scale manufacturing segment held a substantial revenue share of 72.34% in 2023, reflecting a large pipeline of developing gene and cell therapies. With over 2,073 clinical trials for cell therapies and 200 for gene therapies as of 2021, the trend is expected to lead to over 40 new product approvals in the next decade. Conversely, commercial-scale manufacturing is projected to experience the fastest growth, driven by increasing regulatory approvals and the demand for large-scale production.
By Manufacturing Mode: In 2023, the contract manufacturing mode segment dominated with a 66.3% revenue share. This preference is due to the growing demand for advanced therapies and limited in-house capacity among smaller biotech firms. Outsourcing provides flexibility and leverages the expertise of CMOs.
By Workflow: The process development segment captured a 16.97% revenue share in 2023, driven by the critical transition of therapies from clinical trials to regulatory approvals, necessitating robust production methods.
Cell & Gene Therapy Manufacturing Services Market Key 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 Analysis
North America: Dominating the Cell & Gene Therapy Manufacturing Services Market in 2023, North America, particularly the United States, benefits from a high concentration of biopharmaceutical companies, advanced R&D capabilities, and strong governmental support for regenerative medicine. The U.S. FDA's expedited approval pathways for innovative therapies are accelerating the commercialization of cell and gene therapies, fueling market growth.
Asia Pacific: The Asia Pacific region is expected to record the fastest growth during the forecast period, driven by rising R&D investments and collaborations aimed at improving manufacturing capabilities for cell and gene therapies. China and Japan are emerging as key players, with local companies partnering with global leaders to enhance production capacity.
Recent Developments
- April 2023: Catalent expanded its gene therapy manufacturing facility in Harmans, Maryland, enhancing viral vector production capacity.
- February 2023: Thermo Fisher Scientific launched Patheon Commercial Packaging Services for gene and cell therapies in the U.S. and Europe.
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Key Takeaways
- The global Cell & Gene Therapy Manufacturing Services Market is projected to grow at a CAGR of 22.4% from 2024 to 2032, reaching USD 70.7 billion.
- North America dominates the market, while the Asia Pacific region is expected to experience the fastest growth.
- Contract manufacturing maintains a substantial market share, with increasing investments in commercial-scale manufacturing capabilities.
- The gene therapy segment is poised to achieve the highest growth rate due to increased clinical trials and advancements in production technologies.
- Strategic partnerships between biopharmaceutical companies and CMOs are becoming crucial to overcoming capacity constraints and addressing technological complexities.
Table of Contents – Major Key Points
1. Introduction
2. Executive Summary
3. Research Methodology
4. Market Dynamics Impact Analysis
5. Statistical Insights and Trends Reporting
6. Competitive Landscape
7. Cell & Gene Therapy Manufacturing Services Market Segmentation, by Therapy Type
8. Cell & Gene Therapy Manufacturing Services Market Segmentation, by Manufacturing Scale
9. Cell & Gene Therapy Manufacturing Services Market Segmentation, by Manufacturing Mode
10. Cell & Gene Therapy Manufacturing Services Market Segmentation, By Workflow
11. Regional Analysis
12. Company Profiles
13. Use Cases and Best Practices
14. Conclusion
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