| Product Code: ETC13203754 | Publication Date: Apr 2025 | Updated Date: Jul 2025 | Product Type: Market Research Report | |
| Publisher: 6Wresearch | Author: Bhawna Singh | No. of Pages: 190 | No. of Figures: 80 | No. of Tables: 40 |
According to 6Wresearch internal database and industry insights, the Global Cell and Gene Therapy Manufacturing Services Market was valued at USD 3.8 Billion in 2024 and is expected to reach USD 7.6 Billion by 2031, growing at a compound annual growth rate of 4.20% during the forecast period (2025-2031).
The Global Cell and Gene Therapy Manufacturing Services Market is experiencing rapid growth driven by the increasing adoption of personalized medicine and the high demand for advanced therapies to treat complex diseases. The market is characterized by a surge in outsourcing manufacturing services to specialized firms due to the complex nature of cell and gene therapy production processes. Key players in the market are investing heavily in expanding their manufacturing capabilities to cater to the growing demand for these innovative therapies. Factors such as favorable regulatory environment, technological advancements, and strategic collaborations between biopharmaceutical companies and manufacturing service providers are further fueling market growth. North America currently dominates the market, followed by Europe and Asia-Pacific, with ongoing research and development activities expected to drive continued expansion of the global cell and gene therapy manufacturing services market.
The Global Cell and Gene Therapy Manufacturing Services Market is experiencing rapid growth due to the increasing demand for personalized medicine and the development of advanced therapies. Key trends include the adoption of automation and digital technologies to improve manufacturing processes, the expansion of contract manufacturing organizations (CMOs) offering specialized services, and the emphasis on regulatory compliance and quality control. Opportunities in this market lie in the development of scalable manufacturing platforms, partnerships between biopharmaceutical companies and CMOs, and investments in infrastructure and capacity expansion to meet the growing demand for cell and gene therapy products. Overall, the market is poised for significant expansion as more therapies progress through clinical trials and gain regulatory approval, creating a favorable environment for service providers in this sector.
The Global Cell and Gene Therapy Manufacturing Services Market faces several challenges, including complex manufacturing processes, stringent regulatory requirements, high production costs, limited scalability, and lack of standardized manufacturing methods. The highly specialized nature of cell and gene therapy products requires advanced manufacturing facilities and skilled personnel, leading to increased operational costs. Regulatory hurdles pose a significant challenge due to the need for compliance with varying guidelines across different regions, delaying market entry and commercialization. Additionally, the lack of standardized manufacturing processes hinders efficiency and consistency in product quality, impacting the overall growth of the market. Addressing these challenges will be crucial for the continued expansion and success of the Global Cell and Gene Therapy Manufacturing Services Market.
The Global Cell and Gene Therapy Manufacturing Services Market is being primarily driven by the increasing prevalence of chronic diseases and genetic disorders, driving the demand for advanced treatment options. Additionally, the growing investments in research and development activities by biopharmaceutical companies and government initiatives to accelerate the development of cell and gene therapies are contributing to market growth. The advancements in technology, such as automation and closed-system processing, are enhancing manufacturing capabilities and efficiency, further fueling the market expansion. Moreover, the rising adoption of personalized medicine and the potential of cell and gene therapies to provide curative treatments for various diseases are driving the demand for manufacturing services in this sector. These factors collectively are propelling the growth of the Global Cell and Gene Therapy Manufacturing Services Market.
Government policies related to the Global Cell and Gene Therapy Manufacturing Services Market vary across different regions. In the United States, the FDA has implemented the Regenerative Medicine Advanced Therapy (RMAT) designation to expedite the development and review of cell and gene therapies. Additionally, the FDA`s guidelines on current Good Manufacturing Practices (cGMP) set quality standards for manufacturing these therapies. In Europe, the European Medicines Agency (EMA) regulates cell and gene therapy products through the Committee for Advanced Therapies (CAT) and has established the Advanced Therapy Medicinal Products (ATMP) regulatory framework. These policies aim to ensure the safety, efficacy, and quality of cell and gene therapy manufacturing services, promoting innovation while protecting patient welfare.
The Global Cell and Gene Therapy Manufacturing Services Market is expected to experience significant growth in the coming years, driven by the increasing adoption of personalized medicine and advancements in biotechnology. The market is projected to expand due to the rising number of clinical trials and approvals of cell and gene therapy products, creating a demand for specialized manufacturing services. Factors such as the growing investment in research and development, expanding biopharmaceutical industry, and supportive regulatory environment are also contributing to the market`s positive outlook. Additionally, the development of innovative technologies and processes to enhance manufacturing efficiency and scalability will further propel market growth, making this sector a key area of focus for investors and industry players.
In the global cell and gene therapy manufacturing services market, North America is a key region due to its advanced healthcare infrastructure and significant investments in research and development. Europe follows closely behind, with a well-established pharmaceutical industry and supportive regulatory environment driving market growth. Asia Pacific is emerging as a lucrative market, fueled by increasing government initiatives and rising adoption of innovative therapies. The Middle East and Africa region is witnessing gradual growth, supported by improving healthcare infrastructure and growing awareness about advanced treatment options. Latin America is also showing potential for market expansion, driven by collaborations between pharmaceutical companies and research institutions, as well as increasing focus on personalized medicine in the region. Overall, these regional insights highlight diverse opportunities and challenges shaping the global cell and gene therapy manufacturing services market.
Global Cell and Gene Therapy Manufacturing Services Market |
1 Executive Summary |
2 Introduction |
2.1 Key Highlights of the Report |
2.2 Report Description |
2.3 Market Scope & Segmentation |
2.4 Research Methodology |
2.5 Assumptions |
3 Global Cell and Gene Therapy Manufacturing Services Market Overview |
3.1 Global Regional Macro Economic Indicators |
3.2 Global Cell and Gene Therapy Manufacturing Services Market Revenues & Volume, 2021 & 2031F |
3.3 Global Cell and Gene Therapy Manufacturing Services Market - Industry Life Cycle |
3.4 Global Cell and Gene Therapy Manufacturing Services Market - Porter's Five Forces |
3.5 Global Cell and Gene Therapy Manufacturing Services Market Revenues & Volume Share, By Regions, 2021 & 2031F |
3.6 Global Cell and Gene Therapy Manufacturing Services Market Revenues & Volume Share, By Type, 2021 & 2031F |
3.7 Global Cell and Gene Therapy Manufacturing Services Market Revenues & Volume Share, By Indication, 2021 & 2031F |
3.8 Global Cell and Gene Therapy Manufacturing Services Market Revenues & Volume Share, By Application, 2021 & 2031F |
3.9 Global Cell and Gene Therapy Manufacturing Services Market Revenues & Volume Share, By End User, 2021 & 2031F |
4 Global Cell and Gene Therapy Manufacturing Services Market Dynamics |
4.1 Impact Analysis |
4.2 Market Drivers |
4.3 Market Restraints |
5 Global Cell and Gene Therapy Manufacturing Services Market Trends |
6 Global Cell and Gene Therapy Manufacturing Services Market, 2021 - 2031 |
6.1 Global Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Type, 2021 - 2031 |
6.1.1 Overview & Analysis |
6.1.2 Global Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Cell Therapy, 2021 - 2031 |
6.1.3 Global Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Gene Therapy, 2021 - 2031 |
6.2 Global Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Indication, 2021 - 2031 |
6.2.1 Overview & Analysis |
6.2.2 Global Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Oncology Diseases, 2021 - 2031 |
6.2.3 Global Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Cardiovascular Diseases, 2021 - 2031 |
6.2.4 Global Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Orthopedic Diseases, 2021 - 2031 |
6.2.5 Global Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Ophthalmology Diseases, 2021 - 2031 |
6.2.6 Global Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Central Nervous System Disorder, 2021 - 2031 |
6.2.7 Global Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Infectious Diseases, 2021 - 2031 |
6.2.8 Global Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Other Indications, 2021 - 2031 |
6.3 Global Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Application, 2021 - 2031 |
6.3.1 Overview & Analysis |
6.3.2 Global Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Clinical Manufacturing, 2021 - 2031 |
6.3.3 Global Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Commercial Manufacturing, 2021 - 2031 |
6.4 Global Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By End User, 2021 - 2031 |
6.4.1 Overview & Analysis |
6.4.2 Global Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Pharmaceutical & Biotechnology Companies, 2021 - 2031 |
6.4.3 Global Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Academic & Research Institutes, 2021 - 2031 |
6.4.4 Global Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Others, 2021 - 2031 |
7 North America Cell and Gene Therapy Manufacturing Services Market, Overview & Analysis |
7.1 North America Cell and Gene Therapy Manufacturing Services Market Revenues & Volume, 2021 - 2031 |
7.2 North America Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Countries, 2021 - 2031 |
7.2.1 United States (US) Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
7.2.2 Canada Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
7.2.3 Rest of North America Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
7.3 North America Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Type, 2021 - 2031 |
7.4 North America Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Indication, 2021 - 2031 |
7.5 North America Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Application, 2021 - 2031 |
7.6 North America Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By End User, 2021 - 2031 |
8 Latin America (LATAM) Cell and Gene Therapy Manufacturing Services Market, Overview & Analysis |
8.1 Latin America (LATAM) Cell and Gene Therapy Manufacturing Services Market Revenues & Volume, 2021 - 2031 |
8.2 Latin America (LATAM) Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Countries, 2021 - 2031 |
8.2.1 Brazil Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
8.2.2 Mexico Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
8.2.3 Argentina Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
8.2.4 Rest of LATAM Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
8.3 Latin America (LATAM) Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Type, 2021 - 2031 |
8.4 Latin America (LATAM) Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Indication, 2021 - 2031 |
8.5 Latin America (LATAM) Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Application, 2021 - 2031 |
8.6 Latin America (LATAM) Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By End User, 2021 - 2031 |
9 Asia Cell and Gene Therapy Manufacturing Services Market, Overview & Analysis |
9.1 Asia Cell and Gene Therapy Manufacturing Services Market Revenues & Volume, 2021 - 2031 |
9.2 Asia Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Countries, 2021 - 2031 |
9.2.1 India Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
9.2.2 China Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
9.2.3 Japan Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
9.2.4 Rest of Asia Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
9.3 Asia Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Type, 2021 - 2031 |
9.4 Asia Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Indication, 2021 - 2031 |
9.5 Asia Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Application, 2021 - 2031 |
9.6 Asia Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By End User, 2021 - 2031 |
10 Africa Cell and Gene Therapy Manufacturing Services Market, Overview & Analysis |
10.1 Africa Cell and Gene Therapy Manufacturing Services Market Revenues & Volume, 2021 - 2031 |
10.2 Africa Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Countries, 2021 - 2031 |
10.2.1 South Africa Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
10.2.2 Egypt Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
10.2.3 Nigeria Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
10.2.4 Rest of Africa Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
10.3 Africa Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Type, 2021 - 2031 |
10.4 Africa Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Indication, 2021 - 2031 |
10.5 Africa Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Application, 2021 - 2031 |
10.6 Africa Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By End User, 2021 - 2031 |
11 Europe Cell and Gene Therapy Manufacturing Services Market, Overview & Analysis |
11.1 Europe Cell and Gene Therapy Manufacturing Services Market Revenues & Volume, 2021 - 2031 |
11.2 Europe Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Countries, 2021 - 2031 |
11.2.1 United Kingdom Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
11.2.2 Germany Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
11.2.3 France Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
11.2.4 Rest of Europe Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
11.3 Europe Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Type, 2021 - 2031 |
11.4 Europe Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Indication, 2021 - 2031 |
11.5 Europe Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Application, 2021 - 2031 |
11.6 Europe Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By End User, 2021 - 2031 |
12 Middle East Cell and Gene Therapy Manufacturing Services Market, Overview & Analysis |
12.1 Middle East Cell and Gene Therapy Manufacturing Services Market Revenues & Volume, 2021 - 2031 |
12.2 Middle East Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Countries, 2021 - 2031 |
12.2.1 Saudi Arabia Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
12.2.2 UAE Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
12.2.3 Turkey Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, 2021 - 2031 |
12.3 Middle East Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Type, 2021 - 2031 |
12.4 Middle East Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Indication, 2021 - 2031 |
12.5 Middle East Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By Application, 2021 - 2031 |
12.6 Middle East Cell and Gene Therapy Manufacturing Services Market, Revenues & Volume, By End User, 2021 - 2031 |
13 Global Cell and Gene Therapy Manufacturing Services Market Key Performance Indicators |
14 Global Cell and Gene Therapy Manufacturing Services Market - Export/Import By Countries Assessment |
15 Global Cell and Gene Therapy Manufacturing Services Market - Opportunity Assessment |
15.1 Global Cell and Gene Therapy Manufacturing Services Market Opportunity Assessment, By Countries, 2021 & 2031F |
15.2 Global Cell and Gene Therapy Manufacturing Services Market Opportunity Assessment, By Type, 2021 & 2031F |
15.3 Global Cell and Gene Therapy Manufacturing Services Market Opportunity Assessment, By Indication, 2021 & 2031F |
15.4 Global Cell and Gene Therapy Manufacturing Services Market Opportunity Assessment, By Application, 2021 & 2031F |
15.5 Global Cell and Gene Therapy Manufacturing Services Market Opportunity Assessment, By End User, 2021 & 2031F |
16 Global Cell and Gene Therapy Manufacturing Services Market - Competitive Landscape |
16.1 Global Cell and Gene Therapy Manufacturing Services Market Revenue Share, By Companies, 2024 |
16.2 Global Cell and Gene Therapy Manufacturing Services Market Competitive Benchmarking, By Operating and Technical Parameters |
17 Top 10 Company Profiles |
18 Recommendations |
19 Disclaimer |