Product Code: ETC13203776 | Publication Date: Apr 2025 | Updated Date: Jul 2025 | Product Type: Market Research Report | |
Publisher: 6Wresearch | Author: Sachin Kumar Rai | 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 Market was valued at USD 7.2 Billion in 2024 and is expected to reach USD 16 Billion by 2031, growing at a compound annual growth rate of 9.50% during the forecast period (2025-2031).
The Global Cell and Gene Therapy Manufacturing Market is experiencing rapid growth due to advancements in biotechnology and personalized medicine. The market is driven by increasing investment in research and development, along with the rising prevalence of chronic diseases such as cancer and genetic disorders. Key players in the market include prominent pharmaceutical companies, contract development and manufacturing organizations (CDMOs), and academic institutions. Factors such as the need for scalable manufacturing processes, stringent regulatory requirements, and the complexity of manufacturing these therapies present challenges for market growth. However, technological innovations, strategic collaborations, and government initiatives aimed at accelerating the commercialization of cell and gene therapies are expected to drive the market further in the coming years.
The Global Cell and Gene Therapy Manufacturing Market is experiencing rapid growth due to the increasing prevalence of chronic diseases and advancements in biotechnology. Key trends include the adoption of automated manufacturing processes for scalability and efficiency, the development of novel gene editing technologies, and the expansion of manufacturing facilities to meet rising demand. Opportunities in the market include collaborations between biopharmaceutical companies and contract manufacturing organizations, investment in innovative manufacturing technologies such as bioreactors and closed-system processing, and the potential for personalized medicine through the customization of cell and gene therapies. Overall, the market holds promise for significant growth and innovation, driven by the continuous advancements in research and development in the field of cell and gene therapy manufacturing.
The Global Cell and Gene Therapy Manufacturing Market faces several challenges, including complex manufacturing processes requiring specialized facilities and equipment, high costs associated with development and scaling up production, stringent regulatory requirements to ensure safety and efficacy, and limited skilled workforce with expertise in cell and gene therapy manufacturing. Additionally, ensuring consistent quality and scalability of manufacturing processes, addressing supply chain issues, and navigating intellectual property rights and licensing agreements pose further challenges for companies operating in this market. Overcoming these hurdles will be crucial for the industry to meet the growing demand for innovative cell and gene therapies and to realize their full potential in transforming healthcare.
The Global Cell and Gene Therapy Manufacturing Market is primarily driven by factors such as increasing investments in research and development activities, technological advancements in bioprocessing techniques, growing demand for personalized medicine, and the rising prevalence of chronic diseases. Moreover, the supportive regulatory environment and government initiatives to promote cell and gene therapy manufacturing further contribute to market growth. The expanding pipeline of cell and gene therapy products, along with collaborations between biopharmaceutical companies and contract manufacturing organizations, are also driving the market forward. Additionally, the advancements in automation and the scaling up of manufacturing processes to meet the growing demand for these innovative therapies are key drivers shaping the market landscape.
Government policies related to the Global Cell And Gene Therapy Manufacturing Market typically focus on ensuring safety, efficacy, and quality of these advanced therapies. Regulatory agencies such as the FDA in the United States, the EMA in Europe, and PMDA in Japan have established guidelines and requirements for manufacturing practices, product approvals, and post-market surveillance. These policies aim to streamline the development and commercialization of cell and gene therapies while safeguarding patient health and promoting innovation in the industry. Additionally, governments may provide incentives such as grants, tax credits, and accelerated approval pathways to support research and manufacturing activities in this rapidly evolving sector. Overall, government policies play a crucial role in shaping the landscape of the cell and gene therapy manufacturing market by fostering a regulatory framework conducive to growth and innovation.
The Global Cell and Gene Therapy Manufacturing Market is poised for significant growth in the coming years, driven by advancements in biotechnology, increasing investments in research and development, and a growing focus on personalized medicine. The market is expected to expand rapidly as more cell and gene therapy products receive regulatory approval and enter the market. Additionally, the increasing prevalence of chronic diseases and the rising demand for innovative treatment options are further fueling the growth of this market. Key market players are investing in expanding manufacturing capabilities, implementing advanced technologies, and establishing strategic partnerships to meet the growing demand for cell and gene therapy products. Overall, the future outlook for the Global Cell and Gene Therapy Manufacturing Market is promising, with substantial opportunities for growth and innovation on the horizon.
In the Global Cell and Gene Therapy Manufacturing Market, Asia is emerging as a key region due to the presence of a large population base and increasing investments in research and development. North America remains a dominant player with established infrastructure and favorable regulatory environment. Europe is also a significant market with advanced healthcare systems and supportive policies. The Middle East and Africa region is witnessing growth opportunities, driven by rising healthcare investments and collaborations with international players. Latin America is showing potential for growth, fueled by increasing awareness and adoption of cell and gene therapy treatments. Overall, the global market for cell and gene therapy manufacturing is dynamic, with each region offering unique opportunities and challenges for market players.
Global Cell And Gene Therapy Manufacturing 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 Market Overview |
3.1 Global Regional Macro Economic Indicators |
3.2 Global Cell And Gene Therapy Manufacturing Market Revenues & Volume, 2021 & 2031F |
3.3 Global Cell And Gene Therapy Manufacturing Market - Industry Life Cycle |
3.4 Global Cell And Gene Therapy Manufacturing Market - Porter's Five Forces |
3.5 Global Cell And Gene Therapy Manufacturing Market Revenues & Volume Share, By Regions, 2021 & 2031F |
3.6 Global Cell And Gene Therapy Manufacturing Market Revenues & Volume Share, By Therapy Type, 2021 & 2031F |
3.7 Global Cell And Gene Therapy Manufacturing Market Revenues & Volume Share, By Scale, 2021 & 2031F |
3.8 Global Cell And Gene Therapy Manufacturing Market Revenues & Volume Share, By Mode, 2021 & 2031F |
3.9 Global Cell And Gene Therapy Manufacturing Market Revenues & Volume Share, By Workflow, 2021 & 2031F |
4 Global Cell And Gene Therapy Manufacturing Market Dynamics |
4.1 Impact Analysis |
4.2 Market Drivers |
4.3 Market Restraints |
5 Global Cell And Gene Therapy Manufacturing Market Trends |
6 Global Cell And Gene Therapy Manufacturing Market, 2021 - 2031 |
6.1 Global Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Therapy Type, 2021 - 2031 |
6.1.1 Overview & Analysis |
6.1.2 Global Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Cell therapy manufacturing, 2021 - 2031 |
6.1.3 Global Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Gene therapy manufacturing, 2021 - 2031 |
6.2 Global Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Scale, 2021 - 2031 |
6.2.1 Overview & Analysis |
6.2.2 Global Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Pre-commercial/R&D scale manufacturing, 2021 - 2031 |
6.2.3 Global Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Commercial scale manufacturing, 2021 - 2031 |
6.3 Global Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Mode, 2021 - 2031 |
6.3.1 Overview & Analysis |
6.3.2 Global Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Contract manufacturing, 2021 - 2031 |
6.3.3 Global Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By In-house manufacturing, 2021 - 2031 |
6.4 Global Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Workflow, 2021 - 2031 |
6.4.1 Overview & Analysis |
6.4.2 Global Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Cell processing, 2021 - 2031 |
6.4.3 Global Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Cell banking, 2021 - 2031 |
6.4.4 Global Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Process development, 2021 - 2031 |
6.4.5 Global Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Fill & finish operations, 2021 - 2031 |
6.4.6 Global Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Analytical and quality testing, 2021 - 2031 |
6.4.7 Global Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Raw material testing, 2021 - 2031 |
6.4.8 Global Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Vector production, 2021 - 2031 |
6.4.9 Global Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Others, 2021 - 2031 |
7 North America Cell And Gene Therapy Manufacturing Market, Overview & Analysis |
7.1 North America Cell And Gene Therapy Manufacturing Market Revenues & Volume, 2021 - 2031 |
7.2 North America Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Countries, 2021 - 2031 |
7.2.1 United States (US) Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
7.2.2 Canada Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
7.2.3 Rest of North America Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
7.3 North America Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Therapy Type, 2021 - 2031 |
7.4 North America Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Scale, 2021 - 2031 |
7.5 North America Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Mode, 2021 - 2031 |
7.6 North America Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Workflow, 2021 - 2031 |
8 Latin America (LATAM) Cell And Gene Therapy Manufacturing Market, Overview & Analysis |
8.1 Latin America (LATAM) Cell And Gene Therapy Manufacturing Market Revenues & Volume, 2021 - 2031 |
8.2 Latin America (LATAM) Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Countries, 2021 - 2031 |
8.2.1 Brazil Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
8.2.2 Mexico Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
8.2.3 Argentina Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
8.2.4 Rest of LATAM Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
8.3 Latin America (LATAM) Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Therapy Type, 2021 - 2031 |
8.4 Latin America (LATAM) Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Scale, 2021 - 2031 |
8.5 Latin America (LATAM) Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Mode, 2021 - 2031 |
8.6 Latin America (LATAM) Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Workflow, 2021 - 2031 |
9 Asia Cell And Gene Therapy Manufacturing Market, Overview & Analysis |
9.1 Asia Cell And Gene Therapy Manufacturing Market Revenues & Volume, 2021 - 2031 |
9.2 Asia Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Countries, 2021 - 2031 |
9.2.1 India Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
9.2.2 China Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
9.2.3 Japan Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
9.2.4 Rest of Asia Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
9.3 Asia Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Therapy Type, 2021 - 2031 |
9.4 Asia Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Scale, 2021 - 2031 |
9.5 Asia Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Mode, 2021 - 2031 |
9.6 Asia Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Workflow, 2021 - 2031 |
10 Africa Cell And Gene Therapy Manufacturing Market, Overview & Analysis |
10.1 Africa Cell And Gene Therapy Manufacturing Market Revenues & Volume, 2021 - 2031 |
10.2 Africa Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Countries, 2021 - 2031 |
10.2.1 South Africa Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
10.2.2 Egypt Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
10.2.3 Nigeria Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
10.2.4 Rest of Africa Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
10.3 Africa Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Therapy Type, 2021 - 2031 |
10.4 Africa Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Scale, 2021 - 2031 |
10.5 Africa Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Mode, 2021 - 2031 |
10.6 Africa Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Workflow, 2021 - 2031 |
11 Europe Cell And Gene Therapy Manufacturing Market, Overview & Analysis |
11.1 Europe Cell And Gene Therapy Manufacturing Market Revenues & Volume, 2021 - 2031 |
11.2 Europe Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Countries, 2021 - 2031 |
11.2.1 United Kingdom Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
11.2.2 Germany Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
11.2.3 France Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
11.2.4 Rest of Europe Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
11.3 Europe Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Therapy Type, 2021 - 2031 |
11.4 Europe Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Scale, 2021 - 2031 |
11.5 Europe Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Mode, 2021 - 2031 |
11.6 Europe Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Workflow, 2021 - 2031 |
12 Middle East Cell And Gene Therapy Manufacturing Market, Overview & Analysis |
12.1 Middle East Cell And Gene Therapy Manufacturing Market Revenues & Volume, 2021 - 2031 |
12.2 Middle East Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Countries, 2021 - 2031 |
12.2.1 Saudi Arabia Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
12.2.2 UAE Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
12.2.3 Turkey Cell And Gene Therapy Manufacturing Market, Revenues & Volume, 2021 - 2031 |
12.3 Middle East Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Therapy Type, 2021 - 2031 |
12.4 Middle East Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Scale, 2021 - 2031 |
12.5 Middle East Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Mode, 2021 - 2031 |
12.6 Middle East Cell And Gene Therapy Manufacturing Market, Revenues & Volume, By Workflow, 2021 - 2031 |
13 Global Cell And Gene Therapy Manufacturing Market Key Performance Indicators |
14 Global Cell And Gene Therapy Manufacturing Market - Export/Import By Countries Assessment |
15 Global Cell And Gene Therapy Manufacturing Market - Opportunity Assessment |
15.1 Global Cell And Gene Therapy Manufacturing Market Opportunity Assessment, By Countries, 2021 & 2031F |
15.2 Global Cell And Gene Therapy Manufacturing Market Opportunity Assessment, By Therapy Type, 2021 & 2031F |
15.3 Global Cell And Gene Therapy Manufacturing Market Opportunity Assessment, By Scale, 2021 & 2031F |
15.4 Global Cell And Gene Therapy Manufacturing Market Opportunity Assessment, By Mode, 2021 & 2031F |
15.5 Global Cell And Gene Therapy Manufacturing Market Opportunity Assessment, By Workflow, 2021 & 2031F |
16 Global Cell And Gene Therapy Manufacturing Market - Competitive Landscape |
16.1 Global Cell And Gene Therapy Manufacturing Market Revenue Share, By Companies, 2024 |
16.2 Global Cell And Gene Therapy Manufacturing Market Competitive Benchmarking, By Operating and Technical Parameters |
17 Top 10 Company Profiles |
18 Recommendations |
19 Disclaimer |