Report Scope & Overview:
The Cell & Gene Therapy Manufacturing Services Market Size was valued at USD 16.92 billion in 2022 and is expected to reach USD 30.86 billion by 2030, and grow at a CAGR of 7.8% over the forecast period 2023-2030.
Growing agreements and partnerships between CDMOs and pharmaceutical companies are propelling the cell and gene therapy manufacturing services market. The increasing rate of investment in new technologies and pharmaceutical research and development activities are also contributing to the expansion of the cell & gene therapy manufacturing services sector. Furthermore, as cancer and other diseases become more prevalent, the cell and gene therapy manufacturing services market is expanding.
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Excessive operational expenses may limit the expansion of the cell and gene therapy manufacturing services business. It could raise the overall cost of the service and, to some extent, limit the potential in the cell and gene therapy manufacturing services market.
MARKET DYNAMICS:
DRIVERS
Cancer and Chronic Diseases are becoming more common.
Increase in number of investments.
The quantity of clinical preliminaries is expanding.
Regulatory Environment That Is Favorable
RESTRAINTS
Operational charges are high.
OPPORTUNITIES
Approvals for drugs and a healthy pipeline
Rise in number cell therapy.
CHALLENGES
There is a scarcity of reliable vectors for cell and gene therapy.
Scarcity of therapy-specific tests
IMPACT OF COVID-19
The current COVID-19 pandemic has had a favorable impact on the manufacture of cell and gene therapies. Several companies increased their vector production capacities and formed strategic partnerships to develop experimental medicines. This is in response to the urgent need for effective treatments as well as an anti-infection vaccination. Tevogen Bio, for example, teamed up with Biocentric to develop Tevogen’s COVID-19 T-Cell Therapy in March 2021.
The ratio of successful treatment to the number of clinical trials of cellular and gene-modified therapeutic products has improved in recent years in the healthcare industry. This is due to greater science and medical awareness of the safety risks associated with their use. In early 2020, there were 362 phase III clinical studies, with the number likely to rise dramatically in the future years.
By Therapy Type:
The high number of active clinical trials and the increasing number of goods entering the market are both contributing to the rise. To understand the potential of cell therapies for the treatment of various cancer indications, more than 250 clinical studies concentrating on CAR T cell treatments and other cell therapies are being examined. Furthermore, biopharma companies are seeing allogeneic CAR T cell therapy as a more attractive business strategy than current manufacturing and economic models.
By Scale Type:
This is due to a robust and rapidly expanding pipeline of cell and gene therapies around the world. More than 900 clinical trials for various cell treatments are currently conducted as of March 2020. According to the Journal of Gene Medicine, the number of gene therapy clinical studies has increased to 3,036 in 2020. This high figure reflects the rising need for manufacturing services in the development of preclinical product candidates.
By Mode Type:
The main contribution to this area is the presence of a large number of large capital businesses, as well as academic institutes with individualized patient treatment programs. Improved process troubleshooting agility, ownership of supply networks, and efficient creation of a corporate knowledge base to aid future in-house scale-up are all major elements driving the segment growth.
By Workflow type:
The development of very well and robust technologies for cell therapy production has become increasingly critical as more medicines progress from clinical trials to regulatory approval. Process development solutions improve the quality and safety profiles of candidate programs while increasing efficiency.
KEY MARKET SEGMENTS:
By Therapy Type
Gene Therapy Manufacturing
Cell Therapy Manufacturing
Non-Stem Cell Therapy
Stem Cell Therapy
By Scale Type
Commercial Scale Manufacturing
Pre-commercial/ R&D Scale Manufacturing
By Mode type
In-house Manufacturing
Contract Manufacturing
By Workflow type
Cell Processing
Fill & Finish Operations
Vector Production
Analytical And Quality Testing
Cell Banking
Process Development
Raw Material Testing
Others
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REGIONAL ANALYSIS
North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa make up the cell and gene therapy production services market. North America, Europe, and Asia Pacific accounted for the highest proportion of the cell and gene therapy manufacturing services market in 2020. The rising commonness of disease and developing exploration exertion in malignant growth and undifferentiated cells are liable for a significant portion of the North American market.
REGIONAL COVERAGE:
North America
USA
Canada
Mexico
Europe
Germany
UK
France
Italy
Spain
The Netherlands
Rest of Europe
Asia-Pacific
Japan
south Korea
China
India
Australia
Rest of Asia-Pacific
The Middle East & Africa
Israel
UAE
South Africa
Rest of Middle East & Africa
Latin America
Brazil
Argentina
Rest of Latin America
KEY PLAYERS:
There are some of major key players: Merck KGaA, Thermo Fisher Scientific, Catalent Inc., Lonza, Takara Bio Inc., Wuxi Advanced Therapies, F. Hoffmann-La Roche Ltd, Samsung Biologics, Bluebird Bio Inc., Novartis AG, Boehringer Ingelheim, Hitachi Chemical Co., Ltd., Miltenyi Biotec, Cellular Therapeutics.
Catalent Inc-Company Financial Analysis
| Report Attributes | Details |
|---|---|
| Market Size in 2022 | US$ 16.92 Billion |
| Market Size by 2030 | US$ 30.86 Billion |
| CAGR | CAGR of 7.8% From 2023 to 2030 |
| Base Year | 2022 |
| Forecast Period | 2023-2030 |
| Historical Data | 2020-2021 |
| Report Scope & Coverage | Market Size, Segments Analysis, Competitive Landscape, Regional Analysis, DROC & SWOT Analysis, Forecast Outlook |
| Key Segments | • By Type (Gene Therapy Manufacturing, Cell Therapy Manufacturing) • By Scale Type (Commercial Scale Manufacturing, Pre-commercial/ R&D Scale Manufacturing) • By Mode type (In-house Manufacturing, Contract Manufacturing) • By Workflow type (Cell Processing, Fill & Finish Operations, Vector Production, Analytical And Quality Testing, Cell Banking, Process Development, Raw Material Testing, Others) |
| Regional Analysis/Coverage | North America (USA, Canada, Mexico), Europe (Germany, UK, France, Italy, Spain, Netherlands, Rest of Europe), Asia-Pacific (Japan, South Korea, China, India, Australia, Rest of Asia-Pacific), The Middle East & Africa (Israel, UAE, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Rest of Latin America) |
| Company Profiles | Merck KGaA, Thermo Fisher Scientific, Catalent Inc., Lonza, Takara Bio Inc., Wuxi Advanced Therapies, F. Hoffmann-La Roche Ltd, Samsung Biologics, Bluebird Bio Inc., Novartis AG, Boehringer Ingelheim, Hitachi Chemical Co., Ltd., Miltenyi Biotec, Cellular Therapeutics. |
| DRIVERS | • Cancer and Chronic Diseases are becoming more common. • Increase in number of investments. • The quantity of clinical preliminaries is expanding. |
| RESTRAINTS | • Operational charges are high. |
Ans: - The Cell & Gene Therapy Manufacturing Services Market is expected to reach US$ 30.86 billion by 2030.
North America, Europe, and the Asia Pacific accounted for the highest proportion of the cell and gene therapy manufacturing services market.
Ans: - The Cell & Gene Therapy Manufacturing Services Market is to grow at a CAGR of 7.8% over the forecast period 2023-2030.
The challenges faced by Cell & Gene Therapy Manufacturing Services Market is there is a scarcity of reliable vectors for cell and gene therapy, and the Scarcity of therapy-specific tests.
key drivers of the Cell & Gene Therapy Manufacturing Services Market are an Increase in a number of investments, and the quantity of clinical preliminaries is expanding.
Table of Contents
1. Introduction
1.1 Market Definition
1.2 Scope
1.3 Research Assumptions
2. Research Methodology
3. Market Dynamics
3.1 Drivers
3.2 Restraints
3.3 Opportunities
3.4 Challenges
4. Impact Analysis
4.1 COVID-19 Impact Analysis
4.2 Impact of Ukraine- Russia war
4.3 Impact of ongoing Recession
4.3.1 Introduction
4.3.2 Impact on major economies
4.3.2.1 US
4.3.2.2 Canada
4.3.2.3 Germany
4.3.2.4 France
4.3.2.5 United Kingdom
4.3.2.6 China
4.3.2.7 Japan
4.3.2.8 South Korea
4.3.2.9 Rest of the World
5. Value Chain Analysis
6. Porter’s 5 forces Model
7. PEST Analysis
8. Cell & Gene Therapy Manufacturing Services Market Segmentation, by Type
8.1 Gene Therapy Manufacturing
8.2 Cell Therapy Manufacturing
8.2.1 Non-Stem Cell Therapy
8.2.2 Stem Cell Therapy
9. Cell & Gene Therapy Manufacturing Services Market Segmentation, by Scale Type
9.1 Commercial Scale Manufacturing
9.2 Pre-commercial/ R&D Scale Manufacturing
10. Cell & Gene Therapy Manufacturing Services Market Segmentation, By Mode type
10.1 In-house Manufacturing
10.2 Contract Manufacturing
11. Cell & Gene Therapy Manufacturing Services Market Segmentation, By Workflow type
11.1 Cell Processing
11.2 Fill & Finish Operations
11.3 Vector Production
11.4 Analytical and Quality Testing
11.5 Cell Banking
11.6 Process Development
11.7 Raw Material Testing
11.8 Others
12. Regional Analysis
12.1 Introduction
12.2 North America
12.2.1 USA
12.2.2 Canada
12.2.3 Mexico
12.3 Europe
12.3.1 Germany
12.3.2 UK
12.3.3 France
12.3.4 Italy
12.3.5 Spain
12.3.6 The Netherlands
12.3.7 Rest of Europe
12.4 Asia-Pacific
12.4.1 Japan
12.4.2 South Korea
12.4.3 China
12.4.4 India
12.4.5 Australia
12.4.6 Rest of Asia-Pacific
12.5 The Middle East & Africa
12.5.1 Israel
12.5.2 UAE
12.5.3 South Africa
12.5.4 Rest
12.6 Latin America
12.6.1 Brazil
12.6.2 Argentina
12.6.3 Rest of Latin America
13. Company Profiles
13.1 Merck KGaA
13.1.1 Financial
13.1.2 Products/ Services Offered
13.1.3 SWOT Analysis
13.1.4 The SNS view
13.2 Thermo Fisher Scientific
13.3 Catalent Inc.
13.4 Lonza
13.5 Takara Bio Inc.
13.6 Wuxi Advanced Therapies
13.7 F. Hoffmann-La Roche Ltd
13.8 Samsung Biologics
13.9 Bluebird Bio Inc.
13.10 Novartis AG
13.11 Boehringer Ingelheim
13.12 Hitachi Chemical Co., Ltd.
13.12 Miltenyi Biotec
13.13 Cellular Therapeutics
14. Competitive Landscape
14.1 Competitive Benchmarking
14.2 Market Share Analysis
14.3 Recent Developments
15. Conclusion
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