The Cell & Gene Therapy Manufacturing Services Market Size was valued at USD 6.1 billion in 2023 and is expected to reach USD 38.9 billion by 2031, and grow at a CAGR of 22.3% over the forecast period 2024-2031.
An increasing incidence of cancer and other diseases, increased R&D spending by pharmaceutical companies as well as partnerships and agreements with clinical development organisations contributing to market growth. In contrast, the cell and gene therapy manufacturing services market are projected to be adversely affected over the forecast period due to significant operating costs associated with production of cells and gene therapies. Moreover, the market growth is supported by increased investments in cell and gene therapy, the adoption of automation and digitalisation to meet growing demand for production services from cellular and gene therapy companies as well as capacity increases. The demand for cell and gene therapy is increasing, which has led to an increased production capacity. Also, the growing demand for these medicines, pharmaceutical companies are investing in new production facilities, expanding their current establishments and working together with contract manufacturers organisations (CMO).
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DRIVERS
There is an increase in the number of clinical preliminaries
The regulatory environment that is favourable
Increasing investment in the cell and gene therapy sector, both domestically and from governments
Private and public investment in cell and gene therapy companies is on the rise, despite a low number of approvals. Over the past decade, private equity and capital investments in life science have increased significantly. Similarly, there is also a significant increase in the investments made by cell and gene therapy companies.
RESTRAINTS
The production of cell and gene therapy is subject to considerable operational costs.
Cell therapy is costly due to the complexity of both cellular products and treatment logistics, with comparatively low production volumes and a large number of mechanical techniques used in existing procedures. The manufacturing costs for cell therapy are expected to be more than USD 100 000 per patient, whereas the cost of gene therapy can range from $500 000 to $1 million if R&D expenses are excluded. Therefore, for both manufacturers and healthcare providers, the affordability of cell and gene therapy products will be an important issue and a challenge.
OPPORTUNITIES
Approvals for medicinal products and a sound pipeline.
Expanding the capacity of CDMOs to produce cells and gene therapy
Due to a surge in demand for cell and gene therapies, the production of cells and genes has been rapidly developing. Expanding the use of these therapies, such as for more prevalent diseases, requires achieving greater yields and reducing product costs (COGs). In recent years, major investments have been made in this area by large contract development and manufacturing organisations with a number of significant acquisitions and geographical enlargements through the establishment of production capacities. These expansions will support the production of cell and gene therapies and provide growth opportunities for CDMOs providing these services.
CHALLENGES
For cell and gene therapy, there is a shortage of reliable vectors
Scarcity of therapy-specific tests
Before the onset of hostilities with Russia, approximately 13,000 new cases of cancer were diagnosed in Ukraine. The conflict has led to a significant relocation of patients to western regions and foreign nations. The repercussions of conflicts on cancer care underscore the fragmentation caused by the limitations of humanitarian aid to address all requirements and the overwhelming burden placed on countries receiving refugees. In spite of the recent pandemic, which has made it possible to make follow ups more flexible, the outbreak of the war did not cause regulatory agencies to be unprepared. In particular, in order to keep the quality of information high, patients have been relocated as far as possible across Europe.
The cell and gene therapy manufacturing services sector is affected by a slowdown in the global economy. Investments and spending in different sectors, including health care, are correlated with the slowdown in economic activity. This reduction in investment can have a direct effect on the funding available for R&D of cell and gene therapy, which could affect demand for manufacturing services. In addition, healthcare budgets may be under pressure during economic downturns, leading to possible delays or reductions in the adoption of innovative treatments such as cell and gene therapy. As companies can delay or reduce their production plans, this could lead to a reduction in demand for manufacturing services. Moreover, during times of economic downturns, healthcare budgets may be under pressure and there could be delays or reductions in the uptake of innovative treatments such as cell and gene therapies. This could result in a reduction of demand for manufacturing services as companies may be able to postpone or scale back their production plans.
By Type
The segment of cell therapy accounted for the largest market share in 2023. Cell therapy segment growth is driven by the potential use of cell therapies for cancer, autoimmunity, urological problems and infectious diseases and disorders. Furthermore, some additional factors driving the segment growth are the availability of funding for new cell lines, the increasing organic and inorganic growth strategies of companies to increase their production capacity for cell therapy.
By Indication
Oncology Diseases
Cardiovascular Diseases
Orthopedic Diseases
Ophthalmology Diseases
Central Nervous System Disorders
Infectious Diseases
Other Indications
By Application
Clinical Manufacturing
Commercial Manufacturing
In 2023 there was a higher revenue share of over 58.2% for clinical manufacturing categories. Five new cell and gene therapies were approved by the FDA between 2022 and there are several clinical trials under way or to be launched over the following years. In addition to around 30 AAV therapies, over 20 cell and gene therapy are planned to be launched in 2024. In addition, the demand for Clinical Manufacturing Services is driven by companies that are seeking new therapies to treat diseases such as cancer, heart disease, autoimmune disorders and infectious diseases.
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By End User
Pharmaceutical & Biotechnology Companies
Academic & Research Institutes
Other End Users
The pharmaceutical and biotechnology sector is projected to experience approximately a 47% growth rate by 2031. These companies play significant roles in the cell and gene therapy manufacturing services market, functioning as both therapy developers and clients for manufacturing services. Some factors that drive the segment growth includes, potential for new revenue streams, and access to advance manufacturing technologies.
In 2023, North America will continue to lead the market, with a revenue share of around 50%. This is due to an increasing number of new product launches, rising incidences of cancer cases, growing focus on the treatment of rare diseases, increased numbers of clinical trials and presence of important industry players in this region. Moreover, as a result of technical progress across the region, demand for gene therapy is growing. New prospects for treatments and therapies to treat Rare and Genetic Diseases are presented by the development of new platforms that precisely target small molecules, stem cells, gene modification or repair technologies. The discovery of RNA's potential, which had been underestimated in the past, was one of the biggest innovations.
A significant part of the market was held by Europe. There are at least two chronic diseases in the region, affecting around one third of the total population aged 15 years and over. In Europe, the occurrence of more than one chronic illness has increased. This trend is attributed to unhealthy diets, increasing smoking habits, and surging alcohol consumption. In view of the increased prevalence of obesity in regional countries, the EU government will amend legislation and focus on providing healthy food through the implementation of Food Quality Directives. Moreover, smoking is another big concern claiming one life every six seconds in Europe, as tobacco use is high in the region. For instance, more than 17.0% of adults and more than 14.0% of the young generation (15–26-year age group) are using tobacco in Europe. Similarly, the region has recorded an increase in alcohol consumption, which is a high-risk factor for deaths in adults and young people who are drinking heavily. Consequently, demand for therapy manufacturing services in the region is driven by this factor.
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 the Middle East
Africa
Nigeria
South Africa
Rest of Africa
Latin America
Brazil
Argentina
Colombia
Rest of Latin America
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.
In January 2022, Allogen Therapeutics Inc., a clinical-stage biotechnology company leading the way in allogeneic CAR T product development for cancer treatment, and Antion Biosciences Inc. have entered into an exclusive collaboration and global licensing agreement. This partnership aims to utilize Antion's miRNA technology (miCAR) to advance multiplex gene silencing, enhancing the development of next-generation allogeneic CAR T products.
June 2022, OrganaBio, LLC initiated Good Manufacturing Practice (GMP) manufacturing operations at its new cell therapy manufacturing facility in the United States. Contract manufacturing and development of custom solutions for therapeutic developers was offered in the new facility.
| Report Attributes | Details |
|---|---|
| Market Size in 2023 | US$ 16.92 Billion |
| Market Size by 2031 | US$ 30.86 Billion |
| CAGR | CAGR of 7.8% From 2024 to 2031 |
| Base Year | 2023 |
| Forecast Period | 2024-2031 |
| Historical Data | 2020-2022 |
| Report Scope & Coverage | Market Size, Segments Analysis, Competitive Landscape, Regional Analysis, DROC & SWOT Analysis, Forecast Outlook |
| Key Segments | • By Type (Cell Therapy, Gene Therapy) • By Indication (Oncology Diseases, Cardiovascular Diseases, Orthopedic Diseases, Ophthalmology Diseases, Central Nervous System Disorders, Infectious Diseases, Other Indications) • By Application (Clinical Manufacturing, Commercial Manufacturing) • By End User (Pharmaceutical & Biotechnology Companies, Academic & Research Institutes, Other End Users) |
| 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 was valued at USD 6.1 billion in 2023.
North America, Europe, and the Asia Pacific accounted for the highest proportion of the cell and gene therapy manufacturing services market.
Ans: The expected CAGR of the global cell & gene therapy manufacturing services market during the forecast period is 22.3%.
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. Industry Flowchart
3. Research Methodology
4. Market Dynamics
4.1 Drivers
4.2 Restraints
4.3 Opportunities
4.4 Challenges
5. Impact Analysis
5.1 Impact of Russia-Ukraine Crisis
5.2 Impact of Economic Slowdown on Major Countries
5.2.1 Introduction
5.2.2 United States
5.2.3 Canada
5.2.4 Germany
5.2.5 France
5.2.6 UK
5.2.7 China
5.2.8 Japan
5.2.9 South Korea
5.2.10 India
6. Value Chain Analysis
7. Porter’s 5 Forces Model
8. Pest Analysis
9. Ambulatory Surgical Centers Market Segmentation, by Type
9.1 Introduction
9.2 Trend Analysis
9.3 Cell Therapy
9.3.1 Allogeneic
9.3.1.1 Mesenchymal Stem Cells
9.3.1.2 T-cells
9.3.1.3 Induced Pluripotent Stem Cells
9.3.1.4 Natural Killer Cells
9.3.1.5 Hematopoietic Stem Cells
9.3.1.6 Other Allogeneic Cells
9.3.2 Autologous
9.3.2.1 T-cells
9.3.2.2 Hematopoietic Stem Cells
9.3.2.3 Mesenchymal Stem Cells
9.3.2.4 Natural Killer Cells
9.3.2.5 Other Autologous Cells
9.3.3 Viral Vector
9.3.3.1 Retroviral Vectors
9.3.3.2 Adeno-associated Virus Vectors
9.3.3.3 Other Viral Vectors
9.4 Gene Therapy
9.4.1 Viral Vector
9.4.1.1 Retroviral Vectors
9.4.1.2 Adeno-associated Virus Vectors
9.4.1.3 Other Viral Vectors
9.4.2 Non-viral Vector
9.4.2.1 Oligonucleotides
9.4.2.2 Other Non-viral Vectors
10. Ambulatory Surgical Centers Market Segmentation, by Indication
10.1 Introduction
10.2 Trend Analysis
10.3 Oncology Diseases
10.4 Cardiovascular Diseases
10.5 Orthopedic Diseases
10.6 Ophthalmology Diseases
10.7 Central Nervous System Disorders
10.8 Infectious Diseases
10.9 Other Indications
11. Ambulatory Surgical Centers Market Segmentation, by Application
11.1 Introduction
11.2 Trend Analysis
11.3 Clinical Manufacturing
11.4 Commercial Manufacturing
12. Ambulatory Surgical Centers Market Segmentation, by End User
12.1 Introduction
12.2 Trend Analysis
12.3 Pharmaceutical & Biotechnology Companies
12.4 Academic & Research Institutes
12.5 Other End Users
13. Regional Analysis
13.1 Introduction
13.2 North America
13.2.1 USA
13.2.2 Canada
13.2.3 Mexico
13.3 Europe
13.3.1 Eastern Europe
13.3.1.1 Poland
13.3.1.2 Romania
13.3.1.3 Hungary
13.3.1.4 Turkey
13.3.1.5 Rest of Eastern Europe
13.3.2 Western Europe
13.3.2.1 Germany
13.3.2.2 France
13.3.2.3 UK
13.3.2.4 Italy
13.3.2.5 Spain
13.3.2.6 Netherlands
13.3.2.7 Switzerland
13.3.2.8 Austria
13.3.2.9 Rest of Western Europe
13.4 Asia-Pacific
13.4.1 China
13.4.2 India
13.4.3 Japan
13.4.4 South Korea
13.4.5 Vietnam
13.4.6 Singapore
13.4.7 Australia
13.4.8 Rest of Asia Pacific
13.5 The Middle East & Africa
13.5.1 Middle East
13.5.1.1 UAE
13.5.1.2 Egypt
13.5.1.3 Saudi Arabia
13.5.1.4 Qatar
13.5.1.5 Rest of the Middle East
13.5.2 Africa
13.5.2.1 Nigeria
13.5.2.2 South Africa
13.5.2.3 Rest of Africa
13.6 Latin America
13.6.1 Brazil
12.6.2 Argentina
13.6.3 Colombia
13.6.4 Rest of Latin America
14. Company Profiles
14.1 Merck KGaA
14.1.1 Company Overview
14.1.2 Financial
14.1.3 Products/ Services Offered
14.1.4 SWOT Analysis
14.1.5 The SNS View
14.2 Thermo Fisher Scientific
14.2.1 Company Overview
14.2.2 Financial
14.2.3 Products/ Services Offered
14.2.4 SWOT Analysis
14.2.5 The SNS View
14.3 Catalent Inc.
14.3.1 Company Overview
14.3.2 Financial
14.3.3 Products/ Services Offered
14.3.4 SWOT Analysis
14.3.5 The SNS View
14.4 Lonza
14.4.1 Company Overview
14.4.2 Financial
14.4.3 Products/ Services Offered
14.4.4 SWOT Analysis
14.4.5 The SNS View
14.5 Takara Bio Inc.
14.5.1 Company Overview
14.5.2 Financial
14.5.3 Products/ Services Offered
14.5.4 SWOT Analysis
14.5.5 The SNS View
14.6 Wuxi Advanced Therapies
14.6.1 Company Overview
14.6.2 Financial
14.6.3 Products/ Services Offered
14.6.4 SWOT Analysis
14.6.5 The SNS View
14.7 F. Hoffmann-La Roche Ltd
14.7.1 Company Overview
14.7.2 Financial
14.7.3 Products/ Services Offered
14.7.4 SWOT Analysis
14.7.5 The SNS View
14.8 Samsung Biologics
14.8.1 Company Overview
14.8.2 Financial
14.8.3 Products/ Services Offered
14.8.4 SWOT Analysis
14.8.5 The SNS View
14.9 Bluebird Bio Inc.
14.9.1 Company Overview
14.9.2 Financial
14.9.3 Products/ Services Offered
14.9.4 SWOT Analysis
14.9.5 The SNS View
14.10 Novartis AG
14.10.1 Company Overview
14.10.2 Financial
14.10.3 Products/ Services Offered
14.10.4 SWOT Analysis
14.10.5 The SNS View
14.11 Boehringer Ingelheim
14.11.1 Company Overview
14.11.2 Financial
14.11.3 Products/ Services Offered
14.11.4 SWOT Analysis
14.11.5 The SNS View
14.12 Hitachi Chemical Co., Ltd.
14.12.1 Company Overview
14.12.2 Financial
14.12.3 Products/ Services Offered
14.12.4 SWOT Analysis
14.12.5 The SNS View
14.13 Miltenyi Biotec
14.13.1 Company Overview
14.13.2 Financial
14.13.3 Products/ Services Offered
14.13.4 SWOT Analysis
14.13.5 The SNS View
15. Competitive Landscape
15.1 Competitive Benchmarking
15.2 Market Share Analysis
15.3 Recent Developments
15.3.1 Industry News
15.3.2 Company News
15.3.3 Mergers & Acquisitions
16. Use Case and Best Practices
17. Conclusion
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