Market Size of Cell and Gene Therapy Manufacturing Services Industry
Study Period | 2019 - 2029 |
Base Year For Estimation | 2023 |
CAGR | 12.50 % |
Fastest Growing Market | Asia-Pacific |
Largest Market | North America |
Market Concentration | Medium |
Major Players*Disclaimer: Major Players sorted in no particular order |
Cell and Gene Therapy Manufacturing Services Market Analysis
The cell and gene therapy manufacturing services market is projected to register a CAGR of 12.5% during the forecast period.
During the COVID-19 pandemic, the cell and gene therapy manufacturing services market was significantly affected. There were two primary reasons for that, the limited running capacity protocols introduced by the governments and the disruption of supply chain and logistics processes. However, new cell and gene therapy products were also launched during the pandemic for the treatment of COVID-19, which also impacted the market growth. For instance, in April 2022, the United States Food and Drug Administration (FDA) granted clearance to BioCardia's Investigational New Drug (IND) application to commence a Phase I/II clinical trial of COVID-19 stem cell therapy, BCDA-04, in adults recovering from COVID-19-linked acute respiratory distress syndrome (ARDS). These new IND applications in the treatment of COVID-19 helped to increase contract manufacturing services among companies. However, as the pandemic has subsided, the market is expected to have pre-pandemic growth levels during the study's forecast period.
Factors driving the market growth include the high prevalence of cancer and other target diseases and increasing R&D investments in pharmaceutical companies. For instance, according to an article published by the Chinese Medical Journal in February 2022, it was estimated that 2022 there were approximately 4,820,000 and 2,370,000 new cancer cases in China and the United States. The most common cancers were lung cancer in China and breast cancer in the United States. As the number of cancer cases increases, the reliance on gene therapy will also increase, thus, boosting the market's growth.
Furthermore, according to the data published by the National Cancer Center of Japan in June 2022, an estimated 158,200 new cancer cases were expected in Japan in the current year, out of which 89,500 were estimated to be in males and 68,700 in females. Such an increasing incidence of colorectal cancer is expected to drive the demand for gene and cell therapy products, fueling segment growth over the forecast period.
Moreover, as per the report published by the Journal of Orthopedic Surgery and Research in October 2021, the pooled prevalence of osteoporosis worldwide was reported to be 18.3%. Stem cell therapy for osteoporosis could potentially reduce the susceptibility to fractures. Thus, with the rising burden of orthopedic disorders, the demand for cell and gene therapy manufacturing services is also expected to grow.
Furthermore, the rising development of cell therapy facilities is also expected to boost the market growth. For instance, in June 2022, OrganaBio, LLC initiated Good Manufacturing Practice (GMP) manufacturing operations at its new cell therapy manufacturing facility in the United States. The new facility offered contract and development manufacturing for custom solutions for therapeutics developers.
Thus the above-mentioned factors such as the rising prevalence of various diseases such as cancer and osteoporosis, among others are expected to drive the growth of the studied market during the forecast period. However, high operational costs associated with the cell and gene therapy manufacturing are expected to restrain the market growth.
Cell and Gene Therapy Manufacturing Services Industry Segmentation
As per the scope of the report, cell therapy aims to treat disorders and diseases by restoring or changing certain groups of cells or by providing cells to carry therapy through the body. With cell therapy, cells are formed or modified outside the body before being introduced into the patient. The cells may derive from the patient (autologous cells) or a donor (allogeneic cells). Gene therapy aims to treat disorders by replacing or introducing genes into cells- either inside the body (in vivo) or outside of the body (ex vivo). The cell and gene therapy manufacturing services market is segmented by type (cell therapy (allogeneic, autologous, and viral vector) and gene therapy (non-viral vectors and viral vectors)), application (clinical manufacturing and commercial manufacturing), indication (oncology diseases, cardiovascular diseases, orthopaedic diseases, ophthalmology diseases, central nervous system disorders, infectious diseases, and other indications), end user (pharmaceutical and biotechnology companies, academic and research institutes, and other end users), and geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (in USD) for the above segments.
By Service Type | |||||
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By Application | |
Clinical Manufacturing | |
Commercial Manufacturing |
By Indication | |
Oncology | |
Cardiovascular Diseases | |
Orthopedic Diseases | |
Infectious Diseases | |
Other Indications |
By End User | |
Pharmaceutical and Biotechnology Companies | |
Academic and Research Institutes | |
Other End Users |
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Cell and Gene Therapy Manufacturing Services Market Size Summary
The cell and gene therapy manufacturing services market is poised for significant growth, driven by the increasing prevalence of diseases such as cancer and osteoporosis, alongside rising investments in research and development by pharmaceutical companies. The market experienced disruptions during the COVID-19 pandemic due to limited operational capacities and supply chain challenges. However, the introduction of new therapies, such as stem cell treatments for COVID-19, spurred contract manufacturing services. As the pandemic's impact wanes, the market is expected to return to pre-pandemic growth levels. The demand for gene therapy is anticipated to rise with the growing incidence of cancer globally, further fueled by advancements in cell therapy facilities and the development of allogeneic therapies, which offer benefits in treating various conditions.
North America is expected to hold a significant share of the global market, driven by a rising geriatric population and an increasing number of infectious diseases. The region's favorable healthcare infrastructure and active research and development activities contribute to market expansion. Major players like Thermo Fisher Scientific Inc., Merck KGaA, and Charles River Laboratories dominate the market, with ongoing collaborations and facility expansions enhancing their capabilities. These developments, coupled with regulatory approvals for new therapies, are set to boost the demand for cell and gene therapy manufacturing services, supporting the market's growth trajectory over the forecast period.
Cell and Gene Therapy Manufacturing Services Market Size - Table of Contents
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1. MARKET DYNAMICS
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1.1 Market Overview
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1.2 Market Drivers
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1.2.1 High Prevalence of Cancer and Other Target Diseases
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1.2.2 Increasing Grants and R&D Investments in the Pharmaceutical Sector
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1.2.3 Increasing Organic and Inorganic Developments Between Pharmaceutical Companies and CDMOs
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1.3 Market Restraints
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1.3.1 High Operational Costs Associated with the Cell and Gene Therapy Manufacturing
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1.4 Porter's Five Forces Analysis
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1.4.1 Bargaining Power of Suppliers
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1.4.2 Bargaining Power of Buyers/Consumers
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1.4.3 Threat of New Entrants
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1.4.4 Threat of Substitute Products
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1.4.5 Intensity of Competitive Rivalry
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2. MARKET SEGMENTATION (Market Size by Value - USD)
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2.1 By Service Type
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2.1.1 Cell Therapy
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2.1.1.1 Allogeneic
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2.1.1.2 Autologous
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2.1.1.3 Viral Vector
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2.1.2 Gene Therapy
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2.1.2.1 Non-viral Vectors
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2.1.2.2 Viral Vectors
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2.2 By Application
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2.2.1 Clinical Manufacturing
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2.2.2 Commercial Manufacturing
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2.3 By Indication
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2.3.1 Oncology
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2.3.2 Cardiovascular Diseases
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2.3.3 Orthopedic Diseases
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2.3.4 Infectious Diseases
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2.3.5 Other Indications
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2.4 By End User
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2.4.1 Pharmaceutical and Biotechnology Companies
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2.4.2 Academic and Research Institutes
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2.4.3 Other End Users
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2.5 Geography
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2.5.1 North America
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2.5.1.1 United States
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2.5.1.2 Canada
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2.5.1.3 Mexico
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2.5.2 Europe
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2.5.2.1 Germany
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2.5.2.2 United Kingdom
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2.5.2.3 France
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2.5.2.4 Italy
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2.5.2.5 Spain
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2.5.2.6 Rest of Europe
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2.5.3 Asia-Pacific
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2.5.3.1 China
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2.5.3.2 Japan
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2.5.3.3 India
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2.5.3.4 Australia
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2.5.3.5 South Korea
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2.5.3.6 Rest of Asia-Pacific
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2.5.4 Middle East and Africa
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2.5.4.1 GCC
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2.5.4.2 South Africa
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2.5.4.3 Rest of Middle East and Africa
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2.5.5 South America
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2.5.5.1 Brazil
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2.5.5.2 Argentina
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2.5.5.3 Rest of South America
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Cell and Gene Therapy Manufacturing Services Market Size FAQs
What is the current Global Cell and Gene Therapy Manufacturing Services Market size?
The Global Cell and Gene Therapy Manufacturing Services Market is projected to register a CAGR of 12.5% during the forecast period (2024-2029)
Who are the key players in Global Cell and Gene Therapy Manufacturing Services Market?
Charles River Laboratories, Merck KGaA, Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd and Fujifilm Holdings Corporation are the major companies operating in the Global Cell and Gene Therapy Manufacturing Services Market.