Global Cell Therapy Market was valued at USD 5.81 billion in 2019 and is estimated to reach USD 6.13 billion by the year 2020.
It is expected to grow at the CAGR of 5.4% within the time horizon of 2020-2025 because of the increasing incidences of chronic diseases, growing geriatric population and rising research activities on cell-based therapies.
The market value will reach USD 7.97 billion by the year 2025.
- Definition / Scope
- Market Overview
- Market Risks
- Top Market Opportunities
- Market Trends
- Industry Challenges
- Technology Trends
- Pricing Trends
- Regulatory Trends
- Market Size and Forecast
- Market Outlook
- Technology Roadmap
- Distribution Chain Analysis
- Competitive Factors
- Key Market Players
- Strategic Conclusion
- References
- Appendix
Definition / Scope
Cell therapy is concerned with the replacement of the dysfunctional cell with healthy functioning cells. Replacement can be done from the patient itself (autologous) and the compatible donor (allologous).
The cell can be either stem cell or non-stem cell which are used for the advanced management of health disorders and research purposes.
Here, the stem cell is mostly used as they are capable to differentiate into the specific cells in accordance with the repair of the damaged cells. Mostly bone marrow cells, mature, immature, and solid tissue cells, adult stem cells, and embryonic stem cells are used for cell therapy.
This cell therapy is applied for the treatment of complex diseases such as inflammatory, neurogenerative, lateral sclerosis, cancer, diabetes, etc.
The cell therapy market is concerned with the screening, grafting, cloning, and administration of the stem and non-stem cells for the management of complex health disorders. Based on application and therapy type, the cell therapy market is categorized as follows:
Market Overview
The global cell therapy market is valued at USD 5.81 billion in 2019 and is expected to reach USD 6.13 billion by the end of the year 2020.
Its market value is expected to grow at the CAGR of 5.4% within the forecasted period of 2020-2025. Its market value will reach USD 7.97 billion by the year 2025.
Globally, more than 150 companies engaged in cell therapy are investing more than USD 1 billion in this industry. Based on geography, the North America segment is leading the market with a market share of almost 36.11% of the total global cell therapy market.
The market value of the North American cell therapy market is valued at USD 2.1 billion in 2019.
Based on therapy type, Allogenic therapies are leading the cell therapy market that accounts for the market share of almost 58.33% of the total global cell therapy market.
The market value of this segment is valued at USD 3.39 billion in 2019. Increasing incidences of the complex diseases, growing geriatric population, and rising funds on research activities related to cell therapies are the major factors driving the growth and development of the global cell therapy market.
However, stringent government regulations about the use of cell therapy and complications associated with the use of allogenic cell therapies might restrain the growth and development of this market.
The key market players engaged in this market are Vericel Corporation, JCR Pharmaceuticals, Medipost, Osiris Therapeutics, Allocure, Cell Medica, Forticell Bioscience, Mesoblast, etc.
Market Risks
- Complicated and side effects associated with allogenic cell therapy
The injection of the allogenic cell to the patients from the donor is associated with certain health complications. The condition of the complication is dependent on the degree of the matching between donor and receipt and age of the receipt.
The most common side effects are bone marrow suppression, infections, mucositis, interstitial pneumonia syndrome, graft versus host disease, graft failure, etc. Almost 30-40% of the patients develop the GVHD if the donor and receipt are related and 60%- 80% if the donor and receipt aren’t related.
The chances of the occurrence of these complications might create a risk for the growth and development of the cell therapy market.
Top Market Opportunities
- Co-development agreements between entities
The market players engaged in the cell therapy market are focusing on the expansion of the co-development agreements between the entities. For example, the MaxCyte has worked in partnership with more than 40 cellular programs with immune-oncology, regenerative medicine, and gene editing.
This increasing number of collaborations and partnerships between the organizations has facilitated the commercialization of the cell therapy products, which in turn will create a significant opportunity for the growth and development of the cell therapy products.
- Growing aging population
Globally, the proportion of the older population is in increasing trend. Almost 8.5% of the total global population is more than 65 years of age. It has been expected that this proportion is expected to increase to 17% by the end of the year 2050.
The old population is estimated to increase from 617 million to 1.6 billion by the year 2050. The process of aging is associated with the degeneration of the body tissues and vital organs.
Along with this, the incidence of chronic age-related diseases such as chronic obstructive pulmonary disease, diabetes, cancer is also increasing. This growing proportion of the aged population will create a significant opportunity for the growth of the global cell therapy market.
Market Trends
- Increase in incidences of complex chronic diseases
Cell therapy techniques have been established as a potential cure for complex chronic diseases such as cancer, cardiac diseases, neurogenerative disease, inflammatory disease, multiple sclerosis, etc. For instance, T-cells are administered for the treatment of cancer during the immunotherapy treatment.
Almost 2% to 3% of the annual health budget of the high-income countries is spent on the treatment of chronic diseases. The incidence and prevalence of chronic diseases are in increasing trend.
According to the World Health Organization, the prevalence of chronic diseases is estimated to rise by almost 57% by the end of the year 2020.
This rising burden of chronic diseases is driving the growth and development of the global cell therapy market.
- Rising fund in research activities for cell therapy
Globally, more than USD 1 billion is funded for the clinical trials of the cell-based therapies. Along with this, the biotechnological companies are increasing their funding activities on research and therapeutics activities.
For instance, Bayer has funded almost USD 215 million for the development of the century therapeutics. Along with this, the funding of the versant ventures and Fujifilm cellular dynamics has also increased the funding amount by almost USD 35 million and reached USD 250 billion in 2019.
This increasing funding resources are creating a favorable environment for the development of the research activities on cell therapy. It is favoring the growth and development of new technological changes and innovations in the cell therapy market.
- Stringent government regulations on cell therapies and its research
The research activities related to the cell-based therapies go through rigorous safety testing procedures ranging from dose trials to clinical trials. The governmental bodies, international organizations, and the European Union has developed the regulations related to cell therapies and clinical trial applications.
For instance, the Australian regulatory authority has developed the Therapeutic Goods Administration in 2018, which is against the marketing and advertisement of the autologous human cell and tissue therapies to consumers.
Along with this, the European Union has developed the Regulations on Advanced Therapy Medicinal Products, the Canadian government has developed Safety of Human Cells, Tissues, and Organs for Transplantation Regulations, and the USA has developed the Public Health Services Act, the Twenty-first Century Cures Act for the regulation of the cell therapies product and the research activities related to it.
These strict regulations on the clinical trials of cell therapies, approval of the cell therapies product, advertisement, and marketing of the products might restrain the growth and development of the global cell therapy market.
Industry Challenges
- Highly fragmented market
Globally, more than 160 companies are engaged in the manufacture of cell therapy products.
Among these, more than 55 large and mid-sized organizations, more than 100 companies are focused on t-cell and stem cell therapies, more than 70 companies have commercial-scale capacity and more than 20 companies offer automated solutions for cell therapy developers.
This highly fragmented nature of the cell therapy market creates challenges for the market players to establish their market value globally.
Technology Trends
Advancement in technological methods and innovations are creating the environment for the growth and development of the cell therapy market. Some of the key technological changes in this global cell therapy market are discussed as follows:
Acoustic Cell Processing (ACP) platform: This technology has been developed by cognate bio services and flodesign Sonics to bring advancement in accessible lifesaving therapeutics. This technology facilitates the manipulation of the cell through the use of low power ultrasonic standing waves.
Cryopreservation of cellular materials: This technique is used for the preservation of organelles, cells, tissues, and other biological products through the cooling techniques at very low temperatures.
CAR-T cell therapy: In these techniques, the patient’s T cells are taken from the patient’s blood and changed in the laboratory to attack cancer cells.
Epicel for burn wound replacement: This technique provides the permanent skin replacement for the individuals affected with deep dermal and full-thickness burns. This technique is approved by the Food and Drug Administration in the United States.
Pricing Trends
The price of cellular therapy products depends upon the type of therapy, cell type, the adopted technology, and type of application.
The price of the wound care based cell therapy ranges from USD 1,500 to USD 2,500 while the price of the cartilage product ranges from USD 10,000 to USD 35,000.
The price of the intravenously administered cell therapy ranges from USD 90,000 to USD 200,000 while the price of the cell-based gene therapies ranges from USD 500,000 to USD 1,000,000.
On average, the cost of cell therapy products such as Kymriah, Provenge, and yescarta is more than USD 100,000. The price of cell therapy-based products varies based on geography.
The price of the adult stem cell therapy is about USD 5,500 in India, USD 8,000 in the UK, USD 10,000 in the USA, and USD 6,500 in Thailand. The price of the cord blood stem cell therapy is about USD 12,000 in the USA, USD 9,600 in the UK, USD 9,000 in Singapore, and USD 6,500 in India.
Regulatory Trends
The regulations for the cell-based therapy market are set out by the different countries as per their national requirements. Some of the key regulation related to the cell-based therapy market of different countries are discussed as follows:
Safety of Human Cells, Tissues, and Organ for Transplantation Regulations: This regulation has been developed by the government of Canada, which sets out the regulations for transplantation. According to this, the cell, tissue, or organs should perform the same basic function even after the transplantation process.
Guidelines for stem cell research and clinical translation: It is developed by the International Society for Stem Cell Research in 2016.
According to this guideline, the researches based on the clinical applications of the stem cell-based interventions must go through the prospective review, approval, and ongoing monitoring by independent human subjects review committees.
Clinical trial regulations: These frameworks are developed by the European Union for the clinician-researchers and sponsors. According to this, all the members of the EU should use the single online portal in reporting of the data of the clinical trial.
Twenty-first Century Cures Act: It is developed by the government of the United States of America to introduce the new pathway program for the development and review of regenerative medicine advanced therapies. It states that cell therapies must have the potential to address medical needs related to life-threatening diseases.
Therapeutic Goods Administration: It is developed by the Australian Regulatory Authority in 2018 to ban the marketing and advertisement of the autologous human cell and tissue therapies.
Market Size and Forecast
The total market size of the global cell therapy market is valued at USD 5.81 billion in 2019 and is expected to reach USD 6.13 billion by the end of the year 2020.
Its market size is expected to grow at the CAGR of 5.4% within the forecasted period of 2020-2025 because of the increasing incidences of complex diseases, increasing funding on research activities, and growing geriatric populations. Its market value will reach USD 7.97 billion by the end of the year 2025.
More than 150 companies engaged in cell therapy are investing more than USD 1 billion in this industry.
Based on Geography
- North America is leading the market with a market share of almost 36.11% of the total global cell therapy market. The market value of the North American cell therapy market is valued at USD 2.1 billion in 2019.
- Europe accounts for almost a market share of 27.78% of the total global cell therapy market. The market size of this region is valued at USD 1.61 billion in 2019.
- The Asia-Pacific region holds about 18.06% of the total global cell therapy market. Its market size is valued at USD 1.05 billion in 2019.
- The South America region accounts for almost 11.11% of the total global cell therapy market with a market value of USD 0.64 billion in 2019.
- The Middle East and African region account for the remaining 6.94% of the total market value of the global cell therapy market. The market size of this segment is valued at USD 0.4 billion in 2019.
Based on therapy type
- The allogenic therapies segment is leading the cell therapy market globally. It accounts for the market share of almost 58.33% of the total global cell therapy market. The market value of this segment is valued at USD 3.39 billion in 2019.
- The autogenic therapy segment accounts for almost 41.67% market share of the total market value of the global cell therapy market. The market size of this segment is valued at USD 2.42 billion in 2019.
Market Outlook
The market size of the global cell therapy market is expected to grow at the CAGR of 5.4% within the forecasted period of 2020-2025 because of the increasing incidences of complex diseases, increasing funding on research activities, and growing geriatric populations.
Its market value will reach USD 7.97 billion by the end of the year 2025.
Technology Roadmap
The technological changes such as Acoustic Cell Processing (ACP) platform, cryopreservation of cellular materials, engineered hematopoietic and progenitor cell platform are creating a favorable environment for the growth and development of the cell therapy market.
Along with this, the introduction of innovative therapies such as CAR-T cell therapy, Holoclar treatment for curing blindness, Caristem for cartilage cell regeneration, Cord blood cell therapy, and Epicel for burn wound replacement are also driving the growth and development of the cell therapy market globally.
Distribution Chain Analysis
The key steps involved in the operation of this global cell therapy market are genetic screening of cells, modification of cells by genetic sequencing, harvesting, and reinfusion into the patient. At first, the cell of the receipt is examined and the cells are genetically screened.
After this, the cell of the donor is modified by the genetic sequencing and harvested for the production of the cells. Then the harvested cell are reinfused into the patient in the health care institutions.
Competitive Factors
The key market players engaged in this global cell therapy market are focused on the expansion of the cell-therapies based product portfolio. Along with this, they are focused on the establishment of out-licensing and co-development agreements with different entities.
They are focusing to increase the investment in the research activities to address the unmet demand and issues from pharmaceutics, biotechnology, and disease management.
Key Market Players
Short profile of the key market players engaged in the global cell therapy market are discussed as follows:
| Company | Description | Region |
| Vericel Corporation | It is engaged in the manufacture of advanced cell therapy products for sports medicine and severe burn care. | United States |
| JCR Pharmaceuticals | It is engaged in the research, production, and sale of the pharmaceutical raw materials and business | Japan |
| Medipost | It is engaged in the manufacture of stem cell therapies globally with more than 87 registered patents in Korea and other countries. Its products are Caristem, Pneumostem, neurostem, etc. | Korea |
| Osiris Therapeutics | It develops, manufactures, and commercializes the regenerative medicine products such as Stravix, Cartiform, Grafix product line, etc. | USA |
| Allocure | It develops cell therapies for the treatment of kidney diseases, organ transplants, and multi-organ injuries. | UK |
| Kolon Tissue Gene | It is engaged in the development of novel advanced cell therapies for orthopedic diseases and other medical needs. | Korea |
| Forticell Bioscience | It develops the cell therapy products for the treatment of the skin wounds, venous statis ulcers, diabetic ulcers and epidermolysis bullosa diseases | US |
| Stemedica Cell technologies | It is the biopharmaceutical manufacturing company developing the progenitor cell and protein therapeutics for medical conditions. |
Strategic Conclusion
The global cell therapy market is growing at a rate of 5.4% because of the rising incidences of complex chronic diseases, growing geriatric population, and rising funds on research for cell-based therapies.
However, complications associated with the allogenic cell therapies and stringent regulations for the research on cell therapies might restrain the growth of its market.
References
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Appendix
- MEA= Middle East and Africa Region
- EU= European Union
- UK= United States
- USA= United States of America
- USD= United States Dollar
- CAGR= Compound Annual Growth Rate
