Stem Cell Therapy Market

[120 Pages Report] The global stem cell therapy market is estimated to reach USD 145.8 million by 2021, growing at a CAGR of 11.0% during the forecast period. Growing awareness related to the therapeutic potency of stem cells in disease management, development of advanced genome-based cell analysis techniques, increasing public-private investments for stem cell research and development, identification of new stem cell lines, and developments in infrastructure for Stem Cell Banking and processing are some key factors driving the growth of this market. Furthermore, countries such as Japan, South Korea, and China offer new growth opportunities for market players. On the other hand, unclear regulatory guidelines related to the development & commercialization of stem cell therapy products and socio-ethical issues related to the adoption of ESCs in disease treatment are the major factors restraining the market growth.

The base year considered for the study is 2015, and the forecast has been provided for the period between 2016 and 2021.

Market Dynamics

Growing awareness of the therapeutic potency of stem cells in effective disease management

Stem cell therapy has brought significant and revolutionary changes in the field of disease management strategies and patient care. These products offer effective treatment of conditions such as cancer, aGVHD, and vascular diseases. In recent years, stem cell therapy has been considered as a promising candidate in the field of regenerative medicine for the replacement or regeneration of damaged tissues.

There is growing awareness in the industry related to the therapeutic potency of stem cells for effective disease management. This is supported by the rising number of clinical trials and successful research studies that aim to validate the therapeutic potential of stem cell-based products. Among the recent clinical trials are the following:

• Xuzhou Medical University (China) initiated an interventional study in 2016 (last updated in October 2016). This study is aimed at the therapeutic evaluation of adipose-derived stem cells or fat cells for facial rejuvenation.
• The Affiliated Hospital of Academy of Military Medical Sciences (China) initiated an interventional phase 1 and phase 2 study in collaboration with Ivy Institute of Stem Cells Co. Ltd (China) in 2015 (last updated in March 2016). The study is aimed at testing the safety and efficacy of umbilical cord-derived mesenchymal stem cells (UC-MSCs) for treatment of patients with chronic heart ischemia cohort.
• Celal Bayar University (Turkey) initiated an interventional phase 1 study in collaboration with the Scientific and Technological Research Council (Turkey) and Acýbadem Labcell (Turkey) in 2016 (last updated in July 2016). The study is aimed at determining the safety and efficacy of mesenchymal stem cells derived from autologous adipose tissue for the treatment of chronic autoimmune urticaria.
• Asan Medical Center (South Korea) initiated an interventional phase 2 study in 2014 (last updated in January 2016) aimed at determining the efficacy and safety of mesenchymal stem cell in acute severe respiratory failure.
• Stemedica Cell Technologies, Inc. (U.S.) initiated an interventional phase 2 study in collaboration with Stemedica International SA (Switzerland) in 2016 (last updated in October 2016). The study is aimed at assessing the safety, tolerability, and efficacy of ischemia-tolerant allogeneic human mesenchymal stem cells (manufactured by Stemedica) in patients having mild-to-moderate dementia due to Alzheimer's disease.
• The University of Pittsburgh (U.S.) initiated an interventional phase 1 and phase 2 study in collaboration with Miltenyi Biotec GmbH (Germany) in 2008 (last updated in February 2016). The study is aimed at assessing the safety of high-dose immunotherapy    followed by infusion of autologous CD34-selected peripheral blood stem cells (PBSCs) for the treatment of severe Crohn's disease.

As many as 5,888 active NIH-registered stem cell-based clinical trials are being conducted worldwide. These clinical trials are expected to augment the consumer adoption and physician preference for stem cell therapies across major markets. This is expected to drive the demand for stem cell therapy products worldwide during the forecast period.

Unclear regulatory guidelines for product development and commercialization

As compared to drug-based therapeutics, there are a number of policy and regulation-related considerations related to the use of stem cell therapy Before stem cell-based products can be commercialized, manufacturers need to ensure and prove the safety and efficacy of said products (through contamination testing; toxicity testing; fulfillment of cGMP, standards, and controls; preclinical studies; and clinical studies).

In the EU, stem cell therapy products are included under the Advanced Therapy Medicinal Products (ATMP) category. Regulations for ATMP, passed in 2007, came into effect in December 2008. These regulations and guidelines are based on three main directives—Directive 2003/63/EC, which states specific requirements for cell therapy products; Directive 2001/20/EC, which emphasizes conducting clinical trials and sets specific requirements for clinical trials; and Directive 2004/23/EC, which establishes the safety and quality standards for harvesting, testing, storage, processing, and distribution of human tissues and cells (Source: EMA). The Committee for Advanced Therapies within the European Medicines Agency (EMA) monitors the safety and efficacy of ATMPs and provides marketing approval to the product. As of December 2016, the committee has approved only one stem cell therapy product.

In the U.S., the Center for Biologics Evaluation and Research (CBER) (a division of the FDA) is responsible for regulating stem cell therapy products. Regulations in the U.S. are based on three sections—IND regulations (21 CFR 312); biologics regulations (21 CFR 600); and cGMP (21 CFR 211) (Source: U.S. FDA). Stem cell-based products that are minimally manipulated, labeled, and not combined with a drug or device do not require FDA approval for marketing; however, they must follow cGMP guidelines. Hence, there is significant scrutiny on products in the U.S., which has led to the limited commercialization of stem cell therapy products in the country.

However, emerging countries are yet to develop a well-defined regulatory framework for the commercialization of stem cell-based products.

• The regulatory process of the Korean Ministry of Food and Drug Safety (MFDS) is fast and less stringent as compared to other developed countries. In the last five years, the Ministry of Food and Drug Safety (MFDS) of South Korea approved four stem cell drugs and more than 100 clinical trials for stem cell drugs (Source: MFDS, South Korea).
• In India, the Indian Council of Medical Research (ICMR) established the ‘Ethical Guidelines for Biomedical Research on Human subjects’ in 2006. In 2007, the ICMR and Department of Biotechnology (DBT) laid down ‘Guidelines for Stem Cell Research and Therapy’, which focuses on the registered and regulated use of stem cell lines created or imported in India. In 2008, the Central Drugs Standard Control Organization (CDSCO) released a guidance document on the submission requirements for new drug approvals for biotechnological/biological products, which requires the manufacturer to submit the application in Common Technical Document (CTD) format. However, there is no specific form available for the grant/renewal of license of manufacturing of stem cell-based products. This lack of clear regulatory guidelines for product development and commercialization restricts market growth to a certain extent.

Stem cell R&D is also associated with socio-ethical and moral issues. Due to different cultural views across various countries, it is difficult to formulate a single global policy or law to govern stem cell research. Subsequently, the rules and regulations laid down by each country provide a distinct set of variations; this situation has considerably affected both stem cell research as well as government funding patterns for the same. Concerns related to the availability of funding for stem cell research can lead to increased costs for product development and commercialization.

The cardiovascular diseases application segment is expected to witness fastest growth in stem cell therapy market during the forecast period

On the basis of therapeutic applications, the market is classified into musculoskeletal disorders, wounds and injuries, cardiovascular diseases, gastrointestinal diseases, surgery, and other therapeutic applications. The musculoskeletal disorders segment dominates the global stem cell therapy market in 2016, owing to factors such as larger number of commercialized stem cell therapy products for the treatment of musculoskeletal disorders and the increasing prevalence of musculoskeletal disorders (coupled with the growth in geriatric population). However, the cardiovascular diseases segment is expected to register the highest CAGR in the forecast period. Growth in this application segment is attributed to the growing demand for safe and effective treatment options for cardiovascular disease and the growing number of cardiovascular-related stem cell researches across the globe.

The following are the major objectives of the study:

• To define, describe, and forecast the global market on the basis of type, therapeutic application, cell source, and region
• To provide detailed information regarding the major factors influencing growth of the market (drivers, restraints, growth opportunities, and challenges)
• To strategically analyze micromarkets1 with respect to individual growth trends, future prospects, and contributions to the overall market
• To analyze the opportunities in the market for key stakeholders and provide details of the competitive landscape for major market players
• To forecast the size of the market segments with respect to four main regions, namely, North America, Europe, Asia-Pacific, and RoW
• To strategically profile the key market players and comprehensively analyze their market shares and core competencies2
• To track and analyze competitive developments such as new product approvals and launches; expansions; and partnerships, agreements, and collaborations in the stem cell therapy market

During this research study, major players operating in the market in various regions have been identified, and their offerings, regional presence, and distribution channels have been analyzed through in-depth discussions. Top-down and bottom-up approaches have been used to determine the overall market size. Sizes of the other individual markets have been estimated using the percentage splits obtained through secondary sources such as company annual reports, investor presentations, Hoovers, Bloomberg BusinessWeek, and Factiva, along with primary respondents. The entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews with industry experts such as CEOs, VPs, directors, and marketing executives for key insights (both qualitative and quantitative) pertaining to the market. The figure below shows the breakdown of the primaries on the basis of the company type, designation, and region considered during the research study.

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Some of the major players in the stem cell therapy market include Osiris Therapeutics, Inc. (US), MEDIPOST Co., Ltd. (South Korea), Anterogen Co., Ltd. (South Korea), Pharmicell Co., Ltd. (South Korea), Holostem Terapie Avanzate S.r.l. (Italy), JCR Pharmaceuticals Co., Ltd. (Japan), NuVasive, Inc. (US), RTI Surgical, Inc. (US), and AlloSource (US) among others.

Target Audience:

• Stem Cell Therapeutic Product Manufacturing Companies
• Healthcare Service Providers (Including Hospitals and Diagnostic Centers)
• Pharmaceutical Product Manufacturing Companies
• National and Regional Research Boards and Organizations
• Research and Development (R&D) Companies
• Clinical Research Organizations (CROs)
• Research Laboratories and Academic Institutes
• Market Research and Consulting Firms
• Stem Cell Associations and Organizations

Report Scope:

Stem Cell Therapy Market, by Type

• Allogeneic Stem Cell Therapy, by Application
• Musculoskeletal disorders
• Wounds and Injuries
• Surgeries
• acute Graft-Versus-Host Disease (aGVHD)
• Other Applications
• Allogeneic Stem Cell Therapy, by Application
• Wounds and Injuries
• Cardiovascular Diseases
• Gastrointestinal Diseases
• Other Applications

Stem Cell Therapy Market, by Therapeutic Application

• Musculoskeletal disorders
• Wounds and Injuries
• Cardiovascular Diseases
• Surgeries
• Gastrointestinal Diseases
• Other Therapeutic Applications

Stem Cell Therapy Market, by Cell Source

• Adipose Tissue-derived Mesenchymal Stem Cells
• Bone Marrow-derived Mesenchymal Stem Cells
• Cord Blood/Embryonic Stem Cells
• Other Cell Sources

Stem Cell Therapy Market, by Region

• North America
• Europe
• Asia-Pacific
• Rest of the World

Critical questions which the report answers

• Stem cell based treatments are still in research/nascent phased; how their market/commercial usage will evolve in coming decade?
• What are key cell lines those are currently being used commercially for clinical treatment; which are key geographic areas driving revenue growth for these products?
• What is current regulatory scenario for clinical usage of Stem cell based treatments across key healthcare market?
• What is development pipeline of key stem cell lines for major product manufacturers during past 4-5 years?

Available Customizations:

With the given market data, MarketsandMarkets offers customizations as per the company’s specific needs. The following customization options are available for the global stem cell therapy market report:

Product Analysis

• Product Matrix which gives a detailed comparison of the product portfolios of the top five companies

Geographical Analysis

• Further breakdown of the North American stem cell therapy market into the US and Canada
• Further breakdown of the European market into the UK, Germany, France, and Rest of Europe

Company Information

• Detailed analysis and profiling of additional market players (Up to 5)

The global stem cell therapy market is expected to reach USD 145.8 million by 2021, growing at a CAGR of 11.0% during the forecast period. Factors such as the growing awareness related to the therapeutic potency of stem cells in disease management, ongoing development of advanced genome-based cell analysis techniques, increasing public-private investments for stem cell research and product development, identification of new stem cell lines, and developments in infrastructure for stem cell banking and processing are driving the growth of the global stem cell therapy market. However, factors such as unclear regulatory guidelines related to the development & commercialization of stem cell therapy products and socio-ethical issues related to the adoption of ESCs in disease treatment are restraining the growth of this market. In addition to this, technical limitations related to production scale-up pose a key challenge for players operating in this market.

On the basis of type, the global market is divided into two major categories, namely, allogeneic stem cell therapy and autologous stem cell therapy. On the basis of application, the allogeneic market is further divided into—musculoskeletal disorders, wounds and injuries, surgeries, acute Graft-Versus-Host Disease (aGVHD), and other applications.
On the basis of application, the autologous stem cell therapy market is categorized into—wounds and injuries, cardiovascular diseases, gastrointestinal diseases, and other applications. The allogenic stem cell therapy segment is expected to grow at the highest CAGR during the forecast period, owing to the rising commercialization of allogeneic stem cell therapy products, wider therapeutic applications of allogeneic stem cells, easy production scale-up process, and growing number of clinical trials related to allogeneic stem cell therapies.

On the basis of region, this market is classified into North America, Europe, Asia-Pacific, and the Rest of the World. In 2016, the global market is expected to be dominated by North America. Also, this region is expected to be the fastest-growing region during the forecast period. Factors such as growing awareness related to the therapeutic potency of stem cells, increasing number of clinical trials for stem cell-based products, and increasing public-private funding & research grants are driving the growth of this market in the North American region.

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Product Launches: Key Strategy Adopted by the Major Players in this Market

New product launches and approvals are the key growth strategies adopted by major players to strengthen their positions in the global stem cell therapy market. Moreover, strategies such as expansions as well as partnerships and agreements were also adopted by several market players to expand their R&D capabilities and geographic presence in the global market.

As of 2015, Osiris Therapeutics, Inc. (U.S.), MEDIPOST Co., Ltd. (South Korea), Anterogen Co., Ltd. (South Korea), Pharmicell Co., Ltd. (South Korea), Holostem Terapie Avanzate S.r.l. (Italy), JCR Pharmaceuticals Co., Ltd. (Japan), NuVasive, Inc. (U.S.), RTI Surgical, Inc. (U.S.), and AlloSource (U.S.) were some of the key players operating in the global Stem Cell Therapy Market.

Critical questions the report answers:

• Stem cell based treatments are still in research/nascent phased; how their market/commercial usage will evolve in coming decade?
• What are key cell lines those are currently being used commercially for clinical treatment; which are key geographic areas driving revenue growth for these products?
• What is current regulatory scenario for clinical usage of Stem cell based treatments across key healthcare market?
• What is development pipeline of key stem cell lines for major product manufacturers during past 4-5 years?

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