Stem Cell Therapy Market: Growth, Size, Share, and Trends

The global stem cell therapy market, valued at US$259 million in 2022, is forecasted to grow at a robust CAGR of 16.5%, reaching US$286 million in 2023 and an impressive US$615 million by 2028. Market growth is driven mainly by factors such as rise in funding for stem cell research, upsurge in the number of cell therapy production facilities that have GMP certification, and increased in the number of clinical trials associated with stem cell therapies.

Stem Cell Therapy Market Size, Dynamics & Ecosystem

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Stem Cell Therapy Market Dynamics

Driver: Increased funding for stem cell research

Government initiatives and funding mechanisms exert a pivotal influence on the dynamics of the market. Favorable regulatory frameworks and financial support from governmental bodies play a catalytic role in fostering an environment conducive to research and development in stem cell therapies. The need for newer and better therapies for the treatment of autoimmune, neurological, and cardiovascular diseases has resulted in an overall increase in research activities and the availability of funding for cell-based research. In December 2022, Alpha Stem Cell Clinic received an USD 8 million, five-year grant from the California Institute of Regenerative Medicine (CIRM) for the study of the use of self-renewing cells to treat human disease. Furthermore, in November 2019, the Australian government released a 10-year roadmap for stem cell research in Australia—The Stem Cell Therapies Mission. The initiative would provide USD 102 million (AUD 150 million) under the Medical Research Future Fund (MRFF) to support stem cell research to deliver new therapies. The infusion of government funding not only accelerates the pace of clinical trials but also facilitates the translation of research findings into viable therapeutic applications. As a result, the stem cell therapy industry is experiencing a positive ripple effect, with increased investments leading to expanded capabilities, enhanced infrastructure, and ultimately contributing to the overall growth and maturation of the industry.

Restraint: Ethical concerns related to embryonic stem cells

Ethical concerns about embryonic stem cells have been a significant restraining factor for the advancement of stem cell therapy in the market. These concerns primarily revolve around the source of embryonic stem cells, often derived from human embryos, raising ethical dilemmas related to the destruction of potential life. In various regions, regulatory frameworks and public opinion play crucial roles in shaping the environment for stem cell research and therapy. Stringent regulations and ethical considerations can limit the scope and progress of embryonic stem cell-based therapies. This, in turn, impacts the overall growth and acceptance of stem cell therapy within the market.

Opportunity: The emergence of iPSCs as an alternative to ESCs

Induced pluripotent stem cells (iPSCs) are adult stem cells that have been genetically reprogrammed back to an embryonic stem cell-like state. iPSCs function similarly to embryonic stem cells (ESCs), having the ability to differentiate into specialized tissue cells according to the gene expression; this makes iPSCs an effective alternative to ESCs. As ESCs are derived from early-stage embryos, they are associated with socio-ethical issues and laws related to contraception, abortion, and in vitro fertilization. The use of iPSCs bypasses the need for human embryos, thus avoiding socio-ethical objections.

iPSCs can be used for various applications, including the development of regenerative medicine and drug discovery (such as disease modeling and cytotoxicity studies), thus reducing the overall cost of clinical trials. The use of iPSCs for stem cell therapy allows for the generation of pluripotent cells that are identical to the patient’s genetic map. Therefore, owing to such advantages, the use of iPSCs in cell therapy research is increasing and can be beneficial to the overall growth of the market.

Challenge: Technical limitations

Due to technical difficulties faced at various manufacturing stages such as stem cell identification, isolation, storage, and preservation, it becomes difficult for a manufacturer to scale up the production. Limited manufacturing capability for production scale-up is expected to hinder the large-scale manufacturing of stem cells. The scaling-up process is also affected due to the development process adopted during the research phase. Typically, less attention is paid to the scalability of production and the cost associated with it. Different stem cells require different environments for proliferation and differentiation, potentially including mechanical stimuli or flow conditions, variable gas tensions, chemical gradients, 3D frameworks, and supporting-cell paracrine signaling. These factors depend on the source and type of stem cell.

There is a requirement for a basic stem-cell manufacturing solution that supports the production of various stem cells and provides an optimal environment. With current technological advancements, it is possible that a manufacturing solution can be programmed to control some factors; however, it is very difficult to provide a production system that fits all solutions. There are also concerns regarding the possibility of cells adapting to different, more large-scale culture conditions while retaining safety and therapeutic efficacy. These limitations form a key challenge to the growth of the market.

Stem Cell Therapy Market Segmentation & Geographical Spread

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The allogeneic stem cell therapy accounted for the dominant share of the stem cell therapy industry 2022.

The stem cell therapy market is segmented into allogeneic and autologous stem cell therapies based on type. In 2022, the allogeneic stem therapy segment accounted for the largest share of the market. Various factors such as lesser complications associated with the development and manufacturing of stem cells are some of the major factors uplifting the demand for allogenic stem cells.

The adipose tissue-derived stem cell segment dominated the stem cell therapy industry.

Based on cell source, the stem cell therapy market is segmented into adipose tissue-derived MSCs, placental/umbilical cord-derived MSCs, bone marrow-derived MSCs, and other sources. In 2022, the adipose tissue-derived stem cells segment dominated the stem cell therapy with the dominant share, attributed to the growing adoption of these MSCs across different therapeutic indications. Furthermore, increased research and adoption of placental cord-derived stem cells is likely to uplift the market growth in coming years.

In 2022, the musculoskeletal disorders segment has generated highest revenue in the stem cell therapy industry.

Based on therapeutic application, the global stem cell therapy market is segmented into musculoskeletal disorders, cardiovascular diseases, wounds and surgeries, neurological disorders, inflammatory & autoimmune diseases, and other therapeutic applications. The musculoskeletal disorders therapeutic application segment generated highest revenue in 2022. Rise in prevalence of musculoskeletal disorders such as osteoarthritis along with growing demand for regenerative medicine in orthopedic and sports medicine applications are some of the major factors driving the segmental growth.

Asia Pacific region of the stem cell therapy industry is likely to grow at the highest CAGR during the forecast period of 2023-2028.

The stem cell therapy market is segmented into four major regions—North America, Europe, the Asia Pacific and Rest of the World. In 2022, North America accounted for the largest share of the market, and this trend is expected to continue during the forecast period. A robust product pipeline and increased regulatory approvals of stem cell therapy are likely to propel the market growth in the region. Asia Pacific segment is likely to grow at a higher CAGR owing to various factors such as the increasing due to increased adoption of stem cell therapies in the region.

Key players in the market include Smith+Nephew. (UK), MEDIPOST Co.,Ltd (South Korea), Anterogen.Co.,Ltd. (South Korea), CORESTEM (South Korea), Pharmicell Inc. (South Korea), NuVasive, Inc. (US), RTI Surgical (US)), AlloSource (US), JCR Pharmaceuticals Co., Ltd. (Japan), and Takeda Pharmaceutical Company Limited (Japan), among others

Scope of the Stem Cell Therapy Industry

This report categorizes the stem cell therapy market to forecast revenue and analyze trends in each of the following submarkets:

By Type

• Allogeneic Stem Cell Therapy
• Autologous Stem Cell Therapy

By Cell Source

• Adipose tissue-derived MSCs (mesenchymal stem cells),
• Bone marrow-derived MSCs,
• Placental/umbilical cord-derived MSCs
• Other Cell Sources

By Therapeutic Application

• Musculoskeletal Disorders
• Wounds & Surgeries
• Cardiovascular Diseases
• Inflammatory & Autoimmune Diseases
• Neurological Disorders
• Other Therapeutic Applications

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia Pacific (APAC)
  • Japan
  • China
  • India
  • South Korea
  • Rest of Asia Pacific (RoAPAC)
• Rest of World

Recent Developments of Stem Cell Therapy Industry

• In April 2023, US FDA approved Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy.
• In July 2022, CORESTEM (South Korea) continued enrolling participants for the Phase 3 clinical trial of NeuroNata-R. This therapy has received conditional approval for treating ALS patients in South Korea
• In September 2020, Stemedica Cell Technologies received investigational new drug (IND) approval from the US FDA for intravenous allogeneic mesenchymal stem cells (MSCs) to treat moderate to severe COVID-19.

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