Stem cell therapies are viable alternatives to conventional treatments with substantial therapeutic potential; market opportunities are huge, as multiple product candidates are expected to be approved over the coming decade
-- Chief Executive Officer, a US based Small-sized Company
Stem Cell Therapy Market Overview
The stem cell therapy market is estimated to be worth $8.5 billion in 2030 and is expected to grow at CAGR of 30% during the forecast period In addition, as per a report published by the Center for Managing Chronic Disease, University of Michigan, more than 50% of the global population was estimated to be living with some form of chronic illness. The rising prevalence of these clinical conditions has resulted in dire need for the identification of effective therapeutic options. Despite advances in healthcare, there is an evident lack of permanent treatment solutions for many aforementioned diseases. Majority of the currently available treatment options focus on palliative care and are incapable of addressing the root cause of disease, therefore, are unable to improve quality of life of patients.
Since the first bone marrow transplant in 1950s, these regenerative cellular therapies have garnered significant attention within the biopharmaceutical industry. Over the years, advances in the field of cell biology and regenerative medicine have led to the development of a number of stem cell therapies, which are believed to possess the potential to address several unmet needs related to the treatment of a wide range of disease conditions. Stem cell therapies are known for their ability to replace damaged cells and tissues, thereby, curing affiliated disease symptoms. In fact, such interventions have also been shown to enable cell regeneration, restoring normal functioning capabilities in affected organs. Till date, nearly 25 stem cell therapies have been approved; popular examples include EYE-01M (2019), Alofisel® (2018), MACI (2016), Stempeucel® (2016) and Strimvelis® (2016). In addition, several such therapies are presently being evaluated across 540 active clinical trials worldwide. Further, recent studies suggest that stem cell therapies have demonstrated the potential to end the Coronavirus (COVID-19) pandemic. There are speculations, based on credible evidence, that infected patients treated with stem cells are more likely to survive the disease. Specifically, mesenchymal stem cells can be effectively used to improve patients' resistance to the SARS-CoV-2 virus induced pneumonia as these cells have the potential to repair damaged tissues in the patients’ respiratory system leading to speedy recovery. In fact, more than 20 biotech companies and academic institutes are focused on the development and testing of efficacy of stem cell therapies to combat this global pandemic. This emerging field of research has received significant capital investments from several big pharma companies and venture capital funds / investors. Despite the associated optimism, the growth of this market is stunted by a number of development and manufacturing related challenges, primarily revolving around the limited availability of the required expertise and infrastructure to produce such products. However, the availability of innovative technology platforms, large target patient population, encouraging clinical trial results, and extensive government support, the stem cell therapy market is poised to witness a substantial market growth during the forecast period.
Key Companies in Stem Cell Therapy Market
Examples of key stem cell companies engaged in stem cell therapy market (which have also been profiled in this market report; the complete list of stem cell companies is available in the full report) include Anterogen, Athersys, CHA Biotech, Cytopeutics, Hope Biosciences, Mesoblast, Pluristem Therapeutics, Takeda Pharmaceutical and TICEBA. This market report includes an easily searchable excel database of all the stem cell companies developing stem cell therapies, worldwide.
Recent Developments in Global Stem Cell Therapy Market:
Several recent developments have taken place in the field of stem cell therapy market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.
- In September 2023, BioLineRx announced the FDA approval of Motixafortide Plus Filgrastim for stem cell mobilization in patients suffering from multiplr myeloma.
- In August 2023, BlueRock Therapeutics entered into a research collaboration with bit.bio in order to identify transcription factor (TF) combinations for reprogramming induced pluripotent stem cells (iPSCs) into Tregs.
- In August 2023, a research article published in the New England Journal of Medicine revealed that stem cell gene therapy might have the potential for the treatment of Sickle Cell Disease (SCD). The data is backed by the Novartis’ Phase I/II clinical trial for the use of cryopreserved stem cells to reduce vaso-constriction.
Scope of the Report
The “Stem Cell Therapy Market: Focus on Clinical Therapies, 2020–2030 (based on Source (Allogeneic, Autologous); Origin (Adult, Embryonic); Type (Hematopoietic, Mesenchymal, Progenitor); Lineage (Amniotic Fluid, Adipose Tissue, Bone Marrow, Cardiosphere, Chondrocytes, Corneal Tissue, Cord Blood, Dental Pulp, Neural Tissue Placenta, Peripheral Blood, Stromal Cells); and Potency (Multipotent, Pluripotent))” market report features an extensive study of the current market landscape, market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunities of the stem cell therapy market. The market research report features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in stem cell therapy market.
In addition to other elements, the market research report includes:
- A detailed assessment of the current market landscape featuring over 280 stem cell-based therapies approved / under clinical development, including information on drug / therapy developer(s) (such as year of establishment, company size and location of headquarters), phase of development (marketed, phase III, phase II, phase I), source of stem cells (allogeneic and autologous), origin of stem cells (adult and embryonic), type of stem cells (hematopoietic, mesenchymal, progenitor and others), stem cell lineage (amniotic fluid, adipose tissue, bone marrow, cardiosphere, chondrocytes, corneal tissue, cord blood, dental pulp, neural tissue placenta, peripheral blood, stromal cells and others), stem cell potency (multipotent and pluripotent), target indication(s), key therapeutic area(s), route of administration (intravenous, intramuscular, intraarticular, intramyocardial, intracoronary, intrathecal and others), and information on number of stem cells, special drug / therapy designation (if any), commercial geographical rights. In addition, information on the various technology platforms being actively used for the development of stem cell therapies has been provided.
- Identification of contemporary market trends, depicted using five schematic representations, which include [A] a tree map representation of the various industry players involved in the development of stem cell therapies, distributed on the basis of the target therapeutic areas of pipeline candidates and size of the companies (small, mid-sized and large companies), [B] a schematic world map representation, highlighting the geographical locations of various industry players, [C] a bubble analysis comparing the leading players engaged in the generation of stem cell therapies, on the basis of parameters such as pipeline strength (based on the number of therapy candidates developed by a particular company, across different phases of development), number of target indications and the size of the developer company, [D] an insightful grid analysis, highlighting the distribution of therapy candidates on the basis of phase of development, source of stem cell and target therapeutic areas, and [E] an informative heptagon representation, highlighting the distribution of marketed / clinical stem cell therapies across popular target therapeutic areas (based on the number of therapy candidates across each target therapeutic areas).
- Detailed profiles of the key industry players engaged in the development of stem cell-based therapies, featuring a brief overview of the company (such as year of establishment, company size, location of headquarters, key members of the executive team and financial information (if available)), details of their respective product portfolio and an informed future outlook.
- An assessment of over 20 commonly targeted therapeutic indications and details of stem cell-based therapies being developed to treat the same conditions, highlighting disease specific epidemiological facts, contemporary methods of diagnosis, and currently available treatment options and their side-effects.
- A detailed proprietary 2×2 representation that was developed to assess the current market scenario (in terms of existing competition and growth opportunities) across emerging and established market segments.
- An in-depth analysis of more than 1,500 grants that have been awarded to research institutes engaged in stem cell therapy-related projects, in the period between 2015 and 2019 (till November), including analysis based on important parameters, such as year of grant award, amount awarded, administration institute, funding institute center, funding institute center, support period, spending categorization, funding mechanism, grant type, responsible study section, focus area, prominent program officers, and type of recipient organizations. It also features a detailed analysis based on the types of stem cell (based on origin, source, potency and lineage) and therapeutic areas, along with a multivariate grant attractiveness analysis based on parameters, such as amount awarded, support period, grant type, number of indications under investigation.
- A detailed clinical trial analysis on more than 540 completed, ongoing and planned studies of various stem cell therapies, highlighting prevalent trends across various relevant parameters, such as current trial status, trial registration year, phase of development, study design, leading industry sponsors (in terms of number of trials conducted), study focus, type of stem cells, target indication(s), target therapeutic area(s), enrolled patient population and regional distribution of trials.
- A review of the key aspects related to the manufacturing of stem cell therapies, including [A] a detailed discussion on processes and protocols, highlighting the need to outsource various aspects of stem cell therapy development and manufacturing operations, [B] an assessment of the current market landscape of contract manufacturers, providing information on stem cell-focused service providers (such as year of establishment, company size, location of headquarters and manufacturing facilities), scale of stem cell manufacturing (commercial, clinician and preclinical), services offered in addition to manufacturing (culture development / set up, stem cell identification / validation, stem cell banking, regulatory consultancy, fill / finish, cryopreservation and stem cell logistics), source of stem cells (allogeneic and autologous), and origin of stem cells (adult and embryonic), [C] an insightful Harvey ball analysis to identify the key performance indicators / key considerations that industry stakeholders are likely to take into consideration while selecting a suitable CMO / CRO partner.
- A detailed market gap analysis in order to develop a realistic understanding of the demand and supply dynamics within stem cell therapy market, comparing both clinical and commercial capabilities of therapy developers and the availability and capabilities of contract manufacturers, across different geographies.
- An elaborate discussion on the various strategies that can be adopted by stem cell therapy developers across different stages of product development and commercialization (prior to product launch, post-marketing, and near patent expiry), and the key strategies that have been adopted by drug developers for the commercialization of their proprietary product candidates.
- An analysis of contemporary trends, as observed on the Google Trends portal, for the period 2015-2019 and insights from the recent news articles related to stem cell therapies indicating the increasing popularity of this upcoming field of research.
The key objective of stem cell therapy market report is to provide a detailed market analysis in order to estimate the existing market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunity for stem cell therapy market during the forecast period. The research, analyses and insights presented in this market report are based on revenue generation trends based on the sales of approved stem cell therapies. The market report also features the likely distribution of the current and forecasted opportunity within stem cell therapy market across [A] source of stem cells (allogeneic and autologous), [B] origin of stem cells (adult and embryonic), [C] type of stem cells (hematopoietic, mesenchymal, progenitor and others), [D] lineage of stem cells (adipose tissue, bone marrow and cord blood / embryonic stem cells), [E] route of administration (intraarticular, intracoronary, intramuscular, intramyocardial, intrathecal, intravenous, surgical implantation and others), [F] therapeutic area (autoimmune / inflammatory disorders, cardiovascular disorders, metabolic disorders, musculoskeletal disorders, oncological disorders, neurological disorders, ophthalmic disorders, and others), [H] end-users (ambulatory surgery centers, hospitals, and specialty clinics), and [G] key geographical regions (North America, Europe and Asia and rest of the world). To account for the uncertainties associated with the manufacturing of stem cell therapies and to add robustness to our model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.
The opinions and insights presented in the market report were influenced by discussions held with senior stakeholders in the industry. The market research report features detailed transcripts of interviews held with the following industry stakeholders:
- William L Rust (Founder and Chief Executive Officer, Seraxis)
- Xuejun Huang Parsons (Chief Executive Officer, Xcelthera)
- Michel Revel (Co-Founder and Chief Scientist, Kadimastem) and Galit Mazooz-Perlmuter (Director, Business Development, Kadimastem)
- Kikuo Yasui (Director and Chief Operating Officer, Heartseed)
- Gustav Steinhoff (Director and Chairman, Department of Cardiac Surgery, University of Rostock)
- Gilles Devillers (President, Bio Elpida)
- Fiona Bellot (Business Development Manager, Roslin Cell Therapies)
- David Mckenna (Professor and American Red Cross Chair in Transfusion Medicine, University of Minnesota)
- Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing)
- Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, YposKesi)
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market research report are in USD, unless otherwise specified
Frequently Asked Questions
Question 1: What is stem cell therapy? Answer:
Stem cell therapy involves the repair of diseased, injured or dysfunctional tissue with the use of stem cells or their derivatives.
Question 2: How big is the stem cell therapy market? Answer:
The stem cell therapy market size is estimated to be worth $8.5 billion in 2030.
Question 3: What is the projected market growth of the stem cell therapy market? Answer:
The stem cell therapy market is expected to grow at compounded annual growth rate (CAGR) of 30% during the forecast period 2020 – 2030.
Question 4: Who are the leading players in the stem cell therapy market? Answer:
Examples of key companies engaged in stem cell therapy market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Anterogen, Athersys, CHA Biotech, Cytopeutics, Hope Biosciences, Mesoblast, Pluristem Therapeutics, Takeda Pharmaceutical and TICEBA.
Question 5: How many stem cell therapies have been approved to date, developed by players engaged in the stem cell therapy market? Answer:
Till date, nearly 25 stem cell therapies have been approved; popular examples include EYE-01M, Alofisel®, MACI, Stempeucel® and Strimvelis®.
Question 6: How much money has been granted by the government to the companies engaged in the stem cell therapy market? Answer:
Over 600 million has been granted by the government to the players engaged in the regenerative medicine market, to augment the research activities in the domain.
Question 7: How many clinical trials evaluating novel stem cell therapies have been registered by players engaged in the stem cell therapy market? Answer:
More than 540 clinical trials evaluating novel stem cell therapies have been registered by players engaged in the stem cell therapy market.