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Global Stem Cell Market: Focus on Clinical Therapies, 2020-2030 (based on Source ; Origin ; Type ; Lineage ; and Potency )

NEW YORK, March 24, 2020 /PRNewswire/ --

INTRODUCTION
According to the WHO, in 2020, nearly 75% of fatalities that are estimated to be reported across the globe, are likely to be caused due to diseases, such as chronic stroke disease, diabetes, cancer, heart disease, and certain mental health conditions. 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.

Read the full report: https://www.reportlinker.com/p05877767/?utm_source=PRN

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-based treatments 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-based therapies have been approved; popular examples include EYE-01M (2019), Alofisel® (2018), MACI (2016), Stempeucel® (2016) and Strimvelis® (2016). Further, several such therapies are presently being evaluated across 540 active clinical trials worldwide. 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 therapies market is poised to grow in the long-term.

SCOPE OF THE REPORT
The "Global Stem Cell 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))" report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of these therapeutics over the next decade. The report features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. In addition to other elements, the study 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.
• An analysis of potential growth opportunities for stem cell therapies across different therapeutic areas in the established / emerging regions, based on the Ansoff growth model.
• 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 this field, 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.

One of the key objectives of the report was to estimate the existing market size and identify the future opportunity for stem cell therapies over the next decade. The research, analyses and insights presented in this report are based on revenue generation trends based on the sales of approved stem cell therapies. The report also features the likely distribution of the current and forecasted opportunity within stem cell therapies 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 forecast scenarios, portraying the conservative, base and optimistic tracks of the market's evolution.

The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. The 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 report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:
• Annual reports
• Investor presentations
• SEC filings
• Industry databases
• News releases from company websites
• Government policy documents
• Industry analysts' views

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of stem cell therapies market and their likely evolution in the short-mid term and long term.

Chapter 3 provides a brief introduction to stem cell therapies, highlighting details regarding their development and administration. It includes information on various types of stem cell therapies (based on the source, potency and lineage of stem cells), modes of therapy administration and the disease indications targeted by such interventions. It also emphasizes on the challenges related to the development of such therapy candidates. In addition, it provides a detailed description of the regulatory landscape related to stem cell therapies across various geographies, such as the North America (primarily the US), Europe and other key global regions. Further, it includes 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.

Chapter 4 includes information on over 280 stem cell-based therapies approved / under clinical development, providing 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. It also focuses on the 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). In addition, information on the various technology platforms being actively used for the development of stem cell therapies, has been provided.

Chapter 5 features detailed profiles of key industry players engaged in the development of stem cell-based therapies (shortlisted on the basis of number of pipeline products). Each profile features a brief overview of the company along with the information on year of establishment, company size, location of headquarters, key members of the executive team and financial information (if available), details on their respective product portfolio, and an informed future outlook.
Chapter 6 presents an assessment of over 20 most commonly targeted therapeutic indications and details of stem cell-based therapies being developed to treat them, highlighting disease specific epidemiological facts, contemporary methods of diagnosis, and currently available treatment options and their side-effects.

Chapter 7 highlights an analysis of potential growth opportunities for stem cell therapies across different therapeutic areas in the established / emerging markets, based on the Ansoff growth model.

Chapter 8 provides an analysis of more than 1,500 grants that were awarded to research institutes engaged in stem cell therapy-related projects, in the period between 2015 and 2019 (till November) based on the important parameters associated with grants, 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.

Chapter 9 provides a detailed clinical trial analysis of 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.

Chapter 10 features 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.

Chapter 11 presents a detailed market gap analysis in order to develop a realistic understanding of the demand and supply dynamics within this field, comparing both clinical and commercial capabilities of therapy developers and the availability and capabilities of contract manufacturers, across different geographies.

Chapter 12 features 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.

Chapter 13 presents an insightful market forecast analysis, highlighting the likely growth of the stem cell therapy market till the year 2030. In order to provide details on the future opportunity, our projections have been segmented on the basis of [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).

Chapter 14 is a summary of the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 15 features the transcripts of interviews conducted with representatives from renowned organizations that are engaged in the stem cell therapy domain. We have inputs from 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), and Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, YposKesi).

Chapter 16 is an appendix that contains tabulated data and numbers for all the figures provided in the report.

Chapter 17 is an appendix that provides the list of companies and organizations mentioned in the report.

Read the full report: https://www.reportlinker.com/p05877767/?utm_source=PRN

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