Stem Cell Therapies for Cardiovascular & Metabolic Disorders, 2019-2030

NEW YORK, May 16, 2019 /PRNewswire/ -- INTRODUCTION
Cardiovascular disorders and metabolic disorders are considered to be amongst the leading causes of death worldwide. In fact, approximately one-third of the annual number of deaths across the globe are attributed to cardiovascular disorders. In the US, the annual economic burden associated with these disorders is estimated to be over USD 500 billion. According to a study conducted by RTI International for the American Heart Association, the prevalence of cardiovascular diseases is expected to rise to 45% of the overall US population, while affiliated costs are expected to be over USD 1 trillion by 2035. Despite considerable advances in healthcare, most of the currently available treatment options for cardiovascular disorders focus on palliative care and cannot actually repair damaged cardiac tissue. Although heart transplant is a viable option to treat complex cardiovascular conditions, the waiting time associated with this alternative is excruciatingly long.

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Likewise, a significant proportion of the global population suffers from diabetes or some form of metabolism related clinical condition. As per IDF Diabetes Atlas, the treatment of diabetes and related complications incurred USD 727 billion in global healthcare expenditure in 2017. In 2017, it was estimated that 425 million individuals, between the ages 20 years to 79 years, were living with diabetes across the globe, and this number is expected to increase substantially in the foreseen future. Similar to cardiovascular diseases, most of the current treatment options for metabolic disorders are indicated for only controlling / managing disease related symptoms.

Advances in cell biology and regenerative medicine have led to the development of stem cell therapies that can potentially address several unmet needs and potentially offer a cure for various cardiovascular and metabolic disorders. The field of regenerative medicine has evolved substantially in the recent past; the first stem cell therapy, called Cellgram®-AMI (2011), was approved by the Ministry of Foods and Drug Safety of Korea, for the treatment of acute myocardial infarction. Presently, two other stem cell-based treatment options, namely HeartSheet® (heart failure, 2015) and Stempeucel® (critical limb ischemia, 2017), are commercially available for cardiovascular disorders. For metabolic disorders, most stem cell therapy candidates are still under development. However, there is one approved product, called Strimvelis™ for ADA-SCID (2016). Several stakeholders are engaged in efforts to advance the development of regenerative therapies for both cardiovascular and metabolic disorders. In fact, venture capital (VC) firms and government bodies are actively funding several such ongoing research initiatives.

SCOPE OF THE REPORT
The "Stem Cell Therapies for Cardiovascular & Metabolic Disorders, 2019-2030" report features an extensive study of the current market landscape and the future potential of stem cell therapies in treating the aforementioned clinical conditions. The study includes all stem cell therapies that are being developed for the treatment of cardiovascular and metabolic disorders. In addition, we have provided a list of stem cell therapies being developed for stroke, a condition associated with vasculature in the brain. Amongst other elements, the report features the following:
A detailed assessment of the current market landscape of stem cell therapies with respect to target therapeutic area (cardiovascular and metabolic), phase of development (approved, phase III, phase II, phase I and preclinical / discovery), target disease indications (Cardiovascular: heart failure, myocardial infarction, critical limb ischemia, angina, peripheral arterial / vascular diseases, myocardial ischemia, myocardial fibrosis, cardiomyopathy and coronary microvascular dysfunction; Metabolic: diabetes, mucopolysaccharidosis type III, ADA-SCID, obesity, mitochondrial disorders and metachromatic leukodystrophy), source of cells (autologous and allogenic), type of stem cells (adult multipotent, adult pluripotent, embryonic multipotent, embryonic pluripotent and others), stem cell lineage (bone marrow, peripheral blood, adipose tissue, cardiosphere, muscle, Wharton's jelly, umbilical cord, placenta, dental pulp, cord blood and pancreas), and route of administration (intramyocardial, intramuscular, intravenous, intracoronary, subcutaneous implantation and surgical implantation).
An analysis highlighting the key unmet needs across cardiovascular and metabolic disorders, featuring insights generated from social media posts, recent scientific publications, patient blogs and the views of contemporary key opinion leaders as expressed on online platforms.
An overview of the focus areas of therapy developers, including an assessment of the existing opportunity for stem cell therapies across diverse therapeutic indications.
An insightful company competitiveness analysis featuring a three-dimensional bubble representation, highlighting the key players in this domain on the basis of the strength of their respective product portfolios, taking into consideration the number of therapies under development, phase of development of these therapies, number of disease indications being targeted and geographical distribution of affiliated clinical trials.
An analysis of the partnerships that have been established in the domain in the period 2012-2018, covering R&D collaborations, licensing agreements, mergers and acquisitions, product development and / or commercialization agreements, manufacturing agreements, clinical trial agreements, process development agreements, and other relevant deals.
An analysis of the investments made at various stages of development in companies that are focused in this area, including seed financing, venture capital financing, capital raised from IPOs / secondary offerings, debt financing and grants.
An analysis of contemporary peer-reviewed scientific research articles published during the period 2013-2018, highlighting the key focus areas of the ongoing research activity, in terms of therapeutic area, target disease indication, and source of cells.
Comprehensive profiles of approved and late stage clinical products; each profile features an overview of the therapy, its mechanism of action, history of development, current development status, key clinical trial results, details on recommended dose, price and manufacturing process (wherever available).

One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2019-2030. The report includes information on (potential) sales-based revenues generated by stem cell therapies that are currently marketed or are in late stages of development for the treatment of cardiovascular and metabolic disorders. Additionally, it presents details on the likely distribution of the current and forecasted opportunity across [A] target therapeutic areas (cardiovascular and metabolic), [B] target disease indications (myocardial ischemia, heart failure, critical limb ischemia, diabetes, ADA-SCID, metachromatic leukodystrophy, and other cardiovascular and metabolic disorders ), [C] type of stem cells (adult multipotent, adult pluripotent and embryonic multipotent), [D] source of cells (autologous and allogenic), [E] stem cell lineage (bone marrow, peripheral blood and others), [F] route of administration (intramyocardial, intracoronary, intramuscular, intravenous and surgical implantation) and [G] key geographical regions (North America, Europe and Asia Pacific). To account for the uncertainties associated with the development of novel therapy products 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 this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following individuals:
Michel Revel (Chief Scientist, Kadimastem) and Galit Mazooz-Perlmuter (Business Development Manager, Kadimastem)
Xuejun H Parsons (Chief Executive Officer, Xcelthera)

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.

1.1. CHAPTER OUTLINES
Chapter 2 provides an executive summary of the insights captured during our research. It offers a high-level view on the current scenario and the likely evolution of the stem cell therapies market for cardiovascular and metabolic disorders in the short to mid-term and long term.
Chapter 3 features a brief introduction to the basic concepts related to stem cell-based therapies and the intricacies of their development and administration. In addition, it includes information on the various types of stem cell therapies (based on the source, potency and lineage of stem cells), modes of delivery and the diseases targeted by such therapies. Further, it provides details on cardiovascular and metabolic disorders, and the key indications that are being considered for treatment using stem cell therapies. Additionally, it highlights the challenges associated with stem cell therapies and provides brief insights on the anticipated future of such therapies, focusing on the treatment of cardiovascular and metabolic disorders.

Chapter 4 includes information on over 60 therapies that are currently approved / under development by industry players for the treatment of cardiovascular or metabolic disorders. It features a comprehensive analysis of pipeline therapies, highlighting the target therapeutic area (cardiovascular and metabolic), phase of development (approved, phase III, phase II, phase I and preclinical / discovery), target disease indication (Cardiovascular: heart failure, myocardial infarction, critical limb ischemia, angina, peripheral arterial / vascular diseases, myocardial ischemia, myocardial fibrosis, cardiomyopathy and coronary microvascular dysfunction; Metabolic: diabetes, mucopolysaccharidosis type III, ADA-SCID, obesity, mitochondrial disorders and metachromatic leukodystrophy), source of cells (autologous and allogenic), type of stem cells (adult multipotent, adult pluripotent, embryonic multipotent, embryonic pluripotent and others), stem cell lineage (bone marrow, peripheral blood, adipose tissue, cardiosphere, muscle, Wharton's jelly, umbilical cord, placenta, dental pulp, cord blood and pancreas), and route of administration (intramyocardial, intramuscular, intravenous, intracoronary, subcutaneous implantation and surgical implantation). Additionally, the chapter features information on over 40 therapies that are currently being developed by academic players. It also lists over 15 therapies that are being developed for the treatment of stroke.

Chapter 5 highlights the key unmet needs associated with stem cell therapies that are currently available / being developed for cardiovascular and metabolic disorders. The chapter provides detailed analysis of the various challenges and areas of concern, which were identified from views expressed by patients / experts across different platforms, such as social media posts, recent scientific publications, patient blogs, and the inputs of key opinion leaders. The chapter presents insightful word clouds, summarizing the opinions expressed across various public online portals.

Chapter 6 highlights the key target indications (myocardial infarction, heart failure, critical limb ischemia and diabetes) for which more than 7 stem cell therapies are currently under development. For each of these diseases, the chapter provides details on epidemiology, available treatment options, and the current market landscape of stem cell therapies (with respect to type of stem cell therapy, companies involved and phase of development).

Chapter 7 presents a three-dimensional bubble analysis highlighting the key companies (focused on cardiovascular and metabolic disorders) on the basis of the strength of their respective product portfolios, which takes into account the number of therapies under development, phase of development of candidate therapies, number of disease indications being targeted and geographical distribution of affiliated clinical trials.

Chapter 8 features an elaborate discussion and analysis of the various collaborations and partnerships that have been inked amongst players in this market. We have also discussed the different partnership models (including R&D collaborations, licensing agreements, mergers and acquisitions, product development and / or commercialization agreements, manufacturing agreements, clinical trial agreement, process development agreement and other deals), and the most common forms of deals / agreements that have been established from 2012 to 2018.

Chapter 9 presents details on various investments and grants received by companies that are engaged in this domain. It includes a detailed analysis of the funding instances that have taken place during the period between 2012-2018, highlighting the growing interest of the venture capital community and other strategic investors within this market.

Chapter 10 provides a publication analysis, highlighting the recent trends in published literature related to stem cell therapies for cardiovascular and metabolic disorders. The chapter highlights the key focus areas of the ongoing research activity, in terms of type of therapeutic area, target disease indication, and source of cells.

Chapter 11 contains detailed profiles of drugs that are recently approved or are in advanced stages of clinical development (phase III) for cardiovascular disorders. Each profile features an overview of the therapy, its mechanism of action, history of development, current development status, key clinical trial results, details on administered dose, price and manufacturing process (wherever available).

Chapter 12 contains detailed profiles of drugs that are recently approved or are in advanced stages of clinical development (phase II or above) for metabolic disorders. Each profile features an overview of the therapy, its mechanism of action, history of development, current development status, key clinical trial results, details on administered dose, price and manufacturing process (wherever available).

Chapter 13 presents a comprehensive market forecast analysis, highlighting the future potential of the market till the year 2030. It provides the market estimations for therapies that are either already approved or are in the late phases of clinical development (phase III), taking into consideration the target patient population, existing / future competition, likely adoption rates and the likely price. The chapter also presents a detailed segmentation of the opportunity on the basis of [A] target therapeutic area (cardiovascular and metabolic), [B] target disease indications (myocardial ischemia, heart failure, critical limb ischemia, diabetes, ADA-SCID, metachromatic leukodystrophy, and other cardiovascular and metabolic disorders), [C] type of stem cells (adult multipotent, adult pluripotent and embryonic multipotent), [D] source of cells (autologous and allogenic), [E] stem cell lineage (bone marrow, peripheral blood and others), [F] route of administration (intramyocardial, intracoronary, intramuscular, intravenous and surgical implantation) and [G] key geographical regions (North America, Europe and Asia Pacific).

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 is a collection of interview transcripts of the discussions that were held with key stakeholders in this market. The chapter provides details of interviews held with Michel Revel (Chief Scientist, Kadimastem), Galit Mazooz-Perlmuter (Business Development Manager, Kadimastem), and Xuejun H Parsons (Chief Executive Officer, Xcelthera).

Chapter 16 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

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

EXAMPLE HIGHLIGHTS
1. A review of content on both informal (150 patient blogs and over 900 social media posts) and formal (150 scientific articles) literary sources reveal the existence of several unmet needs within the treatment landscape of cardiovascular and metabolic disorders. Industry experts concur on this opinion as well, stating that one of the most pressing concerns is the need for alternative treatment options and novel therapeutic strategies that are more effective in treating the aforementioned types of clinical conditions.
2. Over the years, stem cell therapy has emerged as a promising treatment paradigm, offering a range of benefits, which include potential tissue regeneration capability, and favorable side effects profiles. Till date, four stem cell therapies have been approved for treating cardiovascular / metabolic disorders; these are (in order of approval year) Cellgram®-AMI (2011), HeartSheet® (2015), Strimvelis® (2016) and Stempeucel® (2017), indicated for the treatment of acute myocardial infarction, heart failure, ADA-SCID and critical limb ischemia, respectively.
3. More than 60 stem cell therapy candidates are being evaluated across different stages of development; over 40% of the pipeline candidates are presently in the mid to late-stages of development (phase II and above) and are likely to enter the market in the next 5-10 years. Examples of phase III therapy candidates include (in alphabetical order) aBMC (Cesca Therapeutics), BCDA-01 (BioCardia), CLBS14-NORDA (Caladrius Biosciences), MPC-150-IM (Mesoblast), OTL-200 (Orchard Therapeutics) and PLX-PAD (Pluristem Therapeutics).
4. Around 60% of pipeline stem cell therapy candidates are being developed for the treatment of cardiovascular disorders; of these, more than 70% target heart failure, myocardial infarction and critical limb ischemia. Within metabolic disorders, diabetes is the key target indication; in fact, close to 75% of stem cell therapies for metabolic disorders are being investigated for the treatment of diabetes. Examples include (in alphabetical order) apceth-201 (apceth Biopharma), hPSC (Kadimastem), Neo-islets (SymbioCellTech), SR-01 (Seraxis) and TARGETBCD (Evotec / Sanofi).
5. The niche, but evolving, stem cell therapies landscape is fragmented, featuring a mix of small. mid-sized and large companies. Some of the companies that have been established over the past 5-6 years include (in reverse chronological order), OiDE BetaRevive (part of Daiichi Sankyo) (2019), Semma Therapeutics (2015), Sigilon Therapeutics (2015), Longeveron (2014), and Xcelthera (2013). It is worth mentioning that the field has also witnessed significant contributions from several large firms, such as (in alphabetical order) AstraZeneca, Evotec, Novo Nordisk and Takeda Pharmaceutical. Most of the established players in this domain are presently evaluating their proprietary pipeline candidates in the preclinical stage.
6. Owing to the myriad of ethical concerns associated with the procurement and use of embryonic stem cells, over 80% of pipeline candidates are based on adult stem cells. Cells of the mesenchymal lineage represent the most commonly used type of adult stem cells. However, there are certain companies that claim to have developed ways to use embryonic stem cells for developing therapeutics; examples include Pluristem Therapeutics, ViaCyte, Tianhe Stem Cell Biotechnologies and Xcelthera.
7. It is worth noting that 25% of the strategic partnerships that were inked between various stakeholders in this field, during the period 2012-2018, were R&D agreements. Further, around 150 peer-reviewed articles related to stem cell therapies for cardiovascular and metabolic disorders were published between 2013 and 2018. This is indicative of the fact that research interest and efforts to innovate are presently high within this field.
8. Development efforts have been backed by various private and public investors, resulting in significant capital investments. In fact, since 2012, more than USD 2.0 billion (across 125 funding instances) has been invested in companies involved in the development of stem cell therapies for cardiovascular and metabolic disorders. In 2018 alone, 17 funding instances were reported, amounting to a total capital investment worth over USD 600 million.
9. The stem cell therapies market for cardiovascular and metabolic disorders is poised to experience rapid growth (at a CAGR of more than 10%) over the coming decade. The overall opportunity is anticipated to be distributed across the various types of stem cells, routes of administration and geographical regions. Owing to their favorable side effects profiles, autologous stem cell therapies are likely to capture the dominant market share (over 70%) during the period, 2019–2030. Although the currently approved therapies are available only in specific geographies, in the long term, North America and Europe are expected to hold the majority share as several late stage therapies are likely to receive approvals within these regions.

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