Stem Cells Market Outlook with a Focus on Clinical Therapies 2020-2030: Types of Stem Cells, Route of Administration, Therapeutic Areas, End-users, Key Geographical Regions

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Apr 23, 2020, 16:00 ET

DUBLIN, April 23, 2020 /PRNewswire/ -- The "Global Stem Cells Market: Focus on Clinical Therapies, 2020-2030" report has been added to ResearchAndMarkets.com's offering.

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.

This 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.

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)
[G] key geographical regions (North America, Europe and Asia and rest of the world)

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.

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.

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.

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)

Key Topics Covered

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview
3.2. Overview of Stem Cell Therapies
3.3. Regulatory Guidelines for Stem Cell Therapies
3.4. Prevalent Trends Related to Stem Cell Therapies
3.5. Growth Drivers and Roadblocks

4. MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Stem Cell Therapies: Marketed and Development Pipeline
4.3. Stem Cell Therapies: Additional Information
4.4. Stem Cell Therapies: List of Technology Platforms
4.5. Stem Cell Therapies: List of Therapy Developers
4.6. Heptagon Representation: Analysis by Phase of Development and Key Therapeutic Area
4.7. Grid Representation: Analysis by Phase of Development, Source of Stem Cell and Therapeutic Area
4.8. Tree Map Representation: Analysis by Therapeutic Area and Size of the Company
4.9. World Map Representation: Analysis of Regional Activity

5. COMPANY PROFILES
5.1. Chapter Overview
5.2. Anterogen
5.2.1. Company Overview
5.2.2. Product Portfolio: Clinical-Stage Stem Cell Therapies
5.2.3. Recent Developments and Future Outlook
5.3. Athersys
5.4. CHA Biotech
5.5. Cytopeutics
5.6. Hope Biosciences
5.7. Mesoblast
5.8. Pluristem Therapeutics
5.9. Takeda Pharmaceutical
5.10. TICEBA

6. KEY THERAPEUTIC AREAS
6.1. Chapter Overview
6.2. Autoimmune / Inflammatory Disorders
6.3. Cardiovascular Disorders
6.4. Dermatological Disorders
6.5. Metabolic Disorders
6.6. Oncological Disorders
6.7. Neurological Disorders

7. ANSOFF MATRIX EVALUATION
7.1. Chapter Overview
7.2. Established Therapeutic Areas in Established Regions
7.2.1. Competition
7.2.2. Growth Opportunities
7.3. Established Therapeutic Areas in Emerging Regions
7.4. Emerging Therapeutic Areas in Established Regions
7.5. Emerging Therapeutic Areas in Emerging Regions

8. ACADEMIC GRANTS ANALYSIS
8.1. Chapter Overview
8.2. Scope and Methodology
8.3. Stem Cell Therapies: Analysis of Grants Awarded by the National Institutes of Health (NIH)
8.4. Grant Attractiveness Analysis

9. CLINICAL TRIAL ANALYSIS
9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Stem Cell Therapies: Clinical Trial Analysis

10. STEM CELL MANUFACTURING MARKET LANDSCAPE AND KPIs FOR EVALUATING CONTRACT SERVICES PARTNERS
10.1. Chapter Overview
10.2. Stem Cell Therapy Manufacturing
10.3. Stem Cell Therapy Manufacturing: KPI Analysis
10.4. Concluding Remarks

11. STEM CELL THERAPY DEVELOPERS AND CMOs: OPPORTUNITY ASSESSMENT
11.1. Chapter Overview
11.2. Therapy Developers and CMOs in North America
11.3. Therapy Developers and CMOs in Europe
11.4. Therapy Developers and CMOs in Asia-Pacific and Rest of the World
11.5. Concluding Remarks

12. KEY COMMERCIALIZATION STRATEGIES
12.1. Chapter Overview
12.2. Successful Drug Launch Strategy: ROOTS Framework
12.3. Successful Drug Launch Strategy: Product Differentiation
12.4. Commonly Adopted Commercialization Strategies based on Stage of Product Development
12.5. Key Approved Stem Cell Therapies: Profiles
12.5.1. CARTISTEM
12.5.2. HiQCell
12.5.3. Prochymal
12.5.4. Strimvelis
12.6. Key Commercialization Strategies Adopted by Stem Cell Therapy Developers
12.6.1. Strategies Adopted before Therapy Approval
12.6.2. Strategies Adopted Post Therapy Approval
12.7. Opportunities and Challenges with Unapproved Therapies
12.8. Concluding Remarks

13. MARKET FORECAST
13.1. Chapter Overview
13.2. Scope and Limitations
13.3. Forecast Methodology and Key Assumptions
13.4. Overall Stem Cell Therapies Market, 2020-2030
13.5. Concluding Remarks

14. CONCLUSION

15. EXECUTIVE INSIGHTS
15.1. Chapter Overview
15.2. Seraxis
15.3. Xcelthera
15.4. Kadimastem
15.5. Heartseed
15.6. University of Rostock
15.7. Bio Elpida
15.8. Roslin Cell Therapies
15.9. University of Minnesota
15.10. Waisman Biomanufacturing
15.11. YposKesi

Companies Mentioned

3P Biopharmaceuticals
AA Partners
AbbVie
Aegle Therapeutics
AGC
Albert Einstein College of Medicine
Allele Biotechnology & Pharmaceuticals
Altaco XXI
American CryoStem
Amgen
Andalusian Initiative for Advanced Therapies
Angel Biotechnology
Angiocrine Bioscience
Anterogen
apceth Biopharma
Aspire Health Science
Astellas Pharma
Athersys
Atlantic Bio GMP
Augusta University
Axis Biotec Brasil
Azidus Brasil
Baylor College of Medicine
Baylx
Beckman Research Institute
BHI Therapeutic Sciences
Bio Elpida
BioCardia
BioGenCell
Bioinova
BioNTech IMFS
Bioquark
BioRestorative Therapies
bluebird bio
Bone Therapeutics
BrainStorm Cell Therapeutics
Brigham And Women's Hospital
Bukwang Pharmaceutical
Caladrius Biosciences
Capricor Therapeutics
CAR-T (Shanghai) Biotechnology
Case Western Reserve University
Cedars-Sinai Medical Center
Celgene
Celixir
Cellerant Therapeutics
Cell and Gene Therapy Catapult
Cell Tech Pharmed
CELLforCURE
CellProthera
Cellular Biomedicine Group
CENTOGENE
Cesca Therapeutics
CHA Biolab
CHA Biotech
Chiesi Farmaceutici
Cleans Cells
Cognate BioServices
Columbia University
Cook Myosite
Corestem
CRC for Cell Therapy Manufacturing
Cryosite
Cynata Therapeutics
Cytopeutics
DiscGenics
Duke University
EHL Bio
Eli Lilly
Emory University
EpiBone
Ever Supreme Bio Technology
Ferrer Internacional
Fibrocell Science
Foundation for Biomedical Research and Innovation, Kobe
Fox Chase Cancer Center
FUJIFILM Cellular Dynamics
Gamida Cell
Gates Biomanufacturing Facility
GE Healthcare
GenCure
Genenta Science
GlaxoSmithKline
Global Cell Med
Guy's and St Thomas' NHS Foundation Trust
Gwo Xi Stem Cell
Harvard University
Heartseed
Hebei Newtherapy BIo-Pharma technology
Hemostemix
Histocell
Hitachi Chemical
Holostem Terapie Avanzate
Hope Biosciences
Icahn School of Medicine
ilaya
Indiana University
Institute of Translational Health Sciences
International Stem Cell Corporation
Japan Regenerative Medicine
Japan Tissue Engineering
jCyte
Johns Hopkins University
Johnson & Johnson
Kadimastem
Kangstem Biotech
Karolinska University Hospital
KBI Biopharma
Kemwell Biopharma
King's College London
Lai Corporation
KLSMC Stem Cells
Lifecells
Lineage Cell Therapeutics
Longeveron
Lonza
Magellan Biologicals
Magenta Therapeutics
Massachusetts General Hospital
MaSTherCell
Mayo Clinic
Med Cell Bahamas
Medeor Therapeutics
Medical College of Wisconsin
MEDINET
MEDIPOST
Melbourne Stem Cell Centre
Merck
Meridigen Biotech
Mesoblast
Minovia Therapeutics
National Cancer Institute
National Center for Advancing Translational Sciences
National Eye Institute
National Heart, Lung, and Blood Institute
National Human Genome Research Institute
National Institute of Allergy and Infectious Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Biomedical Imaging and Bioengineering
National Institute of Child Health and Human Development
National Institute of Dental and Craniofacial Research
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Environmental Health Sciences
National Institute of General Medical Sciences
National Institute of Mental Health
National Institute of Neurological Disorders and Stroke
National Institute on Aging
National Institute on Alcohol Abuse and Alcoholism
National Institute on Deafness and Other Communication Disorders
National Institute on Drug Abuse
Nature Cell
NextCell Pharma
NeuroGeneration
Nikon CeLL innovation
Nippon Regenerative Medicine
Nipro
Nohla Therapeutics
Noray Biosciences Group
Novadip Biosciences
Novartis
NuVasive
Orchard Therapeutics
Oregon Health and Science University
Orgenesis
Orthofix
Osiris Therapeutics
Personalized Stem Cells
Pfizer
Pharmicell
Pharmicell
Pluristem Therapeutics
Plus Therapeutics
Princess Margaret Hospital
Promethera Biosciences
Protide Pharmaceuticals
Provia Laboratories
Purdue University
Q Therapeutics
R3 Stem Cell
R Bio
Regeneus
Regenexx
Reliance Life Sciences
ReNeuron
Riordan Technologies
RNL Bio
Roche
ROHTO Pharmaceutical
Roslin Cell Therapies
Roswell Park Cancer Institute
Royal Free Hospital
RTI Surgical
S -Biomedic
SCM LifeScience
Salvat
Samsung BioLogics
SanBio
Sanofi
Sclnow Biotechnology
SCM Lifescience
Scottish National Blood Transfusion Service
Seneca Biopharma
Sentien Biotechnologies
Seraxis
Shandong Qilu Stem Cells Engineering
Shenzhen Hornetcorn Biotechnology
Stanford University
State University of New York At Buffalo
Stem Cell Medicine
Stem Med
Stemedica Cell Technologies
Steminent Biotherapeutics
Stemirac
Stemmatters
Stempeutics Research
Stryker
Swiss Medica XXI Century
Taiwan Bio Therapeutics
Takara Bio
Takeda Pharmaceutical
Talaris Therapeutics
Terumo
The Emmes Company
The University of Iowa
Tianhe Stem Cell Biotechnologies
Tianjin Ever Union Biotechnology
Tianjin Weikai Biological Engineering
TICEBA
TotipotentRX
TreeFrog Therapeutics
Tufts University
Tulane University
U.S. Stem Cell
UC Davis GMP Laboratory
United Therapeutics
University College of London
University of Alabama
University of California
University of Chicago
University of Cincinnati
University of Colorado
University of Illinois
University of Louisiana
University of Manchester
University of Massachusetts
University of Michigan
University of Miami
University of Michigan
University of Minnesota
University of Newcastle
University of Oregon
University of Pennsylvania
University of Pittsburgh
University of Rochester
University of Rostock
University of South Florida
University of Southern California
University of Stanford
University of Texas
University of Wisconsin
US Department of Veterans Affairs
VcanBio Center for Translational Biotechnology
Vericel
Versiti
VetStem
ViaCyte
Viscofan BioEngineering
Waisman Biomanufacturing
Wake Forest University Health Sciences
Washington University
WuXi Advanced Therapies
Xcelthera
Yposkesi

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