Overview
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
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.
Scope of the Report
The “Global Stem Cells 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.
Table of Contents
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- 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
Methodology
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