Global Strategic Report; 243 Pages
2019 Version Launches June 10, 2019
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Mesenchymal stem cells (MSCs) are multipotent cells that can differentiate into a variety of cell types, including osteoblasts, chondrocytes, myocytes, adipocytes, and potentially other cell types.
In addition to secreting factors that can stimulate tissue repair, MSCs can substantially alter their microenvironment, exerting effects that are both anti-inflammatory and anti-fibrotic. MSCs are advantageous over other stem cells types for a variety of reasons, including that they are immuno-privileged, making them an advantageous cell type for allogenic transplantation. MSCs appear to be an exceptionally promising tool for cell therapy, because of their unusual advantages, which include availability, expandability, transplantability, and ethical implications.
Interest in therapeutic applications of human MSCs arises from their diverse ability to differentiate into a range of cell types, as well as their ability to migrate to sites of tissue injury/inflammation or tumor growth. Additionally, MSCs well-suited for use in the exponential growth area of 3D printing, because of their capacity to form structural tissues.
Growing attention is now being given to manufacturing technologies to support commercial-scale production of MSCs. Numerous market competitors are also exploring commercialization strategies for MSC-derived exosomes, because exosomes represent a novel strategy for accessing the therapeutic effects of stem cells without the risks and difficulties of administering the cells to patients.
As the most common stem cell type being used in regenerative medicine, there is substantial potential for growth within the MSC market. Today, there are more than 40,000 scientific publications published about the cell type, more than 800 clinical trials underway worldwide, and Google Trend data reveals that MSC searches are more than twice as common as the next most common adult stem cell type.
Burgeoning Market for Mesenchymal Stem Cells (MSCs)
Mesenchymal stem cells (MSCs) are the most utilized cell type within the regenerative medicine industry. To support this rapidly expanding marketplace, this 200+ page global strategic report presents trend rate data for MSC market, including rates of MSC patents, grants, scientific publications, and clinical trials, as well as social analytics that identify online behavior related to MSCs.
The report describes the current status of mesenchymal stem cell (MSC) research, ongoing clinical trials involving MSCs, late stage MSC clinical trials, and uses of MSCs in cell therapy. It explores recent advances in MSC products and technologies, identifies research priorities by market segment, and assesses 73 leading competitors within the MSC marketplace.
Because MSC therapy is an integrated component of Advanced Therapy Medicinal Products (ATMPs), this market report also provides an introduction to ATMPs.
For pharmaceutical companies, the report reveals how advances in MSC research can reveal potential new drug targets, improve methods of drug delivery, and provide personalized treatment strategies. With “Big Pharma” diversifying their product development pipelines by investing in cell therapy companies, MSC companies now represent promising candidates for collaboration, investment, and acquisition.
Based in Washington, DC, BioInformant is first and only market research firm to specialize in the stem cell industry. Unlike other publishers that hire analysts from foreign countries, BioInformant is an American-based company with more than a decade of experience with tracking the stem cell market (2006 to present). BioInformant compiled this global strategic report using interviews with more than 90 individuals from across the stem cell industry.
BioInformant conducted interviews with representatives from Cynata Therapeutics (first company to bring a iPSC-derived MSC therapeutic product into a clinical trial), RoosterBio (global leader in MSC manufacturing technology that can produce to tens of billions of cells in suspension bioreactors), Pluristem Therapeutics (commercializing placenta-derived mesenchymal-like adherent stromal cells in late-stage clinical trials), BioEden (leading company preserving MSCs derived from dental tissues), Regenexx (world’s leading provider of MSC therapies for orthopedic applications), and many more.
The report also incorporates secondary findings from SEC filings, company websites, press releases, investor presentations, government policy documents, Google Trends, and Google Adwords.
Claim this report to:
- Identify the market segments that compose the MSC industry
- Reveal the key market players competing in each market niche
- Identify opportunities for MSC product development
- Access market size determinations for the MSC market, with projections through 2022
- Exploit emerging opportunities within the MSC marketplace
Table of Contents
1. REPORT OVERVIEW
1.1 Statement of the Report
1.2 Executive Summary
3. ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPs)
3.1 Major Therapeutic Areas of Interests in ATMPs Sector
3.2 Price of Market-Stage ATMPs
3.3 FDA-Approved ATMPs
3.4 EC-Approved ATMPs
4. STEM CELLS: A BRIEF OVERVIEW
4.1 Embryonic Stem Cells (ESCs)
4.2 Induced Pluripotent Stem Cells (iPSCs)
4.3 Types of Specialized Cells Derived from Stem Cells
4.4 Types of Stem Cells in Human Body
4.4.1 Human Embryonic Stem Cells (hESCs)
4.4.2 Embryonic Germ Cells (EG-Cells)
4.4.3 Fetal Stem Cells
4.4.4 Umbilical Cord Stem Cells
4.5 Adult Stem Cells
4.5.1 Hematopoietic Stem Cells (HSCs)
4.5.2 Mesenchymal Stem Cells (MSCs)
4.5.3 Neural Stem Cells (NSCs)
4.6 Characteristics of Different Types of Stem Cells
4.7 Applications of Stem Cells in Medicine
5. MESENCHYMAL STEM CELLS (MSCs): A DETAILED OVERVIEW
5.1 A New Name for MSCs
5.1.1 History and Timeline of MSCs Nomenclature
5.2 Functions of MSCs
5.3 Sources of MSCs
5.4 Isolation and Culturing of hMSCs
5.4.1 Cell Surface Markers in MSCs
5.4.2 In Vitro Differentiation Potential of MSCs
5.5 Key Features of Different Types of MSCs
5.6 Chronic Diseases Treatable by hMSCs
5.7 Common Diseases Registered for MSC-Based Cell Therapy
5.8 Advantages of MSCs in Cell Therapy
5.9 Comparison of MSCs with Other Stem Cell Types
5.10 Drawbacks of Autologous MSCs and Advantages of Allogeneic MSCs
5.10.1 Application Strategies for Allogeneic MSCs
5.11 Mechanism of Action of MSCs in Treating Diseases
5.12 Tissue Regeneration
5.13 Immune Modulation
5.14 Manufacture of MSCs
5.14.1 Safety and Potency Assays
5.14.2 Surface Markers of MSC
5.14.3 BM-MNC Isolation and Plating
5.14.4 Passaging and Harvesting
5.14.5 Cryopreservation of MSCs
5.14.6 Donor Eligibility and Cell Collection
5.14.7 Regulatory Framework of MSC Therapies
5.14.8 Contract Development and Manufacturing Organizations (CDMO)
6. MESENCHYMAL STEM CELLS (MSCs): APPLICATIONS
6.1 MSCs for GvHD
6.2 MSCs for Cardiovascular Repair
6.3 MSCs for Liver Disease
6.4 MSC for Bone/Cartilage Disease
6.5 Approved MSC-Based Products
6.5.3 Mesenchymal Precursor Cells (MPCs) from Mesoblast
6.5.8 Osteocel Plus
6.5.9 Trinity Evolution
6.6 Bone Matrices Containing MSCs
6.6.1 Cost of Bone Matrices Containing MSCs
6.6.2 Tissue Engineered Orthopedic Product Candidates Containing MSCs
6.7 Pricing of Approved Cell Therapy Products
7. STEM CELL RESEARCH PUBLICATIONS, FUNDING AND PATENTS
7.1 Volume of Scientific Papers Published on MSCs
7.1.1 Number of Publications on MSCs by Major Applications
7.2 Stem Cell Research around the World
7.3 NIH Funding for MSCs Research
7.4 Stem Cell Patents Landscape
8. CLINICAL TRIALS INVOLVING MSCS: AN OVERVIEW
8.1 Current Clinical Trial Scenario
8.2 Geographical Share of MSC Clinical Trials
8.2.1 Number of Clinical Trials using MSCs by Geography/Country
8.3 Sources of MSCs for Current Clinical Trials
8.4 Diseases Addressed by MSCs in the Ongoing Clinical Trials
8.5 Active Clinical Trials using MSCs
8.6 MSC Clinical Trial Outcomes, 2011-2016
8.7 Selected Clinical Trials Sponsored by Universities
8.7.1 Celal Bayar University (NCT02824393)
8.7.2 University of Jordan (NCT02118519)
8.7.3 Ankara University (NCT03106662)
8.7.4 University Hospital of Liege (NCT00504803)
8.7.5 Acibadem University (NCT02285673)
8.7.6 University of Sao Paulo (NCT01297972)
8.7.7 Cairo University (NCT02387749)
8.8 Selected Clinical Trials Sponsored by Cell Therapy Companies
8.8.1 Scinow Biotechnology Co., Ltd. (NCT03184935)
8.8.2 Mesoblast Ltd. (NCT00294112)
8.8.3 Cellular Biomedicine Group Ltd. (NCT01809769)
8.8.4 Alliancells Bioscience Corporation Ltd. (NCT01573923)
8.8.5 Pharmicell Co., Ltd. (NCT01676441)
8.8.6 Shenzhen Hometcorn Biotechnology Co., Ltd.
8.8.7 Sclnow Biotechnology Co., Ltd. (NCT03180450)
8.9 Clinical Trials using MSCs for Cardiovascular Diseases
8.9.1 Corporate Investment in Cardiovascular Diseases using MSC Therapy
188.8.131.52 MPC-150-IM from Mesoblast
184.108.40.206 CLBS10 from Caladrius
220.127.116.11 C-Cure from Celyad
18.104.22.168 Ixmyelocel-T from Vericel
22.214.171.124 MultiStem from Athersys
8.10 MSCs for Osteoarthritis
8.11 MSCs in Wound Healing
8.12 MSCs for Liver Diseases
8.13 MSCs for Lung Disorders
8.14 Clinical Trials using MSCs for Eye Disorders
8.15 MSCs for Kidney Disorders
8.16 MSCs for Diabetes
8.17 MSCs for Graft vs. Host Disease (GvHD)
8.18 MSCs for Inflammatory Bowel Diseases
8.19 MSCs for Multiple Sclerosis
8.20 Status of MSC Clinical Research in Specific Diseases
8.20.1 Graft v. Host Disease (GvHD)
8.20.2 OA & RA
8.20.3 Inflammatory Airway and Pulmonary Diseases
8.20.4 Multiple Sclerosis (MS)
8.20.5 Inflammatory Bowel Disease (IBD)
8.20.6 Genetically Engineered MSCs
9. PARTNERING ACTIVITIES IN CELL THERAPY SECTOR
9.1 Collaboration between Lonza and Nikon
9.2 Hitachi’s Purchase of PCT from Caladrius Biosciences
9.3 Collaboration between Regeneus Ltd. and Asahi Glass. Co. on Progenza
9.4 Collaboration between RepliCel Life Sciences and Shiseido Co., Ltd.
9.5 Collaboration between SanBio Life Sciences and Sumitomo
9.6 Partnership and License Agreement between Healios K.K. and Athersys Inc.
9.7 Cell Therapy Ltd.’s License to Daiichi Sankyo
9.8 TiGenix’s License to Takeda Pharmaceuticals
9.9 Celyad’s License to Ono Pharmaceuticals
9.10 Collaboration Kolon Life Sciences and Mitsubishi Tanabe
9.11 Collaboration between Steminent Biotherapeutics and ReproCELL Inc.
9.12 Kite Pharma’s Partnership with Daiichi Sankyo
9.13 Acquisition of Cellular Dynamics by Fujifilm Holdings
9.14 License Agreement between Cynata Therapeutics and Fujifilm
9.15 Gilead to Acquire Kite Pharma
9.16 Big Pharma’s Strategy in Advanced Therapy Sector
9.16.1 Collaboration between Sangamo and Pfizer
9.16.2 Acquisition of 3D Printing Systems from Tissue Regeneration Systems by DePuy Synthes Products (J&J)
9.16.3 New JLABS Opened by J&J
9.16.4 Collaboration between GSK and Miltenyl Biotec
9.17 Big Pharma’s Interest in Cell Therapy
9.17.1 GlaxoSmithKline (GSK)
9.17.6 Johnson & Johnson
9.18 Big Pharma Strategy in Advanced Therapies
9.18.1 Value of Big Pharma Deals in Cell and Gene Therapy
9.19 Recent Events in Advanced Therapies Sector
9.20 Geographical Distribution of Cell Therapy Companies
10. MARKET ANALYSIS
11. COMPANY PROFILES
11.3 AlloSource Inc.
11.4 American CryoStem Corporation
11.4.1 Clinical Adipose-Tissue Platform
11.5 Anterogen Co., Ltd.
11.5.1 Cupistem Injection
11.6 Apceth Biopharma GmbH
11.6.1 Apceth’s Allogeneic MSC Platform
11.6.2 Apceth’s Genetically-Engineered MSCs
11.7 Athersys Inc.
11.8 Astarte Biologics Inc.
11.9 BioCardia Inc.
11.9.1 Product Pipeline
11.10 BioRestorative Therapies Inc.
11.10.2 ThermoStem Program
11.11 Bone Therapeutics SA
11.12 Brainstorm Cell Therapeutics
11.12.1 NurOwn Technology
11.13 Caladrius Biosciences Inc.
11.14 Capricor Therapeutics Inc.
11.15 Cell Applications Inc.
11.16 Cell Cure Neurosciences Ltd.
11.17 CellGenix Technologie Transfer GmbH
11.17.1 Cell Types Offered
11.17.2 CellGro Cytokines
11.17.3 Serum-Free Media
11.17.4 Supplements and Cells
11.18 CellProthera SAS
11.19 Celltex Therapeutics Corporation
11.20 Cellular Dynamics International Inc.
11.21 Celprogen Inc.
11.22 Cell Therapies Pty Ltd.
11.22.1 Contract Manufacturing Services
11.22.2 Apheresis Management Services
11.22.3 Clinical Trial Support Services
11.22.4 Consultancy & Advisory Services
11.23 Celvive Inc.
11.23.1 The StemCell Bag
11.24 Cesca Therapeurics Inc.
11.24.2 AutoXpress (AXP)
11.24.3 Point-of-Care Solutions for Cell-Based Therapies (PXP)
11.25 Celyad SA
11.26 Cyagen Biosciences Inc.
11.27 Cynata Therapeucics Ltd.
11.27.1 Cymerus Platform Technology
11.28 Cytori Therapeutics Inc.
11.28.1 Cytori Cell Therapy
11.29 Escape Therapeutics Inc.
11.30 Future Health BioBank
11.31 Gamida Cell Ltd.
11.31.1 NAM Technology
11.31.4 NAM-NK Cells
11.32 Intercytex Ltd.
11.33 International Stem Cell Corp.
11.34 Invitrx Therapeutics Inc.
11.34.1 Therapeutic Procedures
11.34.2 Invitra ECM Suspension
11.34.3 Cosmetic Procedures
11.35 JCR Pharmaceuticals Co., Ltd.
11.35.1 Temcell HS Inj.
11.36 Kadimastem Ltd.
11.36.1 Solution for Diabetes
11.36.2 Solution for Neurodegenerative Diseases
11.37 Kiadis Pharma N.V.
11.38 Kite Pharma Inc.
11.38.1 Kite Pharma’s Research
11.39 Life Sciences Inc.
11.40 Living Cell Technologies Ltd.
11.41 Lonza Group Ltd.
11.42 Magenta Therapeutics Inc.
11.42.1 Magenta’s Stem Cell Platform
11.43 Medeor Therapeutics Inc.
11.44 Medipost Co., Ltd.
11.45 Mesoblast Inc.
11.45.5 Temcell HS Injection
11.46 NuVasive Inc.
11.47 Neuralstem Inc.
11.48 Octane Biotech Inc.
11.48.1 Turn-Key Production System for Cell and Tissue Therapy
11.48.2 Automated Bioreactors
11.48.3 Atomically Enhanced Implants
11.48.4 Drug-Enhanced Implants
11.48.5 Cell-Enhanced Implants
11.49 Organogenesis Inc.
11.50 Orthofix International N.V.
126.96.36.199 Trinity ELITE
188.8.131.52 Trinity Evolution
11.51 Osiris Therapeutics Inc.
11.52 OxStem Ltd.
11.53 PharmaCell B.V.
11.54 Pharmicell Co. Ltd.
11.55 Pluristem Therapeutics Inc.
11.55.1 PLX Products
11.56 Precious Cells International Ltd.
11.57 Promethera Biosciences S.A.
11.57.1 HepaStem for ACLF
11.57.2 HepaStem for NASH
11.58 Provia Laboratories, LLC
11.59 Regen BioPharma Inc.
11.59.1 HemaXellerate (Phase I/II)
11.60 Regeneus Ltd.
11.61 Reliance Life Sciences Pvt. Ltd.
11.62 Reneuron Group plc
11.62.1 CTX Cell Line
11.62.3 Exosome Platform
11.63 Stemedica Cell Technologies Inc.
11.63.1 BioSmart Technology
11.63.2 Clinical Pipeline
11.64 StemGen Therapeutics
11.64.2 Lipokraft Advance
11.65 Stempeutics Research Pvt. Ltd.
11.66 Stratatech Corp.
11.67 ThermoFischer Scientific Inc.
11.68 TiGenix N.V.
11.68.1 TiGenix’s Pipeline
11.69 U.S. Stem Cell Inc.
11.69.2 MyoCell SDF-1
11.70 Vericel Corporation
11.71 ViaCyte Inc.
11.72 Xintea AB
11.73 Zen-Bio Inc.
List of Figures
Figure 3.1: Major Indications of Advanced Therapy Clinical Trials
Figure 4.1: Differentiation of Stem Cells into Adult Specialized Cells
Figure 4.2: Differentiation of Embryonic Stem Cells into Adult Specialized Cells
Figure 4.3: Differentiation of Induced Pluripotent Stem Cells into Adult Specialized Cells
Figure 4.4: Types of Specialized Cells Derived from Stem Cells
Figure 4.5: Applications of Stem Cells
Figure 5.1: Types of Common Diseases Registered for MSC-Based Cell Therapy
Figure 5.2: Some Mechanisms of MSCs in Therapeutic Application
Figure 5.3: Steps in the Manufacturing Process of MSCs
Figure 6.1: Clinical Trials of MSCs Classified by Disease Type
Figure 7.1: Stem Cell Research Publications Landscape
Figure 7.2: Number of Published Scientific Papers on MSCs
Figure 7.3: Number of Publications on MSCs by Major Applications
Figure 8.1: Currently Active Clinical Trials using MSCs
Figure 8.2: MSC-Based Clinical Trials by Geography
Figure 8.3: Sources of MSCs used in Current Clinical Trials
Figure 8.4: Diseases Addressed by MSCs in the Ongoing Clinical Trials
Figure 9.1: Value of Deals Undertaken by Big Pharma in Gene and Cell Therapy Sector
Figure 9.2: Geographical Distribution of Cell Therapy Companies
Figure 10.1: Global Market for Mesenchymal Stem Cells and Products through 2022
- Alliancells Bioscience Corporation Ltd.
- AlloSource Inc.
- American CryoStem Corporation
- Ankara University
- Anterogen Co., Ltd.
- Apceth Biopharma GmbH
- Asahi Glass. Co.
- Astarte Biologics Inc.
- Athersys Inc.
- Big Pharma
- BioCardia Inc.
- BioRestorative Therapies Inc.
- Bone Therapeutics SA
- Brainstorm Cell Therapeutics
- Cairo University
- Caladrius Biosciences Inc.
- Capricor Therapeutics Inc.
- Celal Bayar University
- Cell Applications Inc.
- Cell Cure Neurosciences Ltd.
- Cell Therapies Pty Ltd.
- Cell Therapy Ltd.
- CellGenix Technologie Transfer GmbH
- CellProthera SAS
- Celltex Therapeutics Corporation
- Cellular Biomedicine Group Ltd.
- Cellular Dynamics International Inc.
- Celprogen Inc.
- Celvive Inc.
- Celyad SA
- Cesca Therapeurics Inc.
- Cyagen Biosciences Inc.
- Cynata Therapeucics Ltd.
- Cytori Therapeutics Inc.
- Daiichi Sankyo
- Escape Therapeutics Inc.
- Fujifilm Holdings
- Future Health BioBank
- Gamida Cell Ltd.
- GlaxoSmithKline (GSK)
- Healios K.K.
- Intercytex Ltd.
- International Stem Cell Corp.
- Invitrx Therapeutics Inc.
- JCR Pharmaceuticals Co., Ltd.
- Johnson & Johnson
- Kadimastem Ltd.
- Kiadis Pharma N.V.
- Kite Pharma Inc.
- Kolon Life Sciences
- Life Sciences Inc.
- Living Cell Technologies Ltd.
- Lonza Group Ltd.
- Magenta Therapeutics Inc.
- Medeor Therapeutics Inc.
- Medipost Co., Ltd.
- Mesoblast Ltd.
- Miltenyl Biotec
- Mitsubishi Tanabe
- Neuralstem Inc.
- NuVasive Inc.
- Octane Biotech Inc.
- Ono Pharmaceuticals
- Organogenesis Inc.
- Orthofix International N.V.
- Osiris Therapeutics Inc.
- OxStem Ltd.
- PharmaCell B.V.
- Pharmicell Co. Ltd.
- Pluristem Therapeutics Inc.
- Precious Cells International Ltd.
- Promethera Biosciences S.A.
- Provia Laboratories, LLC
- Regen BioPharma Inc.
- Regeneus Ltd.
- Reliance Life Sciences Pvt. Ltd.
- Reneuron Group plc
- RepliCel Life Sciences
- ReproCELL Inc.
- SanBio Life Sciences
- Scinow Biotechnology Co., Ltd.
- Shenzhen Hometcorn Biotechnology Co., Ltd.
- Shiseido Co., Ltd.
- Stemedica Cell Technologies Inc.
- StemGen Therapeutics
- Steminent Biotherapeutics
- Stempeutics Research Pvt. Ltd.
- Stratatech Corp.
- Takeda Pharmaceuticals
- ThermoFischer Scientific Inc.
- TiGenix N.V.
- Tissue Regeneration Systems by DePuy Synthes Products (J&J)
- U.S. Stem Cell Inc.
- University Hospital of Liege
- University of Jordan
- University of Sao Paulo
- Vericel Corporation
- ViaCyte Inc.
- Xintea AB
- Zen-Bio Inc.
As the first and only market research firm to specialize in the stem cell industry, BioInformant research has been cited by the Wall Street Journal, Xconomy, and Vogue Magazine. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, and Goldman Sachs, BioInformant is your global leader in stem cell industry data.
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 PubMed.gov Search; Date: 01/14/2017. Search terms: “mesenchymal stem cell” OR “mesenchymal stem cells” OR “mesenchymal stromal cell” OR “mesenchymal stromal cells”. Link.
 ClinicalTrials.gov Search; Date: 01/14/2017. Search terms: “mesenchymal stem cell” OR “mesenchymal stem cells” OR “mesenchymal stromal cell” OR “mesenchymal stromal cells”. Link.
 Google Trends Search; Date: 01/14/2017. Search Terms Compared: “mesenchymal stem cells” vs. “hematopoietic stem cells” vs. “neural stem cells”. Link.
2019 version launches June 10, 2019. Claim it now for 10% off!