Global Strategic Report
250 Pages; November 2015
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. For years it has been clear that MSCs are a leading type of stem cell being investigated for therapeutic applications, because they have the potential to treat a wide range of acute and degenerative diseases.
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 also advantageous over other stem cells types, because they avoid the ethical issues that surround embryonic stem cell research and appear to be immuno-privileged. Importantly, MSCs also well-suited for use in the exponential growth area of 3D printing, because of their unusual capacity to form structural tissues.
To date, there have been more than 30,000 scientific publications published about the cell type and there are now nearly 500 MSC clinical trials underway worldwide, with East Asia, Europe, and the United States representing hot-spots for clinical trial activity.
Furthermore, mesenchymal stem cells surpassed hematopoietic stem cells to become the most common stem cell type to appear within the scientific literature in 2015. MSCs were also the only stem cell type that had an increase in scientific publications from 2014 to 2015.
Google Trend data also shows MSC searches to be approximately twice as common as the next most common adult stem cell type.
Therefore, this global strategic report describes the current status of MSC research, ongoing clinical trials involving MSCs, late stage MSC clinical trials, and possible uses of MSCs in cell therapy. Because MSCs are a sub-segment of the broader cell therapy (CT) and regenerative medicine (RM) markets, it gives an overview of the regenerative medicine industry and overall cell therapy industry.
It also explores recent advances in MSC products and technologies, identifies research priorities by market segment, and assesses 35 leading competitors within the MSC marketplace.
For pharmaceutical companies, it reveals how advances in MSC research can reveal potential new drug targets, improve methods of drug delivery, and provide personalized treatment strategies.
The mesenchymal stem cell market is important because:
1) Mesenchymal stem cells (MSCs) are one of the fastest growing areas of stem cell research
2) MSCs are now more frequently cited than any other stem cell type within the scientific literature
3) Google Trend data shows MSC searches to be approximately twice as common as the next most common adult stem cell type
The main objectives of the report are to consider the following:
– Current status of global regenerative medicine (RM) industry in the utilization of stem cells in general and MSCs in particular
– Current status of global cell therapy (CT) industry, the application of cell therapy in various disease indications, and the total number of clinical trials involving the different types of stem cells
– Current status of MSCs in clinical trials, the dominance of MSCs in the ongoing clinical trials involving stem cells, the various applications of MSCs in different disease indications, and the number of clinical trials involving MSCs for different disease types
– The number of companies involved in the development of MSCs, the clinical trials sponsored by major companies, and their ongoing search for MSCs-based cell therapy products
– Analysis of traditional market metrics (grant rates, clinical trial rates, patent rates, scientific publication rates) and new social analytics (metrics from social media sites, search engines, Google Trends, and more)
Key questions answered in the report are:
– How many companies are currently supporting the regenerative medicine (RM) industry?
– What is the current regional breakdown of RM industry?
– How many RM products have been approved?
– What are the types of diseases are currently being pursued by RM companies?
– What are the major financial events, partnerships and acquisitions in RM sector?
– How do the large pharma companies perceive the value and long-term prospects of RM and cell therapy (CT)?
– What are the major anticipated RM clinical events in 2015-16?
– What are the major therapeutic opportunities for the big pharma in RM and CT?
– How many CT product candidates have reached the Phase III stage and what are they?
– What are the CT product candidates being developed for cardiovascular diseases, central nervous system, wounds, spine and orthopedics, diabetes and autoimmune diseases?
– What are the major commercially available CT products?
– What is the total number of CT clinical trials at the global level?
– What are the major cell types used in CT clinical trials?
– What are the major indications addressed by CT clinical trials?
– What are the major CT clinical trials that have reached Phase III?
– How many CT clinical trials failed in the past year and what are they?
– What are the contributions of MSCs to the cell therapy industry?
– What are the biological properties of MSCs?
– What do MSCs get differentiated into?
– What bioactive molecules do the MSCs secrete?
– What are the immunomodulatory functions of MSCs?
– What are the factors impacting the acquisition of MSCs?
– What are the various sources of MSCs?
– What are the ongoing clinical trials using bone marrow-derived MSCs (BMMSCs) for kidney diseases?
– What are the major clinical trials focusing on diabetes using BMMSCs?
– What are the major clinical trials involving BMMSCs for cardiovascular diseases?
– What are the major clinical trials focusing on liver diseases by BMMSCs?
– What are the brain-related diseases addressed by clinical trials using BMMSCs?
– How many clinical trials are conducted for intestinal diseases using MSCs?
– What are the details of clinical trials conducted for musculoskeletal diseases using MSCs?
– Number of clinical trials using MSCs derived from Wharton’s jelly for various diseases?
– What are the disease indications addressed by umbilical cord blood-derived MSCs (UCBMSCs) in current clinical trials?
– What is the current number of clinical trials using MSCs?
– How many major clinical trials using MSCs have reached the Phase III?
– What are the MSCs-based cell therapy products available in the market?
– What is the current size of the MSC marketplace?
TABLE OF CONTENTS
1. Executive Summary
2. Report Overview
2.1 Target Demographic
2.2 Key Findings
2.3 Statement of the Report
3. Research Methodology
3.1 Input Sources
3.2 Research & Analysis Methodologies
3.3 Criteria for Identiyfing MSC Market Leaders
4. Mesenchymal Stem Cell (MSC Definitions & Nomenclature)
4.2. Alternative Nomenclature
5. MSC Criteria & Characteristics
5.1 Discovery – Key Dates in the Discovery of Mesenchymal Stem Cells
5.2 Physical Assessment
5.3 Functional Attributes
5.4. Benefits of MSCs Relative to Other Stem Cells
6. MSC Isolation Sources
6.1 Adult Sources
6.2 Fetal Sources
7. Commercial Interest In MSC
7.1 Cell Types Derived from MSCs
7.2 Therapeutic Potential of MSCs
8. Introduction To Regenerative Medicine (RM Industry)
8.1 Regenerative Medicine (RM and Advanced Therapies Industry: A Brief Overview)
8.2 Global Breakdown of Regenerative Medicine (RM Industry by Region)
8.3 Breakdown of Global RM Companies by Type
8.4 Number of RM Clinical Trials by Phase of Development
8.5 Major Financial Events in the RM Industry
8.6 Major Partnerships and Acquisitions in RM Industry
8.7 Major Regulatory Milestones in RM Industry
8.8 Major Pharma and Biotech Companies Active in Advanced Therapies
8.9 Major Corporate Partnerships in RM Industry
8.10 Anticipated Major RM Clinical Events
9. Introduction To The Stem Cell Therapy Industry
9.1 Types of Stem Cells Used in Cell Therapy
9.2 Types of Stem Cells Used in Cell Therapy, by Differentiation Potential
10. Cell Therapy (CT Products: Successes And Failures)
10.1 Cell Therapy Product Candidates in Late-Stage Clinical Development
10.2 Cell Therapy Products Being Developed for Cardiovascular Indication
10.3 Cell Therapy Products Being Developed for Other Indications
10.4 Major Commercially Available Cell Therapy Products
10.5 Cell Therapy Products Approved in South Korea
10.6 Major Cell Therapies in Phase III
10.7 Clinical Trial Failures in Cell Therapy
11. The Market For Mesenchymal Stem Cell Therapies
11.1 Market Potential – All Stem Cell Types
11.2. Market Potential – Mesenchymal Stem Cells
11.3 Global Market for Stem Cells by Disease Indication
12. Research And Therapeutic Applications Of MSCs
12.1 Basic Research Applications
12.2 Cell Transplantation for Site-Specific Repair
12.3 Directed Differentiation of Mesenchymal Stem Cells
12.4 Drug Delivery Applications: Engineered MSCs as Carriers of Anti-Cancer Drugs
12.5 Drug Screening
12.6 Gene Transfer Studies
12.7 MSC-Mediated Inhibition of Immune Effector Cells
12.8 Supporting Hematopoietic Cell Applications
12.9 Use of 3-D Scaffolds for Tissue Engineering
12.10 Topical Therapy and Use of MSCs in Wound Healing
13. MSC Product Development Variables – Attributes & Acquisition
13.1 Biological Properties of MSCs Contributing to Therapeutic Effects
13.2 Factors Impacting MSCs Acquisition
13.3 Major Clinical Sources of MSCs
14. Clinical Applications Of Mesenchymal Stem Cells
14.1 Bone Marrow-Derived Mesenchymal Stem Cells (BMMSCs)
14.2 Adipose-Derived Mesenchymal Stem Cells (ADSCs)
14.3 Mesenchymal Stem Cells (MSCs Derived from Wharton’s Jelly
14.4 Umbilical Cord Blood-Derived MSCs (UCBMSCs)
14.5 Dominance of MSCs in Cell Therapy Clinical Trials
15. Major Diseases Addressed By MSCs In Current Clinical Trials
15.1 MSCs for Treating Liver Diseases
15.2 MSCs for Neurodegenerative Diseases
15.3 Clinical Trials Using MSCs for Autoimmune Diseases
15.4 Clinical Trials Using MSCs for Diabetes
15.5 MSCs for Cardiovascular Repair
15.6 MSCs for Musculoskeletal Diseases
15.7 MSCs in Neuron/Spinal Cord Diseases
15.8 MSC Infusion for GvHD
15.9 MSCs for Crohn’s Disease
15.10 MSCs in Wound Healing
15.11 Increasing Focus on Immunological Properties of MSCs
15.12 Selected MSCs Late-Stage Pipeline Cell Therapies
16. Market Opportunities For Biobanking Of Mesenchymal Stem Cells
16.1 Types of Mesenchymal Stem Cell Biobanking
16.2 Dental Stem Cell Banking (MSC Biobanking)
16.3 Umbilical Cord Tissue (MSC Biobanking)
16.4 Adipose-Derived MSCStorage
16.5 Other Types of MSCBio-Banking: Placental Tissue, Menstrual Stem Cells, Peripheral Blood Stem Cells, Bone Marrow Stem Cells, and More
17. Key Market Metrics Forf MSC
17.1 Global Breakdown of Mesenchymal Stem Cell Clinical Trials
17.2 Patent Analysis
17.3 Scientific Publication Analysis
17.4 Grant Rate Analysis
18. Social Analytics For Mesenchymal Stem Cells
18.1 Marketing Cost Analysis: Search Term “Mesenchymal Stem Cell”
18.2 MSC Articles Receiving Most Social Media Shares over Past 12 Months
18.3 Google Trend Data for MSCs
18.4 Twitter Hashtag Data
19. Selected Company Profiles
19.1 American Type Culture Collection Inc. (ATCC)
19.2 Anterogen Co., Ltd.
19.3 Apceth GmbH & Co. KG
19.4 BioCardia Inc.
19.5 BioRestorative Therapies Inc.
19.6 Bone Therapeutics SA
19.7 BrainStorm Cell Therapeutics Inc.
19.8 CellGenix Technologie Transfer GmbH
19.9 Celprogen Inc.
19.10 CellTherapies P/L
19.11 Cesca Therapeutics Inc.
19.12 Cyagen Biosciences Inc.
19.13 Cynata Therapeutics Ltd.
19.14 Cytori Therapeutics Inc.
19.15 Escape Therapeutics
19.17 Kite Pharma Inc.
19.18 Life Technologies Corporation
19.19 Lonza Group Ltd.
19.20 Medipost Co. Ltd.
19.21 Mesoblast Ltd.
19.22 NuVasive Inc.
19.23 Ocata Therapeutics Inc.
19.24 Organogenesis Inc.
19.25 Orthofix International N.V.
19.26 Osiris Therapeutics Inc.
19.27 Pluristem Therapeutics Inc.
19.29 Regeneus Ltd.
19.30 ScienCell Research Laboratories
19.31 STEMCELL Technologies Inc.
19.32 Stemedica Cell Technologies Inc.
19.33 Stempeutics Research Pvt. Ltd.
19.34 TiGenix N.V.
19.35 Vericel Corporation
List of Tables
Table 1. Adult Sources for Mesenchymal Stem Cell (MSC Isolation)
Table 2. Fetal Sources for Mesenchymal Stem Cell (MSC Isolation)
Table 3. Differentiation Capacity of Mesenchymal Stem Cells
Table 4. Global Breakdown of RM Companies by Region
Table 5. Global Breakdown of RM Companies by Type
Table 6. Number of RM Clinical Trials by Phase
Table 7. Major Financial Events in RM Industry in 2014
Table 8. Major Partnerships and Acquisitions in RM Industry in 2014
Table 9. Major Regulatory Milestones in RM Industry in 2014
Table 10. Major Pharma and Biotech Companies Active in Advanced Therapies
Table 11. Areas of Focus Among Large Pharmaceutical and Biotech Companies Involved with Advanced Therapies
Table 12. Major Corporate Partnerships in RM Industry in 2014
Table 13. Anticipated Major RM Clinical Events in 2015
Table 14. Different Types of Stem Cells Used in Cell Therapy and their Characteristics
Table 15. Mesenchymal Stem Cell Product Candidates in Late-Stage Clinical Development
Table 16. Cell Therapy Products Approved in South Korea
Table 17. Major Companies and Products in Development within Cell Therapy Sector
Table 18. Mesenchymal Stem Cell Research Applications
Table 19. Global Market for Stem Cell Therapies by Disease Indication, Through 2021
Table 20. Origin and Cell Types Derived from MSCs
Table 21. Important Bioactive Molecules Secreted by MSCs and Their Functions
Table 22. Immunomodulatory Effects of MSCs on Immune Cells
Table 23. Cell Surface Antigen Expressions of MSCs Isolated from Different Sources
Table 24. Major Clinical Sources of MSCs
Table 25. A Sample of Clinical Trials using BMMSCs for Kidney Diseases
Table 26. A Sample of Clinical Trials Using BMMSCs for Diabetes
Table 27. A Sample of Clinical Trials Using BMMSCs for Heart Disease
Table 28. A Sample of Clinical Trials Using BMMSCs for Liver Diseases
Table 29. Clinical and Experimental Therapies Using MSCs for Neural Diseases
Table 30. A Sample of Clinical Trials Using BMMSCs for Intestinal Diseases
Table 31. A Sample of Clinical Trials Using BMMSCs for Musculoskeletal Diseases
Table 32. ADSCs Transplantation in Clinical Trials by Region/Country in Phase III
Table 33. Selected ADSC Secretomes and their Functions
Table 34. A Summary of Clinical Trials Using WJ-MSCs
Table 35. Clinical Trials Using UCBMSCs and Targeted Diseases
Table 36. Clinical Trials Using MSCs by Disease Type, 2014
Table 37. A Sample of Clinical Trials Using MSCs for Liver Disorders
Table 38. A Sample of Clinical Trials Using MSCs for Neurodegenerative Diseases
Table 39. A Sample of Phase I and II Clinical Trials for Autoimmune Diseases as of 2012
Table 40. A Sample of Clinical Trials Using MSCs for Diabetes
Table 41. A Sample of Clinical Trials Using MSCs for Cardiovascular Diseases
Table 42. Clinical Trials Involving MSCs for Bone and Cartilage Repair
Table 43. Studies Using MSCs for Musculoskeletal Indications by Country
Table 44. A Sample of Current Clinical Trials Using MSCs for Osteoarthritis
Table 45. A Sample of Clinical Trials Involving MSCs for Bone and Cartilage Repair
Table 46. Sample of Clinical Trials in Different Countries Using MSCs for Neuron and Spinal Cord Diseases
Table 47. Clinical Experience of MSCs in GvHD Treatment
Table 48. A Sample of Clinical Trials Using MSCs for Crohn’s Disease
Table 49. Clinical Studies using MSCs for Wound Healing
Table 50. Number of MSC Scientific Publications about Immune/Inflammation by Year
Table 51. Selected MSCs Late-Stage Pipeline Cell Therapies
Table 52. Types of Mesenchymal Stem Cell Biobanking
Table 53. Companies Offering Dental Stem Cell Storage (Diversified Cord Blood Banks and Specialty Companies
Table 54. Medical Conditions Being Investigated for Potential to be Treated with Cord Tissue Derived Mesenchymal Stem Cells (CT-MSCs)
Table 55. U.S. Cord Blood Banks Offering Cord Tissue Storage in 2013
Table 56. U.S. Cord Blood Banks Offering Cord Tissue Storage in 2015
Table 57. Pricing Structures for Cord Tissue Storage
Table 58. Companies Offering Adipose-Derived MSC Storage (Both Diversified Cord Blood Banks and Specialty Companies)
Table 59. Geographical Breakdown of MSC Clinical Trial Activity
Table 60. Breakdown of MSC Clnical Trial Activity by Sponsoring/Collaborating Organization
Table 61. Industry Participants Sponsoring/Collaborating on MSC Clinical Trials
Table 62. Top Industry Participants Sponsoring/Collaborating on MSC Clinical Trials
Table 63. Mesenchymal Stem Cell Patents Filed in 2015
Table 64. Analysis of MSC Scientific Publications per Year
Table 65. Number of MSC Grant Rates, by Year (Reporter Analysis)
Table 66. Number of MSC Projects Funded by NIH Support by Year
Table 67. Amount of Funding for MSC Projects Supported by NIH by Year
Table 68. Geographical Assessment of MSC Grants Funded by NIH Support
Table 69. Leading Principal Investigators for MSC Research
Table 70. MSC Grants Funded by NIH-Support in 2015 Fiscal Year
Table 71. Breakdown of MSC Grants Funded by NIH-Support by Subject
Table 72. Google Adwords Pay-Per-Click (PPC Costs for MSCs
Table 73. Most Shared MSC Articles of the Past 12 Months
Table 74. Most Shared Stem Cell Articles of the Past 12 Months (All Stem Cell Types)
Table 75. Google Trend Data Showing Related Searches for “Mesenchymal Stem Cells” over a 5-Year History
Table 76. Google Trend Data Showing Related Searches for “Stem Cells” over a 5-Year History
Table 77. Rates of Twitter Usage by Country
Table 78. Top 10 Hashtags Related to “#Mesenchymal” on Twitter
Table 79.Top 10 Hashtags Related to “#StemCells” on Twitter
Table 80. Top 5 MSC Influencers on Twitter
Table 81. Top Five Stem Cell Influencers on Twitter
Table 82. BioCardia’s Product Pipeline Overview
Table 83. Bone Therapeutics’ Product Pipeline
Table 84. Cyagen’s Mesenchymal Cells
Table 85. Cyagen’s Adipose-Derived MSCs
Table 86. Gyagen’s MSCs with GFP
Table 87. Adipose-Derived Mesenchymal Cells with GFP
Table 88. Cyagen’s Stem Cell Culture Media
Table 89. Cyagen’s Stem Cell Differentiation Media
Table 90. Primary Cells from Cyagen
Table 91. Cyagen’s Cryopreservation Media
Table 92. Cyagen’s Primary Cell Culture Media
Table 93. General Cell Culture Supplements and Specialty Reagents from Cyagen
Table 94. Escape Therapeutics’ Pipeline Products
Table 95. Kite Pharma’s Pipeline and Clinical Trials
Table 96. Mesoblast’s Product Pipeline Overview
Table 97. Ocata’s Pipeline of Therapeutic Programs
Table 98. Regeneus’ Product Pipeline
Table 99. Stempeucel in Clinical Trials by Indication
Table 100. Vericel Corporation’s Product Portfolio
Table 101. Summary Table for the Companies and Their Product Types
List of Figures
Figure 1. Benefits of MSCs Relative to Other Stem Cells
Figure 2. Global Breakdown of RM Companies by Region
Figure 3. Major Financial Events in RM Industry in 2014
Figure 4. Major Partnerships and Acquisitions in RM Industry in 2014
Figure 5. Major Regulatory Milestones in RM Industry in 2014
Figure 6. Five Types of Stem Cells, by Differentiation Potential
Figure 7. Global Market for Stem Cell Therapies by Disease Indication, Through 2021
Figure 8. Clinical Trials Using MSCs by Disease Type, 2014
Figure 9. Number of MSC Scientific Publications about Immune/Inflammation by Year
Figure 10. Comparison of Umbilical Cord Blood vs. Umbilical Cord Tissue
Figure 11. Percentage of Mesenchymal Stem Cell (MSC Clinical Trials by Phase
Figure 12. Geographical Assessment of MSC Clinical Trial Activity
Figure 13. Breakdown of MSC Clinical Trial Activity by Sponsor/Collaborating Organization
Figure 14. Top Industry Participants Sponsoring/Collaborating on MSC Clinical Trials
Figure 15. Analysis of MSC Scientific Publications per Year
Figure 16. 5-Year Projections for MSC Scientific Publication Rates (2016-2020)
Figure 17. Google Adwords Price-Per-Click for Term “Mesenchymal Stem Cells” (Plural Search Term; U.S. Only)
Figure 18. Google Adwords Price-Per-Click for Term “Mesenchymal Stem Cell” (Singular Search Term; U.S. Only)
Figure 19. Google Adwords Price-Per-Click for Term “Mesenchymal Stem Cells” (Plural Search Term; Geography: Worldwide)
Figure 20. Google Adwords Price-Per-Click for Term “Mesenchymal Stem Cell” (Singular Search Term; Geography: Worldwide)
Figure 21. Search Terms Containing or Relating to the Phrase “Mesenchymal Stem Cell” (Geography: USA Only)
Figure 22. Search Terms Containing or Relating to the Phrase “Mesenchymal Stem Cell” (Geography: Worldwide)
Figure 23. Comparison of Google Trend Data for “Mesenchymal Stem Cells” (Plural vs. “Mesenchymal Stem Cell” (Singular over a 10-Year History)
Figure 24. Google Trend Data for “Mesenchymal Stem Cells” over a 5-Year History
Figure 25. Google Trend Data Showing Regional Interest in “Mesenchymal Stem Cells” over a 5-Year History
Figure 26. Google Trend Data Showing City-by-City Interest in “Mesenchymal Stem Cells” over a 5-Year History
Figure 27. Groundbreaking Years in Hematopoietic Stem Cell Transplant History
Figure 28. Google Trend Data for “Stem Cells” over a 10-Year History
Figure 29. Google Trend Data – Comparison of All Types of Stem Cells over a 5-Year History
Figure 30. Google Trend Data Showing Regional Interest in “Stem Cells” over a 5-Year History
Figure 31. Google Trend Data Showing City-by-City Interest in “Stem Cells” over a 5-Year History
Figure 32. Top 10 Hashtags Related to “#Mesenchymal” on Twitter
Figure 33. Top 10 Hashtags Related to “#StemCells” on Twitter
– American Type Culture Collection Inc. (ATCC)
– Anterogen Co., Ltd.
– Apceth GmbH & Co. KG
– BioCardia Inc.
– BioRestorative Therapies Inc.
– Bone Therapeutics SA
– BrainStorm Cell Therapeutics Inc.
– CellGenix Technologie Transfer GmbH
– CellTherapies P/L
– Celprogen Inc.
– Cesca Therapeutics Inc.
– Cyagen Biosciences Inc.
– Cynata Therapeutics Ltd.
– Cytori Therapeutics Inc.
– Escape Therapeutics
– Kite Pharma Inc.
– Life Technologies Corporation
– Lonza Group Ltd.
– Medipost Co. Ltd.
– Mesoblast Ltd.
– NuVasive Inc.
– Ocata Therapeutics Inc.
– Organogenesis Inc.
– Orthofix International N.V.
– Osiris Therapeutics Inc.
– Pluristem Therapeutics Inc.
– Regeneus Ltd.
– STEMCELL Technologies Inc.
– ScienCell Research Laboratories
– Stemedica Cell Technologies Inc.
– Stempeutics Research Pvt. Ltd.
– TiGenix N.V.
– Vericel Corporation
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