Description
Global Strategic Report
October 2019; 224 Pages
Mesenchymal stem cells (MSCs) are multipotent cells that can differentiate into a variety of cell types, including osteoblasts, chondrocytes, myocytes, adipocytes, and 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. MSCs are also well-suited for use in the exponential growth field 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 exploring commercialization strategies for MSC-derived extracellular vesicles (EVs) and exosomes, because these extracelluar “packages” 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 within regenerative medicine, there is huge potential for growth within the MSC market. There are more than one-hundred thousand scientific publications published about MSCs, as well as 900+ MSC clinical trials underway worldwide, including trials within the U.S., E.U., China, Middle East, and South Korea.
While many early-stage MSC trials have demonstrated safety and efficacy, only a small number have reached Phase III, indicating that a limited number of MSC products have near-term market potential and the therapeutic market for MSCs remains early-stage.
As of 2019, ten MSC-based products have received regulatory approvals, including nine cell therapy approvals and one tissue engineering approval. Population aging and an increasing prevalence of chronic disease are also driving interest in MSC-based therapies, with Google Trend data revealing that MSC searches are more than twice as common as the next most common stem cell type.
The main objectives of this report are to provide the reader with the following details:
- A brief overview of the MSC industry
- Biological factors secreted by MSCs
- The manufacturing process of MSCs
- Bioreactors used in the manufacture of MSCs
- Microcarriers used for the expansion of MSCs
- Cost of manufacturing autologous and allogeneic MSCs
- Services offered by CMOs/CDMOs in the manufacture of MSCs
- Major diseases addressed by MSCs in the ongoing clinical trials
- Consumption of MSCs for academic research, clinical trials, product development, and exosome production
- Brief account of approved cell therapy, gene therapy and tissue engineering products
- Details of approved MSC-based cell therapeutics
- Recent business developments pertinent to MSCs
- Market size determinations for MSCs and MSC-based products
- Details of products and product candidates developed by companies which are focusing exclusively on MSCs
Key questions answered in the report are:
- How many MSC-based products have been approved so far?
- Which countries have approved the products?
- What are the various names within the scientific literature to indicate MSCs?
- What are the functions of MSCs?
- Which tissue sources yield MSCs?
- What cell types do the MSCs differentiate into?
- What are the soluble factors secreted by MSCs and what functions do the soluble factors perform?
- What types of bioreactors are used for culturing and expanding the MSCs?
- How much do allogeneic and autologous MSCs cost?
- Which are the major cell manufacturing facilities in the U.S.?
- Which are the major cell manufacturing facilities in Europe?
- What are the major disease types addressed by MSCs in the ongoing clinical trials?
- What is the current consumption of MSCs in academic and preclinical settings?
- What is the current consumption and future demand for MSCs for developing cell therapies?
- What MSC-based products have been approved?
- What is the global market size for MSCs being used within academic research, preclinical studies, clinical trials and product development?
- What is the global market size for the approved MSC-based therapeutics from 2018 to 2025?
- Who are the leading competitors involved with developing MSC-based therapeutics?
As the first and only market research firm to specialize in the stem cell industry, BioInformant has a unique understanding of the rapidly evolving MSC Industry. Founded in 2006, BioInformant has collected more than 13 years of historical data on the industry, providing it with a robust historical database of data on which to make future market projections. Headquartered in Washington, DC, BioInformant is strategically positioned near industry lawmakers, the National Institutes of Health (NIH), U.S. FDA, and the Maryland Biotech Corridor, among other critical resources. In addition to leveraging an experienced team of analysts, this experience provides BioInformant with access to Key Opinion Leaders (KOLs) from across the MSC sector, including dozens of executives who were interviewed for this report.
As the world’s first and only market research firm to specialize in the stem cell industry, BioInformant has conducted interviews with representatives from Cynata Therapeutics (first company to bring a iPSC-derived MSC therapeutic product into a clinical trial), RoosterBio (specializes in manufacturing tens of billions of MSCs 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 more. With research cited by major news outlets that include the Wall Street Journal, Nature Biotechnology, Xconomy, and Vogue Magazine, BioInformant is your global leader in stem cell industry data.
Table of Contents
1. REPORT OVERVIEW
1.1 Statement of the Report
1.2 Executive Summary
2. MESENCHYMAL STEM CELLS (MSCS): AN INTRODUCTION
2.1 The Various Names for MSCs
2.3 Timeline of MSC Nomenclature
2.4 Functions of MSCs
2.5 Sources of MSCs
2.5.1 Bone Marrow-Derived MSCs (BM-MSCs)
2.5.2 Adipose-Derived MSCs (AD-MSCs)
2.5.2.1 Comparison of Yield by Isolation Method
2.5.3 Umbilical Cord-Derived MSCs (UC-MSCs)
2.6 Cell Surface Markers in MSCs
2.7 In Vitro Differentiation Potential of MSCs
2.8 Soluble Factors Secreted by MSCs
3. MANUFACTURE OF MESENCHYMAL STEM CELLS
3.1 Methods of Isolation of MSCs
3.2 From Conventional Cultures to Bioreactors
3.2.1 Monolayer Culture Systems
3.2.2 Bioreactor-Based Cell Expansion
3.2.2.1 Stirred Tank Bioreactor
3.2.2.2 Rocking Bioreactor
3.2.2.3 Hollow Fiber Bioreactors
3.2.2.4 Fixed-Bed Bioreactors
3.2.3 Main Features of the Commercial Bioreactors
3.2.4 Microcarriers used for the Expansion of MSCs
3.3 Downstream Processing of hMSCs
3.3.1 Cell Detachment and Separation
3.3.2 Cell Washing and Concentration
3.3.3 Safety and Potency Assays
3.4 Surface Markers for Identification
3.4 MSC Manufacturing Bottlenecks and Solutions
4. COMPARISON OF AUTOLOGOUS & ALLOGENEIC CELL MANUFACTURING
4.1 Manufacturing of Allogeneic Cells
4.2 Cost Differential
4.3 Donor Screening and Testing
4.4 Release Testing
4.5 Comparison of the Two Business Models
4.5.1 Risk of Immune Reaction
4.5.2 Risk of Cross Contamination
4.5.3 Commercially Attractive Option
5. COST OF CELL MANUFACTURING
5.1 Cost Breakdown
5.2 Opportunities for Cost Reduction
5.3 Partial Automation vs. Full Automation
5.4 Partial Automation: Most Attractive Option
6. CONTRACT MANUFACTURING OF MSCs
6.1 CMOS
6.2 CDMOs
6.2.1 Opportunities for MSC Equipment and Media System Developers
6.3 Leading Cell Therapy CMOS
6.4 Global Cell Manufacturing Capacity
7. DISEASES ADDRESSED BY MSCS IN CLINICAL TRIALS
7.1 MSCs in Hematological Diseases and Graft-versus-Host Diseases (GvHD)
7.2 MSCs in Cardiovascular Diseases
7.3 MSCs in Neurological Diseases
7.4 MSCs in Bone and Cartilage Diseases
7.5 MSCs in Lung, Liver, and Kidney Diseases
8. CLINICAL TRIALS LANDSCAPE OF MSCS
8.1 Phases of Studies
8.2 Sources of Cells for Clinical Trials using MSCs
8.3 Share of Autologous vs. Allogeneic Transfusions of MSCs in Clinical Trials
8.4 MSC-Based Clinical Trial Location by Geography
9. CONSUMPTION OF MSCS
9.1 Consumption of MSCs within Cardiac Applications
9.2 Dosing of MSCs within Cell Therapy and Tissue Engineering
9.3 Rates of MSCs Scientific Publications
9.4 Frequency of MSC Online Searches (Google Trends)
9.5 Pricing of MSCs
9.6 Disruptive Technologies to Threaten the Demand for MSCs)
10. APPROVED CELL-BASED MEDICINAL PRODUCTS
10.1 Approved Cell-Based Medicinal Products by Region/Country
10.2 Approved Cell-Based Medicinal Products by Therapy Type
10.3 Major Cell Types used in Approved Cell-Based Medicinal Products
10.4 Price of Cell-Based Therapies
10.5 MSC-Based Medicinal Products
10.5.1 Alofisel
10.5.2 Chondrocytes-T-Ortho-ACI
10.5.3 Spherox
10.5.4 Ossgrow
10.5.5 Stempeucel
10.5.6 Prochymal (remestemcel-L)
10.5.7 Temcell HS
10.5.8 Neuronata-R
10.5.9 Cupistem
10.5.10 Cellgram-AMI
11. RECENT BUSINESS DEVELOPMENTS IN MSCS AND RELATED SECTORS
11.1 Novartis to Acquire CELLforCURE
11.2 Novartis’ Agreement with Cellular Biomedicine Group
11.3 AveXis to Acquire a Biologics Manufacturing Campus in Longmont
11.4 The Leasing of Hoofddorp Facility by Kite Pharma
11.4.1 Other Additions to Kite Pharma
11.5 Celgene’s New Manufacturing Center
11.6 Roche to Acquire Spark Therapeutics
11.7 Astella Pharma’s New Facilities
11.8 Novo Nordisk to have a New Facility in Fremont
11.9 Catalent to Acquire Paragon Bioservices
11.10 Paragon’s New Facility
11.11 Thermo Fisher Scientific to Acquire the CDMO, Brammer Bio
11.12 Lonza’s Acquisition of Octane Biotech
11.13 Lonza Installing Multiple Cell Therapy Suites
11.14 Fujifilm’s New GMP Production Facility
11.15 Bluebird bio’s New Facility in Durham
11.16 Allogene Therapeutics’ Facility in Newark
11.17 Rubius Therapeutics’ Facility in Rhode Island
11.18 Hitachi Chemical to Acquire Apceth Biopharma
12. MARKET ANALYSIS
12.1 Global Market for Mesenchymal Stem Cells (MSCs)
12.2 Global Market for MSCs and MSC-Based Therapeutics
13. COMPANY PROFILES
13.1 AlloSource, Inc
13.1.1 ProChondrix CR
13.1.2 AlloFuse (Cellular Allograft Matrix)
13.2 American Type Culture Collection (ATCC)
13.2.1 Stem Cell Products
13.3 Anterogen, Co., Ltd
13.3.1 Cupistem Injection
13.3.2 Queencell
13.4 Athersys, Inc
13.4.1 MultiStem
13.5 BioCardia, Inc.
13.6 Brainstorm Cell Therapeutics, Inc.
13.6.1 Autologous MSC-NTF Cells
13.7 CellGenix Technologie Transfer GmbH
13.7.1 Products
13.8 Celltex Therapeutics Corporation
13.8.1 Banking Services
13.8.2 Therapies
13.9 Cesca Therapeutics, Inc.
13.9.1 CellXpress (CXP)
13.9.2 CXP + BioArchive
13.9.3 PXP
13.9.4 AutoXpress (AXP)
13.9.5 CAR-TXpress
13.10 Cynata Therapeutics Ltd.
13.10.1 Cymerus Platform
13.11 CO.DON AG
13.11.1 Spherox
13.12 Corestem, Inc
13.12.1 NeuroNATA-R
13.13 Cytori Therapeutics, Inc
13.13.1 Cytori Cell Therapy
13.14 Escape Therapeutics, Inc
13.15 HemaCare Corporation
13.15.1 Products
13.16 Invitrx Therapeutics, Inc
13.16.1 Invitra CBSC
13.16.2 Invitra WJ-C
13.17 iXCells Biotechnologies
13.17.1 Products
13.18 JCR Pharmaceuticals, Co., Ltd.
13.18.1 STEMCELL HS Inj
13.19 MEDIPOST, CO., Ltd.
13.19.1 CARTISTEM
13.19.2 PNEUMOSTEM
13.19.3 NEUROSTEM
13.20 Mesoblast Ltd
13.20.1 Product Candidates
13.21 NuVasive, Inc
13.21.1 Osteocel Plus
13.22 Orthocell, Ltd
13.22.1 Ortho-ATI
13.22.2 Ortho-ACI
13.22.3 CelGro
13.23 Osiris Therapeutics, Inc
13.23.1 Grafix PRIME & GrafixPL PRIME
13.23.2 Stravix
13.23.3 Cartiform
13.23.4 BIO
13.23.5 Prochymal
13.24 Pharmicell, Co., Ltd
13.24.1 Cellgram-AMI
13.25 Pluristem Therapeutics, Inc.
13.25.1 PLX Products
13.26 Regeneus, Ltd.
13.27 Reliance Life Sciences
13.27.1 Products
13.28 RoosterBio, Inc.
13.28.1 Products
13.29 San-Bio, Inc.
13.30 ScienCell Research Laboratories, Inc
13.30.1 Products
13.31 StemBioSys, Inc
13.31.1 CELLvo Matrix Technology
13.31.2 CELLvo Cells Technology
13.32 STEMCELL Technologies Canada, Inc
13.32.1 Products
13.33 Stempeutics Research Pvt., Ltd.
13.33.1 Stempeucel
13.33.2 Stempeutron
13.33.3 Stempeucare (Cutisera)
13.34 Takeda Pharmaceuticals U.S.A. Inc
13.34.1 Alofisel
14. MSC-DERIVED EXOSOMES AND EVs
14.1. Characteristics of MSC-Derived Exosomes
14.2 Advantages of MSC-Derived Exosomes
14.3 Therapeutic Effects of MSC-Derived Exosomes
14.4 Characterization of MSC-Derived Exosomes
14.5 Patent Analysis for MSC-Derived Exosomes
15. REGULATORY OVERSIGHT OF MSC THERAPEUTICS
List of Figures
Figure 3.1: Monolayer Culture Systems
Figure 3.2: Stirred Tank Bioreactor
Figure 3.3: Rocking Bioreactor
Figure 3.4: Hollow Fiber Bioreactors
Figure 3.5: Fixed-Bed Bioreactor
Figure 4.1: Annual Cost of Manufacturing Autologous and Allogeneic Cells
Figure 5.1: Cost of Goods (CoG) Breakdown in Autologous Cell Manufacturing
Figure 5.2: Impact of HeadCount on Overall COG per Batch
Figure 5.3: CoG Breakdown in Partially-Automated Cell Manufacturing
Figure 5.4: CoG Breakdown in Fully-Automated Cell Manufacturing
Figure 8.1: Major Diseases Addressed by MSCs in Clinical Trials
Figure 8.2: The Percent Share of MSC-Based Studies under Different Phases
Figure 8.3: Percent Share of Sources of Cells for Clinical Trials using MSCs
Figure 8.4: Share of Autologous vs. Allogeneic Transfusions of MSCs in Clinical Trials
Figure 8.5: MSC-Based Clinical Trial Location by Geography
Figure 10.1: Approved Cell-Based Medicinal Products by Region/Country
Figure 10.2: Approved Cell-Based Medicinal Products by Therapy Type
Figure 10.3: Approved Cell-Based Medicinal Products by Cell Type
Figure 12.1: Global Market for Mesenchymal Stem Cells by Geography, 2018-2025
Figure 12.2: Global Market for MSCs and MSC-Based Therapeutics, 2018-2025
List of Tables
Table 2.1: Timeline of MSC Nomenclature
Table 2.2: Adult Sources of MSC Isolation
Table 2.3: Fetal Sources of MSCs
Table 2.4: Advantages and Disadvantages of Bone Marrow-Derived MSCs
Table 2.5: Advantages and Disadvantages of Adipose-Derived MSCs
Table 2.6: Comparison of Yield and Viability of AD-MSCs by Isolation Methods
Table 2.7: Advantages and Disadvantages of Umbilical Cord-Derived MSCs
Table 2.8: Positive and Negative Markers for MSCs Derived from Different Sources
Table 2.9: In vitro Differentiation Potential of MSCs
Table 2.10: Soluble Factors Secreted by MSCs
Table 2.11: Biological Functions of Soluble Factors Secreted by MSCs
Table 3.1: MSC Discovery, Characterization, and Clinical Applications
Table 3.2: Methods of Isolation and Required Culture Media
Table 3.3: Monolayer Culture Systems and Bioreactors
Table 3.4: Main Features of Commercially Available Bioreactors
Table 3.5: Microcarriers used in Bioreactors
Table 3.6: Basic Assays for MSCs
Table 3.7: Surface Markers Present in MSCs and Fibroblasts
Table 4.1: Comparison of Allogeneic and Autologous Therapies
Table 5.1: Cost of Goods in the Manufacture of Cells
Table 5.2: CoG Breakdown in Partially-Automated Cell Manufacturing
Table 5.3: CoG Breakdown in Fully-Automated Cell Manufacturing
Table 5.4: Higher Throughput in Partly Automated Facilities
Table 6.1: Global Distribution of CMOS
Table 7.1: Examples of On-Going MSC-Based Clinical Trials Addressing GvHD
Table 7.1: Examples of On-Going MSC-Based Clinical Trials Addressing Heart Diseases
Table 7.3: MSC-Based Clinical Trials Addressing Neurological Diseases
Table 7.4: MSC-Based Clinical Trials to Address Orthopedic Disorders
Table 7.9: MSC-Based Clinical Trials Addressing Liver Disorders
Table 8.1: Major Diseases Addressed by MSCs in Clinical Trials
Table 10.1: Approved Cell-Based Medicinal Products
Table 10.2: Prices of Cell and Gene-Based Therapies
Table 10.3: MSC-Based Approved Products
Table 12.1: Global Market for MSCs by Geography, 2018-2025
Table 12.2: Global Market for MSCs and MSC-Based Therapeutics, 2018-2025
Table 13.1: Athersy’s Product Candidates using MultiStem Cells
Table 13.2: BioCardia’s Product Pipeline
Table 13.3: Brainstorm’s Product Pipeline
Table 13.4: Cynata’s Product Candidates
Table 13.5: Corestem’s Product/Product Candidates
Table 13.6: Escape Therapeutics’ Product Pipeline
Table 13.7: Mesoblast’s MSC-Based Products/Product Candidates
Table 13.8: Pharmicell’s MSC-Based Products in Development
Table 13.9: Pluristem’s Product Pipeline
Table 13.10: Regeneus’ Human Health Development Pipeline
Table 13.11: San-Bio’s Product Pipeline
Table 13.12: Stempeutics’ Product Candidates
Companies Mentioned
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About BioInformant
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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