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Mesenchymal Stem Cells - Advances & Applications, 2019

Mesenchymal Stem Cells - Advances & Applications, 2019

EXECUTIVE SUMMARY


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. 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.


  • REPORT OVERVIEW
    • Statement of the Report
    • Target Demographic
    • Report Sources
    • Purpose
      • To Survey Recent MSC Advancements
      • To Provide a "Snapshot" of the Global MSC Market
      • To Assess Opportunities for Commercialization
      • To Identify Major Market Players and Assess the Competitive Environment
      • To Identify Existing and Emerging Trends
      • To Identify Critical Opportunities and Threats within the MSC Market
    • Executive Summary
  • MESENCHYMAL STEM CELLS (MSCS): AN INTRODUCTION
    • The Various Names for MSCs
    • Timeline of MSC Nomenclature
      • Table Timeline of MSC Nomenclature
    • Sources of MSCs
      • Adult Sources
        • Table Adult Sources for Mesenchymal Stem Cell (MSC) Isolation
      • Fetal Sources
        • Table Fetal Sources for Mesenchymal Stem Cell (MSC) Isolation
      • Bone Marrow-Derived MSCs (BM-MSCs)
        • Table Advantages and Disadvantages of Bone Marrow-Derived MSCs
      • Adipose-Derived MSCs (AD-MSCs)
        • Table Advantages and Disadvantages of Adipose-Derived MSCs
      • Comparison of Yield by Isolation Method
        • Table Comparison of Yield and Viability of AD-MSCs by Isolation Methods
      • Umbilical Cord-Derived MSCs (UC-MSCs)
        • Table Advantages and Disadvantages of Umbilical Cord-Derived MSCs
    • Cell Surface Markers in MSCs
      • Table Positive and Negative Markers for MSCs Derived from Different Sources
    • In Vitro Differentiation Potential of MSCs
      • Table In Vitro Differentiation Potential of MSCs
    • Soluble Factors Secreted by MSCs
      • Table Soluble Factors Secreted by MSCs
      • Table Biological Functions of Soluble Factors Secreted by MSCs
    • Benefits of MSCs Relative to Other Stem Cells
      • Well-Characterized
      • Non-Controversial
      • Diverse Differentiation Potential
      • Ease of Growth in Culture
      • Flexible Propagation
      • Clinically Relevant Volumes
      • Role as Regulatory Cells
      • Delivery of Gene Products
      • Favorable Immune Status
      • Commercially Available Research Tools
    • Commerical Interest in MSCs
      • Table Differentiation Capacity of Mesenchymal Stem Cells
  • MANUFACTURE OF MESENCHYMAL STEM CELLS
    • Table MSC Discovery, Characterization and Clinical Applications
    • Methods of Isolation of MSCs
      • Table Methods of Isolation and Required Culture Media
    • From Conventional Cultures to Bioreactors
      • Monolayer Culture Systems
      • Bioreactor-Based Cell Expansion
        • Table Monolayer Culture Systems and Bioreactors
      • Main Features of the Commercial Bioreactors
        • Table Main Features of Commercially Available Bioreactors
      • Microcarriers used for the Expansion of MSCs
        • Table Microcarriers used in Bioreactors
    • Downstream Processing of hMSCs
      • Cell Detachment and Separation
      • Cell Washing and Concentration
      • Safety and Potency Assays
        • Table Basic Assays for MSCs
    • Surface Markers for Identification
      • Table Surface Markers Present in MSCs and Fibroblasts
  • COMPARISON OF AUTOLOGOUS & ALLOGENEIC CELL MANUFACTURING
    • Manufacturing of Allogeneic Cells
    • Cost Differential
    • Donor Screening and Testing
    • Release Testing
    • Comparison of the Two Business Models
      • Risk of Immune Reaction
      • Risk of Cross Contamination
      • Commercially Attractive Option
        • Table Comparison of Allogeneic and Autologous Therapies
  • COST OF CELL MANUFACTURING
    • Cost Breakdown
      • Table Cost of Goods in the Manufacture of Cells
    • Opportunities for Cost Reduction
    • Partial Automation vs. Full Automation
      • Table Cost of Good (CoG) Breakdown in Partially-Automated Cell Manufacturing
      • Table CoG Breakdown in Fully-Automated Cell Manufacturing
    • Partial Automation: Most Attractive Option
      • Table Higher Throughput in Partly Automated Facilities
    • MSC Manfacturing Bottlenecks and Solutions
  • CONTRACT MANUFACTURING OF MSCs
    • CMOs
    • CDMOs
      • Opportunities for MSC Equipment and Media System Developers
        • Table Bioreactor Start-Up Kits for MSC Manufacturing by RoosterBio
      • Expansion of CMO and CDMO Manufacturing Capacity
    • Autologous vs. Allogeneic MSC Therapy Manufacturing
    • Leading Cell Therapy CMOs
      • Table Global Distribution of CMOs
    • Global Cell Manufacturing Capacity
      • Cell Therapy Manufacturing Partnerships
  • DISEASES ADDRESSED BY MSCS IN CLINICAL TRIALS
    • MSCs in Hematological Diseases and Graft-versus-Host Diseases (GvHD)
      • Table Examples of On-Going MSC-Based Clinical Trials Addressing GvHD
    • MSCs in Cardiovasculr Diseases
      • Table Examples of On-Going MSC-Based Clinical Trials Addressing Heart Diseases
    • MSCs in Neurological Diseases
      • Table MSC-Based Clinical Trials Addressing Neurological Diseases
    • MSCs in Bone and Cartilage Diseases
      • Table MSC-Based Clinical Trials to Address Orthopedic Disorders
    • MSCs in Lung, Liver and Kidney Diseases
      • Table MSC-Based Clinical Trials Addressing Liver Disorders
  • CLINICAL TRIALS LANDSCAPE OF MSCS
    • Table Major Diseases Addressed by MSCs in Clinical Trials
    • Phases of Studies
    • Sources of Cells for Clinical Trials using MSCs
    • Share of Autologous vs. Allogeneic Transfusions of MSCs in Clinical Trials
    • MSC-Based Clinical Trial Location by Geography
  • CONSUMPTION OF MSCS
    • Consumption of MSCs within Cardiac Applications
    • Dosing of MSCs within Cell Therapy and Tissue Engineering Products
    • Rates of MSC Scientific Publications
      • Table Number of MSC Scientific Publications By Year
    • Frequency of MSC Online Searches (Google Trends)
    • Pricing of MSCs
      • Expanding Utilization of MSCs within New Market Applications
      • Manufacturing MSCs in Unlimited Quantities – Cynata Therapeutics
    • Disruptive Technologies to Threaten the Demand for MSCs
  • APPROVED CELL-BASED MEDICINAL PRODUCTS
    • Table Approved Cell-Based Medicinal Products
    • Approved Cell-Based Medicinal Products by Region/Country
    • Approved Cell-Based Medicinal Products by Therapy Type
    • Major Cell Types used in Approved Cell-Based Medicinal Products
    • Price of Cell-Based Therapies
      • Table Prices of Cell and Gene-Based Therapies
    • MSC-Based Medicinal Products
      • Alofisel
      • Chondrocytes-T-Ortho-ACI
      • Spherox
      • Ossgrow
      • Stempeucel
      • Prochymal (remestemcel-L)
      • Temcell HS
      • Neuronata-R
      • Cupistem
      • Cellgram-AMI
        • Table MSC-Based Approved Products
  • RECENT BUSINESS DEVELOPMENTS IN MSCS AND RELATED SECTORS
    • Novartis to Acquire CELLforCURE
    • Novartis' Agreement with Cellular Biomedicine Group
    • AveXis to Acquire a Biologics Manufacturing Campus in Longmont
    • The Leasing of Hoofddorp Facity by Kite Pharma
      • Other Additions to Kite Pharma
    • Celgene's New Manufacturing Center
    • Roche to Acquire Spark Therapeutics
    • Astella Pharma's New Facilities
    • Novo Nordisk to have a New Facility in Fremont
    • Catalent to Acquire Paragon Bioservices
    • Paragon's New Facility
    • Thermo Fisher Scientific to Acquire the CDMO, Brammer Bio
    • Lonza's Acquisition of Octane Biotech
    • Lonza Installing Multiple Cell Therapy Suites
    • Fujifilm's New GMP Production Facility
    • Bluebird bio's New Facility in Durham
    • Allogene Therapeutics' Facility in Newark
    • Rubius Therapeutics' Facility in Rhode Island
    • Hitachi Chemical to Acquire Apceth Biopharma
  • MARKET ANALYSIS
    • Global Market for Mesenchymal Stem Cells (MSCs)
      • Table Global Market for MSCs by Geography, 2018-2025
    • Global Market for MSCs and MSC-Based Therapeutics
      • Table Global Market for MSCs and MSC-Based Therapeutics, 2018-2025
  • COMPANY PROFILES
    • AlloSource, Inc.
      • ProChondrix CR
      • AlloFuse (Cellular Allograft Matrix)
    • American Type Culture Collection (ATCC)
      • Stem Cell Products
    • Anterogen, Co., Ltd.
      • Cupistem Injection
      • Queencell
    • Athersys, Inc.
      • MultiStem
        • Table Athersy's Product Candidates using MultiStem Cells
    • BioCardia, Inc.
      • Table BioCardia's Product Pipeline
    • Brainstorm Cell Therapeutics, Inc.
      • Autologous MSC-NTF Cells
        • Table Brainstorm's Product Pipeline
    • CellGenix Technologie Transfer GmbH
      • Products
    • Celltex Therapeutics Corporation
      • Banking Services
      • Therapies
    • Cesca Therapeutics, Inc.
      • CellXpress (CXP)
      • CXP + BioArchive
      • PXP
      • AutoXpress (AXP)
      • CAR-TXpress
    • Cynata Therapeutics Ltd.
      • Cymerus Platform
        • Table Cynata's Product Candidates
    • CO.DON AG
      • Spherox
    • Corestem, Inc.
      • NeuroNATA-R
        • Table Corestem's Product/Product Candidates
    • Cytori Therapeutics, Inc.
      • Cytori Cell Therapy
    • Escape Therapeutics, Inc.
      • Table Escape Therapeutics' Product Pipeline
    • HemaCare Corporation
      • Products
    • Invitrx Therapeutics, Inc.
      • Invitra CBSC
      • Invitra WJ-C
    • iXCells Biotechnologies
      • Products
    • JCR Pharmaceuticals, Co., Ltd.
      • TEMCELL HS Inj.
    • MEDIPOST, CO., Ltd.
      • CARTISTEM
      • PNEUMOSTEM
      • NEUROSTEM
    • Mesoblast Ltd.
      • Product Candidates
        • Table Mesoblast's MSC-Based Products/Product Candidates
    • NuVasive, Inc.
      • Osteocel Plus
    • Orthocell, Ltd.
      • Ortho-ATI
      • Ortho-ACI
      • CelGro
    • Osiris Therapeutics, Inc.
      • Grafix PRIME & GrafixPL PRIME
      • Stravix
      • Cartiform
      • BIO4
      • Prochymal
    • Pharmicell, Co., Ltd.
      • Cellgram-AMI
        • Table Pharmicell's MSC-Based Products in Development
    • Pluristem Therapeutics, Inc.
      • PLX Products
        • Table Pluristem's Product Pipeline
    • Regeneus, Ltd.
      • Table Regeneus' Human Health Development Pipeline
    • Reliance Life Sciences
      • Products
    • RoosterBio, Inc.
      • Products
    • San-Bio, Inc.
      • Table San-Bio's Product Pipeline
    • ScienCell Research Laboratories, Inc.
      • Products
    • StemBioSys, Inc.
      • CELLvo Matrix Technology
      • CELLvo Cells Technology
    • STEMCELL Technologies Canada, Inc.
      • Products
    • Stempeutics Research Pvt., Ltd.
      • Stempeucel
      • Stempeutron
      • Stempeucare (Cutisera)
        • Table Stempeutics' Product Candidates
    • Takeda Pharmaceuticals U.S.A. Inc.
      • Alofisel
  • MSC-DERIVED EXOSOMES AND EVs
    • Key Characteristics of MSC-Derived Exosomes
      • Table Key Characteritics of Exosomes
    • Advantages of MSC-Derived Exosomes
    • Therapeutic Effects of MSC-Derived Exosomes
    • Charactertization of MSC-derived Exosomes
      • Table Methods for Characterizing MSC-Derived Exosomes
    • Patent Analysis for MSC-Derived Exosomes
      • Table MSC-Derived Exosome Patents (Title Only; Google Patent Search)
  • REGULATION OF MSC THERAPEUTICS
    • 21st Century Cures Act and REGROW Act
    • Accelerated Approval Pathways in Japan
    • Accelerated Approval Pathways Worldwide
  • APPENDIX
    • Interview with Dr. Ross Macdonald, CEO of Cynata Therapeutics
    • Interview with Dr. Paul Wotton, Board Member of Cynata Therapeutics and Previous CEO of Ocata Therapeutics
    • Interview with Dr. Jon Rowley, Founder and CTO of RoosterBio, Inc.
    • Interview with Dr. Priya Baraniak, Director of BD & Strategic Marketing at RoosterBio, Inc.
    • Interview with Mr Yaky Yanay, President and Co-CEO of Pluristem Therapeutics
    • Interview with Mr Alec Lee, President and Extem Bioscience
    • Philip Askenase, MD, Professor of Medicine and Pathology at Yale University School of Medicine (Leading Authority in MSC-Derived Exosomes)

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