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Mesenchymal Stem Cells - Advances & Applications, 2019

Published By :

BioInformant

Published Date : Jul 2019

Category :

Stem Cell

No. of Pages : 224 Pages

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.

Table of Content

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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