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.