Executive Summary – Mesenchymal Stem Cells – Advances & Applications
BioInformant, the only market research firm to exclusively serve the stem cell sector, announces the release of its global strategic report, “Mesenchymal Stem Cells – Advances and Applications.” Published November 2015, it presents 250 pages of coverage for the rapidly-evolving mesenchymal stem cell (MSC) industry.
Called the "most innovative market research firm in the world,” BioInformant tracks MSC industry metrics using continuously maintained dashboards combined with systems to trigger alerts when data exhibits unexpected variation.
A unique attribute of BioInformant is that its management team comes from a BioInformatics background – the science of collecting and analyzing complex biological data. BioInformant is the only known research firm to apply these data analysis techniques to the field of market research. This is important, because 2015 saw the first “thaw and use” ink to make MSCs readily available for 3D printing (RoosterBio and CELLINK), a novel manufacturing approach to produce a nearly unlimited supply of MSCs from iPSCs derived from a single donor (Cynata Therapeutics), and the recommendation for approval of a MSC product in Japan (JR-031 developed by Mesoblast's Japanese partner, JCR Pharmaceuticals Co. Ltd). It is clear that the scope of the MSC industry is expanding and advanced analytics are required.
In addition, the 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 also gives an overview of the regenerative medicine industry and overall cell therapy industry.
The report 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.
BioInformant has a Decade of Historical Data and Utilizes Continuously Maintained Dashboards
Founded in 2006 in Washington, DC, BioInformant is distinctively suited to tracking the MSC industry, because it has been following the industry for a decade, providing a robust database of historical data.
Importantly, BioInformant is always innovating. It tracks traditional market metrics, which include trend rate data for MSC clinical trials, scientific publications, grants, patents, product launches, new market entrants, industry acquisitions, collaborations, and more. However, it also tracks recently discovered social analytics, which are metrics derived from social media sites, search engines, online advertising platforms, and more. It is the only known research firm to take this duel-approach to market analysis.
Another unique attribute of BioInformant is that its management team comes from a BioInformatics background – the science of collecting and analyzing complex biological data. BioInformant is the only known research firm to apply these data analysis techniques to the field of market research.
BioInformant research has been cited on prominent news outlets that include the Wall Street Journal, Nature Biotechnology, CBS News, Medical Ethics, the Center for BioNetworking, and more. BioInformant serves notable clients across the stem cell spectrum, with Fortune 500 companies on its client list including GE Healthcare, Pfizer, Goldman Sachs, Beckton Dickinson, and many more.
Opportunities for Commercializing Mesenchymal Stem Cells
Mesenchymal stem cells (MSCs) are multipotent stem cells that can differentiate into a variety of cell types, including osteoblasts, chondrocytes, myocytes, adipocytes, beta-pancreatic islets cells, and potentially, other cell types. MSCs are of intense therapeutic interest, because they represent a population of cells with the potential to treat a range of acute and degenerative diseases. They are advantageous over other stem cells types for a variety of reasons. They avoid the ethical issues that surround embryonic stem cell research, and repeated studies have found MSCs to be immuno-privileged, which make them an advantageous cell type for allogenic transplantation. MSCs also being explored for use in 3D printing applications, because of their unique capacity to form structural tissues.
Because MSCs represent a valuable market segment, stem cell executives and investors must to have a clear understanding of opportunities and threats occurring within the marketplace. As the technology surrounding MSC production has advanced, novel approaches to MSC manufacturing have emerged. As clinical trials investigating MSCs have increased in number, new companies have entered the marketplace to explore clinical applications.
Other emerging threats that could impact the MSC industry include inconsistent or negative clinical findings, competing technologies, and the potential for other stem cell types to provide better efficiency or function. Fluctuating government perspectives on whether the manipulation of stem cells prior to transplantation into humans should be allowed is also a current “hot topic” among regulatory bodies within the U.S. and other regions worldwide, with such legislation affecting the Regenexx® technology and other therapeutic applications involving MSCs.
However, there is also great potential for growth of the MSC market, with more than 30,000 scientific publications published about the cell type, more than 400 clinical trials underway worldwide, and Google Trend data showing MSC searches to be more than twice as common as the next most popular stem cell type.
Therefore, 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: (Regenerative Medicine = RM; Cell Therapy= CT)
- 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
The content and metrics contained in this report were compiled using a broad range of sources, including:
- Stem Cell Grant Databases (RePORT Database, CIRM, MRC, Wellcome Trust - UK)
- Stem Cell Patent Databases (United States Patent and Trade Office, World Intellectual Property Organization)
- Stem Cell Clinical Trial Databases (ClinicalTrials.gov, International Clinical Trials Registry Platform, European Union Clinical Trials Register )
- Stem Cell Scientific Publication Databases (PubMed, Highwire Press, Google Scholar)
- Stem Cell Product Launch Announcements (Trade Journals, Google News)
- Stem Cell Industry Events (Google News, Google Alerts)
- Stem Cell Company News (SEC Filings, Investor Publications, Historic Performance)
- Interviews with Stem Cell Industry Leaders and Executives
- SEC Filings and Related Investor Publications
- Social Analytics Tools for Twitter, LinkedIn, Google Search, Google Trends, and More
- BioInformant’s Proprietary Dashboard of MSC Industry Metrics and 10-Year Historical Database
Key findings within this report include:
- Trend rate data for MSC grants, clinical trials, scientific publications, and patents
- Recent advances in MSC research and clinical applications
- Market size determinations, including future projections through 2020
- Deal-making within the MSC marketplace, including key acquisitions and partnerships
- Competitive assessment of the MSC marketplace, by market segment
- Research priorities by market segment
- Top influencers with the MSC marketplace
- Social analytics for the MSC marketplace
- Twitter User Data, Google Trends User Data, Google Adwords Costs, and Hashtag
- Overview of the broader regenerative medicine (RM) and cell therapy (CT) marketplace
- Company profiles for 35 MSC industry leaders