There has been enthusiastic media attention in recent year towards the study of the human microbiome. It denotes the trillions of microbes which exist symbiotically in the human body.
In areas of health care applications such as therapeutics, metagenomics, and metabolomic profiling and the in vitro diagnostics (IVD) are the major areas where human microbiome is being used which has caught attention, according to Kalorama Information.
In its report titled Human Microbiome Applications in IVVD and Other Healthcare, the healthcare market research firm note about 118 microbiome-related players in the market related to research, diagnostics and drug development, and investment of venture capital.
“Spurred on by the Human Microbiome Project, healthcare companies have become more interested in microbiome research,” said Bruce Carlson, Publisher of Kalorama Information. “Despite the fact that efforts to develop microbiome-based diagnostics and therapies remain in their early stages, microbiome companies have attracted significant investment.”
With the aim of monitoring disease progress, tests to measure changes in the microbiome have already been launched by some IVD companies. Genetic Analysis SA, IS-Diagnostics, Metabiomics Corporation, Proderm IQ, Epibiome, and uBiome are some of the companies that are included in that list. At present there are twenty-two microbiome-based tests which are in varying stages of development, noted the Kalorama’s report. The list of studies being conducted include precision or personalized medicine approaches to the microbiome, microbiome-based diagnostic biomarkers and selected molecular microbiome-based tests.
There are pharmaceutical firms that are interested in developing new therapeutics and hence a number of competitors in the microbiome market are gathering knowledge and data about the microbiome. About seventeen microbiome-based therapeutics that are being researched, the study found while conducting a survey of the present microbiome-related drug candidates. This included fecal microbiota transplants (FMT).
Fecal microbiota for transplantation could be accessed by patients infected with the bacterium Clostridium difficile and who do not respond to existing therapies according to the new draft guidance as announced by the U.S. Food and Drug Administration (FDA) in February 2016.
Any physicians and scientists who want to access the treatment for clinical practice or research would have to apply for an IND application to the FDA because it considers FMT as an investigational new drug (IND).
For recurrent C difficile infections, orphan drug designations for their INDs as FMT treatments have bene granted to two companies – Rebiotix and Seres Therapeutics. In the U.S., this disease affects between 85,000 and 110,000 people annually.
(Adapted from Prnewswire.com)