ROCKVILLE, Md., Dec. 11, 2017 /PRNewswire/ -- Study of the human microbiome – the trillions of microbes that exist symbiotically within the human body – has increased in recent years, attracting enthusiastic media attention. According to Kalorama Information, this attention is warranted due to the growing interest in the human microbiome in in vitro diagnostics (IVD) and other healthcare applications, including areas such as therapeutics, metagenomics, and metabolomic profiling. The healthcare market research firm found some 118 microbiome-related players as it examined the current research, diagnostics and drug development, and investment of venture capital in the market in Human Microbiome Applications in IVD and Other Healthcare.
"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."
The microbiome's complicated relationship with its human host is increasingly considered crucial to health. Microbiome research has therefore taken off. Researchers are evaluating a number of diseases and chronic health conditions associated with disturbances in the microbiome, including:
- autoimmune disorders like multiple sclerosis and rheumatoid arthritis
- skin diseases like eczema, psoriasis and acne
- colon cancer
- acute diarrhea
- urogenital conditions
- mental disorders such as depression
- metabolic syndrome
- C. difficile
- gastrointestinal disorders including Crohn's disease, ulcerative colitis and irritable bowel syndrome (IBS)
- neurological disease
- cardiovascular disease
- drug side-effects
Some IVD companies have already launched tests to measure changes in the microbiome to monitor disease progress. Examples of companies offering microbiome diagnostic products or services include Genetic Analysis SA, IS-Diagnostics, Metabiomics Corporation, Proderm IQ, Epibiome, and uBiome. Kalorama's report notes some twenty-two microbiome-based tests currently in different stages of development, including selected molecular microbiome-based tests, microbiome-based diagnostic biomarkers, and precision or personalized medicine approaches to the microbiome.
Pharma Company Interest
Many competitors in the microbiome market are amassing knowledge and data about the microbiome in order to partner with pharmaceutical firms interested in developing new therapeutics. Kalorama's report examines some seventeen microbiome-based therapeutics in development, surveying current microbiome-related drug candidates, including fecal microbiota transplants (FMT).
In February 2016, the U.S. Food and Drug Administration (FDA) announced new draft guidance that aimed to further assure that patients infected with the bacterium Clostridium difficile and not responding to standard therapies could access fecal microbiota for transplantation.
FDA considers FMT an investigational new drug (IND), which requires physicians and scientists to file an IND application if they intend to use the treatment for clinical practice or research. However, FDA has issued guidance stating that FMT may be used to treat C. difficile infection not responsive to standard therapies outside of a clinical trial.
Two companies – Rebiotix and Seres Therapeutics – have been granted orphan drug designations for their INDs as FMT treatments for recurrent C. difficile infections, which affect between 85,000 and 110,000 people in the US annually.
Microbiome companies and start-ups offer a wide array of products and services. They can be roughly grouped into research-based companies, companies involved in testing, therapeutics-based companies, direct-to-consumer service providers, and more, including companies involved in metagenomic data analysis, metabolomics, sample preparation and processing, mass spectrometry, medical devices, stool banks, contract research (CROs), consumer dermatology, and probiotic science.
Kalorama's report profiles some 118 firms in the market, including companies offering microbiome diagnostic products or services such as Atlas Biomed, DNA Genotek, Enterome, Metabolon, CIPAC Therapeutics, and Synthetic Biologics. Human Microbiome Applications in IVD and Other Healthcare can be found at: https://www.kaloramainformation.com/Human-Microbiome-Applications-IVD-Healthcare-11309671/.
About Kalorama Information
Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.
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SOURCE Kalorama Information