Transparency Market Research (TMR) has published a new report titled, “Human Microbiome Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2018–2026”. According to the report, the global human microbiome diagnostic market to worth US$ 1888.9 Mn by 2026. It is projected to expand at a CAGR of 9.8% from 2018 to 2026. Microbiome is the genetic component of the entire range of microorganisms, including bacteria, fungi, protozoa, and viruses which live inside and on the human body. The beneficial bacteria present in the microbiome assist the digestion of food, regulation of the immune system, and protection against other disease-causing bacteria. This ability is being harnessed by start-ups and companies in the microbiome-based therapeutics market to create drugs aimed at treating conditions which have been shown to have a link with imbalance in the microbiome. In this report, the human microbiome market has been analyzed by studying it as two individual markets, the microbiome-based diagnostics market and the microbiome-based therapeutics market. The forecast period for human microbiome diagnostics market is 2018 to 2026 while that for human microbiome therapeutics is 2020 to 2026.

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Advances in metagenomics and next-generation sequencing have made microbiome-based testing easier and cheaper, paving the way to carry out rapid analysis of the genomic content of microorganisms from human sample. This has bolstered the development process for microbiome-based diagnostics. Gastrointestinal and metabolic disorders are likely to capture the leading share of the diagnostics market in 2018 owing to rise in interest of companies toward developing an easy analysis platform for gut health-based disorders, such as irritable bowel syndrome and Crohn’s disease. Although cancer is likely to capture a minor share of the market in 2018, much lower than gut health and metabolic disorders, it is a niche operating area for the company involved in developing a diagnostic test for detecting cancer. For instance, Metabiomics is developing molecular diagnostics for detecting markers of colorectal cancer. Existing tests for colorectal cancer rely on invasive colonoscopies; and thus, the non-invasive test developed by Metabiomics (which uses a stool sample to evaluate patient’s gut microbiome) will be a unique opportunity for the company to excel in a market having huge unmet needs.

Women’s health has been an ignored area, traditionally, in terms of launch of novel diagnostics and therapeutics. However, awareness regarding health and hygiene is rising among women and so is the need for products catering to their needs. For instance, in October 2016, Becton, Dickinson and Company received U.S. Food and Drug Administration (FDA) market authorization for a first-of-its-kind molecular test to detect the common causes for vaginitis. The test uses a microbiome-based algorithm for bacterial vaginosis detection. Such tests are anticipated to fuel the growth of the women’s health segment in microbiome diagnostics. In terms of technology, both metagenomic sequencing and 16s rRNA sequencing are projected to capture an equal share of the diagnostics market owing to a host of benefits associated with these techniques. The suitability of metagenomic sequencing to characterize organisms other than just bacteria is likely to make it a preferred technique for those aiming at developing tests which profile a comprehensive range of diseases.

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Presently, there is no approved microbiome-based therapy for treatment of diseases. Overall, the anticipated launch of new drugs for gut health indications (presently in phase I/II/III) in this market during the forecast period is likely to boost the growth of the segment, and thus, contribute to the overall growth of the global therapeutics market. In the microbiome-therapeutics market, start-ups with novel candidates have begun to raise expectations on the promise of this kind of therapy. Seres Therapeutics was a prominent player to emerge as a strong contender in the market, however, phase II setback for SER-109 in 2016 made drug developers cautious with their own studies. However, Seres quickly found out that its SER-109 phase 2 study failure was caused due to misdiagnosis of certain patients and suboptimal dosing in others. Seres had started a new, redesigned clinical trial for SER-109. Thus, the zeal of scientists and clinical experts toward finding a pertinent solution to diseases with unmet medical needs using the novel approach of repopulating the affected area with the beneficial microbiota is expected to propel the market in the future.

In terms of revenue, North America is likely to continue to dominate the global human microbiome market during the forecast period, owing to early adoption of technologies and large number of ongoing clinical trials. The region is projected to be a highly attractive market for gastrointestinal disorder, with a significant attractiveness index. According to the CDC, it has been estimated that in the U.S., Clostridium difficile infection (CDI) is one of the top three critical and urgent antibiotic-resistant bacterial threats. Around 820,000 patients in the U.S. experience a first occurrence of CDI every year; and recurrent CDI has been estimated to affect up to 110,000 patients every year. Unfortunately, the only treatment available for CDI presently is antibiotics, which can only worsen the problem on subsequent infections. The success of Fecal Microbiota Transplantation in clinical trials is a starting point for many companies to venture into the microbiome-based therapeutics domain. Moreover, start-ups in the microbiome market have been spin-offs of prestigious universities in the U.S. This is likely to boost the market for microbiome-based therapies in North America.

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The report also provides profiles of leading players operating in the global human microbiome market. AOBiome LLC, Seres Therapeutics, uBiome, Inc., Rebiotix, Inc., Enterome, Biosciences, and Synthetic Biologics, Inc are the major players operating in the market. Their products are currently in the highest phase of development (Phase 3) and have the potential to be first approved microbiome therapeutic in the world.

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