Harnessing Microbiome Science for Therapeutic Development

Microbiome science has become a key area of research for biopharmaceutical companies. Multiple start-ups are developing novel therapeutics and diagnostic/screening platforms and services. In the era of personalized medicine, the microbiome industry’s growth trajectory parallels that of genomics in the early 2000s. Among the milestones in the microbiome field is the application of next-generation sequencing toward identifying and assessing microbial levels in the human gut. Using these microbial biomarkers, scientists are identifying novel drug targets and probiotic or prebiotic products that could help to balance the body’s microbial ecosystem.

The chart below shows the global market division of microbiomic products by applications according to Frost & Sullivan research.

• Therapeutics: Medicines that are being developed primarily for treating a host of gastrointestinal and skin disorders.
• Over the counter (OTC): The majority of these products are probiotic or prebiotic dietary supplements. However, a small segment of research focuses on topical application products for common skin conditions.
• Diagnostics: Products in this space are developed either for direct consumer sale as companion diagnostics or for aiding drug discovery. 

Patent Landscape

The focus on microbiome research is illustrated by the rapid pace of patents published in microbiome-related research from 2012 to 2016. Frost & Sullivan research shows that microbiome patents grew by an order of magnitude from 2012 to 2016, as shown in the table below.

Global Microbiome Patents Published by Year 2012 - 2016

2012	2013	2014	2015	2016
89	204	413	717	833

Mysteries of the Gut Microbiome

Unraveling the secrets of the gut microbiome’s 100 trillion bacteria holds the key to controlling patients’ blood sugar levels. High blood sugar levels pose a host of problems ranging from energy loss to excessive hunger and weight gain that can cause obesity and, in many cases, diabetes.

DayTwo Inc. of Adanim, Israel, has developed a computer application to optimize blood sugar levels based on five years of gut microbiome research conducted at the Weizmann Institute of Science in Israel. Registrants provide stool and blood samples that Day Two analyzes via proprietary software to create an individualized nutrition profile for the patient to achieve optimal health.

Ixcela of Boston, has designed a do-it-yourself gut microbiome analysis with its proprietary blood sampling technology that analyzes 12 metabolites that control the biochemical balance and health of the patient’s gut microbiome.

Diagnostic Advances Based on Biomarkers

Microbiomics is being used to detect and measure the concentration of biomarkers—substances in the blood such as cholesterol, glucose, cortisol and creatine kinease that can indicate disease or infection. These new diagnostic tools will enable clinicians to make better-informed decisions to maintain or restore their patients’ health.

Origin Sciences of Cambridge, UK, has developed a mucosal sampling platform, OriCol™, to detect the biomarkers that can determine colorectal health. OriCol is attached to a proctoscope to address patients who do not want to take their own stool samples.

InsideTracker of Boston, Mass., has designed an algorithm that analyzes hundreds of data points in blood to provide the optimized biomarkers based on each patient’s age, sex, ethnicity, and activity level. The company provides a specific action plan to improve health through proper nutrition.

Next-Generation Medicines

Perhaps the most intriguing application for microbiomic research is the development of new drugs to treat chronic disorders, such as lactose intolerance, which affects 40 million Americans, according to the Statistic Brain Research Institute in research dated April 2017. 

Ritter Pharmaceuticals in Los Angeles, has developed the microbiome-based drug RP-G28 (currently in Phase 2 trials) that is believed to be the first therapeutic designed to reduce the symptoms of lactose intolerance.

Pioneers Sought

Echoing the trend of other emerging medical technologies, Frost & Sullivan sees pharmaceutical companies pursuing acquisitions of or funding smaller biotechnology players that are developing microbiomic-based therapeutics for disease intervention. This is reflected in the increase in funding opportunities for microbiomics solutions.

A case in point is The Clorox Company of Oakland, Calif., purchasing Renew Life Holdings Corporation of Palm Harbor, Fla., a developer of probiotics for digestive health, for approximately $290 million in May 2016. The acquisition is part of the bleach giant’s strategy to add companies with expertise in fast-growing industries with robust margins.

Another agreement was struck between Nestlé Health Science and Seres Therapeutics Inc., a Cambridge, Mass., developer of microbiome-based products to treat Clostridium difficile infection and inflammatory bowel disease, including ulcerative colitis and Crohn’s disease. This deal is worth $120 million upfront, and has a potential value more than $1.9 billion.

Future Trends in Probiotics and Prebiotics

Frost & Sullivan sees probiotics such as Renew Life’s as a future application area for microbiome-based products and therapies because of growing consumer demand for bacteria and yeasts that improve digestive health. The development of prebiotics, essentially the use of ingredients to promote good gut bacteria, also will gain traction. ISOthrive LLC of Manassas, Va., has formulated a slightly sweet, zero-calorie fermented prebiotic nectar so that 1/4 tablespoon daily will feed beneficial gut bacteria.

The global demand for more effective medicines and healthier nutrition will continue to drive the development of microbiomic products. Advanced genomic sequencing and computer algorithms will create both medicines and therapeutics based on individual microbiomes for better outcomes and healthier lives that will prevent or minimize disease. 

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