Therapeutics targeting ways to influence the human microbiome to either treat or prevent disease has been of substantially growing interest in the past decade, and as of late, with a lot of financing activity to back it up.

In fact, human microbiome therapeutics may hold the key to treating many infections, diseases and conditions today for which there are few good treatment options or where antibiotics are no longer viable.

But first, what is the microbiome?

At the most basic level, a microbiota is an “ecological community of commensal, symbiotic and pathogenic microorganisms” found in and on all multicellular organisms, including both plants and animals. For the sake of this discussion, the microbiome we’re talking about is the collective genomes of the microbes (composed of bacteria, bacteriophage, fungi, protozoa and viruses) that live inside and on the human body.

The role of this “community” is as varied as the different microbes that go into it, including everything from assisting in nutrient uptake and uptake efficiency, understanding and predicting disease susceptibility, enhancing the immune system, impacting central nervous system health, curing or treating disease and more.

In short, our microbiome is ourselves.

It can show us what we should be eating at a more personalized level. It can impact our mood and decision making and cognitive health. It can strengthen our immune system and reduce our reliance on antibiotics. It enables us to evolve in ways that we can’t at the macro scale. It can give us insights into how to manage, diagnose and treat infectious and non-infectious diseases.

Microbiome treatments for just about everything

From a therapeutic standpoint, then, the human microbiome can do a lot of different things. The challenge for researchers now is to harness this power and apply it to effective therapies that can be applied to patients in a medical setting.

But that work is progressing quickly.

As of 2017 there were more than 70 microbiome modulators in clinical development, up from 27 just a year earlier. As recently as 2014, researchers were working on just a handful of modulators per year, so the development of this space has clearly taken off recently. According to Pharmaprojects, as of 2018 there are a total of 24 novel pipeline microbiome modulators currently under development to treat infectious diseases such as Clostridium difficile infection (aka C. diff; more than half of all microbiome modulators being developed for infectious disease are for C. diff) and Methicillin-resistant staphylococcus aureas (MRSA). Beyond that, there are 21 modulators in development for gastrointestinal disorders (such as inflammatory bowel disease, Ulcerative colitis, Crohn’s disease and Irritable bowel syndrome), 10 for metabolic Diseases (like Lactose intolerance, liver diseases and Insulin-related syndromes), 8 for different cancers, 8 for dermatological conditions (like atopic dermatitis, acne and eczema) and 3 for neurological conditions (like glioblastoma multiforme, depression and anxiety.)

The technologies underlying all of these treatments vary from condition to condition, but in general all microbiome therapies fall into one of four categories: preventive, curative, restorative and symptom-focused. And they function in one of three ways:

Additive: Treatment involves the supplementation of the host microbiota with either individual strains or a consortium of natural or engineered microorganism. This typically involves the use of single strains, bacterial consortia / communities or engineered microorganisms.

Subtractive: Involving the specific elimination of negative members of the microbiome to cure or treat disease, using targeted antibiotics, bacteriophages and contrabiotics.

Modulatory: The administration of non-living agents (prebiotics) to modulate the composition or activity of the endogenous microbiome. These treatments often make use of dead bacteria, small molecules, prebiotics, peptides, etc. to affect the microbiome.

A look ahead

As it stands right now, the market for human microbiome therapeutic treatments is on track to reach or exceed $1.7 billion by 2024, with the market for human microbiome-based diagnostics expected to reach $700 million in that time. The compound annual growth rate of the segment should exceed 9% per year starting in 2020.

That said, researchers are currently focusing their attention on treatments for gut-brain axis conditions, gut-based diseases (like Crohn’s Disease), consumer applications, inflammation, diet and nutrition improvements, drug / antibiotic development and more.

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