How will emerging microbiome-based therapies impact disease markets, especially in gastrointestinal diseases?

Key Findings:

Research on the human microbiome is beginning to mature, with microbiome-based therapies reaching the clinical trial phase of development for many disease areas. There have been significant investments in this space, notably including multiple deals made through the Janssen Human Microbiome Institute and several multimillion dollar IPOs, including Seres Therapeutics and Evelo Biosciences. However, no microbiome-based therapy has yet received an FDA approval in the immune and inflammatory disease space. With several therapies progressing to Phase II clinical trials and many more in early-phase development, it is becoming increasingly important to understand the potential of this emerging group of therapies.

In a new report, Microbiome Therapies for Immune & Inflammatory Diseases, we observed therapies delivering live bacteria are poised to make the biggest impact, and microbiome-derived small molecules or drugs designed to modulate a patient’s innate microbiome also represent fruitful avenues of research. Gastrointestinal diseases are likely to be the first immune and inflammatory diseases to benefit from these discoveries, with treatments for Ulcerative Colitis and Crohn’s Disease anticipated to launch within the next 5-10 years. Therapies for psoriasis, psoriatic arthritis, atopic dermatitis, and allergic asthma are also in development, but will likely reach the market after GI-specific therapies.

Implications for decision makers:

  • Interviewed physicians with expertise in microbiome-based research are optimistic about the potential of microbiome-based therapies. Despite mixed results from OTC therapies delivering live bacteria, the interviewed KOLs have largely favorable opinions of live bacterial products currently in development, especially those that will deliver a consortium of bacteria.
  • The outlook for small molecules designed to modulate the microbiome is more mixed, with some yielding promising results in early-phase development while others are perceived as less likely to deliver improvements.
  • Physicians agree that therapies must show impact on already-established clinical trial end points and recognize that there may be additional regulatory hurdles. However, once the first therapy secures FDA approval, others are likely to follow rapidly, and physicians are confident they will be incorporated into their clinical practice.

The full Microbiome Therapies for Immune & Inflammatory Diseases report answers:

  • How do physicians familiar with microbiome research evaluate the potential of microbiome-based therapies, and what therapies are seen as most promising?
  • What therapy areas will benefit from microbiome-based therapies? How will such therapies fit into the existing treatment algorithms?
  • Will particular modes of administration be more successful? Are live bacteria or microbiome-derived small molecules more likely to succeed, and what clinical trial outcomes will be most influential?
  • What potential hurdles will such therapies face in the market? How do physicians anticipate regulatory agencies will respond?


Markets covered: United States.

Methodology: In-depth interviews with five-thought-leading experts, including four gastroenterologists and one allergist, in combination with DRG’s ongoing indication-specific surveys and disease-area expertise.

Indication coverage: Ulcerative colitis, Crohn’s Disease, irritable bowel syndrome, asthma, allergic dermatitis, psoriasis, psoriatic arthritis and rheumatoid arthritis.

Key drugs covered: SGM-1019, EB8018, AOB102, SER-287, RBX2660, Blautix

Key companies mentioned: Seres Therapeutics, Enterome, AOBiome, Evelo Biosciences, Second Genome, Vendanta Biosciences, Synlogic, 4D Pharma.


Discover more about DRG’s ongoing research into microbiome-based therapies and how to access this full report:

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