Research on the human microbiome is beginning to mature, with microbiome-based therapies reaching the clinical trial phase of development for many disease areas. Significant investments have been made in this space, notably multiple deals made through the Janssen Human Microbiome Institute and several multimillion dollar IPOs, including those from Seres Therapeutics and Evelo Biosciences. Despite this activity, no microbiome-based therapy has yet received 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, understanding the potential of this emerging group of therapies is becoming increasingly important.


  • How do physicians familiar with microbiome research evaluate the potential of microbiome-based therapies, and what immune and inflammatory therapies are seen as most promising?
  • What diseases will benefit from microbiome-based therapies? How will such therapies fit into existing treatment algorithms?
  • Will particular mechanisms of administration be more successful? Will live bacteria or microbiome-derived small molecules be effective?
  • What potential hurdles will such therapies face in the market? How do physicians anticipate regulatory agencies will respond?


Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research. This special report is based on a modified Disease Landscape and Forecast template, with abbreviated epidemiological data and current treatment analysiswhile offering expanded content covering significant investments in the microbiome space.


United States and EU5.


Five interviews with thought-leading U.S. physicians familiar with microbiome-based research, including gastroenterologists. Supported by survey data collected for this report and other DRG research.


Diagnosed prevalent population of included disease areas by country, including combined gastrointestinal conditions and allergic conditions.


Phase II: 3 drugs. Coverage of select preclinical and Phase I products.

Table of contents

  • Crohn's Disease - Landscape & Forecast - Special Topics: Microbiome Therapies For Immune & Inflammatory Diseases

Author(s): Kristine Mackin, PhD

Kristine Mackin, Ph.D., is an analyst on the immune and inflammatory disorders team at Decision Resources Group. She currently focuses on respiratory diseases, including asthma and COPD.

She holds a doctorate in biochemistry from Brandeis University, where she studied the evolution of bacteriorhodopsin and the relationship between type I and type II rhodopsins. During her B.A. in Chemistry at Carleton College, she researched proinsulin processing. Prior to joining DRG, Dr. Mackin was involved with literature and market research for a new company pitch during an internship at Puretech Ventures in Boston, MA.

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