Research on the human microbiome is expanding beyond C. difficile, with microbiome-based therapies reaching the clinical trial phase of development for additional disease areas. Investments in this space, including multiple deals made through the Janssen Human Microbiome Institute and several multimillion dollar IPOs, are supporting ongoing development, with several important clinical trial readouts expected in 2020. FDA approval of SER-109, the first microbiome-based therapy for C. difficile, is expected within the next few years and will break ground for a new regulatory approval pathway. With new therapies entering Phase II clinical trials, and more in early-phase R&D, it is increasingly important to understand the potential of the microbiome-based therapy market.


  • 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 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?


Special Topics: Microbiome-Based Therapies 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.

Table of contents

  • Microbiome - Special Topics - Multi-indication: Microbiome - (US/EU5)

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.