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 those of Seres Therapeutics and Evelo Biosciences. However, no microbiome-based therapy has yet received FDA approval, although FMT is widely accepted for use in recurrent C. difficile infections and proprietary microbiome-based candidates are proceeding to Phase III clinical trials. With new therapies entering Phase II clinical trials, and more in early-phase R&D, it is becoming increasingly important to understand the potential of this emerging group of therapies.


  • 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 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?


United States, EU5.

Primary Research

  • 10 interviews with thought-leading specialists, including oncologists, gastroenterologists, and metabolic specialists.
  • Supported by survey data collected for this special report and other DRG research.


High-level overview of relevant epidemiological figures for select indications. FORECAST Drug-level sales in 2028.


Phase II: 5 drugs; coverage of select preclinical and Phase I products.


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 & Forecast template, with abbreviated epidemiological data and current treatment analysis, but including expanded content covering ongoing early-phase research and regulatory concerns specific to live bacterial products.

Table of contents

  • Multi-indication: Microbiome - (US/EU5)
    • Market Outlook
      • Key Findings
        • Market Overview
      • Market Drivers and Constraints
        • What Factors Are Driving the Market for Microbiome-Based Therapies?
        • What Factors Are Constraining the Market for Microbiome-Based Therapies?
      • Drug-Class-Specific Trends
        • Single-Strain Live Microbial-Therapy-Specific Trends
        • Multi-Strain Live Microbial-Therapy-Specific Trends
        • Bacteria-Derived Small Molecules
    • Forecast
    • Etiology and Pathophysiology
      • Disease Overview
      • Gastrointestinal Diseases
        • Overview
        • Etiology
        • Pathophysiology
      • Oncology
        • Overview
        • Etiology
        • Pathophysiology
      • Key Pathways and Drug Targets
    • Current Treatment
      • Key Findings
      • Treatment Goals
      • Medical Practice
        • Looking for More?
    • Unmet Need Overview
      • Current and Future Attainment of Unmet Needs in Microbiome-Based Therapies
    • Emerging Therapies
      • Key Findings
      • Key Emerging Therapies
        • Notable Developments Among Key Emerging Microbiome-Based Therapies
        • Single-strain Live Microbial Therapies
        • Multi-strain Live Microbial Therapies
        • Bacteria-derived Small Molecules
      • Early-Phase Pipeline Analysis
        • Notable Developments in the Early-Phase Pipeline for Microbiome-Based Therapies
    • Access & Reimbursement Overview
      • Region-Specific Reimbursement Practices
        • United States
        • EU5
      • Looking for More?
    • Methodology
      • Bottom-Up Forecasting Overview
        • Patient Populations
        • Drug-Specific Assumptions
      • Bottom-Up Forecast Assumptions
        • General Sources of Data
        • General Statements About Pricing
        • Dosing, Days of Therapy, and Compliance
        • Out-Year Forecasting
        • Emerging Therapy Prices
      • Primary Market Research
        • Experts Interviewed
    • Appendix
      • Microbiome-Based Therapies Bibliography

Author(s): Kristine Mackin, PhD

Kristine Mackin, 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 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.