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.

QUESTIONS ANSWERED

  • 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?

PRODUCT DESCRIPTION

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)
    • COVID-19
      • Key Findings
        • Commercial Outlook
          • Key Findings
            • Microbiome-Based Therapies SWOT Analysis
          • 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 Microbial Therapy Specific Trends
            • Multistrain Microbial Therapy Specific Trends
            • Bacteria-Derived Small Molecule Specific Trends
        • Forecast
          • Sales of Key Microbiome-Based Therapies
        • Etiology and Pathophysiology
          • Disease Overview
            • Gastrointestinal Diseases
              • Overview
              • Etiology
              • Key Microbes Involved in Gastrointestinal Diseases
              • Pathophysiology
              • Key Pathways Involved in Gastrointestinal Diseases
              • Pro- and Anti-Inflammatory Pathways Driven by the Gut Microbiome
            • Oncology
              • Overview
              • Etiology
              • Key Microbes Involved in Oncology
              • Pathophysiology
              • Key Pathways Involved in Oncology
              • Impact of Microbial Metabolites on the Immune System and Inflammatory Markers
            • Key Pathways and Drug Targets
              • Key Development Pathways
          • Current Treatment
            • Key Findings
              • Treatment Goals
                • Key Endpoints Used in Clinical Trials for Microbiome-Based Therapies
              • Medical Practice
                • Looking for More?
            • Unmet Need Overview
              • Current and Future Attainment of Unmet Needs in Microbiome-Based Therapies
              • Top Unmet Needs in Microbiome-Based Therapies: Current and Future Attainment
              • Expert Insight: Unmet Need in Microbiome-Based Therapies
            • Emerging Therapies
              • Key Findings
                • Pipeline Trends in Microbiome-Based Therapies
              • Key Emerging Therapies
                • Key Microbiome-Based Therapies in Development
                • Estimated Launch Dates of Key Emerging Microbiome-Based Therapies
                • Blautix Profile
                • Key Ongoing Clinical Trials of Blautix (MRx1234)
                • Analysis of the Clinical Development Program for Blautix
                • Expert Insight: Blautix
                • Expectations for Launch and Sales Opportunity of Blautix
                • EPD-1503 Profile
                • Key Ongoing Clinical Trials of EPD-1503
                • Analysis of the Clinical Development Program for EPD-1503
                • Expert Insight: EPD-1503
                • Expectations for Launch and Sales Opportunity of EPD-1503
                • EDP-1815 Profile
                • Key Ongoing Clinical Trials of EDP-1815
                • Analysis of the Clinical Development Program for EDP-1815
                • Expert Insight: EDP-1815
                • Expectations for Launch and Sales Opportunity of EDP-1815
                • SNYB1618 Profile
                • Key Ongoing Clinical Trials of SYNB1618
                • Analysis of the Clinical Development Program for SYNB1618
                • Expert Insight: SYNB1618
                • Expectations for Launch and Sales Opportunity of SYNB1618
                • RBX-2660 Profile
                • Analysis of the Clinical Development Program for RBX-2660
                • Expert Insight: RBX-2660
                • Expectations for Launch and Sales Opportunity of RBX-2660
                • SER-287 Profile
                • Key Ongoing Clinical Trials of SER-287
                • Analysis of the Clinical Development Program for SER-287
                • Expert Insight: SER-287
                • Expectations for Launch and Sales Opportunity of SER-287
                • MaaT-013 Profile
                • Key Ongoing Clinical Trials of MaaT-013
                • Analysis of the Clinical Development Program for MaaT-013
                • Expert Insight: MaaT-013
                • Expectations for Launch and Sales Opportunity of MaaT-013
                • EB-8018 Profile
                • Key Ongoing Clinical Trials of EB-8018
                • Analysis of the Clinical Development Program for EB-8018
                • Expert Insight: EB-8018
                • Expectations for Launch and Sales Opportunity of EB-8018
              • Early-Phase Pipeline Analysis
                • Notable Developments in the Early-Phase Pipeline for Microbiome-Based Therapies
                • Select Microbiome-Based Therapies in Early-Phase Development
              • Key Discontinuations and Failures of Microbiome-Based Therapies
                • Expert Insight: Key Discontinuations and Failures
            • Access & Reimbursement Overview
              • Region-Specific Reimbursement Practices
                • Key Market Access Considerations for Microbiome-Based Therapies: United States
                • General Reimbursement Environment: United States
                • Expert Insight: Market-Access Considerations for Microbiome-Based Therapies
                • Key Market Access Considerations for Microbiome-Based Therapies: EU5
                • General Reimbursement Environment: EU5
                • Expert Insight: Market-Access Considerations for Microbiome-Based Therapies
              • Looking for More?
            • Methodology
              • Bottom-Up Forecasting Overview
                • Patient Populations
                • Drug-Specific Assumptions
              • Bottom-Up Forecast Assumptions
                • General Sources of Data
                • Drug-Treatment Rate Assumptions for IBS-C and IBS-D
                • Patient-Share Assumptions for Microbiome-Based Therapies
                • General Statements About Pricing
                • Sources for Drug Prices
                • 2019 Exchange Rates
                • Price per Treated Day: 2029
                • Dosing, Days of Therapy, and Compliance
                • Out-Year Forecasting
                • Emerging Therapy Prices
              • Primary Market Research
                • Experts Interviewed
            • Appendix
              • Key Abbreviations Related to Microbiome-Based Therapies
              • Microbiome-Based Therapies Bibliography

          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.