Microbiome – Special Topics – Multi-indication: Microbiome – (US/EU5)
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.
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
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Appendix
Key Abbreviations Related to Microbiome-Based Therapies
Microbiome-Based Therapies Bibliography
Kristine Mackin, Ph.D.
Kristine Mackin, Ph.D., is a principal analyst on the Immune and Inflammatory Disorders team at Clarivate. Her expertise includes emerging microbiome-based therapies, psoriatic arthritis, chronic obstructive pulmonary disease, and asthma. Previously, Dr. Mackin was involved with a new company pitch focusing on the infant microbiome, now realized as Commense, during an internship at Puretech Ventures in Boston. 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.