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.
Table of contents
- Microbiome - Special Topics - Multi-indication: Microbiome - (US/EU5)
- COVID-19
- Key Findings
- Commercial Outlook
- Forecast
- Etiology and Pathophysiology
- Current Treatment
- Unmet Need Overview
- Emerging Therapies
- Access & Reimbursement Overview
- Methodology
- Bottom-Up Forecasting Overview
- 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
- Appendix
- COVID-19
Kristine Mackin, Ph.D., is a director 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.