Microbiome | Special Topics | Multi-Indication – Microbiome-Based Therapies | US/EU5 | 2019

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.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 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?Geographies 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. Epidemiology High-level overview of relevant epidemiological figures for select indications. FORECAST Drug-level sales in 2028.EMERGING THERAPIES Phase II: 5 drugs; coverage of select preclinical and Phase I products.PRODUCT DESCRIPTION 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.