This Market Spotlight report covers the Primary Sclerosing Cholangitis market, comprising disease background, treatment overview, key pipeline drugs, recent events and analyst opinion, upcoming events, clinical trials, probability of success, and a 10-year global disease prevalence forecast.

Key Takeaways

• Datamonitor Healthcare estimates that in 2016, there were 227,400 prevalent cases of primary sclerosing cholangitis (PSC) worldwide among adults aged 30 years and over, and forecasts that number to increase to 265,700 prevalent cases by 2025.
• The majority of industry-sponsored drugs in active clinical development for PSC are in Phase II, with only one drug in Phase III. Therapies in the pipeline for PSC focus on a wide variety of targets. The majority of pipeline drugs in development are administered via the oral route, with a smaller number of drugs being tested in intravenous and subcutaneous formulations.
• High-impact upcoming events in the PSC space comprise topline Phase II trial results for BTT-1023, cenicriviroc, and DUR-928. The overall likelihood of approval of a Phase I autoimmune/immunology-other asset is 20.2%, and the average probability a drug advances from Phase III is 69.4%. Drugs, on average, take 9.8 years from Phase I to approval, compared to 8.7 years in the overall autoimmune/immunology space.
• The clinical trials distribution across Phase I–IV indicates that the majority of trials for PSC have been in the mid-phase of development, with 77.8% of trials in Phase II, and only 11.1% of trials each in Phase I and Phase III.
• The US leads in terms of the number of PSC clinical trials globally, while the UK leads the major EU markets. Gilead Sciences is the only company with more than one clinical trial in the PSC space. The company has conducted two Phase II trials.