This Market Spotlight report covers the Primary Sclerosing Cholangitis (PSC) market, comprising key pipeline drugs, recent events and analyst opinion, upcoming events, clinical trials, probability of success, licensing and asset acquisition deals, and a 10-year disease prevalence forecast.

Key Takeaways

• Datamonitor Healthcare estimates that in 2019, there were 241,800 prevalent cases of primary sclerosing cholangitis (PSC) worldwide among adults aged 30 years and over, and forecasts that number to increase to 277,300 prevalent cases by 2028.
• The majority of industry-sponsored drugs in active clinical development for PSC are in Phase II, with only two drugs 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 the remainder being tested in intravenous and subcutaneous formulations.
• The only high-impact upcoming event for drugs in the PSC space is topline Phase II trial results for HTD1801. The overall likelihood of approval of a Phase I autoimmune/immunology-other asset is 20.8%, and the average probability a drug advances from Phase III is 69.8%. Drugs, on average, take 9.7 years from Phase I to approval, compared to 9.2 years in the overall autoimmune/immunology space.
• The distribution of clinical trials across Phase I–IV indicates that the majority of trials for PSC have been in the early and midphases of development, with 85% of trials in Phase I–II, and only 15% in Phase III.
• The US leads in terms of the number of PSC clinical trials globally, while the UK leads the major European markets.
• Gilead Sciences has three completed trials and two ongoing trials in PSC.
• Gilead Sciences and Takeda are the only companies to have conducted Phase III trials for PSC.