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.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
Published: 16 February 2022
Number of pages:25
This Market Spotlight report covers the Primary Sclerosing Cholangitis (PSC) market, comprising key pipeline drugs, clinical trials, probability of success, licensing and asset acquisition deals, and a 10-year disease prevalence forecast.
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 just a single product 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 one product being tested in an intravenous formulation.
High-impact upcoming events for drugs in the PSC space comprise topline Phase II trial results for CM-101, topline Phase IIa trial results for PLN-74809, and topline Phase IIb trial results for volixibat.
The overall likelihood of approval of a Phase I autoimmune/immunology-other asset is 21.7%, and the average probability a drug advances from Phase III is 67.8%. Drugs, on average, take 10.2 years from Phase I to approval, compared to 9.4 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 four completed trials and one ongoing trial in PSC.
Gilead Sciences and Takeda are the only companies to have conducted Phase III trials for PSC
6 KEY TAKEAWAYS
7 DISEASE BACKGROUND
12 PIPELINE DRUGS
17 KEY UPCOMING EVENTS
18 PROBABILITY OF SUCCESS
19 CLINICAL TRIAL LANDSCAPE
20 Sponsors by status
21 Sponsors by phase
LIST OF FIGURES
11 Figure 1: Trends in prevalent cases of PSC, 2019–28
12 Figure 2: Overview of pipeline drugs for PSC in the US
12 Figure 3: Pipeline drugs for PSC, by company
13 Figure 4: Pipeline drugs for PSC, by drug type
13 Figure 5: Pipeline drugs for PSC, by classification
17 Figure 6: Key upcoming events in PSC
18 Figure 7: Probability of success in the autoimmune/immunology-other pipeline
19 Figure 8: Clinical trials in PSC
19 Figure 9: Top 10 drugs for clinical trials in PSC
20 Figure 10: Top 10 companies for clinical trials in PSC
20 Figure 11: Trial locations in PSC
21 Figure 12: PSC trials status
22 Figure 13: PSC trials sponsors, by phase
LIST OF TABLES
10 Table 1: Prevalent cases of PSC, 2019–28
14 Table 2: Pipeline drugs for PSC in the US
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