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Market Spotlight: Primary Sclerosing Cholangitis (PSC)

  • Report

  • 28 Pages
  • June 2021
  • Region: Global
  • Citeline
  • ID: 4462141
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

  • The publisher 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.
  • 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 19.2%, and the average probability a drug advances from Phase III is 67.3%. Drugs, on average, take 10.0 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 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.

Table of Contents

OVERVIEWKEY TAKEAWAYS
DISEASE BACKGROUND
  • Subtypes

TREATMENTEPIDEMIOLOGYPIPELINE DRUGS
RECENT EVENTS AND ANALYST OPINION
  • Seladelpar for PSC (November 25, 2019)

KEY UPCOMING EVENTSPROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
  • ChemomAb Goes Public Via Merger With Anchiano

CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase

BIBLIOGRAPHYAPPENDIX
LIST OF FIGURES
Figure 1: Trends in prevalent cases of PSC, 2019–28
Figure 2: Overview of pipeline drugs for PSC in the US
Figure 3: Pipeline drugs for PSC, by company
Figure 4: Pipeline drugs for PSC, by drug type
Figure 5: Pipeline drugs for PSC, by classification
Figure 6: Key upcoming events in PSC
Figure 7: Probability of success in the autoimmune/immunology-other pipeline
Figure 8: Clinical trials in PSC
Figure 9: Top 10 drugs for clinical trials in PSC
Figure 10: Top 10 companies for clinical trials in PSC
Figure 11: Trial locations in PSC
Figure 12: PSC trials status
Figure 13: PSC trials sponsors, by phase
LIST OF TABLES
Table 1: Prevalent cases of PSC, 2019–28
Table 2: Pipeline drugs for PSC in the US
Table 3: Seladelpar for PSC (November 25, 2019)