- The author estimates that in 2016, there were approximately 716,000 incident cases of biliary tract cancer worldwide, and forecasts that number to increase to 784,000 incident cases by 2025.
- The majority of industry-sponsored drugs in active clinical development for biliary tract cancer are in Phase II. Therapies in mid-to-late-stage development for biliary tract cancer focus on a wide variety of targets, with the majority being administered via the oral and intravenous routes.
- High impact upcoming events comprise topline Phase III trial results for derazantinib. There has been only one licensing and asset acquisition deal involving gallbladder and biliary tract cancer drugs during 2013-18. The exclusive acquisition agreement signed in 2017 between Mundipharma and CellAct for $250m for the acquisition of CAP7-1 was the only deal.
- The distribution of clinical trials across Phase I-IV indicates that the majority of trials for biliary tract neoplasms have been in the early and mid-phases of development, with 94.1% of trials in Phase I-II, and only 5.9% in Phase III.
- The US has a substantial lead in the number of biliary tract neoplasms clinical trials globally. The UK leads the major EU markets, while Japan has the top spot in Asia.
- Clinical trial activity in the biliary tract neoplasms space is dominated by completed and ongoing trials. AstraZeneca, Eli Lilly, and Sanofi have the highest number of completed clinical trials for biliary tract neoplasms, with three trials each.
- Eli Lilly has carried out the most Phase II trials in biliary tract neoplasms, followed by Sanofi.
KEY UPCOMING EVENTS
LICENSING AND ASSET ACQUISITION DEALS
Mundipharma Acquires “Smart” Chemo Drug From CellAct
CLINICAL TRIAL LANDSCAPE
LIST OF FIGURES
Figure 1: Trends in incident cases of biliary tract cancer, 2016-25
Figure 2: Overview of pipeline drugs for biliary tract cancer in the US
Figure 3: Pipeline drugs for biliary tract cancer, by company
Figure 4: Pipeline drugs for biliary tract cancer, by drug type
Figure 5: Pipeline drugs for biliary tract cancer, by classifications
Figure 6: Key upcoming events in biliary tract cancer
Figure 7: Licensing and asset acquisition deals in biliary tract cancer, 2013-18
Figure 8: Parent patents in biliary tract cancer
Figure 9: Clinical trials in biliary tract cancer
Figure 10: Top 10 drugs for clinical trials in biliary tract cancer
Figure 11: Top 10 companies for clinical trials in biliary tract cancer
Figure 12: Trial locations in biliary tract cancer
Figure 13: Biliary tract cancer trials status
Figure 14: Biliary tract cancer trials sponsors, by phase
LIST OF TABLES
Table 1: Incident cases of biliary tract cancer, 2016-25
Table 2: Pipeline drugs for biliary tract cancer in the US