Market Spotlight: Biliary Tract Cancer
Market Spotlight: Biliary Tract Cancer
This Market Spotlight report covers the Biliary Tract Cancer market, comprising key pipeline drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease incidence forecast, and licensing and acquisition deals.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
This Market Spotlight report covers the Biliary Tract Cancer market, comprising key pipeline drugs, recent events and analyst opinion, clinical trials, upcoming events, probability of success, patent information, a 10-year disease incidence forecast, and licensing and acquisition deals.
- Datamonitor Healthcare estimates that in 2018, there were approximately 397,700 incident cases of biliary tract cancer (BTC) worldwide, and forecasts that number to increase to 425,600 incident cases by 2027.
- The majority of industry-sponsored drugs in active clinical development for BTC are in Phase II, with one drug in the NDA/BLA phase.
- Therapies in development for BTC focus on a wide variety of targets, with the majority being administered via the oral or intravenous routes.
- High-impact upcoming events for drugs in the BTC space comprise topline Phase IIa trial results for Xermelo, an expected PDUFA date for pemigatinib, and topline Phase III trial results for Imfinzi and fimaCHEM.
- The overall likelihood of approval of a Phase I solid tumors asset is 5.6%, and the average probability a drug advances from Phase III is 40.7%. Drugs, on average, take 9.5 years from Phase I to approval, compared to 9.3 years in the overall oncology space.
- There has been only one licensing and asset acquisition deal involving gallbladder and BTC drugs during 2014–19. 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 vast majority of trials for biliary tract neoplasms have been in the early and mid-phases of development, with 90% of trials in Phase I–II, and only 10% 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 China and South Korea share the top spot in Asia.
- Bristol-Myers Squibb has the highest number of ongoing clinical trials for biliary tract neoplasms, with six trials. AstraZeneca and Bristol-Myers Squibb lead industry sponsors with the highest overall number of clinical trials for biliary tract neoplasms.
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
9 Radiation therapy
10 Palliative therapy
14 PIPELINE DRUGS
24 RECENT EVENTS AND ANALYST OPINION
24 Varlitinib for BTC (November 11, 2019)
25 Tibsovo for BTC (September 30, 2019)
27 Pemigatinib for BTC (September 27, 2019)
29 Tibsovo for BTC (May 15, 2019)
31 Derazantinib for BTC (January 9, 2019)
32 FoundationOne Infigratinib Companion Diagnostic for BTC (June 19, 2018)
35 KEY UPCOMING EVENTS
36 PROBABILITY OF SUCCESS
37 LICENSING AND ASSET ACQUISITION DEALS
38 PARENT PATENTS
39 CLINICAL TRIAL LANDSCAPE
40 Sponsors by status
41 Sponsors by phase
42 Recent events
LIST OF FIGURES
13 Figure 1: Trends in incident cases of BTC, 2018–27
14 Figure 2: Overview of pipeline drugs for BTC in the US
14 Figure 3: Pipeline drugs for BTC, by company
15 Figure 4: Pipeline drugs for BTC, by drug type
15 Figure 5: Pipeline drugs for BTC, by classification
25 Figure 6: Varlitinib for BTC (November 11, 2019): Phase II/III – TreeTopp
27 Figure 7: Tibsovo for BTC (September 30, 2019): Phase III – ClarIDHy
29 Figure 8: Pemigatinib for BTC (September 27, 2019): Phase II – Cholangiocarcinoma (FIGHT-202)
31 Figure 9: Tibsovo for BTC (May 15, 2019): Phase III – ClarIDHy
32 Figure 10: Derazantinib for BTC (January 9, 2019): Phase II – FIDES-01
35 Figure 11: Key upcoming events in BTC
36 Figure 12: Probability of success in the BTC pipeline
37 Figure 13: Licensing and asset acquisition deals in BTC, 2014–19
38 Figure 14: Parent patents in BTC
39 Figure 15: Clinical trials in BTC
39 Figure 16: Top 10 drugs for clinical trials in BTC
40 Figure 17: Top 10 companies for clinical trials in BTC
40 Figure 18: Trial locations in BTC
41 Figure 19: BTC trials status
42 Figure 20: BTC trials sponsors, by phase
LIST OF TABLES
12 Table 1: Incident cases of BTC, 2018–27
16 Table 2: Pipeline drugs for BTC in the US
24 Table 3: Varlitinib for BTC (November 11, 2019)
26 Table 4: Tibsovo for BTC (September 30, 2019)
28 Table 5: Pemigatinib for BTC (September 27, 2019)
30 Table 6: Tibsovo for BTC (May 15, 2019)
31 Table 7: Derazantinib for BTC (January 9, 2019)
33 Table 8: FoundationOne Infigratinib Companion Diagnostic for BTC (June 19, 2018)
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