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 2017, there were approximately 732,000 incident cases of biliary tract cancer (BTC) worldwide, and forecasts that number to increase to 800,000 incident cases by 2026.
- The majority of industry-sponsored drugs in active clinical development for BTC are in Phase II. Therapies in mid-to-late-stage 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 II trial results for Xermelo, and topline Phase III trial results for varlitinib and fimaCHEM.
- The overall likelihood of approval of a Phase I solid tumors asset is 5.8%, and the average probability a drug advances from Phase III is 40.3%. 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–III indicates that the vast majority of trials for biliary tract neoplasms have been in the early and mid-phases of development, with 91% of trials in Phase I–II, and only 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 South Korea has the top spot in Asia.
- Eli Lilly has the highest number of ongoing clinical trials for biliary tract neoplasms, with four trials. AstraZeneca leads industry sponsors with the highest overall number of clinical trials for biliary tract neoplasms, followed by Eli Lilly
6 KEY TAKEAWAYS
7 DISEASE BACKGROUND
8 Radiation therapy
9 Palliative therapy
13 PIPELINE DRUGS
20 RECENT EVENTS AND ANALYST OPINION
20 Tibsovo for BTC (May 15, 2019)
21 Derazantinib for BTC (January 9, 2019)
22 Lenvima for BTC (March 7, 2018)
24 KEY UPCOMING EVENTS
25 PROBABILITY OF SUCCESS
26 LICENSING AND ASSET ACQUISITION DEALS
27 PARENT PATENTS
28 CLINICAL TRIAL LANDSCAPE
29 Sponsors by status
30 Sponsors by phase
LIST OF FIGURES
12 Figure 1: Trends in incident cases of BTC, 2017–26
13 Figure 2: Overview of pipeline drugs for BTC in the US
13 Figure 3: Pipeline drugs for BTC, by company
14 Figure 4: Pipeline drugs for BTC, by drug type
14 Figure 5: Pipeline drugs for BTC, by classification
21 Figure 6: Tibsovo for BTC (May 15, 2019): Phase III – ClarIDHy
22 Figure 7: Derazantinib for BTC (January 9, 2019): Phase II – Intrahepatic Cholangiocarcinoma (iCCA)
24 Figure 8: Key upcoming events in BTC
25 Figure 9: Probability of success in the BTC pipeline
26 Figure 10: Licensing and asset acquisition deals in BTC, 2014–19
27 Figure 11: Parent patents in BTC
28 Figure 12: Clinical trials in BTC
28 Figure 13: Top 10 drugs for clinical trials in BTC
29 Figure 14: Top 10 companies for clinical trials in BTC
29 Figure 15: Trial locations in BTC
30 Figure 16: BTC trials status
31 Figure 17: BTC trials sponsors, by phase
LIST OF TABLES
11 Table 1: Incident cases of BTC, 2017–26
15 Table 2: Pipeline drugs for BTC in the US
20 Table 3: Tibsovo for BTC (May 15, 2019)
21 Table 4: Derazantinib for BTC (January 9, 2019)
23 Table 5: Lenvima for BTC (March 7, 2018)
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