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 2016, there were approximately 716,000 incident cases of Biliary tract cancer (BTC) 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 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 III trial results for derazantinib and topline Phase II/III trial results for varlitinib.
- The overall likelihood of approval of a Phase I solid tumor asset is 5.6%, and the average probability a drug advances from Phase III is 39.4%. Drugs, on average, take 9.5 years from Phase I to approval, compared to 9.2 years in the overall oncology space.
- There has been only one licensing and asset acquisition deal involving gallbladder and BTC 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 during the period.
- 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 93% of trials in Phase I–II, and only 7% in Phase III.
- The US has a substantial lead in the number of biliary tract neoplasms clinical trials globally. The UK and Germany lead 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 trials. Eli Lilly has the highest number of completed clinical trials for biliary tract neoplasms, with four trials.
- AstraZeneca leads the industry sponsors with the highest number of clinical trials for biliary tract neoplasms, followed by Eli Lilly and Aslan Pharmaceuticals.
6 KEY TAKEAWAYS
7 DISEASE BACKGROUND
8 Radiation therapy
9 Palliative therapy
13 PIPELINE DRUGS
19 RECENT EVENTS AND ANALYST OPINION
19 Lenvima for BTC (March 7, 2018)
20 CX-4945 for BTC (January 20, 2017)
22 KEY UPCOMING EVENTS
23 PROBABILITY OF SUCCESS
24 LICENSING AND ASSET ACQUISITION DEALS
24 Basilea Licenses ArQule’s Derazantinib
24 ArQule Grants Roivant/Sinovant Exclusive Derazantinib Rights In China
25 Aslan Revises Varlitinib License With Array, Getting Commercial Rights
25 Mundipharma Acquires “Smart” Chemo Drug From CellAct
26 PARENT PATENTS
27 CLINICAL TRIAL LANDSCAPE
28 Sponsors by status
29 Sponsors by phase
30 Recent events
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: CX-4945 for BTC (January 20, 2017): Phase I/II – w/Gemcitabine & Cisplatin (Cholangiocarcinoma)
22 Figure 7: Key upcoming events in BTC
23 Figure 8: Probability of success in the BTC pipeline
24 Figure 9: Licensing and asset acquisition deals in BTC, 2013–18
26 Figure 10: Parent patents in BTC
27 Figure 11: Clinical trials in BTC
27 Figure 12: Top 10 drugs for clinical trials in BTC
28 Figure 13: Top 10 companies for clinical trials in BTC
28 Figure 14: Trial locations in BTC
29 Figure 15: BTC trials status
30 Figure 16: 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
19 Table 3: Lenvima for BTC (March 7, 2018)
20 Table 4: CX-4945 for BTC (January 20, 2017)
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