Biliary Tract Cancer Market Spotlight Report 2021 - ResearchAndMarkets.com

The "Market Spotlight: Biliary Tract Cancer" report has been added to ResearchAndMarkets.com's offering.

Biliary tract cancer (BTC), also known as cholangiocarcinoma or bile duct adenocarcinoma, is a cancer that originates from the cells which line the bile duct. These are a group of rare and heterogeneous malignancies with poor prognosis. BTCs are genetically and clinically divergent.

Key Takeaways

• The publisher estimates that in 2019, there were approximately 405,800 incident cases of biliary tract cancer (BTC) worldwide, and forecasts that number to increase to 433,300 incident cases by 2028.
• The only approved drug in the BTC space is Pemazyre, which targets fibroblast growth factor receptor. It is administered via the oral route.
• The majority of industry-sponsored drugs in active clinical development for BTC are in Phase II, with one drug in the NDA/BLA stage.
• 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 II trial results for M7824 and fimaCHEM, topline Phase IIa trial results for Xermelo, topline Phase IIb/III trial results for surufatinib, topline Phase III trial results for Imfinzi, an expected CHMP opinion for Pemazyre, and an estimated PDUFA date for infigratinib.
• The overall likelihood of approval of a Phase I solid tumors asset is 5.5%, and the average probability a drug advances from Phase III is 42.7%. Drugs, on average, take 9.7 years from Phase I to approval, compared to 9.6 years in the overall oncology space.
• 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 91% of trials in Phase I-II, and only 9% in Phase III-IV.
• The US has a substantial lead in the number of biliary tract neoplasms clinical trials globally. The UK leads the major European markets, while South Korea has the top spot in Asia.
• Eli Lilly has the highest number of completed clinical trials for biliary tract neoplasms, with five trials.
• AstraZeneca leads industry sponsors with the highest overall number of clinical trials for biliary tract neoplasms.

Key Topics Covered:

OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

• Subtypes

TREATMENT

• Surgery
• Radiation therapy
• Chemotherapy
• Targeted therapy
• Palliative therapy

EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION

• Futibatinib for BTC (April 11, 2021)
• Bintrafusp Alfa for BTC (March 16, 2021)
• Tibsovo for BTC (January 17, 2021)
• Tibsovo for BTC (September 21, 2020)
• Varlitinib for BTC (November 11, 2019)

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS

• Japan Approves Incyte's Pemazyre for Unresctable BTC
• Real-Time Review: Danyelza, Gavreto Graduate; infigratinib Joins Up
• Merck KGaA Rebounds After COVID-19 Lockdowns

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

• Agios Sells Cancer Portfolio To Servier To Focus On Genetic Diseases
• Lexicon Sells Cancer Supportive Care Therapy To TerSera
• Sirnaomics To Use Precision NanoSystems Technology To Advance Pipeline

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

• Sponsors by status
• Sponsors by phase
• Recent events

BIBLIOGRAPHY

APPENDIX

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View source version on businesswire.com: https://www.businesswire.com/news/home/20220127005832/en/