DelveInsight’s “Biliary Tract Cancer Treatment Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of Biliary Tract Cancer, historical and forecasted epidemiology, as well as the Biliary Tract Cancer market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

Discover which therapies are expected to grab the Biliary Tract Cancer Market Share @ Biliary Tract Cancer Market Outlook

Key Takeaways from the Biliary Tract Cancer Market Report

• In June 2025, AstraZeneca announced a study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator’s choice of chemotherapy in participants with BTC after surgical resection with curative intent.
• In June 2025, Merck Sharp & Dohme LLC conducted a Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers.
• In the 7MM, the United States accounted for the highest Biliary Tract Cancer market size, with nearly 48% of the market share of the Biliary Tract Cancer market as compared to EU4 and the UK and Japan in 2023.
• In 2023, among EU4 and the UK, Italy accounted for the largest Biliary Tract Cancer market size, while Spain accounted for the smallest Biliary Tract Cancer market share.
• The clinical features of Biliary Tract Cancer depend on the location of the tumor. Patients with extrahepatic tumors usually present with painless jaundice from biliary obstruction, and patients with intrahepatic tumors usually present with pain. Common complaints include pruritus, abdominal pain, malaise, fatigue, pruritus jaundice, and fever.
• Biliary tract cancer is usually diagnosed with the clinical examination of the abdomen, using imaging scans, ultrasound, magnetic resonance imaging (MRI) or computed tomography (CT), and biopsy.
• In 2023, Japan accounted for the highest number of total incident cases of Biliary Tract Cancer in the 7MM.
• In the United States, Biliary Tract Cancer occurs majorly in the age group of 70–79 years, constituting approximately ~30% of the total age-specific cases of Biliary Tract Cancer.
• Among the EU4 and the UK, the mutation-specific cases of Biliary Tract Cancer were highest in TP53 mutations, followed by KRAS mutations in 2023.
• The leading Biliary Tract Cancer Companies such as Incyte Corporation, Loxo Oncology, Bayer, Roche, Genentech, QED Therapeutics, Agios Pharmaceuticals, Servier Pharmaceuticals, Merck Sharp & Dohme, AstraZeneca, Taiho Oncology, Delcath Systems, Eisai, TransThera Sciences (Nanjing), Basilea Pharmaceutica, Zymeworks, BeiGene and others.
• Promising Biliary Tract Cancer Pipeline Therapies such as Durvalumab, Nivolumab, Futibatinib, Ivosidenib, Zanidatamab, Gemcitabine, XmAb20717, ZW25 (Zanidatamab) and others.

Stay ahead in the Biliary Tract Cancer Therapeutics Market with DelveInsight’s Strategic Report @ Biliary Tract Cancer Treatment Market

Biliary Tract Cancer Epidemiology Segmentation in the 7MM

• Total Biliary Tract Cancer Incident Cases
• Biliary Tract Cancer Age-specific Cases
• Biliary Tract Cancer Stage-specific Cases
• Total Incident Cases of Biliary Tract Cancer by tumor location in the 7MM
• Biliary Tract Cancer Mutation-specific Cases
• Biliary Tract Cancer Treated Cases

Download the report to understand which factors are driving Biliary Tract Cancer Epidemiology trends @ Biliary Tract Cancer Prevalence

Biliary Tract Cancer Marketed Drugs

• PEMAZYRE (pemigatinib): Incyte

PEMAZYRE is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on the overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

• IMFINZI (durvalumab): AstraZeneca

IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with gemcitabine and cisplatin as treatment of adult patients with locally advanced or metastatic Biliary Tract Cancer.The approval for the treatment of adult patients with locally advanced or metastatic by the US FDA was based on the results from the TOPAZ-1 Phase III trial.

Biliary Tract Cancer Emerging Therapies

• CTX-009: Compass Therapeutics

CTX-009 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Preclinical and early clinical data of CTX-009 suggest that blockade of both pathways provides robust antitumor activity across several solid tumors, including colorectal cancer, gastric cancer, cholangiocarcinoma, pancreatic cancer, and non-small cell lung cancer. Partial responses to CTX-009 as monotherapy have been observed in heavily pre-treated patients with cancer who were resistant to currently approved anti-VEGF therapies.

• Zanidatamab: Jazz Pharmaceuticals/Zymeworks

Zanidatamab is a novel, late-stage oncology asset with the potential to transform the standard of care in multiple HER2-expressing cancers. It has demonstrated compelling data in biliary tract cancers and gastroesophageal adenocarcinoma with the potential to benefit patients across multiple tumor types.A pivotal Phase II clinical trial evaluating zanidatamab monotherapy in patients with previously treated advanced or metastatic HER2-amplified Biliary Tract Cancer.

To learn more about Biliary Tract Cancer Treatment guidelines, visit @ Biliary Tract Cancer Clinical Trials Assessment

Biliary Tract Cancer Companies

Incyte Corporation, Loxo Oncology, Bayer, Roche, Genentech, QED Therapeutics, Agios Pharmaceuticals, Servier Pharmaceuticals, Merck Sharp & Dohme, AstraZeneca, Taiho Oncology, Delcath Systems, Eisai, TransThera Sciences (Nanjing), Basilea Pharmaceutica, Zymeworks, BeiGene and others.

Biliary Tract Cancer Market Outlook

Bile duct cancer begins when healthy cells in the bile duct change and grow out of control, forming a mass called a tumor. A tumor can be benign or cancerous. A benign tumor can grow but will not spread. A cancerous tumor is malignant, meaning it can grow and spread to other parts of the body. Treatment options for the early-stage disease include surgery, followed by adjuvant chemotherapy. For patients with locally advanced and metastatic disease, the combination of gemcitabine and cisplatin has been shown to improve survival.

Biliary Tract Cancer Treatment Market

The biliary tract comprises of gallbladder and intra and extrahepatic biliary tree. Bile is directed through these ducts to the second part of duodenum at major duodenal papilla. The epithelium of the biliary tract is lined with cells called cholangiocytes. Carcinoma of the biliary tract arises from the malignant transformation of the epithelium of the bile ducts which is made up of these cholangiocytes, and is categorized on the basis of its anatomical location as; 1) Intrahepatic cholangiocarcinoma 2) Extrahepatic cholangiocarcinoma, which includes; perihilar tumor also known as Klatskin tumor (originating from the epithelium of the bile duct at the junction of right and left hepatic ducts with the cystic duct where it forms the common bile duct) and distal cholangiocarcinoma outspreading to encompass the gallbladder, ampulla of Vater and pancreatic biliary ducts.

Learn more about the FDA-approved drugs for Biliary Tract Cancer @ Drugs for Biliary Tract Cancer Treatment

Scope of the Biliary Tract Cancer Market Report

• Coverage- 7MM
• Study Period0- 2020-2034
• Biliary Tract Cancer Companies- Incyte Corporation, Loxo Oncology, Bayer, Roche, Genentech, QED Therapeutics, Agios Pharmaceuticals, Servier Pharmaceuticals, Merck Sharp & Dohme, AstraZeneca, Taiho Oncology, Delcath Systems, Eisai, TransThera Sciences (Nanjing), Basilea Pharmaceutica, Zymeworks, BeiGene and others.
• Biliary Tract Cancer Pipeline Therapies- Durvalumab, Nivolumab, Futibatinib, Ivosidenib, Zanidatamab, Gemcitabine, XmAb20717, ZW25 (Zanidatamab) and others.
• Biliary Tract Cancer Market Dynamics: Biliary Tract Cancer Market Drivers and Barriers
• Biliary Tract Cancer Market Access and Reimbursement, Unmet Needs and Future Perspectives

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Biliary Tract Cancer (BTC)

4. Key Events

5. Biliary Tract Cancer Market Overview at a Glance

6. Disease Background and Overview

7. Current Treatment Practices of Biliary Tract Cancer

8. Guidelines: Diagnosis and Treatment

9. Biliary Tract Cancer Epidemiology and Market Forecast Methodology

10. Biliary Tract Cancer Epidemiology and Patient Population

11. Biliary Tract Cancer Patient Journey

12. Marketed Biliary Tract Cancer Therapies

13. Emerging Biliary Tract Cancer Therapies

14. Biliary Tract Cancer (BTC) Market Analysis

15. Biliary Tract Cancer Unmet Needs

16. Biliary Tract Cancer SWOT Analysis

17. KOL Views

18. Biliary Tract Cancer Market Access and Reimbursement

19. Biliary Tract Cancer Market Access and Reimbursement

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight

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