DelveInsight’s report on Biliary Tract Cancer provides a detailed examination of the disease, covering historical patterns, epidemiological forecasts, and market trends in the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. It assesses existing treatment approaches, upcoming therapies, and the market presence of current and novel interventions. The report details the present and projected market size for Biliary Tract Cancer from 2020 to 2034 in the seven major markets (7MM). Additionally, it describes treatment guidelines, major market influences, challenges, and unresolved needs, highlighting expansion prospects and evaluating the future outlook for the Biliary Tract Cancer market.

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Key Highlights from the Biliary Tract Cancer Market Report

• In 2023, the overall Biliary Tract Cancer market value reached approximately USD 1000 million, projected to grow by 2034 during the study period (2020-2034) in the 7MM.

• On October 27, 2025, AstraZeneca unveiled a study to compare the effectiveness and safety of T-DXd combined with rilvegostomig or T-DXd alone against gemcitabine plus cisplatin and durvalumab in patients with advanced, untreated HER2-positive BTC.

• In the 7MM, the United States had the largest share of total Biliary Tract Cancer cases, representing about 30% of all incident cases in the 7MM in 2023.

• In the US, among mutation-specific Biliary Tract Cancer cases, TP53 mutations were most common, followed by KRAS mutations in 2023.

• Among the EU4 and the UK, Italy reported the highest number of Biliary Tract Cancer cases, followed by Germany, while Spain had the lowest.

• In 2023, regarding stage-specific cases, Stage IV represented the majority in Japan, with projections for an increase by 2034.

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

• Promising Biliary Tract Cancer therapies include PEMAZYRE (pemigatinib), IMFINZI (durvalumab), CTX-009, Zanidatamab, and others.

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Biliary Tract Cancer Epidemiology Segmentation in the 7MM

• Total Incident Cases of Biliary Tract Cancer in the 7MM

• Age-specific Cases of Biliary Tract Cancer in the 7MM

• Stage-specific Cases of Biliary Tract Cancer in the 7MM

• Total Incident Cases of Biliary Tract Cancer by Tumor Location in the 7MM

• Mutation-specific Cases of Biliary Tract Cancer in the 7MM

• Treated Cases of Biliary Tract Cancer in the 7MM

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Biliary Tract Cancer Marketed Drugs

• PEMAZYRE (pemigatinib): Incyte
  PEMAZYRE is a kinase inhibitor approved for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement, as confirmed by an FDA-approved test. Approval was granted under accelerated review based on response rate and duration. Continued approval depends on confirmatory trial results. PEMAZYRE is a small molecule targeting FGFR1, 2, and 3 with IC50 values under 2 nM, and also inhibits FGFR4 at higher concentrations. It blocks FGFR phosphorylation and signaling, reducing viability in cancer cells with FGFR alterations. It showed anti-tumor effects in mouse models of tumors with FGFR mutations, including a cholangiocarcinoma model with FGFR2 fusion.

• IMFINZI (durvalumab): AstraZeneca
  IMFINZI is a PD-L1 blocking antibody approved in combination with gemcitabine and cisplatin for adults with locally advanced or metastatic Biliary Tract Cancer. U.S. FDA approval stemmed from the TOPAZ-1 Phase III trial. PD-L1 expression, induced by inflammation, occurs on tumor and immune cells, inhibiting T-cell function via PD-1 and CD80. Durvalumab, a human IgG1κ monoclonal antibody, binds PD-L1 to disrupt these interactions, enhancing immune responses without triggering ADCC. In vitro, it boosted T-cell activation, and in mouse models, it reduced tumor size.

Biliary Tract Cancer Emerging Therapies

• CTX-009: Compass Therapeutics
  CTX-009 is a bispecific antibody targeting DLL4/Notch and VEGF-A pathways, essential for angiogenesis and tumor blood supply. Preclinical and initial clinical data indicate strong anti-tumor effects in various solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic, and lung cancers. Monotherapy partial responses were seen in heavily treated patients resistant to approved anti-VEGF drugs.

• Zanidatamab: Jazz Pharmaceuticals/Zymeworks
  Zanidatamab is an advanced oncology candidate with potential to change care standards in HER2-positive cancers. It has shown promising results in biliary tract cancers and gastroesophageal adenocarcinoma, offering benefits across tumor types. A key Phase II trial is evaluating zanidatamab alone in patients with previously treated advanced or metastatic HER2-amplified Biliary Tract Cancer.

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Biliary Tract Cancer Companies

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

Biliary Tract Cancer Market Outlook

Bile duct cancer arises when normal bile duct cells mutate uncontrollably, forming tumors that may be benign or malignant. Malignant tumors can invade other areas. Early-stage options include surgery with adjuvant chemotherapy. For advanced cases, gemcitabine and cisplatin combination improves survival. Since VITRAKVI's 2018 U.S. approval, biliary tract cancer has seen advancements for various patient groups.

Biliary Tract Cancer Market Drivers

• Increasing Incidence and Prevalence: Growing global cases, especially in older populations, boost demand for advanced treatments.

• Diagnostic Advancements: Better imaging, molecular testing, and biomarkers improve early detection and tailored therapies.

• Targeted Therapy Developments: Approvals of drugs like PEMAZYRE, LYTGOBI, and FGFR/IDH inhibitors broaden options for specific patient groups.

• Immunotherapy Approvals: Agents such as IMFINZI and KEYTRUDA (with chemotherapy) show survival gains in first-line use, driving adoption.

• Robust R&D Pipeline: Late-stage candidates like Tinengotinib, Zanidatamab, and Rilvegostomig are poised to transform treatment.

• Rising Healthcare Expenditure: Increased oncology investments and better access to therapies fuel growth in the 7MM.

Biliary Tract Cancer Market Barriers

• High Costs: Targeted and immunotherapies are costly, restricting access in some markets.

• Tumor Variability: Genetic differences complicate responses and limit broad use of targeted drugs.

• Delayed Diagnosis: Most cases are advanced, reducing surgical eligibility.

• Low Awareness: Limited public and medical knowledge in certain areas hinders timely diagnosis.

• Regulatory and Reimbursement Issues: Prolonged approvals and strict reimbursement slow uptake.

• Side Effects and Resistance: Chemotherapy toxicity and resistance to targeted agents affect long-term outcomes.

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Scope of the Biliary Tract Cancer Market Report

• Coverage: 7MM.

• Study Period: 2020-2034.

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

• Biliary Tract Cancer Therapies: PEMAZYRE (pemigatinib), IMFINZI (durvalumab), CTX-009, Zanidatamab, and others.

• Therapeutic Assessment: Covers current marketed and emerging therapies.

• Market Dynamics: Includes drivers and barriers.

• Competitive Intelligence Analysis: SWOT, PESTLE, Porter's five forces, BCG Matrix, market entry strategies.

• Unmet Needs, KOL Views, Analyst Views, Market Access and Reimbursement.

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Table of Contents

1. Key Insights

2. Executive Summary

3. Biliary Tract Cancer Competitive Intelligence Analysis

4. Biliary Tract Cancer Market Overview at a Glance

5. Biliary Tract Cancer Disease Background and Overview

6. Biliary Tract Cancer Patient Journey

7. Biliary Tract Cancer Epidemiology and Patient Population

8. Biliary Tract Cancer Treatment Algorithm, Current Treatment, and Medical Practices

9. Biliary Tract Cancer Unmet Needs

10. Key Endpoints of Biliary Tract Cancer Treatment

11. Biliary Tract Cancer Marketed Products

12. Biliary Tract Cancer Emerging Therapies

13. Biliary Tract Cancer Seven Major Market Analysis

14. Attribute Analysis

15. Biliary Tract Cancer Market Outlook (7 major markets)

16. Biliary Tract Cancer Access and Reimbursement Overview

17. KOL Views on the Biliary Tract Cancer Market

18. Biliary Tract Cancer Market Drivers

19. Biliary Tract Cancer Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

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