Biliary Tract Cancer Treatment Market Size (7MM) was ~USD 1000 million in 2023, which is expected to increase by 2034, estimates DelveInsight

DelveInsight's "Biliary Tract Cancer Market Insights, Epidemiology, and Market Forecast-2034′′ report offers an in-depth understanding of the Biliary Tract Cancer, historical and forecasted epidemiology as well as the Biliary Tract Cancer market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

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Key Takeaways from Biliary Tract Cancer Market Report
• In 7MM, the United States accounted for the highest number of total incidence of Biliary Tract Cancer, which is around 30% of the total incident cases of Biliary Tract Cancer in the 7MM, in 2023.
• In the US, among the mutation-specific cases of Biliary Tract Cancer, TP53 cases were highest, followed by KRAS cases in 2023.
• Among the EU4 and the UK, Italy accounted for the highest number of Biliary Tract Cancer cases, followed by Germany, whereas Spain accounted for the lowest number of Biliary Tract Cancer cases.
• In 2023, as far as stage-specific cases are concerned, Stage IV accounted for the highest number of cases in Japan. These cases are anticipated to increase by 2034.
• The leading Biliary Tract Cancer Companies such as 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.
• Promising Biliary Tract Cancer Therapies such as PEMAZYRE (pemigatinib), IMFINZI (durvalumab), CTX-009, Zanidatamab, and others.

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Biliary Tract Cancer Overview
Biliary Tract Cancer refers to a group of rare but aggressive malignancies that develop in the bile ducts, gallbladder, or ampulla of Vater-the structures responsible for transporting bile from the liver to the small intestine. These cancers interfere with bile flow, leading to symptoms such as jaundice, abdominal pain, nausea, weight loss, and itching. Most cases are diagnosed in advanced stages, as early symptoms are often vague or nonspecific. Risk factors include chronic inflammation, gallstones, biliary infections, primary sclerosing cholangitis, and certain congenital abnormalities.

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

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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). PEMAZYRE is a small molecule kinase inhibitor that targets FGFR1, 2, and 3 with IC50 values of less than 2 nM. PEMAZYRE also inhibited FGFR4 in vitro at a concentration approximately 100 times higher than those that inhibit FGFR1, 2, and 3. PEMAZYRE inhibited FGFR1-3 phosphorylation and signaling and decreased cell viability in cancer cell lines by activating FGFR amplifications and fusions that resulted in constitutive activation of FGFR signaling. Constitutive FGFR signaling can support the proliferation and survival of malignant cells. PEMAZYRE exhibited anti-tumor activity in mouse xenograft models of human tumors with FGFR1, 2, or FGFR3 alterations resulting in constitutive FGFR activation, including a patient-derived xenograft model of cholangiocarcinoma that expressed an oncogenic FGFR2-Transformer-2 beta homolog (TRA2b) fusion protein and the KG1 leukemia model that carries a translocation of FGFR1 (FGFR1OP2-FGFR1).

• 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. Expression of programmed cell death ligand-1 (PD-L1) can be induced by inflammatory signals (e.g., IFN-gamma) and can be expressed on both tumor cells and tumor-associated immune cells in the tumor microenvironment. PD-L1 blocks T-cell function and activation through interaction with PD-1 and CD80 (B7.1). By binding to its receptors, PD-L1 reduces cytotoxic T-cell activity, proliferation, and cytokine production. Durvalumab is a human immunoglobulin G1 kappa (IgG1?) monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80 (B7.1). Blockade of PD-L1/PD-1 and PD-L1/CD80 interactions releases the inhibition of immune responses without inducing antibody-dependent cell-mediated cytotoxicity (ADCC). PD-L1 blockade with durvalumab led to increased T-cell activation in vitro and decreased tumor size in co-engrafted human tumor and immune cell xenograft mouse models.

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. Compass holds the global rights to CTX-009 (also known as ABL001) except for rights in Korea, held by Handok, and rights in China, which were out-licensed to Elpiscience Biopharma. Currently, CTX-009 is in the Phase III stage of clinical development for the treatment of Biliary Tract Cancer.

• 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.

Biliary Tract Cancer Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Biliary Tract Cancer market or expected to get launched during the study period. The analysis covers Biliary Tract Cancer market uptake by drugs, patient uptake by therapies, and sales of each drug. Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share. The report also covers the Biliary Tract Cancer Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

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. After receiving initial approval in the United States in 2018 in the form of VITRAKVI, biliary tract cancer has seen approvals for various patient segments. A notable recent development is the approval from the US FDA in November 2023 for Merck's KEYTRUDA in combination with chemotherapy (gemcitabine and cisplatin), presenting competition to AstraZeneca's IMFINZI. While KEYTRUDA showed a slightly lower reduction in the risk of death compared to IMFINZI, both demonstrated improvements in first-line biliary tract cancer, with IMFINZI gaining FDA approval in September 2022.

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Scope of the Biliary Tract Cancer Market Report
• Study Period: 2020-2034
• Coverage: 7MM
• 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.
• Biliary Tract Cancer Therapeutic Assessment: Biliary Tract Cancer current marketed and Biliary Tract Cancer emerging therapies
• Biliary Tract Cancer Market Dynamics: Biliary Tract Cancer market drivers and Biliary Tract Cancer market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Biliary Tract Cancer Unmet Needs, KOL's views, Analyst's views, Biliary Tract Cancer Market Access and Reimbursement

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Table of Contents
1. Biliary Tract Cancer Market Report Introduction
2. Executive Summary for Biliary Tract Cancer
3. SWOT analysis of Biliary Tract Cancer
4. Biliary Tract Cancer Patient Share (%) Overview at a Glance
5. Biliary Tract Cancer Market Overview at a Glance
6. Biliary Tract Cancer Disease Background and Overview
7. Biliary Tract Cancer Epidemiology and Patient Population
8. Country-Specific Patient Population of Biliary Tract Cancer
9. Biliary Tract Cancer Current Treatment and Medical Practices
10. Biliary Tract Cancer Unmet Needs
11. Biliary Tract Cancer Emerging Therapies
12. Biliary Tract Cancer Market Outlook
13. Country-Wise Biliary Tract Cancer Market Analysis
14. Biliary Tract Cancer Market Access and Reimbursement of Therapies
15. Biliary Tract Cancer Market Drivers
16. Biliary Tract Cancer Market Barriers
17. Biliary Tract Cancer Appendix
18. Biliary Tract Cancer Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

About Us

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