Biliary Tract Cancer Market: Analysis of Epidemiology, Pipeline Products, and Key Companies Working, DelveInsight | Incyte Corporation, Loxo Oncology, Bayer, Roche, Genentech, QED Therapeutics, Agios Pharmaceuticals, Servier Pharmaceuticals, Merck Sharp &

Biliary Tract Cancer emerging therapies such as PEMAZYRE (pemigatinib), IMFINZI (durvalumab), CTX-009, Zanidatamab, and others are expected to boost the Biliary Tract Cancer Market in the upcoming years.

DelveInsight has launched a new report on "Biliary Tract Cancer - Market Insights, Epidemiology, and Market Forecast-2034" that delivers 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, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

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Some of the key facts of the Biliary Tract Cancer Market Report:

In December 2024, Jazz Pharmaceuticals announced that the U.S. FDA had granted accelerated approval for Ziihera® (zanidatamab-hrii) 50mg/mL for intravenous administration. The approval covers the treatment of adults with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer (BTC), as identified through an FDA-approved test.
In the seven major markets (7MM), the United States held the largest market share for Biliary Tract Cancer (BTC) in 2023, accounting for nearly 48% of the total market size, surpassing the combined market sizes of the EU4, the UK, and Japan. Among the EU4 and the UK, Italy had the largest BTC market, whereas Spain had the smallest share.
In 2023, the total market size for Biliary Tract Cancer (BTC) in the seven major markets (7MM) was approximately USD 1,000 million. This figure is projected to grow by 2034 over the course of the study period (2020-2034).
Biliary tract cancers are malignancies arising from the epithelial lining of the biliary tree and encompass gallbladder cancer (GBC) and cholangiocarcinoma (CCA). CCA is further categorized into intrahepatic CCA, perihilar CCA (Klatskin's tumor), and distal CCA.
The clinical presentation of BTC varies based on tumor location. Extrahepatic tumors typically cause painless jaundice due to bile duct obstruction, while intrahepatic tumors often present with pain. Other common symptoms include pruritus, abdominal pain, malaise, fatigue, jaundice, and fever. BTC is diagnosed through abdominal examinations, imaging techniques such as ultrasound, MRI, and CT scans, as well as biopsy analysis.
In 2023, Japan recorded the highest number of incident BTC cases among the 7MM. In the U.S., BTC was most prevalent in individuals aged 70-79, accounting for approximately 30% of all age-specific cases. Across the EU4 and the UK, TP53 mutations were the most frequently observed genetic alterations in BTC cases, followed by KRAS mutations.
Early-stage BTC is primarily managed through surgical resection, often followed by adjuvant chemotherapy. For locally advanced cases, loco-regional therapies such as trans-arterial chemoembolization (TACE) and external beam radiation therapy (EBRT) may be utilized. In patients with locally advanced or metastatic disease, the combination of gemcitabine and cisplatin has been shown to enhance survival outcomes.
Chemotherapy remains the dominant treatment approach; however, new therapies in development, such as CX-4945 and CTX-009, are expected to shift the BTC treatment landscape between 2024 and 2034. Several targeted therapies have already gained FDA approval, including PEMAZYRE (pemigatinib) and LYTGOBI (futibatinib), both FGFR2 inhibitors. In October 2023, the FDA expanded the indication for KEYTRUDA (pembrolizumab), a PD-1 immune checkpoint inhibitor, allowing its use in combination with gemcitabine and cisplatin for treating locally advanced, unresectable, or metastatic BTC.
Beyond PD-1 and FGFR2, researchers are exploring additional genetic targets for BTC treatment. TAFINLAR (dabrafenib) and MEKINIST (trametinib) have been approved in the U.S. for treating BRAFV600E-positive solid tumors. Meanwhile, VITRAKVI (larotrectinib) and ROZLYTREK (entrectinib) are utilized for NTRK fusion-positive solid tumors.
Real-world data analysis reveals evolving treatment trends and survival outcomes in BTC, highlighting differences in regimen selection across various treatment lines. Despite recent advancements, challenges remain, including low overall survival rates, high mortality, and complexities in treatment decision-making due to factors such as advanced disease stage and patient age.
Key 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 are evaluating new drugs for Biliary Tract Cancer to improve the treatment landscape.
Promising Biliary Tract Cancer pipeline therapies in various stages of development include PEMAZYRE (pemigatinib), IMFINZI (durvalumab), CTX-009, Zanidatamab, and others.
Key benefits of the Biliary Tract Cancer market report:
Biliary Tract Cancer market report covers a descriptive overview and comprehensive insight of the Biliary Tract Cancer Epidemiology and Biliary Tract Cancer market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan.)
The Biliary Tract Cancer market report provides insights on the current and emerging therapies.
Biliary Tract Cancer market report provides a global historical and forecasted market covering drug outreach in 7MM.
The Biliary Tract Cancer market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Biliary Tract Cancer market.

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Biliary Tract Cancer Overview

Bile duct cancer develops when healthy bile duct cells grow uncontrollably, forming a tumor. While benign tumors remain localized, malignant ones can spread to other areas of the body.

Early-stage treatment typically involves surgery followed by adjuvant chemotherapy. For locally advanced or metastatic cases, a combination of gemcitabine and cisplatin has shown improved survival rates.

Since the initial U.S. approval of VITRAKVI in 2018, several therapies have been introduced for different patient segments. In November 2023, the FDA approved Merck's KEYTRUDA in combination with chemotherapy (gemcitabine and cisplatin) as a competitor to AstraZeneca's IMFINZI, which was approved in September 2022. Other recent approvals include LYTGOBI (September 2022), competing with Incyte's PEMAZYRE (April 2020), as well as therapies like ROZLYTREK, TIBSOVO, and the combination of TAFINLAR and MEKINIST.

Leading pharmaceutical companies are advancing targeted therapies for biliary tract cancer, including Tinengotinib (TransThera Sciences), Rilvegostomig (AstraZeneca/Compugen), and Zanidatamab (Jazz Pharmaceuticals/Zymeworks). Several of these candidates are in the late stages of development and are expected to enter the U.S. market soon.

Biliary Tract Cancer Market Outlook

The biliary tract consists of the gallbladder and both intrahepatic and extrahepatic bile ducts, which transport bile to the second part of the duodenum via the major duodenal papilla. The inner lining of the biliary tract is composed of specialized cells called cholangiocytes. Biliary tract carcinoma arises from the malignant transformation of these cells and is classified based on its location into:
Intrahepatic cholangiocarcinoma
Extrahepatic cholangiocarcinoma, which includes:
Perihilar cholangiocarcinoma (Klatskin tumor): Originating at the junction of the right and left hepatic ducts with the cystic duct, forming the common bile duct.
Distal cholangiocarcinoma: Extending to involve the gallbladder, ampulla of Vater, and pancreatic biliary ducts.
Chronic inflammatory conditions increase the risk of malignant transformation in the biliary epithelium. The most well-established condition linked to biliary tract cancer is primary sclerosing cholangitis (PSC), which is strongly associated with chronic inflammatory bowel disease, particularly ulcerative colitis.
The symptoms of biliary tract cancer vary depending on tumor location. Most tumors originate at the hepatic duct bifurcation, while others develop in the distal common bile duct or within the liver. Extrahepatic tumors often cause painless jaundice due to bile duct obstruction, whereas intrahepatic tumors typically present with pain.
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Biliary Tract Cancer Marketed Drugs:
PEMAZYRE (pemigatinib): Incyte
IMFINZI (durvalumab): AstraZeneca
Biliary Tract Cancer Emerging Therapies:
CTX-009: Compass Therapeutics
Zanidatamab: Jazz Pharmaceuticals/Zymeworks
Scope of the Biliary Tract Cancer Market Report

Study Period: 2020-2034
Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Key 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
Key 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

Table of Contents

1. Report Introduction
2. Executive Summary
3. SWOT analysis
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. Unmet Needs
11. Biliary Tract Cancer Emerging Therapies
12. Biliary Tract Cancer Market Outlook
13. Country-Wise Biliary Tract Cancer Market Analysis (2020-2034)
14. Market Access and Reimbursement of Therapies
15. Market drivers
16. Market barriers
17. Appendix
18. Biliary Tract Cancer Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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Related Reports:

Biliary Tract Cancer Pipeline Insights, DelveInsight

"Biliary Tract Cancer Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Biliary Tract Cancer market. A detailed picture of the Biliary Tract Cancer pipeline landscape is provided, which includes the disease overview and Biliary Tract Cancer treatment guidelines.

Contact Info:

Kritika Rehani, Team Leader Marketing & Branding
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info@delveinsight.com
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+14699457679

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

This release was published on openPR.