The Biliary Tract Cancer market report also offers comprehensive insights into the Biliary Tract Cancer market size, share, Biliary Tract Cancer epidemiology, emerging therapies, market drivers and barriers, ongoing clinical trials, key collaboration in the space, market uptake by key therapies and companies actively pushing Biliary Tract Cancer market size growth forward.
Some of the key highlights from the Biliary Tract Cancer Market Insights Report:
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Several key pharmaceutical companies, including 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 developing novel products to improve the Biliary Tract Cancer treatment outlook.
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In November 2024, Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Ziihera® (zanidatamab-hrii) 50mg/mL injection for intravenous use. This approval is for the treatment of adults with previously treated, unresectable, or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), identified through an FDA-approved test. Ziihera’s accelerated approval was based on a 52% objective response rate (ORR) and a median duration of response (DOR) of 14.9 months, as assessed by an independent central review. Continued approval will depend on confirming clinical benefit in a follow-up trial. The Phase 3 HERIZON-BTC-302 trial is ongoing, evaluating zanidatamab in combination with standard-of-care therapy compared to standard-of-care therapy alone for the first-line treatment of HER2-positive BTC.
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In August 2024, Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage biopharmaceutical company, completed patient enrollment in its COMPANION-002 trial, a randomized Phase 2/3 study with 150 patients. The trial evaluates CTX-009 for individuals with biliary tract cancer (BTC).
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In June 2024, Bold Therapeutics, a leader in metallotherapeutics, announced positive Phase 2 safety and efficacy results for its lead asset, BOLD-100, in the treatment of advanced metastatic biliary tract cancer (BTC) and gastric cancer (GC) at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, IL.
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In 2023, the United States held the largest share of the Biliary Tract Cancer market in the 7MM, with nearly 48% of the market, compared to the EU4, the UK, and Japan. Among the EU4 and the UK, Italy had the largest market share for Biliary Tract Cancer, while Spain had the smallest.
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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 drug is approved for the treatment of adults with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer (BTC), as identified through an FDA-approved test.
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Biliary tract cancers, which are epithelial malignancies of the biliary tree, include gallbladder cancer (GBC) and cholangiocarcinoma (CCA). CCA is further categorized into intrahepatic, perihilar (Klatskin’s tumor), and distal types. The symptoms of Biliary Tract Cancer vary based on tumor location. Extrahepatic tumors commonly cause painless jaundice due to biliary obstruction, while intrahepatic tumors typically present with pain. Patients often report pruritus, abdominal pain, fatigue, jaundice, and fever.
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Diagnosis of Biliary Tract Cancer generally involves abdominal clinical examination, imaging scans such as ultrasound, MRI, or CT, and biopsy. In 2023, Japan recorded the highest number of new Biliary Tract Cancer cases in the 7MM.
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In the United States, Biliary Tract Cancer predominantly affects individuals aged 70–79, representing about 30% of all age-specific cases. Among the EU4 and the UK, TP53 mutations were most common in Biliary Tract Cancer cases, followed by KRAS mutations in 2023.
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For early-stage Biliary Tract Cancer, treatment typically includes surgery followed by adjuvant chemotherapy. In cases of locally advanced disease, loco-regional therapies such as trans-arterial chemoembolization (TACE) and external beam radiation therapy (EBRT) may be considered. For advanced and metastatic cases, a combination of gemcitabine and cisplatin has shown survival benefits.
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Chemotherapy regimens dominate the current treatment landscape, but emerging therapies like CX-4945 and CTX-009 are expected to positively impact the treatment landscape between 2024 and 2034. Drugs like PEMAZYRE (pemigatinib) and LYTGOBI (futibatinib), both FGFR2 inhibitors, have been approved by the FDA. Another key target for Biliary Tract Cancer treatment is the PD-1 immune checkpoint molecule. In October 2023, the FDA expanded the use of KEYTRUDA (pembrolizumab) in combination with gemcitabine and cisplatin for treating locally advanced unresectable or metastatic Biliary Tract Cancer.
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Researchers are also exploring other mutations in Biliary Tract Cancer tumors to develop more treatment options. TAFINLAR (dabrafenib) and MEKINIST (trametinib) have been approved for BRAFV600E solid tumors, while VITRAKVI (larotrectinib) and ROZLYTREK (entrectinib) are used for NTRK fusion-positive solid tumors.
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Real-world data analysis reveals evolving treatment patterns and survival outcomes, showing variation in therapy use across treatment lines. Despite advancements, challenges such as low survival rates, high mortality, and factors like advanced age and disease stage complicate treatment decisions and patient outcomes.
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As per DelveInsight analysis, the Biliary Tract Cancer market is anticipated to witness growth at a considerable CAGR
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Biliary Tract Cancer Overview
The biliary tract consists of the gallbladder and the intrahepatic and extrahepatic biliary trees. Bile flows through these ducts to the second part of the duodenum at the major duodenal papilla. The lining of the biliary tract is composed of cells known as cholangiocytes. Biliary tract carcinoma originates from the malignant transformation of the bile duct epithelium, which is made up of these cholangiocytes. It is classified based on its anatomical location into: 1) Intrahepatic cholangiocarcinoma, and 2) Extrahepatic cholangiocarcinoma, which includes perihilar tumors (also called Klatskin tumors) that arise from the bile duct epithelium at the junction of the right and left hepatic ducts and the cystic duct, forming the common bile duct, and distal cholangiocarcinoma, which can extend to the gallbladder, ampulla of Vater, and pancreatic biliary ducts.
Chronic inflammatory conditions can cause changes in the biliary tract epithelium, leading to cancer. One of the most well-established conditions linked to biliary tract cancer is primary sclerosing cholangitis (PSC), which is commonly associated with chronic inflammatory bowel diseases, particularly ulcerative colitis.
The clinical presentation of biliary tract cancer depends on the tumor’s location. Most tumors start at the hepatic duct bifurcation, while others occur in the distal common bile duct or within the liver. Patients with extrahepatic tumors typically present with painless jaundice due to biliary obstruction, whereas those with intrahepatic tumors generally experience pain.
Do you know the treatment paradigms for different countries? Download our Biliary Tract Cancer Market Sample Report
Biliary Tract Cancer Epidemiology Insights
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In 2023, Italy had the highest number of Biliary Tract Cancer cases among the EU4 countries and the UK, with Germany following behind, while Spain had the fewest cases.
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Regarding stage-specific cases, Stage IV had the highest incidence in Japan, and this number is expected to rise by 2034.
Biliary Tract Cancer Epidemiology Segmentation
DelveInsight’s Biliary Tract Cancer market report is prepared on the basis of epidemiology model. It offers comprehensive insights to the Biliary Tract Cancer historical patient pools and forecasted Biliary Tract Cancer patients. The report provides in-depth data of various subtypes and for the same epidemiology is segmented further. The Biliary Tract Cancer Market report proffers epidemiological analysis for the study period 2020-34 in the 7MM segmented into:
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Biliary Tract Cancer Prevalence
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Age-Specific Biliary Tract Cancer Prevalence
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Gender-Specific Biliary Tract Cancer Prevalence
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Diagnosed and Treatable Cases of Biliary Tract Cancer
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Biliary Tract Cancer Market Insights
Companies involved in the development of therapies for Biliary Tract Cancer include TransThera Sciences, AstraZeneca/Compugen, Jazz Pharmaceuticals/Zymeworks, and others. The launch of emerging therapies and additional treatments is expected to significantly boost the Biliary Tract Cancer market size during the forecast period from 2024 to 2034.
In 2023, the total market size for Biliary Tract Cancer was approximately USD 1 billion, with projections indicating growth by 2034 throughout the study period (2020–2034) in the 7MM.
The United States had the largest Biliary Tract Cancer market size in 2023, followed by Japan. During the forecast period, pipeline candidates like CX-4945 and CTX-009 are anticipated to contribute to the market’s expansion.
By 2034, chemotherapy regimens are expected to generate the largest Biliary Tract Cancer market size in the United States, reaching approximately USD 360 million.
Biliary Tract Cancer Marketed Drugs
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PEMAZYRE (pemigatinib): Incyte
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IMFINZI (durvalumab): AstraZeneca
Biliary Tract Cancer Emerging Drugs
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CTX-009: Compass Therapeutics
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Zanidatamab: Jazz Pharmaceuticals/Zymeworks
Biliary Tract Cancer Key Companies
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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
For more information, visit Biliary Tract Cancer Market Analysis, Patient Pool, and Emerging Therapies
Scope of the Biliary Tract Cancer Market Report:
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11 Years Forecast
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7MM Coverage
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Descriptive overview of Biliary Tract Cancer, causes, signs and symptoms, diagnosis, treatment
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Comprehensive insight into Biliary Tract Cancer epidemiology in the 7MM
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Biliary Tract Cancer marketed and emerging therapies
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Biliary Tract Cancer companies
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Biliary Tract Cancer market drivers and barriers
Table of Contents:
1 Biliary Tract Cancer Market Key Comprehensive Insights
2 Biliary Tract Cancer Market Report Introduction
3 Competitive Intelligence Analysis for Biliary Tract Cancer
4 Biliary Tract Cancer Market Analysis Overview at a Glance
5 Executive Summary of Biliary Tract Cancer
6 Biliary Tract Cancer Epidemiology and Market Methodology
7 Biliary Tract Cancer Epidemiology and Patient Population
8 Biliary Tract Cancer Patient Journey
9 Biliary Tract Cancer Treatment Algorithm, Biliary Tract Cancer Current Treatment, and Medical Practices
10 Key Endpoints in Biliary Tract Cancer Clinical Trials
11 Biliary Tract Cancer Marketed Therapies
12 Biliary Tract Cancer Emerging Therapies
13 Biliary Tract Cancer: 7 Major Market Analysis
14 Attribute analysis
15 Access and Reimbursement Overview of Biliary Tract Cancer
16 Biliary Tract Cancer Market Key Opinion Leaders Reviews
18 Biliary Tract Cancer Market Drivers
19 Biliary Tract Cancer Market Barriers
20 SWOT Analysis
21 Disclaimer
22 DelveInsight Capabilities
23 About DelveInsight
Related Reports:
Biliary Tract Cancer Epidemiology 2034
DelveInsight’s “Biliary Tract Cancer – Epidemiology Forecast to 2034” report delivers an in-depth understanding of the disease, historical and forecasted Biliary Tract Cancer epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
Biliary Tract Cancer Pipeline 2024
“Biliary Tract Cancer Pipeline Insights, 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.
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