Biliary Tract Cancer Market: Growth Momentum Across 7MM to 2034 - 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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Some of the key facts of the Biliary Tract Cancer Market Report:
• The Biliary Tract Cancer market size is anticipated to grow with a significant CAGR during the study period (2020-2034).
• In September 2025, Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it has received CE IVDR approval for two label extensions of its VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx* assay. HER2, a receptor protein expressed in multiple cancers, acts as a predictive biomarker to determine a patient's eligibility for HER2-targeted therapies. The VENTANA HER2 (4B5) test is the first and only companion diagnostic approved to identify HR-positive metastatic breast cancer patients with HER2-ultralow expression. Such patients may qualify for treatment with ENHERTU® (trastuzumab deruxtecan), a specially designed HER2-directed antibody-drug conjugate (ADC) developed by Daiichi Sankyo and co-developed and commercialized with AstraZeneca.
• In April 2025, Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage biopharmaceutical company specializing in oncology and antibody-based therapies, reported that its ongoing Phase 2/3 COMPANION-002 trial evaluating tovecimig (previously CTX-009) in combination with paclitaxel for advanced biliary tract cancer (BTC) met the primary efficacy endpoint with statistically significant top-line results.
• In January 2025, The Phase 3 SWOG S1815 trial (NCT03768414) revealed that adding nab-paclitaxel (Abraxane) to the standard chemotherapy regimen of gemcitabine and cisplatin did not lead to a statistically significant improvement in overall survival (OS) or progression-free survival (PFS) compared to gemcitabine and cisplatin alone in patients with newly diagnosed advanced biliary tract cancer.
• In December 2024, Jazz Pharmaceuticals announced that the U.S. FDA has granted accelerated approval for Ziihera® (zanidatamab-hrii) 50mg/mL for intravenous administration. This approval is for the treatment of adults with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer (BTC), confirmed by an FDA-approved test.
• In November 2024, CTX-009 is a bispecific antibody that targets both Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A), two pathways crucial for angiogenesis and tumor vascularization. Preclinical and early clinical data suggest that inhibiting both pathways offers strong anti-tumor effects across various solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic, and non-small cell lung cancer. Partial responses have been observed in heavily pre-treated cancer patients who were resistant to approved anti-VEGF therapies. The COMPANION-002 trial, a Phase 2/3 study, is evaluating the combination of CTX-009 and paclitaxel versus paclitaxel alone in patients with previously treated, advanced metastatic or recurrent biliary tract cancers (BTC). Clinical trial information: NCT05506943.
• In August 2024, Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage biopharmaceutical company focused on oncology and developing proprietary antibody-based therapeutics for various diseases, today announced the completion of patient enrollment in its COMPANION-002 trial. The trial, a randomized Phase 2/3 study, involves 150 patients and evaluates CTX-009 in individuals with biliary tract cancer (BTC).
• In June 2024, Bold Therapeutics, a global leader in the development of innovative 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.
• Chemotherapy regimens currently dominate the market. However, several promising therapies in development, such as CX-4945 and CTX-009, are anticipated to significantly impact the Biliary Tract Cancer treatment landscape during the forecast period (2024-2034).
• In 2023, the United States held the largest share of the Biliary Tract Cancer market in the 7MM, representing nearly 48% of the market, compared to the EU4, the UK, and Japan.
• In 2023, the United States represented approximately 30% of the total incident cases of Biliary Tract Cancer in the 7MM, accounting for the highest number of cases within this region.
• In the United States, the majority of Biliary Tract Cancer cases occur in individuals aged 70-79 years, accounting for approximately 30% of all age-specific cases.
• In the United States, TP53 mutations were the most prevalent among mutation-specific cases of Biliary Tract Cancer in 2023, followed by KRAS mutations.
• Key Biliary Tract Cancer Companies: Merck Sharp & Dohme, AstraZeneca, Taiho Oncology, Delcath Systems, TransThera Sciences (Nanjing), Basilea Pharmaceutica, Eisai, Zymeworks, BeiGene, Xencor, Inc., Bristol-Myers Squibb, Leap Therapeutics, Inc., Compass Therapeutics, Boehringer Ingelheim, ZielBio, Inc., GeneQuantum Healthcare (Suzhou) Co., Ltd., BioNTech SE, SOTIO Biotech, Carisma Therapeutics Inc, Rain Oncology Inc, Avacta Life Sciences Ltd, DualityBio Inc., and others
• Key Biliary Tract Cancer Therapies: Keytruda (pembrolizumab), Imfinzi (durvalumab), Futibatinib (TAS-120), Melphalan, E7090 (tasurgratinib), TT-00420, ARQ 087 (Derazantinib), Lenvima (lenvatinib), Zanidatamab, XmAb20717, Nivolumab + DKN-01, CTX-009, MEDI5752, Brigimadlin, ZB131, GQ1001, BNT141, SO-C101, CT-0508, RAIN-32, AVA6000, DB-1303, and others
• The Biliary Tract Cancer market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Biliary Tract Cancer pipeline products will significantly revolutionize the Biliary Tract Cancer market dynamics.

Biliary Tract Cancer Overview
Biliary Tract Cancer (BTC) is a rare and aggressive cancer that originates in the bile ducts, which are responsible for carrying bile from the liver to the small intestine. It includes cancers of the bile ducts inside and outside the liver, as well as the gallbladder. Symptoms can be vague and may include jaundice, abdominal pain, and weight loss, often leading to delayed diagnosis. BTC is typically diagnosed in later stages, making treatment more challenging. Treatment options may include surgery, chemotherapy, and targeted therapies, depending on the cancer's location and stage.

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Biliary Tract Cancer Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Biliary Tract Cancer Epidemiology Segmentation:
The Biliary Tract Cancer market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:
• Total Prevalence of Biliary Tract Cancer
• Prevalent Cases of Biliary Tract Cancer by severity
• Gender-specific Prevalence of Biliary Tract Cancer
• Diagnosed Cases of Episodic and Chronic Biliary Tract Cancer

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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 Therapies and Key Companies
• Keytruda (pembrolizumab): Merck Sharp & Dohme
• Imfinzi (durvalumab): AstraZeneca
• Futibatinib (TAS-120): Taiho Oncology
• Melphalan: Delcath Systems
• E7090 (tasurgratinib): Eisai
• TT-00420: TransThera Sciences (Nanjing)
• ARQ 087 (Derazantinib): Basilea Pharmaceutica
• Lenvima (lenvatinib): Eisai and Merck & Co
• Zanidatamab: Zymeworks and BeiGene
• XmAb20717: Xencor, Inc.
• Nivolumab + DKN-01: Bristol-Myers Squibb/Leap Therapeutics, Inc.
• CTX-009: Compass Therapeutics
• MEDI5752: AstraZeneca
• Brigimadlin: Boehringer Ingelheim
• ZB131: ZielBio, Inc.
• GQ1001: GeneQuantum Healthcare (Suzhou) Co., Ltd.
• BNT141: BioNTech SE
• SO-C101: SOTIO Biotech
• CT-0508: Carisma Therapeutics Inc
• RAIN-32: Rain Oncology Inc
• AVA6000: Avacta Life Sciences Ltd
• DB-1303: DualityBio Inc.

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Biliary Tract Cancer Market Drivers
• Rising incidence of biliary tract cancers globally, particularly cholangiocarcinoma, driven by aging populations and lifestyle risk factors.
• High unmet medical need due to late-stage diagnosis and limited effectiveness of conventional chemotherapy.
• Advancements in molecular profiling enabling targeted therapies and precision oncology approaches.
• Increasing R&D investments and growing clinical trial activity focused on immunotherapies and targeted agents.
• Regulatory incentives such as orphan drug designation and fast-track approvals supporting innovation.

Biliary Tract Cancer Market Barriers
• Late diagnosis and disease heterogeneity complicating patient stratification and treatment outcomes.
• Limited availability of approved therapies, especially in earlier lines of treatment.
• High development and treatment costs restricting patient access and reimbursement.
• Challenges in conducting large-scale clinical trials due to low prevalence and geographic variability.
• Safety concerns and modest response rates associated with current treatment options.

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: Merck Sharp & Dohme, AstraZeneca, Taiho Oncology, Delcath Systems, TransThera Sciences (Nanjing), Basilea Pharmaceutica, Eisai, Zymeworks, BeiGene, Xencor, Inc., Bristol-Myers Squibb, Leap Therapeutics, Inc., Compass Therapeutics, Boehringer Ingelheim, ZielBio, Inc., GeneQuantum Healthcare (Suzhou) Co., Ltd., BioNTech SE, SOTIO Biotech, Carisma Therapeutics Inc, Rain Oncology Inc, Avacta Life Sciences Ltd, DualityBio Inc., and others
• Key Biliary Tract Cancer Therapies: Keytruda (pembrolizumab), Imfinzi (durvalumab), Futibatinib (TAS-120), Melphalan, E7090 (tasurgratinib), TT-00420, ARQ 087 (Derazantinib), Lenvima (lenvatinib), Zanidatamab, XmAb20717, Nivolumab + DKN-01, CTX-009, MEDI5752, Brigimadlin, ZB131, GQ1001, BNT141, SO-C101, CT-0508, RAIN-32, AVA6000, DB-1303, 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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