Biliary Tract Cancers (BTCs) Epidemiology Forecast 2034

Key Highlights

• BTC is predominantly diagnosed at advanced stages, with a majority of patients presenting with unresectable or metastatic disease. Early-stage diagnosis remains uncommon due to nonspecific symptoms and the absence of effective screening strategies. Consequently, overall prognosis remains poor, with five-year survival rates remaining low across all subtypes, particularly for advanced-stage disease.
• In Western countries, intrahepatic cholangiocarcinoma (iCCA) has shown a rising incidence trend, while extrahepatic cholangiocarcinoma (eCCA) appears relatively stable or slight increasing, suggesting differences in etiologic drivers and diagnostic coding over time.
• Gall Bladder Cancer (GBC) incidence in the United States has generally been declining over the past two decades.
• In East Asian countries like Japan, the proportion of eCCA and GBC cases is higher.
• BTC epidemiologic trends vary by subtype. iCCA incidence has increased markedly over the past two decades, driving most BTC growth, likely due to improved diagnostics, greater imaging use, and changing risk factors. eCCA incidence is stable or slightly increasing, partly due to reclassification. In contrast, GBC incidence has declined, especially among women, and ampullary cancer remains rare with stable or declining rates.
• Stage-specific survival data from the Surveillance, Epidemiology, and End Results Program (SEER) highlight marked differences by stage at diagnosis. For intrahepatic bile duct cancers, the 5-year relative survival is about 25% for localized disease, but falls sharply to ~3% for distant metastatic disease. Extrahepatic bile duct cancers show a similar pattern, with ~19–20% survival for localized disease and ~2% for distant-stage disease.

Biliary Tract Cancer (BTC) Epidemiology forecast

• 2025 Incident Cases of BTC: ~65,500
• 2036 Incident Cases of BTC: ~74,500
• BTC Growth Rate (2026–2036): 1.2% CAGR

DelveInsight's ‘Biliary Tract Cancer (BTC) – Epidemiology Forecast – 2036’ report delivers an in-depth understanding of the BTC, historical and forecasted epidemiology, in the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan.

Biliary Tract Cancer (BTC) Understanding

BTC Overview and Diagnosis

BTC’s are a heterogeneous group of malignancies originating from the biliary system, including the gallbladder, bile ducts, and the ampulla of Vater. Although relatively rare, BTCs are associated with a high mortality rate and an overall poor prognosis. With reported 5-year survival rates of approximately 10–17%, BTCs are among the most aggressive and treatment-refractory malignancies, with outcomes second only to those observed in pancreatic cancer. BTC constitute epithelial malignancies of the biliary tree and include the following: GBC and CCA. CCA is further divided into intrahepatic CCA, perihilar CCA (Klatskin’s tumor), and distal CCA.

BTC is usually diagnosed with the clinical examination of the abdomen, using imaging scans, ultrasound, Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), and biopsy. Further investigations can help determine the stage of cancer. BTC is staged according to tumor size, and the tumor commonly metastasizes via lymphatic spread to the regional lymph nodes, followed by hematogenous metastasis to the liver, lungs, and peritoneum. In addition, patients usually develop distant metastasis in the late stages of the disease. The staging is used to decide the best treatment.

Further details are provided in the report.

Biliary Tract Cancer (BTC) Epidemiology

Key Findings from BTC Epidemiological Analysis and Forecast

• In the 7MM, Japan recorded the highest number of Incident cases of BTC accounting for ~22,000 cases in 2025, which are expected to continue increasing at a CAGR of 1.2%
• Among the EU4 and the UK, Italy accounted for the highest number of BTC cases, followed by the UK and Germany, whereas Spain accounted for the lowest number of cases in 2025.
• In the US, the 65+ age group accounted for ~65% of BTC cases in 2025, while patients 45–64 years represented ~30%, and <44 years accounted for only ~5%.
• BTC represent a rare but highly lethal group of malignancies in the 7MM, with CCA accounting for a substantial proportion of cases and disease burden. The epidemiology of CCA is heterogeneous across the 7MM, reflecting regional differences in underlying risk factors, healthcare access, diagnostic practices, and disease classification.
• Japan demonstrates a consistently higher disease burden compared with Western markets, likely driven by a greater prevalence of biliary tract disorders and long-standing clinical recognition of BTC.

Scope of the Report

• The report covers a segment of a descriptive overview of BTC, explaining their causes, signs and symptoms, and pathogenesis.
• Comprehensive insight has been provided into the epidemiology forecasts, the future growth potential of the diagnosis rate, and disease progression.

Report Insights

• Biliary Tract Cancer (BTC) Patient population forecast

Report Key Strengths

• Epidemiology-based (Epi-based) bottom-up forecasting
• 11-year forecast
• Patient Burden trends (by geography)

FAQs

• What are the disease risks, burdens, and unmet needs of BTC? What will be the growth opportunities across the 7MM concerning the patient population with BTC?
• What is the historical and forecasted BTC patient pool in the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?

Reasons to Buy

• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand key opinion leaders’ perspectives around the diagnostic challenges to overcome barriers in the future.
• Detailed insights on various factors hampering disease diagnosis and other existing diagnostic challenges.