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Biliary Tract Cancers (BTCs)
Biliary tract cancers (BTCs), also referred to as cholangiocarcinomas, are uncommon and highly aggressive tumors that develop within the bile ducts—the network that transports bile from the liver to the gallbladder and small intestine. These malignancies can arise in different areas of the biliary tree, including intrahepatic, perihilar, and distal sections. Due to the absence of noticeable symptoms in early stages, BTCs are typically identified only after the disease has progressed, complicating treatment. Common signs of the disease include jaundice, unintentional weight loss, abdominal discomfort, and itching. Key risk factors include chronic liver conditions such as hepatitis, cirrhosis, and primary sclerosing cholangitis.
While treatment advancements—including surgery, chemotherapy, and targeted therapies—have been made, outcomes remain generally poor because of late diagnosis and limited effective options. BTCs predominantly affect people over the age of 50, with both genders impacted, and regional differences observed in incidence rates. Current research is centered on early diagnostic tools and more effective therapeutic approaches to improve patient survival.
Curious about the numbers? Dive into the data with our infographic
Epidemiological Segmentation (2020–2034)
Epidemiological analysis of BTC in the 7 major markets (7MM) is categorized into:
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Total incident cases
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Age-specific incidence
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Stage-wise distribution
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Tumor location-specific incidence
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Mutation-specific cases
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Number of treated cases
BTC Epidemiology (2023 Highlights)
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In 2023, the U.S. contributed about 30% of all new BTC cases across the 7MM.
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Within the U.S., TP53 mutation-positive BTC cases were the most common, followed by KRAS-positive cases.
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Among EU4 and the UK, Italy recorded the highest number of BTC cases; Spain had the fewest.
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In the U.S., the majority of cases occurred in individuals aged 70 to 79, comprising around 30% of all age-related cases.
BTC Market Overview
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The market size for biliary tract cancers in the 7MM reached approximately USD 1 billion in 2023.
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Market Growth Drivers
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Increased focus on targeted therapy and immunotherapy research.
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Rising number of clinical trials exploring novel BTC treatments.
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Progress in diagnostic tools and biomarkers that enable earlier detection.
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Boost in pharmaceutical investment in rare cancers and personalized medicine.
Market Challenges
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Lack of effective, widely available targeted treatments.
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Late detection contributes to limited treatment effectiveness and poorer outcomes.
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High treatment costs, particularly for advanced therapies and surgeries.
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Limited public and clinical awareness of BTC, resulting in delays in diagnosis and intervention.
One graphic, all the essentials— Click to explore
Promising Pipeline Therapies
Emerging drugs under development include:
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Tinengotinib
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Rilvegostomig
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ENHERTU (trastuzumab deruxtecan)
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LENVIMA (lenvatinib)
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Tasurgratinib (by Eisai)
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Silmitasertib (CX-4945)
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Among others
Key Companies in the BTC Space
Major pharmaceutical and biotech firms involved in BTC drug development include:
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Compass Therapeutics
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Jazz Pharmaceuticals
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Zymeworks
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AstraZeneca
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Daiichi Sankyo
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Merck Sharp & Dohme
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Eisai
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Senhwa Biosciences
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Seagen
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Pfizer
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TransThera Sciences
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Compugen
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