<h2 dir="ltr">Biliary Tract Cancer&nbsp;</h2>
is a group of rare but highly aggressive malignancies arising from the epithelial lining of the biliary system, including <a href="https://www.delveinsight.com/report-store/gallbladder-cancer-market">Gall Bladder Cancer</a> (GBC), <a href="https://www.delveinsight.com/report-store/intrahepatic-cholangiocarcinoma-market">intrahepatic cholangiocarcinoma</a> (iCCA), extrahepatic cholangiocarcinoma (eCCA), and cancer of the ampulla of Vater.&nbsp;
<h2 dir="ltr">Symptoms&nbsp;</h2>
<ul>
<li dir="ltr" aria-level="1">
Chills
</li>
<li dir="ltr" aria-level="1">
Clay-colored stool
</li>
<li dir="ltr" aria-level="1">
Dark urine
</li>
<li dir="ltr" aria-level="1">
Fever
</li>
<li dir="ltr" aria-level="1">
Itching&nbsp;
</li>
<li dir="ltr" aria-level="1">
Appetite loss
</li>
<li dir="ltr" aria-level="1">
Nausea
</li>
<li dir="ltr" aria-level="1">
Upper right abdomen pain
</li>
<li dir="ltr" aria-level="1">
Jaundice&nbsp;
</li>
<li dir="ltr" aria-level="1">
Weight loss
</li>
</ul>
<h2 dir="ltr">Diagnosis</h2>
<ul>
<li dir="ltr" aria-level="1">
Ultrasound
</li>
<li dir="ltr" aria-level="1">
CT Scan
</li>
<li dir="ltr" aria-level="1">
MRI/MRCP
</li>
<li dir="ltr" aria-level="1">
PET Scan
</li>
<li dir="ltr" aria-level="1">
Liver Function Tests
</li>
<li dir="ltr" aria-level="1">
ERCP
</li>
<li dir="ltr" aria-level="1">
Percutaneous Biopsy
</li>
</ul>
&ldquo;The diagnosis of biliary tract cancer is often challenging due to nonspecific clinical symptoms such as jaundice, abdominal pain, <a href="https://www.delveinsight.com/report-store/weight-loss-weight-management-obesity-epidemiology-forecast">weight loss</a>, and <a href="https://www.delveinsight.com/report-store/pruritus-market">pruritus</a>.&rdquo;
<h2 dir="ltr">Epidemiology Segmentation&nbsp;</h2>
<ul>
<li dir="ltr" aria-level="1">
Total Incident Cases of BTC&nbsp;
</li>
<li dir="ltr" aria-level="1">
Tumor Site-specific Incident Cases of BTC
</li>
<li dir="ltr" aria-level="1">
Age-specific Incident Cases of BTC&nbsp;
</li>
<li dir="ltr" aria-level="1">
Stage-specific Incident Cases of BTC&nbsp;
</li>
<li dir="ltr" aria-level="1">
Mutation-specific Incident Cases of BTC&nbsp;
</li>
<li dir="ltr" aria-level="1">
Line-wise treated cases of BTC
</li>
</ul>
<h2 dir="ltr">Epidemiology Insights</h2>
total incident cases in the 7MM - 66K
US - 29%
EU4 and the UK - 37%
Japan - 34%
<a title="Biliary Tract Cancer Market" href="https://www.delveinsight.com/sample-request/biliary-tract-cancers-btcs-market"><img src="https://assets.delveinsight.com/delveinsight-meta-images/image-1779086238022.png" alt="Biliary Tract Cancer Market" width="248" height="135"></a>
&ldquo;The age-related rise in disease burden reflects the cumulative impact of chronic biliary inflammation, long-standing metabolic disorders, and prolonged exposure to environmental and lifestyle risk factors.&rdquo;
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.
*these figures represent the 2025 data
<h2 dir="ltr">Approved Drugs</h2>
<ul>
<li dir="ltr" aria-level="1">
<a href="https://www.delveinsight.com/report-store/pemazyre-drug-insight-and-market-forecast">PEMAZYRE</a>: Incyte
</li>
<li dir="ltr" aria-level="1">
<a href="https://www.delveinsight.com/report-store/rozlytrek-entrectinib-drug-insight-market-forecast">ROZLYTREK</a>: Roche/Genentech
</li>
<li dir="ltr" aria-level="1">
<a href="https://www.delveinsight.com/report-store/vitrakvi-market-drug-insight-and-market-forecast">VITRAKVI</a>: Bayer/Loxo Oncology
</li>
<li dir="ltr" aria-level="1">
<a href="https://www.delveinsight.com/report-store/tibsovo-drug-insight-and-market-forecast">TIBSOVO</a>: Agios Pharmaceuticals/Servier Pharmaceuticals
</li>
<li dir="ltr" aria-level="1">
<a href="https://www.delveinsight.com/report-store/lytgobi-futibatinib-drug-insight-and-market-forecast">LYTGOBI</a>: Taiho
</li>
<li dir="ltr" aria-level="1">
<a href="https://www.delveinsight.com/report-store/keytruda-emerging-drug-insight-and-market-forecast">KEYTRUDA</a>: Merck
</li>
<li dir="ltr" aria-level="1">
<a href="https://www.delveinsight.com/report-store/imfinzi-drug-insight-and-market-forecast">IMFINZI</a>: AstraZeneca
</li>
<li dir="ltr" aria-level="1">
<a href="https://www.delveinsight.com/report-store/tafinlar-mekinist-drug-insight-and-market-forecast">TAFINLAR + MEKINIST</a>: Novartis
</li>
<li dir="ltr" aria-level="1">
RETEVMO: Eli Lilly
</li>
<li dir="ltr" aria-level="1">
ZIIHERA: Jazz Pharmaceuticals
</li>
<li dir="ltr" aria-level="1">
ENHERTU: AstraZeneca and Daiichi Sankyo
</li>
<li dir="ltr" aria-level="1">
TASFYGO: Eisai
</li>
</ul>
&ldquo;Curative management of BTC, including cholangiocarcinoma and gallbladder cancer, is primarily based on surgical resection, followed by adjuvant capecitabine, which has demonstrated a survival benefit in the postoperative setting. However, recurrence rates remain high, underscoring a substantial unmet need for more effective adjuvant strategies.&rdquo;
&ldquo;In recent years, the integration of precision oncology has significantly reshaped the treatment landscape for advanced BTC. Targeted therapies directed against FGFR2 fusions, IDH1 mutations, BRAF V600E mutations, NTRK fusions, HER2 amplifications, and microsatellite instability (MSI-H) have enabled more personalized treatment approaches. These advances have been particularly impactful in intrahepatic cholangiocarcinoma, where the prevalence of actionable genomic alterations is higher, marking a shift from empiric chemotherapy toward biomarker-driven treatment paradigms for selected patient populations.&rdquo;
<h2 dir="ltr">Unmet Needs</h2>
<ul>
<li dir="ltr" aria-level="1">
Lack of Effective Early Detection and Diagnostic Biomarkers
</li>
<li dir="ltr" aria-level="1">
Insufficient Understanding of Disease Heterogeneity&nbsp;
</li>
<li dir="ltr" aria-level="1">
Limited Impact of Current Systemic Therapies
</li>
<li dir="ltr" aria-level="1">
Translational Gaps Between Preclinical Research and Clinical Outcomes&nbsp;
</li>
</ul>
<h2 dir="ltr">Market Insights</h2>
CAGR of 9.4% is predicted for the market during the forecast period (2026-2036)
market size in the 7MM in 2025 - USD 1.3 billion
In the 7MM, excluding conventional chemotherapy, IMFINZI holds the largest market share in 2025, generating approximately USD 330 million, followed by PEMAZYRE.
Surgical resection remains the mainstay curative option for localized BTC and CCA, with resectability strongly determining long-term outcomes.
<h2 dir="ltr">Market Drivers</h2>
<ul>
<li dir="ltr" aria-level="1">
Rising BTC Incidence
</li>
<li dir="ltr" aria-level="1">
Rising Opportunities in HER2 Targeted Therapies
</li>
<li dir="ltr" aria-level="1">
Emerging BTC Competitive Landscape
</li>
</ul>
<h3 dir="ltr">SWOT Analysis</h3>
<ul>
<li dir="ltr" aria-level="1">
Strengths
</li>
<ul>
<li dir="ltr" aria-level="2">
Zanidatamab represents a potential game-changer for HER2-positive BTC, offering best-in-class durability of response compared with the short-lived remissions achieved with chemotherapy.&nbsp;
</li>
</ul>
<li dir="ltr" aria-level="1">
Weakness
</li>
<ul>
<li dir="ltr" aria-level="2">
The diagnosis of BTC at an early stage remains a significant challenge since, in most cases, patients can remain asymptomatic for a long period during the early stages of BTCs, or symptoms can be unspecified.
</li>
</ul>
<li dir="ltr" aria-level="1">
Opportunities
</li>
<ul>
<li dir="ltr" aria-level="2">
Increasing cognizance about different mutations, pathways, and other regimens has changed the focus on curable treatment options with emerging candidates that will lead the growth of the global market.
</li>
</ul>
<li dir="ltr" aria-level="1">
Threats
</li>
<ul>
<li dir="ltr" aria-level="2">
Only a small subset of patients harbor actionable alterations, limiting the eligible population for targeted therapies, increase the risk of slow enrollment and study termination.
</li>
</ul>
</ul>
Emerging Drugs
(Drug: companies logos)
&nbsp;
<div dir="ltr" align="left">
<table><colgroup><col width="96"><col width="98"><col width="69"><col width="101"></colgroup>
<tbody>
<tr>
<td>
Drug Name
</td>
<td>
Company
</td>
<td>
ROA
</td>
<td>
MOA
</td>
</tr>
<tr>
<td>
Tinengotinib
</td>
<td>
TransThera Sciences
</td>
<td>
Oral
</td>
<td>
Multi-kinase inhibitor ( FGFR1&ndash;3 alongside VEGFRs, Aurora kinases, and JAK kinases)
</td>
</tr>
<tr>
<td>
Rilvegostomig
</td>
<td>
AstraZeneca
</td>
<td>
IV infusion
</td>
<td>
PD-1/TIGIT inhibitor
</td>
</tr>
<tr>
<td>
Nanvuranlat (JPH203)
</td>
<td>
J-Pharma/
OHARA Pharmaceutical
</td>
<td>
IV infusion
</td>
<td>
L-type amino acid transporter (LAT) 1 inhibitor
</td>
</tr>
<tr>
<td>
Tovecimig&nbsp;
(CTX-009)
</td>
<td>
Compass Therapeutics
</td>
<td>
IV infusion
</td>
<td>
DLL4 and VEGF-A inhibitors
</td>
</tr>
<tr>
<td>
Lenvatinib mesylate (LENVIMA)&nbsp;
</td>
<td>
Merck/Eisai
</td>
<td>
Oral
</td>
<td>
Multi- RTK inhibitor
</td>
</tr>
<tr>
<td>
Tucatinib (TUKYSA)
</td>
<td>
Seagen/Pfizer
</td>
<td>
Oral
</td>
<td>
HER2 inhibitor&nbsp;
</td>
</tr>
<tr>
<td>
BOLD-100
</td>
<td>
Bold Therapeutics
</td>
<td>
IV
</td>
<td>
Selective GRP78 inhibitor
</td>
</tr>
</tbody>
</table>
</div>
&nbsp;
<h2 dir="ltr">Biliary Tract Cancer Market: Key Insights</h2>
total incident cases in the 7MM in 2025 - 66K
CAGR of 9.4% is predicted for the market during the forecast period (2026-2036)
market size in the 7MM in 2025 - USD 1.3 billion
<a title="Biliary Tract Cancer Market" href="https://www.delveinsight.com/sample-request/biliary-tract-cancers-btcs-market"><img src="https://assets.delveinsight.com/delveinsight-meta-images/image-1779086238027.png" alt="Biliary Tract Cancer Market" width="230" height="306"></a>
Key Companies: Incyte, Roche, Genentech, Bayer, Loxo Oncology, Agios Pharmaceuticals, Servier Pharmaceuticals, Taiho, Merck, AstraZeneca, Eli Lilly, Novartis, Jazz Pharmaceuticals
<h2 dir="ltr">Biliary Tract Cancer Epidemiology Insights</h2>
total incident cases in the 7MM - 66K
US - 29%
EU4 and the UK - 37%
Japan - 34%
<a title="Biliary Tract Cancer Market" href="https://www.delveinsight.com/sample-request/biliary-tract-cancers-btcs-market"><img src="https://assets.delveinsight.com/delveinsight-meta-images/image-1779086238022.png" alt="Biliary Tract Cancer Market" width="248" height="135"></a>
&ldquo;The age-related rise in disease burden reflects the cumulative impact of chronic biliary inflammation, long-standing metabolic disorders, and prolonged exposure to environmental and lifestyle risk factors.&rdquo;
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.
*these figures represent the 2025 data
<h2 dir="ltr">Biliary Tract Cancer Market Insight</h2>
CAGR of 9.4% is predicted for the market during the forecast period (2026-2036)
market size in the 7MM in 2025 - USD 1.3 billion
In the 7MM, excluding conventional chemotherapy, IMFINZI holds the largest market share in 2025, generating approximately USD 330 million, followed by PEMAZYRE.
Surgical resection remains the mainstay curative option for localized BTC and CCA, with resectability strongly determining long-term outcomes.
&nbsp;

Biliary Tract Cancer Market Infographic

Biliary Tract Cancer Symptoms, Treatment, epidemiology, companies, drugs, infographic is a short guide to understand the problem and market landscape