Biliary Tumor Market Size & Share Analysis - Growth Trends and Forecast (2026 - 2031)

Global Biliary Tumor Market Trends and Insights

First-Line Shift to Immunotherapy Plus Gemcitabine-Cisplatin as Global Standard of Care

Durvalumab added to gemcitabine-cisplatin extended median overall survival to 12.8 months, compared with 11.5 months with chemotherapy alone, a result that secured global regulatory approvals and immediate guideline endorsements.^{[1]Dy Oh, “Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer,” New England Journal of Medicine, nejm.org} Uptake is brisk in the United States and Western Europe, where 60-70% of eligible patients now begin combination therapy, although Latin America and parts of Asia still face reimbursement delays. Pharmacy budgets are feeling pressure because durvalumab’s annual cost surpasses USD 150,000, dwarfing the generic backbone’s outlay. The October 2023 approval of pembrolizumab plus chemotherapy created a competing regimen and fragmented prescribing patterns. Health systems are therefore negotiating outcomes-based agreements to contain rising spend.

Expanding Biomarker Testing Enabling FGFR2, IDH1, and HER2 Targeted Uptake

Next-generation sequencing is now recommended for all advanced cases to detect FGFR2 fusions, IDH1 mutations, HER2 amplification, BRAF alterations, and mismatch-repair deficiency.^{[2]National Comprehensive Cancer Network, “Hepatobiliary Cancers, Version 1.2025,” nccn.org} FGFR2-positive tumors respond to futibatinib, which delivered a 42% objective response rate in the FOENIX-CCA2 trial and gained accelerated approval in 2022. IDH1-mutant disease is treatable with ivosidenib, although clinical benefit is modest. Tissue-based panels still require roughly two weeks, driving interest in liquid biopsy assays that can return results in under a week, yet payer coverage for blood-based testing is inconsistent. Asia Pacific illustrates both promise and constraint: major urban hubs offer broad NGS access, but rural patients often remain untested and thus ineligible for precision therapy.

HER2-Positive Segment Unlocked by Zanidatamab Approval

Zanidatamab became the first HER2-directed drug approved for biliary tumors in November 2024, following a 41.3% response rate and a median overall survival of 12.5 months in the HERIZON-BTC-01 study. Roughly 15-20% of patients harbor HER2 amplification, creating a new addressable niche of several thousand cases annually in the United States alone. Companion diagnostics using immunohistochemistry and fluorescence in situ hybridization have become routine, though inter-lab variability in scoring is a recognized challenge. Jazz Pharmaceuticals acquired the originator of zanidatamab for USD 1.5 billion in 2024, underscoring big pharma's demand for differentiated rare-oncology assets.

Rising Incidence and Awareness in High-Burden APAC Markets

Cholangiocarcinoma incidence exceeds 85 per 100,000 in Northeast Thailand due to endemic liver-fluke infection, the highest rate worldwide. China is logging 3-5% yearly increases in urban intrahepatic cases, linked to hepatitis B and aflatoxin exposure, while Japan reports stable but elevated incidence reflecting better imaging. Public-health campaigns promoting cooked-fish consumption are lowering pediatric infection rates in Thailand, yet legacy adult cohorts will sustain high volumes through 2035. Screening pilots using ultrasound and CA19-9 testing are under way in Thai villages, but cost-effectiveness analyses remain inconclusive. Urban centers across Asia are adopting Western treatment algorithms, though rural–urban disparities in diagnostic turnaround and therapy initiation persist.

Low Prevalence of Actionable Biomarkers Limits Addressable Pool

FGFR2 fusions appear in only 10-15% of intrahepatic cases and are rare elsewhere, while IDH1 mutations occur in 13-20% of tumors, leaving the majority without a druggable target. HER2 amplification offers another 15-20% niche, but not all HER2-positive patients respond because resistance mechanisms remain unclear. Intratumoral heterogeneity complicates therapy: metastatic sites may lack the FGFR2 fusion seen in the primary lesion, reducing systemic efficacy. Circulating-tumor-DNA assays track clonal evolution, yet their sensitivity in biliary tumors is only 60-70%. Pharmaceutical firms therefore weigh the commercial viability of drugs targeting alterations present in fewer than 1,000 U.S. patients per year.

Late Diagnosis and Poor ECOG Reduce Time on Therapy and Continuation Rates

Roughly two-thirds of patients present with unresectable or metastatic disease, and many already have an ECOG performance status of 2 or worse, limiting tolerance for intensive regimens.^{[3]Jorge Bridgewater, “Quality of Life in Advanced Biliary Cancer,” Journal of Gastrointestinal Oncology, jgo.amegroups.com} In real-world settings, ECOG 2 patients discontinue treatment within 3-4 months, compared with 6-8 months in fitter cohorts. Up to half require biliary stent placement before systemic therapy can begin, and stent occlusion interrupts treatment in about 20-30% of cases. Rural Asia illustrates the problem: median ECOG at diagnosis in Northeast Thailand is 2–3, compared with 1–2 in Bangkok, reflecting delayed imaging access. The lack of effective population-level screening perpetuates late-stage presentation.

Segment Analysis

By Type: Diagnostics Outpace Treatment Growth

Diagnostics achieved a 7.30% CAGR, topping Treatment’s growth and signaling the central role of biomarker discovery. Gemcitabine-cisplatin remains the backbone of care, but immunotherapy is the fastest-expanding sub-segment as new combinations shift first-line paradigms. Targeted therapy generates high revenue per patient, although its reach is constrained by the frequency of biomarkers. Locoregional interventions such as Y-90 radioembolization and SBRT are used for unresectable intrahepatic disease, with TheraSphere usage up 12% year over year.

Diagnostics revenues stem chiefly from next-generation sequencing panels that detect FGFR2 fusions, IDH1 mutations, and HER2 amplification. Liquid biopsy adoption is rising because blood-based testing trims turnaround to a single week, an advantage when tissue is scarce. Companion diagnostics for zanidatamab and futibatinib generate predictable recurring demand. These trends ensure that the Diagnostics slice of the biliary tumor market continues to outpace the broader biliary tumor market.

By End User: Diagnostics Centers Capture Decentralized Testing

Hospitals held 43.28% of 2025 value because they host infusion suites and interventional radiology services. Even so, specialized Diagnostics Centers are repeating a pattern seen in other solid tumors, posting a 6.90% CAGR thanks to economies of scale, automated workflows, and shorter assay cycles. Outpatient Y-90 radioembolization is migrating to ambulatory sites, reinforcing a gradual shift of complex procedures outside traditional inpatient walls.

Reference laboratories process thousands of panels monthly, lowering the unit price to USD 2,500-3,500 and shrinking results time to 7-10 days. Specialty Clinics linked to academic centers receive disproportionate shares of zanidatamab prescriptions because they offer access to clinical trials. Community oncologists increasingly outsource genomic testing, accelerating the diagnostics' entry into the biliary tumor market.

Note: Segment shares of all individual segments available upon report purchase

Geography Analysis

North America accounted for 44.25% of revenue in 2025, driven by rapid FDA approvals and broad payer coverage that deliver timely access to new immunotherapies and HER2-targeted agents. The United States alone accounts for 85% of regional spend, with incidence creeping upward due to non-alcoholic steatohepatitis and obesity. Canada joined the durvalumab cohort only at the end of 2024, while Mexico limits first-line immunotherapy to privately insured patients.

Asia Pacific is the fastest-expanding region, with an 8.48% CAGR. Thailand remains the global epicenter because of liver-fluke infection rates above 85 per 100,000, whereas China’s urban incidence surge is tied to hepatitis B and aflatoxin exposure. Japan’s supportive reimbursement and prompt PMDA approvals shorten therapy roll-outs, and South Korea’s NHIS added futibatinib in 2025, sharply improving access for FGFR2-positive patients.

EMA approvals are universal, but individual HTA bodies apply varying cost-effectiveness thresholds, leading to reimbursement delays. Germany, France, and the United Kingdom collectively shape regional uptake, yet Southern and Eastern nations lag. Middle East, Africa, and South America remain small slices of the biliary tumor market because diagnostic infrastructure is sparse and payer budgets are tight.