Biliary Tract Cancers Market – Global Industry Size, Share, Trends, Opportunity, & Forecast, Segmented By Cancer Type (Intrahepatic Cholangiocarcinoma (ICC), Extrahepatic Cholangiocarcinoma, Gallbladder Cancer), By End-User (Hospitals, Specialty Cancer Centres, Ambulatory Surgical Centres, Others), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 675.69 MIllion
CAGR (2026-2031)	4.75%
Fastest Growing Segment	Extrahepatic Cholangiocarcinoma (EHC)
Largest Market	North America
Market Size (2031)	USD 892.63 MIllion

Market Overview

The Global Biliary Tract Cancers Market will grow from USD 675.69 MIllion in 2025 to USD 892.63 MIllion by 2031 at a 4.75% CAGR. The Global Biliary Tract Cancers Market encompasses diagnostic tools and therapeutic agents designed for malignancies arising in the bile ducts and gallbladder, including cholangiocarcinoma and gallbladder carcinoma. Primary drivers propelling market trajectory include the growing incidence of chronic liver conditions and demographic shifts toward an older population globally. Furthermore, increased investment in molecular profiling is facilitating the development of novel therapeutic avenues. According to the American Cancer Society, in 2025, approximately 12,610 new cases of gallbladder and nearby large bile duct cancers will be diagnosed in the United States.

Despite these positive factors, the market faces a substantial challenge regarding the frequency of diagnosis at an advanced disease stage. Symptoms often manifest only when the cancer has progressed significantly, rendering curative surgery impossible for a majority of patients and limiting the applicability of many existing treatments. This factor complicates clinical development and restricts the commercial potential of early intervention therapies, thereby impeding overall market expansion.

Key Market Drivers

The emergence of novel targeted therapies and immunotherapies is aggressively expanding the Global Biliary Tract Cancers Market by addressing the historically limited efficacy of standard chemotherapy. Pharmaceutical developers are leveraging genomic insights to create agents that specifically target molecular alterations such as HER2 amplification and FGFR2 fusions. A pivotal advancement occurred when, according to Jazz Pharmaceuticals, November 2024, in the 'FDA Approves Zanidatamab for Biliary Tract Cancer' press release, the bispecific antibody zanidatamab demonstrated a confirmed objective response rate of 52% in patients with HER2-positive biliary tract cancer. These innovations significantly enhance clinical outcomes, reducing the reliance on palliative care and incentivizing further investment in precision oncology pipelines.

The rising global incidence of biliary tract malignancies acts as a concurrent primary driver, creating sustained demand for these advanced diagnostic and therapeutic interventions. This increasing disease burden is attributed to a complex interplay of factors including aging populations and the growing prevalence of chronic liver diseases. According to AstraZeneca, April 2024, in the 'Imfinzi Plus Chemotherapy Doubled Overall Survival Rate' press release, approximately 210,000 people worldwide are diagnosed with biliary tract cancer each year, representing a significant patient population requiring effective clinical management. This trend is expected to persist; according to the Multidisciplinary Digital Publishing Institute, in 2024, incidence rates for intrahepatic cholangiocarcinoma are anticipated to reach 2.13 per 100,000 by 2029, underscoring the urgent need for scalable therapeutic solutions.

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Key Market Challenges

The high frequency of diagnosis at an advanced disease stage constitutes a major barrier to the Global Biliary Tract Cancers Market. Because symptoms often remain undetected or vague until the malignancy has progressed significantly, a vast majority of patients are ineligible for curative surgery, which currently limits the utilization of adjuvant therapies. This restricts the commercial landscape, compelling pharmaceutical developers to focus on palliative care regimens that generally offer shorter treatment durations and lower success rates than early-stage interventions. Consequently, the lack of effective early detection methods reduces the addressable market for high-value curative drugs, directly slowing overall sector growth.

The severe impact of this diagnostic delay is illustrated by the poor prognosis associated with metastatic disease, which drastically shrinks the pool of patients eligible for long-term therapy. According to the American Society of Clinical Oncology, in 2024, the five-year relative survival rate for intrahepatic cholangiocarcinoma diagnosed at a distant stage was reported to be only 3 percent. This statistical reality underscores the difficulty in sustaining a robust market for therapies, as the patient population at the advanced stage faces extremely high mortality rates, thereby limiting the window for therapeutic efficacy and revenue generation.

Key Market Trends

Pharmaceutical companies are increasingly pursuing Orphan Drug Designations to accelerate the development of novel therapeutics for biliary tract cancers, effectively bypassing traditional regulatory hurdles associated with small patient populations. This strategic focus allows developers to secure market exclusivity and financial incentives, which are crucial for mitigating the risks inherent in targeting rare malignancies with historically poor prognoses. A pertinent example of this trend is the advancement of liposomal formulations designed to improve drug delivery and efficacy in refractory cases. According to BioSpace, July 2025, in the 'FF-10832 Granted FDA Orphan Drug Designation for the Treatment of Biliary Tract Cancer' press release, the FDA's designation for the investigational agent FF-10832 was predicated on the urgent need to address high disease recurrence rates of 50% to 70% in patients with unresectable or metastatic presentations.

Concurrently, clinical practice is shifting toward the utilization of liquid biopsy for non-invasive genomic characterization, facilitating the precise identification of actionable mutations such as FGFR2 fusions without the risks of invasive tissue sampling. This integration of routine molecular profiling enables oncologists to monitor tumor evolution and treatment resistance in real-time, thereby optimizing the selection of targeted therapies throughout the continuum of care. The commercial traction of these diagnostic tools is evident as healthcare providers rapidly adopt blood-based assays to guide decision-making. According to Guardant Health, April 2025, in the 'Guardant Health Reports First Quarter 2025 Financial Results' press release, the company projected that its oncology test volume would accelerate to greater than 25% growth in 2025, reflecting the surging demand for comprehensive genomic profiling in managing advanced solid tumors.

Segmental Insights

Based on recent industry analysis, the Extrahepatic Cholangiocarcinoma (EHC) segment represents the fastest-growing category within the Global Biliary Tract Cancers Market, primarily driven by rising global incidence rates and significant improvements in diagnostic precision. This growth is substantially supported by the aging global population and the widespread adoption of advanced imaging modalities, such as endoscopic retrograde cholangiopancreatography (ERCP), which facilitate the earlier detection of extrahepatic lesions. Furthermore, the market expansion is accelerated by a transforming therapeutic landscape, where the introduction of novel immunotherapies and targeted drug regimens is improving patient outcomes and driving higher treatment adoption rates in this specific segment.

Regional Insights

North America maintains a leading position in the Global Biliary Tract Cancers Market due to its established healthcare infrastructure and favorable reimbursement policies. The region benefits from active regulatory support, particularly from the US Food and Drug Administration, which expedites the approval process for novel therapeutics and orphan drugs. Additionally, the concentrated presence of major pharmaceutical entities conducting extensive clinical research fosters continuous market development. High diagnosis rates and access to advanced treatment options further contribute to the region's dominance in the global landscape.

Recent Developments

• In December 2024, Elevar Therapeutics entered into an exclusive global licensing agreement with Relay Therapeutics to develop and commercialize lirafugratinib, a highly selective FGFR2 inhibitor. Under the terms of the collaboration, Elevar Therapeutics assumed responsibility for the global clinical development and commercialization of the asset, which had shown promise in treating FGFR2-altered solid tumors, including cholangiocarcinoma. This strategic partnership aimed to leverage Elevar’s late-stage development capabilities to accelerate the delivery of this precision oncology therapy to patients with FGFR2-driven biliary tract cancers, addressing a critical unmet medical need.
• In December 2024, TransThera Sciences presented preliminary clinical data for its novel multi-kinase inhibitor, tinengotinib, in combination with atezolizumab at the ESMO Asia Congress. The Phase Ib/II study results highlighted the potential synergistic effects of combining the targeted therapy with an immune checkpoint inhibitor for patients with advanced biliary tract carcinoma who had progressed on prior treatments. The data indicated encouraging antitumor activity and a manageable safety profile, supporting further evaluation of this combination strategy as a potential treatment to overcome resistance mechanisms in refractory biliary tract cancers.
• In November 2024, Jazz Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanidatamab-hrii for the treatment of previously treated, unresectable, or metastatic HER2-positive biliary tract cancer. This approval marked the first HER2-targeted bispecific antibody specifically authorized for this indication in the United States. The regulatory decision was supported by data from the Phase 2b HERIZON-BTC-01 clinical trial, which demonstrated a compelling objective response rate and durability of response in patients with this aggressive malignancy. This development introduced a significant new therapeutic option in the biliary tract cancer market.
• In April 2024, AstraZeneca released updated exploratory results from the Phase III TOPAZ-1 trial, demonstrating a sustained overall survival benefit for patients with advanced biliary tract cancer treated with durvalumab in combination with standard-of-care chemotherapy. The data, presented at the Cholangiocarcinoma Foundation Conference, showed that the immunotherapy regimen reduced the risk of death by 26% compared to chemotherapy alone after a median follow-up of over three years. These findings reinforced the role of immune checkpoint inhibitors in improving long-term outcomes for patients in the global biliary tract cancers market.

Key Market Players

• Bristol-Myers Squibb
• Eli Lilly and Company
• F. Hoffmann-La Roche Ltd.
• Johnson & Johnson Services, Inc
• Merck & Co., Inc.
• Novartis AG
• Pfizer Inc.
• Sanofi SA
• Bayer AG
• AstraZeneca plc

By Cancer Type	By End-User	By Region
Intrahepatic Cholangiocarcinoma (ICC) Extrahepatic Cholangiocarcinoma Gallbladder Cancer	Hospitals Specialty Cancer Centres Ambulatory Surgical Centres Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Biliary Tract Cancers Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Biliary Tract Cancers Market , By Cancer Type:

• Intrahepatic Cholangiocarcinoma (ICC)
• Extrahepatic Cholangiocarcinoma
• Gallbladder Cancer

• Biliary Tract Cancers Market , By End-User:

• Hospitals
• Specialty Cancer Centres
• Ambulatory Surgical Centres
• Others

• Biliary Tract Cancers Market , By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE