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Biliary Tract Cancer Market is Predicted to Exhibit Remarkable Growth at a CAGR of 10.1% During the Forecast Period (2025-2034) | DelveInsight

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CMPX Compass Therapeutics' drug Tovecimig (CTX-009) is mentioned as an emerging therapy for biliary tract cancer (BTC) in clinical trials, indicating potential future market growth and contribution to the expanding treatment landscape. MRK Merck's drug Lenvatinib mesylate (LENVIMA), developed in partnership with Eisai, is highlighted as an emerging therapy for biliary tract cancer (BTC), suggesting a positive outlook for the company's involvement in this growing market. PFE Pfizer, in collaboration with Seagen, is developing Tucatinib (TUKYSA), an emerging therapy for biliary tract cancer (BTC). Its inclusion in the competitive landscape points to potential market growth and positive contributions from Pfizer. BOLD Bold Therapeutics' drug BOLD-100 is listed among emerging therapies for biliary tract cancer (BTC) in clinical trials. This suggests a positive outlook for the company as it contributes to the expanding treatment options in this growing market. REPL Replimune's drug RP3-003 is mentioned as being in the clinical trial landscape for biliary tract cancer (BTC). This inclusion indicates potential future growth and contribution to the expanding treatment options in the BTC market. RDHL RedHill Biopharma's drug Opaganib (ABC294640) is listed as an emerging therapy in the clinical trial landscape for biliary tract cancer (BTC), suggesting potential for market growth and positive contribution. RLAY Relay Therapeutics, in partnership with Elevar Therapeutics, has Lirafugratinib (RLY-4008) in development for biliary tract cancer (BTC). Its mention as an emerging therapy indicates potential for market growth and positive contribution. LLY Eli Lilly's drug Olomorasib (LY3537982) is noted as an emerging therapy in the clinical trial landscape for biliary tract cancer (BTC), suggesting potential for market growth and positive contribution from the company. INCY Incyte's drug Pemigatinib (PEMAZYRE) is mentioned as a marketed therapy for biliary tract cancer (BTC). Its inclusion and discussion in the report indicate a positive market presence and contribution to treatment options. JAZZ Jazz Pharmaceuticals' drug Zanidatamab (ZIIHERA) is listed as a marketed therapy for biliary tract cancer (BTC). Its mention signifies a positive contribution to the market and potential for continued growth.

Biliary Tract Cancer Market is Predicted to Exhibit Remarkable Growth at a CAGR of 10.1% During the Forecast Period (2025-2034) | DelveInsight LAS VEGAS, March 2, 2026 /PRNewswire/ -- The biliary tract cancer market is experiencing steady growth driven by rising global incidence and improved diagnostic capabilities. Increasing adoption of targeted therapies and immuno-oncology approaches is expanding treatment options. Additionally, the launch of emerging drugs such as Tinengotinib (TransThera Sciences), Rilvegostomig (AstraZeneca), Nanvuranlat (JPH203) (J-Pharma/OHARA Pharmaceutical), Tovecimig (CTX-009) (Compass Therapeutics), Lenvatinib mesylate (LENVIMA) (Merck/Eisai), and others will further boost the market growth.

Recently published Biliary Tract Cancer Market Insights report includes a comprehensive understanding of current treatment practices, biliary tract cancer emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Biliary Tract Cancer Market Summary

Discover the biliary tract cancer market share by therapy type @ https://www.delveinsight.com/sample-request/biliary-tract-cancers-btcs-market?utm_source=cision&utm_medium=pressrelease&utm_campaign=spr

Key Factors Driving the Growth of the Biliary Tract Cancer Market

Aparna Thakur, Assistant Project Manager, Forecasting and Analytics at DelveInsight, said that 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, thereby shifting from empiric chemotherapy to biomarker-driven treatment paradigms for selected patient populations.

Biliary Tract Cancer Market Analysis

Biliary Tract Cancer Competitive Landscape

Some of the BTC drugs in the clinical trial landscape include Tinengotinib (TransThera Sciences), Rilvegostomig (AstraZeneca), Nanvuranlat (JPH203) (J-Pharma/OHARA Pharmaceutical), Tovecimig (CTX-009) (Compass Therapeutics), Lenvatinib mesylate (LENVIMA) (Merck/Eisai), Tucatinib (TUKYSA) (Seagen/Pfizer), BOLD-100 (Bold Therapeutics), Silmitasertib (CX-4945) (Senhwa Biosciences), VG161 (Virogin Biotech), RP3-003 (Replimune), Sevabertinib (BAY 2927088) (Bayer), Opaganib (ABC294640) (RedHill Biopharma), Lirafugratinib (RLY-4008) (Relay Therapeutics/Elevar Therapeutics), Olomorasib (LY3537982) (Eli Lilly), CGT4859 (Cogent Biosciences), MT-4561 (Tanabe Pharma America), and others.

TransThera Sciences' Tinengotinib is an experimental oral multikinase inhibitor being evaluated for cholangiocarcinoma, with a particular focus on patients with FGFR alterations and disease progression after prior treatments. In contrast to first-generation selective FGFR inhibitors, it targets FGFR1–3, as well as VEGFRs, Aurora kinases, and JAK kinases, providing broader coverage of tumor growth, angiogenesis, and mechanisms of acquired resistance. The therapy is currently under investigation in a global Phase III study for cholangiocarcinoma.

AstraZeneca's Rilvegostomig is a pioneering bispecific checkpoint inhibitor designed to simultaneously block PD-1 and TIGIT on the same immune effector cell, thereby reactivating antitumor immunity and enabling durable responses. Its TIGIT-targeting arm is derived from COM902, a fully owned antibody developed by Compugen, one of only two Fc-reduced anti-TIGIT antibodies in clinical development. Rilvegostomig is now being tested in several Phase III trials involving patients with BTC.

The anticipated launch of these emerging therapies are poised to transform the biliary tract cancer market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the biliary tract cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

Discover more about the emerging BTC therapies and pipeline drugs @ Biliary Tract Cancer Drugs

Recent Developments in the Biliary Tract Cancer Market

What is Biliary Tract Cancer?

Biliary tract cancer is a rare but aggressive group of cancers that arises in the bile ducts, gallbladder, or ampulla of Vater, structures responsible for transporting bile from the liver to the small intestine. These cancers can block the normal flow of bile, leading to symptoms such as jaundice, abdominal pain, weight loss, and itching. Because early symptoms are often subtle, biliary tract cancer is frequently diagnosed at an advanced stage, making treatment more challenging. Management typically involves a combination of surgery, chemotherapy, radiation therapy, and, in some cases, targeted or immunotherapies.

Biliary Tract Cancer Epidemiology Segmentation

The biliary tract cancer epidemiology section provides insights into the historical and current biliary tract cancer patient pool and forecasted trends for the leading markets. In 2024, the majority of BTC patients in Japan were diagnosed at an advanced stage (77% of total cases), whereas early-stage disease accounted for the remaining 23%.

The biliary tract cancer treatment market report proffers epidemiological analysis for the study period 2020–2034 in the leading markets, segmented into:

Biliary Tract

Cancer Market

Report Metrics

Details

Study Period

2020–2034

Coverage

7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Biliary Tract

Cancer Market

CAGR

10.1 %

Biliary Tract

Cancer Market

Size in 2024

USD 1.1 Billion

Key Biliary Tract

Cancer

Companies

TransThera Sciences (HKG: 2617), AstraZeneca (LON: AZN), J-Pharma, OHARA Pharmaceutical (TYO:

5218), Compass Therapeutics (NASDAQ: CMPX), Merck (NYSE: MRK), Eisai (TYO: 4523), Seagen (NASDAQ:

SGEN), Pfizer (NYSE: PFE), Bold Therapeutics (NASDAQ: BOLD), Senhwa Biosciences, Virogin Biotech,

Replimune (NASDAQ: REPL), Bayer (ETR: BAYN), RedHill Biopharma (NASDAQ: RDHL), Relay Therapeutics

(NASDAQ: RLAY), Elevar Therapeutics, Eli Lilly (NYSE: LLY), Cogent Biosciences (Cogent Biosciences),

Tanabe Pharma America (TYO: 4508), Incyte (NASDAQ: INCY), Roche (SWX: ROG), Genentech, Loxo

Oncology (NASDAQ: LOXO), Jazz Pharmaceuticals (NASDAQ: JAZZ), Daiichi Sankyo (TYO: 4568), and others

Key Biliary Tract

Cancer Therapies

Tinengotinib, Rilvegostomig, Nanvuranlat (JPH203), Tovecimig (CTX-009), Lenvatinib mesylate

(LENVIMA), Tucatinib (TUKYSA), BOLD-100, Silmitasertib (CX-4945), VG161, RP3-003, Sevabertinib (BAY

2927088), Opaganib (ABC294640), Lirafugratinib (RLY-4008), Olomorasib (LY3537982), CGT4859, MT-

4561, PEMAZYRE, ROZLYTREK, VITRAKVI, ZIIHERA, ENHERTU, TASFYGO, and others

Scope of the Biliary Tract Cancer Market Report

Download the report to understand the BTC therapy market share by company @ Biliary Tract Cancer Market Analysis

Table of Contents

1

Biliary Tract Cancer Market Key Insights

2

Biliary Tract Cancer Market Report Introduction

3

Executive Summary

4

Key Events

4.5

News Flow

5

Epidemiology and Market Forecast Methodology

6

BTC Market Overview at a Glance

7

Disease Background and Overview

7.1

Introduction

7.2

Classification of BTC

7.3

Staging

7.4

Signs and Symptoms

7.5

Causes and Risk Factors

7.6

Pathophysiology

7.7

Genetic Findings in BTC

7.8

Biomarkers

7.9

Diagnosis of BTC

7.10

Differential Diagnosis

7.11

Treatment

7.12

Diagnostic and Treatment Guidelines for BTC

8

Epidemiology and Patient Population

8.1

Key Findings

8.2

Assumptions and Rationale

8.3

Total Incident Cases of BTC in the 7MM

8.4

The United States

8.4.1

Total Incident Cases of BTC in the United States

8.4.2

Tumor Location-specific of BTC in the United States

8.4.3

Age-specific Incident Cases of BTC in the United States

8.4.4

Stage-specific Incident Cases of BTC in the United States

8.4.5

Mutation-specific Incident Cases of BTC in the United States

8.4.6

Systemic inflammation in BTC in the United States

8.5

EU4 and the UK

8.6

Japan

9

Biliary Tract Cancer Patient Journey

10

Marketed Biliary Tract Cancer Therapies

10.1

Key Cross Competition

10.2

Pemigatinib (PEMAZYRE): Incyte

10.2.1

Product Description

10.2.2

Regulatory Milestones

10.2.3

Other Developmental Activities

10.2.4

Summary of Pivotal Trials

10.2.5

Analyst's View

10.3

Entrectinib (ROZLYTREK): Roche/Genentech

10.4

Larotrectinib (VITRAKVI): Bayer/Loxo Oncology

10.5

Ivosidenib (TIBSOVO): Agios Pharmaceuticals/Servier Pharmaceuticals

10.6

Futibatinib (LYTGOBI): Taiho

10.7

Pembrolizumab (KEYTRUDA): Merck

10.8

Durvalumab (IMFINZI): AstraZeneca

10.9

Dabrafenib (TAFINLAR) + Trametinib (MEKINIST): Novartis

10.10

Selpercatinib (RETEVMO): Eli Lilly

10.11

Zanidatamab (ZIIHERA): Jazz Pharmaceuticals

10.12

Trastuzumab deruxtecan (ENHERTU): AstraZeneca and Daiichi Sankyo

10.13

Tasurgratinib (TASFYGO): Eisai

11

Emerging Biliary Tract Cancer Therapies

11.1

Key Cross Competition

11.2

Tinengotinib (TT-00420): TransThera Sciences

11.2.1

Product Description

11.2.2

Other Developmental Activities

11.2.3

Clinical Development

11.2.3.1

Clinical Trial Information

11.2.4

Safety and Efficacy

11.2.5

Analyst Views

11.3

Rilvegostomig: AstraZeneca and Compugen

11.4

Nanvuranlat (JPH203): J-Pharma/OHARA Pharmaceutical

11.5

Tovecimig (CTX-009): Compass Therapeutics

11.6

Lenvatinib mesylate (LENVIMA): Merck and Eisai

11.7

Tucatinib (TUKYSA): Seagen/Pfizer

11.8

BOLD-100: Bold Therapeutics

11.1

VG161: Virogin Biotech

12

BTC Market: 7MM Analysis

12.1

Key Findings

12.2

Biliary Tract Cancer Market Outlook

12.3

Conjoint Analysis

12.4

Key Biliary Tract Cancer Market Forecast Assumptions

12.5

Total Market Size of BTC in the 7MM

12.6

Total Market Size of BTC by Therapies in the 7MM

12.7

The United States Biliary Tract Cancer Market

12.7.1

Total Market Size of BTC in the United States

12.7.2

Total Market Size of BTC by Therapies in the United States

12.8

EU4 and the UK Biliary Tract Cancer Market

12.9

Japan Biliary Tract Cancer Market

13

Biliary Tract Cancer Market Unmet Needs

14

Biliary Tract Cancer Market SWOT Analysis

15

KOL Views on BTC

16

Biliary Tract Cancer Market Access and Reimbursement

16.1

The United States

16.2

In EU4 and the UK

16.3

Japan

16.4

Summary and Comparison of Market Access and Pricing Policy Developments in 2025

16.5

Market Access and Reimbursement of BTC Therapies

17

Bibliography

18

Biliary Tract Cancer Market Report Methodology

Related Reports

Biliary Tract Cancer Clinical Trial Analysis

Biliary Tract Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key BTC companies, including Yantai Rongchang Pharmaceutical, RemeGen, EMD Serono, SMT bio Co., Ltd., CSPC ZhongQi Pharmaceutical Technology Co., Ltd., InnoPharmax Inc., Lee's Pharmaceutical Limited, Hoffmann-La Roche, Shanghai Miracogen Inc., Zymeworks Inc., Bristol-Myers Squibb, Eli Lilly and Company, Ipsen, Threshold Pharmaceuticals, Leap Therapeutics, Hutchison Medipharma Limited, Array BioPharma, Redx Pharma Plc, Compass Therapeutics, Lee's Pharmaceutical Limited, and others.

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