Biliary Tumor Treatment Landscape to Grow Significantly with Pipeline Therapies Targeting FGFR2, HER2, and Beyond | DelveInsight

Biliary Tumor Treatment Landscape to Grow Significantly with Pipeline Therapies Targeting FGFR2, HER2, and Beyond | DelveInsight
Biliary Tumor Market Insights, Epidemiology, and Market Forecast–2032
The biliary tumor market is experiencing notable expansion, driven by increasing disease awareness, rising healthcare expenditures worldwide, and breakthrough therapeutic developments from pharmaceutical companies, such as Elicio Therapeutics, RemeGen, SMT bio Co., Ltd., AstraZeneca, Merck, Bayer, and Takeda, focusing on novel approaches to treat and improve the disease condition.

DelveInsight’s “Biliary Tumor Market Insights, Epidemiology, and Market Forecast–2032” report delivers a comprehensive understanding of the biliary tumor treatment landscape, historical and forecasted epidemiology, as well as market trends across the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. The report thoroughly evaluates current treatment practices, emerging therapies, market share analysis of individual treatments, and biliary tumor market forecasts through 2032, providing essential insights for stakeholders in the biliary tumor therapeutic market.

According to DelveInsight’s analysis, the biliary tumor market is positioned for significant growth during the forecast period, driven by enhanced understanding of disease pathogenesis, better diagnostic pathways, and innovative therapeutic developments currently in the pipeline.

Download the Biliary Tumor Market report to understand which factors are driving the biliary tumor therapeutic market trends and opportunities.

The biliary tumor epidemiological analysis includes historical and forecasted patient pool data for individual seven major countries. The analysis shows that the overall incidence is relatively low across 7MM. However, the United States has the largest share of diagnosed biliary tumor patient pool, primarily due to more awareness and better diagnostics.

The DelveInsight report categorizes the biliary tumor patient population analysis by providing insights about historical and current patient pools, along with forecasted trends for individual countries within the 7MM. This classification approach is essential for understanding disease distribution, progression patterns, and treatment responses across different biliary tumor presentations and remains crucial for accurate epidemiological assessment.

To learn more about the country-wise biliary tumor epidemiological analysis, download the Biliary Tumor Market Report.

The current biliary tumors treatment landscape continues to evolve, with the report providing a detailed analysis of both marketed drugs and late-stage pipeline therapies in development. The drug chapters segment of the report encompasses a comprehensive evaluation of clinical trial details, pharmacological actions, regulatory agreements and collaborations, approval processes, and advantages and disadvantages of included treatments.

The need for more effective therapies for these aggressive and often late-diagnosed cancers is driving the evolution of the biliary tumors treatment landscape. While surgical resection remains the only potentially curative option, most patients present with advanced disease, which necessitates systemic treatment approaches.

Currently, the standard of care for advanced or metastatic biliary tract cancer involves chemotherapy, typically a combination of gemcitabine and cisplatin. Recent advancements have incorporated immunotherapy into first-line treatments, with combinations of durvalumab or pembrolizumab alongside gemcitabine and cisplatin demonstrating improved overall survival compared to chemotherapy alone. Beyond first-line therapy, targeted therapies are gaining attention due to the discovery of several actionable genetic alterations in biliary tract cancer cells. Drugs like pemigatinib and futibatinib specifically target FGFR2 fusions, while ivosidenib targets IDH1 mutations. Other targeted agents include BRAF inhibitors (dabrafenib plus trametinib), HER2 inhibitors (zanidatamab, trastuzumab deruxtecan), and NTRK inhibitors (larotrectinib, entrectinib), which are used for specific genetic profiles. The effectiveness of these targeted therapies underscores the increasing emphasis on routine molecular testing of tumors at the time of diagnosis to guide treatment decisions.

According to the DelveInsight report, the biliary tumor pipeline therapies show promise, with several investigational drugs moving through mid-stage and late-stage development. Notable candidates include Rilvegostomig, a bispecific antibody targeting PD-1 and TIGIT to enhance immune responses, and SHR-A1811, an antibody-drug conjugate aimed at HER2-positive tumors.

Additionally, small-molecule inhibitors targeting PRMT5 are currently in early clinical stages. Other emerging therapeutic options include drugs targeting genetic alterations, such as FGFR2 inhibitors (pemigatinib, futibatinib), TRK inhibitors (larotrectinib, entrectinib), RET inhibitors (selpercatinib, pralsetinib), BRAF/MEK inhibitors, and KRAS inhibitors (adagrasib). These pipeline drugs are in various phases of clinical trials, aiming to improve outcomes for patients with advanced or unresectable biliary tumors by targeting key molecular pathways involved in tumor growth and immune evasion.

Recent developments in the biliary tumor drug landscape have substantially expanded treatment options. In May 2024, AstraZeneca initiated Phase III clinical trials for Rilvegostomig, a promising bispecific antibody targeting PD-1 and TIGIT, aiming to further improve immune-based treatment strategies.

Furthermore, in November 2024, the FDA granted accelerated approval to zanidatamab (Ziihera), a bispecific HER2-directed antibody, for previously treated, unresectable, or metastatic HER2-positive biliary tract cancer, offering new hope to patients with HER2 overexpression who do not respond to chemotherapy. Also in November 2024, Japan approved TASFYGO (tasurgratinib succinate) for biliary tract cancer with FGFR2 gene fusion or rearrangement, addressing a genetically defined patient subset.

Discover recent advancements in the biliary tumor treatment landscape through comprehensive pipeline analysis and competitive intelligence evaluation.

Looking ahead, the biliary tumor market is expected to witness continued innovation driven by a better understanding of disease pathogenesis, novel therapeutic target identification, and improved treatment algorithms. While progress has been made in therapeutic development, challenges remain in addressing unmet medical needs, improving treatment accessibility, and developing more effective therapeutic options across diverse patient populations. Emerging therapies focusing on innovative mechanisms of action, targeted therapeutic approaches, and personalized medicine strategies hold promise for addressing current limitations and further transforming the biliary tumor treatment landscape.

As research and development continue and disease awareness grows, the biliary tumor market is positioned for continued expansion and therapeutic innovation through 2032. The market transformation will be driven by rising awareness of the disease, incremental healthcare spending across global markets, and the ability for drug manufacturers to penetrate deeper into underserved patient populations.

Table of Contents

1. Key Insights

2. Executive Summary of Biliary Tumor

3. Competitive Intelligence Analysis for Biliary Tumor

4. Biliary Tumor Market Overview at a Glance

5. Biliary Tumor: Disease Background and Overview

6. Biliary Tumor Patient Journey

7. Biliary Tumor Epidemiology and Patient Population

8. Treatment Algorithm, Current Treatment, and Medical Practices

9. Biliary Tumor Unmet Needs

10. Key Endpoints of Biliary Tumor Treatment

11. Biliary Tumor Marketed Products

12. Biliary Tumor Emerging Therapies

13. Biliary Tumor: Seven Major Market Analysis

14. Attribute analysis

15. 7MM: Market Outlook

16. Access and Reimbursement Overview of Biliary Tumor

17. KOL Views

18. Biliary Tumor Market Drivers

19. Biliary Tumor Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight

Related Reports

Biliary Tumor Pipeline Insight

Biliary Tumor pipeline insight provides comprehensive insights about the Biliary Tumor pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the Biliary Tumor companies, including Jazz Pharmaceuticals, TransThera Sciences, Chia Tai Tianqing Pharmaceutical, Jiangsu HengRui Medicine, RemeGen, Shanghai Miracogen, ModeX Therapeutics, Intensity Therapeutics, GeneQuantum Healthcare, Elicio Therapeutics, SystImmune, and Lanova Medicines Limited, among others.

About DelveInsight

DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.

Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Arpit Anand
Email: Send Email
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Las Vegas
State: Nevada
Country: United States
Website: https://www.delveinsight.com/consulting/due-diligence-services