
Biliary Tumors Pipeline Analysis Report 2025
Description
Biliary tumors, primarily cholangiocarcinomas, arise from the bile ducts and can be classified as intrahepatic or extrahepatic based on their location. These tumors are often aggressive and can cause symptoms like jaundice due to bile obstruction. Risk factors include chronic liver diseases and infections. The diagnosis typically involves imaging and biopsy, while treatment options may include surgery, chemotherapy, and palliative care. Early detection is crucial, as prognosis is generally poor with advanced disease stages.
Report Coverage
The Biliary Tumors Pipeline Analysis Report by Expert Market Research gives comprehensive insights into biliary tumors therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for biliary tumors. The biliary tumors report assessment includes the analysis of over 25 pipeline drugs and 10+ companies. The biliary tumors pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials including their adverse effects on patients suffering from the condition, and alignment with biliary tumors treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to biliary tumors.
Biliary Tumors Pipeline Outlook
Biliary cancer (mainly cholangiocarcinomas) is caused by chronic inflammation and genetic changes in bile duct cells (cholangiocytes). Biliary intraepithelial neoplasia (BilIN) develops when persistent inflammation from diseases such as primary sclerosing cholangitis, liver cirrhosis, or biliary cysts causes metaplasia and dysplasia. KRAS mutations account for 40% of the cases and are considered early molecular events. Later, TP53 mutations lead to malignant transformation. These tumors cause liver malfunction and jaundice by blocking bile ducts. Modern molecular classifications have improved diagnosis accuracy by identifying subtypes with unique therapy targets. Due to delayed discovery, the prognosis is still dismal; for intrahepatic variations, the 5-year survival rate is less than 20%.
The location and stage of the malignancy determine how biliary tumors are treated. The sole remaining treatment is surgery, which may include partial liver resection and tumor removal. Palliative treatments including stenting, percutaneous drainage, or photodynamic therapy reduce symptoms like jaundice in instances that are advanced or incurable. Chemotherapy (such as gemcitabine and cisplatin), immunotherapy, and targeted medicines for genetic alterations (such as FGFR2, IDH1) are examples of systemic treatments. Although promising, emerging approaches like as CAR-T cell therapy encounter obstacles because of the tumor's immunosuppressive microenvironment.
Biliary Tumors Epidemiology
Biliary tumors, such as gallbladder cancer and cholangiocarcinoma, vary by region. About 8,000 persons in the United States are affected with bile duct cancer each year. Intrahepatic cases are more prevalent than extrahepatic ones. Intrahepatic and extrahepatic malignancies have respective incidence rates of 1.49 and 0.96 per 100,000 people. Because of risk factors such as liver flukes, Southeast Asia and South America report greater prevalences worldwide. Globally, intrahepatic cholangiocarcinoma has become more common, especially in men.
Biliary Tumors – Pipeline Therapeutic Assessment
This section of the report covers the analysis of biliary tumors drug candidates based on several segmentations including:
By Phase
The report covers phase I, phase II, phase III, phase IV, and early phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis , phase III covers a major share of the total clinical trials, with a substantial number of biliary tumors drugs undergoing clinical development.
Biliary Tumors – Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under biliary tumors pipeline analysis include small molecules, biologics, peptides, and immunotherapies, among others. The biliary tumors report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for biliary tumors.
Biliary Tumors Clinical Trials – Key Players
The EMR report for the biliary tumors drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed biliary tumors therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in biliary tumors clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for biliary tumors. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of biliary tumors drug candidates:
Drug: Ramucirumab
Ramucirumab by Eli Lilly and Company is being evaluated in a Phase 2 clinical trial for patients with advanced biliary tumors. The study assesses the efficacy and safety of Ramucirumab, an anti-VEGFR2 monoclonal antibody, in combination with paclitaxel. The goal is to determine its potential to improve progression-free survival and overall clinical outcomes. This industry-funded trial targets individuals with biliary tract cancers who have progressed on previous therapies.
Drug: Pembrolizumab
Pembrolizumab by Merck Sharp & Dohme LLC is being studied in a Phase 3 clinical trial for patients with advanced biliary tumors. The trial evaluates the safety and efficacy of pembrolizumab, an anti-PD-1 monoclonal antibody, as part of an immunotherapy regimen. The study aims to determine its potential in prolonging survival and improving clinical outcomes in individuals with biliary tract cancers who have progressed after prior treatments.
Key Questions Answered in the Biliary Tumors – Pipeline Insight Report
The Biliary Tumors Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for biliary tumors. it provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into biliary tumor collaborations, regulatory environments, and potential growth opportunities.
Related Report
Global Cancer Therapeutics Market
Global Clinical Trials Market
Report Coverage
The Biliary Tumors Pipeline Analysis Report by Expert Market Research gives comprehensive insights into biliary tumors therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for biliary tumors. The biliary tumors report assessment includes the analysis of over 25 pipeline drugs and 10+ companies. The biliary tumors pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials including their adverse effects on patients suffering from the condition, and alignment with biliary tumors treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to biliary tumors.
Biliary Tumors Pipeline Outlook
Biliary cancer (mainly cholangiocarcinomas) is caused by chronic inflammation and genetic changes in bile duct cells (cholangiocytes). Biliary intraepithelial neoplasia (BilIN) develops when persistent inflammation from diseases such as primary sclerosing cholangitis, liver cirrhosis, or biliary cysts causes metaplasia and dysplasia. KRAS mutations account for 40% of the cases and are considered early molecular events. Later, TP53 mutations lead to malignant transformation. These tumors cause liver malfunction and jaundice by blocking bile ducts. Modern molecular classifications have improved diagnosis accuracy by identifying subtypes with unique therapy targets. Due to delayed discovery, the prognosis is still dismal; for intrahepatic variations, the 5-year survival rate is less than 20%.
The location and stage of the malignancy determine how biliary tumors are treated. The sole remaining treatment is surgery, which may include partial liver resection and tumor removal. Palliative treatments including stenting, percutaneous drainage, or photodynamic therapy reduce symptoms like jaundice in instances that are advanced or incurable. Chemotherapy (such as gemcitabine and cisplatin), immunotherapy, and targeted medicines for genetic alterations (such as FGFR2, IDH1) are examples of systemic treatments. Although promising, emerging approaches like as CAR-T cell therapy encounter obstacles because of the tumor's immunosuppressive microenvironment.
Biliary Tumors Epidemiology
Biliary tumors, such as gallbladder cancer and cholangiocarcinoma, vary by region. About 8,000 persons in the United States are affected with bile duct cancer each year. Intrahepatic cases are more prevalent than extrahepatic ones. Intrahepatic and extrahepatic malignancies have respective incidence rates of 1.49 and 0.96 per 100,000 people. Because of risk factors such as liver flukes, Southeast Asia and South America report greater prevalences worldwide. Globally, intrahepatic cholangiocarcinoma has become more common, especially in men.
Biliary Tumors – Pipeline Therapeutic Assessment
This section of the report covers the analysis of biliary tumors drug candidates based on several segmentations including:
By Phase
- Late-Stage Products (Phase 3 and Phase 4)
- Mid-Stage Products (Phase 2)
- Early-Stage Products (Phase I)
- Preclinical and Discovery Stage Products
- Small Molecule
- Peptide
- Recombinant Fusion Proteins
- Polymer
- Monoclonal Antibody
- Gene Therapy
- Others
- Oral
- Parenteral
- Others
The report covers phase I, phase II, phase III, phase IV, and early phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis , phase III covers a major share of the total clinical trials, with a substantial number of biliary tumors drugs undergoing clinical development.
Biliary Tumors – Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under biliary tumors pipeline analysis include small molecules, biologics, peptides, and immunotherapies, among others. The biliary tumors report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for biliary tumors.
Biliary Tumors Clinical Trials – Key Players
The EMR report for the biliary tumors drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed biliary tumors therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in biliary tumors clinical trials:
- Eli Lilly and Company
- Merck Sharp & Dohme LLC
- AstraZeneca
- Boehringer Ingelheim
- Jazz Pharmaceuticals
- Seagen (Pfizer)
- Fujifilm Pharmaceuticals U.S.A., Inc.
- 3D Medicines (Sichuan) Co., Ltd.
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for biliary tumors. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of biliary tumors drug candidates:
Drug: Ramucirumab
Ramucirumab by Eli Lilly and Company is being evaluated in a Phase 2 clinical trial for patients with advanced biliary tumors. The study assesses the efficacy and safety of Ramucirumab, an anti-VEGFR2 monoclonal antibody, in combination with paclitaxel. The goal is to determine its potential to improve progression-free survival and overall clinical outcomes. This industry-funded trial targets individuals with biliary tract cancers who have progressed on previous therapies.
Drug: Pembrolizumab
Pembrolizumab by Merck Sharp & Dohme LLC is being studied in a Phase 3 clinical trial for patients with advanced biliary tumors. The trial evaluates the safety and efficacy of pembrolizumab, an anti-PD-1 monoclonal antibody, as part of an immunotherapy regimen. The study aims to determine its potential in prolonging survival and improving clinical outcomes in individuals with biliary tract cancers who have progressed after prior treatments.
Key Questions Answered in the Biliary Tumors – Pipeline Insight Report
- Which companies/institutions are leading the biliary tumors drug development?
- What is the efficacy and safety profile of biliary tumors pipeline drugs?
- Which company is leading the biliary tumors pipeline development activities?
- What is the current biliary tumors commercial assessment?
- What are the opportunities and challenges present in the biliary tumors pipeline landscape?
- Which company is conducting major trials for biliary tumors drugs?
- Which companies/institutions are involved in biliary tumors collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What are the geographies covered for clinical trials in biliary tumors?
The Biliary Tumors Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for biliary tumors. it provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into biliary tumor collaborations, regulatory environments, and potential growth opportunities.
Related Report
Global Cancer Therapeutics Market
Global Clinical Trials Market
Table of Contents
200 Pages
- 1 Preface
- 1.1 Introduction
- 1.2 Objectives of the Study
- 1.3 Research Methodology & Assumptions
- 2 Executive Summary
- 3 Overview of Biliary Tumors
- 3.1 Signs and Symptoms
- 3.2 Causes
- 3.3 Risk Factors
- 3.4 Types of Biliary Tumors
- 3.5 Diagnosis
- 3.6 Treatment
- 4 Patient Profile: Biliary Tumors
- 4.1 Patient Profile Overview
- 4.2 Patient Psychology and Emotional Impact Factors
- 4.3 Risk Assessment and Treatment Success Rate
- 5 Biliary Tumors: Epidemiology Snapshot
- 5.1 Biliary Tumors Incidence by Key Markets
- 5.2 Biliary Tumors – Patients Seeking Treatment in Key Markets
- 6 Biliary Tumors: Market Dynamics
- 6.1 Market Drivers and Constraints
- 6.2 SWOT Analysis
- 7 Biliary Tumors: Key Facts Covered
- 7.1 Top Countries Contributing to Clinical Trials in Asia-Pacific
- 7.2 Top Countries Contributing to Clinical Trials in Europe
- 7.3 Top Countries Contributing to Clinical Trials in North America
- 7.4 Top Countries Contributing to Clinical Trials in Other Regions
- 8 Biliary Tumors, Drug Pipeline Assessment
- 8.1 Assessment by Treatment Type
- 8.2 Assessment by Route of Administration
- 8.3 Assessment by Drug Class
- 9 EMR Drug Pipeline Comparative Analysis
- 9.1 List of Biliary Tumors Pipeline Drugs
- 9.1.1 By Company
- 9.1.2 By Phase
- 9.1.3 By Indication
- 9.1.4 By Trial Status
- 9.1.5 By Funder Type
- 9.2 EMR Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
- 10 Biliary Tumors Drug Pipeline - Mid-Stage Products (Phase III & IV) (Top Drugs)
- 10.1 Comparative Analysis for Mid-Stage Drugs
- 10.1.1 Study Type
- 10.1.2 Recruitment Status
- 10.1.3 Company
- 10.1.4 Funder Type
- 10.2 Product Level Analysis*
- 10.2.1 Drug: Pembrolizumab
- 10.2.1.1 Product Description
- 10.2.1.2 Trial ID
- 10.2.1.3 Sponsor Name
- 10.2.1.4 Study Type
- 10.2.1.5 Drug Class
- 10.2.1.6 Eligibility Criteria
- 10.2.1.7 Study Record Dates
- 10.2.1.7.1 First Submitted
- 10.2.1.7.2 First Posted
- 10.2.1.7.3 Last Update Posted
- 10.2.1.7.4 Last Verified
- 10.2.1.8 Indication
- 10.2.1.9 Study Design
- 10.2.1.10 Recruitment Status
- 10.2.1.11 Enrollment (Estimated)
- 10.2.1.12 Location Countries
- 10.2.1.13 Recent Results
- 10.2.2 Drug: CTX-009
- 10.2.3 Other Drugs
- 11 Biliary Tumors Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
- 11.1 Comparative Analysis for Mid-Stage Drugs
- 11.1.1 Study Type
- 11.1.2 Recruitment Status
- 11.1.3 Company
- 11.1.4 Funder Type
- 11.2 Product Level Analysis*
- 11.2.1 Drug: Belzutifan
- 11.2.1.1 Product Description
- 11.2.1.2 Trial ID
- 11.2.1.3 Sponsor Name
- 11.2.1.4 Study Type
- 11.2.1.5 Drug Class
- 11.2.1.6 Eligibility Criteria
- 11.2.1.7 Study Record Dates
- 11.2.1.7.1 First Submitted
- 11.2.1.7.2 First Posted
- 11.2.1.7.3 Last Update Posted
- 11.2.1.7.4 Last Verified
- 11.2.1.8 Indication
- 11.2.1.9 Study Design
- 11.2.1.10 Recruitment Status
- 11.2.1.11 Enrollment (Estimated)
- 11.2.1.12 Location Countries
- 11.2.1.13 Recent Results
- 11.2.2 Drug: Brigimadlin
- 11.2.3 Other Drugs
- 12 Biliary Tumors Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
- 12.1 Comparative Analysis for Early-Stage Drugs
- 12.1.1 Study Type
- 12.1.2 Recruitment Status
- 12.1.3 Company
- 12.1.4 Funder Type
- 12.2 Product Level Analysis*
- 12.2.1 Drug: FF-10832
- 12.2.1.1 Product Description
- 12.2.1.2 Trial ID
- 12.2.1.3 Sponsor Name
- 12.2.1.4 Study Type
- 12.2.1.5 Drug Class
- 12.2.1.6 Eligibility Criteria
- 12.2.1.7 Study Record Dates
- 12.2.1.7.1 First Submitted
- 12.2.1.7.2 First Posted
- 12.2.1.7.3 Last Update Posted
- 12.2.1.7.4 Last Verified
- 12.2.1.8 Indication
- 12.2.1.9 Study Design
- 12.2.1.10 Recruitment Status
- 12.2.1.11 Enrollment (Estimated)
- 12.2.1.12 Location Countries
- 12.2.2 Drug: AI-061
- 12.2.3 Other Drugs
- 13 Biliary Tumors, Key Drug Pipeline Companies
- 13.1 Eli Lilly and Company
- 13.1.1 Company Snapshot
- 13.1.2 Pipeline Product Portfolio
- 13.1.3 Financial Analysis
- 13.1.4 Recent News and Developments
- 13.2 Merck Sharp & Dohme LLC
- 13.2.1 Company Snapshot
- 13.2.2 Pipeline Product Portfolio
- 13.2.3 Financial Analysis
- 13.2.4 Recent News and Developments
- 13.3 AstraZeneca
- 13.3.1 Company Snapshot
- 13.3.2 Pipeline Product Portfolio
- 13.3.3 Financial Analysis
- 13.3.4 Recent News and Developments
- 13.4 Boehringer Ingelheim
- 13.4.1 Company Snapshot
- 13.4.2 Pipeline Product Portfolio
- 13.4.3 Financial Analysis
- 13.4.4 Recent News and Developments
- 13.5 Jazz Pharmaceuticals
- 13.5.1 Company Snapshot
- 13.5.2 Pipeline Product Portfolio
- 13.5.3 Financial Analysis
- 13.5.4 Recent News and Developments
- 13.6 Seagen (Pfizer)
- 13.6.1 Company Snapshot
- 13.6.2 Pipeline Product Portfolio
- 13.6.3 Financial Analysis
- 13.6.4 Recent News and Developments
- 13.7 Fujifilm Pharmaceuticals U.S.A., Inc.
- 13.7.1 Company Snapshot
- 13.7.2 Pipeline Product Portfolio
- 13.7.3 Financial Analysis
- 13.7.4 Recent News and Developments
- 13.8 3D Medicines (Sichuan) Co., Ltd.
- 13.8.1 Company Snapshot
- 13.8.2 Pipeline Product Portfolio
- 13.8.3 Financial Analysis
- 13.8.4 Recent News and Developments
- 14 Regulatory Framework for Drug Approval, By Region
- 15 Terminated or Suspended Pipeline Products
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