Biliary Tumor Market Summary

• The Biliary Tumor Market Size is aniticipated to grow with a significnat CAGR during the study period (2020-2034).
• The leading Biliary Tumor companies developing therapies include - AstraZeneca, Merck, Taiho Oncology, Jazz Pharmaceuticals, Eli Lilly, Roche, Bayer, and Daiichi Sankyo

Key Factors Impacting the  Biliary Tumor Market  Growth

Rising Incidence of Biliary Tumors

The increasing prevalence of biliary tumors, including cholangiocarcinoma and gallbladder cancer, is a primary driver of market growth. Early detection and improved diagnostic capabilities are also contributing to a higher number of diagnosed cases globally.

Advancements in Diagnostic Technologies

Innovations in imaging techniques, molecular diagnostics, and biomarker identification have enhanced early detection and accurate diagnosis of biliary tumors, fueling market expansion.

Development of Targeted Therapies and Immunotherapies

The introduction of targeted treatments and immunotherapies has significantly improved patient outcomes, encouraging adoption of advanced therapeutic options and driving market growth.

Increasing Research and Clinical Trials

Ongoing clinical trials and research initiatives focusing on novel drugs, combination therapies, and personalized medicine are expanding the therapeutic landscape, positively impacting market growth.

Government Support and Funding

Rising government initiatives, funding for cancer research, and favorable reimbursement policies are promoting innovation and accessibility, further boosting the biliary tumor market.

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DelveInsight's "Biliary Tumor Market Insights, Epidemiology, and Market Forecast-2034" report delivers an in-depth understanding of the Biliary Tumor, historical and forecasted epidemiology as well as the Biliary Tumor market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The Biliary Tumor market report provides current treatment practices, emerging drugs, Biliary Tumor market share of the individual therapies, current and forecasted Biliary Tumor market Size from 2020 to 2034 segmented by seven major markets. The Report also covers current Biliary Tumor treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the Biliary Tumor market.

Biliary Tumor Disease Understanding

Biliary Tumor Diagnosis

Early and accurate diagnosis of biliary tumors is critical for effective management and improved patient outcomes. Diagnostic approaches typically include imaging techniques such as ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI), which help identify the location and size of the tumor. Endoscopic procedures, including endoscopic retrograde cholangiopancreatography (ERCP), are often employed to obtain tissue samples for histopathological examination. Additionally, the use of biomarkers and molecular testing is becoming increasingly important for detecting biliary tumors at an early stage and guiding personalized treatment strategies.

Biliary Tumor Treatment

The treatment of biliary tumors depends on the tumor type, stage, and overall patient health. Surgical resection remains the standard approach for localized tumors and offers the best chance of long-term survival. For advanced or unresectable cases, treatment options include chemotherapy, targeted therapy, and immunotherapy to manage disease progression and improve quality of life. Palliative interventions, such as stent placement and biliary drainage, are also used to alleviate symptoms and manage complications. Ongoing research into novel therapies and combination regimens continues to expand treatment possibilities, aiming to improve patient outcomes in this challenging disease area.

Biliary Tumor Epidemiology 

The Biliary Tumor epidemiology section provides insights about the historical and current Biliary Tumor patient pool and forecasted trends for individual seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the Biliary Tumor market report also provides the diagnosed patient pool and their trends along with assumptions undertaken. 

Key Findings from Biliary Tumor Epidemiological Analyses and Forecast

• The Biliary Tumor disease epidemiology covered in the report provides historical as well as forecasted Biliary Tumor epidemiology scenario in the 7MM covering the United States, EU5 countries (Germany, Spain, Italy, France, and the United Kingdom), and Japan from 2020 to 2034.
• As per the American Cancer Society’s estimates, in 2025, there are 12,610 diagnosed cases of the gallbladder and extrahepatic bile duct cancer in the US.
• According to our analysis, the US accounted for approximately 19,500 biliary tract cancer cases in 2024, representing around 30% of the total cases across the 7MM.
• In 7MM, Stage IV biliary tract cancer accounted for the largest number of cases, approximately 19,000 in 2024.

Biliary Tumor Drug Analysis

The drug chapter segment of the Biliary Tumor report encloses the detailed analysis of Biliary Tumor marketed drugs and late-stage (Phase-III and Phase-II) Biliary Tumor pipeline drugs. It also helps to understand the Biliary Tumor clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Biliary Tumor Marketed Drugs

The Biliary Tumor report provides the details of the marketed products/off-label treatments available for Biliary Tumor treatment.

Biliary Tumor Emerging Drugs

The Biliary Tumor report provides the details of the emerging therapies under the late and mid-stage of development for Biliary Tumor treatment.

Tinengotinib: TransThera Sciences

Tinengotinib is an innovative, global Phase III stage spectrum-selective kinase inhibitor that exerts antitumor effects by targeting tumor cells and improving the tumor microenvironment. Ongoing Chloangiocarcinoma clinical trials in the US and China have revealed the potential of Tinengotinib to be efficacious in various solid tumors.

• In November 2021, TransThera announced that the US FDA had granted FTD to its Phase II stage product TT-00420 (tinengotinib) for the treatment of patients with cholangiocarcinoma who have no standard treatment options.
• In November 2019, TT-00420 was already granted ODD by the FDA to treat Cholangiocarcinoma.

Silmitasertib (CX-4945): Senhwa Biosciences

Silmitasertib (CX-4945), a synthetically derived small molecule, is provided as a sodium salt in hard gelatin capsule shells with oral administration. CK2 (Casein kinase 2) is a protein kinase that has elevated activity in many cancers and has a direct role in DNA damage repair. The DNA repair pathways enable tumor cells to survive damage induced by treatment with chemotherapeutic agents. Inhibitors of DNA repair pathways have been shown to increase the efficacy of DNA-damaging chemotherapeutic drugs when these are used in combination.

Silmitasertib, in combination with gemcitabine + cisplatin, yields promising preliminary evidence of efficacy in patients with locally advanced or metastatic cholangiocarcinoma. Based on Phase Ib/II, a randomized Phase III trial is planned.

MRG 002: Miracogen

MRG 002, is an antibody-drug conjugate (ADC) composed of a humanized immunoglobulin G1 (IgG1) monoclonal antibody directed against the tumor-associated antigen (TAA) human epidermal growth factor receptor 2 conjugated to the microtubule-disrupting cytotoxic agent monomethyl auristatin E (MMAE), with potential antineoplastic activity. An open-label, single-arm, multi-center, phase II Clinical Study of MRG002 are conducted by Miracogen for the treatment of patients with HER2-positive unresectable, locally advanced or metastatic biliary tract cancer. MRG002 is administrated by an IV infusion of 2.6 mg/kg on Day 1 of every 3 weeks (21-day cycle).

Disitamab vedotin: Yantai Rongchang Pharmaceutical

Disitamab Vedotin is an antibody-drug conjugate with a drug structure consisting of three parts Anti-human epidermal growth factor receptor 2 extracellular domain (HER2 ECD) antibody; Linker (MC-Val-Cit-PAB, Linker); and Cytotoxic Monomethyl Auristatin E (Monomethyl Auristatin E, MMAE). This product is white to light yellow loose body, after reconstitution, it is colorless to light yellow clear liquid.

Envafolimab: Alphamab Oncology

Envafolimab is a PD-L1 single-domain antibody Fc fusion protein independently developed by Alphamab. Based on the unique design, Envafolimab has advantages in safety, convenience and compliance, and can be used for patients who are not suitable for intravenous infusion with a lower medical cost. On March 30, 2020, Alphamab, 3D Medicines and Simcere reached a three-way strategic collaboration. Alphamab, as the original research party, is responsible for production and quality, 3D Medicines is responsible for global clinical development in the field of oncology, registration and commercialization abroad, and Simcere is responsible for the exclusive commercial promotion of the product in mainland China. At present, Envafolimab is being evaluated in clinical trials for multiple cancer indications in China, the United States and Japan, and the research for multiple indications have entered the registration/clinical Phase III. Envafolimab has been awarded orphan drug designation (ODD) by FDA in the United States for the treatment of advanced biliary tract cancer.

DKN-01: Leap Therapeutics

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways and has an important role in promoting tumor proliferation, metastasis, angiogenesis, and in mediating an immune suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK cell ligands on tumor cells. The U.S. Food and Drug Administration has granted DKN-01 Orphan Drug Designation for the treatment of gastric and gastroesophageal junction cancer and Fast Track Designation in combination with tislelizumab for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high DKK1 protein, following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy. Currently the drug is in Phase II of development.

Biliary Tumor Market Outlook

The Biliary Tumor market outlook of the report helps to build a detailed comprehension of the historic, current, and forecasted Biliary Tumor market trends by analyzing the impact of current Biliary Tumor therapies on the market, unmet needs, drivers and barriers, and demand for better technology.

This segment gives a thorough detail of Biliary Tumor market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria's, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated Biliary Tumor market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

According to DelveInsight, the Biliary Tumor market in 7MM is expected to witness a major change in the study period 2020-2034.

The United States Biliary Tumor Market Outlook

This section provides the total Biliary Tumor market size and market size by therapies in the United States.

EU-5 Countries: Biliary Tumor Market Outlook

The total Biliary Tumor market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom is provided in this section.

Japan Biliary Tumor Market Outlook

The total Biliary Tumor market size and market size by therapies in Japan is also mentioned.

Biliary Tumor Competitive Landscape

• AstraZeneca,
• Merck,
• Taiho Oncology,
• Jazz Pharmaceuticals,
• Eli Lilly,
• Roche, 
• Bayer,
• Daiichi Sankyo, and others

Biliary Tumor Drugs Uptake

This section focuses on the rate of uptake of the potential Biliary Tumor drugs recently launched in the Biliary Tumor market or expected to get launched in the market during the study period 2020-2034. The analysis covers Biliary Tumor market uptake by drugs; patient uptake by therapies; and sales of each drug.   

Biliary Tumor Drugs Uptake helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allow the comparison of the drugs on the basis of Biliary Tumor market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Biliary Tumor Clinical Trials Analysis

The Biliary Tumor report provides insights into different therapeutic candidates in Phase II, and Phase III stage. It also analyses Biliary Tumor key players involved in developing targeted therapeutics.

Biliary Tumor Pipeline Development Activities

The Biliary Tumor report covers the detailed information of collaborations, acquisition, and merger, licensing, patent details, and other information for Biliary Tumor emerging therapies.

Biliary Tumor Market Access and Reimbursement

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In a report, we take reimbursement into consideration to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Latest KOL Views on Biliary Tumor Market Report

To keep up with current Biliary Tumor market trends, we take KOLs and SMEs ' opinion working in the Biliary Tumor domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Biliary Tumor market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

 Biliary Tumor Competitive Intelligence Analysis

We perform Competitive and Market Intelligence analysis of the Biliary Tumor Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Biliary Tumor Market Report

• The Biliary Tumor Market report covers the descriptive overview of Biliary Tumor, explaining its causes, signs and symptoms, pathophysiology, diagnosis and currently available therapies
• Comprehensive insight has been provided into the Biliary Tumor epidemiology and treatment in the 7MM
• Additionally, an all-inclusive account of both the current and emerging therapies for Biliary Tumor is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
• A detailed review of the Biliary Tumor market; historical and forecasted is included in the report, covering drug outreach in the 7MM
• The Biliary Tumor Market report provides an edge while developing business strategies, by understanding trends shaping and driving the global Biliary Tumor market

Biliary Tumor Market Report Highlights

• In the coming years, the Biliary Tumor market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
• The key Biliary Tumor Market companies and academics are working to assess challenges and seek opportunities that could influence Biliary Tumor R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition      
• Major Biliary Tumor players are involved in developing therapies for Biliary Tumor. The launch of emerging therapies will significantly impact the Biliary Tumor market
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Biliary Tumor
• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities

Biliary Tumor Market Report Insights

• Biliary Tumor Patient Population
• Biliary Tumor Therapeutic Approaches
• Biliary Tumor Pipeline Analysis
• Biliary Tumor Market Size and Trends
• Biliary Tumor Market Opportunities
• Impact of upcoming Biliary Tumor Therapies

Biliary Tumor Market Report Key Strengths

• 11 Years Forecast
• 7MM Coverage
• Biliary Tumor Epidemiology Segmentation
• Key Biliary Tumor Market Cross Competition
• Highly Analyzed Biliary Tumor Market
• Biliary Tumor Market Drugs Uptake

Biliary Tumor Market Report Assessment

• Current Biliary Tumor Market Treatment Practices
• Biliary Tumor Market Unmet Needs
• Biliary Tumor Pipeline Product Profiles
• Biliary Tumor Market Attractiveness
• Biliary Tumor Market Drivers 
• Biliary Tumor Market Barriers

Key Questions Answered in the Biliary Tumor Market Report

Biliary Tumor Market  Insights:

• What was the Biliary Tumor drug class share (%) distribution in 2020 and how it would look like in 2034?
• What would be the Biliary Tumor total market size as well as market size by therapies across the 7MM during the forecast period (2020-2034)?
• What are the key findings pertaining to the market across 7MM and which country will have the largest Biliary Tumor market size during the forecast period (2020-2034)?
• At what CAGR, the Biliary Tumor market is expected to grow by 7MM during the forecast period (2020-2034)?
• What would be the Biliary Tumor market outlook across the 7MM during the forecast period (2020-2034)?
• What would be the Biliary Tumor market growth till 2034, and what will be the resultant market Size in the year 2034?
• How would the unmet needs affect the market dynamics and subsequent analysis of the associated trends?

Biliary Tumor Epidemiology Insights:

• What are the disease risk, burden, and regional/ethnic differences of the Biliary Tumor?
• What are the key  Biliary Tumor factors driving the epidemiology trend for seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What is the historical Biliary Tumor patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What would be the forecasted patient pool of Biliary Tumor in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• Where will be the growth opportunities in the 7MM with respect to the patient population pertaining to Biliary Tumor?
• Out of all 7MM countries, which country would have the highest prevalent population of Biliary Tumor during the forecast period (2020-2034)?
• At what CAGR the patient population is expected to grow in 7MM during the forecast period (2020-2034)?

Current Biliary Tumor Treatment Scenario, Marketed Drugs and Emerging Therapies:

• What are the current options for the Biliary Tumor treatment in addition to the approved therapies?
• What are the current treatment guidelines for the treatment of Biliary Tumor in the USA, Europe, and Japan?
• What are the Biliary Tumor marketed drugs and their respective MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
• How many companies are developing therapies for the treatment of Biliary Tumor?
• How many therapies are in-development by each company for Biliary Tumor treatment?
• How many  Biliary Tumor emerging therapies are in mid-stage, and late stage of drug development for Biliary Tumor treatment?
• What are the key collaborations (Industry - Industry, Industry - Academia), Mergers and acquisitions, licensing activities related to the Biliary Tumor therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies being developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Biliary Tumor and their status?
• What are the current challenges faced in drug development?
• What are the key designations that have been granted for the emerging therapies for Biliary Tumor?
• What are the global historical and forecasted market of Biliary Tumor?

Reasons to Buy the Biliary Tumor Market Forecast Report

• The report will help in developing business strategies by understanding trends shaping and driving the Biliary Tumor market
• To understand the future market competition in the Biliary Tumor market and Insightful review of the key market drivers and barriers
• Organize sales and marketing efforts by identifying the best opportunities for Biliary Tumor in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
• Organize sales and marketing efforts by identifying the best opportunities for Biliary Tumor market
• To understand the future market competition in the Biliary Tumor market