Bile Duct Neoplasms Market Summary

• The Bile Duct Neoplasms Market Size is expected to witness significant competition, wherein chemotherapy is likely to maintain dominance in the market. In a nutshell, potential therapies are being investigated for treating Bile Duct Neoplasms.
• The United States accounted for the largest Bile Duct Neoplasms market size, in comparison to EU4 (Germany, France, Italy, and Spain) and the UK, and Japan in 2023.

Bile Duct Neoplasms Market Insight and Trends

• Bile Duct Neoplasms are cancers of the bile duct system, originating in the liver or extrahepatic bile ducts, which end at the ampulla of Vater. They occur in three main areas: intrahepatic, extrahepatic (perihilar), and distal extrahepatic.
• The overall Bile Duct Neoplasms incidence across the 7MM was around 45,000 in 2023, out of which ~45% cases were intrahepatic.
• Bile Duct Neoplasms are primarily diagnosed at the old aged and are more prevalent in population aged 80 and above. Further, the mutation-specific cases of Bile Duct Neoplasms were highest in TP53 mutations, followed by KRAS mutations in the 7MM.
• Currently, an estimated 80% of the Bile Duct Neoplasms patient pool receive treatment in adjuvant settings. The main options for the treatment of Bile Duct Neoplasms are surgery, chemotherapy, targeted therapy, immunotherapy, and radiotherapy being chemotherapy as the cornerstone therapy in adjuvant settings.
• In February 2024, Biosyngen announced that BST02 had been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of all types of liver cancer, including hepatocellular carcinoma and Bile Duct Neoplasms.
• There are now several approved treatments for those with Bile Duct Neoplasms including PEMAZYRE (pemigatinib), TIBSOVO (ivosidenib), and LYTGOBI (futibatinib). Among the therapies specifically targeting different alterations of FGFR mutation, PEMAZYRE is expected to garner the highest market share.
• Bile Duct Neoplasms has an active pipeline with key pharmaceutical Bile Duct Neoplasms companies like TransThera Sciences, Senhwa Biosciences, Lisata Therapeutics, Relay Therapeutics, and others working on improving the Bile Duct Neoplasms treatment market landscape of the indication. Among all emerging drugs, Senhwa’s CX-4945 is likely to capture significant share of the Bile Duct Neoplasms market in the upcoming years.
• Even though it is too soon to comment on the promising candidate to enter the Bile Duct Neoplasms market during the forecast period (2020–2034), it is safe to assume that the future of this market is good. Eventually, the drug, if approved, will create a significant difference in the landscape of Bile Duct Neoplasms in the coming years.

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Factors Affecting Bile Duct Neoplasms Market Growth

Rising Global Incidence & Disease Burden

The increasing prevalence of bile duct neoplasms, particularly cholangiocarcinoma, is a major driver of market growth. Aging populations, higher rates of chronic liver diseases such as hepatitis and cirrhosis, and endemic parasitic infections are contributing to the rising number of diagnosed cases worldwide.

Advancements in Diagnostic Capabilities

Continuous improvements in imaging technologies, including MRI, CT, and MRCP, along with advances in molecular and genomic profiling, are enabling earlier diagnosis and better patient stratification, thereby expanding the eligible treatment population.

Emergence of Targeted Therapies & Precision Medicine

The development of targeted therapies such as FGFR and IDH inhibitors, along with growing adoption of immunotherapies, is transforming the treatment landscape. These therapies offer improved clinical outcomes compared to conventional chemotherapy, driving increased demand and investment.

Strong R&D Pipeline & Clinical Trials

A robust research and development ecosystem, supported by rising investments and an expanding number of clinical trials, is accelerating the introduction of innovative treatment candidates focused on genetic and immune-based targets, supporting long-term market expansion.

Expanded Healthcare Infrastructure & Access

Increasing healthcare expenditure and strengthening medical infrastructure, particularly in emerging economies, are improving access to advanced diagnostic tools and therapies, thereby broadening the overall market reach.

Awareness & Educational Initiatives

Growing awareness among healthcare professionals and patients, supported by educational programs and screening initiatives, is improving diagnosis rates and promoting early treatment, which in turn increases therapy utilization.

Economic & Demographic Trends

Population growth, urbanization, and the rising elderly demographic are increasing disease incidence and healthcare demand. Simultaneously, economic development and higher healthcare spending are supporting wider adoption of advanced bile duct neoplasm treatments.

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

The Bile Duct Neoplasms market report provides current treatment practices, emerging drugs, Bile Duct Neoplasms market share of the individual therapies, current and forecasted Bile Duct Neoplasms market Size from 2020 to 2034 segmented by seven major markets. The Report also covers current Bile Duct Neoplasms 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 Bile Duct Neoplasms market.

Scope of the Bile Duct Neoplasms Market Report
Report Metrics	Details
Study Period	2020 to 2034
Geography Covered	United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
Forecast Period	2024 to 2034
Bile Duct Neoplasms Market CAGR	Request Sample to Know
Bile Duct Neoplasms Market Size	Request Sample to Know
Key Bile Duct Neoplasms Companies	Medivir, Hutchison Medipharma, Agios Pharmaceuticals, TransThera Biosciences, Senhwa Biosciences, Eisai, EMD Serono, Taiho Oncology, Sirnaomics, RedHill Biopharma, MacroGenics, Chia Tai Tianqing Pharmaceutical Group, Sirtex Medical, and others.

Bile Duct Neoplasms Disease Understanding and Treatment Algorithm

Bile duct neoplasms are rare but aggressive tumors that arise from the bile ducts, which transport bile from the liver to the gallbladder and small intestine. These neoplasms may be benign or malignant, with malignant forms collectively referred to as Bile Duct Neoplasms being far more common and clinically significant.

Bile duct tumors are classified based on their anatomical location:

• Intrahepatic bile duct neoplasms – originate within the liver
• Perihilar bile duct neoplasms (Klatskin tumors) – occur at the hepatic duct bifurcation
• Distal extrahepatic bile duct neoplasms – develop near the pancreas or small intestine

Bile Duct Neoplasms Diagnosis

Diagnosis typically involves a combination of:

• Imaging techniques (ultrasound, CT scan, MRI/MRCP)
• Endoscopic procedures (ERCP, EUS-guided biopsy)
• Tumor markers such as CA 19-9 (supportive, not definitive)
• Histopathological confirmation

Bile Duct Neoplasms Treatment

It covers the details of conventional and current medical therapies available in the Bile Duct Neoplasms market for the treatment of the condition. It also provides Bile Duct Neoplasms treatment algorithms and guidelines in the United States, Europe, and Japan.

Bile Duct Neoplasms Epidemiology 

The Bile Duct Neoplasms epidemiology section provides insights about the historical and current Bile Duct Neoplasms 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 Bile Duct Neoplasms market report also provides the diagnosed patient pool and their trends along with assumptions undertaken. 

Key Findings from Bile Duct Neoplasms Epidemiological Analyses and Forecast

• According to the findings, Bile Duct Neoplasms represents approximately 3% of gastrointestinal malignancies worldwide and constitutes around 10–15% of all primary liver cancers, being only second to hepatocellular carcinoma.
• As per DelveInsight's estimates, the total incident cases of Bile Duct Neoplasms in the United States were ~14,000 in 2023.
• In the United States, out of all the Bile Duct Neoplasms cases, intrahepatic cancer accounted were around 6000.
• It is observed that  Bile Duct Neoplasms occurs majorly in the age group of 70–79 years.

Bile Duct Neoplasms Drugs Analysis

The drug chapter segment of the Bile Duct Neoplasms treatment market report encloses a detailed analysis of Bile Duct Neoplasms marketed drugs and late-stage (Phase III and Phase II) Bile Duct Neoplasms pipeline drugs. It also deep dives into the pivotal Bile Duct Neoplasms clinical trials details, recent and expected market approvals, patent details, the latest Bile Duct Neoplasms news, and recent deals and collaborations.

Marketed Bile Duct Neoplasms Drugs

• PEMAZYRE (pemigatinib): Incyte

PEMAZYRE is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic Bile Duct Neoplasms with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. Recommended dosage is 13.5 mg orally once daily for 14 consecutive days, followed by 7 days of therapy in 21-day cycles. Continue treatment until disease progression or unacceptable toxicity occurs.

It has been granted Breakthrough designation, and Orphan Drug Designation and was given a priority review for the treatment of adults with previously treated, unresectable, locally advanced, or metastatic Bile Duct Neoplasms.

TIBSOVO (ivosidenib): Agios Pharmaceuticals/Servier Pharmaceuticals

TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test, for the treatment of adult patients with locally advanced or metastatic Bile Duct Neoplasms who have been previously treated. The recommended dosage of TIBSOVO is 500 mg taken orally once daily until disease progression or unacceptable toxicity. It has been granted orphan drug designation and fast-track Designation by the US FDA and orphan designation by the European Commission.

Note: Detailed current therapies assessment will be provided in the full report of Bile Duct Neoplasms...

Emerging Bile Duct Neoplasms Drugs

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 Bile Duct Neoplasms 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 Bile Duct Neoplasms who have no standard treatment options.
• In November 2019, TT-00420 was already granted ODD by the FDA to treat Bile Duct Neoplasms.

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 Bile Duct Neoplasms. Based on Phase Ib/II, a randomized Phase III trial is planned.

Note: Detailed emerging therapies assessment will be provided in the final report...

Bile Duct Neoplasms Market Outlook

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

This segment gives a thorough detail of Bile Duct Neoplasms 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 Bile Duct Neoplasms market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

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

Key Findings from Bile Duct Neoplasms Market Report

• Key Bile Duct Neoplasms Companies, such as TransThera Sciences, Senhwa Biosciences, Lisata Therapeutics, Relay Therapeutics, and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Bile Duct Neoplasms.
• The United States accounted for the largest Bile Duct Neoplasms market size, in comparison to EU4 (Germany, France, Italy, and Spain) and the UK, and Japan in 2023.
• Japan accounts for the second highest Bile Duct Neoplasms market size in the 7MM during the forecast period 2024–2034.
• Among EU4 and the UK, Italy had the highest Bile Duct Neoplasms market size.

Bile Duct Neoplasms Regional Analysis

The United States Bile Duct Neoplasms Market Outlook

This section provides the total Bile Duct Neoplasms market size and market size by therapies in the United States.

EU-5 Countries: Bile Duct Neoplasms Market Outlook

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

Japan Bile Duct Neoplasms Market Outlook

The total Bile Duct Neoplasms market size and market size by therapies in Japan is also mentioned.

Bile Duct Neoplasms Drugs Uptake

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

Bile Duct Neoplasms 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 Bile Duct Neoplasms market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Bile Duct Neoplasms Clinical Trial Activities

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

Bile Duct Neoplasms Pipeline Development Activities

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

Reimbursement Scenario in Bile Duct Neoplasms

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 Bile Duct Neoplasms

To keep up with the real-world scenario in current and emerging Bile Duct Neoplasms market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility. DelveInsight’s analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging treatment patterns of Bile Duct Neoplasms. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the Bile Duct Neoplasms market and the unmet needs.

Bile Duct Neoplasms Competitive Intelligence Analysis

We perform Competitive and Market Intelligence analysis of the Bile Duct Neoplasms 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 Bile Duct Neoplasms Market Report

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

Bile Duct Neoplasms Market Report Highlights

• In the coming years, the Bile Duct Neoplasms 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 companies and academics are working to assess challenges and seek opportunities that could influence Bile Duct Neoplasms R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition      
• Major Bile Duct Neoplasms companies are involved in developing therapies for Bile Duct Neoplasms. The launch of emerging therapies will significantly impact the Bile Duct Neoplasms market
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Bile Duct Neoplasms
• 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

Bile Duct Neoplasms Market Report Insights

• Bile Duct Neoplasms Patient Population
• Bile Duct Neoplasms Therapeutic Approaches
• Bile Duct Neoplasms Pipeline Analysis
• Bile Duct Neoplasms Market Size
• Bile Duct Neoplasms Market Trends
• Bile Duct Neoplasms Market Opportunities
• Impact of upcoming Bile Duct Neoplasms Therapies

Bile Duct Neoplasms Market Report Key Strengths

• 11 Years Forecast
• 7MM Coverage
• Bile Duct Neoplasms Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Bile Duct Neoplasms Market
• Bile Duct Neoplasms Drugs Uptake

Bile Duct Neoplasms Market Report Assessment

• Current Treatment Practices
• Bile Duct Neoplasms Unmet Needs
• Bile Duct Neoplasms Pipeline Product Profiles
• Bile Duct Neoplasms Market Attractiveness
• Bile Duct Neoplasms Market Drivers
• Bile Duct Neoplasms Market Barriers

Key Questions Answered in the Bile Duct Neoplasms Market Report

Bile Duct Neoplasms Market Insights

• What was the Bile Duct Neoplasms drug class share (%) distribution in 2024 and how it would look like in 2034?
• What would be the Bile Duct Neoplasms total market size as well as market size by therapies across the 7MM during the forecast period (2024-2034)?
• What are the key findings pertaining to the market across 7MM and which country will have the largest Bile Duct Neoplasms market size during the forecast period (2024-2034)?
• At what CAGR, the Bile Duct Neoplasms market is expected to grow by 7MM during the forecast period (2024-2034)?
• What would be the Bile Duct Neoplasms market outlook across the 7MM during the forecast period (2024-2034)?
• What would be the Bile Duct Neoplasms 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?

Bile Duct Neoplasms Epidemiology Insights

• What are the disease risk, burden, and regional/ethnic differences of the Bile Duct Neoplasms?
• What are the key 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 Bile Duct Neoplasms 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 Bile Duct Neoplasms 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 Bile Duct Neoplasms?
• Out of all 7MM countries, which country would have the highest prevalent population of Bile Duct Neoplasms during the forecast period (2024-2034)?
• At what CAGR the patient population is expected to grow in 7MM during the forecast period (2024-2034)?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:

• What are the current options for the Bile Duct Neoplasms treatment in addition to the approved therapies?
• What are the current treatment guidelines for the treatment of Bile Duct Neoplasms in the USA, Europe, and Japan?
• What are the Bile Duct Neoplasms 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 Bile Duct Neoplasms?
• How many therapies are in-development by each company for Bile Duct Neoplasms treatment?
• How many are emerging therapies in mid-stage, and late stage of development for Bile Duct Neoplasms treatment?
• What are the key collaborations (Industry - Industry, Industry - Academia), Mergers and acquisitions, licensing activities related to the Bile Duct Neoplasms 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 Bile Duct Neoplasms 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 Bile Duct Neoplasms?
• What are the global historical and forecasted market of Bile Duct Neoplasms?

Reasons to buy the Bile Duct Neoplasms Market Report

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