Cholangiocarcinoma Market

• The Cholangiocarcinoma 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 cholangiocarcinoma.
• The United States accounted for the largest Chloangiocarcinoma market size, in comparison to EU4 (Germany, France, Italy, and Spain) and the UK, and Japan in 2023.
• Cholangiocarcinomas 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 cholangiocarcinoma incidence across the 7MM was around 45,000 in 2023, out of which ~45% cases were intrahepatic.
• Cholangiocarcinoma are primarily diagnosed at the old aged and are more prevalent in population aged 80 and above. Further, the mutation-specific cases of cholangiocarcinoma were highest in TP53 mutations, followed by KRAS mutations in the 7MM.
• Currently, an estimated 80% of the Chloangiocarcinoma patient pool receive treatment in adjuvant settings. The main options for the treatment of cholangiocarcinoma 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 cholangiocarcinoma.
• There are now several approved treatments for those with cholangiocarcinoma 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.
• Cholangiocarcinoma has an active pipeline with key pharmaceutical Chloangiocarcinoma companies like TransThera Sciences, Senhwa Biosciences, Lisata Therapeutics, Relay Therapeutics, and others working on improving the Cholangiocarcinoma treatment market landscape of the indication. Among all emerging drugs, Senhwa’s CX-4945 is likely to capture significant share of the Cholangiocarcinoma market in the upcoming years.
• Even though it is too soon to comment on the promising candidate to enter the Cholangiocarcinoma 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 cholangiocarcinoma in the coming years.

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DelveInsight's “Cholangiocarcinoma Market Insights, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of Cholangiocarcinoma, historical and forecasted epidemiology as well as the Cholangiocarcinoma market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Cholangiocarcinoma treatment market market report provides real-world prescription pattern analysis, emerging drugs, Cholangiocarcinoma market share of individual therapies, and historical and forecasted 7MM Cholangiocarcinoma market size from 2020 to 2034. The report also covers current Cholangiocarcinoma treatment market practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Cholangiocarcinoma Treatment Market

Cholangiocarcinoma (CCA), in essence, is an umbrella term that denotes cancer arising from the biliary tree. Multiple subtypes of cholangiocarcinoma exist depending on their anatomical origin: intrahepatic Cholangiocarcinoma (iCCA), perihilar Cholangiocarcinoma (pCCA), and distal extrahepatic Cholangiocarcinoma (dCCA). Perihilar CCA and distal CCA collectively are called extrahepatic cholangiocarcinoma (eCCA). One of the frequent symptoms of cholangiocarcinoma is jaundice. This happens because the bile duct or ducts become blocked, preventing the normal flow of bile from the liver to the intestines. To allow the bile to flow again, a stent (usually a metal stent) will be inserted into the bile duct to hold it open. The Cholangiocarcinoma report provides an overview of Cholangiocarcinoma pathophysiology, diagnostic approaches, and detailed treatment algorithm along with a real-world scenario of a patient’s journey beginning from the first symptom, the time taken for diagnosis to the entire treatment process.

Cholangiocarcinoma Treatment

Chloangiocarcinoma Treatment options for the early-stage disease include surgery, followed by adjuvant chemotherapy. For patients with locally advanced disease, loco-regional therapies (e.g., trans-arterial chemoembolization [TACE] and external beam radiation therapy [EBRT]) may be considered. For patients with locally advanced and metastatic disease, the combination of gemcitabine and cisplatin has been shown to improve survival. Next-generation sequencing has identified somatic mutations in oncogenes (i.e., KRAS), tumor suppressors (i.e., TP53 and SMAD4), and chromatin-modifying genes (i.e., ARID1A, BAP1, and PBMR1) in cholangiocarcinomas. Genetic alterations in the IDH1/2, BAP1, and FGFR2 are mostly restricted to intrahepatic cholangiocarcinomas (iCCAs), whereas mutations in KRAS and SMAD4 are more commonly observed in extrahepatic cholangiocarcinomas (eCCAs).

Cholangiocarcinoma Epidemiology

The Cholangiocarcinoma epidemiology chapter in the report provides historical as well as forecasted in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The Cholangiocarcinoma epidemiology is segmented with detailed insights into Incident Cases of Cholangiocarcinoma, Incident Cases of Cholangiocarcinoma by tumor location, mutation-specific cases, age-specific cases, stage-specific cases, total treated cases. According to the findings, Cholangiocarcinoma 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 cholangiocarcinoma in the United States were ~14,000 in 2023.
• In the United States, out of all the cholangiocarcinoma cases, intrahepatic cancer accounted were around 6000.
• It is observed that  cholangiocarcinoma occurs majorly in the age group of 70–79 years.

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Cholangiocarcinoma Drug Chapters

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

Marketed Cholangiocarcinoma Drugs

• PEMAZYRE (pemigatinib): Incyte

PEMAZYRE is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma 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 cholangiocarcinoma.

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 cholangiocarcinoma 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 Cholangiocarcinoma...

Emerging Cholangiocarcinoma 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 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.

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

Cholangiocarcinoma Market Outlook

Key Chloangiocarcinoma 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 Cholangiocarcinoma.

• The United States accounted for the largest Chloangiocarcinoma market size, in comparison to EU4 (Germany, France, Italy, and Spain) and the UK, and Japan in 2023.
• Japan accounts for the second highest Chloangiocarcinoma market size in the 7MM during the forecast period 2024–2034.
• Among EU4 and the UK, Italy had the highest Chloangiocarcinoma market size.

Cholangiocarcinoma Drugs Uptake

This section focuses on the uptake rate of potential Chloangiocarcinoma drugs expected to be launched in the market during 2024–2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key Chloangiocarcinoma companies evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Further detailed analysis of emerging therapies drug uptake in the report...

Cholangiocarcinoma Pipeline Development Activities

The Chloangiocarcinoma treatment market report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key Chloangiocarcinoma companies involved in developing targeted therapeutics.

Pipeline Development Activities

The Chloangiocarcinoma drugs market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging Cholangiocarcinoma therapies.

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KOL Views on Cholangiocarcinoma 

To keep up with the real-world scenario in current and emerging Cholangiocarcinoma 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 Cholangiocarcinoma. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the Cholangiocarcinoma market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival. Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Chloangiocarcinoma Market Access and Reimbursement

PEMAZYRE is the first FDA-approved prescription medicine that is used to treat adults with bile duct cancer (cholangiocarcinoma) that has spread or cannot be removed by surgery who have already received a previous treatment and whose tumor has a certain type of abnormal FGFR2 gene. At IncyteCARES for PEMAZYRE, the team can help the patient understand one’s insurance coverage, explore financial assistance options, and provide as-needed support. The Chloangiocarcinoma therapeutics market report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Cholangiocarcinoma Market Report Scope

• The Chloangiocarcinoma therapeutics market report covers a segment of key events, an executive summary, descriptive overview, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the Chloangiocarcinoma epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country specific Chloangiocarcinoma treatment guidelines.
• Additionally, an all-inclusive account of both the current and Chloangiocarcinoma emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current Chloangiocarcinoma treatment market landscape.
• A detailed review of the Cholangiocarcinoma treatment market, historical and forecasted Chloangiocarcinoma market size, Chloangiocarcinoma market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The Cholangiocarcinoma therapeutics market report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM Cholangiocarcinoma therapeutics market.

Cholangiocarcinoma Market Report Insights

• Cholangiocarcinoma Patient Population
• Cholangiocarcinoma Therapeutic Approaches
• Cholangiocarcinoma Pipeline Analysis
• Cholangiocarcinoma Market Size
• Cholangiocarcinoma Market Trends
• Existing and future Chloangiocarcinoma Drugs Market Opportunity

Cholangiocarcinoma Market Report Key Strengths

• 10 Years Cholangiocarcinoma Market Forecast
• 7MM Coverage
• Cholangiocarcinoma Epidemiology Segmentation
• Inclusion of Country specific treatment guidelines
• KOL’s feedback on approved and emerging therapies
• Key Cross Competition
• Conjoint analysis
• Cholangiocarcinoma Drugs Uptake
• Key Cholangiocarcinoma Market Forecast Assumptions

Cholangiocarcinoma Market Report Assessment

• Current Cholangiocarcinoma Treatment Market Practices
• Cholangiocarcinoma Unmet Needs
• Cholangiocarcinoma Pipeline Product Profiles
• Cholangiocarcinoma Treatment Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)
• Cholangiocarcinoma Market Drivers
• Cholangiocarcinoma Market Barriers

FAQs

• What is the growth rate of the 7MM Cholangiocarcinoma treatment market?
• What was the Cholangiocarcinoma market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
• Is there any unexplored patient setting that can open the window for growth in the future?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the Cholangiocarcinoma market dynamics and subsequent analysis of the associated trends? Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
• What are the current and emerging options for the treatment of Cholangiocarcinoma?
• How many Chloangiocarcinoma companies are developing therapies for the Cholangiocarcinoma treatment?
• What are the recent novel therapies, targets, Cholangiocarcinoma mechanisms of action, and technologies developed to overcome the limitations of existing Cholangiocarcinoma therapies?
• Patient/physician acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved Cholangiocarcinoma therapies?

Reasons to Buy Cholangiocarcinoma Therapeutics Market Report

• The Chloangiocarcinoma treatment market report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Cholangiocarcinoma Drugs Market.
• Insights on patient burden/ Chloangiocarcinoma prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• Understand the existing Cholangiocarcinoma market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming Cholangiocarcinoma companies in the Chloangiocarcinoma therapeutics market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing Chloangiocarcinoma therapeutics market so that the upcoming Cholangiocarcinoma companies can strengthen their development and launch strategy.

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