Intrahepatic Cholangiocarcinoma Market Report 2034 | AstraZeneca, Delcath Systems Inc., Jiangsu HengRui Medicine Co., Syndax Pharmaceuticals, Hutchison Medipharma Limited, Medivir, Newish Technology, Relay Therapeutics, Exelixis, Forma Therapeutics, Xenco

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

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

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Key highlights from the intrahepatic cholangiocarcinoma market report:

Intrahepatic cholangiocarcinoma, or intrahepatic bile duct cancer, is a rare cancer that arises in the bile ducts within the liver, accounting for about 10% of all cholangiocarcinoma cases. Despite its rarity, the incidence of intrahepatic bile duct cancer is projected to increase at a compound annual growth rate (CAGR) of approximately 2% from 2024 to 2034.

In 2023, the United States represented nearly 50% of the total market size for intrahepatic cholangiocarcinoma across the seven major markets (7MM). Among these countries, the age group of 80 years and older had the highest number of diagnosed cases.

Regarding mutation-specific cases, TP53 mutations were identified as the most prevalent in 2023 across the 7MM. Challenges in accessing a sufficient patient population and obtaining diagnostic samples for recurrent disease hinder effective translational research.

The current treatment landscape for cholangiocarcinoma includes complete resection, considered the gold standard, and first-line chemotherapy, both of which are associated with high rates of disease relapse.

In March 2024, the European Union approved a Phase III clinical trial for cholangiocarcinoma, and the European Medicines Agency granted Orphan Drug Designation to Tinengotinib for the treatment of biliary tract cancer. Additionally, in April 2024, Compass Therapeutics received FDA Fast Track Designation for CTX-009, in combination with paclitaxel, for patients with metastatic or locally advanced biliary tract tumors that have been previously treated.

Key players in the development of targeted therapies for cholangiocarcinoma include CTX-009 (Compass Therapeutics), Tinengotinib (TransThera Sciences), and CX-4945 (Senhwa Biosciences). Some of these therapies are entering the late stages of development, and DelveInsight analysts anticipate their market launch in the U.S. for the treatment of cholangiocarcinoma.
Intrahepatic Cholangiocarcinoma Overview

Intrahepatic cholangiocarcinoma (ICC) is a rare and aggressive form of cancer that originates in the bile ducts within the liver. It accounts for about 10-20% of all cholangiocarcinomas and is characterized by the proliferation of malignant cells in the intrahepatic bile duct epithelium.

Causes
The exact cause of ICC is not well understood, but several risk factors are associated with its development:

Chronic Liver Disease: Conditions like cirrhosis and hepatitis B or C infections.
Biliary Tract Disorders: Primary sclerosing cholangitis (PSC) and choledochal cysts.
Exposure to Chemicals: Certain industrial chemicals, such as aromatic compounds.
Genetic Factors: Some genetic syndromes and mutations may increase risk.
Age and Gender: More common in older adults and slightly more prevalent in men.
Signs and Symptoms
Symptoms of ICC can be nonspecific and may resemble those of other liver diseases. Common signs and symptoms include:

Jaundice: Yellowing of the skin and eyes due to bile duct obstruction.
Abdominal Pain: Typically in the upper right quadrant.
Weight Loss: Unintentional and often significant.
Fatigue: Generalized tiredness or weakness.
Itching: Associated with bile salt accumulation in the bloodstream.
Dark Urine and Pale Stools: Indicative of bile duct obstruction.
Diagnosis
Diagnosing ICC involves a combination of imaging studies and biopsy:

Imaging Studies:

Ultrasound: Initial imaging to detect liver abnormalities.
CT Scan: Detailed imaging to evaluate the liver and surrounding structures.
MRI: Helpful in assessing the biliary tree and liver lesions.
ERCP (Endoscopic Retrograde Cholangiopancreatography): Can help visualize bile ducts and obtain tissue samples.
Biopsy:

A tissue sample from the liver can be obtained through percutaneous, laparoscopic, or endoscopic methods for histopathological examination.
Blood Tests:

Tumor markers (like CA 19-9) and liver function tests may be conducted.
Treatment Options
Treatment for ICC depends on the stage of the disease, liver function, and overall health of the patient:

Surgical Resection:

The primary treatment for early-stage ICC is surgical removal of the tumor, which may involve partial hepatectomy or liver transplantation.
Liver Transplantation:

Considered in select cases, especially for patients with underlying liver disease.
Chemotherapy:

Often used in advanced cases or as adjuvant therapy after surgery. Common regimens may include gemcitabine and cisplatin.
Radiation Therapy:

May be utilized as palliative treatment to relieve symptoms or in conjunction with surgery.
Targeted Therapies:

Investigational drugs targeting specific genetic mutations (e.g., FGFR2 fusions) are being explored.
Clinical Trials:

Participation in clinical trials may provide access to new treatments and therapies.
Intrahepatic cholangiocarcinoma is a challenging malignancy with poor prognosis, but advancements in diagnosis and treatment options are ongoing. Early detection and a multidisciplinary approach to treatment can improve outcomes for affected patients. Regular follow-ups and monitoring are crucial for managing this condition.

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Intrahepatic Cholangiocarcinoma Market

The market for intrahepatic cholangiocarcinoma is undergoing significant transformation, driven by promising advancements in targeted and personalized therapies. Despite the challenges posed by late diagnoses and the rarity of the disease, the development of drugs aimed at FGFR2 and IDH-1 mutations offers renewed hope. Increased research efforts, enhanced molecular diagnostics, and the rise of precision medicine are contributing to market growth. However, high treatment costs and difficulties in recruiting participants for clinical trials remain ongoing challenges. The future outlook is optimistic, with expectations for expanded treatment options and improved patient outcomes as new therapies gain approval and become available.

Key Findings
PEMAZYRE is projected to lead the market for FGFR-targeted therapies in bile tract cancer, with an anticipated market share of approximately $285 million by 2034, thanks to its first-mover advantage and Incyte's plans for frontline treatment.

Drugs targeting HER2 mutations in biliary tract cancer, including ENHERTU, zanidatamab, and tucatinib in combination with HERCEPTIN, are expected to collectively generate around $60 million in sales across the seven major markets (7MM) by 2034.

The approval of KEYTRUDA in combination with chemotherapy for biliary tract cancer represents a significant advancement, enhancing market competition. The differing efficacy profiles and patent timelines of KEYTRUDA and IMFINZI could influence their market share and long-term treatment strategies.

Real-world data indicates shifting treatment patterns and survival outcomes for biliary tract cancer, highlighting variations in regimen use across different lines of therapy. Challenges such as low overall survival rates, high mortality, and factors like age and disease stage complicate treatment decisions and impact patient outcomes.


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Intrahepatic Cholangiocarcinoma Epidemiology

In 2023, the United States represented approximately 30% of the total incident cases of cholangiocarcinoma across the seven major markets (7MM). In Japan, there were around 6,400 reported cases of intrahepatic cholangiocarcinoma in the same year. Among mutation-specific cases of intrahepatic cholangiocarcinoma in the U.S., TP53 mutations were the most common, followed by KRAS mutations.

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Intrahepatic Cholangiocarcinoma Drugs Uptake

This section focuses on the uptake rate of the potential Intrahepatic Cholangiocarcinoma drugs recently launched in the Intrahepatic Cholangiocarcinoma market or expected to be launched in 2020-2034. The analysis covers the Intrahepatic Cholangiocarcinoma market uptake by drugs, patient uptake by therapies, and sales of each drug.

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

Intrahepatic Cholangiocarcinoma Emerging Drugs
Derazantinib: Basilea Pharmaceutica
Derazantinib is an orally administered small molecule inhibitor of the fibroblast growth factor receptor (FGFR) family of kinases. Derazantinib is currently in a registrational phase 2 study inIntrahepatic cholangiocarcinoma (iCCA). In January 2020, Basilea reported results from an interim analysis from this study. The efficacy results were encouraging and the analysis also confirmed the safety profile and tolerability of derazantinib observed in previous clinical studies.
Durvalumab: AstraZeneca
Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment.
Intrahepatic Cholangiocarcinoma Pipeline Development Activities

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

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Intrahepatic Cholangiocarcinoma Therapeutics Assessment

Major pharma companies such as AstraZeneca, Delcath Systems Inc., Jiangsu HengRui Medicine Co., Syndax Pharmaceuticals, Hutchison Medipharma Limited, Medivir, Newish Technology (Beijing) Co., Relay Therapeutics, Exelixis, Forma Therapeutics, Xencor, Zymeworks, RedHill Biopharma Limited, Genoscience Pharma, Kinnate Biopharma, Taiho Oncology, Sirtex Medical, and others are working proactively in the Intrahepatic Cholangiocarcinoma Therapeutics market to develop novel therapies which will drive the Intrahepatic Cholangiocarcinoma treatment markets in the upcoming years.

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Intrahepatic Cholangiocarcinoma Report Key Insights

1. Intrahepatic Cholangiocarcinoma Patient Population
2. Intrahepatic Cholangiocarcinoma Market Size and Trends
3. Key Cross Competition in the Intrahepatic Cholangiocarcinoma Market
4. Intrahepatic Cholangiocarcinoma Market Dynamics (Key Drivers and Barriers)
5. Intrahepatic Cholangiocarcinoma Market Opportunities
6. Intrahepatic Cholangiocarcinoma Therapeutic Approaches
7. Intrahepatic Cholangiocarcinoma Pipeline Analysis
8. Intrahepatic Cholangiocarcinoma Current Treatment Practices/Algorithm
9. Impact of Emerging Therapies on the Intrahepatic Cholangiocarcinoma Market

Table of Contents

1. Key Insights
2. Executive Summary
3. Intrahepatic Cholangiocarcinoma Competitive Intelligence Analysis
4. Intrahepatic Cholangiocarcinoma Market Overview at a Glance
5. Intrahepatic Cholangiocarcinoma Disease Background and Overview
6. Intrahepatic Cholangiocarcinoma Patient Journey
7. Intrahepatic Cholangiocarcinoma Epidemiology and Patient Population
8. Intrahepatic Cholangiocarcinoma Treatment Algorithm, Current Treatment, and Medical Practices
9. Intrahepatic Cholangiocarcinoma Unmet Needs
10. Key Endpoints of Intrahepatic Cholangiocarcinoma Treatment
11. Intrahepatic Cholangiocarcinoma Marketed Products
12. Intrahepatic Cholangiocarcinoma Emerging Therapies
13. Intrahepatic Cholangiocarcinoma Seven Major Market Analysis
14. Attribute Analysis
15. Intrahepatic Cholangiocarcinoma Market Outlook (7 major markets)
16. Intrahepatic Cholangiocarcinoma Access and Reimbursement Overview
17. KOL Views on the Intrahepatic Cholangiocarcinoma Market
18. Intrahepatic Cholangiocarcinoma Market Drivers
19. Intrahepatic Cholangiocarcinoma Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer

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