Cholangiocarcinoma Market Insights 2034: Medication, EMA, PDMA, FDA Approvals, Clinical Trials, Treatment Market, Epidemiology, NICE Approvals, Therapies, Companies by DelveInsight

The cholangiocarcinoma market is driven by chemotherapy dominance, with the US leading in size. In 2023, ~45,000 cases occurred in the 7MM, 45% intrahepatic, mainly in those 80+. TP53 & KRAS mutations are common. ~80% receive adjuvant therapy. Key drugs include PEMAZYRE, TIBSOVO & LYTGOBI. Senhwa's CX-4945 may gain future share. Biosyngen's BST02 got FDA FTD in 2024. With active pipelines, the market outlook through 2034 is positive amid strong pharma interest.
(Albany, USA) 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, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan. The Cholangiocarcinoma market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Cholangiocarcinoma market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Cholangiocarcinoma treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Cholangiocarcinoma market.

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Some facts of the Cholangiocarcinoma Market Report are:

* According to DelveInsight, Cholangiocarcinoma market size is expected to grow at a decent CAGR by 2034.
* In 2021, the total Cholangiocarcinoma market size was USD 786.1 million which is expected to rise during the study period (2020-2034).
* Leading Cholangiocarcinoma companies working in the market are AstraZeneca, Decalth Systems, Power Life Sciences, Genfit, Servier Affaires Medicales, Basilea Pharmaceutica, Taiho Oncology, Eisai Pharmaceuticals, TransThera Sciences, Incyte Corporation, Roche, Agios Pharmaceuticals, Servier Pharmaceuticals, and Others.
* Key Cholangiocarcinoma Therapies expected to launch in the market are PEMAZYRE (pemigatinib), TIBSOVO (ivosidenib), LYTGOBI (futibatinib), and others.
* In May 2025, Tango Therapeutics Inc. announced a study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 225 participants.
* In April 2025, Servier (Servier Affaires Medicales) announced an Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
* In February 2025, Eisai Inc. announced results of a Multicenter, Open-Label, Phase 2 Trial of E7090 in Subjects With Unresectable Advanced or Metastatic Cholangiocarcinoma With FGFR 2 Gene Fusion
* In January 2025, Servier announced results of a Phase 2, Open-label, Multicenter Study of Orally Administered Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
* In December 2024, Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company revolutionizing drug discovery through advanced computational and experimental technologies, and Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. focused on improving treatment outcomes for patients with limited therapeutic options, announced today an exclusive global licensing agreement for lirafugratinib (RLY-4008). Lirafugratinib is a selective oral small molecule inhibitor of fibroblast growth factor receptor 2 (FGFR2), being developed for patients with FGFR2-driven cholangiocarcinoma (CCA) and other FGFR2-altered solid tumors. The partnership follows Relay's recent positive FDA interaction and previously reported promising data in cholangiocarcinoma and other solid tumors.
* In September 2024, Lisata Therapeutics, Inc. (Nasdaq: LSTA), a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and other serious diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to certepetide for the treatment of cholangiocarcinoma.
* On March 2024, Genfit announced an open-label, multicenter Phase 1b/2a study to evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of GNS561 in combination with trametinib in Advanced KRAS Mutated Cholangiocarcinoma after failure of standard-of-care first line therapy.
* On Feb 2024, TransThera Sciences (Nanjing), Inc announced a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma
* On March 2023, Power Life Sciences Inc announced a Clinical Study Experiences of Cholangiocarcinoma Patients to Identify Trial Attributes Affecting Completion Rates for Specific Demographic Groups.

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Cholangiocarcinoma Overview

Cholangiocarcinoma, also known as bile duct cancer, is a rare but aggressive form of cancer originating in the bile ducts, which transport bile from the liver to the small intestine. This cancer is classified into three types based on its location: intrahepatic (within the liver), perihilar (at the liver's hilum), and distal (further down the bile duct). The majority of cholangiocarcinomas are adenocarcinomas, which arise from the mucus glands in the bile duct.

Risk factors for cholangiocarcinoma include primary sclerosing cholangitis, chronic liver disease, bile duct cysts, liver flukes, and certain genetic conditions. Symptoms often appear late and may include jaundice, abdominal pain, weight loss, and itching, making early detection challenging.

Diagnosis typically involves imaging studies such as MRI, CT scans, and cholangiography, along with biopsy and blood tests. Treatment options vary depending on the cancer's stage and location but may include surgery, radiation therapy, chemotherapy, and targeted therapies. Liver transplantation is an option for some patients with early-stage disease.

Despite advances in treatment, the prognosis for cholangiocarcinoma remains poor, emphasizing the need for ongoing research and improved therapeutic strategies. Early diagnosis and multidisciplinary care are crucial for enhancing patient outcomes.

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Cholangiocarcinoma Market

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

The cholangiocarcinoma market is driven by rising incidence in the aging population, growing awareness, advances in diagnostics, and the development of targeted therapies addressing specific mutations like FGFR, IDH1, and others. The approval of drugs such as PEMAZYRE, TIBSOVO, and LYTGOBI reflects this momentum. However, market growth faces barriers including late-stage diagnosis limiting surgical eligibility, high treatment costs, modest survival benefits of current therapies, and the complex tumor biology that hinders drug development.

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

Cholangiocarcinoma Epidemiology

The Cholangiocarcinoma epidemiology section provides insights into the historical and current Cholangiocarcinoma patient pool and forecasted trends for seven individual 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 Cholangiocarcinoma market report also provides the diagnosed patient pool, trends, and assumptions.

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Cholangiocarcinoma Drugs Uptake

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

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 Cholangiocarcinoma market share and size, which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Cholangiocarcinoma Therapies and Key Companies

* PEMAZYRE (pemigatinib): Incyte
* TIBSOVO (ivosidenib): Agios Pharmaceuticals/Servier Pharmaceutical
* LYTGOBI (futibatinib): Taiho Pharma
* Imfinzi (durvalumab): Astrazeneca
* Melphalan: Decalth Systems
* Derazantinib: Basilea Pharmaceuticals
* Futibatinib (TAS-120): Taiho Oncology
* E7090: Eisai Pharmaceuticals
* TT-0040: TransThera Sciences (Nanjing), Inc.

Cholangiocarcinoma Pipeline Development Activities

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

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Cholangiocarcinoma Therapeutics Assessment

Major key companies are working proactively in the Cholangiocarcinoma Therapeutics market to develop novel therapies which will drive the Cholangiocarcinoma treatment markets in the upcoming years are AstraZeneca (LSE: AZN), Decalth Systems (Private), Power Life Sciences (Private), Genfit (EPA: GNFT), Servier Affaires Medicales (Private), Basilea Pharmaceutica (SWX: BSLN), Taiho Oncology (Private), Eisai Pharmaceuticals (TYO: 4523), TransThera Sciences (Private), Incyte Corporation (NASDAQ: INCY), Roche (SWX: ROG), Agios Pharmaceuticals (NASDAQ: AGIO), Servier Pharmaceuticals (Private), and others.

Cholangiocarcinoma Report Key Insights

1. Cholangiocarcinoma Patient Population

2. Cholangiocarcinoma Market Size and Trends

3. Key Cross Competition in the Cholangiocarcinoma Market

4. Cholangiocarcinoma Market Dynamics (Key Drivers and Barriers)

5. Cholangiocarcinoma Market Opportunities

6. Cholangiocarcinoma Therapeutic Approaches

7. Cholangiocarcinoma Pipeline Analysis

8. Cholangiocarcinoma Current Treatment Practices/Algorithm

9. Impact of Emerging Therapies on the Cholangiocarcinoma Market

Table of Contents

1. Key Insights

2. Executive Summary

3. Cholangiocarcinoma Competitive Intelligence Analysis

4. Cholangiocarcinoma Market Overview at a Glance

5. Cholangiocarcinoma Disease Background and Overview

6. Cholangiocarcinoma Patient Journey

7. Cholangiocarcinoma Epidemiology and Patient Population

8. Cholangiocarcinoma Treatment Algorithm, Current Treatment, and Medical Practices

9. Cholangiocarcinoma Unmet Needs

10. Key Endpoints of Cholangiocarcinoma Treatment

11. Cholangiocarcinoma Marketed Products

12. Cholangiocarcinoma Emerging Therapies

13. Cholangiocarcinoma Seven Major Market Analysis

14. Attribute Analysis

15. Cholangiocarcinoma Market Outlook (7 major markets)

16. Cholangiocarcinoma Access and Reimbursement Overview

17. KOL Views on the Cholangiocarcinoma Market

18. Cholangiocarcinoma Market Drivers

19. Cholangiocarcinoma Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

About DelveInsight

DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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