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DelveInsight, a leading market research firm, announces the release of its latest report, “DelveInsight’s Primary Sclerosing Cholangitis Market Insights, Epidemiology, and Market Forecast 2034”. This comprehensive report provides an in-depth understanding of Primary Sclerosing Cholangitis, including historical and forecasted epidemiology, market trends, and treatment scenarios across the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.

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Key Takeaways from the Primary Sclerosing Cholangitis Market

• The market size for Primary Sclerosing Cholangitis in the leading markets is expected to grow USD 80 million by 2034.

• The United States accounted for the highest Primary Sclerosing Cholangitis treatment market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries, the United Kingdom, and Japan.

• The US recorded the highest diagnosed Primary Sclerosing Cholangitis prevalence in 2023, with approximately 31 thousand cases, and is expected to grow further.

• Among European countries, Germany had the highest prevalence (~5 thousand cases), followed by the UK, while Spain reported the lowest prevalence (~0.1 thousand cases).

• Japan accounted for around 3 thousand diagnosed prevalent cases in 2023, representing nearly 5% of the total 7MM burden.

• In the US, males accounted for the majority of diagnosed cases (~21 thousand) compared to females (~10 thousand) in 2023.

• In Japan, 62% of diagnosed cases were asymptomatic, while 38% were symptomatic in 2023.

• Inflammatory Bowel Disease (IBD) remains the leading comorbidity, with approximately 23 thousand associated cases in the US in 2023, a figure expected to increase over the forecast period.

• Leading Primary Sclerosing Cholangitis companies developing emerging therapies, such as Gilead Sciences, Phenex Pharmaceuticals, HighTide Therapeutics, Dr. Falk Pharma, Mirum Pharmaceuticals, Pliant Therapeutics, Inc, NGM Biopharmaceuticals, CymaBay Therapeutics, Chemomab Therapeutics, and others, are developing new therapy for Primary Sclerosing Cholangitis that can be available in the Primary Sclerosing Cholangitis market in the coming years.

• The promising Primary Sclerosing Cholangitis therapies in clinical trials include HTD 1801, PLN-74809 (bexotegrast), and others.

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Key Factors Driving the Primary Sclerosing Cholangitis Market

Primary Sclerosing Cholangitis Market Drivers

• Rising diagnosed prevalence of Primary Sclerosing Cholangitis across major markets.

• Growing awareness and improvements in early disease diagnosis.

• Strong pipeline development with emerging therapies such as bexotegrast and HTD1801.

• Increased R&D investments and clinical trial activity by leading pharmaceutical companies.

Primary Sclerosing Cholangitis Market Landscape

• Primary Sclerosing Cholangitis treatment primarily focuses on symptom management and slowing disease progression through ursodeoxycholic acid, endoscopic interventions, immunosuppressants, antibiotics, and antipruritic therapies. Liver transplantation remains the only curative option for advanced disease. With current treatments offering limited long-term benefits, emerging therapies such as HTD1801 hold promise for addressing significant unmet medical needs.

Primary Sclerosing Cholangitis Competitive Landscape

• HTD 1801: HighTide Biopharma

HTD1801 is a first-in-class oral therapeutic composed of two active components, berberine and ursodeoxycholic acid, combined as a novel ionic salt. The drug functions as a lipid modulator and has demonstrated the ability to significantly reduce liver fat accumulation. HTD1801 has completed a Phase II clinical trial in Primary Sclerosing Cholangitis (PSC) and continues to be evaluated in Phase II studies for additional chronic diseases. It has been granted both Orphan Drug Designation (ODD) and Fast Track Designation (FTD). In June 2021, HighTide Therapeutics presented topline results from its PSC study of HTD1801 at the International Liver Congress 2021.

• PLN-74809 (bexotegrast): Pliant Therapeutics, Inc.

PLN-74809 (Bexotegrast) is an oral dual-selective αvβ6/αvβ1 integrin inhibitor being developed for Primary Sclerosing Cholangitis (PSC). By blocking integrin-mediated activation of TGF-β, a key driver of fibrosis, the therapy aims to slow or prevent scar tissue formation in affected bile ducts. In July 2022, Pliant Therapeutics received FDA Fast Track Designation (FTD) for PLN-74809 in PSC.

Recent Developments in the Primary Sclerosing Cholangitis Market

• In May 2026, Ipsen announced result of A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis

What is Primary Sclerosing Cholangitis?

Primary Sclerosing Cholangitis (PSC) is a rare, chronic liver disease characterized by inflammation and scarring of the bile ducts inside and outside the liver. Over time, the bile ducts become narrowed or blocked, leading to bile buildup, liver damage, and potentially liver failure. PSC is often associated with inflammatory bowel diseases, particularly ulcerative colitis. Common symptoms include fatigue, itching, abdominal discomfort, and jaundice, although some patients remain asymptomatic for years. Currently, there is no cure for PSC, and treatment focuses on managing symptoms, preventing complications, and, in advanced cases, liver transplantation.

Download the report to understand which factors are driving Primary Sclerosing Cholangitis Epidemiology Trends @ Primary Sclerosing Cholangitis Prevalence

Primary Sclerosing Cholangitis Epidemiology Segmentation

The Primary Sclerosing Cholangitis epidemiology section provides insights into the historical and current Primary Sclerosing Cholangitis patient pool and forecasted trends for the leading markets. The Primary Sclerosing Cholangitis market report proffers epidemiological analysis for the study period 2020–2034 in the leading markets, segmented into:

• Diagnosed PSC Prevalence Across the 7MM

• Gender-Based PSC Prevalence in the 7MM

• Symptom-Specific PSC Patient Distribution in the 7MM

• Comorbidity-Associated PSC Cases in the 7MM

Download the sample page to understand which factors are driving Primary Sclerosing Cholangitis Epidemiology Trends @ Primary Sclerosing Cholangitis Prevalence

Scope of the Primary Sclerosing Cholangitis Market Report

• Coverage- 7MM

• Study Period- 2020-2034

• Forecast Period- 2024-2034

• Primary Sclerosing Cholangitis companies: Gilead Sciences, Phenex Pharmaceuticals, HighTide Therapeutics, Dr. Falk Pharma, Mirum Pharmaceuticals, Pliant Therapeutics, Inc, NGM Biopharmaceuticals, CymaBay Therapeutics, Chemomab Therapeutics, and others.

• Therapeutic Assessment: Primary Sclerosing Cholangitis current marketed and emerging therapies

• Primary Sclerosing Cholangitis Market Dynamics: Key Market Forecast Assumptions of Emerging Primary Sclerosing Cholangitis Drugs and Market Outlook

• Competitive Intelligence Analysis: SWOT analysis and Market entry strategies

• Unmet Needs, KOL’s views, Analyst’s views, Primary Sclerosing Cholangitis Market Access and Reimbursement

Table of Contents

1. Primary Sclerosing Cholangitis Market Key Insights

2. Primary Sclerosing Cholangitis Market Report Introduction

3. Primary Sclerosing Cholangitis Market Overview at a Glance

4. Primary Sclerosing Cholangitis Market Executive Summary

5. Disease Background and Overview

6. Primary Sclerosing Cholangitis Treatment and Management

7. Primary Sclerosing Cholangitis Epidemiology and Patient Population

8. Patient Journey

9. Primary Sclerosing Cholangitis Marketed Drugs

10. Primary Sclerosing Cholangitis Emerging Drugs

11. Seven Major Primary Sclerosing Cholangitis Market Analysis

12. Primary Sclerosing Cholangitis Market Outlook

13. Potential of Current and Emerging Therapies

14. KOL Views

15. Unmet Needs

16. SWOT Analysis

17. Appendix

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

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