Primary Sclerosing Cholangitis Treatment Market Size in the 7MM is expected to grow at a significant CAGR by 2034, estimates DelveInsight

DelveInsight's "Primary Sclerosing Cholangitis Market Insights, Epidemiology, and Market Forecast - 2034" report deliver an in-depth understanding of the Primary Sclerosing Cholangitis, historical and forecasted epidemiology as well as the Primary Sclerosing Cholangitis therapeutics market trends in the United States, EU4 and the UK (Germany, France, Italy, Spain) and the United Kingdom, and Japan.

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Key Takeaways from the Primary Sclerosing Cholangitis Market Report
• On 30 October 2025, Ipsen conducted a study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC). PSC is a rare disease of the liver that leads to injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in the liver, which then causes further damage, and leads to disease progression. This study will compare elafibranor to a placebo, a treatment. The main objective of the trial will be to study the safety and side effects of the study drug. The trial will also study the study drug's effects on blood tests and other tests related to PSC disease activity.
• On 24 October 2025, LISCure Biosciences announced a study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis. This is phase 2, randomized, double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of LB-P8 in adult patients with primary sclerosing cholangitis (PSC).
• The highest diagnosed Primary Sclerosing Cholangitis prevalence were accounted by the US in 2023 (~31 thousand), which are expected to show a rise in the future.
• Among the European countries, Germany had the highest diagnosed Primary Sclerosing Cholangitis prevalence with ~5 thousand cases, followed by the UK in 2023. On the other hand, Spain had the lowest prevalent population (~0.1 thousand cases).
• Japan had ~3 thousand total diagnosed prevalent cases of Primary Sclerosing Cholangitis in 2023, accounting for approximately 5% in 7MM.
• In 2023, in the US, the gender-specific diagnosed Primary Sclerosing Cholangitis prevalence were highest for male (~21 thousand) and female (~10 thousand).
• In 2023, 62% of diagnosed Primary Sclerosing Cholangitis prevalence in Japan were asymptomatic, while 38% were symptomatic.
• The major comorbidity associated with Primary Sclerosing Cholangitis is IBD. As per our estimates, in 2023, ~23 thousand cases belonged to IBD in the US, and is expected to increase during the forecast period.
• The leading Primary Sclerosing Cholangitis Companies such as Gilead Sciences, Phenex Pharmaceuticals, HighTide Therapeutics, Dr. Falk Pharma, Mirum Pharmaceuticals, Pliant Therapeutics, NGM Biopharmaceuticals, CymaBay Therapeutics, Chemomab Therapeutics, and others.
• Promising Primary Sclerosing Cholangitis Therapies such as Ritivixibat, HK-660S, Cenicriviroc 150 mg, Elafibranor 80 mg, BTT1023, PLN-74809, Curcumin, Volixibat and others.

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Primary Sclerosing Cholangitis Epidemiology Segmentation in the 7MM
• Diagnosed Primary Sclerosing Cholangitis Prevalent Cases
• Gender-specific Diagnosed Primary Sclerosing Cholangitis Prevalent Cases
• Symptom-specific Diagnosed Primary Sclerosing Cholangitis Prevalent cases
• Comorbidity-specific Diagnosed Primary Sclerosing Cholangitis Prevalent cases

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Primary Sclerosing Cholangitis Emerging Drugs
• HTD 1801: HighTide Biopharma
HTD1801 is a first-in-class new molecular entity and is an ionic salt of two active moieties - berberine and ursodeoxycholic acid. It is administered orally, acts as a lipid modulator, and significantly reduces liver fat. It has completed a Phase II trial to treat PSC and is currently under Phase II trials for other chronic disorders. The drug has received ODD and FTD. In June 2021, HighTide Therapeutics Inc. announced the topline results of the study of HTD1801 in Primary Sclerosing Cholangitis were presented at the International Liver Congress 2021.

• PLN-74809 (bexotegrast): Pliant Therapeutics, Inc.
PLN-74809 is an oral, small molecule, a dual-selective inhibitor of αvβ6 and αvβ1 being developed to treat PSC. While present at very low levels in healthy tissues, these integrins are upregulated in the lungs of IPF patients and the bile ducts of PSC patients where they activate TGF-β, a key driver of the fibrotic process. Blocking these integrins is designed to stop TGF-β activation, potentially halting the growth of scar tissue. In July 2022, Pliant Therapeutics recieved received FTD from the US FDA for the Primary Sclerosing Cholangitis treatment market.

Primary Sclerosing Cholangitis Market Outlook
Primary Sclerosing Cholangitis market is multimodality based and requires a specialist team with varying skills. The absence of definitive evidence implies that practice is based on expert opinion and local expertise. PSC can be unpredictable; therefore, periodic follow-up in specialist centers is often helpful for patients, as is involvement with support groups. Despite clinical trials of numerous pharmacotherapies over several decades, safe and effective medical therapy remains to be established. Liver transplantation is an option for selected patients with severe complications of PSC, and its outcomes are generally favorable. Treatment is directed toward the specific symptoms that are apparent in each individual and at slowing the progression of the disorder.

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

Scope of the Primary Sclerosing Cholangitis Market Report
• Coverage- 7MM
• Study Period- 2020-2034
• Primary Sclerosing Cholangitis Companies- Gilead Sciences, Phenex Pharmaceuticals, HighTide Therapeutics, Dr. Falk Pharma, Mirum Pharmaceuticals, Pliant Therapeutics, NGM Biopharmaceuticals, CymaBay Therapeutics, Chemomab Therapeutics, and others.
• Primary Sclerosing Cholangitis Therapies- Ritivixibat, HK-660S, Cenicriviroc 150 mg, Elafibranor 80 mg, BTT1023, PLN-74809, Curcumin, Volixibat and others.
• Primary Sclerosing Cholangitis Market Dynamics: Primary Sclerosing Cholangitis Market Drivers and Barriers
• Primary Sclerosing Cholangitis Market Access and Reimbursement, Unmet Needs and Future Perspectives

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Table of Contents
1. Key Insights
2. Primary Sclerosing Cholangitis Market Report Introduction
3. Primary Sclerosing Cholangitis Market Overview at a Glance
4. Primary Sclerosing Cholangitis Epidemiology and Market Forecast Methodology
5. Key Events
6. Primary Sclerosing Cholangitis Executive Summary
7. Disease Background and Overview of Primary Sclerosing Cholangitis
8. Primary Sclerosing Cholangitis Epidemiology and Patient Population
9. Primary Sclerosing Cholangitis Patient Journey
10. Primary Sclerosing Cholangitis Emerging Drugs
11. Primary Sclerosing Cholangitis Market Analysis
12. Key Opinion Leaders' Views
13. SWOT Analysis
14. Unmet Needs
15. Reimbursement and Market Access
16. Appendix
17. Bibliography
18. Report Methodology
19. About DelveInsight

About Us

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This release was published on openPR.