Primary Sclerosing Cholangitis Market - A Global and Regional Analysis: Focus on Country and Regional Analysis - Analysis and Forecast, 2025-2035
Description
Market Overview
The global primary sclerosing cholangitis market is expected to witness significant growth from 2023 to 2035. Primary sclerosing cholangitis is a chronic liver disease characterized by inflammation and scarring of the bile ducts, which can ultimately lead to liver cirrhosis and liver failure. The increasing prevalence of primary sclerosing cholangitis, combined with rising awareness among healthcare professionals and patients, is contributing to the market's expansion. While the disease remains rare, its growing recognition, coupled with advancements in diagnostic techniques and the development of targeted therapies, is fueling demand for effective treatments. The introduction of biologic therapies, immunosuppressive agents, and novel drugs to manage liver fibrosis and inflammation represents key drivers in the market. Moreover, government initiatives and better access to healthcare systems globally are further supporting market growth. However, challenges such as high treatment costs, a limited number of approved therapies, and the complexity of disease management remain significant obstacles that companies must overcome in order to meet patient needs effectively.
Impact
Increasing demand for primary sclerosing cholangitis therapies is anticipated to support the growth of the global primary sclerosing cholangitis market during the forecast period 2025-2035.
The global primary sclerosing cholangitis market is expected to grow at a significant rate due to advancements in treatment, the development of innovative therapies, and increasing awareness among patients and healthcare providers.
Recent Developments:
In June 2024, Ipsen reported that elafibranor showed a favorable safety profile and dose-dependent efficacy in primary sclerosing cholangitis patients over 12 weeks, leading to significant improvements in liver biomarkers, including alkaline phosphatase (ALP), and stabilization of liver fibrosis markers.
In July 2024, Pliant Therapeutics, Inc. announced positive 24-week results from the 320 mg cohort of its INTEGRIS-PSC Phase 2a trial, evaluating bexotegrast in PSC patients with suspected moderate to severe liver fibrosis.
Demand – Drivers and Limitations
The following are the drivers for the global Primary Sclerosing Cholangitis market:
Increasing Prevalence of Primary Sclerosing Cholangitis: The growing number of diagnosed primary sclerosing cholangitis cases, particularly in regions with improving healthcare access and awareness, is a major driver of market growth. The increasing recognition of the disease, coupled with better diagnostic tools, is fueling demand for effective treatments.
Advancements in Research and Drug Development: The continuous progress in research and clinical trials has led to the development of novel therapies and biologics aimed at slowing the progression of primary sclerosing cholangitis and alleviating symptoms, contributing to market expansion.
Improved Understanding of Disease Pathophysiology: As the understanding of primary sclerosing cholangitis' underlying mechanisms evolves, new targeted therapies are being developed that specifically address inflammation and fibrosis, offering hope for better disease management.
The global Primary Sclerosing Cholangitis market is expected to face some limitations too, due to the following challenges:
High Treatment Costs: The cost of developing and administering therapies for primary sclerosing cholangitis, including biologics and advanced treatments, remains high. This limits accessibility for many patients, especially in low-income regions or for those without adequate insurance coverage.
Limited Approved Therapies: Despite ongoing research, the number of approved drugs for PSC is still relatively limited, and many existing treatments are not curative, which hampers overall market growth and patient outcomes.
Side Effects and Safety Concerns: Some therapies, particularly immunosuppressive and biologic treatments, come with significant side effects, including risks of infections and liver complications, which can deter patients from adhering to long-term treatment regimens.
How Can This Report Add Value to an Organization?
Product/Innovation Strategy: Product launches and innovations in the global primary sclerosing cholangitis market are focused on advancing treatment options to improve patient care. These innovations aim to enhance the efficacy of therapies and streamline the detection and management of the disease.
Competitive Strategy: Enterprises led by market leaders in the global primary sclerosing cholangitis market are continuously working on updating their product portfolios with innovative treatments to maintain competitiveness. A detailed competitive benchmarking of the key players in the global primary sclerosing cholangitis market has been conducted, providing insights into how these companies compare in terms of product offerings, market share, and innovation. This benchmarking provides readers with a clear understanding of the market landscape and the positions of the leading players. Additionally, comprehensive competitive strategies, such as partnerships, agreements, and collaborations, will help readers identify untapped revenue opportunities in the global primary sclerosing cholangitis market.
Key Market Players and Competition Synopsis
The primary sclerosing cholangitis market is home to several key players that are actively engaged in the development and marketing of therapies aimed at managing this rare and chronic liver disease. Prominent companies lead the market, with a focus on expanding their therapeutic portfolios through research and development, clinical trials, and strategic partnerships. These companies are exploring novel biologics, immunosuppressive therapies, and targeted treatments to address the progression of primary sclerosing cholangitis, focusing on liver fibrosis and inflammation.
The companies are also expanding their influence in the market through collaborations and mergers to enhance their product offerings and improve patient outcomes. The competition among these companies is intensifying, as they work toward gaining regulatory approvals and launching innovative treatments. This dynamic landscape presents a promising environment for new and existing players, as they strive to meet the unmet needs of PSC patients and improve the quality of life for those affected by the disease.
Some of the prominent names established in this market are:
Merck KGaA
HighTide Therapeutics Inc.
Chemomab Therapeutics Ltd.
NGM Biopharmaceuticals
Dr. Falk Pharma
Mirum Pharmaceuticals, Inc.
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Please Note: It will take 7-10 business days to complete the report upon order confirmation.
The global primary sclerosing cholangitis market is expected to witness significant growth from 2023 to 2035. Primary sclerosing cholangitis is a chronic liver disease characterized by inflammation and scarring of the bile ducts, which can ultimately lead to liver cirrhosis and liver failure. The increasing prevalence of primary sclerosing cholangitis, combined with rising awareness among healthcare professionals and patients, is contributing to the market's expansion. While the disease remains rare, its growing recognition, coupled with advancements in diagnostic techniques and the development of targeted therapies, is fueling demand for effective treatments. The introduction of biologic therapies, immunosuppressive agents, and novel drugs to manage liver fibrosis and inflammation represents key drivers in the market. Moreover, government initiatives and better access to healthcare systems globally are further supporting market growth. However, challenges such as high treatment costs, a limited number of approved therapies, and the complexity of disease management remain significant obstacles that companies must overcome in order to meet patient needs effectively.
Impact
Increasing demand for primary sclerosing cholangitis therapies is anticipated to support the growth of the global primary sclerosing cholangitis market during the forecast period 2025-2035.
The global primary sclerosing cholangitis market is expected to grow at a significant rate due to advancements in treatment, the development of innovative therapies, and increasing awareness among patients and healthcare providers.
Recent Developments:
In June 2024, Ipsen reported that elafibranor showed a favorable safety profile and dose-dependent efficacy in primary sclerosing cholangitis patients over 12 weeks, leading to significant improvements in liver biomarkers, including alkaline phosphatase (ALP), and stabilization of liver fibrosis markers.
In July 2024, Pliant Therapeutics, Inc. announced positive 24-week results from the 320 mg cohort of its INTEGRIS-PSC Phase 2a trial, evaluating bexotegrast in PSC patients with suspected moderate to severe liver fibrosis.
Demand – Drivers and Limitations
The following are the drivers for the global Primary Sclerosing Cholangitis market:
Increasing Prevalence of Primary Sclerosing Cholangitis: The growing number of diagnosed primary sclerosing cholangitis cases, particularly in regions with improving healthcare access and awareness, is a major driver of market growth. The increasing recognition of the disease, coupled with better diagnostic tools, is fueling demand for effective treatments.
Advancements in Research and Drug Development: The continuous progress in research and clinical trials has led to the development of novel therapies and biologics aimed at slowing the progression of primary sclerosing cholangitis and alleviating symptoms, contributing to market expansion.
Improved Understanding of Disease Pathophysiology: As the understanding of primary sclerosing cholangitis' underlying mechanisms evolves, new targeted therapies are being developed that specifically address inflammation and fibrosis, offering hope for better disease management.
The global Primary Sclerosing Cholangitis market is expected to face some limitations too, due to the following challenges:
High Treatment Costs: The cost of developing and administering therapies for primary sclerosing cholangitis, including biologics and advanced treatments, remains high. This limits accessibility for many patients, especially in low-income regions or for those without adequate insurance coverage.
Limited Approved Therapies: Despite ongoing research, the number of approved drugs for PSC is still relatively limited, and many existing treatments are not curative, which hampers overall market growth and patient outcomes.
Side Effects and Safety Concerns: Some therapies, particularly immunosuppressive and biologic treatments, come with significant side effects, including risks of infections and liver complications, which can deter patients from adhering to long-term treatment regimens.
How Can This Report Add Value to an Organization?
Product/Innovation Strategy: Product launches and innovations in the global primary sclerosing cholangitis market are focused on advancing treatment options to improve patient care. These innovations aim to enhance the efficacy of therapies and streamline the detection and management of the disease.
Competitive Strategy: Enterprises led by market leaders in the global primary sclerosing cholangitis market are continuously working on updating their product portfolios with innovative treatments to maintain competitiveness. A detailed competitive benchmarking of the key players in the global primary sclerosing cholangitis market has been conducted, providing insights into how these companies compare in terms of product offerings, market share, and innovation. This benchmarking provides readers with a clear understanding of the market landscape and the positions of the leading players. Additionally, comprehensive competitive strategies, such as partnerships, agreements, and collaborations, will help readers identify untapped revenue opportunities in the global primary sclerosing cholangitis market.
Key Market Players and Competition Synopsis
The primary sclerosing cholangitis market is home to several key players that are actively engaged in the development and marketing of therapies aimed at managing this rare and chronic liver disease. Prominent companies lead the market, with a focus on expanding their therapeutic portfolios through research and development, clinical trials, and strategic partnerships. These companies are exploring novel biologics, immunosuppressive therapies, and targeted treatments to address the progression of primary sclerosing cholangitis, focusing on liver fibrosis and inflammation.
The companies are also expanding their influence in the market through collaborations and mergers to enhance their product offerings and improve patient outcomes. The competition among these companies is intensifying, as they work toward gaining regulatory approvals and launching innovative treatments. This dynamic landscape presents a promising environment for new and existing players, as they strive to meet the unmet needs of PSC patients and improve the quality of life for those affected by the disease.
Some of the prominent names established in this market are:
Merck KGaA
HighTide Therapeutics Inc.
Chemomab Therapeutics Ltd.
NGM Biopharmaceuticals
Dr. Falk Pharma
Mirum Pharmaceuticals, Inc.
*PDF email from publisher allows for 1-3 users, with permission to print*
Please Note: It will take 7-10 business days to complete the report upon order confirmation.
Table of Contents
- Executive Summary
- Scope of Study
- Market/Product Definition
- Inclusion and Exclusion
- Key Questions Answered
- Analysis and Forecast Note
- 1. Global Primary Sclerosing Cholangitis Market: Industry Outlook
- 1.1 Trends: Current and Future Impact Assessment
- 1.2 Epidemiological Analysis
- 1.3 Regulatory Landscape
- 1.4 Pipeline Analysis
- 1.5 Market Dynamics
- 1.5.1 Market Drivers
- 1.5.1.1 Impact Analysis
- 1.5.2 Market Restraints
- 1.5.2.1 Impact Analysis
- 1.5.3 Market Opportunities
- 1.5.3.1 Impact Analysis
- 2. Global Primary Sclerosing Cholangitis Market, By Region, $Million, 2024-2035
- 2.1 North America
- 2.1.1 Market Dynamics
- 2.1.2 Market Sizing and Forecast
- 2.1.2.1 North America Primary Sclerosing Cholangitis Market, by Country
- 2.1.2.1.1 U.S.
- 2.2 Europe
- 2.2.1 Market Dynamics
- 2.2.2 Market Sizing and Forecast
- 2.2.2.1 Europe Primary Sclerosing Cholangitis Market, by Country
- 2.2.2.1.1 U.K.
- 2.2.2.1.2 Germany
- 2.2.2.1.3 France
- 2.2.2.1.4 Italy
- 2.2.2.1.5 Spain
- 2.3 Asia-Pacific
- 2.3.1 Market Dynamics
- 2.3.2 Market Sizing and Forecast
- 2.3.2.1 Asia-Pacific Primary Sclerosing Cholangitis Market, by Country
- 2.3.2.1.1 Japan
- 2.4 Rest-of-the-World
- 2.4.1 Market Dynamics
- 2.4.2 Market Sizing and Forecast
- 3. Global Primary Sclerosing Cholangitis Market - Competitive Landscape and Company Profiles
- 3.1 Key Strategies and Development
- 3.1.1 Mergers and Acquisitions
- 3.1.2 Partnership, Alliances and Business Expansion
- 3.1.3 New Offerings
- 3.1.4 Regulatory Activities
- 3.1.5 Funding Activities
- 3.2 Company Profiles
- 3.2.1 Merck KGaA
- 3.2.1.1 Overview
- 3.2.1.2 Top Products/Product Portfolio
- 3.2.1.3 Top Competitors
- 3.2.1.4 Target Customers
- 3.2.1.5 Key Personnel
- 3.2.1.6 Analyst View
- 3.2.2 HighTide Therapeutics Inc.
- 3.2.2.1 Overview
- 3.2.2.2 Top Products/Product Portfolio
- 3.2.2.3 Top Competitors
- 3.2.2.4 Target Customers
- 3.2.2.5 Key Personnel
- 3.2.2.6 Analyst View
- 3.2.3 Chemomab Therapeutics Ltd.
- 3.2.3.1 Overview
- 3.2.3.2 Top Products/Product Portfolio
- 3.2.3.3 Top Competitors
- 3.2.3.4 Target Customers
- 3.2.3.5 Key Personnel
- 3.2.3.6 Analyst View
- 3.2.4 NGM Biopharmaceuticals
- 3.2.4.1 Overview
- 3.2.4.2 Top Products/Product Portfolio
- 3.2.4.3 Top Competitors
- 3.2.4.4 Target Customers
- 3.2.4.5 Key Personnel
- 3.2.4.6 Analyst View
- 3.2.5 Dr. Falk Pharma
- 3.2.5.1 Overview
- 3.2.5.2 Top Products/Product Portfolio
- 3.2.5.3 Top Competitors
- 3.2.5.4 Target Customers
- 3.2.5.5 Key Personnel
- 3.2.5.6 Analyst View
- 3.2.6 Mirum Pharmaceuticals, Inc.
- 3.2.6.1 Overview
- 3.2.6.2 Top Products/Product Portfolio
- 3.2.6.3 Top Competitors
- 3.2.6.4 Target Customers
- 3.2.6.5 Key Personnel
- 3.2.6.6 Analyst View
- 3.2.7 Others
- 4. Research Methodology
- List of Figures
- Figure: Global Primary Sclerosing Cholangitis Market, 2024 and 2035
- Figure: Global Primary Sclerosing Cholangitis Market, Epidemiological Analysis
- Figure: Global Primary Sclerosing Cholangitis Market Key Trends, Impact Analysis, 2023-2035
- Figure: Global Primary Sclerosing Cholangitis Market, Competitive Landscape, January 2022-September 2025
- Figure: North America Primary Sclerosing Cholangitis Market, $Million, 2024-2035
- Figure: Europe Primary Sclerosing Cholangitis Market, $Million, 2024-2035
- Figure: Asia-Pacific Primary Sclerosing Cholangitis Market, $Million, 2024-2035
- List of Tables
- Table: Market Snapshot
- Table: Global Primary Sclerosing Cholangitis Market, Regulatory Scenario
- Table: Global Primary Sclerosing Cholangitis Market Dynamics, Impact Analysis
- Table: Global Primary Sclerosing Cholangitis Market (by Region), $Million, 2024-2035
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