Summary

Overview
Global Primary Sclerosing Cholangitis (PSC) market reached US$ XX million in 2023 and is expected to reach US$ XX million by 2031 growing with a CAGR of XX% during the forecast period 2024-2031.
The primary sclerosing cholangitis market is driven by factors such as the increasing prevalence of primary sclerosing cholangitis, research activities, technological advancements, research funding, and collaboration among key players.
Inflammatory bowel disease, which is characterized by intestinal inflammation that results in open sores (ulcers) in the intestines and stomach pain, is frequently linked to primary sclerosing cholangitis. Inflammatory bowel disease, most frequently an ulcerative type of ulcerative colitis, affects about 70% of persons with primary sclerosing cholangitis. Additionally, compared to those without the ailment, those with primary sclerosing cholangitis are more likely to have an autoimmune problem such as type 1 diabetes, celiac disease, or thyroid disease.
The increasing prevalence of primary sclerosing cholangitis
As per the article published in Hepatology in 2022, in North America and Western Europe, where estimates of incidence and prevalence are roughly 1-1.5 cases per 100,000 person-years and 6-16 cases per 100,000, respectively, these regions have been the focus of the majority of studies conducted to date. African Americans in the US appear to experience PSC at rates comparable to Whites. Although PSC can happen at any age, the peak incidence occurs between the ages of 25 and 45, with a median age at diagnosis ranging from 36 to 39 years.
The incidence rate for children has been calculated to be 0.2 per 100,000 person-years. In general, men make up about two-thirds of PSC patients; however, the male prevalence is substantially smaller among PSC patients without IBD. Women with PSC tend to be older when diagnosed. The prevalence of PSC among patients with IBD, including non-Europeans and children, has been estimated to be 0.6%–4.3%. At least 70%–80% of individuals with PSC also have IBD.
Up to 35% of children and 5% of adults with PSC have PSCAIH overlap. PSC prevalence was found to be 8.1%–9.0% in adults and 15.1% in children in studies using universal liver biopsy or cholangiography screening of individuals with IBD, indicating that there may be tens of thousands of undiagnosed patients in North America alone.
The increasing research activities
In July 2023, Galmed Pharmaceuticals Ltd., a clinical-stage biopharmaceutical company for liver, metabolic, and fibrotic diseases, partnered with OnKai. Starting with Galmed's cutting-edge Primary Sclerosing Cholangitis (PSC) clinical development program, OnKai used its artificial intelligence (AI), models for enrollment and execution of clinical trials in underserved communities.
Using five novel participation models that OnKai created for integrating underprivileged populations in clinical studies, it is projected that the innovative planning tool developed by OnKai will produce an extensive enrollment plan for each trial phase. The pilot in the chosen local clinics will be continually supported by OnKai's Smart-Grid AI Platform. Local clinics will be provided with the resources and remuneration they need to assist their patients throughout the process, making sure that their unique needs are not neglected.
Side effects associated with primary sclerosing cholangitis medication therapy
Side effects associated with primary sclerosing cholangitis medication therapy restraining the market growth. The side effects include digestive system symptoms Mild gastrointestinal symptoms such as diarrhea, nausea, vomiting, abdominal pain, or bloating may be experienced by some people. The majority of the time, these symptoms are transient and get better with time. The itching, or pruritus, is an adverse effect of ursodeoxycholic acid (UDCA) medication. Itching can range from minor to moderate, and it can be controlled with additional drugs or therapies designed to reduce pruritus.
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Segment Analysis
The global primary sclerosing cholangitis market is segmented based on treatment, disease stage, patient age, end-user and region.
The medication-based therapies segment is expected to hold a dominant position in the market over the forecast period
The medication-based therapies segment accounted for the highest market stake accounting for approximately 3/5th of the primary sclerosing cholangitis market in 2022. The medicine most extensively researched in PSC is ursodeoxycholic acid (UDCA). It is a 3,7-dihydroxy bile acid that is hydrophilic. Increased bile flow, direct and indirect cytoprotection, cell membrane stabilization, immunomodulation, diluting the pool of hydrophobic bile acids, and down-regulation of apoptosis are a few potential advantages of PSC.
The anti-inflammatory and anti-senescent effects of UDCA are additional benefits. Consistent evidence of its effectiveness in PSC has not been found. Low-dose UDCA studies (13–15 mg/kg/day) have improved ALP after 12 months but not liver histology or transplant-free survival. Inconclusive evidence supports the use of intermediate-dose UDCA (17–23 mg/kg/day). In the largest research to date, UDCA did not reduce the requirement for LT, CCA, or overall mortality statistically significantly at doses of 17–23 mg/kg.
Geographical Analysis
North America holds a dominant position in the global primary sclerosing cholangitis market
North America is estimated to hold around 1/3rd of the total market share throughout the forecast period. For instance, in July 2022, Pliant announced that the U.S. Food and Drug Administration (FDA) granted PLN-74809, an oral, dual-selective vß6/vß1 integrin inhibitor, Fast Track designation for the potential treatment of primary sclerosing cholangitis (PSC).
The INTEGRIS-PSC Phase 2a clinical trial (NCT04480840) is testing PLN-74809, the Company's primary therapeutic candidate.
COVID-19 Impact Analysis
The COVID-19 pandemic has had a significant impact on the primary sclerosing cholangitis market. Due to the pandemic, clinical trials testing novel treatments or interventions for primary sclerosing cholangitis may have been postponed or altered. Data gathering, participant monitoring, and participant recruitment may have been impacted, potentially impeding the advancement of primary sclerosing cholangitis market research and development.
Russia-Ukraine Conflict Analysis
The Russia-Ukraine war may affect the primary sclerosing cholangitis market due to a lack of facilities being impacted during times of geopolitical instability and economic uncertainty. The healthcare system in impacted areas may be severely strained by the conflict. Damage to the infrastructure and the loss of medical staff could have an effect on how medical services are delivered, including the PSC diagnosis and treatment. Patients who require specialized treatment may face difficulties due to scarce resources and restricted access to facilities.
By Treatment
• Medication-based Therapies
o Bile acid sequestrants
o Antibiotics
o Antihistamines
o Opioid antagonists
o Ursodeoxycholic acid (UDCA)
• Bile Duct Blockages
o Balloon dilation
o Stent placement
• Liver Transplantation
By Disease Stage
• Early-stage PSC
• Moderate-stage PSC
• Advanced-stage PSC
By Patient Age
• Child (0-18)
• Adult (18 and above)
By End-User
• Hospitals
• Specialty Clinics
• Others
By Region
• North America
o U.S.
o Canada
o Mexico
• Europe
o Germany
o U.K.
o France
o Italy
o Spain
o Rest of Europe
• South America
o Brazil
o Argentina
o Rest of South America
• Asia-Pacific
o China
o India
o Japan
o South Korea
o Rest of Asia-Pacific
• Middle East and Africa
Competitive Landscape
The major global players in the market include Intercept Pharmaceuticals, Gilead Sciences, Bristol Myers Squibb, Takeda Pharmaceutical Company Limited, Johnson & Johnson, Allergan, Genfit, Pliant Therapeutics, ChemomAb Therapeutics Ltd., and Dr. Falk Pharma among others.
Key Developments
• In June 2023, ChemomAb Therapeutics Ltd., a clinical-stage biotechnology company developing novel therapeutics to treat rare fibro-inflammatory diseases with high unmet medical needs, announced the release of a peer-reviewed research article describing how CCL24 is a key driver of the fibrotic and inflammatory disease processes that result in primary sclerosing cholangitis (PSC), a rare disease of the bile ducts that has no FDA-approved treatments and is frequently fatal.
Why Purchase the Report?
• To visualize the global primary sclerosing cholangitis market segmentation based on the treatment, disease stage, patient age, end-user and region and understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of primary sclerosing cholangitis market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.
The global primary sclerosing cholangitis market report would provide approximately 69 tables, 66 figures and 195 Pages.
Target Audience 2024
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

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Table of Contents

1. Methodology and Scope
1.1. Research Methodology
1.2. Research Objective and Scope of the Report
2. Definition and Overview
3. Executive Summary
3.1. Snippet by Treatment
3.2. Snippet by Disease Stage
3.3. Snippet by Patient Age
3.4. Snippet by End-User
3.5. Snippet by Region
4. Dynamics
4.1. Impacting Factors
4.1.1. Drivers
4.1.1.1. Rising prevalence of primary sclerosing cholangitis
4.1.2. Restraints
4.1.2.1. Side effects associated with primary sclerosing cholangitis
4.1.3. Opportunity
4.1.3.1. Technological advancements
4.1.4. Impact Analysis
5. Industry Analysis
5.1. Porter's 5 Forces Analysis
5.2. Supply Chain Analysis
5.3. Unmet Needs
5.4. Patent Analysis
5.5. Regulatory Analysis
5.6. SWOT Analysis
5.7. Russia-Ukraine Analysis
5.8. Artificial Intelligence Impact
6. COVID-19 Analysis
6.1. Analysis of COVID-19
6.1.1. Scenario Before COVID-19
6.1.2. Scenario During COVID-19
6.1.3. Scenario Post COVID-19
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During the Pandemic
6.5. Manufacturers’ Strategic Initiatives
6.6. Conclusion
7. By Treatment
7.1. Introduction
7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
7.1.2. Market Attractiveness Index, By Treatment
7.2. Medication-based Therapies*
7.2.1. Introduction
7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.2.3. Bile acid sequestrants
7.2.4. Antibiotics
7.2.5. Antihistamines
7.2.6. Opioid antagonists
7.2.7. Ursodeoxycholic acid (UDCA)
7.3. Bile Duct Blockages
7.3.1. Balloon dilation
7.3.2. Stent placement
7.4. Liver Transplantation
8. By Disease Stage
8.1. Introduction
8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Stage
8.1.2. Market Attractiveness Index, By Disease Stage
8.2. Early-stage*
8.2.1. Introduction
8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Moderate-stage
8.4. Advanced-stage
9. By Patient Age
9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Patient Age
9.1.2. Market Attractiveness Index, By Patient Age
9.2. Child*
9.2.1. Introduction
9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Adult
10. By End-User
10.1. Introduction
10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
10.1.2. Market Attractiveness Index, By End-User
10.2. Hospitals*
10.2.1. Introduction
10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
10.3. Specialty Clinics
10.4. Others
11. By Region
11.1. Introduction
11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
11.1.2. Market Attractiveness Index, By Region
11.2. North America
11.2.1. Introduction
11.2.2. Key Region-Specific Dynamics
11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Stage
11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Patient Age
11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
11.2.7.1. U.S.
11.2.7.2. Canada
11.2.7.3. Mexico
11.3. Europe
11.3.1. Introduction
11.3.2. Key Region-Specific Dynamics
11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Stage
11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Patient Age
11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
11.3.7.1. Germany
11.3.7.2. U.K.
11.3.7.3. France
11.3.7.4. Italy
11.3.7.5. Spain
11.3.7.6. Rest of Europe
11.4. South America
11.4.1. Introduction
11.4.2. Key Region-Specific Dynamics
11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Stage
11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Patient Age
11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
11.4.7.1. Brazil
11.4.7.2. Argentina
11.4.7.3. Rest of South America
11.5. Asia-Pacific
11.5.1. Introduction
11.5.2. Key Region-Specific Dynamics
11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Stage
11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Patient Age
11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
11.5.7.1. China
11.5.7.2. India
11.5.7.3. Japan
11.5.7.4. Australia
11.5.7.5. Rest of Asia-Pacific
11.6. Middle East and Africa
11.6.1. Introduction
11.6.2. Key Region-Specific Dynamics
11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Stage
11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Patient Age
11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
12. Competitive Landscape
12.1. Competitive Scenario
12.2. Product Benchmarking
12.3. Company Share Analysis
12.4. Key Developments and Strategies
13. Company Profiles
13.1. Intercept Pharmaceuticals*
13.1.1. Company Overview
13.1.2. Product Portfolio and Description
13.1.3. Financial Overview
13.1.4. Key Developments
13.2. Gilead Sciences
13.3. Bristol Myers Squibb
13.4. Takeda Pharmaceutical Company Limited
13.5. Johnson & Johnson
13.6. Allergan
13.7. Genfit
13.8. Pliant Therapeutics
13.9. ChemomAb Therapeutics Ltd.
13.10. Dr. Falk Pharma
LIST NOT EXHAUSTIVE
14. Appendix
14.1. About Us and Services
14.2. Contact Us