Primary Sclerosing Cholangitis Market Size, Share, Growth, Forecast and Outlook (2024-2031)

Global Primary Sclerosing Cholangitis (PSC) Market is segmented By Treatment (Medication-based Therapies, Bile Duct Blockages, 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) and By Region (North America, Europe, South America, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031

Market Overview

Global Primary Sclerosing Cholangitis (PSC) market reached US$ YY million in 2023 and is expected to reach US$ YY million by 2031 growing with a CAGR of YY% 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. 

Market Scope

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Market Dynamics

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.

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. 

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