Primary Sclerosing Cholangitis Market

Market Overview:

The 7 major primary sclerosing cholangitis markets are expected to exhibit a CAGR of 5.84% during 2024-2034.

The primary sclerosing cholangitis market has been comprehensively analyzed in IMARC's new report titled "Primary Sclerosing Cholangitis Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034". Primary sclerosing cholangitis (PSC) refers to a chronic liver disease characterized by inflammation, scarring, and narrowing of the bile ducts inside as well as outside the liver. Some of the common symptoms include fatigue, itching (pruritus), abdominal pain or discomfort, jaundice, dark urine, pale stools, unintended weight loss, etc. These indications can vary in severity and may be intermittent. Additionally, the ailment is often associated with inflammatory bowel disease, particularly ulcerative colitis, and individuals suffering from PSC may experience various related symptoms, such as diarrhea, rectal bleeding, abdominal cramping, etc. Diagnosing primary sclerosing cholangitis involves a combination of clinical evaluation, imaging studies, and laboratory procedures. The diagnostic process typically begins with a thorough medical history and physical examination, followed by blood tests to assess liver function and identify specific serological markers associated with PSC. Numerous imaging techniques, including magnetic resonance cholangiopancreatography and endoscopic retrograde cholangiopancreatography, are used to visualize the bile ducts and check for characteristic abnormalities like strictures or narrowing. Additionally, a liver biopsy may be performed in certain cases to confirm the diagnosis or rule out other liver conditions.

The increasing cases of immune system dysfunction in which the immune system mistakenly attacks the bile ducts, thereby leading to inflammation and scarring, are primarily driving the primary sclerosing cholangitis market. Besides this, the rising prevalence of several associated risk factors, such as alterations in the composition and function of the gut microbiota, chronic inflammation in the bile ducts, genetic predisposition, a history of chronic bacterial cholangitis, etc., is propelling the market growth. Additionally, the widespread adoption of antibiotics, including ciprofloxacin and trimethoprim, for managing bacterial infections and preventing recurrent episodes of cholangitis is acting as another significant growth-inducing factor. Apart from this, the escalating application of immune modulators, such as obeticholic acid (OCA) and fibrates, to modulate the immune response and reduce liver inflammation in patients is also bolstering the market growth. Furthermore, the ongoing advancements in endoscopic techniques, including the introduction of digital cholangioscopy and single-operator cholangioscopy, which enable the removal of bile duct stones, biopsy of suspicious lesions, and dilation of strictures with improved precision, are expected to drive the primary sclerosing cholangitis market in the coming years.

IMARC Group's new report provides an exhaustive analysis of the primary sclerosing cholangitis market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for primary sclerosing cholangitis and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc., have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the primary sclerosing cholangitis market in any manner.

Recent Developments:

• In July 2024, Chemomab Therapeutics Ltd. announced positive topline results from the Phase 2 SPRING study, which assessed its first-in-class monoclonal antibody, CM-101, in patients with primary sclerosing cholangitis. Treatment with CM-101 met its primary endpoint of safety and tolerability while also demonstrating anti-fibrotic, anti-inflammatory, and anti-cholestatic effects across a wide range of disease-related secondary efficacy endpoints, including statistically significant improvement in liver stiffness, a key primary sclerosing cholangitis disease marker.
• In March 2024, LISCure Biosciences reported that the U.S. FDA had given Fast Track designation to LB-P8, LISCure's experimental medication for the treatment of primary sclerosing cholangitis.
• In February 2024, Pliant Therapeutics reported 12-week interim results from the 320 mg dose group of INTEGRIS-PSC, a multinational, randomized, double-blind, placebo-controlled Phase 2a clinical trial of bexotegrast in patients with primary sclerosing cholangitis and suspected moderate to severe liver fibrosis. The 320 mg group met its primary and secondary objectives, indicating that bexotegrast was well tolerated across a 12-week treatment period, with plasma concentrations increasing with dose.
• In November 2023, Galmed Pharmaceuticals Ltd. announced a minimum of at least 6 months in the beginning of its primary sclerosing cholangitis Phase 2a Study, investigating the safety and efficacy of its lead medication, Aramchol meglumine, for the treatment of primary sclerosing cholangitis.

Key Highlights:

• The incidence in the United States is estimated to be between one and sixteen per 100,000 people.
• Approximately 80% of patients with primary sclerosing cholangitis have associated inflammatory bowel disease.
• There is a 2:1 male predominance when primary sclerosing cholangitis is coupled with inflammatory bowel disease and a minor female predominance in the absence of inflammatory bowel disease.
• The average age at diagnosis is 30 to 40 years old.
• The prevalence rate of primary sclerosing cholangitis among patients with inflammatory bowel disease is believed to be around 5%.

Drugs:

Urso Forte (Ursodeoxycholic Acid) is a bile acid that helps improve abnormal biochemical testing in patients with primary sclerosing cholangitis.  It works by boosting bile flow and protecting liver cells.

A3907 is the first oral systemic apical sodium-dependent bile acid transporter (ASBT) inhibitor with excellent oral bioavailability. It has the potential to block intestinal and renal bile acid reuptake, as well as ASBT expression by cholangiocytes. Due to its high oral bioavailability, A3907 can inhibit ASBT in the colon and kidney, potentially increasing bile acid elimination via fecal and urine excretion.

Volixibat is a minimally absorbed, orally administered experimental treatment that selectively inhibits the ileal bile acid transporter (IBAT), a protein that recycles bile acids from the gut to the liver. Volixibat is now being investigated in primary sclerosing cholangitis. It acts by inhibiting an essential bile acid transport protein found on the surface of the small intestine. This leads to more bile acids being discharged in the stool.

Time Period of the Study

• Base Year: 2023
• Historical Period: 2018-2023
• Market Forecast: 2024-2034
   

Countries Covered

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan
   

Analysis Covered Across Each Country

• Historical, current, and future epidemiology scenario
• Historical, current, and future performance of the primary sclerosing cholangitis market
• Historical, current, and future performance of various therapeutic categories in the market
• Sales of various drugs across the primary sclerosing cholangitis market
• Reimbursement scenario in the market
• In-market and pipeline drugs

Competitive Landscape:

This report also provides a detailed analysis of the current primary sclerosing cholangitis marketed drugs and late-stage pipeline drugs.

In-Market Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance
   

Late-Stage Pipeline Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance
   

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.

Key Questions Answered in this Report:

Market Insights

• How has the primary sclerosing cholangitis market performed so far and how will it perform in the coming years?
• What are the markets shares of various therapeutic segments in 2023 and how are they expected to perform till 2034?
• What was the country-wise size of the primary sclerosing cholangitis market across the seven major markets in 2023 and what will it look like in 2034?
• What is the growth rate of the primary sclerosing cholangitis market across the seven major markets and what will be the expected growth over the next ten years?
• What are the key unmet needs in the market?
   

Epidemiology Insights

• What is the number of prevalent cases (2018-2034) of primary sclerosing cholangitis across the seven major markets?
• What is the number of prevalent cases (2018-2034) of primary sclerosing cholangitis by age across the seven major markets?
• What is the number of prevalent cases (2018-2034) of primary sclerosing cholangitis by gender across the seven major markets?
• How many patients are diagnosed (2018-2034) with primary sclerosing cholangitis across the seven major markets?
• What is the size of the primary sclerosing cholangitis patient pool (2018-2023) across the seven major markets?
• What would be the forecasted patient pool (2024-2034) across the seven major markets?
• What are the key factors driving the epidemiological trend of primary sclerosing cholangitis?
• What will be the growth rate of patients across the seven major markets?
   

Primary Sclerosing Cholangitis: Current Treatment Scenario, Marketed Drugs and Emerging Therapies

• What are the current marketed drugs and what are their market performance?
• What are the key pipeline drugs and how are they expected to perform in the coming years?
• How safe are the current marketed drugs and what are their efficacies?
• How safe are the late-stage pipeline drugs and what are their efficacies?
• What are the current treatment guidelines for primary sclerosing cholangitis drugs across the seven major markets?
• Who are the key companies in the market and what are their market shares?
• What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the primary sclerosing cholangitis market?
• What are the key regulatory events related to the primary sclerosing cholangitis market?
• What is the structure of clinical trial landscape by status related to the primary sclerosing cholangitis market?
• What is the structure of clinical trial landscape by phase related to the primary sclerosing cholangitis market?
• What is the structure of clinical trial landscape by route of administration related to the primary sclerosing cholangitis market?