Primary Sclerosing Cholangitis (PSC) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Primary Sclerosing Cholangitis (PSC) Market Outlook

Thelansis’s “Primary Sclerosing Cholangitis (PSC) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Primary Sclerosing Cholangitis treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Primary Sclerosing Cholangitis (PSC) Overview

Primary sclerosing cholangitis (PSC) is a chronic liver condition characterized by inflammation and fibrosis of the bile ducts. It is closely linked to inflammatory bowel disease (IBD), and the extent of biliary system involvement can vary. Most PSC patients also have underlying IBD, such as ulcerative colitis or Crohn's disease. Ulcerative colitis is more common in PSC patients, accounting for 85% of cases, whereas Crohn's disease is less prevalent at 15%. Approximately 2.5-7.5% of all ulcerative colitis patients may develop PSC. In over 80% of PSC cases, strictures (narrowing of bile ducts) are present both within and outside the liver. However, around 10% only have intrahepatic strictures, and less than 5% have extrahepatic strictures exclusively. Most individuals with PSC are asymptomatic and are typically diagnosed through abnormal liver function tests in routine blood work. Despite advanced disease, many patients remain symptom-free for extended periods. The clinical course of PSC varies widely and is unpredictable. A consistently low serum alkaline phosphatase level (less than 1.5 times the upper normal limit) is associated with a favorable prognosis. Patients with small duct PSC generally have a good prognosis, no documented cases of bile duct malignancy, and progression to severe liver disease is uncommon. The Mayo risk score, incorporating factors like age, serum bilirubin, serum albumin, serum AST, and a history of variceal bleeding, helps predict survival in PSC patients. Currently, there are no FDA-approved medications for treating or curing primary sclerosing cholangitis (PSC).

• The incidence of primary sclerosing cholangitis ranges between 0.4 and 1.30 cases per 100,000 people per year.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2023-2033

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

Visit our social media pages: