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

Primary Biliary Cholangitis (PBC) Market Outlook

Thelansis’s “Primary Biliary Cholangitis (PBC) 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 Biliary Cholangitis treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Primary Biliary Cholangitis (PBC) Overview

Primary biliary cholangitis (PBC), once known as primary biliary cirrhosis, is a chronic ailment involving progressive damage, inflammation, and eventual destruction of the liver's small bile ducts. Bile, a crucial digestive fluid produced by the liver, plays a vital role in processing food and expelling toxins, cholesterol, and aged red blood cells from the body. However, when these bile ducts suffer harm, bile accumulates in the liver, leading to irreversible scarring of liver tissue, a condition known as cirrhosis. Activated CD4 and CD8 lymphocytes drive the continual deterioration of these small and medium-sized bile ducts. In adults experiencing cholestasis (elevated levels of alkaline phosphatase (ALP) or gamma-glutamyl transferase (GGT)), suspicions of PBC arise once obstructive jaundice and systemic diseases have been ruled out through abdominal ultrasound. A confirmed diagnosis is made when disease-specific autoantibodies, such as antimitochondrial autoantibodies (AMA titer>1:40) and anti-nuclear autoantibodies (ANA) anti-sp100 and anti-gp210, are detected. Other conditions include autoimmune hepatitis, primary sclerosing cholangitis, alcoholic and non-alcoholic steatohepatitis, and drug-induced hepatotoxicity. The primary goal of treatment is to alleviate symptoms and slow the progression of the disease. Ursodeoxycholic acid (UDCA) at a dose of 13-15 mg/kg/day effectively improves transplant-free survival, though its impact on fatigue and itching is limited. For patients with insufficient responses (25%-40%), obeticholic acid may be introduced. Cholestyramine is the initial treatment for itching, with rifampin recommended for those intolerant or resistant to it. In patients with normal or near-normal liver biochemistry while on UDCA, their liver transplant-free survival is comparable to that of the general population. Conversely, those with abnormal liver biochemistry on treatment face significantly reduced survival rates. Following a liver transplant, the recurrence of PBC can be as high as 18% at five years and up to 30% at ten years, with risk factors for recurrence still lacking consensus. While hepatocellular carcinoma (HCC) is rare in PBC, non-response to UDCA after a year of therapy and male gender increase the likelihood of developing HCC.

• The prevalence of PBC in the United States has risen substantially, with a 114% increase in men (from 7.7 to 15.4 per 100,000 persons) and a rise from 33.5 to 57.8 per 100,000 persons in women.

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.

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