Primary Biliary Cholangitis – Landscape & Forecast – Niche & Rare Disease Landscape & Forecast (US/EU5)

Primary biliary cholangitis (PBC) is a rare autoimmune liver disease, characterized by inflammation and progressive damage leading to destruction of interlobular bile ducts, followed by cholestasis. Without adequate management, PBC culminates in liver fibrosis, cirrhosis, end-stage organ disease, and death. As the first agent to be approved for PBC, ursodeoxycholic acid (UDCA), which launched nearly two decades ago, transformed the treatment of PBC by greatly reducing mortality rates. Since 2016, the following second-line therapies have been approved for the treatment of PBC: obeticholic acid (Ocaliva), elafibranor (Iqirvo), and seladelpar (Livdelzi). In November 2024, the European Commission (EC) revoked the conditional marketing authorization for obeticholic acid in the EU. In September 2025, obeticholic acid was voluntarily withdrawn from the U.S. market for the treatment of PBC. Given the medical advances in the treatment of other liver disorders, there is renewed interest in the development of new PBC agents to address areas of unmet need and thus these agents could gain share in what is poised to become a highly competitive market.

Questions answered

• How large is the PBC population, and how will it change through 2034? What percentage of the PBC population receives drug treatment?
• What is the current treatment landscape and medical practice in PBC, and what are the greatest unmet needs according to experts?
• Which pipeline products are the most promising, and what sales / uptake could they secure in PBC?
• What are the drivers and constraints in the PBC market, and how will the market evolve over the forecast period?

Content highlights

Geography: United States and EU5.

Primary research:

• Country-specific interviews with thought-leading hepatologists.
• Survey data collected for this and other Clarivate research

Epidemiology: Diagnosed prevalence of PBC by country, drug-treated cases of PBC by country

Forecast: Drug-level sales and patient share of key PBC therapies in 2024 and 2034

Drug treatments: Coverage of key current and late-phase emerging therapies

Product description

Niche & Rare Disease Landscape & Forecast offers comprehensive market intelligence with world-class epidemiology, keen insight into current and emerging therapies, and drug forecasts supported by detailed primary and secondary research, enabling you to:

• Optimize your long-term disease and development strategy.
• Quantify market potential for your pipeline assets and those of your competitors.
• Understand a disease from top to bottom, including key patient populations, the current and future therapeutic landscape, and the evolving market trajectory.
• Gauge the commercial outlook and impact of key market events.