{"id":572760,"date":"2025-09-23T00:00:00","date_gmt":"2025-09-23T00:00:00","guid":{"rendered":"https:\/\/clarivate.com\/life-sciences-healthcare\/report\/nrlfmd0004-2025-biopharma-primary-biliary-cholangitis-landscape-forecast-niche-rare-disease-landscape-forecast-us\/"},"modified":"2026-04-27T23:17:03","modified_gmt":"2026-04-27T23:17:03","slug":"nrlfmd0004-2025-biopharma-primary-biliary-cholangitis-landscape-forecast-niche-rare-disease-landscape-forecast-us","status":"publish","type":"report","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/report\/nrlfmd0004-2025-biopharma-primary-biliary-cholangitis-landscape-forecast-niche-rare-disease-landscape-forecast-us\/","title":{"rendered":"Primary Biliary Cholangitis &#8211; Landscape &#038; Forecast &#8211; Niche &#038; Rare Disease Landscape &#038; Forecast (US\/EU5)"},"content":{"rendered":"<p>Primary biliary cholangitis (<abbr data-abbreviation-entity=\"5885\" title=\"primary\u00a0biliary\u00a0cirrhosis\/cholangitis\">PBC<\/abbr>) 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, <abbr data-abbreviation-entity=\"5885\" title=\"primary\u00a0biliary\u00a0cirrhosis\/cholangitis\">PBC<\/abbr> culminates in liver fibrosis, cirrhosis, end-stage organ disease, and death. As the first agent to be approved for <abbr data-abbreviation-entity=\"5885\" title=\"primary\u00a0biliary\u00a0cirrhosis\/cholangitis\">PBC<\/abbr>, ursodeoxycholic acid (<abbr data-abbreviation-entity=\"7499\" title=\"ursodeoxycholic acid\">UDCA<\/abbr>), which launched nearly two decades ago, transformed the treatment of <abbr data-abbreviation-entity=\"5885\" title=\"primary\u00a0biliary\u00a0cirrhosis\/cholangitis\">PBC<\/abbr> by greatly reducing mortality rates. Since 2016, the following second-line therapies have been approved for the treatment of <abbr data-abbreviation-entity=\"5885\" title=\"primary\u00a0biliary\u00a0cirrhosis\/cholangitis\">PBC<\/abbr>: obeticholic acid (Ocaliva), elafibranor (Iqirvo), and seladelpar (Livdelzi). In November 2024, the European Commission (<abbr data-abbreviation-entity=\"5851\" title=\"European Commission\">EC<\/abbr>) 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 In September 2025, obeticholic acid was voluntarily withdrawn from the U.S. market for the treatment of <abbr data-abbreviation-entity=\"5885\" title=\"primary\u00a0biliary\u00a0cirrhosis\/cholangitis\">PBC<\/abbr>. Given the medical advances in the treatment of other liver disorders, there is renewed interest in the development of new <abbr data-abbreviation-entity=\"5885\" title=\"primary\u00a0biliary\u00a0cirrhosis\/cholangitis\">PBC<\/abbr> agents to address areas of unmet need and thus these agents could gain share in what is poised to become a highly competitive market.<\/p>\n<p><strong>Questions answered<\/strong><\/p>\n<ul class=\"round-bullets\">\n<li>How large is the <abbr data-abbreviation-entity=\"5885\" title=\"primary\u00a0biliary\u00a0cirrhosis\/cholangitis\">PBC<\/abbr> population, and how will it change through 2034? What percentage of the <abbr data-abbreviation-entity=\"5885\" title=\"primary\u00a0biliary\u00a0cirrhosis\/cholangitis\">PBC<\/abbr> population receives drug treatment?<\/li>\n<li>What is the current treatment landscape and medical practice in <abbr data-abbreviation-entity=\"5885\" title=\"primary\u00a0biliary\u00a0cirrhosis\/cholangitis\">PBC<\/abbr>, and what are the greatest unmet needs according to experts?<\/li>\n<li>Which pipeline products are the most promising, and what sales \/ uptake could they secure in <abbr data-abbreviation-entity=\"5885\" title=\"primary\u00a0biliary\u00a0cirrhosis\/cholangitis\">PBC<\/abbr>?<\/li>\n<li>What are the drivers and constraints in the <abbr data-abbreviation-entity=\"5885\" title=\"primary\u00a0biliary\u00a0cirrhosis\/cholangitis\">PBC<\/abbr> market, and how will the market evolve over the forecast period?<\/li>\n<\/ul>\n<p><strong>Content highlights<\/strong><\/p>\n<p><strong>Geography:<\/strong> United States and <abbr data-abbreviation-entity=\"6092\" title=\"France, Germany, Italy, Spain, UK\">EU5<\/abbr>.<\/p>\n<p><strong>Primary research: <\/strong><\/p>\n<ul class=\"round-bullets\">\n<li>Country-specific interviews with thought-leading hepatologists.<\/li>\n<li>Survey data collected for this and other Clarivate research<\/li>\n<\/ul>\n<p><strong>Epidemiology: <\/strong>Diagnosed prevalence of <abbr data-abbreviation-entity=\"5885\" title=\"primary\u00a0biliary\u00a0cirrhosis\/cholangitis\">PBC<\/abbr> by country, drug-treated cases of <abbr data-abbreviation-entity=\"5885\" title=\"primary\u00a0biliary\u00a0cirrhosis\/cholangitis\">PBC<\/abbr> by country<\/p>\n<p><strong>Forecast: <\/strong>Drug-level sales and patient share of key <abbr data-abbreviation-entity=\"5885\" title=\"primary\u00a0biliary\u00a0cirrhosis\/cholangitis\">PBC<\/abbr> therapies in 2024 and 2034<\/p>\n<p><strong>Drug treatments: <\/strong>Coverage of key current and late-phase emerging therapies<\/p>\n<p><strong>Product description<\/strong><\/p>\n<p>Niche &#038; Rare Disease Landscape &#038; 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:<\/p>\n<ul class=\"round-bullets\">\n<li>Optimize your long-term disease and development strategy.<\/li>\n<li>Quantify market potential for your pipeline assets and those of your competitors.<\/li>\n<li>Understand a disease from top to bottom, including key patient populations, the current and future therapeutic landscape, and the evolving market trajectory.<\/li>\n<li>Gauge the commercial outlook and impact of key market events.<\/li>\n<\/ul>\n","protected":false},"template":"","class_list":["post-572760","report","type-report","status-publish","hentry","report-gateway-biopharma","biopharma-therapy-areas-primary-biliary-cholangitis","biopharma-geography-us","biopharma-date-2297"],"acf":[],"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/report\/572760","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/report"}],"about":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/types\/report"}],"version-history":[{"count":2,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/report\/572760\/revisions"}],"predecessor-version":[{"id":575734,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/report\/572760\/revisions\/575734"}],"wp:attachment":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media?parent=572760"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}