PUBLISHER: The Business Research Company | PRODUCT CODE: 1811012
PUBLISHER: The Business Research Company | PRODUCT CODE: 1811012
Primary biliary cholangitis (PBC) therapeutics are treatments aimed at managing and slowing the progression of primary biliary cholangitis, a chronic autoimmune liver disease that harms the bile ducts. These therapies function by improving bile flow, reducing inflammation, and preventing liver fibrosis. Their primary goal is to decrease liver inflammation, enhance bile drainage, prevent fibrosis, and delay liver failure.
The primary drug categories for PBC therapeutics include ursodeoxycholic acid, obeticholic acid, and others. Ursodeoxycholic acid is a bile acid that helps improve liver function by reducing bile accumulation and slowing liver damage, particularly in cholestatic liver conditions like PBC. These drugs operate through various mechanisms of action such as receptor agonists, receptor modulators, enzyme activators, enzyme inhibitors, and more. They are distributed through multiple channels including hospital pharmacies, retail drug stores, and online pharmacies, serving key users for both human and veterinary applications.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.
The primary biliary cholangitis therapeutics market research report is one of a series of new reports from The Business Research Company that provides primary biliary cholangitis therapeutics market statistics, including the primary biliary cholangitis therapeutics industry global market size, regional shares, competitors with the primary biliary cholangitis therapeutics market share, detailed primary biliary cholangitis therapeutics market segments, market trends, opportunities, and any further data you may need to thrive in the primary biliary cholangitis therapeutics industry. This primary biliary cholangitis therapeutics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.
The primary biliary cholangitis therapeutics market size has grown rapidly in recent years. It will grow from $0.89 billion in 2024 to $1.01 billion in 2025 at a compound annual growth rate (CAGR) of 13.3%. Growth during the historic period was driven by increasing awareness of autoimmune liver diseases, expanding clinical evidence supporting liver function testing, growing investment in hepatology research, and a rising prevalence of autoimmune conditions.
The primary biliary cholangitis therapeutics market size is expected to see rapid growth in the next few years. It will grow to $1.64 billion in 2029 at a compound annual growth rate (CAGR) of 12.9%. Growth in the forecast period is expected to be driven by the increased use of second-line therapies, a growing pipeline of new therapeutics, rising adoption of combination treatments, expanded global access to diagnostics and specialty care, and enhanced patient advocacy and education efforts. Key trends anticipated include personalized treatment strategies, broader availability of second-line therapies, focus on non-invasive biomarkers, greater attention to symptom management, and the integration of real-world evidence (RWE).
The rising prevalence of liver diseases is anticipated to drive the growth of the primary biliary cholangitis therapeutics market in the coming years. Liver diseases encompass various conditions that disrupt normal liver function, often causing inflammation, scarring, or liver failure. This increase in liver disease cases is largely attributed to higher alcohol consumption, as excessive drinking damages liver cells and leads to chronic inflammation. Primary biliary cholangitis therapeutics help manage these conditions by targeting bile duct inflammation, slowing disease progression, and preserving liver function. These treatments improve patient outcomes by reducing symptoms, enhancing quality of life, and postponing the need for liver transplantation. For example, in March 2022, the US Centers for Disease Control and Prevention reported that deaths from chronic liver diseases in Texas rose to 5,079, up from 4,930 in 2021. Therefore, the growing prevalence of liver diseases is supporting the expansion of the primary biliary cholangitis therapeutics market.
Leading companies in the primary biliary cholangitis therapeutics market are focusing on developing innovative products and securing approvals for drugs like peroxisome proliferator-activated receptor (PPAR) agonists, which improve bile acid metabolism and slow disease progression. PPAR agonists activate PPAR proteins that regulate genes involved in metabolism, inflammation, and energy balance. For instance, in August 2024, Gilead Sciences Inc., a US pharmaceutical company, received accelerated approval from the U.S. Food and Drug Administration (FDA) for Livdelzi (seladelpar) to treat primary biliary cholangitis (PBC) in adults who have shown an inadequate response to ursodeoxycholic acid (UDCA) or cannot tolerate it. Livdelzi is an oral, selective PPARδ agonist that activates the PPARδ receptor to regulate genes that reduce liver inflammation, improve bile acid metabolism, and slow the progression of PBC.
In March 2024, Gilead Sciences Inc. acquired CymaBay Therapeutics Inc. for $4.3 billion. This acquisition aims to enhance Gilead's liver disease portfolio by incorporating CymaBay's investigational therapy, seladelpar, which shows promise as a treatment for primary biliary cholangitis (PBC), a rare and chronic liver condition. CymaBay Therapeutics Inc. is a US-based pharmaceutical firm specializing in developing innovative therapies for PBC.
Major players in the primary biliary cholangitis therapeutics market are F. Hoffmann-La Roche Ltd, Parvus Therapeutics, Novartis AG, Gilead Sciences Inc., Viatris Inc., Ipsen Pharma, Hanmi Pharmaceutical Co. Ltd., Intercept Pharmaceuticals, Enanta Pharmaceuticals, Mirum Pharmaceuticals, Calliditas Therapeutics AB, Dr. Falk Pharma GmbH, NGM Biopharmaceuticals Inc., Durect Corporation, COUR Pharmaceuticals, HighTide Therapeutics Inc., Pliant Therapeutics Inc., Tiziana Life Sciences, Phenex Pharmaceuticals, and Synlogic Therapeutics.
North America was the largest region in the primary biliary cholangitis therapeutics market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in primary biliary cholangitis therapeutics report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the primary biliary cholangitis therapeutics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The primary biliary cholangitis therapeutics market consists of sales of Livdelzi, Iqirvo, Volixibat, fibrates, immunosuppressants, and emerging biologics. Values in this market are 'factory gate' values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
Primary Biliary Cholangitis Therapeutics Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on primary biliary cholangitis therapeutics market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for primary biliary cholangitis therapeutics ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The primary biliary cholangitis therapeutics market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.