Obeticholic Acid Market Report 2025

The obeticholic acid market size has grown rapidly in recent years. It will grow from $0.9 billion in 2024 to $1.01 billion in 2025 at a compound annual growth rate (CAGR) of 12.3%. The growth in the historic period can be attributed to the increasing prevalence of primary biliary cholangitis (PBC), the rising incidence of non-alcoholic steatohepatitis (NASH), the expanding healthcare infrastructure in emerging markets, the increase in liver disease diagnostics and screening rates, the rising healthcare expenditure, and the investment in liver disease research.

The obeticholic acid 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 12.8%. The growth in the forecast period can be attributed to the increasing prevalence of primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH), growing demand for innovative liver disease treatments, rising awareness about liver diseases and available treatments, expansion of global healthcare access in emerging markets, and rising awareness about liver diseases and available treatments. Major trends in the forecast period include adoption for NASH treatment, partnerships and collaborations for further development, integration of digital health tools for monitoring and compliance, a shift toward non-alcoholic fatty liver disease (NAFLD) treatment, advances in liver disease biomarkers, and diagnostic technologies.

The forecast of 12.8% growth over the next five years reflects a modest reduction of 0.4% from the previous estimate for this market. This reduction is primarily due to the impact of tariffs between the US and other countries. The imposition of tariffs may burden U.S. hepatology centers by increasing prices of farnesoid x receptor agonists sourced from the UK and Canada, potentially reducing treatment options for primary biliary cholangitis and raising rare liver disease management costs. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.

The increasing prevalence of liver diseases is expected to drive the growth of the obeticholic acid market. Liver diseases are conditions that impair the liver's ability to function effectively. This rise in liver diseases can be attributed to factors such as excessive alcohol consumption, which damages liver cells, leading to inflammation, cirrhosis, and eventual liver failure. Obeticholic acid aids in treating liver disease by activating the farnesoid X receptor (FXR), which helps reduce bile acid buildup, decreases inflammation, and slows fibrosis progression, thereby improving liver function. For example, in December 2024, the UK’s Office for Health Improvement and Disparities reported a 3.6% increase in premature deaths from alcoholic liver disease, reaching 5,984 in 2023, up from 5,776 in 2022. This rise in liver disease cases is driving the market for obeticholic acid.

Companies operating in the obeticholic acid market are working on innovative products such as FXR agonists to improve liver disease treatment and patient outcomes. FXR agonists are compounds that activate the FXR, a receptor involved in regulating bile acid metabolism, inflammation, and fibrosis in the liver. These agonists are used to treat conditions such as primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH) and help enhance liver function. For instance, in February 2024, Intercept Pharmaceuticals Inc., a U.S.-based biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) had accepted its supplemental New Drug Application (sNDA) for Ocaliva to treat PBC. The FDA's acceptance indicates progress toward validating the clinical benefits of obeticholic acid for PBC treatment.

In July 2022, Advanz Pharma Corp. Limited, a UK-based pharmaceutical company, acquired Intercept Pharmaceuticals. With this acquisition, Advanz Pharma aimed to strengthen its presence in the specialty pharmaceuticals sector by adding the commercialization rights to Ocaliva (obeticholic acid) for the treatment of PBC. Intercept Pharmaceuticals, a U.S.-based biopharmaceutical company, specializes in providing obeticholic acid.

Major players in the obeticholic acid market are Pfizer Inc., GlaxoSmithKline (GSK), Gilead Sciences Inc., Amgen Inc., Genfit, Teva Pharmaceutical Industries Ltd., Regeneron Pharmaceuticals, WuXi AppTec, Bayer AG, Sumitomo Dainippon Pharma Co. Ltd., Horizon Therapeutics, Dr. Reddy’s Laboratories, Lupin Limited, Hepalink Pharmaceutical Group5, Alembic Pharmaceuticals, Intercept Pharmaceuticals Inc., Enanta Pharmaceuticals, Viva Life sciences, Omgene Life Sciences Pvt. Ltd., Zydus Cadila.

North America was the largest region in the Obeticholic Acid market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in obeticholic acid report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the obeticholic acid market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The obeticholic acid market consists of sales of products including tablets, generic obeticholic acid, ocaliva support services, patient education kits, and obeticholic acid + ursodeoxycholic acid (UDCA). 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.

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 resulting trade tensions in spring 2025 are having a significant impact on the pharmaceutical sector. Companies are grappling with higher costs on imported active pharmaceutical ingredients (APIs), glass vials, and laboratory equipment - many of which have limited alternative sources. Generic drug manufacturers, already operating with minimal profit margins, are particularly affected, with some scaling back production of low-margin medications. Biotech firms are also experiencing delays in clinical trials due to shortages of specialized reagents linked to tariffs. In response, the industry is shifting API production to regions like India and Europe, building up inventory reserves, and advocating for tariff exemptions on essential medicines.

The obeticholic acid market research report is one of a series of new reports that provides obeticholic acid market statistics, including the obeticholic acid industry global market size, regional shares, competitors with the obeticholic acid market share, detailed obeticholic acid segments, market trends, and opportunities, and any further data you may need to thrive in the obeticholic acid industry. This obeticholic acid 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.

Obeticholic acid is a medication primarily used to treat liver diseases, particularly for patients with primary biliary cholangitis (PBC), a chronic liver condition. It is a synthetic bile acid that activates a receptor called the farnesoid X receptor (FXR), which helps regulate bile acid production, liver function, and inflammation.

The main product types of obeticholic acid include tablets, capsules, and other forms. Tablets are solid dosage forms designed for convenient oral administration. The drug is distributed through various channels, such as hospital pharmacies, retail pharmacies, and online pharmacies. It is used to treat nonalcoholic steatohepatitis, primary biliary cholangitis, and other related conditions.

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.

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