Ursodeoxycholic Acid Global Market Report 2025

The ursodeoxycholic acid market size has grown rapidly in recent years. It will grow from $0.86 billion in 2024 to $0.96 billion in 2025 at a compound annual growth rate (CAGR) of 11.1%. The expansion during the historical period can be attributed to factors such as the rising incidence of gallstone disease, increased awareness regarding liver health, higher diagnosis rates of primary biliary cholangitis, a greater shift toward non-invasive liver testing, and the aging global population.

The ursodeoxycholic acid market size is expected to see rapid growth in the next few years. It will grow to $1.44 billion in 2029 at a compound annual growth rate (CAGR) of 10.8%. The projected growth will be driven by the rising burden of lifestyle-related health issues, growing reliance on hepatoprotective medications, increased need for long-term liver disease treatments, a robust pipeline of clinical trials focused on bile acid derivatives, and growing interest in less invasive surgical options. Key market trends in the coming years include advancements in targeted drug delivery methods, combining UDCA with other liver-protecting substances, new drug formulation strategies, development of bile acid analogs, and the emergence of RNA-based therapies aimed at liver regeneration.

The growing prevalence of liver diseases is anticipated to drive the expansion of the ursodeoxycholic acid market in the coming years. Liver diseases encompass various conditions that hinder the liver's normal function, such as infections, inflammation, fatty liver, cirrhosis, and liver cancer. One of the key contributors to this increase in liver-related conditions is the rising level of alcohol consumption, as prolonged excessive drinking can cause significant liver damage. Ursodeoxycholic acid plays a crucial role in treating liver diseases by enhancing bile flow and decreasing the levels of toxic bile acids, which makes it particularly effective in managing conditions like primary biliary cholangitis. It helps improve patient outcomes by slowing the progression of liver damage and aiding in the dissolution of cholesterol gallstones, thereby boosting the overall effectiveness of treatments. For example, in April 2024, the Office for Health Improvement and Disparities, a UK-based government department, reported 6,664 premature deaths from liver disease among males and 3,929 among females, reflecting a 22.8% increase for males and a 33.1% increase for females compared to previous years. This surge in liver disease cases is contributing to the growth of the ursodeoxycholic acid market.

Leading companies in the ursodeoxycholic acid (UDCA) market are increasingly developing advanced therapies, such as bile acid derivatives, to improve the treatment of liver diseases, particularly cholestatic liver disorders. Bile acid derivatives are chemically modified forms of bile acids designed to support liver function and manage various liver conditions. For instance, in November 2024, Nora Pharma Inc., a pharmaceutical company based in Canada, introduced a generic version of Ursodiol (ursodeoxycholic acid) aimed at treating cholestatic liver diseases, including primary biliary cholangitis (PBC). This medication is used to enhance liver function and decelerate liver damage progression, especially when administered early in the disease course. Additionally, it helps dissolve and prevent cholesterol gallstones by altering bile composition and reducing toxic bile acid levels.

In November 2022, Sunshine Biopharma Inc., a pharmaceutical company based in the United States, acquired Nora Pharma Inc. for an undisclosed sum. Through this acquisition, Sunshine Biopharma intends to diversify its revenue sources, strengthen its presence in the generic and biosimilar drug sectors, and make strides toward becoming a fully integrated pharmaceutical company. Nora Pharma Inc., headquartered in Canada, markets ursodeoxycholic acid under the brand name NRA-Ursodiol.

Major players in the ursodeoxycholic acid market are Mankind Pharma Pvt. Ltd, Abbott Healthcare Pvt. Ltd., Shandong Octagon Chemicals Limited, J.S.C. Grindeks, Arch Pharmalabs, Ind Swift Laboratories Ltd., Symbiotec Pharmalab, Suzhou Tianlu Bio-pharmaceutical Co. Ltd, Zeal MediPharma, Prodotti Chimici e Alimentari S.P.A., Mitsubishi Tanabe Pharma Corporation, ICE Pharma Inc, Xi'an Tian Guangyuan Biotech Co. Ltd, Aamorb Pharmaceuticals Inc., Axplora Inc, Octavius Pharma Pvt. Ltd, Sichuan Elixir Pharmaceutical Co. Ltd, Signova Pharma Pvt. Ltd., Sinoway Industrial Co. Ltd, and Valence Labs Pvt. Ltd.

North America was the largest region in the ursodeoxycholic acid market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in ursodeoxycholic acid report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the ursodeoxycholic acid market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Ursodeoxycholic acid (UDCA) is a naturally occurring bile acid produced in small quantities by the human liver. It is utilized as a medication for dissolving specific types of gallstones and for treating various liver and gallbladder conditions. UDCA aids in dissolving cholesterol-based gallstones and enhances bile flow, thereby safeguarding liver cells from damage. It is widely regarded as a safe and effective treatment for managing cholestatic liver diseases.

There are two primary types of ursodeoxycholic acid: synthetic and extracted. Synthetic UDCA is a laboratory-produced form of the natural bile acid, designed to treat liver disorders and dissolve cholesterol gallstones by enhancing bile flow and minimizing liver cell damage. This formulation can be administered orally, via intravenous injection, or subcutaneously. It is mainly prescribed for conditions such as gallstones, primary biliary cholangitis, primary sclerosing cholangitis, and non-alcoholic fatty liver disease. Distribution channels include hospital pharmacies, retail outlets, and online platforms, serving end users such as hospitals, specialized clinics, research centers, and other institutions.

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

The ursodeoxycholic acid market consists of sales of ursodiol tablets, ursodeoxycholic acid capsules, suspensions, injectables, and combination drugs. 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.

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