Ursodeoxycholic acid (UDCA) is a bile acid taken as either a tablet or liquid to treat gallstones and to treat and prevent the progression of cystic fibrosis-related liver disorder. UDCA modifies the bile acid pool by decreasing levels of hydrophobic bile acids while increasing proportion of nontoxic hydrophilic bile acids. UDCA can delay development of gastroesophageal varices and progression to cirrhosis. Moreover it can improve long-term survival in patients with primary biliary cirrhosis.

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Significant improvement in liver health can be achieved during UDCA therapy in patients with intrahepatic cholestasis of pregnancy, primary sclerosing cholangitis, nonalcoholic fatty liver disease, cystic fibrosis-associated liver disease, total parenteral nutrition-induced cholestasis, graft related liver disease, and in some pediatric cholestatic liver diseases.

The global ursodeoxycholic acid market size was valued at US$ 346.2 million in 2017, and is expected to witness a CAGR of 7.0% over the forecast period (2018 – 2026).

Market Dynamics

Increasing incidence of gallstones and cystic fibrosis is expected to propel demand for UDCA, thereby driving the ursodeoxycholic acid market growth. According to a study published in the journal Gastroenterology, 2009, cholelithiasis, the presence of gallstones in the gallbladder, is estimated to occur in 10 – 15% of the adult population in the U.S. Although, gallstones can occur at any age, it is rare before the age of 30. A progressive increase in risk of cholelithiasis is observed with age and in patients over 50, the prevalence ranges is between 25-30%.

Increasing prevalence of gall stones and cystic fibrosis is expected to drive growth of the ursodeoxycholic acid market

Ursodeoxycholic acid is increasingly being used for the treatment of chronic cholestatic liver diseases. Increasing prevalence of cystic fibrosis and gall stones is a major factor driving growth of the global ursodeoxycholic acid market during the forecast period. According to the Cystic Fibrosis Foundation 2015 data, around 30,000 people suffered from cystic fibrosis in the U.S. Moreover, around 1,000 new cases of cystic fibrosis are diagnosed in the country, annually. According to the American Gastroenterological Association 2017 report, gallstones is affecting 10-15% of the U.S. population annually, which accounts for around 25 million people.

Women are more likely to develop gallstones in comparison to men. High estrogen levels during pregnancy, birth control pills or hormone replacement therapy are the major factors that produce gallstones in women. Moreover, occurrence of gallstones is also high in older adults and individuals with a family history of gallstones. Surgery is the usual treatment for symptomatic gallstones, however treatment with ursodeoxycholic acid can dissolve smaller stones, which are made mainly of cholesterol.
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Ursodeoxycholic Acid Market - Competitive Landscape

Key players operating in the global ursodeoxycholic acid market include, Abil Chempharma, Arcelor Chemicals, Biotavia Labs, Daewoong Chemical, Dipharma Francis, Erregierre, Grindeks, ICE, Mitsubishi Tanabe, Pharma Zell, Suzhou Tianlu, and Zhangshanbelling.

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