Global Ursodeoxycholic Acid Market – Market Insights
Ursodeoxycholic acid (UDCA) is a bile acid taken as either a tablet or liquid to treat gallstones and to treat and prevent progression of cystic fibrosis-related liver disorders. 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.
Significant improvement in liver health can be achieved through 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$ 457.3 million in 2017 and is expected to exhibit a CAGR of 10.1% over the forecast period (2018 – 2026).
Figure 1. Global Ursodeoxycholic Acid Market Value (US$ Mn), by Region, 2018
Source: Coherent Market Insights Analysis (2019)
Increasing prevalence of gall stones and cystic fibrosis to propel the ursodeoxycholic acid market growth
Ursodeoxycholic acid is being increasingly used for treatment of chronic cholestatic liver diseases. Increasing prevalence of cystic fibrosis and gall stones is the 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.
However, drawbacks such as low efficacy (around 40%), slowness in action, and possibility of stone recurrence are expected to hinder the market growth.
Figure 2. Global Ursodeoxycholic Acid Market Share (%), by Dosage Form, 2026
Source: Coherent Market Insights Analysis (2019)
Increasing research studies on ursodeoxycholic acid to bolster the market growth
Increasing research studies conducted on application of ursodeoxycholic acid (UDCA) in other disease indications is expected to fuel growth of the global ursodeoxycholic acid market. According to the University of Sheffield August 2018 study, UDCA improves mitochondrial dysfunction, which is known to be a causative factor for both sporadic and familial Alzheimer’s disease.
According to the Cure Parkinson’s Trust, U.K. 2018 article, researchers demonstrated that UDCA could protect dopamine cells grown in culture from apoptosis, or programmed cell death, by regulating a specific cell survival pathway.
According to a study published by National Center for Biotechnology Information (NCBI) in 2016, UDCA can be introduced as a novel approach for management of Parkinson's disease through anti-apoptotic and anti-inflammatory mechanisms.
Moreover, UDCA can reduce the rotenone-induced nuclear factor-κB expression and tumor necrosis factor alpha level with its anti-inflammatory properties.
Major players operating in the global ursodeoxycholic acid market include Dipharma Francis Srl, ERREGIERRE S.p.A., Grindeks, Industria Chimica Emiliana, Mitsubishi Tanabe Pharma Corporation, Zhongshan Belling Biotechnology Co., Glenmark Pharmaceutical Limited, Abil Chempharma Private Limited, Biotavia Labs Pvt Ltd, Daewoong Bio Inc., PharmaZell GmbH, and Suzhou Tianlu Bio-pharmaceutical Co., Ltd.
Market players are focused on strategies such as acquisition, in order to expand their offerings and strengthen their market presence in the U.S. For instance, in May 2018, Dipharma Francis Srl acquired Kalexsyn, Inc., a contract research organization (CRO) that provides chemistry services to the biotechnology and pharmaceutical industry. Such strategic moves will strengthen the company’s technical competency in the development of industrial manufacturing processes for active pharmaceutical ingredients (API).
Ursodeoxycholic acid (UDCA) is a naturally occurring bile acid and is used for dissolving gallstones that are rich in cholesterol. It is also used to improve the flow of bile in primary biliary cirrhosis. UDCA solubilizes cholesterol gallstones, and improves liver function in case of cholestatic diseases. UDCA can be obtained from cholic acid, which is the most abundant and least expensive bile acid available.
Factors such as increasing prevalence of gallstones and cystic fibrosis, combined with approval for new indications, is expected to drive market growth over the forecast period. For instance, according to the American Gastroenterological Association 2017 report, gallstones affects 10-15% of the U.S. population annually, which accounts for around 25 million people. In May 2017, IntraBio Ltd. received orphan designation from the European Commission, for ursodeoxycholic acid for the treatment of Niemann-Pick disease. However, the occurrence of possible side effects including nausea, vomiting, itching or dry skin, headache, and sleep disturbances are factors restricting growth of the market.
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