Global ursodeoxycholic acid market is estimated to witness promising growth, due to increasing adoption in treatment of liver diseases and rising prevalence of obesity
Global Ursodeoxycholic Acid Market is estimated to be valued at USD 590.1 Mn in 2024, exhibiting a CAGR of 10.2% over the forecast period (2024-2031). Increasing usage of ursodeoxycholic acid in treatment of liver diseases such as primary sclerosing cholangitis and primary biliary cholangitis can drive the market growth. Furthermore, rising prevalence of obesity worldwide can also drive the market growth as obese individuals are more prone to develop liver diseases.
Market Dynamics:
Global ursodeoxycholic acid market growth is driven by factors like growing cases of obesity and increasing adoption of UDCA in treatment of liver diseases. Obesity has emerged as a major risk factor for non-alcoholic fatty liver disease (NAFLD), owing to sedentary lifestyle and consumption of junk food. As per WHO, over 1.9 billion adults were overweight in 2016, and out of these, 650 million were obese. This will boost need for ursodeoxycholic acid. Rising focus on development
Increasing prevalence of liver diseases
Ursodeoxycholic acid is a bile acid that is predominantly used for treating liver diseases such as primary biliary cholangitis. Increasing burden of liver diseases globally can boost demand for ursodeoxycholic acid. As per statistical estimates, it is estimated that liver diseases affect over 1 billion people worldwide. Rising prevalence of risk factors such as obesity, excessive alcohol consumption, infections like hepatitis, and others can boost cases of chronic liver diseases. This growing patient pool suffering from conditions indicated for ursodeoxycholic acid treatment can drive the market growth over the forecast period.
Growing awareness regarding benefits of UDCA in gallstone dissolution
Ursodeoxycholic acid is effective in dissolving and preventing the recurrence of gallstones by altering the composition of bile such that cholesterol gets dissolved into it. With growing awareness regarding the role of UDCA in gallstone dissolution, there has been increase in its prescription rates and consumption. Several clinical guidelines now recommend UDCA as the first line treatment for gallstone disease in both adults and children. This increasing clinical acceptance of UDCA for gallstones can drive the market growth.
Intense market competition
Global ursodeoxycholic acid market is highly competitive with presence of numerous generic and branded products. The market participants face pricing pressures due to increasing competition among manufacturers. Moreover, availability of alternative treatment options for diseases indicated for UDCA also adds to the competitive nature of the market. For instance, in primary biliary cholangitis, second line treatments like obeticholic acid are now being preferred over UDCA in moderate to advanced disease stages.
Rising healthcare expenditure and low penetration in developing nations boost opportunities
While developed economies have established healthcare infrastructure and a significant patient pool already under UDCA treatment, the developing world still holds sizeable untapped market potential. Low- and middle-income countries have insufficient access to therapies like UDCA and also have rising healthcare expenditures to enhance access. This acts as a significant opportunity for market stakeholders to penetrate developing markets and benefit from their growing healthcare spending. Furthermore, these regions also have a higher probability of disease occurrence, without adequate diagnosis and management. Low existing penetration levels in developing regions can drive the ursodeoxycholic acid market growth.
Uncertainty around long-term safety profiles
While pharmaceutical applications of ursodeoxycholic acid are well established, there still exist uncertainties regarding its continuous long-term consumption and associated safety risks. Prolonged usage of UDCA has apprehensions around potential carcinogenic effects, even though well-designed clinical studies have not reported clear links. This uncertainty negatively impacts prescriber and patient confidence in UDCA for chronic applications like primary biliary cholangitis. Lack of robust long term safety data is often cited by regulatory agencies for rejecting continuous intake of UDCA beyond 1-2 years.
COVID-19 pandemic disrupted supply chains and manufacturing temporarily
The coronavirus pandemic disrupted global biz activity to a huge extent. The market also faced negative impacts due to restriction induced impediments in 2020. Restricted movement initially disrupted procurement of raw materials as well as distribution of finished products. Social distancing necessitated the reduction of labor in manufacturing plants, limiting capacity utilization. These COVID-19 induced supply chain disruptions hampered market growth. However, operations have resumed gradually with phased reopening across regions and it is estimated COVID-19 impact will recede growth.
Link - https://www.coherentmarketinsights.com/market-insight/ursodeoxycholic-acid-market-2199
Key Developments:
- On August 14, 2024, Gilead Sciences, Inc. announced that the U.S. FDA had granted accelerated approval for Livdelzi (seladelpar) to treat primary biliary cholangitis (PBC) in adults. It can be used with ursodeoxycholic acid (UDCA) for those with an inadequate response, or as monotherapy for those unable to tolerate UDCA. Livdelzi is not recommended for patients with decompensated cirrhosis.
- In June 2024, Ipsen announced that the U.S. FDA had granted accelerated approval for Iqirvo (elafibranor) 80 mg tablets for treating primary biliary cholangitis (PBC) in adults. It can be used in combination with ursodeoxycholic acid (UDCA) for those with an inadequate response to UDCA, or as monotherapy for those unable to tolerate UDCA. Iqirvo is now available for eligible patients in the U.S.
- In April 2022, PharmaZell, Farmabios, and Novasep merged to form Axplora, significantly bolstering the company’s presence in the active pharmaceutical ingredients sector. This merger is expected to propel the market's exponential expansion.
- In August 2020, ICE s.p.a. acquired New Zealand Pharmaceuticals (NZP), a company specializing in the production of active pharmaceutical ingredients (APIs) and intermediates derived from bile. This acquisition enhanced ICE's geographic reach, expanded its product knowledge, and strengthened its bile acid portfolio, contributing to the company's global market expansion.
Key Players:
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, Suzhou Tianlu Bio-pharmaceutical Co., Ltd., Dr. Falk Pharma, Teva Pharmaceuticals, Epic Pharma, Lannett Company, Inc., Mylan N.V., Bruschettini S.p.A., Impax Laboratories, Inc., Shanghai Pharma
