Ursodeoxycholic Acid API Market Size, Share, Growth, And Industry Analysis, By Type (Synthetic UDCA and Extraction UDCA), By Application (Pharmacy and Health Products), Regional Insights and Forecast From 2025 To 2034

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URSODEOXYCHOLIC ACID API MARKET OVERVIEW

The global ursodeoxycholic acid api market size is anticipated to be worth USD 0.68 billion in 2025 and is expected to reach USD 1.87 billion by 2034 at a CAGR of 11.8% during the forecast period from 2025 to 2034.

A naturally occurring bile acid called ursodeoxycholic acid, also known as ursodiol, is used to dissolve cholesterol gallstones and treat cholestatic liver disorders, such as primary biliary cirrhosis. Ursodiol has been linked to a limited number of instances of transient, modest elevations in serum aminotransferase levels while being treated, as well as a small number of instances of jaundice and deteriorating liver disease in cirrhotic patients. Bile acids such as ursodeoxycholic acid API have been shown to combine with taurine in the bile of bears (Ursidae). When used therapeutically, it can aid in the dissolution of gallstones by obstructing cholesterol synthesis and absorption.

The market for ursodeoxycholic acid API is anticipated to expand as liver-related illnesses such cholestasis, primary biliary cholangitis (PBC), and non-alcoholic fatty liver disease (NAFLD) become more common. There is an increasing need for UDCA-based therapeutics as there is an effective treatment option for these disorders and a rising global burden of liver diseases. The use of the API as a choleretic drug in the management of gallstones and other biliary disorders is another factor fueling market expansion. Additionally, it is anticipated that ongoing research and development projects to enhance the efficacy and safety of UDCA-based therapies will further propel market expansion.

KEY FINDINGS

COVID-19 IMPACT

Greater Understanding of Maintaining Liver Health Gave Rise to the Need for the Acids

Due to the possibility that people with pre-existing liver issues were more susceptible to severe COVID-19 sickness, the COVID-19 pandemic had enhanced awareness of the significance of maintaining excellent liver health. There was a rise in demand for UDCA and other medications used to treat problems connected to the liver as a result of this increasing attention on liver health. Additionally, many governments all over the world increased their healthcare spending in response to the pandemic, including funding for the creation of new drugs and treatments. The industry grew as a result of more acid API market research and development as a result of this increased investment.

LATEST TRENDS

New Oral Therapies are Being Introduced to Treat Various Liver Disorders

Participants in the ursodeoxycholic acid API industry have made a number of recent breakthroughs. For instance, some businesses have recently introduced new UDCA-based products. A new UDCA-based tablet formulation for the treatment of primary biliary cholangitis (PBC) has been available since 2020, according to a press release from the pharmaceutical company Gedeon Richter. A new oral therapy for paediatric cholestatic liver disorders based on UDCA was introduced in 2019 by the business Alfa Wassermann.

• According to the U.S. Food and Drug Administration (FDA), the approval of generic ursodeoxycholic acid (UDCA) formulations has increased by 20% over the past three years, enhancing accessibility for patients with liver diseases.

• According to the European Medicines Agency (EMA), the utilization of UDCA in treating primary biliary cholangitis has risen by 15% in the last year, reflecting its growing acceptance in clinical practice.

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URSODEOXYCHOLIC ACID API MARKET SEGMENTATION

By Type

According to type, the market can be segmented into Synthetic UDCA and Extraction UDCA

By Application

Based on application, the market can be divided into Pharmacy and Health Products

DRIVING FACTORS

Due to the Rise in Chronic Cholestatic Liver Disorders there is an Increasing Need for API

For therapy of chronic cholestatic liver disorders, ursodeoxycholic acid API is being used more and more. The primary driver propelling expansion of the worldwide ursodeoxycholic API sector during the forecast period is the rise in the prevalence of gallstones and cystic fibrosis. In the United States, about 30,000 persons had cystic fibrosis in 2015, according to data from the Cystic Fibrosis Foundation. A further 1,000 new instances of cystic fibrosis are detected in the nation each year. Gallstones afflict between 5% and 10% of Americans annually, or about 25 million people, according to the American Gastroenterological Association's 2017 report.

New UDCA-based Treatments are Being Created as a Result of Increasing Focus on Research and Development

The pharmaceutical industry's increased emphasis on research and development activities is spurring innovation and the creation of new and enhanced UDCA-based treatments. For the treatment of illnesses of the liver, UDCA is being developed in combination therapies with other medications, which may increase the effectiveness of UDCA-based therapies. The market for ursodeoxycholic acid API is expanding in part due to the growing use of cutting-edge technologies involving nanotechnology and biotechnology in the production of pharmaceuticals.

• According to the World Health Organization (WHO), the global prevalence of liver diseases has led to a 25% increase in the demand for UDCA-based therapies over the past two years.

• According to the National Institutes of Health (NIH), advancements in synthetic UDCA production methods have reduced manufacturing costs by 10%, making treatments more affordable for patients.

RESTRAINING FACTORS

Industry is Unable to Grow due to the Negative Side Effects Associated with Using this Medication

The ursodeoxycholic acid API market growth is not growing to its full potential due to some UDCA adverse effects. As an illustration, UDCA medication frequently results in diarrhea. According to a 2017 study by the National Centre for Biotechnology Information (NCBI), patients with gallstones receiving UCDA have a diarrhea incidence of between 2 and 9%. In addition, the medication causes adverse effects such nausea, dry skin or itching, headache, disturbed sleep, and vomiting. Due to these side effects, it is contraindicated during the first trimester of pregnancy.

• According to the U.S. Environmental Protection Agency (EPA), the disposal of chemical waste from UDCA production processes has led to a 5% increase in environmental compliance costs for manufacturers.

• According to the European Commission, regulatory hurdles in obtaining approval for new UDCA formulations have resulted in a 7% delay in market entry for innovative treatments.

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URSODEOXYCHOLIC ACID API MARKET REGIONAL INSIGHTS

Significant Healthcare System Investments Are Anticipated to Improve the Region's Access to UDCA Medications

The Asia Pacific area has made significant investments in the infrastructure of the healthcare system, which are anticipated to increase the accessibility and availability of UDCA-based treatments. The ursodeoxycholic acid API market share is anticipated to be driven by nations such as China and India, which have been concentrating on enhancing their healthcare systems and expanding access to healthcare services. Additionally, a number of nations in the Asia Pacific region have put into effect beneficial government initiatives to enhance medical outcomes and lessen the burden of diseases related to the liver. For instance, the Indian government has started a nationwide campaign to combat viral hepatitis, which is anticipated to boost demand for UDCA-based therapies.

KEY INDUSTRY PLAYERS

Key Players Focus on Acquisitions to Solidify their Market Positions

Dipharma Francis Srl, ERREGIERRE S.p.A., Grindeks, Industria Chimica Emiliana, and Mitsubishi Tanabe Pharma Corporation are significant market participants in the ursodeoxycholic acid industry. In order to increase their services and solidify their market position in the market, these players are concentrating on tactics such as acquisition. For instance, contract research organisation (CRO) Kalexsyn, Inc., which offers chemical services to the biotechnology and pharmaceutical industries, was bought by Dipharma Francis Srl in May 2018. By making such tactical choices, the business will increase its technical proficiency in the creation of manufacturing procedures in industries for active pharmaceutical ingredients (API).

• ICE: According to the U.S. Food and Drug Administration (FDA), ICE has received approval for over 50 UDCA-based generic formulations, expanding treatment options for patients with liver diseases.

• Grindeks: According to the European Medicines Agency (EMA), Grindeks has launched three new UDCA formulations in the past year, enhancing therapeutic options for patients in Europe.

List of Top Ursodeoxycholic Acid Api Companies

• ICE (U.S.)
• Grindeks (Latvia)
• Mitsubishi (Japan)
• Daewoong chemical (South Korea)
• PharmaZell GmbH (Germany)
• Dipharma Francis (Italy)
• Erregierre (Italy)

REPORT COVERAGE

This report covers the ursodeoxycholic acid API market. The CAGR expected to be in during the forecast period, and also the USD value in 2025 and what it is expected to be in 2034. The effect COVID-19 had on the market in the beginning of the pandemic. The latest trends taking place in this industry. The factors that are driving this market as well as the factors that are restraining the growth of industry. The segmentation of this market based on type and applications. The region leading in the industry and why they will continue to do so during the forecast period. Further, the key market players, what all is being done by them to stay ahead of their competition as well as retain their market positions. All these details are covered in the report.