• April 2022, three companies PharmaZell, Farmabios and Novasep merged to become Axplora. This merger strengthened and increased the active pharmaceutical ingredients sector of the company which is expected to generate more revenue. This will be the market to grow exponentially

• August 2020, ICE s.p.a. acquired New Zealand Pharmaceuticals (NZP), manufacture a range of active pharmaceutical ingredients (API’s) and pharmaceutical intermediates derived from bile. This gave better geographic coverage, product knowledge and expansion of bile acid, thereby it helped to increase the product portfolio. This will help the market to expand globally.

In this report, the Ursodeoxycholic Acid Market has been segmented by Dosage Form, Mode of Extraction, Application and Geography.

Ursodeoxycholic Acid Market, Segmentation by Dosage Form

The Ursodeoxycholic Acid Market has been segmented by Dosage Form into Solid and Liquid.

Solid

Solid dosage forms lead the ursodeoxycholic acid market with approximately 80% share. Preferred in the form of tablets and capsules, these formats offer convenient administration, stability, and high patient adherence, making them the first choice in treating liver and gallbladder diseases.

Liquid

Liquid formulations account for nearly 20% of the market. Ideal for pediatric and elderly populations, they provide easy-to-swallow options and are frequently used in clinical and home-based care where solid forms may not be suitable.

Ursodeoxycholic Acid Market, Segmentation by Mode of Extraction

The Ursodeoxycholic Acid Market has been segmented by Mode of Extraction into Synthetic and Biological.

Synthetic

Synthetic ursodeoxycholic acid leads the market with an estimated 85% share. Known for its high purity, batch consistency, and cost-efficiency, it is the preferred extraction method for pharmaceutical companies seeking scalable and controlled production.

Biological

Biological extraction methods account for nearly 15% of the market. Sourced from natural bile derivatives, this segment appeals to consumers seeking naturally derived formulations, though its limited scalability and complex regulations restrain widespread adoption.

Ursodeoxycholic Acid Market, Segmentation by Route of Administration

The Ursodeoxycholic Acid Market has been segmented by Route of Administration into Oral and Intravenous.

Oral

Oral administration leads the ursodeoxycholic acid market with nearly 92% share. It is widely preferred in the form of capsules and tablets due to its ease of use, safety profile, and effectiveness in treating chronic liver diseases and gallstones, particularly in outpatient settings.

Intravenous

Intravenous administration accounts for around 8% of the market. Though less common, it is essential in cases where oral intake is not feasible, such as in critically ill or post-operative patients, and is typically limited to inpatient care environments.

Ursodeoxycholic Acid Market, Segmentation by Application

The Ursodeoxycholic Acid Market has been segmented by Application into Gallstones, Cystic Fibrosis, Liver Cirrhosis and Others.

Gallstones

Gallstones dominate the ursodeoxycholic acid market with a share of approximately 50%. The drug is highly effective in dissolving cholesterol-rich gallstones, especially in patients who are unfit for surgery, making it the most widely prescribed indication across outpatient care settings.

Cystic Fibrosis

Cystic fibrosis accounts for nearly 20% of the market. Ursodeoxycholic acid improves biliary secretion and liver function in CF patients, particularly those with hepatic involvement, making it a key therapy in long-term disease management.

Liver Cirrhosis

Liver cirrhosis represents about 20% of global application share. UDCA is used in treating biliary cirrhosis and primary sclerosing cholangitis, where it helps delay disease progression and supports liver function stabilization.

Others

The others segment makes up around 10% of the market and includes rare conditions like intrahepatic cholestasis of pregnancy (ICP). Growing clinical trials and off-label applications are driving interest in this niche but emerging area.

Ursodeoxycholic Acid Market, Segmentation by Geography

In this report, the Ursodeoxycholic Acid Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Ursodeoxycholic Acid Market Share (%), by Geographical Region, 2024

North America

North America dominates the ursodeoxycholic acid market with an estimated 38% share. The region’s leadership is supported by a high prevalence of gallstone and liver conditions, advanced pharmaceutical distribution networks, and widespread awareness of hepatobiliary health.

Europe

Europe holds approximately 27% of the market. The region benefits from well-established healthcare systems, favorable drug reimbursement policies, and a rising elderly population that frequently requires long-term liver disease management.

Asia Pacific

Asia Pacific makes up around 23% and shows the fastest growth due to the rising burden of chronic liver disorders, expanding access to affordable generics, and growing investments in public healthcare infrastructure.

Middle East and Africa

Middle East and Africa contribute close to 6% of the global market. While infrastructure gaps persist, improvements in diagnostic capabilities and government health initiatives are enabling steady regional market growth.

Latin America

Latin America accounts for nearly 6% of the market. Expanding healthcare access, a rising focus on liver health awareness, and availability of low-cost UDCA options support demand across key countries like Brazil and Mexico.

This report provides an in depth analysis of various factors that impact the dynamics of Global Ursodeoxycholic Acid Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunities Analysis.

Drivers

• Liver disease prevalence
• Increasing pharmaceutical applications

• Rising demand for cholestatic liver disorders - Rising demand for cholestatic liver disorder treatments is a key driver of growth in the ursodeoxycholic acid market. Cholestatic liver diseases, including primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), are being diagnosed more frequently due to improved awareness and advancements in diagnostic capabilities. Ursodeoxycholic acid is widely recognized as a first-line therapy for these conditions, offering effective bile flow regulation and liver function improvement, which has led to increased global usage.
  
  As the prevalence of liver-related autoimmune and metabolic disorders continues to rise, especially in aging and at-risk populations, the need for long-term pharmacological management is also growing. Healthcare providers are increasingly prescribing ursodeoxycholic acid for its proven efficacy and favorable safety profile, contributing to the expanding demand for targeted liver disease therapies and fueling steady market expansion.

Restraints

• Side effects concerns
• Stringent regulatory requirements

• Limited awareness in developing regions - Limited awareness in developing regions acts as a significant restraint on the growth of the ursodeoxycholic acid market. In many low- and middle-income countries, there is a lack of knowledge among both healthcare providers and patients about cholestatic liver disorders and their available treatments. This results in delayed diagnosis, under-treatment, and minimal use of specialized therapies like ursodeoxycholic acid, even when symptoms are present.

  The absence of widespread screening programs, limited access to hepatology specialists, and insufficient healthcare education further contribute to the low adoption of ursodeoxycholic acid in these areas. Without targeted awareness initiatives and improvements in diagnostic infrastructure, market penetration remains restricted, despite the growing burden of liver diseases in these regions.

Opportunities

• Technological advancements in production
• Emerging markets expansion
• Novel therapeutic applications

• Collaborative research and development efforts - Collaborative research and development efforts present a significant opportunity for the growth of the ursodeoxycholic acid market. Pharmaceutical companies, academic institutions, and healthcare organizations are increasingly forming partnerships to explore new indications, optimize formulations, and improve therapeutic outcomes for liver diseases. These collaborations accelerate innovation by combining clinical expertise, research capabilities, and financial resources, fostering the development of more effective treatment protocols involving ursodeoxycholic acid.

  Such joint efforts also support clinical trials and real-world studies that validate the drug’s efficacy in broader applications, including metabolic and pediatric liver disorders. As these partnerships yield more evidence-based data, they enhance market credibility and regulatory acceptance, encouraging wider adoption and enabling access to new patient populations across global markets.

Key players in Global Ursodeoxycholic Acid Market include:

• Daewoong Pharmaceutical Co., Ltd
• Mitsubishi Tanabe Pharma Corporation
• Dr. Falk Pharma GmbH
• Grindeks
• Dipharma Francis S.r.l
• Zhejiang Jiuzhou Pharmaceutical Co., Ltd
• Suzhou Tianlu Bio-Pharmaceutical Co., Ltd
• Biotavia Labservices Pvt. Ltd
• Zydus Pharmaceuticals Ltd
• Taj Pharmaceuticals Limited

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis