Ursodeoxycholic Acid

Global Ursodeoxycholic Acid Market to Reach US$1.0 Billion by 2030

The global market for Ursodeoxycholic Acid estimated at US$572.1 Million in the year 2024, is expected to reach US$1.0 Billion by 2030, growing at a CAGR of 10.3% over the analysis period 2024-2030. Solid Dosage Form, one of the segments analyzed in the report, is expected to record a 11.4% CAGR and reach US$767.7 Million by the end of the analysis period. Growth in the Liquid Dosage Form segment is estimated at 7.4% CAGR over the analysis period.

The U.S. Market is Estimated at US$155.9 Million While China is Forecast to Grow at 14.2% CAGR

The Ursodeoxycholic Acid market in the U.S. is estimated at US$155.9 Million in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$212.9 Million by the year 2030 trailing a CAGR of 14.2% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 7.3% and 9.1% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 8.1% CAGR.

Global Ursodeoxycholic Acid Market – Key Trends & Drivers Summarized

Why Is Ursodeoxycholic Acid Central to Modern Hepatobiliary Therapies?

Ursodeoxycholic acid (UDCA), a secondary bile acid originally found in bear bile and now synthesized for pharmaceutical use, has become a cornerstone treatment for several chronic liver and gallbladder-related disorders. It plays a pivotal role in managing primary biliary cholangitis (PBC), gallstone dissolution in non-candidates for surgery, and intrahepatic cholestasis of pregnancy (ICP), among other conditions. As the global burden of liver diseases continues to rise—driven by alcohol consumption, metabolic syndrome, hepatitis infections, and autoimmune liver diseases—the need for effective, non-invasive treatments like UDCA is more urgent than ever. Its ability to improve bile flow, reduce bile acid toxicity, and protect hepatocytes makes it a first-line option for many hepatologists. Notably, UDCA’s use in pediatrics is expanding, especially in treating neonatal cholestasis and cystic fibrosis-related liver complications. With an aging global population and increasing liver disease screening rates, the clinical relevance of UDCA is only intensifying. Its non-surgical nature, relatively favorable side effect profile, and ability to delay disease progression without immunosuppression make it an indispensable asset in chronic liver care.

How Are Innovations in Formulations and Delivery Enhancing Efficacy and Patient Adherence?

Formulation innovation is playing a crucial role in expanding the usability and effectiveness of ursodeoxycholic acid across varied patient demographics. Traditional UDCA tablets and capsules are being reformulated into dispersible, chewable, and liquid forms to cater to pediatric patients and those with dysphagia. Sustained-release and microencapsulated delivery formats are also emerging, designed to offer more stable bile acid levels and better bioavailability over longer durations. In parallel, fixed-dose combinations of UDCA with other bile acid modulators or antioxidants are being developed to enhance therapeutic impact, particularly in patients with advanced liver dysfunction. Additionally, pharmaceutical manufacturers are optimizing excipients to improve gastrointestinal tolerance, one of the main reasons patients discontinue long-term UDCA therapy. These improvements in delivery systems are not only enhancing compliance but also reducing variability in drug absorption, which is critical in chronic, slow-progressing diseases like PBC. Research is also underway to understand the potential synergistic effects of combining UDCA with next-generation agents like FXR agonists or obeticholic acid, potentially ushering in a new era of combination hepatoprotective therapies.

Why Are Global Health Trends Creating New Opportunities for UDCA Utilization?

Several macro health trends are aligning to widen the therapeutic and commercial scope of UDCA. First, the surge in non-alcoholic fatty liver disease (NAFLD) and its more severe form, non-alcoholic steatohepatitis (NASH), is prompting off-label interest in bile acid modulators, including UDCA, for their cytoprotective and anti-inflammatory properties. Although not yet formally approved for NASH, UDCA continues to be studied and sometimes prescribed as adjunct therapy in specific cases. Secondly, rising awareness and diagnosis of rare autoimmune liver diseases—facilitated by improved serological testing and patient registries—are expanding the eligible patient pool for UDCA. In obstetrics, greater screening for intrahepatic cholestasis of pregnancy in high-risk groups, including those with twin pregnancies or IVF histories, is increasing UDCA prescriptions as a frontline intervention to reduce perinatal complications. Furthermore, evolving global pharmacovigilance standards are helping clinicians identify and manage adverse drug interactions more effectively, ensuring safer long-term use of UDCA even in polypharmacy scenarios. As public health priorities shift toward early detection and preventive liver care, UDCA’s role is being reinforced in both specialist and primary care pathways.

What Are the Key Factors Driving Growth in the Ursodeoxycholic Acid Market?

The growth in the ursodeoxycholic acid market is driven by several factors tied to disease prevalence, pharmaceutical innovation, and global healthcare accessibility. Increasing incidence of chronic liver diseases—including PBC, cholestatic liver disorders, and bile acid metabolism abnormalities—is driving demand across both adult and pediatric populations. Advances in drug formulation technologies are enabling wider adoption through patient-friendly delivery formats such as oral liquids and delayed-release tablets, which cater to diverse age groups and comorbidities. The expanding scope of UDCA in managing conditions like ICP and its exploration in NAFLD/NASH management are further propelling demand. Regulatory approvals and updated clinical guidelines in Europe, North America, and Asia-Pacific are legitimizing wider use, especially as newer bile acid therapies remain costlier or less accessible. Additionally, the rise in routine liver function testing and better diagnostic capabilities are allowing earlier initiation of therapy, increasing lifetime treatment value. Pharmaceutical market dynamics, such as the growth of generics and increased API manufacturing in Asia, are lowering treatment costs and supporting market expansion in emerging economies. Collectively, these factors are shaping a robust and upward growth trajectory for the UDCA market.

SCOPE OF STUDY:

The report analyzes the Ursodeoxycholic Acid market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Dosage Form (Solid Dosage Form, Liquid Dosage Form); Mode of Extraction (Synthetic, Biological); Application (Gastrointestinal Disorders, Liver Disorders, Cystic Fibrosis, Other Applications); Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Select Competitors (Total 42 Featured) -

• ABC Farmaceutici SpA
• Adare Pharma Solutions
• ALP Pharm
• Anhui Biochem Pharmaceutical Co., Ltd.
• API Corporation
• Apicore
• Arch Pharmalabs Ltd.
• Asia Pioneer Pharmaceuticals
• Axplora
• Beijing Geyuantianrun Bio-tech Co., Ltd.
• Chengdu Chenlv Biological Technology Co., Ltd.
• Daewoong Pharmaceutical Co., Ltd.
• Dipharma Francis S.r.l.
• Erregierre S.p.A.
• Glenmark Pharmaceuticals Ltd.
• Grindeks
• Guangzhou Tosun Pharmaceutical Co., Ltd.
• Hanways Chempharm Co., Ltd.
• ICE Pharma
• Mankind Pharma Ltd.

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