Global Ursodeoxycholic Acid Market
Market Size in USD Billion
CAGR :
% 
USD
638.58 Million
USD
1,378.84 Million
2024
2032
 Forecast Period |
2025 –2032 |
 Market Size (Base Year) |
USD 638.58 Million |
 Market Size (Forecast Year) |
USD 1,378.84 Million |
 CAGR |
% |
| Major Markets Players |
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Global Ursodeoxycholic Acid Market Segmentation, By Type (Synthetic and Biological), Application (Gall Stones and Primary Biliary Cholangitis), Mode (In-house and Contract Manufacturing), Use (Human and Veterinary) - Industry Trends and Forecast to 2032
Ursodeoxycholic Acid Market Size
- The global Ursodeoxycholic Acid market size was valued at USD 638.58 million in 2024 and is expected to reach USD 1,378.84 million by 2032, at a CAGR of 10.10% during the forecast period
- The market growth is primarily driven by the increasing prevalence of liver-related disorders such as primary biliary cholangitis, gallstones, and cystic fibrosis-associated liver disease, coupled with the growing geriatric population
- Moreover, advancements in drug formulation and the rising awareness regarding liver health among consumers and healthcare professionals are propelling the adoption of ursodeoxycholic acid-based treatments. These dynamics are significantly contributing to the market’s expansion across both developed and emerging regions
Ursodeoxycholic Acid Market Analysis
- Ursodeoxycholic acid (UDCA), a secondary bile acid used primarily to treat liver and gallbladder disorders, has become an essential therapeutic agent in managing conditions such as primary biliary cholangitis and cholesterol gallstones due to its hepatoprotective and anti-inflammatory properties
- The increasing demand for ursodeoxycholic acid is largely driven by the rising global prevalence of liver diseases, increasing awareness of hepatobiliary health, and growing prescription rates for chronic liver conditions, especially in aging populations
- North America dominated the ursodeoxycholic acid market with the largest revenue share of 39.4% in 2024, attributed to high diagnosis rates, well-established healthcare infrastructure, and increasing adoption of advanced treatment regimens, with the U.S. witnessing significant demand from both hospitals and specialty clinics
- Asia-Pacific is expected to witness the fastest growth in the ursodeoxycholic acid market during the forecast period, supported by a rising burden of liver disorders, improving healthcare access, and expanding pharmaceutical manufacturing capacities in countries such as China and India
- The synthetic segment dominated the ursodeoxycholic acid market with a market share of 65.9% in 2024, driven by its cost-effectiveness, stable supply chain, and increasing preference among generic drug manufacturers
Report Scope and Ursodeoxycholic Acid Market Segmentation
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Attributes |
Ursodeoxycholic Acid Key Market Insights |
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Segments Covered |
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Countries Covered |
North America
Europe
Asia-Pacific
Middle East and Africa
South America
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Key Market Players |
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Market Opportunities |
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Value Added Data Infosets |
In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include in-depth expert analysis, pricing analysis, brand share analysis, consumer survey, demography analysis, supply chain analysis, value chain analysis, raw material/consumables overview, vendor selection criteria, PESTLE Analysis, Porter Analysis, and regulatory framework. |
Ursodeoxycholic Acid Market Trends
“Increased Application in Non-Liver Diseases and Expanded Formulations”
- A notable and emerging trend in the global ursodeoxycholic acid (UDCA) market is the broadening scope of its clinical applications beyond traditional hepatobiliary disorders, including research into its potential therapeutic benefits for metabolic syndrome, cystic fibrosis, and certain inflammatory and autoimmune diseases
- For instance, recent studies have explored UDCA's role in managing conditions such as non-alcoholic steatohepatitis (NASH), due to its anti-inflammatory and cytoprotective properties. This expanded indication profile is generating renewed interest among researchers and pharmaceutical developers
- Moreover, the development of advanced UDCA formulations such as combination therapies and modified-release capsules is enhancing patient compliance and treatment efficacy. Pharmaceutical companies are working on delivering UDCA in more patient-friendly formats, especially for pediatric and geriatric populations
- Biopharmaceutical companies are also investigating UDCA derivatives and analogs to optimize its absorption and reduce gastrointestinal side effects, aiming to broaden its therapeutic utility and improve tolerability. These innovations are anticipated to significantly expand market reach
- The trend towards personalized medicine is further supporting the demand for UDCA as healthcare providers seek targeted liver therapies based on individual patient profiles and disease etiology. As clinical trials continue to explore UDCA’s multi-system effects, its positioning as a versatile treatment is expected to strengthen
- This shift toward diversified applications and enhanced drug delivery systems is shaping the future direction of the UDCA market, attracting new investments and research collaborations in both established and emerging therapeutic areas
Ursodeoxycholic Acid Market Dynamics
Driver
“Rising Liver Disease Burden and Therapeutic Dependence on UDCA”
- The increasing global incidence of liver-related diseases, including primary biliary cholangitis (PBC), gallstones, and drug-induced liver injury, is a primary driver of the ursodeoxycholic acid market’s growth
- For instance, UDCA remains the only FDA-approved pharmacological therapy for PBC, making it a critical treatment option in hepatology. This regulatory positioning and long-standing clinical use underpin its sustained demand
- The aging population, combined with lifestyle-induced liver disorders such as NASH and alcohol-related liver disease, has further heightened the need for effective hepatoprotective agents such as UDCA
- Increased awareness and early diagnosis of liver diseases, especially in developed healthcare systems, are facilitating higher prescription rates of UDCA. The inclusion of UDCA in clinical guidelines by organizations such as the American Association for the Study of Liver Diseases (AASLD) reinforces its clinical importance
- Government and institutional efforts to expand access to essential medicines in developing countries, along with improving healthcare infrastructure, are also contributing to the global expansion of UDCA utilization
Restraint/Challenge
“Side Effects and Stringent Regulatory Scrutiny”
- Despite its therapeutic benefits, the ursodeoxycholic acid market faces challenges due to potential side effects such as gastrointestinal discomfort, diarrhea, and in rare cases, hypersensitivity reactions. These adverse effects may lead to reduced adherence among sensitive patients
- Furthermore, regulatory agencies such as the FDA and EMA maintain strict requirements for quality, safety, and efficacy in UDCA manufacturing and distribution. Compliance with these standards can result in delays in product approvals, particularly for new formulations or generic entrants
- For instance, inconsistent bioavailability between generic and branded formulations has prompted additional scrutiny in bioequivalence studies, potentially delaying market entry for smaller players
- Patent expirations and pricing pressure in mature markets have also affected the profitability of established brands, while competition among generic manufacturers continues to intensify
- Overcoming these challenges through improved formulation technologies, rigorous clinical testing, and adherence to regulatory frameworks will be crucial for maintaining long-term market competitiveness and patient trust
Ursodeoxycholic Acid Market Scope
The market is segmented on the basis of type, application, mode of manufacturing, and use.
- By Type
On the basis of type, the ursodeoxycholic acid market is segmented into synthetic and biological. The synthetic segment dominated the market with the largest revenue share of 65.9% in 2024, attributed to its cost-efficiency, high availability, and scalable production. Synthetic UDCA is widely used in generic formulations, providing consistent therapeutic outcomes, and is a preferred option for large-scale pharmaceutical manufacturing.
The biological segment is expected to witness the fastest growth rate from 2025 to 2032, driven by increasing research into naturally-derived compounds and growing demand for bio-identical therapies. This growth is supported by regulatory shifts favoring biologics and an increased consumer preference for naturally sourced ingredients, especially in premium and personalized medicine sectors.
- By Application
On the basis of application, the ursodeoxycholic acid market is segmented into gallstones and primary biliary cholangitis (PBC). The gallstones segment accounted for the highest market share in 2024, as UDCA remains a frontline, non-surgical therapy for cholesterol gallstones, especially in patients unfit for surgery or seeking non-invasive treatment. Rising incidences of gallstone formation due to sedentary lifestyles and dietary factors are fueling segment growth.
The primary biliary cholangitis segment is projected to register the fastest CAGR through 2032, as UDCA is the only FDA-approved therapy for PBC. Increased awareness and early diagnosis of autoimmune liver diseases are contributing to rising prescriptions, particularly in North America and Europe, where healthcare access and diagnostic rates are higher.
- By Mode of Manufacturing
On the basis of mode, the ursodeoxycholic acid market is divided into in-house and contract manufacturing. The in-house manufacturing segment dominated the market in 2024, supported by large pharmaceutical companies’ vertical integration strategies to ensure quality control, regulatory compliance, and cost savings. In-house production also enables firms to closely manage supply chains and adapt to fluctuating raw material prices.
The contract manufacturing segment is expected to experience faster growth from 2025 to 2032, driven by increasing outsourcing trends among small and mid-sized pharmaceutical players seeking to reduce operational burdens and expand global reach. The growing network of specialized CDMOs (Contract Development and Manufacturing Organizations) with expertise in bile acid processing supports this segment's rapid expansion.
- By Use
On the basis of use, the ursodeoxycholic acid market is bifurcated into human and veterinary. The human segment held the largest market share in 2024, as UDCA remains a well-established treatment for chronic liver disorders, with broad adoption across hospitals, specialty clinics, and retail pharmacies. High prescription volume and extensive clinical validation reinforce this segment's dominance.
The veterinary segment is expected to grow at the fastest rate from 2025 to 2032, owing to rising attention toward animal liver health, especially in companion animals such as dogs and cats suffering from cholestatic liver diseases. Increasing veterinary drug approvals and specialized pet care awareness are encouraging the use of UDCA in veterinary applications.
Ursodeoxycholic Acid Market Regional Analysis
- North America dominated the ursodeoxycholic acid market with the largest revenue share of 39.4% in 2024, attributed to high diagnosis rates, well-established healthcare infrastructure, and increasing adoption of advanced treatment regimens
- Patients and healthcare providers in the region prioritize evidence-based therapies, with UDCA being the first-line treatment for conditions such as primary biliary cholangitis and gallstones, supported by strong clinical guidelines
- This market leadership is further reinforced by high diagnosis rates, an aging population, and the presence of leading pharmaceutical companies engaged in UDCA production and research, solidifying North America’s role as a key consumer and innovator in the global UDCA market
U.S. Ursodeoxycholic Acid Market Insight
The U.S. ursodeoxycholic acid market captured the largest revenue share of 79% in 2024 within North America, driven by the country’s high prevalence of liver and gallbladder disorders, advanced diagnostic capabilities, and established treatment guidelines. The widespread clinical use of UDCA for conditions such as primary biliary cholangitis and gallstones supports consistent demand. Moreover, a strong pharmaceutical presence, along with ongoing research into expanded UDCA indications, reinforces the market's growth. Insurance coverage and reimbursement policies for liver disease therapies further promote UDCA usage.
Europe Ursodeoxycholic Acid Market Insight
The Europe ursodeoxycholic acid market is projected to expand at a substantial CAGR throughout the forecast period, supported by a rising incidence of liver diseases and the aging population. Regulatory approvals for UDCA as a first-line therapy in managing chronic cholestatic liver disorders underpin its strong clinical adoption. In addition, national health systems across countries such as Germany, France, and Italy ensure broad access to essential medicines, fostering steady market growth. Increased clinical trials exploring UDCA’s application beyond liver conditions are also enhancing its relevance across Europe.
U.K. Ursodeoxycholic Acid Market Insight
The U.K. ursodeoxycholic acid market is anticipated to grow at a noteworthy CAGR during the forecast period, driven by the rising awareness of liver health and the National Health Service’s support for UDCA therapy in standard treatment protocols. Growing diagnoses of autoimmune liver conditions and gallstones, along with academic research into new hepatobiliary therapies, is expected to sustain market momentum. The presence of key pharmaceutical companies and a favorable regulatory landscape encourage the availability of both branded and generic UDCA products.
Germany Ursodeoxycholic Acid Market Insight
The Germany ursodeoxycholic acid market is expected to expand at a considerable CAGR during the forecast period, supported by a strong healthcare infrastructure, early adoption of evidence-based therapies, and increasing rates of chronic liver disease. Germany's rigorous pharmacovigilance and emphasis on high-quality medications contribute to the dominance of clinically proven treatments such as UDCA. Moreover, the country’s robust pharmaceutical manufacturing sector plays a critical role in both domestic supply and export potential, enhancing market resilience.
Asia-Pacific Ursodeoxycholic Acid Market Insight
The Asia-Pacific ursodeoxycholic acid market is poised to grow at the fastest CAGR of 22.4% during the forecast period of 2025 to 2032, fueled by rising healthcare awareness, increasing liver disease burden, and growing access to diagnostics in countries such as China, Japan, and India. Government healthcare initiatives and the expansion of insurance schemes are improving treatment accessibility. Furthermore, cost-effective production and a growing presence of generic manufacturers are making UDCA more affordable, broadening its reach across diverse population segments.
Japan Ursodeoxycholic Acid Market Insight
The Japan ursodeoxycholic acid market is gaining traction due to the country’s aging demographic, high liver disease prevalence, and advanced healthcare system. UDCA is well established in Japan’s therapeutic landscape, particularly for managing primary biliary cholangitis and gallstones. The market is further driven by continued research into bile acid metabolism and personalized medicine. Japan’s regulatory support for innovative formulations and emphasis on patient-centric care contribute to increasing adoption of UDCA therapies.
India Ursodeoxycholic Acid Market Insight
The India ursodeoxycholic acid market accounted for the largest market revenue share in Asia Pacific in 2024, attributed to rising liver disease cases, rapid healthcare infrastructure development, and increased public health awareness. The country’s growing middle class and large population base contribute to rising demand for affordable, effective hepatoprotective therapies. Domestic pharmaceutical companies play a key role in manufacturing and distributing generic UDCA, making it widely accessible. Government initiatives promoting essential drug availability are also propelling market expansion.
Ursodeoxycholic Acid Market Share
The Ursodeoxycholic Acid industry is primarily led by well-established companies, including:
- Dr. Falk Pharma GmbH (Germany)
- Zydus Lifesciences Limited (India)
- Mitsubishi Tanabe Pharma Corporation (Japan)
- Sanofi (France)
- Apotex Inc. (Canada)
- Teva Pharmaceutical Industries Ltd. (Israel)
- Sun Pharmaceutical Industries Ltd. (India)
- Cadila Pharmaceuticals Ltd. (India)
- Glenmark Pharmaceuticals Ltd. (India)
- Amneal Pharmaceuticals LLC (U.S.)
- Strides Pharma Science Limited (India)
- Allergan plc (Ireland)
- Macleods Pharmaceuticals Ltd. (India)
- Alkem Laboratories Ltd. (India)
- Cipla Limited (India)
- Hikma Pharmaceuticals PLC (U.K.)
- Torrent Pharmaceuticals Ltd. (India)
- PharmaZell GmbH (Germany)
- Lupin Limited (India)
- Wockhardt Ltd. (India)
What are the Recent Developments in Global Ursodeoxycholic Acid Market?
- In May 2024, Dr. Falk Pharma GmbH, a global leader in hepatology, announced the initiation of a new clinical trial assessing the long-term benefits of ursodeoxycholic acid in combination with novel agents for patients with primary biliary cholangitis (PBC). This study aims to expand therapeutic protocols and improve quality of life for patients with chronic liver conditions. The development reflects Dr. Falk’s ongoing commitment to advancing evidence-based care in hepatobiliary medicine
- In April 2024, Zydus Lifesciences Ltd., a major Indian pharmaceutical company, received approval from the U.S. FDA for its generic version of ursodeoxycholic acid tablets, expanding its presence in the U.S. generics market. This milestone not only enhances access to affordable liver disease treatments but also strengthens Zydus’s footprint in regulated markets with a focus on essential therapeutic areas
- In February 2024, Mitsubishi Tanabe Pharma Corporation announced positive real-world data from a post-marketing surveillance study in Japan on the efficacy and tolerability of UDCA in treating intrahepatic cholestasis. The study supports UDCA’s continued relevance in managing complex liver diseases and reinforces the brand’s trust among healthcare providers
- In January 2024, Sanofi S.A. launched a liver health awareness campaign across select European countries, emphasizing early diagnosis and the benefits of ursodeoxycholic acid in managing bile acid disorders. The campaign aims to improve public knowledge, encourage regular liver function screenings, and boost treatment adherence, especially among aging populations at higher risk for chronic liver diseases
- In December 2023, Apotex Inc., a Canadian pharmaceutical company, entered a distribution agreement to expand the availability of its UDCA formulations in Latin America. The collaboration supports Apotex’s strategy of reaching underserved markets with cost-effective, high-quality generics and addresses the rising burden of liver diseases in the region through improved accessibility to essential medications
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Research Methodology
Data collection and base year analysis are done using data collection modules with large sample sizes. The stage includes obtaining market information or related data through various sources and strategies. It includes examining and planning all the data acquired from the past in advance. It likewise envelops the examination of information inconsistencies seen across different information sources. The market data is analysed and estimated using market statistical and coherent models. Also, market share analysis and key trend analysis are the major success factors in the market report. To know more, please request an analyst call or drop down your inquiry.
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