Global Ursodeoxycholic Acid Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

• 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.

Ursodeoxycholic acid (UDCA) is a bile acid derivative primarily used in the treatment of certain liver diseases, particularly gallstones and cholestatic liver diseases. The global UDCA market has witnessed steady growth over recent years, driven by rising incidences of liver diseases worldwide and increasing awareness regarding the efficacy of UDCA in managing these conditions. Additionally, the expanding geriatric population, who are more prone to liver ailments, further fuels market growth.

One significant factor contributing to market expansion is the growing demand for UDCA as a therapeutic option for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), which are becoming increasingly prevalent due to sedentary lifestyles and poor dietary habits. Moreover, ongoing research and development activities aimed at exploring the potential applications of UDCA in treating other medical conditions, such as metabolic disorders and certain cancers, are anticipated to propel market growth further.

Regionally, North America and Europe are the leading markets for UDCA, owing to well-established healthcare infrastructure, high healthcare expenditure, and a large patient pool suffering from liver diseases. However, the Asia-Pacific region is expected to exhibit the fastest growth rate during the forecast period, attributed to improving healthcare facilities, rising disposable income levels, and increasing awareness regarding liver health among the populace.

Despite the promising growth prospects, the UDCA market faces challenges such as stringent regulatory requirements and the presence of alternative treatment options. Additionally, the market is characterized by intense competition among key players, leading to price fluctuations and the need for innovative marketing strategies to maintain market share. Nonetheless, with continued advancements in healthcare technology and a growing focus on liver health, the UDCA market is poised for significant expansion in the coming years.

Global Ursodeoxycholic Acid Segment Analysis

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

Global Ursodeoxycholic Acid Market, Segmentation by Dosage Form

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

The global ursodeoxycholic acid market is witnessing significant segmentation based on dosage form, with solid and liquid formulations emerging as the primary categories. Solid dosage forms typically include tablets and capsules, which are convenient for patients to consume and ensure accurate dosing. These formulations offer advantages such as stability, ease of storage, and longer shelf life compared to liquid forms.

On the other hand, liquid dosage forms of ursodeoxycholic acid may include suspensions or solutions. Liquid formulations are often preferred in situations where patients have difficulty swallowing solid dosage forms, such as pediatric or geriatric populations. Additionally, liquid forms may offer faster absorption, leading to quicker therapeutic effects, making them desirable in certain clinical scenarios.

The choice between solid and liquid dosage forms of ursodeoxycholic acid often depends on various factors, including patient preferences, medical conditions, and healthcare provider recommendations. While solid formulations provide convenience and stability, liquid formulations offer advantages in terms of ease of administration and potentially faster onset of action. Pharmaceutical companies are continually innovating to develop novel formulations that enhance patient adherence and improve therapeutic outcomes in the global ursodeoxycholic acid market.

Global Ursodeoxycholic Acid Market, Segmentation by Mode of Extraction

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

Synthetic extraction involves the chemical synthesis of ursodeoxycholic acid in laboratories. This method offers advantages such as precise control over the purity and composition of the final product. Pharmaceutical companies often prefer synthetic extraction due to its scalability and cost-effectiveness. Moreover, synthetic ursodeoxycholic acid ensures consistent quality, which is crucial for meeting regulatory standards and maintaining product efficacy. As a result, the synthetic segment holds a significant share in the global market.

Hand, biological extraction involves obtaining ursodeoxycholic acid from natural sources such as bear bile and bovine bile. This method has been traditionally practiced for centuries, especially in regions where these sources are abundant. Biological extraction is perceived as more natural and sustainable compared to synthetic methods. However, it poses challenges related to sustainability, animal welfare, and potential contamination risks. Despite these challenges, the biological segment continues to contribute to the global market, particularly in niche applications and alternative medicine practices.

The choice between synthetic and biological extraction depends on various factors, including cost considerations, regulatory compliance, and market demand. While synthetic extraction dominates the market due to its advantages in terms of scalability and quality control, biological extraction remains relevant, especially in markets where consumers prioritize natural and ethically sourced products. Both segments are expected to witness steady growth as the demand for ursodeoxycholic acid continues to rise globally, driven by increasing incidences of liver diseases and growing awareness about its therapeutic benefits.

Global Ursodeoxycholic Acid Market, Segmentation by Application

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

One key segment is gallstones, where ursodeoxycholic acid serves as a primary treatment option. Gallstones, formed from cholesterol or bilirubin, can lead to painful symptoms and complications if left untreated. Ursodeoxycholic acid helps dissolve these stones, offering a non-invasive alternative to surgery in many cases.

Another important application of ursodeoxycholic acid is in cystic fibrosis management. Cystic fibrosis, a genetic disorder affecting the lungs and digestive system, can lead to thick, sticky mucus production, obstructing ducts and causing inflammation. Ursodeoxycholic acid plays a role in managing bile duct abnormalities associated with cystic fibrosis, potentially improving liver function and overall health outcomes for patients.

Liver cirrhosis represents another significant segment for ursodeoxycholic acid usage. Cirrhosis, characterized by progressive scarring of the liver tissue, can result from various causes such as chronic alcoholism, hepatitis infections, or other liver diseases. Ursodeoxycholic acid has shown promise in slowing disease progression and improving liver function in some cases, although its effectiveness can vary depending on factors such as the underlying cause and severity of cirrhosis.

Ursodeoxycholic acid finds utility in other medical conditions, contributing to its market growth. These may include primary biliary cholangitis, primary sclerosing cholangitis, and other hepatobiliary disorders. As research continues to uncover the therapeutic potential of ursodeoxycholic acid, its market is expected to expand further, driven by the growing prevalence of liver and bile-related ailments globally.

Global Ursodeoxycholic Acid Market, Segmentation by Geography

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

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

North America holds a dominant position in the global ursodeoxycholic acid market, primarily due to the high prevalence of liver diseases such as primary biliary cholangitis and non-alcoholic fatty liver disease (NAFLD) in the region. Moreover, the presence of well-established healthcare infrastructure, increasing adoption of advanced pharmaceuticals, and favorable reimbursement policies further contribute to the market growth in North America.

In Europe, the market for ursodeoxycholic acid is also witnessing significant growth, attributed to the rising incidence of liver disorders and increasing healthcare expenditure. Countries such as Germany, the UK, and France are major contributors to the market growth in this region. Additionally, strategic initiatives by market players, such as partnerships, collaborations, and product launches, are further fueling the market growth in Europe.

The Asia Pacific region is expected to witness the fastest growth in the global ursodeoxycholic acid market during the forecast period. Factors such as growing healthcare infrastructure, increasing awareness about liver diseases, and rising disposable income levels are driving the market growth in this region. Moreover, the presence of a large patient pool and initiatives by governments to improve healthcare access and affordability are propelling the market growth in Asia Pacific.

In the Middle East and Africa region, the market for ursodeoxycholic acid is also anticipated to grow steadily, supported by the increasing prevalence of liver diseases and improving healthcare infrastructure. However, limited access to healthcare facilities and lower awareness about liver disorders may hinder the market growth to some extent in this region.

Latin America is also expected to contribute significantly to the global ursodeoxycholic acid market, driven by factors such as rising healthcare expenditure, increasing prevalence of liver diseases, and growing awareness about the benefits of ursodeoxycholic acid in treating these conditions. However, challenges such as regulatory hurdles and economic instability may impact the market growth in Latin America.

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

• Liver disease prevalence
• Increasing pharmaceutical applications
• Rising demand for cholestatic liver disorders

• Growing geriatric population: The global ursodeoxycholic acid market is experiencing significant growth, primarily driven by the expanding geriatric population worldwide. Ursodeoxycholic acid, a bile acid produced naturally by the body, is utilized in the treatment of various liver and gallbladder disorders, including gallstones and primary biliary cirrhosis. With the aging population, the prevalence of these conditions is on the rise, fueling the demand for pharmaceutical interventions like ursodeoxycholic acid. Additionally, as people age, they become more susceptible to liver-related ailments, further contributing to the market's growth.

  Advancements in medical research and technology have led to the discovery of new therapeutic applications for ursodeoxycholic acid, broadening its market potential. Clinical studies continue to explore its efficacy in treating conditions such as non-alcoholic fatty liver disease (NAFLD) and cholestatic liver diseases, further driving demand for the compound. The growing understanding of the role bile acids play in maintaining liver health has also spurred interest in ursodeoxycholic acid as a therapeutic agent, propelling market expansion.

  Favorable government initiatives aimed at improving healthcare infrastructure and increasing access to essential medications are bolstering market growth. Governments and healthcare organizations across the globe are focusing on addressing the healthcare needs of aging populations, which includes ensuring the availability of drugs like ursodeoxycholic acid. Additionally, rising healthcare expenditure and the growing prevalence of lifestyle-related liver diseases in both developed and developing countries are expected to further propel market growth in the coming years. Overall, these factors indicate a promising outlook for the global ursodeoxycholic acid market, with sustained expansion anticipated in the foreseeable future.

Restraints

• Side effects concerns
• Stringent regulatory requirements
• High treatment costs

• Limited awareness in developing regions: The global ursodeoxycholic acid market is experiencing robust growth driven by its widespread applications in the pharmaceutical and healthcare sectors. Ursodeoxycholic acid, commonly known as UDCA, is primarily used in the treatment of gallstones, primary biliary cirrhosis, and other liver disorders. The market is propelled by the increasing prevalence of liver diseases globally, coupled with the growing demand for effective medications. Additionally, the rising awareness regarding the benefits of UDCA in treating cholestatic liver diseases is fueling market expansion.

  Despite the promising growth prospects, the market faces challenges related to limited awareness in developing regions. In many parts of the world, particularly in low- and middle-income countries, there is inadequate knowledge about liver diseases and their treatments, including the use of UDCA. This lack of awareness among patients and healthcare professionals hampers market penetration and restricts the adoption of UDCA-based therapies. Moreover, limited access to healthcare facilities and affordability issues further exacerbate the situation, hindering the uptake of UDCA medications in these regions.

  To address the issue of limited awareness in developing regions, concerted efforts are needed from stakeholders across the healthcare ecosystem. This includes pharmaceutical companies, healthcare organizations, governments, and non-profit organizations. Initiatives aimed at raising awareness about liver diseases, their symptoms, and available treatment options, including UDCA, can play a crucial role in bridging the knowledge gap. Educational campaigns, community outreach programs, and collaborations with local healthcare providers can help disseminate information and promote the use of UDCA in regions where awareness is lacking. By enhancing understanding and access to UDCA therapies, the global market can unlock significant growth opportunities while improving healthcare outcomes for patients worldwide.

Opportunities

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

• Collaborative research and development efforts: The global ursodeoxycholic acid market is witnessing a significant surge in collaborative research and development efforts, driven by the growing recognition of its therapeutic potential across various medical conditions. Ursodeoxycholic acid, commonly known as UDCA, is a naturally occurring bile acid primarily used in the treatment of gallstones and cholestatic liver diseases. However, recent studies have highlighted its promising role in treating a broader spectrum of disorders, including autoimmune diseases, metabolic disorders, and even certain types of cancers.

  One key driver of collaborative research in the UDCA market is the increasing understanding of its mechanisms of action and its potential applications beyond its traditional uses. Pharmaceutical companies, academic institutions, and research organizations are pooling their resources to explore the efficacy of UDCA in treating conditions such as non-alcoholic fatty liver disease (NAFLD), primary sclerosing cholangitis (PSC), and cystic fibrosis-related liver disease. By leveraging their collective expertise and resources, these collaborations aim to accelerate the development of new formulations, optimize dosing regimens, and identify novel indications for UDCA.

  Collaborative efforts in the UDCA market extend beyond basic research to encompass clinical trials and regulatory initiatives. With the rising demand for evidence-based medicine and stringent regulatory requirements, stakeholders are increasingly partnering to conduct large-scale clinical studies to validate the safety and efficacy of UDCA in diverse patient populations. These collaborations not only expedite the drug development process but also enhance the credibility of UDCA as a therapeutic agent. Moreover, partnerships with regulatory authorities facilitate the approval and commercialization of UDCA-based products, ensuring timely access for patients in need. Overall, collaborative research and development efforts are poised to drive innovation and expand the therapeutic landscape of the global UDCA market in the coming years.

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