Global Ursodeoxycholic Acid Market – Industry Trends and Forecast to 2031

Global Ursodeoxycholic Acid Market, By Type (Synthetic, Biological), Application (Gall Stones, Primary Biliary Cholangitis), Mode (In-house, Contract Manufacturing), Use (Human, Veterinary) – Industry Trends and Forecast to 2031.

Ursodeoxycholic Acid Market Analysis and Size

The growth in demand for ursodeoxycholic acid (UDCA) can be attributed to several factors, including the increasing prevalence of liver diseases such as primary biliary cholangitis and gallstones and the growing volume of research focused on UDCA. UDCA is readily available in various forms, including both branded and generic versions, and is offered in a wide range of strengths. This accessibility benefits both patients and healthcare providers ensuring a broader reach and ease of use, thereby promoting high market progress.                                

Data Bridge Market Research analyses that the global ursodeoxycholic acid market that was USD 580.00 million in 2023, is expected to reach USD 1,252.35 million by 2031, and is expected to undergo a CAGR of 10.1% during the forecast period 2024-2031.  “Synthetic” dominates the material segment of the ursodeoxycholic acid market as the utilization of synthetic ursodeoxycholic acid (UDCA) API in the pharmaceutical and medical fields offers a multitude of advantages. 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 depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Report Scope and Market Segmentation

Market Definition

Ursodeoxycholic acid is an active pharmaceutical ingredient (API) that is isolated or synthesized and used as the primary therapeutic component in various pharmaceutical formulations. It is employed for its hepatoprotective (liver-protective) properties and its ability to dissolve cholesterol gallstones. UDCA is commonly used in medications for treating liver and gallbladder disorders, such as primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and certain cases of gallstone disease. 

Global Ursodeoxycholic Acid Market Dynamics

Drivers

• Increasing Incidence of Liver Disorders

The rising prevalence of liver diseases such as primary biliary cholangitis (PBC), non-alcoholic fatty liver disease (NAFLD), and primary sclerosing cholangitis (PSC) among populations globally is a significant driver for the UDCA market. Ursodeoxycholic acid is commonly used for the treatment of these liver disorders due to its hepatoprotective properties, which is expected to drive the demand for UDCA.

• Growing Awareness and Diagnosis

With increasing awareness about liver disorders and advancements in diagnostic technologies, more cases of liver diseases are being diagnosed at an early stage. As a result, there is a growing demand for effective treatments such as UDCA, further boosting the market growth.

• Rising Demand for Pharmaceutical Therapies

With improvements in healthcare infrastructure and increasing healthcare expenditure in emerging economies, there is a growing demand for pharmaceutical therapies, including UDCA, for the treatment of liver disorders. This trend is expected to propel the growth of the global UDCA market, particularly in regions witnessing rapid urbanization and economic development.

Opportunities

• Expansion in Emerging Markets

There is a significant opportunity for UDCA manufacturers to expand their presence in emerging markets such as China, India, Brazil, and other parts of Asia and Latin America. These regions have large populations with increasing disposable incomes, improving healthcare infrastructure, and a rising prevalence of liver disorders.

• Strategic Partnerships and Collaborations

Collaboration with research institutions, academic centers, and pharmaceutical companies presents opportunities for UDCA manufacturers to accelerate drug development, gain access to novel technologies, and expand their product portfolio. Collaborative efforts can facilitate the exchange of scientific knowledge, resources, and expertise, ultimately leading to the development of innovative UDCA-based therapies and enhancing market competitiveness.

Restraints

• Limited Treatment Options for Severe Liver Diseases

While UDCA is commonly used for the treatment of liver disorders such as primary biliary cholangitis (PBC), its efficacy in more severe liver diseases such as advanced cirrhosis or hepatocellular carcinoma is limited. Patients with advanced liver diseases may require alternative treatment options such as liver transplantation or targeted therapies, reducing the potential market size for UDCA in these indications.

• Adverse Effects and Health Concerns

Although UDCA is generally well-tolerated, it may cause adverse effects such as diarrhea, abdominal pain, and elevated liver enzymes in some patients. Health concerns related to long-term use, drug interactions, and potential hepatotoxicity may limit the widespread adoption of UDCA, especially in certain patient populations such as pregnant women or individuals with pre-existing liver conditions. Addressing these safety concerns through rigorous monitoring and risk mitigation strategies is

Challenges

• Price Competition from Generics and Biosimilars

The availability of generic versions of UDCA and potential future entry of biosimilar products pose a challenge to branded UDCA manufacturers. Generic and biosimilar competitors often offer lower-priced alternatives, leading to pricing pressures and erosion of market share for branded products. This intensifying competition can impact the profitability and market sustainability of UDCA manufacturers.

• Regulatory and Compliance Challenges

UDCA manufacturers face regulatory and compliance challenges related to product quality, safety, and efficacy standards imposed by health authorities worldwide. Compliance with evolving regulatory requirements, pharmacovigilance obligations, and manufacturing standards necessitates significant investment in quality assurance and regulatory affairs. Failure to meet regulatory expectations can result in delays in product approvals, market withdrawals, or sanctions, posing a challenge for UDCA manufacturers.

This global ursodeoxycholic acid market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the global ursodeoxycholic acid market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Recent Developments

• In 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
• In 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

Global Ursodeoxycholic Acid Market Scope

The global ursodeoxycholic acid market is segmented on the basis of type, application, mode and use. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Type

• Synthetic Ursodeoxycholic Acid
• Biological Ursodeoxycholic Acid

Application

• Primary Biliary Cholangitis (PBC)
• Gall Stones
• Other Applications

 Mode

• In-House Manufacturing
• Contract Manufacturing

 Use

• Human
• Veterinary

Global Ursodeoxycholic Acid Market Regional Analysis/Insights

The global ursodeoxycholic acid market is analysed and market size insights and trends are provided by country, type, application, mode and use as referenced above.

The countries covered in the global ursodeoxycholic acid market report are U.S., Canada, Mexico, U.K., Germany, France, Spain, Italy, Netherlands, Switzerland, Russia, Belgium, Turkey, Rest of Europe, China, Japan, India, Australia, South Korea, Singapore, Thailand, Malaysia, Indonesia, Philippines, rest of Asia-Pacific (APAC), Brazil, rest of South America in South America, South Africa, and rest of Middle East and Africa in Middle East and Africa (MEA).

North America ursodeoxycholic acid market is dominating due to the rise of large API manufacturers, the presence of major market players and increased technological advancement in the region.

Asia-Pacific is projected to observe significant amount of growth in the ursodeoxycholic acid market due to the rapid necessity for telemedicine and healthcare support. Moreover, the modernization and development in telecommunication is further anticipated to propel the growth of the ursodeoxycholic acid market in the region in the coming years.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.   

Healthcare Infrastructure growth Installed base and New Technology Penetration

The global ursodeoxycholic acid market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for global ursodeoxycholic acid market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the global ursodeoxycholic acid market. The data is available for historic period 2016-2021.

Competitive Landscape and Global Ursodeoxycholic Acid Market Share Analysis

The global ursodeoxycholic acid market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to global ursodeoxycholic acid market.

Some of the major players operating in the global ursodeoxycholic acid market are:

• ICE S.p.a.  (Italy)
• Merck KGa  (Germany)
• Daewoong Bio  (South Korea)
• Glenmark Pharmaceuticals Ltd  (India)
• Dipharma Francis S.r.l. (Italy)
• IOL Chemicals and Pharmaceuticals  (India)
• Kimia Biosciences Ltd  (India)
• Cerata Pharmaceuticals  (U.S.)
• Changde Yungang Biotechnology Co. Ltd.  (China)
• Osmopharm SA  (Switzerland)
• Tianjin NWS Biotechnology and Medicine Co. Ltd (China)
• Zhongshan Belling Biotechnology Co. Ltd.  (China)
• Axplora  (U.S.)
• Anant Pharmaceuticals Pvt Ltd  (India)