Ursodeoxycholic Acid Market by Application (Primary Biliary Cholangitis, Gallstones Treatment, Hepatitis C, Non-Alcoholic Fatty Liver Disease), by End-Use Industry (Hospitals, Clinics, Ambulatory Surgical Centers), and by Region; Insights & Forecast (2024 – 2030)

As per Intent Market Research, the Ursodeoxycholic Acid Market was valued at USD 1.4 Billion in 2024-e and will surpass USD 2.7 Billion by 2030; growing at a CAGR of 11.6% during 2025 - 2030.

Ursodeoxycholic acid (UDCA) is a naturally occurring bile acid that has proven therapeutic benefits for a range of liver-related conditions, including primary biliary cholangitis (PBC), gallstones, hepatitis C, and non-alcoholic fatty liver disease (NAFLD). It has been widely adopted as a treatment to reduce liver inflammation, promote bile flow, and improve liver function. With increasing incidences of liver diseases worldwide, the demand for UDCA-based therapies has grown, particularly as a non-invasive and well-tolerated treatment option. The global ursodeoxycholic acid market is supported by an expanding population of individuals with chronic liver conditions and a growing awareness of liver health.

The market for UDCA is characterized by a range of applications, including primary biliary cholangitis, gallstones treatment, hepatitis C, and NAFLD. Hospitals, clinics, and ambulatory surgical centers are the primary end-use industries for UDCA, providing a broad spectrum of services from diagnosis to treatment. As new research uncovers further applications for UDCA, its therapeutic potential continues to expand, with the market expected to see steady growth in the coming years.

Primary Biliary Cholangitis Segment Is Largest Owing to the High Prevalence of the Disease

The primary biliary cholangitis (PBC) segment is the largest application for ursodeoxycholic acid, owing to the high prevalence of PBC, a chronic liver disease that gradually damages the bile ducts in the liver. UDCA is considered the first-line treatment for PBC, helping to slow the disease's progression, reduce symptoms, and improve overall liver function. It works by decreasing the buildup of bile acids in the liver, thus preventing further damage to the liver tissue. This segment dominates the market due to PBC's chronic nature and the established effectiveness of UDCA in managing the condition.

PBC affects a significant portion of the adult population, particularly women, and the long-term use of UDCA has shown promising results in extending survival and improving quality of life for patients. The widespread use of UDCA for PBC, backed by extensive clinical data, is the driving force behind its dominance in the market. As awareness of PBC continues to grow and more patients are diagnosed, the demand for UDCA in treating this condition is expected to remain high, solidifying the segment’s leadership in the market.

Gallstones Treatment Segment Is Fastest Growing Due to Rising Incidence of Gallbladder Diseases

The gallstones treatment segment is the fastest growing in the ursodeoxycholic acid market, driven by the increasing prevalence of gallstones and the growing awareness of non-surgical treatment options. UDCA is used in patients with non-calcified gallstones, as it helps dissolve the stones and prevent further formation. It is a preferred alternative for patients who are not candidates for surgery, particularly in cases of small, cholesterol-based stones. The rising adoption of UDCA as a non-invasive treatment option is contributing to the rapid growth of this segment.

As lifestyle changes and dietary habits continue to influence the incidence of gallstones, the demand for effective non-surgical treatments like UDCA is expected to grow. Studies supporting the efficacy of UDCA in dissolving cholesterol gallstones, combined with its favorable side-effect profile, are likely to drive further adoption of this therapy. The growing preference for non-invasive treatments, particularly in an aging population, positions the gallstones treatment segment as the fastest growing in the ursodeoxycholic acid market.

Hospitals Are Largest End-Use Industry Due to Advanced Treatment Facilities and Expertise

Hospitals are the largest end-use industry for ursodeoxycholic acid treatments, owing to their advanced medical facilities and expertise in managing complex liver diseases. Hospitals provide comprehensive care, including diagnosis, administration of UDCA, and long-term management of patients with conditions such as primary biliary cholangitis, gallstones, and hepatitis C. The infrastructure and medical staff in hospitals are equipped to offer specialized treatments and handle any complications that may arise during therapy.

Additionally, hospitals are well-positioned to administer UDCA in conjunction with other therapies, particularly in cases of co-existing conditions like hepatitis C or non-alcoholic fatty liver disease. With the growing burden of liver diseases, hospitals continue to dominate the market for UDCA, ensuring that patients receive the highest level of care and access to the latest treatment options.

North America Is Largest Region Due to High Disease Incidence and Advanced Healthcare Infrastructure

North America is the largest region for the ursodeoxycholic acid market, driven by the high incidence of liver diseases, particularly primary biliary cholangitis and gallstones, and the region’s advanced healthcare infrastructure. The United States, in particular, is a significant contributor to the market due to its large healthcare system, widespread use of UDCA in liver disease management, and high rates of liver-related conditions. The region’s robust healthcare infrastructure ensures that patients have access to effective treatments, including UDCA, which is supported by insurance coverage and government health programs.

Moreover, ongoing research and clinical trials in North America continue to explore the broader applications of UDCA, which will likely contribute to further market growth. The increasing awareness of liver health and the availability of advanced treatments in North America are expected to maintain the region's dominance in the ursodeoxycholic acid market.

Leading Companies and Competitive Landscape

The ursodeoxycholic acid market is competitive, with several key pharmaceutical companies involved in its production and distribution. Leading companies such as Teva Pharmaceutical Industries, Mylan N.V., Hepalink, and GSK have established a strong presence in the market, manufacturing both branded and generic formulations of UDCA. These companies are focused on expanding the availability of UDCA-based treatments, improving patient outcomes, and exploring new indications for the drug.

The competitive landscape is marked by a combination of generic and branded products, with generic formulations driving down the cost of treatment. Additionally, companies are investing in research to explore the potential benefits of UDCA for other liver conditions, which could further expand the market. Strategic collaborations, partnerships, and acquisitions are common in this space as companies seek to strengthen their market position and diversify their portfolios. With continued innovation and an increasing focus on liver health, the market for ursodeoxycholic acid is poised for sustained growth.

Recent Developments:

• AbbVie launched an improved formulation of Ursodeoxycholic Acid aimed at providing better patient compliance for those with biliary diseases.
• Teva Pharmaceuticals expanded its generic Ursodeoxycholic Acid product offerings, making the drug more accessible to a global market.
• Mylan N.V. entered into a partnership with a leading healthcare provider to distribute Ursodeoxycholic Acid in emerging markets, enhancing its market presence.
• Lupin Pharmaceuticals announced the completion of clinical trials for a new UDCA-based treatment aimed at improving liver health in non-alcoholic fatty liver disease patients.
• Eisai Co., Ltd. secured regulatory approval for its advanced formulation of Ursodeoxycholic Acid targeting both hepatitis C and biliary conditions.

List of Leading Companies:

• AbbVie Inc.
• Mylan N.V.
• Hikma Pharmaceuticals
• Teva Pharmaceutical Industries Ltd.
• Sun Pharmaceutical Industries Ltd.
• Zydus Cadila
• Apotex Inc.
• Lupin Pharmaceuticals
• Amgen Inc.
• Chiesi Farmaceutici S.p.A.
• Merck & Co., Inc.
• Eisai Co., Ltd.
• Kern Pharma
• Hetero Labs Ltd.
• Dr. Reddy's Laboratories Ltd.

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