Global Ursodeoxycholic Acid Market - 2024-2031

Report Overview

The Global Ursodeoxycholic Acid Market reached US$ 581.17 million in 2023 and is expected to reach US$ 1120.55 million by 2031 growing with a CAGR of 9.8% during the forecast period 2024-2031.

Ursodeoxycholic acid (UDCA) is a therapeutic agent utilized in the treatment and management of cholestatic liver diseases. It is a bile acid that plays a crucial role as an active pharmaceutical ingredient (API) in medications aimed at treating liver and gallbladder disorders. It is either isolated from natural sources or synthesized in laboratories.

UDCA functions primarily by modifying the composition of bile, which is a digestive fluid produced by the liver. It reduces the concentration of cholesterol in bile, thereby decreasing the saturation of bile with cholesterol. This action is significant because high cholesterol levels in bile can lead to the formation of gallstones. By promoting the dissolution of cholesterol gallstones, UDCA serves as a non-surgical treatment option, particularly for patients who are not candidates for surgery due to various health concerns, such as age or comorbidities.

Market Dynamics: Drivers

Increasing prevalence of liver diseases

The demand for the global ursodeoxycholic acid market is driven by multiple factors. One of the primary factors is the increasing prevalence of liver diseases. The global burden of liver diseases, particularly cholestatic liver disorders such as primary biliary cholangitis (PBC) and non-alcoholic fatty liver disease (NAFLD), is increasing significantly. This rise is largely attributed to lifestyle changes, obesity, and an aging population, which collectively contribute to a higher demand for therapeutic agents like ursodeoxycholic acid (UDCA).

As per NCBI research publication in February 2023, nonalcoholic fatty liver disease (NAFLD) is one of the most prevalent liver diseases globally. The estimated global incidence of NAFLD is approximately 47 cases per 1,000 individuals, with a higher occurrence in males than in females. Furthermore, the estimated global prevalence of NAFLD among adults stands at 32%, with 40% of men affected compared to 26% of women.

Moreover, key players in the industry product launches, government initiatives such as R&D activities, and a rising number of clinical trials are driving this market growth. For instance, one of the major players in the industry Biofield Pharma Pvt Ltd has launched a new product called 'URSOGET' containing 300 mg of ursodeoxycholic acid as a tablet. The tablets are packaged in ALU-ALU blister packs, with each pack containing 10 tablets (10 x 10 size).

Also, in June 2023, Ipsen and GENFIT stated positive topline data from the pivotal ELATIVE Phase III trial. In the trial the efficacy and safety of elafibranor, an investigational dual a, δ PPAR agonist, is being assessed for the treatment of patients with the rare cholestatic liver disease, Primary Biliary Cholangitis, who have an inadequate response or intolerance to the current standard of care therapy, ursodeoxycholic acid.

Restraints

Factors such as adverse effects associated with the UDCA, availability of alternative treatment options, regulatory challenges, and limited awareness among individuals, are expected to hamper the market.

Market Segment Analysis

The global ursodeoxycholic acid market is segmented based on type, form, application, distribution channels, and region.

The primary biliary cholangitis (PBC) segment accounted for approximately 48.6% of the global ursodeoxycholic acid market share

The primary biliary cholangitis (PBC) segment is expected to hold the largest market share over the forecast period. Primary biliary cholangitis (PBC) is a long-lasting autoimmune liver disease marked by the gradual destruction of the bile ducts within the liver. In this condition, the immune system erroneously targets the cells that line the bile ducts, resulting in inflammation and scarring. This damage leads to the gradual narrowing and blockage of the bile ducts, which hampers the normal flow of bile from the liver.

As bile builds up in the liver due to these damaged ducts, it can trigger additional inflammation and further harm the liver tissue. Over time, this accumulation may result in cirrhosis, a serious condition where healthy liver tissue is replaced by scar tissue, severely impairing the liver's functionality.

Moreover, key players in the industry more focus on UDCA treatment, and getting positive results from the clinical trials are helping to propel this segment's growth in the market. For instance, in August 2023, CymaBay Therapeutics, Inc. announced that results from the ENHANCE phase 3 global study evaluating seladelpar for treating primary biliary cholangitis (PBC) have been published in the journal Hepatology. This study is significant as it investigates the safety and efficacy of seladelpar, a selective peroxisome proliferator-activated receptor delta (PPAR-delta) agonist, in patients with PBC who have not responded adequately to first-line treatments, particularly ursodeoxycholic acid (UDCA).

Market Geographical Share

North America accounted for approximately 43.4% of the global ursodeoxycholic acid market share

North America region is expected to hold the largest market share over the forecast period owing to the increasing prevalence of liver diseases, particularly primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and non-alcoholic fatty liver disease (NAFLD), is a significant driver for the demand for ursodeoxycholic acid (UDCA) in North America.

Moreover, in this region, a major number of key player's presence, well-advanced healthcare infrastructure, and growing R&D activities are driving this market growth. As per NCBI research publications in October 2022, in the United States, an estimated 20-25 million people are affected by gallstones, a condition that can lead to significant health complications. Gallstones are hardened deposits of digestive fluid that can form in the gallbladder, and while many individuals may have gallstones, not all will experience symptoms or require treatment. However, for those who do, over 700,000 cholecystectomies (surgical removal of the gallbladder) are performed annually to alleviate symptoms and prevent complications.

In addition, key player's product launches and approvals are driving this market growth. For instance, in June 2024, Ipsen announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo (elafibranor) for treating primary biliary cholangitis (PBC). This approval permits the use of Iqirvo in two specific situations in conjunction with ursodeoxycholic acid (UDCA) for adults who have not shown sufficient response to UDCA treatment. As a standalone therapy for patients who are unable to tolerate UDCA.

Market Segmentation

By Type

Synthetic Ursodeoxycholic Acid (UDCA)

Biological Ursodeoxycholic Acid (UDCA)

By Form

Tablets

Capsules

Suspension

By Application

Gallstones

Primary Biliary Cholangitis (PBC)

Primary Sclerosing Cholangitis (PSC)

Non-Alcoholic Fatty Liver Disease (NAFLD)

Other Liver and Biliary Diseases

By Distribution Channel

Hospital Pharmacies

Retail Pharmacies

Online Pharmacies

By Region

North America

U.S.

Canada

Mexico

Europe

Germany

U.K.

France

Spain

Italy

Rest of Europe

South America

Brazil

Argentina

The rest of South America

Asia-Pacific

China

India

Japan

South Korea

Rest of Asia-Pacific

Middle East and Africa

Market Competitive Landscape

The major global players in the ursodeoxycholic acid market include Glenmark Pharmaceuticals Inc., Biobrick Pharma, Casca Remedies Pvt. Ltd., Wellona Pharma, ADDII BIOTECH PRIVATE LIMITED., Curivo Healthcare, Zoic Life Sciences, Biofield Pharma Pvt Ltd, Jabs Biotech Pvt. Ltd, and Captee among others.

Key Developments

In August 2024, Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC). This approval allows Livdelzi to be used in combination with ursodeoxycholic acid (UDCA) for adults who have not responded adequately to UDCA and as a monotherapy for patients who are unable to tolerate UDCA.

Why Purchase the Report?

To visualize the global ursodeoxycholic acid market segmentation based on type, form, application, distribution channels, and region and understand key commercial assets and players.

Identify commercial opportunities by analyzing trends and co-development.

Excel data sheet with numerous data points of the ursodeoxycholic acid market with all segments.

PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.

Product mapping is available in Excel consisting of key products of all the major players.

The global ursodeoxycholic acid market report would provide approximately 70 tables, 63 figures, and 183 pages.

Target Audience 2024

Manufacturers/ Buyers

Industry Investors/Investment Bankers

Research Professionals

Emerging Companies