AI Driving Ursodeoxycholic Acid Market Growth, USD 463.2 Million Increase Projected 2024-2028 Due to Rising Liver Transplants - Technavio Report

NEW YORK, Sept. 17, 2024 /PRNewswire/ -- Report with the AI impact on market trends- The global ursodeoxycholic acid market size is estimated to grow by USD 463.2 million from 2024-2028, according to Technavio. The market is estimated to grow at a CAGR of 12.16% during the forecast period. Rise in number of liver transplants is driving market growth, with a trend towards growing demand for combination therapies. However, expiry of patents on branded drugs leading to competition with manufacturers of generics poses a challenge. Key market players include Abil Chempharma Pvt. Ltd., Anant Pharmaceuticals Pvt. Ltd., Axplora, Cerata Pharmaceuticals LLP, Changde Yungang Biotechnology Co. Ltd., Daewoong Bio Inc., Dipharma Francis S.r.l., Glenmark Pharmaceuticals Ltd., ICE S.p.a., JSC Grindeks, Kimia Biosciences Ltd., Merck KGaA, Mitsubishi Chemical Group Corp., Octavius Pharma Pvt. Ltd., Osmopharm SA, Panjin Hengchanglong Pharmaceutical Co. Ltd., Suzhou Tianlu Bio Pharmaceutical Co. Ltd., Tianjin NWS Biotechnology and Medicine Co. Ltd., Travere Therapeutics Inc., and Zhongshan Belling Biotechnology Co. Ltd..

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Key Market Trends Fueling Growth

Ursodeoxycholic acid (UDCA) is a bile acid utilized extensively as a therapeutic agent for various liver disorders and diseases, including Primary Biliary Cholangitis (PBC) and gallstone dissolution. The global ursodeoxycholic acid market growth is driven by the increasing preference for combination therapies in treating liver diseases. Combination therapies involve using two or more medications concurrently to enhance treatment efficacy and improve patient outcomes. In the context of liver disorders, UDCA in combination with other drugs, such as prednisolone or mycophenolate mofetil, has proven to be more effective in managing disease progression and alleviating symptoms. For instance, a study published in the Journal of Hepatology reported a higher biochemical response rate in PBC patients when UDCA was combined with prednisolone. Another study in the American Journal of Gastroenterology demonstrated improved liver function and reduced disease progression risk in PSC patients using UDCA and mycophenolate mofetil. Ongoing research and development activities focused on novel UDCA-based combination therapies will further fuel market growth. Additionally, the rising global prevalence of liver diseases and growing awareness of combination therapies' benefits will boost UDCA demand and market expansion during the forecast period. 

The Ursodeoxycholic Acid (UDCA) market is experiencing significant growth due to its effectiveness in addressing various liver disorders, including cholestasis. UDCA-based therapeutics have become popular oral therapies in pharmacies and health product stores for treating liver diseases like primary biliary cholangitis and gallstones. The use of nanotechnology and biotechnology in producing UDCA medications has improved their bioavailability and efficacy. However, negative side effects such as diarrhea, dry skin, itching, headache, disturbed sleep, and vomiting are common concerns for patients. The healthcare system continues to prioritize liver-protective properties of UDCA in managing inflammation and improving liver function. Both branded and generic versions of UDCA medications are available in the market, offering patients and healthcare providers various strengths and costs. UDCA's cholesterol gallstones and primary sclerosing cholangitis applications further expand its market reach. 

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Market Challenges

• When a patent on a branded ursodeoxycholic acid (UDCA) formulation expires, it allows generic drug manufacturers to enter the market, offering less expensive alternatives. This can lead to intense competition among vendors, resulting in price erosion for makers of original branded UDCA products. Multiple generic drug manufacturers can cause market saturation, reducing market share for each individual vendor and making it challenging for branded UDCA product manufacturers to maintain their position and sustain growth. An example is the impact of the patent expiry on Intercept Pharmaceuticals' Actigall, a UDCA formulation, in 2016. Generic drug companies often employ aggressive pricing and marketing tactics, forcing branded pharmaceutical manufacturers to allocate additional resources to protect their market position or make it harder for them to effectively promote their products. These negative impacts, including competition, price erosion, market saturation, and marketing disruption, can hinder the growth of the global ursodeoxycholic acid market.
• Ursodeoxycholic Acid (UDCA) is a crucial bile acid used in the treatment of various liver diseases, including cholestatic disorders and gallstones. However, the market faces several challenges. Raw material sourcing and shortages can impact production. Clinical trials for UDCA in organ transplantation and gastrointestinal symptoms like diarrhea, abdominal discomfort, and nausea require high purity and stringent quality control for consistency and safety. Regulatory approval processes can also be lengthy and complex. Impurities in UDCA can lead to safety concerns and regulatory issues. Moreover, UDCA's efficacy in treating conditions like cirrhosis, primary biliary cirrhosis, and cystic fibrosis can vary, with some patients experiencing side effects like mitochondrial dysfunction and apoptosis. Grindeks, a leading UDCA manufacturer, must maintain technical competency to address these challenges. UDCA's slow action and potential for stone recurrence necessitate careful dosage form selection. Additionally, UDCA's use in treating gastroesophageal varices and mitigating the effects of cholesterol requires ongoing research and development. The Cystic Fibrosis Foundation and bears (Ursidae) are among the organizations exploring UDCA's potential in treating cystic fibrosis.

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Segment Overview 

This ursodeoxycholic acid market report extensively covers market segmentation by

1. Type 
• 1.1 Synthetic ursodeoxycholic acid
• 1.2 Extraction ursodeoxycholic acid
2. Application 
• 2.1 Pharmacy products
• 2.2 Health products
3. Geography 
• 3.1 North America
• 3.2 Europe
• 3.3 Asia
• 3.4 Rest of World (ROW)

1.1 Synthetic ursodeoxycholic acid- Synthetic ursodeoxycholic acid (UDCA) is produced through chemical processes using various precursor compounds and is a preferred choice for pharmaceutical applications due to its consistent and controlled quality. The manufacturing process enables precise control over purity and composition, ensuring highest levels of efficacy. Advanced synthesis methods, such as enzymatic synthesis, offer milder reaction conditions, higher selectivity, and reduced environmental impact. Products like Ursocol from Sun Pharmaceutical and Urosod from Dr. Falk Pharma are widely used for gallstones, PBD, and liver disorders. Synthetic UDCA's longer shelf life and availability in different dosages and formulations make it convenient for researchers to develop new formulations and drug delivery systems. Its advantages make synthetic UDCA a suitable alternative for pharmaceutical companies and researchers, leading to increased demand and growth of the global ursodeoxycholic acid market.

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Research Analysis

Ursodeoxycholic acid (UDCA) is a bile acid that plays a crucial role in promoting liver health and aiding in the treatment of various liver diseases. It is particularly effective in conditions such as primary biliary cholangitis, where it helps reduce inflammation and improve liver function. UDCA is available in both branded and generic versions, with strengths ranging from 150mg to 1000mg. Patients and healthcare providers often prescribe UDCA to manage gallstones, gastroesophageal varices, cirrhosis, primary biliary cirrhosis, and cholestasis. UDCA is available in liquid form and as hydrophobic bile acids. UDCA-based therapeutics are also being explored for the treatment of liver disorders, including cystic fibrosis. Taurine, another amino acid, is sometimes used in combination with UDCA to enhance its therapeutic effects. The development of UDCA-based therapies through nanotechnology and biotechnology is also an emerging trend in the healthcare industry.

Market Research Overview

Ursodeoxycholic Acid (UDCA) is a bile acid with liver-protective properties, primarily used in the treatment of various liver diseases, including primary biliary cholangitis, gallstones, and primary sclerosing cholangitis. UDCA's role in liver health is essential due to its anti-inflammatory and anti-apoptotic effects, which help in mitigating mitochondrial dysfunction and promoting cell survival pathways. UDCA comes in both branded and generic versions, with strengths varying from 150mg to 1200mg. Patients and healthcare providers benefit from UDCA's ability to dissolve cholesterol gallstones and improve liver function. However, UDCA's slow action and potential for stone recurrence are pitfalls. Raw material shortages and regulatory approval processes pose challenges in ensuring a consistent supply of high-purity UDCA. UDCA is available as a liquid, hydrophobic bile acid, and is used in the treatment of gastroesophageal varices, cirrhosis, and primary biliary cirrhosis. Its use extends to the treatment of cystic fibrosis and cholestatic liver disorders, such as jaundice. UDCA-based therapeutics are also explored in the field of nanotechnology and biotechnology. Despite its benefits, UDCA may cause negative side effects, including diarrhea, dry skin, itching, headache, disturbed sleep, and vomiting. These side effects can be managed through careful dosage form selection and stringent quality control measures. In conclusion, UDCA plays a vital role in the healthcare system, particularly in the treatment of various liver disorders. Its liver-protective properties, anti-inflammatory effects, and ability to dissolve cholesterol gallstones make it an essential medication for patients. However, challenges such as raw material shortages, regulatory approval processes, and negative side effects must be addressed to ensure consistent, high-quality UDCA for patients.

Table of Contents:

1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation

• Type
• Synthetic Ursodeoxycholic Acid
• Extraction Ursodeoxycholic Acid
• Application
• Pharmacy Products
• Health Products
• Geography
• North America
• Europe
• Asia
• Rest Of World (ROW)

7 Customer Landscape
8 Geographic Landscape
9 Drivers, Challenges, and Trends
10 Company Landscape
11 Company Analysis
12 Appendix

About Technavio

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SOURCE Technavio