URSODEOXYCHOLIC ACID MARKET ANALYSIS
Global ursodeoxycholic acid market is estimated to be valued at USD 590.1 Mn in 2024 and is expected to reach USD 1,165.2 Mn by 2031, exhibiting a compound annual growth rate (CAGR) of 10.2% from 2024 to 2031.
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Market Driver - Increasing prevalence of gallstones
Rising prevalence of gallstones across the globe can drive the market growth. Gallstones are solid deposits of cholesterol or bilirubin that form in the gallbladder. These are very common among adults aged 40 years and above. According to recent studies, around 10-15% of the adult population in America and Europe have gallstones. The major risk factors that lead to rise in gallstones include obesity, diabetes, rapid weight loss, and high cholesterol levels.
With changing lifestyles and dietary patterns, there have been increase in consumption of high fat/calorie diets. These diets interfere with normal gallbladder functioning and increase the likelihood of stones forming over time. As modernization spreads across developing regions, the westernization of diets also brings along non-communicable diseases like obesity.
The treatment for symptomatic gallstones is generally a surgical procedure called cholecystectomy, which involves removal of the gallbladder. Ursodeoxycholic acid (UDCA) plays an important adjuvant or alternative role in the management of gallstones. It helps dissolve small cholesterol gallstones and reduces symptoms in some patients, thus, delaying or avoiding surgery. It also finds application in dissolving residual stones post-surgery. With increasing patient pool suffering from gallstones, there will be huge demand for UDCA and related formulations.
For Instance, In April 2022, approximately 20 million Americans are estimated to have gallstone disease, according to an article from NCBI. Annually, nearly 300,000 cholecystectomy procedures are performed among these individuals. About 20% of gallstones are symptomatic, while approximately 10% are asymptomatic.
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Increasing awareness about liver conditions
There has been increase in awareness about liver conditions, their symptoms, and available treatment options among the general population as well as healthcare practitioners globally. Various factors have contributed to this positive trend - widespread availability of health information through internet and social media platforms, health advocacy programs by medical associations, growing health consciousness among urban populations.
Conditions like non-alcoholic fatty liver disease (NAFLD) and autoimmune disorders like primary biliary cholangitis (PBC) were earlier neglected or misunderstood but now these are being diagnosed early and managed actively. Population studies indicate epidemic proportions of NAFLD prevalence rates in developing nations like India and China mirroring their obesity crisis. Autoimmune liver diseases are also increasing. More patients are seeking medical help for persistent non-specific symptoms like fatigue, abdominal pain and being correctly diagnosed.
This has boosted demand for drugs to treat underlying liver conditions. Ursodeoxycholic acid (UDCA) is used to treat PBC since several decades with proven benefits. It is also often prescribed off-label for NAFLD patients. Various international liver foundations and patient advocacy groups are raising awareness about conditions and championing UDCA's role in treating these conditions. As more patients get screened and diagnosed early coupled with growing experience with therapies like UDCA, its use will likely expand in tandem with evolving treatment landscape for liver diseases.
Key Takeaways from Analyst:
Global ursodeoxycholic acid market growth is driven by increasing prevalence of liver diseases and gallstones. Ursodeoxycholic acid is used for treatment of primary biliary cirrhosis and portal hypertension associated with liver disease. Rising awareness regarding benefits of UDCA in management of cholestatic liver diseases can drive the market growth. Growing geriatric population who are more prone to developing gallstones and liver diseases can offer new opportunities for market players. North America currently dominates the market due to well-established healthcare infrastructure and higher spending on health-related issues. However, Asia Pacific is likely to emerge as the fastest growing market with nations like China and India showing lucrative potential.
Availability of alternative treatment options for liver diseases and easy availability of generic versions can hamper the market growth. High cost of branded ursodeoxycholic acid can also hamper its widespread adoption in developing regions. Regulations mandated by authorities for approval of UDCA formulations also increases the development cost. Lack of awareness in underdeveloped nations coupled with poor healthcare facilities can hamper the market growth.
Market Challenge - High costs associated with ursodeoxycholic acid
Global ursodeoxycholic acid market growth can be hampered due to high costs associated with ursodeoxycholic acid. Ursodeoxycholic acid is used for the treatment of liver and gallbladder disorders but it is available at a very high price, which makes it unaffordable for many patients. The high production costs involved in manufacturing ursodeoxycholic acid contributes to its elevated prices. As ursodeoxycholic acid is synthesized from natural plant and bear bile extracts, the complex extraction and purification processes also increases its production costs. Low volume production of ursodeoxycholic acid adds to its unit costs. The exorbitant price of ursodeoxycholic acid treatment poses a significant barrier to its widespread adoption, especially in price-sensitive developing markets. Unless more cost-effective production techniques are developed or generic versions are introduced, the high costs will hamper the ursodeoxycholic acid market growth.
Market Opportunity- Increasing research funding for developing alternate treatments
Global ursodeoxycholic acid market can witness growth opportunities from increasing research funding for developing alternate treatments. Several government and private research organizations are funding research projects focusing on development of novel drug molecules and therapies that can replace ursodeoxycholic acid. This is mainly due to the limitations associated with ursodeoxycholic acid like its undesirable side-effect profile and high costs of therapy. Increasing research grants and investments in this domain have accelerated the pace of research. Several new drug candidates are under clinical trials that can potentially overcome the shortcomings of ursodeoxycholic acid. Successful development of effective and affordable alternate treatment options will open up new avenues of growth for ursodeoxycholic acid market players. The market is expected to transition towards these newer treatment forms in the future.
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By Dosage Form - Convenience drives preference for solid dosage form
In terms of dosage form, solid dosage form segment is estimated to contribute the highest market share of 59.2% in 2024, owing to its convenience of use. Solid dosage forms such as tablets and capsules are highly preferred by patients as these are easy to carry, store and administer. The fixed dosage makes solid dosage forms more reliable for ensuring compliance to the prescribed treatment regimen as compared to liquid forms, which need measuring. Solid dosage forms also help mask the unpleasant taste that is commonly associated with active pharmaceutical ingredients (API). This makes them a preferred choice, especially for pediatric patients and the elderly. The stability of solid dosage forms also allows for longer shelf life and easier distribution compared to liquids. Manufacturers prefer solid dosage forms due to their simplicity of production and higher yield. With solid fill capabilities common across manufacturing sites, solid dosage forms provide flexibility in production.
By Mode of Extraction - Control and consistency boosts synthetic extraction
In terms of mode of extraction, synthetic segment is estimated to contribute the highest market share of 54.3% in 2024, owing to control and consistency it provides. The synthetic process allows manufacturers to precisely control reaction conditions and obtain the API in its purest form. This ensures batch-to-batch consistency in quality, safety and efficacy - a critical requirement for pharmaceutical products. The synthetic process also helps scale up production in a predictable manner to meet rising global demand. In contrast, biological extraction relies on natural sources and living organisms, introducing variability that complicates manufacturing and scale-up. The established synthetic chemistry routes also make the process more amenable to automation and continuous manufacturing for high volumes. This brings down production costs.
By Application - Targeting gastrointestinal ailments drives preference for GI applications
In terms of application, gastrointestinal disorders segment is estimated to contribute the highest market share of 42% in 2024, as ursodeoxycholic acid is primarily used and researched for gastrointestinal applications. Ursodeoxycholic acid has proven benefits in dissolving cholesterol gallstones and improving liver functions. This positions it as a promising treatment for common GI conditions like gallstones, cholecystitis, cirrhosis and hepatitis. Growth in gastrointestinal disorders due to changing lifestyles and demographics in emerging markets has stimulated research and uptake. Gastrointestinal applications allow for direct delivery of ursodeoxycholic acid to the target absorption site in the small intestine through oral administration. This locoregional action maximizes therapeutic benefits while reducing systemic side effect - an added advantage over alternative applications. Managing gastrointestinal health also has high compliance from patients.
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North America has established itself as the dominant region in the global ursodeoxycholic acid market with an estimated market share of 40.3% in 2024, owing to high prevalence of liver and gallbladder disorders in the U.S. and Canada. Moreover, strong presence of leading pharmaceutical companies in the region engaged in the production of ursodeoxycholic acid and its formulations has boosted manufacturing capacity. These companies have also undertaken various clinical trials to expand the therapeutic application of ursodeoxycholic acid, which has increased its consumption.
In terms of pricing, North America commands a premium in the global market due to high purchasing power of consumers and dominant market position of regional players. The import of ursodeoxycholic acid formulations is restricted through strategic agreements to ensure steady supply for domestic players. Exports from the region have also increased with the approval of new drug applications in international markets.
Asia Pacific has emerged as the fastest growing regional market for ursodeoxycholic acid. Countries like China, India, Japan, and South Korea are majorly contributing to the rapid growth of the Asia Pacific market. This can be attributed to rising geriatric population, increasing healthcare expenditure, and growing awareness regarding liver disorders in the region.
The market growth is driven by improving accessibility of ursodeoxycholic acid drugs due to favorable governmental policies and subsidies. Regional manufacturers are focusing on capacity expansion to cater to rising demand from the domestic market. Growing imports from European and North American markets to meet the shortfall in supply have complemented the market growth. These trends are anticipated to favor the Asia Pacific region to outpace other regions in terms of future demand.
Ursodeoxycholic Acid Market Report Coverage
| Report Coverage | Details | ||
|---|---|---|---|
| Base Year: | 2023 | Market Size in 2024: | US$ 590.1 Mn |
| Historical Data for: | 2019 to 2023 | Forecast Period: | 2024 to 2031 |
| Forecast Period 2024 to 2031 CAGR: | 10.2% | 2031 Value Projection: | US$ 1,165.2 Mn |
| Geographies covered: |
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| Segments covered: |
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| Companies covered: |
Dipharma Francis Srl, ERREGIERRE S.p.A., Grindeks, Industria Chimica Emiliana, Mitsubishi Tanabe Pharma Corporation, Zhongshan Belling Biotechnology Co., Glenmark Pharmaceutical Limited, Abil Chempharma Private Limited, Biotavia Labs Pvt Ltd, Daewoong Bio Inc., PharmaZell GmbH, Suzhou Tianlu Bio-pharmaceutical Co., Ltd., Dr. Falk Pharma, Teva Pharmaceuticals, Epic Pharma, Lannett Company, Inc., Mylan N.V., Bruschettini S.p.A., Impax Laboratories, Inc., Shanghai Pharma |
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| Restraints & Challenges: |
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*Definition: Global ursodeoxycholic acid market involves the production and sales of ursodeoxycholic acid (UDCA), which is a bile acid that is used for the medical treatment of liver disease and gallstones. UDCA is prescribed to dissolve gallstones and improve liver function in people suffering from conditions like primary biliary cirrhosis.
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About Author
Vipul Patil is a dynamic management consultant with 6 years of dedicated experience in the pharmaceutical industry. Known for his analytical acumen and strategic insight, Vipul has successfully partnered with pharmaceutical companies to enhance operational efficiency, cross broader expansion, and navigate the complexities of distribution in markets with high revenue potential.
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