Ursodeoxycholic Acid (UDCA) Market

Ursodeoxycholic Acid (UDCA) Market Synopsis

Ursodeoxycholic Acid (UDCA) Market Size Was Valued at USD 586.7 Million in 2023, and is Projected to Reach USD 1,406.21 Million by 2032, Growing at a CAGR of 10.2% From 2024-2032.

Ursodeoxycholic Acid (UDCA) Is one of the naturally occurring bile acid belonging to the ursodeoxycholic class that is majorly recommended for the treatment of liver ailments like primary biliary cirrhosis, Gall stones, and particular liver diseases—including NAFLD. UDCA can lower the cholesterol content of bile and dissolve cholesterol gallstones, and has positive effects that support liver function. The market for UDCA is a emergent submarket of the pharmaceutical market and it is stimulated by proven efficacy of the product in the treatment of liver diseases and in particular by protective effect of liver cells from damage and stimulating effect on liver tissue regeneration. UDCA is marketed either as capsules or tablets and the dosage form is an oral prescription medication in different countries. Heathcare demands are increasing all across the world and due to the growing awareness regarding the liver diseases this market for Ursodeoxycholic Acid will grow rapidly in the future. Furthermore, the shifting market towards synthetic UDCA and prospects for expanding its applications will also cause consistent market growth.

Ursodeoxycholic Acid (UDCA) market has been growing over years, thanks to the rising incidences of liver disorders the world over. UDCA is mostly used to treat conditions associated with the biliary tract, including gallstones, and primary biliary cirrhosis. The drivers of the global market are the increasing levels of awareness of liver diseases including those in the developing regions where there is high prevalence of liver related diseases. Furthermore, growing policies for enhancement of healthcare sector and the enhancing healthcare expenditure also have a positive impact for the growth of UDCA market. Another factor that has acted positively towards the development of UDCA demand is the research by the pharma industry for other indications for UDCA such as other chronic liver ailments, in addition to the main indication for BA. The increasing incidence rates of obesity and metabolic syndrome along with other risks factors involved in liver diseases will further drive the market growth with UDCA as a standard treatment for liver health.

Regionally, North America and Europe are the largest consumers of UDCA due to high instances of liver diseases and the excellent health structure system. Nevertheless, high growth is being observed in Asia-Pacific region due to the continuous rise in health care spend and increasing number of people aging. The market is also experiencing a growth in developed markets of the emerging economies for the increasing prevalence of the diseases affecting liver, better health care facility and availability of treatment. Through new applications emerging in the market place, firms are dedicating efforts toward increasing R&D to identify new uses for the UDCA in the global markets. This, combined with partnerships, mergers and acquisitions, will also define competition and the growth of the market further.

Ursodeoxycholic Acid (UDCA) Market Outlook, 2023 and 2032: Future Outlook

Ursodeoxycholic Acid (UDCA) Market Trend Analysis

Trend: Advancements in Synthetic UDCA Production

One the major trends observed in the global Ursodeoxycholic Acid (UDCA) market is shifting from using natural UDCA to synthetic UDCA. Synthetic UDCA is popular due to affordable costs in manufacturing and applicability compared to the natural variety with more predictable and stable manufacturing process. Advances in chemical synthesis have enabled an increase in UDCA supply chain accessibility hence more patients can access the UDCA. Moreover, the application possibility of the synthetic UDCA on the formulation of drugs has made new therapeutic application fields, such as the treatment of more liver diseases and metabolic diseases. Utilizing analytic data, it will be seen that the market will have future growth due to the constant technological development in UDCA synthetic research and production techniques.

Driver: Rising Prevalence of Liver Diseases

The global Ursodeoxycholic Acid (UDCA) market is principally driven by growth in liver ailments around the world. Chronic ailments like gallstones, NAFLD, cirrhosis, and PBC are emerging conditions present day, primarily in the developed states that is due to the upsurge of life style diseases and metabolic disorders. As the health conscious and the access to enhanced favorable diagnosis technologies escalates, more people receive their diagnosis for liver diseases; this in turn fuels the need for suitable therapies like UDCA. Due to increasing average age of the world’s population, liver diseases that are related to aging are more common, which will even more increase the demand for UDCA treatments.

Restraint: High Cost of Treatment

While UDCA has been effective in providing solution to liver problems, one of the major challenges within this market is the relatively high cost of treatment. The cost of UDCA, and particularly the pricing in the developing countries implies that a significant population will be locked out due to the high costs. Additionally, treatment with UDCA is usually life-long treatment and thus the total costs of therapy are much higher. In many cases, the cost raises patients’ concern as to whether they are going to afford that particular treatment, this may in turn slow down the growth of the market in region with lower economic status. The continuous advancement of cost-cutting measures, shifting of drug viability and development of cheaper substitutes for the products would be essential in growth of a market.

Opportunity: Expansion in Emerging Markets

The rapidly developing healthcare sector and the rising awareness of liver disorders in the new generation of developing countries are the biggest opportunity for the Ursodeoxycholic Acid (UDCA) market. Thus it can be assumed that as countries such as India, China and Brazil continue to develop economically and modernize their health care systems, the need for UDCA will also increase. Increasing disposable income together with better healthcare facilities will many more people to afford the UDCA treatments hence growing the size of the market for this generic product. In addition, awareness of liver diseases in these areas remains relatively high, which way is presenting companies with opportunities to explore virtually uncharted markets and offer affordable treatments, which will create the overall growth for UDCA.

Ursodeoxycholic Acid (UDCA) Market Segment Analysis

Ursodeoxycholic Acid (UDCA) Market Segmented on the basis of Dosage Form, Mode of Extraction and Application.

By Type

o   Solid Dosage Form

o   Liquid Dosage Form

By Mode of Extraction

o   Synthetic

o   Biological

By Application

o   Gastrointestinal Disorders

o   Liver Disorders

o   Cystic Fibrosis

o   Others

By Dosage Form, Solid Dosage Form segment is expected to dominate the market during the forecast period

The market has been divided into numerous categories based on form and among them the solid dosage forms include tablet and capsule and this segment is expected to dominate the Ursodeoxycholic Acid (UDCA) market in the forecast period. The strengths of the SDFFs include; ease of administration compared to the liquid preparations, accurate measurement and they have a longer shelf life. These advantages combined with the fact that, compared to the past, there is a shift toward oral administration of drugs have greatly boosted the uptake solid dosage forms in the management of liver diseases. This segment is also expected to grow as patients’ acceptability increases, effective formulations of the segment have entered the market and ease to use. In addition, development opportunities are identified in the formulations of solid UDCA dosage specification drugs will improve the patient compliant and continue to promote this market.

The solid dosage form segment has already well developed, and there are many manufacturers of UDCA tablets and capsules in the world. These dosage forms can be easily transported and can be put into store hence it is suitable to transport across the globe. Furthermore, the proliferation of the generic versions of UDCA tablets and capsules has also the driving force for growth on the solid dosage form segment. The increased implementation of the oral treatment regimen for liver diseases in many countries will also drive the demand for solid dosage forms of the UDCA higher.

By Mode of Extraction, Synthetic segment expected to held the largest share

The synthetic part of the ursodeoxycholic acid industry is predicted to stay dominant accumulating the greatest proportion through the forecast period. They include the direct extraction from the plant, chemical synthesis of UDCA and its isomers, enzymatic synthesis from cholic acid and chemical synthesis from unsubstituted CDCA. Since synthetic UDCA can be produced in fairly large scale and the quality of this compound can be easily controlled, pharmaceutical firms prefer to use it. Furthermore, the latest development of technologies in synthetic processes in the chemical synthesis field in recent years stimulated the demand of synthetic UDCA in global markets. Consequently, the market share for synthetic UDCA is expected to be significantly higher than that of naturally extracted UDCA.

The specific segment of synthetic UDCA has also grown due to the simple fact that more and more pharmaceutical manufacturers are switching to synthetic methods of production due to high demand for UDCA. Synthetic UDCA finds application not only in the treatment of gallstones, but in chronic liver diseases as well, which explains the growth of the segment. Since there are ongoing investigations in drawing down the synthetic UDCA production techniques, the segment is anticipated to maintain a huge UDCA market share in the future years.

Ursodeoxycholic Acid (UDCA) Market Regional Insights

North America is Expected to Dominate the Market Over the Forecast period 

The synthetic part of the ursodeoxycholic acid industry is predicted to stay dominant accumulating the greatest proportion through the forecast period. They include the direct extraction from the plant, chemical synthesis of UDCA and its isomers, enzymatic synthesis from cholic acid and chemical synthesis from unsubstituted CDCA. Since synthetic UDCA can be produced in fairly large scale and the quality of this compound can be easily controlled, pharmaceutical firms prefer to use it. Furthermore, the latest development of technologies in synthetic processes in the chemical synthesis field in recent years stimulated the demand of synthetic UDCA in global markets. Consequently, the market share for synthetic UDCA is expected to be significantly higher than that of naturally extracted UDCA.

The specific segment of synthetic UDCA has also grown due to the simple fact that more and more pharmaceutical manufacturers are switching to synthetic methods of production due to high demand for UDCA. Synthetic UDCA finds application not only in the treatment of gallstones, but in chronic liver diseases as well, which explains the growth of the segment. Since there are ongoing investigations in drawing down the synthetic UDCA production techniques, the segment is anticipated to maintain a huge UDCA market share in the future years.

Ursodeoxycholic Acid (UDCA) Market Share, by Geography, 2023 (%)

Active Key Players in the Ursodeoxycholic Acid (UDCA) Market

o   Alnylam Pharmaceuticals (USA)

o   Amgen Inc. (USA)

o   Baxalta (USA)

o   Beijing Chia Tai Tianqing Pharmaceutical Co., Ltd. (China)

o   Cadila Pharmaceuticals (India)

o   Chong Kun Dang Pharmaceutical Corp. (South Korea)

o   Dr. Reddy’s Laboratories Ltd. (India)

o   Hunan Dongting Pharmaceutical Co. (China)

o   Lupin Pharmaceuticals, Inc. (India)

o   Medivir AB (Sweden)

o   Mylan N.V. (USA)

o   Novartis AG (Switzerland)

o   Qingdao Haizheng Pharmaceutical Co. Ltd. (China)

o   Sandoz International GmbH (Switzerland)

o   Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (China)

o   Other key Players

Global Ursodeoxycholic Acid (UDCA) Market Scope