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The Ursodeoxycholic Acid Market size is estimated to grow by USD 358.41 million at a CAGR of 10.65% between 2022 and 2027. The increase in liver transplants, the rising prevalence of primary sclerosing cholangitis and related conditions, and the broadening of indications for ursodeoxycholic acid (UDCA) are driving factors for market growth. These factors reflect a growing need for liver disease treatments and therapies, highlighting the market's potential for expansion. As liver-related conditions become more prevalent, the demand for liver transplants and associated treatments is expected to rise. Additionally, the expanding use of UDCA for various indications underscores its versatility and effectiveness in addressing liver disorders. These trends indicate a significant opportunity for market growth, driven by the increasing incidence of liver diseases and the expanding treatment options available to patients.
There is increasing adoption of UDCA for the treatment of specific liver diseases, including PBC and PSC. Additionally, there are potential benefits of UDCA in other indications as per new research and clinical trials. For instance, as per recent research and clinical research, it is concluded that UDCA is effective in dissolving gallstones, which are caused due to the excess generation of cholesterol or bilirubin, especially in patients who are symptomatic but are unable or unwilling to undergo surgery. The demand for UDCA for gallstone dissolution is fuelled by the increasing awareness about these alternative treatment options. Hence, it is expected to positively impact the market growth.
It also includes an in-depth analysis of drivers, trends, and challenges. Our report examines historic data from 2017 to 2021, besides analyzing the current market scenario.
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This report provides a detailed analysis of the market by Type (Synthetic ursodeoxycholic acid and Extraction ursodeoxycholic acid ), Application (Pharmacy products and Health products ), and Geography (North America, Europe, Asia, and Rest of the World (ROW)).
The synthetic ursodeoxycholic acid segment is estimated to witness significant growth during the forecast period. Ursodeoxycholic Acid (UDCA), a bile acid, is extensively used in pharmaceutical applications for treating liver diseases, including primary biliary cholangitis and primary sclerosing cholangitis. UDCA's liver-protective properties are effective in managing gallstones, inflammation, and improving liver function.
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The synthetic ursodeoxycholic acid segment was the largest segment and was valued at USD 208.36 million in 2017. Patients and healthcare providers rely on UDCA's consistent quality and efficacy, ensured through synthetic production. Synthetic UDCA's high purity and stringent quality control enable safety and regulatory approval. Branded and generic versions of UDCA are available in various strengths, catering to diverse patient needs. UDCA's role extends to managing cholesterol gallstones and gastrointestinal symptoms like diarrhea, abdominal discomfort, and nausea. However, challenges such as raw material shortages, impurities, and clinical trial complexities can impact UDCA's production and availability. In addition to its use in liver diseases, UDCA is also relevant for cirrhosis, cystic fibrosis, and gastroesophageal varices. Ensuring UDCA's safety and consistency is crucial, especially in mass production, where it is essential to meet the growing demand and maintain a steady supply for pharmaceutical companies. UDCA's hydrophobic nature and potential use in organ transplantation further highlight its importance in healthcare. Hence, such factors are expected to fuel the growth of this segment which in turn will drive the market growth during the forecast period.
There is an increasing adoption of UDCA in the pharmaceutical industry for the treatment of different liver disorders, gallstones, PSC, and PBC. Ursodeoxycholic Acid (UDCA) is a significant component in pharmaceutical treatments for cholesterol gallstones, liver disorders including Primary Sclerosing Cholangitis (PSC) and Primary Biliary Cholangitis (PBC), and mitochondrial dysfunction related to cholestatic liver disorders. The market for UDCA-based therapeutics is driven by the increasing prevalence of these conditions and the need for effective symptomatic relief. Ursodeoxycholic Acid exhibits efficacy in dissolving gallstones and improving liver function. However, its slowness in action and potential for stone recurrence necessitate personalized dosage forms and formulations. Ursofalk, produced by Dr. Falk Pharma, is a widely used UDCA-based medication for gallstone treatment and PBC management. Grindeks and other pharmaceutical companies contribute to the market with their technical competency and diverse product offerings.
UDCA's anti-inflammatory and anti-apoptotic properties make it an essential component in healthcare systems addressing cholestatic liver disorders, jaundice, and other liver diseases. Despite its benefits, UDCA may cause negative side effects such as diarrhea, dry skin, itching, headache, disturbed sleep, and vomiting. Oral therapies and advancements in nanotechnology and biotechnology aim to mitigate these side effects and improve overall patient experience. In summary, the market for Ursodeoxycholic Acid is fueled by the rising incidence of cholesterol gallstones and cholestatic liver disorders. UDCA-based therapeutics, such as Ursofalk, offer effective symptomatic relief and personalized treatment approaches. However, potential side effects necessitate ongoing research and development to enhance efficacy and patient experience. Hence, such factors are expected to fuel the growth of this segment which in turn will drive the market growth during the forecast period.
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North America is estimated to contribute 36% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that will shape the market during the forecast period. The Ursodeoxycholic Acid (UDCA) market in North America is primarily driven by the high prevalence of cholestatic liver disorders, such as Primary Sclerosing Cholangitis (PSC), and the increasing incidence of irritable bowel syndrome. UDCA is an effective symptomatic therapy for these conditions, and its easy availability in the region, due to the presence of numerous pharmaceutical companies, including AbbVie, Johnson and Johnson, Amneal Pharmaceuticals, Lannett Co., Epic Pharma, Apotex, and Pharmascience, ensures its widespread use. UDCA is particularly beneficial for treating gallstones and mitigating the negative effects of cholesterol.
However, its slowness in action and potential for stone recurrence necessitate careful dosage management. UDCA functions by mitigating mitochondrial dysfunction and protecting dopamine cells, thereby promoting cell survival pathways and exhibiting anti-apoptotic and anti-inflammatory properties. UDCA-based therapeutics are available in various dosage forms, including oral therapies, and are accessible through pharmacies and health products. Despite its benefits, UDCA can cause negative side effects, such as diarrhea, dry skin, itching, headache, disturbed sleep, and vomiting. The healthcare system plays a crucial role in ensuring the effective and safe use of UDCA. Other companies, such as Grindeks, are also making strides in the UDCA market through their technical competency and innovative approaches, including nanotechnology and biotechnology. Hence, such factors are expected to drive market growth in the region during the forecast period.
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Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market. The report also includes detailed analyses of the competitive landscape of the market and information about 20 market companies, including:
Abil Chempharma Pvt. Ltd: The company offers ursodeoxycholic acid in the form of acid tablets.
Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.
The market encompasses branded and generic versions of this essential bile acid used in the treatment of various liver disorders, including Primary Biliary Cholangitis (PBC), gallstones, and Cirrhosis. This plays a crucial role in improving liver function by reducing inflammation and promoting the flow of bile. Patients suffering from PBC, a chronic condition characterized by cholestasis and inflammation of the bile ducts, significantly benefit from UDCA-based therapeutics. Healthcare providers often prescribe UDCA to manage symptoms of liver diseases, such as gastroesophageal varices and cystic fibrosis. Pharmacies and health products retailers stock both branded and generic UDCA formulations, offering patients flexibility in their treatment choices. Advancements in nanotechnology and biotechnology have led to the development of innovative oral therapies, enhancing the efficacy and bioavailability of UDCA. These advancements are expected to fuel the growth of the UDCA market, catering to the increasing demand for effective treatments for liver disorders. Our researchers analyzed the data with 2022 as the base year, along with the key drivers, trends, and challenges.
One of the key factors driving the market growth is the rise in number of liver transplants. Liver diseases, including primary biliary cholangitis and gallstones, are a significant cause of global mortality, resulting in approximately two million deaths annually due to complications such as cirrhosis and liver cancer. With increasing awareness of the need for treatment, the demand for liver-protective medications, such as Ursodeoxycholic Acid (UDCA), has grown. UDCA is a bile acid with liquid, hydrophobic properties, used to improve liver function and reduce inflammation in various liver conditions, including cholesterol gallstones and primary sclerosing cholangitis. Branded and generic versions of these are available in various strengths to cater to patients' needs. Healthcare providers often prescribe UDCA to manage gastrointestinal symptoms, such as diarrhea, abdominal discomfort, and nausea, associated with liver diseases.
However, the production of UDCA faces challenges, including raw material shortages and clinical trials to ensure high purity, stringent quality control, consistency, safety, and regulatory approval. Ursodeoxycholic acid plays a crucial role in liver health, particularly in managing conditions like primary biliary cirrhosis and cirrhosis. It is also used in the treatment of gallstone disease and cystic fibrosis. Despite its benefits, the market faces pitfalls and challenges, including the need for raw materials, ensuring consistency and safety, and managing impurities to maintain regulatory approval. Hence, such factors are expected to drive market growth during the forecast period.
A key factor shaping the market growth is the growing demand for combination therapies. Ursodeoxycholic acid (UDCA), a bile acid, is extensively utilized in treating various liver diseases, including primary biliary cholangitis (PBC) and gallstone dissolution. The market growth is driven by the increasing preference for combination therapies in managing liver disorders. UDCA, when combined with immunosuppressants or steroids, enhances treatment efficacy and improves patient outcomes. This is a liver-protective agent used for treating cholesterol gallstones and primary sclerosing cholangitis (PSC). It is available in branded and generic versions, with varying strengths, to cater to diverse patient needs. Healthcare providers prescribe UDCA due to its anti-inflammatory properties, which help reduce liver inflammation and improve liver function.
However, challenges in the market include raw material shortages, regulatory approval processes, and ensuring high purity and stringent quality control to maintain consistency and safety. Impurities in these can lead to gastrointestinal symptoms such as diarrhea, abdominal discomfort, and nausea. Ensuring safety and regulatory approval is crucial for patients undergoing long-term UDCA therapy, especially those with cirrhosis, cystic fibrosis, or gastroesophageal varices.
Hence, such factors are expected to drive market growth during the forecast period.
Adverse effects and safety concerns associated with UDCA are one of the key challenges hindering the market growth. The expiration of patent protection on Ursodeoxycholic Acid (UDCA) formulations can significantly impact the global market for this liver-protective bile acid. This is commonly used in the treatment of liver diseases, including primary biliary cholangitis and gallstones, to improve liver function and reduce inflammation. With the entry of generic versions, patients and healthcare providers have access to alternatives at lower costs. However, this competition can lead to price erosion for manufacturers of branded products, potentially reducing profit margins. The availability of multiple generic versions can result in market saturation. Ursodeoxycholic acid is a hydrophobic bile acid with important liver-protective properties. It is used in the treatment of various liver diseases, including cholesterol gallstones and primary sclerosing cholangitis.
However, the production involves challenges such as raw material shortages, regulatory approval processes, and ensuring high purity and stringent quality control to maintain consistency and safety. Impurities in UDCA can lead to gastrointestinal symptoms such as diarrhea, abdominal discomfort, and nausea. Ensuring the highest quality and safety standards is crucial for the success of UDCA medications in the market. In the context of liver health, this plays a vital role in managing various liver diseases. Its use extends to conditions such as cirrhosis, primary biliary cirrhosis, and cystic fibrosis. However, the production and distribution of these involve pitfalls and challenges, including raw material availability, regulatory approval processes, and maintaining high purity and stringent quality control. Clinical trials and organ transplantation are ongoing areas of research for UDCA and its potential applications in treating various liver diseases. Hence, such factors are expected to hinder market growth during the forecast period.
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The market report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.
Global Market Customer Landscape
The market research report provides comprehensive data (region wise segment analysis), with forecasts and estimates in "USD Million" for the period 2023 to 2027, as well as historical data from 2017 to 2022 for the following segments
Ursodeoxycholic Acid (UDCA) is a bile acid that plays a crucial role in the treatment of various liver diseases. The primary applications of UDCA are in the management of primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC). The global market is driven by the increasing prevalence of liver diseases and the rising awareness and adoption of UDCA as a therapeutic agent. The market is expected to grow significantly due to the increasing demand for effective treatments for liver diseases. The market is segmented based on application, end-user, and region. The major applications of UDCA include the treatment of PBC, PSC, and other liver diseases. The end-users of UDCA include hospitals, clinics, and research institutions.
Furthermore, the market is expected to grow at a steady pace in regions such as North America, Europe, and Asia Pacific. The key players in the market include Actavis plc, F. Hoffmann-La Roche Ltd, and Teva Pharmaceutical Industries Ltd. These companies are focusing on expanding their product portfolios and increasing their market presence through strategic collaborations and partnerships. In conclusion, the UDCA market is expected to grow significantly due to the increasing prevalence of liver diseases and the rising awareness and adoption of UDCA as a therapeutic agent. The market is segmented based on application, end-user, and region, and the key players include Actavis plc, F. Hoffmann-La Roche Ltd, and Teva Pharmaceutical Industries Ltd. Hydrophobic bile acids, along with nontoxic hydrophilic bile acids, play crucial roles in the metabolism of fats and cholesterol, contributing to the prevalence of gallstones and graft-related liver disease, particularly in bears (Ursidae), where taurine metabolism is essential.
Market Scope |
|
Report Coverage |
Details |
Page number |
152 |
Base year |
2022 |
Historic period |
2017 - 2021 |
Forecast period |
2023-2027 |
Growth momentum & CAGR |
Accelerate at a CAGR of 10.65% |
Market growth 2023-2027 |
USD 358.41 million |
Market structure |
USD Fragmented |
YoY growth 2022-2023(%) |
9.87 |
Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
Performing market contribution |
North America at 36% |
Key countries |
US, Canada, Germany, China, and India |
Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
Key companies profiled |
Abil Chempharma Pvt. Ltd., Anant Pharmaceuticals Pvt. Ltd., 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., Osmopharm SA, Panjin Hengchanglong Pharmaceutical Co. Ltd., Suzhou Tianlu Bio Pharmaceutical Co. Ltd., Tianjin NWS Biotechnology and Medicine Co. Ltd., Travere Therapeutics Inc., Zhongshan Belling Biotechnology Co. Ltd., Axplora, Cerata Pharmaceuticals LLP, and Octavius Pharma Pvt. Ltd. |
Market dynamics |
Parent market analysis, Market Forecasting, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, Market growth and Forecasting, COVID-19 impact and recovery analysis and future consumer dynamics, Market condition analysis for the market forecast period |
Customization purview |
If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Type
7 Market Segmentation by Application
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Trends
11 Vendor Landscape
12 Vendor Analysis
13 Appendix
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