Ursodeoxycholic Acid Market – By Type (Synthetic, Biological), Application (Gall Stones, Primary Biliary Cholangitis), Mode (In-house, Contract Manufacturing), Use (Human, Veterinary), Global Forecast, 2023 – 2032

Ursodeoxycholic Acid Market Size

Ursodeoxycholic Acid Market size was accounted for USD 581.7 million in 2022 and is likely to reach USD 1.4 billion by 2032 with CAGR of 10.1%. The growth in demand for ursodeoxycholic acid (UDCA) can be attributed to several factors, including the increasing prevalence of liver diseases such as primary biliary cholangitis and gallstones and the growing volume of research focused on UDCA.

UDCA has a well-established history of usage and is known for its ability to enhance liver function, reduce inflammation, and decelerate the progression of various liver diseases. Moreover, UDCA is readily available in various forms, including both branded and generic versions, and is offered in a wide range of strengths. This accessibility benefits both patients and healthcare providers ensuring a broader reach and ease of use, thereby promoting high market progress.

Ursodeoxycholic acid is an active pharmaceutical ingredient (API) that is isolated or synthesized and used as the primary therapeutic component in various pharmaceutical formulations. It is employed for its hepatoprotective (liver-protective) properties and its ability to dissolve cholesterol gallstones. UDCA is commonly used in medications for treating liver and gallbladder disorders, such as primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and certain cases of gallstone disease.

COVID-19 Impact

The impact of the COVID-19 pandemic on the Ursodeoxycholic Acid market has been wide-ranging. In the initial phases of the pandemic, disruptions in global supply chains were observed, which had repercussions on the manufacturing and distribution of pharmaceuticals, including UDCA. This resulted in challenges related to the availability of essential raw materials and potential shortages of UDCA. UDCA manufacturers have encountered difficulties in sourcing these raw materials, leading to production delays and potential product shortages.

Further, the COVID-19 pandemic also led to the suspension or delay of numerous clinical trials, including those involving UDCA. These factors had a relatively minor influence on the market in 2020. However, it's worth noting that some researchers explored the potential of UDCA in preventing COVID-19 infection in patients who had undergone organ transplantation. For instance, an article titled "Merit of an Ursodeoxycholic Acid Clinical Trial in COVID-19 Patients" published on June 2020, suggested conducting a randomized open-label unblinded clinical trial to assess the role of UDCA in the treatment of COVID-19.

Ursodeoxycholic Acid Market Trends

The escalating prevalence of liver and gallbladder disorders is a major driver for the growth of the market. Conditions like primary biliary cirrhosis, non-alcoholic fatty liver disease (NAFLD), gallstones, cystic fibrosis of liver, and others are increasingly diagnosed worldwide. For instance, according to the article published in Journal of Cystic Fibrosis, in 2022, around 162,428 people are estimated to be living with CF all over the globe. Ursodeoxycholic acid (UDCA) has great potential as an effective cystic fibrosis therapeutics.

Also, UDCA is undergoing extensive research for potential applications in addressing non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). For instance, in primary biliary cirrhosis, UDCA has been established as a standard treatment that can significantly slow disease progression. Additionally, UDCA is employed as a non-surgical option for certain gallstone types, as it aids in dissolving them. Thus, the continuous increase in the prevalence of liver and gallbladder disorders necessitates effective treatments, which in turn propels the demand for UDCA API-containing medications.
 

Ursodeoxycholic Acid Market Restraint

Side effects associated with UDCA may significantly obstruct the growth of the market. Common side effects include gastrointestinal symptoms such as diarrhoea, abdominal discomfort, and nausea. These side effects can range in severity, and their occurrence varies among patients. For some individuals, these side effects can be manageable and transient, while for others, they may be more pronounced and disruptive to daily life. The occurrence of side effects can impact patient compliance and adherence to treatment regimens, thereby hindering the market growth to some extent.

Ursodeoxycholic Acid Market Analysis

Based on type, the global ursodeoxycholic acid market is segmented into synthetic ursodeoxycholic acid and biological ursodeoxycholic acid. The synthetic ursodeoxycholic acid segment accounted for highest business share in 2022 and is expected to reach USD 958.6 million by end of 2032. The utilization of synthetic Ursodeoxycholic Acid (UDCA) API in the pharmaceutical and medical fields offers a multitude of advantages. One of the foremost benefits lies in its capacity for high purity and stringent quality control, ensuring consistency and safety in pharmaceutical formulations.

This precise control over the manufacturing process minimizes impurities, a critical factor in pharmaceutical safety and effectiveness. Moreover, synthetic UDCA API can be produced in strict compliance with regulatory standards, including Good Manufacturing Practices (GMP), making it suitable for pharmaceutical products requiring regulatory approval. All these factors together contribute towards high segment progress.

Based on application, the ursodeoxycholic acid market is segmented into primary biliary cholangitis (PBC), gallstones, and other applications. In 2022, the primary biliary cholangitis segment accounted for highest revenue share of 62.9%. Ursodeoxycholic Acid (UDCA) API plays a pivotal role in the treatment of primary biliary cholangitis (PBC) and serves as the standard first-line therapy. One of the primary factors contributing to the extensive utilization of UDCA in the treatment of PBC is its well-documented and established effectiveness.

Rigorous clinical trials and comprehensive research have provided conclusive evidence that UDCA is successful in slowing down the progression of PBC, enhancing liver function, and alleviating associated disease symptoms. Additionally, UDCA has been proven to lower the levels of toxic bile acids in both the liver and bile, thereby reducing cholestatic symptoms like itching and yellowing of the skin (jaundice). Such wide advantages offered by UDCA in treating primary biliary cholangitis, makes it a drug of choice for treatment, thereby aiding in overall market progress.

By mode, the ursodeoxycholic acid market is segmented into in-house manufacturing and contract manufacturing. The in-house manufacturing segment accounted for highest market share in global market and is likely to grow at CAGR of 9.8% over the forecast timeframe. In-house manufacturing allows pharmaceutical companies to have direct control and management over every step of the production process. They can establish and enforce rigorous quality control standards, including Good Manufacturing Practices (GMP), to consistently develop high-quality UDCA API. This ensures that the Active Pharmaceutical Ingredients (API) is safe, effective, and contaminant free, sustaining the expectations of regulatory authorities and healthcare professionals.

Additionally, in-house manufacturing minimizes outsourcing costs associated with contract manufacturing and over time, allows companies to fine-tune their manufacturing processes to achieve cost savings. Thus, the aforementioned factors aid in high segment market share.

By use, the ursodeoxycholic acid market is segmented into human and veterinary. The human use segment is anticipated to grow at CAGR of 10%, to reach USD 1.2 billion by 2032. The pharmacological properties of UDCA are well-studied in humans, and its safety & efficacy profiles are well-established within the human population. Also, UDCA is widely used in humans to treat liver and gallbladder disorders such as primary biliary cholangitis (PBC), gallstones, and non-alcoholic fatty liver disease (NAFLD). These diseases are specific to humans and usually have different underlying causes and mechanisms compared to analogous conditions in animals. Such advantages associated with UDCA intake in humans is expected to spur the market trends.

The North America ursodeoxycholic acid market dominated the global market and accounted for USD 203.7 million in 2022. North America exhibits a relatively elevated prevalence of liver and gallbladder ailments, encompassing primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), non-alcoholic fatty liver disease (NAFLD), and gallstones. UDCA has gained recognition as a therapeutic choice for managing these conditions, leading to its widespread adoption in the region.

Additionally, a well-established pharmaceutical industry with several pharmaceutical companies in North America further enhance the regional market growth. Moreover, the region benefits from a robust healthcare infrastructure, advanced research and development facilities, a sizable and well-off patient populace, and a strong emphasis on patient adherence, all of which further drive this upward trend.
 

Ursodeoxycholic Acid Market Share

Major market players operating in the UDCA market is as mentioned below:

• ICE S.p.a.
• Merck KGa
• Daewoong Bio
• Glenmark Pharmaceuticals Ltd
• Dipharma Francis S.r.l.
• IOL Chemicals and Pharmaceuticals
• Kimia Biosciences Ltd
• Cerata Pharmaceuticals
• Changde Yungang Biotechnology Co. Ltd.
• Osmopharm SA
• Tianjin NWS Biotechnology and Medicine Co. Ltd
• Zhongshan Belling Biotechnology Co. Ltd.
• Axplora
• Anant Pharmaceuticals Pvt Ltd

The global ursodeoxycholic acid market is highly competitive and consists of several major players. ICE s.p.a., Merck KGa, and Daewoong Bio accounts for largest market share in the overall ursodeoxycholic acid API market. These market players are engaged in strategic collaborations, partnerships, mergers, etc., to maintain their position in the market, capture the highest market share, and outperform the competition. By meticulously assessing the market share of each company, considering factors such as product offerings, production capacity, geographic reach, etc., one can unveil valuable insights into the competitive landscape of its market and strategically position themselves for success in this sector.
 

Ursodeoxycholic Acid Industry News:

• In April 2022, three companies PharmaZell, Farmabios and Novasep merged to become Axplora. This merger strengthened and increased the active pharmaceutical ingredients sector of the company which is expected to generate more revenue.
   
• In August 2020, ICE s.p.a. acquired New Zealand Pharmaceuticals (NZP), manufacture a range of active pharmaceutical ingredients (API’s) and pharmaceutical intermediates derived from bile. This gave better geographic coverage, product knowledge and expansion of bile acid, thereby it helped to increase the product portfolio.
   

 The ursodeoxycholic acid market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2018 to 2032, for the following segments:

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By Type

• Synthetic ursodeoxycholic acid
• Biological ursodeoxycholic acid

By Application

• Primary Biliary Cholangitis (PBC)
• Gall stones
• Other applications

By Mode

• In-house manufacturing
• Contract manufacturing

By Use

• Human
• Veterinary

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • France
  • Italy
  • Germany
  • UK
  • Russia
  • Spain
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Malaysia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of Middle East & Africa