Ursodeoxycholic Acid Market Analysis

Ursodeoxycholic Acid Market Analysis

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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.