Dotinurad—Exploring Its Potential and Applications in Modern Medicine I

Dotinurad (Youlesi) is a novel uric acid excretion-promoting drug jointly developed by Fuji Yakuhin and Eisai. It is primarily used to treat Hyperuricemia and gout, both of which are associated with elevated uric acid levels.

Zhuhai HRD Pharmaceutical Co., Ltd. is set to complete the process validation for Dotinurad by February 2025, marking a significant milestone in the production of Dotinurad's active pharmaceutical ingredient (Api). As a professional API manufacturer, we are committed to product innovation and process optimization to meet the evolving demands of the market.

Market Prospects

The demand for Dotinurad continues to grow!

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Global Increase in Gout Patients

According to “The Lancet Rheumatology”, the global number of gout patients reached 55.8 million in 2020 and is projected to rise to 95.8 million by 2050, a 72.6% increase. This highlights gout as a growing public health issue requiring more attention and intervention.

Market Size Expansion

The global gout drug market is expected to grow from $2.6 billion in 2020 to $3.9 billion by 2025, with a compound annual growth rate (CAGR) of 9.1%. Although the Chinese market experienced a decline in 2021 due to centralized procurement policies, online pharmacy sales grew by nearly 30%, demonstrating market resilience and potential.

Large Patient Population in China

The prevalence of hyperuricemia in China is 13.3%, affecting approximately 177 million people. The incidence of gout is 1.1%, with about 14.66 million new cases annually and over 80 million existing patients. By 2030, the number of hyperuricemia and gout patients in China is expected to reach 240 million.

Expanding Gout Treatment Market

The global gout drug market is on an upward trend, projected to reach $7.7 billion by 2030. In China, the market size grew from ¥900 million in 2016 to ¥2.8 billion in 2020 and is expected to reach ¥10.8 billion by 2030.

Rising Prevalence and Younger Patients

Globally, gout prevalence ranges from 0.03% to 15.3% across different ethnic groups. In China, hyperuricemia affects approximately 177 million people, with gout affecting about 14.66 million.

Competitive Landscape

Globally, there are 147 drugs in late-stage clinical development or already on the market for hyperuricemia and gouty arthritis. URAT1 is the most actively researched target. As a novel selective URAT1 inhibitor, Dotinurad holds significant advantages and potential in this rapidly growing market.

In summary, Dotinurad is entering a fast-growing and highly promising market. With the increasing global prevalence of gout and the demand for new treatments, Dotinurad is poised to play a significant role in the treatment of hyperuricemia and gout.