Adapalene

The global prevalence of acne has remained high for a long time, with the incidence rate reaching 85% among people aged 12 to 25. Topical retinoids are the first-line option for the treatment of mild to moderate acne. Adapalene is a third-generation retinoid receptor-selective agonist, which can specifically bind to the retinoic acid receptor γ in skin keratinocytes. It exerts its effects by regulating the differentiation of follicular epithelial cells, reducing the formation of microcomedones, and simultaneously inhibiting neutrophil chemotaxis and arachidonic acid-mediated inflammatory reactions. It is indicated for the local treatment of acne vulgaris mainly manifested by comedones, papules and pustules, and can also be used to improve acne in sebaceous gland-rich areas such as the face, chest and back. Compared with traditional retinoids, it has lower skin irritation and better patient compliance.

In 2023, the global market size of adapalene API was approximately USD 120 million, with a compound annual growth rate of 4.7% from 2019 to 2023. The growth in demand was mainly driven by the expansion of the acne patient population and the increase in retail demand driven by the approval and launch of over-the-counter formulations. In terms of the competitive landscape, the patents of the original research enterprise have all expired. At present, the global supply is dominated by generic pharmaceutical enterprises. China is the core exporter of adapalene API, with production capacity accounting for 62% of the total global supply. Domestic API manufacturers have all passed the new version of GMP certification, and some leading enterprises have obtained FDA and CEP certifications at the same time, occupying a dominant position in the global mid- and low-end markets, while there is still room for substitution in the high-end market.

CATO can provide a full set of impurity reference standards for adapalene API. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Core categories are sufficiently in stock, and can quickly respond to the reference standard needs of manufacturers in the whole process of R&D, registration and quality control, without additional waiting for the customization cycle.