Adapalene

The global prevalence of acne has remained high for a long time, with the incidence rate among adolescents reaching over 80%. Patients with moderate to severe acne face significantly higher risks of sequelae such as post-inflammatory hyperpigmentation and scarring, and there is an urgent clinical need for topical therapeutic drugs with both anti-inflammatory and keratinocyte differentiation regulating effects. Adapalene is a third-generation topical retinoid. By selectively binding to skin retinoic acid receptor γ and retinol X receptor α, it inhibits excessive proliferation of follicular epithelial cells, reduces keratin accumulation, and downregulates the expression of pro-inflammatory cytokines. With both comedolytic and anti-inflammatory effects, it is the first-line topical treatment option for mild to moderate acne, and can also be used as the basic medication for combination therapy of severe acne, with the applicable population covering adolescents and adult patients aged 12 and above.

The global market size of adapalene maintains a steady growth trend, reaching approximately USD 720 million in 2023, with a projected compound annual growth rate of 3.8% by 2028. In terms of the domestic market, the total sales in public medical institutions and retail channels reached approximately RMB 1.26 billion in 2023. With the improvement of diagnosis and treatment awareness among acne patients, the growth rate has remained above 6% in the past three years. At present, the domestic preparation market is dominated by generic drugs, with the original research product accounting for about 23%. More than 15 generic drug manufacturers have passed the consistency evaluation. The average winning bid price of adapalene gel in provincial centralized procurement has dropped by more than 60% compared with the price of the original research product, and the market penetration rate continues to rise.

The original research manufacturer of adapalene is Galderma, with the original trade name "Differin". Its compound patent in China expired in 2017. The core dosage form of the original research product is 0.1% adapalene gel, with single-unit specifications of 30g and 15g. It has been included in the China Listed Drug Catalogue as a reference listed drug, and is also included in the FDA Reference Listed Drug Catalogue. In terms of domestic API registration, 28 adapalene API registration information entries are currently available on the CDE platform, of which 17 are in the status of "A (approved for use in marketed preparations)". More than 30 domestic enterprises have obtained marketing approval for adapalene preparations such as gel and cream. (Data as of June 2025, please refer to the official CDE website for the latest information.)

In response to the needs of adapalene generic drug R&D and quality control, CATO can provide a full set of impurity reference standards for this API. Relevant products comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are in stock. Spot orders placed before 16:00 can be shipped on the same day, which can efficiently support the full-scenario needs of drug R&D, quality research and routine testing.