Anastrozole

Breast cancer is the malignant tumor with the highest incidence rate among women worldwide, among which about 70% belong to the hormone receptor-positive subtype, and endocrine therapy is the core means of whole-course management for such patients. Anastrozole, as a third-generation highly selective non-steroidal aromatase inhibitor, inhibits the growth of estrogen-dependent breast cancer cells by blocking the activity of aromatase and reducing the production of estrogen in peripheral tissues. It is mainly used for adjuvant therapy of early breast cancer in postmenopausal women, first-line and second-line treatment of advanced breast cancer, and can also be used for postmenopausal women with advanced breast cancer whose disease progresses after tamoxifen treatment. Compared with traditional endocrine drugs, it has a lower risk of adverse reactions in the reproductive system.

The global market size of anastrozole has long remained above US$1.2 billion. With the gradual popularization of clinical evidence that the adjuvant treatment cycle after early breast cancer surgery is extended to 10 years, the market size still maintains a compound annual growth rate of about 3%. Driven by the improvement of breast cancer screening coverage and the expansion of postmenopausal patient population in the Chinese market, the compound growth rate in the past 5 years has reached 7.2%, and the terminal sales of public medical institutions exceeded 1.8 billion yuan in 2023. At present, the domestic market is coexisted by original research drugs and generic drugs. After the implementation of centralized drug procurement, the penetration rate of generic drugs has exceeded 85%, and the demand for API continues to grow along with the expansion of generic drug production capacity. In 2023, the domestic consumption of anastrozole API increased by 21% year-on-year, of which exports accounted for about 35%.

The original research enterprise of anastrozole is AstraZeneca, and the original trade name is Arimidex. The expiration date of its core compound patent in China is 2020. The main dosage form approved by the original research is tablet, with a specification of 1mg. It has been included in the Catalogue of Marketed Drugs in China as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. Up to now, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China has registered a total of 12 valid registration numbers for anastrozole API, among which 7 are in A status. More than 30 domestic enterprises have been approved to produce anastrozole tablets, and the preparation supply is sufficient. (Data as of June 2025, please refer to the official CDE website for the latest information)

Impurity research and quality control at the R&D and production ends are the core links for the marketing and compliant supply of anastrozole generics. CATO provides a full set of impurity reference standards for this API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They are compliant with multiple regulations including Chinese Pharmacopoeia and FDA, and can fully meet the full-scenario needs of pharmaceutical enterprises such as R&D and declaration, daily quality inspection, etc.