Estrone

Menopause-related symptoms are common problems that trouble the health of middle-aged and elderly women. Estrogen replacement therapy is the core intervention scheme in clinical treatment. As an important member of natural steroidal estrogens, estrone can regulate the function of the endocrine axis by binding to estrogen receptors, effectively relieve postmenopausal discomforts such as hot flashes and night sweats, vaginal atrophy, and decreased bone mineral density. It can also be used for endometrial preparation in assisted reproductive technology, and is a key intermediate for the synthesis of other estrogen drugs such as estradiol and ethinylestradiol, occupying an irreplaceable position in gynecological diagnosis and treatment and the steroidal drug industry chain.

The global market size related to estrone was approximately USD 180 million in 2023, and the compound annual growth rate is expected to remain at around 4.2% from 2024 to 2030. The growth momentum mainly comes from the expansion of the global menopausal female population, the rising demand for assisted reproduction, and the capacity expansion of downstream steroidal drugs. In the current competitive landscape, European and Chinese enterprises dominate the supply of active pharmaceutical ingredients (APIs). Relying on the mature steroidal hormone synthesis industry chain, domestic enterprises have obvious cost advantages, and China is the core export region of estrone APIs in the world.

The original research enterprise of estrone is Pfizer, with the original brand name Estrace. The compound patent in the US market expired in 1985. The main dosage forms of the original product are oral tablets and vaginal cream. The tablet specifications include 0.5mg, 1mg and 2mg, and the vaginal cream specification is 0.1mg/g. The original dosage forms have been included in the FDA Reference Listed Drug Catalog, and no original preparation has been approved for import in China yet. In terms of domestic API registration, up to now, the estrone APIs of multiple enterprises have obtained A status through CDE registration, and can be legally supplied to domestic preparation manufacturers. In addition, the DMFs of several other enterprises are under review. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for estrone, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products fully meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and sufficiently satisfy the reference standard use needs in the whole process of API R&D, quality research and production.