Estradiol

As a core representative of steroidal estrogens, estradiol is the endogenous estrogen with the strongest activity in women of childbearing age. It regulates the development of the reproductive system, bone metabolism, cardiovascular homeostasis and other multi-system physiological functions through specific binding to estrogen receptors. Clinically, it is mainly used for the treatment of perimenopausal syndrome, ovarian insufficiency and primary amenorrhea related to estrogen deficiency. It is also a core medication for endometrial preparation in assisted reproductive technology and osteoporosis prevention in postmenopausal women, covering multiple disease scenarios throughout the whole life cycle of women, and has irreplaceable clinical value.

At present, the global market size of estradiol preparations exceeds USD 2.8 billion, with an annual compound growth rate maintained at around 6.2%. The core growth drivers come from the expansion of the global menopausal female population and the continuous rise in demand for assisted reproduction. In the domestic market, estradiol has been included in the fourth batch of national centralized drug procurement. The price of selected products has dropped by more than 80%, and clinical accessibility has been greatly improved. The overall market size is stably above RMB 1.8 billion. The supply of active pharmaceutical ingredients (APIs) is dominated by local enterprises, and the competitive landscape is relatively fragmented.

The original research enterprise of estradiol is Bayer Pharma, and the original research trade name is "Progynova". Its core compound patent expired in 2003. The current mainstream dosage forms include 1mg oral tablets, 0.06mg/24h transdermal patches and gels. The original research oral tablets have been included in the China Listed Drug Catalogue as reference listed drugs. According to the domestic API registration platform, more than 12 enterprises have obtained A-status registration numbers for estradiol APIs, and more than 30 domestic preparations have been approved, covering multiple administration routes such as oral administration and transdermal administration. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for estradiol. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products are in sufficient stock and available for spot supply. Orders placed before 16:00 can be shipped on the same day, which fully meets the R&D requirements of API manufacturers in the whole process of impurity research and quality control.