Estetrol

The dynamic changes of estrogen levels in pregnant women are the core element to maintain the normal progress of pregnancy. As a pregnancy-specific endogenous estrogen substance, estetrol is only synthesized and secreted by the fetal-placental unit, and is a specific biomarker for evaluating fetal health. Different from other estrogens such as estradiol and estriol, the serum concentration of estetrol increases steadily with the increase of gestational weeks. It is mainly used in clinical screening of fetal chromosomal abnormalities in the first and second trimesters and evaluation of placental function, and can also assist in judging the prognosis of pregnancy-related diseases such as threatened abortion and fetal growth restriction, making it one of the important clinical detection indicators in obstetrics.

At present, the global market size of estetrol-related testing and API has reached 120 million US dollars, and the compound growth rate in the past three years has maintained at around 8.3%. The growth momentum mainly comes from the continuous increase in the demand for obstetric birth defect prevention and control. From the perspective of competition pattern, European pharmaceutical companies are the main suppliers of global estetrol API, accounting for 62% of the global production capacity. Only a few domestic enterprises have the compliant mass production capacity. With the annual increase of the penetration rate of prenatal screening in China, the space for domestic substitution is gradually expanding.

At present, there is no original research marketed therapeutic preparation of estetrol, and its related applications are concentrated in the field of diagnostic reagent supporting. No domestic enterprise has obtained the API marketing registration number of this variety, and no related preparation has been approved for marketing. The core patents are mainly concentrated in the direction of synthesis process, and the earliest process patent will expire in 2035. (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 estetrol. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They are compliant with multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API manufacturers for process research, quality standard establishment and declaration and registration.