Progesterone

As the most important natural progestogen in the female body, progesterone plays an irreplaceable core role in the regulation of reproductive endocrine. Its mechanism of action is to specifically bind to progesterone receptors, promote the transformation of the endometrium from the proliferative phase to the secretory phase, and provide a suitable environment for embryo implantation. Meanwhile, it inhibits the contraction of uterine smooth muscle and reduces the sensitivity of the pregnant uterus to oxytocin, thereby maintaining pregnancy stability. It is widely used clinically in hormone replacement therapy for threatened abortion, habitual abortion, dysfunctional uterine bleeding, amenorrhea and menopausal syndrome, covering multiple clinical scenarios such as fetal protection for women of childbearing age, regulation of menstrual disorders, and perimenopausal health management.

The global progesterone market size had exceeded USD 1.8 billion in 2023, and it is expected to grow at a compound annual growth rate of 6.2% to USD 2.43 billion by 2028. The growth is mainly driven by the continuous rise in demand for assisted reproduction, the increased awareness of menopausal hormone replacement therapy, and the steady increase in the diagnosis and treatment rate of gynecological diseases. In terms of the domestic market, progesterone preparations are the mainstream varieties in the field of gynecological medication, with an annual sales volume of more than RMB 2 billion in public medical institutions. The competitive pattern presents a situation where original research drugs and generics coexist. The trend of oral and vaginal administration formulations replacing traditional injections is obvious. After the implementation of centralized procurement, the accessibility of relevant preparations has been greatly improved, and the demand for upstream API has also increased steadily.

The original research enterprise of progesterone is Merck Group, and the original brand name is "Utrogestan" (Chinese brand name "安琪坦"), whose core compound patent expired in the 1990s. At present, the main formulation of the original research drug approved in China is progesterone soft capsule, with specifications including 100mg and 200mg. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the National Medical Products Administration, and is also listed as a reference preparation by the FDA. In terms of domestic API registration, as of now, there are more than 30 progesterone API registration numbers, of which more than 10 are in A status, covering a number of domestic API manufacturers, and a number of domestic progesterone preparation varieties have been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full range of progesterone impurity reference standards, which meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most of the products are in stock all the year round. For in-stock orders, payment before 16:00 can be delivered on the same day, which can fully meet the reference standard use needs of different stages such as API R&D, quality research and consistency evaluation.