Pregnenolone

Hormone drugs are the core category for the treatment of endocrine system diseases, among which the precursor synthesis pathways of adrenocortical hormones and sex hormones have long been a key direction of drug research and development. Pregnenolone belongs to steroid API, and is a key intermediate for the synthesis of various hormone drugs such as progesterone, hydrocortisone and desoxycortone. It can also directly act on the body to regulate adrenocortical function, and is mainly used in the production of related hormone preparations in clinical links to assist in improving the symptoms related to adrenocortical hypofunction. Meanwhile, it is also an indispensable upstream raw material in the production chain of reproductive and rheumatology immunology hormone drugs.

The global market size of steroid hormone APIs was approximately USD 4.8 billion in 2023, and the compound annual growth rate is expected to remain around 5.2% by 2028, among which the demand for steroid intermediates accounts for more than 35% of the overall market. In terms of competition pattern, China is the core supplier of steroid intermediates such as pregnenolone in the world, with production capacity accounting for more than 70% of the global total, and the industry concentration is relatively high. Leading enterprises rely on the advantages of biological fermentation technology to continuously reduce production costs. Moreover, with the intensive approval of downstream hormone generic drugs, the annual growth rate of domestic market demand for pregnenolone has remained stable at around 8% in the past three years, and there is no clear centralized procurement related policy impact for the time being.

As a basic steroid intermediate, pregnenolone does not have an exclusive trade name corresponding to a single original research enterprise. The related synthesis patent expired as early as the 1950s, and it is now in the public patent domain. At present, the pregnenolone APIs of several domestic enterprises have completed registration in CDE, and the corresponding downstream preparations such as hydrocortisone and progesterone have been approved for marketing for many years, and the relevant reference preparations have been included in the FDA Reference Preparation Catalog and the Chinese *Collection of Chemical Drug Catalog*. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for pregnenolone, most of which support spot supply. Spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable compliance support for the quality research and declaration and registration links of API manufacturers and preparation R&D institutions.