睾酮

The incidence of diseases such as male hypogonadism and late-onset hypogonadism continues to rise along with the intensification of population aging. As a core drug for androgen replacement therapy, testosterone is a key endogenous hormone regulated by the hypothalamic-pituitary-gonadal axis. It exerts its effects by binding to androgen receptors, can maintain male secondary sexual characteristics, bone mineral density and muscle mass, and can also be used for palliative treatment of female breast cancer and hormone replacement for patients with gonadal dysgenesis, making it an indispensable basic drug in the field of endocrinology.

The global market size of testosterone-related preparations had exceeded 2.8 billion US dollars in 2023, with a compound annual growth rate maintained at around 5.2%, among which novel dosage forms such as transdermal preparations and gels account for more than 60%. Driven by the improvement of male health awareness and the growth of assisted reproduction demand in the domestic market, the sales growth rate of testosterone preparations has reached 7.8% in the past 3 years. At present, the competitive landscape is dominated by generic drugs, with original research products accounting for about 18%, and more than 20 domestic enterprises have obtained approval documents for relevant preparations. After the implementation of centralized drug procurement, the average price reduction of the selected products reached 62%, which further improved clinical accessibility.

The original research enterprise of testosterone is Abbott, and the original research trade name is AndroGel. The US patent for its core gel dosage form expired in 2022, and the domestic compound patent has passed the protection period. The main dosage forms of the original research include gels, injections and patches, with common specifications of 1% gel 5g per tube and testosterone undecanoate injection 250mg/2ml. The relevant original research dosage forms have been included in the FDA Reference Listed Drug Catalog, among which testosterone undecanoate soft capsules have been included in China's *Catalog of Reference Preparations for Chemical Drugs*. At present, there are more than 40 testosterone API registration numbers in China, among which more than 15 are in A status. Various dosage forms such as testosterone undecanoate and testosterone propionate have been approved for marketing as domestic preparations. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of testosterone impurity reference standards, which fully cover synthetic process impurities, degradation impurities and isomer impurities. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can meet the full-process R&D needs such as API registration and declaration, quality research, and stability investigation.