Prednisolone

Glucocorticoid drugs have always occupied an irreplaceable position in the treatment of autoimmune diseases and inflammation-related diseases. As a typical representative of intermediate-acting glucocorticoids, prednisolone binds to intracellular glucocorticoid receptors, inhibits the transcription of inflammatory factors, reduces the activity of immune cells, and has multiple effects of anti-inflammation, anti-allergy and immunosuppression. It is widely used clinically in the treatment of rheumatoid arthritis, systemic lupus erythematosus, bronchial asthma, nephrotic syndrome and other diseases, and can also be used for the intervention of allergic diseases and rejection reactions after organ transplantation. The applicable population covers adults and children, and the dosage should be adjusted strictly according to the indications to reduce the risk of adverse reactions.

The global prednisolone market size has maintained steady growth for a long time. The overall market size in 2023 was approximately USD 1.87 billion, and the compound annual growth rate from 2024 to 2030 is expected to remain at around 3.2%. The competitive landscape is characterized by the dominance of generic drugs, which account for more than 90% of the market share. China and India are the world's main suppliers of API, and China alone accounts for more than 60% of the global total production capacity. In terms of the domestic market, prednisolone preparations have been included in multiple batches of the national centralized procurement catalog, the average winning bid price has dropped by more than 70% compared with that before centralized procurement, and the accessibility at the primary level has been significantly improved.

The original research enterprise of prednisolone is Pfizer, and the original research trade name is Delta-Cortef. Its core compound patent expired worldwide in the 1970s. At present, the main dosage forms approved for the original research product are oral tablets, with specifications including 5mg, 10mg and 20mg. The relevant dosage forms have been included in the FDA Reference Listed Drug Catalog, and are also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. In terms of domestic API registration, more than 20 enterprises have completed the A-status registration of prednisolone API in CDE. The domestically approved prednisolone preparations cover multiple dosage forms such as tablets, injections and eye ointments, which can fully meet the use needs of different clinical scenarios. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of prednisolone impurity reference standards. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are in regular stock. Orders placed before 16:00 can be shipped on the same day, which can provide stable reference material support for API R&D, quality research and consistency evaluation work.