Ioversol

The imaging quality of contrast agents directly affects the diagnostic accuracy of diseases of the cardiovascular, nervous and other systems. As a second-generation non-ionic low-osmolar iodine contrast agent, ioversol achieves imaging by selectively absorbing X-rays in blood vessels or tissue gaps. Its osmotic pressure is only 1/3 of that of traditional ionic iodine contrast agents, and the incidence rates of nephrotoxicity and anaphylactoid reactions are significantly reduced. It is clinically mainly used for various imaging examinations such as cardiovascular angiography, urography and CT enhanced scanning in adults and children, and is especially suitable for high-risk subjects such as those with hepatic and renal insufficiency and allergic constitution. It is a mainstream iodine contrast agent variety with high safety in current interventional radiology and conventional imaging examinations.

The global market size of ioversol was approximately USD 1.28 billion in 2023, with a compound annual growth rate of around 3.7% in the recent 5 years. The growth momentum mainly comes from the rising demand for imaging examinations driven by the high incidence of chronic diseases worldwide, and the rigid demand for high-safety contrast agents due to the popularization of interventional surgeries. The domestic market has now formed a pattern of joint competition between original research drugs and generic drugs. Since 2022, ioversol injections from 6 domestic enterprises have passed the consistency evaluation. The winning bid price of this variety in provincial centralized procurement has dropped by up to 68% compared with that of the original research product, and the market share of the winning enterprises is rapidly increasing. The overall market has entered a stage of full competition with cost performance as the core.

The original research enterprise of ioversol is Bristol-Myers Squibb in the United States, and the original research trade name is Optiray. Its core compound patent in the United States expired in 2006, and the compound patent in China expired in 2007. The main dosage form approved for the original research product is injection, covering various specifications such as 160mgI/ml, 240mgI/ml, 300mgI/ml, 320mgI/ml, 350mgI/ml and 370mgI/ml. The original research product has been included in the Reference Preparation List of the China Listed Drug Catalog, and is also included in the FDA Reference Preparation Catalog. According to the domestic API registration platform, 8 enterprises including Hengrui Medicine and Stellite have obtained A-status registration for ioversol APIs, and 11 domestic enterprises have obtained approval for the marketing of ioversol injections. (Data as of September 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for ioversol API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the impurity reference needs of pharmaceutical enterprises in the process of R&D, quality research and production.