Iohexol

As a core category of non-ionic X-ray contrast agents, iohexol clearly displays the morphology of lumens by forming a density difference under X-ray irradiation, and is one of the most widely used contrast agents in clinical practice at present. Its osmotic pressure is close to that of human plasma, and the incidence of adverse reactions is much lower than that of ionic contrast agents. It is suitable for angiography, urography and CT enhanced scanning in adults and children, and can also be used for body cavity examinations such as subarachnoid angiography. It has high medication safety for patients with renal insufficiency, and is a routine and essential drug in the radiology departments of major medical institutions.

The global market size of iohexol has stabilized at more than USD 1.2 billion in recent years, and the growth rate of the Chinese market has continued to be higher than the global average. In 2023, the domestic market size exceeded RMB 4.5 billion, with a compound annual growth rate maintained at around 8%. The competitive landscape presents a situation where the originator and generics coexist. Domestic enterprises have gradually occupied the mid- and low-end markets by virtue of cost advantages, while the high-end market is still dominated by originator products. With the continuous release of demand for medical imaging examinations, the market gap of iohexol API still has room for further expansion.

The originator enterprise of iohexol is GE Healthcare, and the originator brand name is Omnipaque. Its core compound patent expired globally in 2003. The dosage forms approved for the originator product cover injections, with specifications including 10ml:3g, 20ml:6g, 50ml:15g, 100ml:30g and other commonly used specifications, which have been included in the FDA Reference Listed Drug Catalog and the *Catalogue of Reference Preparations for Chemical Drugs* of China. At present, more than 20 domestic enterprises have obtained A status for their iohexol APIs through CDE registration, corresponding to more than 60 approved preparation varieties. The winning products of centralized procurement all take domestic APIs as the main supply source. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the quality control needs of iohexol, CATO can provide a full set of impurity reference standards for this API. Most products are in stock, and in-stock products ordered 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 work needs of enterprises related to impurity research, quality standard establishment and consistency evaluation.