Gadodiamide

For the imaging diagnosis needs of multiple parts such as the central nervous system, abdomen and chest, gadolinium-based contrast agents are the core drugs used to improve tissue contrast in current magnetic resonance imaging (MRI) examinations. As a representative variety of non-ionic extracellular gadolinium-based contrast agents, gadodiamide shortens the relaxation time of hydrogen protons through the paramagnetism of gadolinium ions, significantly increasing the signal difference between diseased tissues and normal tissues. Its osmotic pressure is close to the physiological level of the human body, and the incidence rate of anaphylactoid reactions is low. It is suitable for MRI contrast-enhanced examinations of adults and children (including neonates), especially for follow-up patients who require multiple contrast examinations.

The global market size of gadolinium-based contrast agents was approximately USD 1.8 billion in 2024, and is expected to reach USD 2.6 billion by 2030, with a compound annual growth rate of around 6%. Among them, non-ionic varieties account for more than 65% of the market share due to their safety advantages. In terms of the domestic market, the original research product still occupies the main market share of gadodiamide at present. With the continuous improvement of the penetration rate of MRI examinations and the gradual expansion of the centralized procurement scope of contrast agents, the substitution space for generic drugs is gradually being released. There is no publicly verifiable segment market size data available at present.

The original research enterprise of gadodiamide is GE Healthcare, and the original research trade name is Omniscan. Its core patent in the United States expired in 2007, and the core patent in Europe also expired in 2006. The main dosage form of the original research marketed product is injection, with conventional specifications including 10ml:2.87g, 15ml:4.305g and 20ml:5.74g. It has been included in the FDA Reference Listed Drug Catalog, and is also included in the Chinese Catalog of Reference Preparations for Chemical Drugs. As of June 2025, there is no registration information of gadodiamide API marketing applications submitted by enterprises in the database of the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China. Only the original research imported gadodiamide injection has been approved for marketing in China, and no generic preparation has been approved. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of gadodiamide impurity reference standards, supporting the qualitative and quantitative analysis needs of different R&D stages. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and provide stable reference standard support for enterprises' API R&D, quality research and registration declaration.