Chemiluminescence immunodiagnosis technology uses chemiluminescence agents, catalytic enzymes and other substances to label antigens or antibodies. When the labeled antigen or antibody is combined with the corresponding antibodies and antigens, the luminescent substrate is affected by the luminescence agents, catalytic enzymes and other substances. Redox reactions. Compared with traditional biochemical diagnosis, chemiluminescence has the advantages of high automation, good specificity, high accuracy, and wide detection range.
Chemiluminescence is a battleground for IVD giants. The luminescence products of multinational giants entered China from the beginning of the 21st century. Siemens first entered the Chinese market in 2003, followed by bioMérieux, Beckman, Johnson & Johnson, and Abbott. In 2006, Roche's electrochemistry Luminous entered China, and imported brands quickly expanded their territory. Later, multinational companies such as Soling, Sysmex, Tosoh and others have also stepped up their efforts in the Chinese market.
Since the first batch of domestically produced automatic chemiluminescence immunoassay analyzers launched by New Industries and Mike in 2011, domestic brands have joined the competition. At present, the domestic luminescence market has basically formed a "4+4" competition pattern. Four foreign giants such as Roche, Abbott, Siemens, and Beckman account for more than 70% of the market share. The top three hospitals are its main customers, and the new industry of domestic enterprises, Antu Bio , Mike Biology and Mindray Medical have nearly 10% market share.
Objectively speaking, the current domestic brands' chemiluminescence has a certain gap with imported brands in indicators such as accuracy, stability, reagent quality and instrument detection speed, and because of the coexistence of multiple technical routes of chemiluminescence detection, it is difficult for manufacturers to trace the value to the source. The product quality is proved by other methods, and the possibility of domestic brands replacing imported brands on a large scale in the short term is low. In the long run, chemiluminescence is a relatively mature detection method after all. As the quality of domestic products is gradually recognized and accepted by the top three hospitals, the low-value detection items of the laboratory will gradually be replaced. We believe that it will account for the total amount of luminescence detection. More than 30% of infectious diseases are expected to take the lead in realizing import substitution. The test results of domestic Antu Biology and other companies are almost the same as Roche's "gold standard". After five years, the overall domestic share of chemiluminescence is expected to reach more than 30%.
In terms of chemiluminescence raw materials, domestic manufacturers of chemiluminescence reagents are gradually getting rid of the current situation of relying heavily on foreign imports for core raw materials such as enzymes, antigens and antibodies. For example, Antu Bio has achieved more than 70% of raw materials in-house. With the continuous development of research and development, domestic IVD The gaps in the field of diagnostic raw materials will be gradually filled. As one of the manufacturers of R&D chemiluminescent reagents, Desheng will also occupy a place in the field of diagnostic raw materials.
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