IVD reagents industrial technology and medical testing technology are closely related. The development of the industry is accompanied by the development of biochemistry, immunology, molecular biology, automation, informatization, and other fields.
IVD reagents definition: the removal of blood, body fluids, tissues, and other specimens from the human body, and then use IVD reagents, kits, calibrators, quality control products, instruments, etc. to detect and verify samples. They are used for disease prevention, diagnosis, treatment monitoring, prognosis judgment, prediction, and health evaluation.
The instruments, reagents and consumables required in the detection process constitute the IVD reagents system, which brings together related technologies such as biology, medicine, machinery, optics, electronics, computers, engineering design, and manufacturing.
The role of IVD reagent industrial technology for clinical medicine and medical testing is to improve diagnostic efficiency, speed up testing, ensure testing quality, expand testing scope, improve automation level, and reduce testing costs.
According to different classification methods, it can be divided into different IVD reagents products:
According to the detection principle or detection method, IVD reagents products can be divided into eight categories: biochemical diagnostic products, immunodiagnostic products, molecular diagnostic products, microbiological diagnostic products, urine diagnostic products, coagulation diagnostic products, hematology and flow cytometry diagnostic products, on-site rapid diagnostic products, etc.
Among them, biochemical, immunological, molecular, and point-of-care diagnostic products are the main four categories of IVD reagents reagents in China.
According to the level of product risk classification, IVD reagents products can be divided into first-class products, second-class products, and third-class products.
The development of IVD reagents industrial technology and the development of medical testing are carried out simultaneously.
At present, the global IVD raw materials market is prominently characterized by a large number of participants, a small individual scale, and a highly fragmented industry. Even the global market share of leading companies such as Fapon Biotech, HyTest, BBI Solution, and Meridian is less than 5%. Whereas, a large number of small and medium-sized laboratories occupy a place in the industry by supplying several special projects.
The highly fragmented competitive landscape is mainly because there are many technical paths and links involved in the raw materials of IVD reagents. Taking expression systems as an example, there are E. coli expression systems, yeast expression systems, insect cell-baculovirus expression systems, and mammalian cell expression systems. It is difficult to master multiple expression systems at the same time, which limits the product expansion ability of small and medium-sized laboratories.