Technical analysis of the in vitro diagnostic industry

In vitro diagnosis is divided into three categories: biochemical diagnosis, immunodiagnosis, and molecular diagnosis according to methodology, as well as point-of-care rapid diagnosis POCT differentiated from biochemical, immunological and molecular diagnosis. Testing items mainly include hematology and flow cytometry testing, urine testing, tissue testing, microbial testing, tissue testing, element testing, genetic testing, etc.

Biochemical diagnosis developed earlier in my country. It is a routine diagnosis and testing project in hospitals, focusing on the monitoring of diseases that have occurred. The future growth rate will be slow, and the localization rate of reagents has reached more than 70%. Most of the instruments have also been made domestically. At present, the domestically produced instruments only have a gap with foreign instruments in terms of instrument detection speed and integration.

Immunodiagnosis is the largest in vitro diagnostic sub-industry in my country and is still undergoing rapid development. High-end chemiluminescence has gradually replaced enzyme-linked immunoassay as the mainstream immunodiagnostic method in my country, focusing on the monitoring of infected diseases, and the market scale has reached More than 70% of the total immunodiagnostic market. The low-end reagents and instruments have a relatively high degree of localization, but the high-end markets such as tertiary hospitals are still monopolized by overseas giants. In the future, import substitution in the high-end immunodiagnostic market is the direction of development.

Molecular diagnosis is in the early stage of development worldwide, and has unique advantages in detecting the early stage of infection and possible genetic diseases.

At the CMEF (China International Medical Equipment Fair) in the spring of 2018, Roche Diagnostics exhibited the cobas® 8000 system, which can carry out a variety of combinations of biochemical and immune modules according to the needs of customer laboratories. It can support connecting up to 4 analysis modules, including high-throughput biochemical detection modules c702 and c701. With the development of customer laboratories, not only can more modules be expanded on the original system, but also can be easily connected to the CCM assembly line Further improve laboratory automation and testing efficiency.

Siemens Medical's Aptio automation system workstation can integrate clinical biochemistry, immunity, plasma protein, blood, coagulation and other analysis systems. It is a modular design high-speed processing and large-volume sample automation system. Beckman exhibited a complete set of laboratory-wide solutions, including automated assembly lines and information system solutions; immune analysis solutions; biochemical analysis solutions; blood/urine analysis solutions; microbiological analysis solutions Program.

On the whole, industry giants are accelerating the deployment of pipeline projects and modules covering laboratory testing, in addition to intensive cultivation in their original areas of advantage, and are moving towards automation, streamlining, high-speed, intelligent equipment and more comprehensive, A complete overall solution strives to achieve full coverage.