Mass spectrometers typically consist of an injection system, ion source, mass analyzer, ion detector, vacuum system, electronic measurement and control system, and data processing system. Their main working principle is to ionize the sample into a gaseous ion mixture, and then use electromagnetic principles to separate the ions according to their mass-to-charge ratio to measure the intensity of the ion current.
The main differences between mass spectrometry testing technology and other in vitro diagnostic technologies are: (i) The detection results are based on the chemical properties such as molecular weight and structure of the sample, offering better sensitivity and specificity; (ii) It is suitable for various samples such as sputum and blood, meeting the growing demand for microbial detection; (iii) It is suitable for multi-indicator clinical testing and can identify and classify almost all pathogens. Therefore, mass spectrometers have the advantage of higher sensitivity compared to other detection methods, applicability to a variety of samples, and multi-indicator clinical testing.
With the continuous iteration of mass spectrometry testing technology, its application in the field of clinical medicine has deepened in recent years, covering applications from small molecule quantification testing to microbial identification and bio-macromolecule analysis, mainly including sub-scenarios such as neonatal screening, endocrine testing, therapeutic drug testing, protein/peptide, microbial testing, and major disease screening.
From the perspective of the industrial chain of clinical mass spectrometry testing, the upstream market consists of instrument and reagent manufacturers, the midstream market consists of mass spectrometry testing services and comprehensive solution providers, and the downstream terminal market consists of hospitals and independent medical laboratories.
From the perspective of reagents,Currently, the number of approved domestic clinical mass spectrometry kits far exceeds that of overseas products, with application scenarios mainly concentrated in mature fields such as vitamin testing and neonatal screening, and about 80% use liquid chromatography-tandem mass spectrometry (LC-MS). In terms of the characteristics of leading companies, they are mostly holding companies established by in vitro diagnostic companies. Their advantage is that they can rely on the existing technology and resources of their parent companies to form a business closed loop and sustainability. The operational model of the overall solution provided will be the future development trend of the industry.
From the perspective of instruments,The Chinese mass spectrometer market is mostly monopolized by overseas manufacturers, with the top three importers occupying more than half of the Chinese market share. Among them, economically developed provinces and cities with key scientific research are the main importers. However, with the deepening process of domestic substitution in recent years, the growth rate of mass spectrometer imports has gradually slowed down.
