At present, the products of most manufacturers are often concentrated in one or two market segments, and cannot provide a full range of diagnostic reagent product services and technical support.
Enterprises are generally small in scale and few in variety, and there is a relatively large room for improvement in the concentration of enterprises in the industry.
The complete in vitro diagnostic industry chain includes upstream raw material supply industry and downstream demand industry.
The main problems in the current diagnostic reagent industry chain are the lack of upstream high-quality core raw materials and the weak production capacity of supporting equipment for large-scale automation and high-capacity detectors.
Mastering the integrated production of core raw materials and supporting instruments has become the only export breakthrough for the company.
Although molecular diagnosis currently only accounts for about 5% of the IVD market, its growth rate is higher than that of biochemical diagnosis and immunodiagnosis.
Compared with biochemical and immunodiagnostic reagents, molecular diagnostic reagents have the advantages of strong specificity, high sensitivity, and short window period, can perform qualitative and quantitative detection, and have higher technical barriers.
Molecular diagnostic reagents are the fastest-growing sub-industry among all types of diagnostic reagents, with an overall growth rate of 14% worldwide, and diagnostic reagents have become a hot product that major IVD leading companies are vying to develop.
At present, the molecular diagnostics market is relatively mature, with a high degree of global market concentration, with 70% of the market concentrated in the United States.
Since the beginning of the 21st century, diagnostic reagent technology supported by high-tech advancement and comprehensive application, with its incomparable advantages in traditional testing equipment and testing technology, has achieved rapid development in the world.
Its main feature is that it emphasizes quick results. Compared with the traditional clinical laboratory, diagnostic reagents have reduced the measurement time by two-thirds, which greatly shortens the turnaround time of experimental results.
The advancement of technology has greatly promoted the rapid rise of the diagnostic reagent industry, which not only conforms to the needs of the market, but also outlines a bright prospect for the development of laboratory medicine in the future.
At present, the application scope of diagnostic reagent technology is continuously expanding, from the initial blood glucose detection and pregnancy test to the detection of blood coagulation status, myocardial damage, acid-base balance, infectious diseases and therapeutic drug concentration.
The fields of application have also covered medical treatment, monitoring of major epidemics, food hygiene and safety, environmental protection, forensic medicine, military and disaster relief and so on.
Diagnostic reagents show great technical advantages especially in emergency rescue.
