In Vitro Diagnostic Industry in China - Diagnosis of Blood and Body Fluids XVIII

3.5 Continuous Research and Development of New Blood Coagulation Test Items

There is a huge gap between the development and popularity of coagulation test items in China and developed countries, with a huge room for growth in the coagulation testing industry. Chinese coagulation testing industry is still in the early stage; in terms of the abundance of test items, more than 150 test items of coagulation have been carried out in developed countries such as the United States, accounting for 1/3 of the routine tests. However, due to starting late, only four to eight test items are popularized in China, with a huge difference in the test items from the developed countries. Therefore, there is a huge growth potential in the test field. In terms of the IVD consumption, the per capita IVD expenditure in China is less than half of the global average, and far behind the developed countries such as Europe and the United States.

In the Chinese thrombus and hemostasis diagnostic market, seven items (PT/APTT/TT/FIB/D-D/FDP/AT) are the mainstream test items, with the revenue from reagents accounting for more than 90%; special test items (items other than PT/APTT/TT/FIB/ D-D/FDP/AT) are still very limited nationwide, and the revenue from reagents accounts for not more than 10%.

At present, the in vitro diagnosis of thrombosis and hemostasis in China tends to be disease prevention, disease diagnosis, and drug monitoring from the screening of thrombotic diseases and bleeding diseases. The types of thrombosis and hemostasis testing items carried out in Grade III hospitals will also continue to increase (including PC/PS/LA/vWF/Anti-Xa/FVIII/FIX, etc.). More and more thrombus molecular markers such as TAT, PAP, TM, and tPAIC will be popularized in clinical practices, which are close to the testing quality of imported reagents.

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