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

3. Future Development Trend of Blood Coagulation Industry

Presently, the domestic IVD market shows a slow overall growth rate, but with the emergence of new projects, the improvement of industry concentration, and the emergence of assembly line trends, etc., the blood coagulation market will become thriving.

3.1 The Improvement of Academic Cognition Drives the Growth of Demand for Blood Coagulation Testing

Clinically, bleeding and thrombosis are common in various departments of medical institutions. In the past, the in vitro diagnosis of thrombosis and hemostasis in domestic clinical departments is applied in the screening of bleeding causes and bleeding diseases. With the deepening of domestic clinical cognition, the applications of in vitro diagnosis of thrombosis and hemostasis for screening, diagnosis, treatment, and monitoring of thrombosis and thrombotic diseases are continuously developing. Therefore, in recent years, various discipline associations such as cardiology, orthopedics, vascular surgery, respiratory, and oncology have successively issued guidelines and expert consensuses related to the prevention and treatment of various thrombotic diseases, promoting the clinicians’ recognition of thrombotic diseases-related diagnostic items.

At present, in the Chinese market, the clinical applications of thrombosis and hemostasis testing technologies tend to disease prevention, disease diagnosis, and drug monitoring from the screening of thrombotic diseases and bleeding diseases. With the development of novel direct oral anticoagulants (DOACs), numerous clinical validations have shown that single-target anticoagulation therapy also requires the targeted monitoring.

Therefore, the implementation of the special test items for bleeding and coagulation (including PC/PS/LA/vWF/Anti-Xa/FVIII/FIX, etc.) not only makes up for the blank of traditional laboratory monitoring but also continuously advances the diagnostic level to precise treatment and individualized treatment, conforming to the development trend of the clinical technology applications. Under the guidance of clinical needs, the above special test items for bleeding and coagulation also follow the law of gradually developing from Grade III hospitals to Grade II and below hospitals and finally are applied and popularized in the domestic market, bringing the development of a new round of blood coagulation testing.

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