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

Blood Coagulation Analyzer and Reagents

1. Overview of Domestic Blood Coagulation Market

Conventional thrombosis and hemostasis diagnostic applications are mainly concentrated on screening for bleeding disorders and diagnosis of bleeding origins, with a relatively narrow scope of application and relatively poor accuracy. Modern in vitro thrombosis and hemostasis diagnostic technology can be applied in multiple aspects, such as screening, monitoring, diagnosis, and treatment, with greater targeting and accuracy, and can remind patients to take preventive treatment in advance based on their conditions, meanwhile, it can also assist physicians in formulating more accurate diagnosis and treatment plans for patients, thereby improving the level of thrombosis diagnosis and treatment in hospitals and reducing treatment expenses for patients.

As indicated in the Study Report on Thrombosis and Hemostasis Diagnostic Market in China 2025 released by B&Y Consulting, the market size of China’s thrombosis and hemostasis diagnostics industry reached RMB 5.83 billion in 2024, representing a year-on-year growth of 12.7% compared with 2023. This growth was primarily driven by the accelerating aging of the population, the high prevalence of cardiovascular and cerebrovascular diseases, and the continuously increasing clinical demand for coagulation function testing. With the wider adoption of precision medicine and ongoing technological advancements, the clinical application of thrombosis and hemostasis diagnostics has gradually expanded, extending beyond traditional hospital laboratories to multiple clinical settings such as emergency departments, ICUs, and surgical units.

The coagulation test accounts for over 95% of the domestic thrombosis and hemostasis in vitro diagnostic market share, with major overseas manufacturers such as Stago, Werfen, and Sysmex holding over 80% of the domestic market share. The three giants in the thrombosis and hemostasis diagnostics market, Sysmex from Japan (Sysmex Group), Instrumentation Laboratory (IL, Werfen Group), and Stago from France (Stago Group), have a total market share of about 66%. The coagulation instruments used in the domestic grade III market are still mainly imported, besides the above three, there are also Sekisui from Japan, BE from Germany, etc. Among domestic thrombosis and hemostasis diagnostic companies in China, Shanghai Sun Biotech, Succeeder, and Mindray as well as new entrants in the field of blood coagulation such as BSBE hold a relatively small but increasing market share year by year.

In the domestic in vitro thrombosis and hemostasis diagnostic market, foreign companies such as Sysmex, Stago, and IL have taken the absolute lead with their technology and first-mover advantage, and cover most of the Grade III hospitals in China. Domestic brands are primarily targeting Grade II hospitals while covering primary care institutions, private hospitals, and continuously breaking through to Grade III hospitals.

To sum up, in the future, with the increase in the number of installed domestic coagulation instruments, the localization rate of in vitro thrombosis and hemostasis diagnostic instruments in China will further rise and boost the sales of domestic in vitro thrombosis and hemostasis diagnostic reagents and consumables. The share of domestic brands in the in vitro thrombosis and hemostasis diagnosis market in China is also expected to increase gradually.

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