In Vitro Diagnostic Industry in China - Clinical Chemistry X

3.1.2 Development of Major Biochemical Diagnostic Companies

As companies developed with biochemical reagents, BSBE, Leadman, Medicalsystem, Maccura, Dirui, and Zybio are still flourishing in the biochemistry field; they are also developing new products and expanding into other areas based on the biochemical diagnosis while maintaining the existing biochemical product lines. For example, the leading companies in the fields of immunity and chemiluminescence, such as Autobio, Snibe, Getein Biotech are continuously improving their product lines to enter the biochemical markets. 

Biochemical-Based IVD Companies

Since 2013, BSBE has successively established biochemical strategic cooperation with well-known domestic and foreign companies such as Abbott, Beckman, Roche, Hitachi, Mindray, and signed a Technology Licensing and Transfer Cooperation Agreement with Abbott, which has created the technology export of Chinese IVD companies.

In 2020, China National Pharmaceutical Investment Co., Ltd., a subsidiary of Sinopharm Group, invested in BSBE, and BSBE joined the Sinopharm, promoting the cooperation in the IVD field between the state-owned enterprises and privately owned enterprises.

As an established biochemical company, Leadman mainly engages in the biochemical diagnostic reagents, and actively researches and develops chemiluminescence products. Mindray has innovatively incorporated four independent testing systems (biochemistry, immunity, hematology, and coagulation) through the modular combination, forming a fully automatic detection module-the assembly line M6000.

Biochemistry line is the most traditional one of Medicalsystem. Medicalsystem has always focused on improving the innovation in the product raw material, reagents and instruments, and the diagnostic service levels.

Maccura self-produces and sells biochemical reagents. Its products are increasingly competitive against international brands in the domestic high-end markets such as Grade III and above hospitals, and have a broad space for substituting the imported products. In addition, Maccura is actively participating in the overall packaging of the laboratory tests to form an intensive service.

Dirui expands its business services to 8 major segments of IVD (biochemical analysis, urinalysis, blood cell analysis, chemiluminescence immunoassay, gynecological secretion analysis, coagulation analysis, molecular diagnosis, standardized laboratory) from its initial urinalysis test strips. It will continue to enter the fields of mass spectrometry, POCT, molecular diagnosis, etc., while enriching and improving the existing products, to complete the comprehensive development of the IVD market.

Zybio started its business in biochemistry. It is also expanding its product lines in addition to focusing on the biological raw materials, chemical raw materials, and biochemical product series. Nowadays, its product lines cover multiple segments of IVD such as biochemical analysis system, chemiluminescence immunoassay system, POCT, molecular diagnostic system, mass spectrometry analysis system, coagulation analysis system. In addition, it carries out independent R&D and cooperation with well-known research institutions at home and abroad.

KHB is actively launching new products to the markets, covering the fields of biochemistry, immunity, chemiluminescence, dry chemistry, POCT and related instruments, etc.

IVD Companies That Enter the Biochemical Field Later

Autobio is a leader in China's immunodiagnosis industry. In order to accelerate the development of "product line + technology + channel," it acquired 75% of the equity of Beijing Bio-Top Biotechnology Co., Ltd. and quickly entered the biochemical diagnosis industry; meanwhile, it serves as the agent of Canon Medical's biochemistry analyzer series and forms a good synergistic effect with self-produced biochemical test reagents.

Snibe has been focusing on the research of chemiluminescence immunoassay and is the first-line company in the field of chemiluminescence in China. It also involves in the biochemical diagnosis and establishes the biochemical immune assembly lines with the independent intellectual property rights. By working with Thermo Fisher, it provides an overall solution of Satlas-TCA laboratory automation, and sells fully biochemical analysis instruments and supporting reagents across the world. Its supporting reagents cover numerous test items.

Getein Biotech focuses on the fields of POCT, radiation biochemistry, luminescence, etc. In order to meet the multi-dimensional needs of terminal hospitals for different testing items, Getein has continuously researched and developed biochemical testing reagents with its self-produced biochemistry analyzers.

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