Foreword: New coronavirus detection reagents play a pivotal role in the new crown epidemic, and in vitro diagnosis (IVD) has always been an important part of clinical practice. In vitro diagnosis refers to products and services that obtain clinical diagnostic information by testing human samples (blood, body fluids, tissues, etc.), and then judge diseases or body functions. The detection principles and methods involve immunology, microbiology, molecular biology Science and other disciplines, and a wide variety of products, manufacturing involving medicine, machinery, electronics, composite materials and other industries. IVD products are mainly composed of diagnostic equipment and diagnostic reagents. This article focuses on IVD reagents.

In vitro diagnostic reagents can be divided into biochemical diagnosis, immunodiagnosis, molecular diagnosis, blood diagnosis, microbial diagnosis and point-of-care testing (POCT) according to the testing principle.

The global in vitro diagnostic reagent market is dominated by five giants. Roche, Abbott, Danaher, Siemens, and Thermo Fisher account for more than 50% of the global market share, and Johnson & Johnson, Sysmex, Beckman Coulter, Companies such as Bole are relatively strong in the IVD field, and it is expected that the monopoly pattern will continue in the next few years.

Status of the Chinese market

Coincidentally, overseas giants occupy about 40% of the market share in China by virtue of their high-quality IVD products and the way that machines are bound to reagents.

In China's biochemical diagnosis market, listed companies are concentrated and the competition is the most intense. Among them, Zhongsheng Beijing Enterprises and Kehua Biotechnology are the longest listed IVD companies. There are more than 1,000 IVD companies in China, but the market share of companies such as Mike Bio, Wanfu Bio, Antu Bio, Meikang Bio, and Kehua Bio can still achieve steady growth. In Figure 2, the growth rate of the four companies is relatively stable, and the operating income in 2019 has increased by 2-3 times compared with 2015.

Immunodiagnostics is the segment with the largest market share in the IVD industry. Chemiluminescence in immunodiagnostics is a rapidly developing segment, and magnetic particle chemiluminescence reagents still maintain a dominant position. It is worth noting that, with the global spread of the new crown epidemic, as of March 17, 2020, there are currently 64 IVD companies in China whose new crown virus detection products have obtained EU access qualifications or CE certificates, including Wanfu Biological, Antu Bio, Kehua Bio, Meikang Bio, Mike Bio, Jidan Bio, Sannuo Bio, Daan Gene, Dean Diagnostics, BGI, Shengxiang Bio and other companies have entered the international COVID-19 testing market.

Molecular diagnosis, as the technical foundation of precision medicine, benefits from the development of precision medicine and the continuous upgrading of molecular diagnosis technology, as well as the continuous increase in the demand for prenatal diagnosis and tumor genetic testing, and the market potential of molecular diagnosis continues to increase. trend of rapid growth. As shown in Figure 2, the fastest growing company is Dean Diagnostics in the field of molecular diagnostics, and its operating income has increased from 1.858 billion yuan in 2015 to 8.437 billion yuan in 2019.

POCT diagnosis is a field that has developed rapidly in recent years, with high gross profit margins. Sannuo Bio, Wanfu Bio and Jidan Bio-represented have outstanding performance in blood glucose detection, cardiac markers, and inflammatory infection detection.