Health & Beauty

As an independent branch of the medical device industry, in vitro diagnostic (IVD) related products play an important role in the process of disease prevention, diagnosis, and treatment.

my country's IVD industry started in the 1980s and started relatively late. Although it has continued to develop in recent years, there is still a big gap between the overall technical level of the industry and developed countries and regions. In recent years, my country’s population aging process has accelerated, residents’ income has increased, and the public’s awareness of health care has also increased. Coupled with the continuous innovation of local IVD companies, IVD has become one of the most active and fastest-growing industries in China.

Symbiosis of demand and competition

While the domestic market demand continues to expand, my country's IVD products overseas are expanding faster than other medical products, and exports are growing rapidly.

In 2020, due to the impact of the new crown pneumonia epidemic, the export of some conventional IVD products in my country will be affected, but the detection products related to the prevention and control of the epidemic, such as new crown virus antibodies, antigens, nucleic acids, and neutralization test reagents, are favored by the global medical market. The overall performance of IVD companies is improving, with the highest sales increasing several tens of times year-on-year. According to statistics from the China Chamber of Commerce for Import and Export of Medicines and Health Products, according to the HS codes of major diagnostic reagents (38220010, 30021500, 38220090), the export volume of diagnostic reagents in my country will reach US$5.08 billion in 2020, a year-on-year increase of 902%. Among them, the export value of reagent products represented by 30021500 was US$3.178 billion, a year-on-year increase of 1540%. The export value of testing equipment also increased to varying degrees (see Table 1). In terms of imports, the import value of reagent products increased slightly, and the import value of testing equipment dropped significantly (see Table 2). From a regional perspective, the main export markets for my country's in vitro diagnostic reagents in 2020 will be the United States, Brazil, India and other countries and regions. Zhejiang, Fujian, and Guangdong are my country's main export provinces of in vitro diagnostic reagents in 2020.

In 2021, although the market demand for IVD products will not surge like in 2020, it will also be significantly better than other medical device products for epidemic prevention. As the global epidemic prevention and control moves toward normalization, the market demand for detection reagents related to epidemic prevention and control will stabilize, and at the same time, homogeneity competition will gradually become fierce. The situation of rising volume and price may not occur again, and competition in price and speed of research and development of new products will intensify.

Opportunities and challenges coexist

Opportunities and challenges coexist in the development of my country's IVD industry in the international market. The development of the IVD industry will present the following characteristics: First, companies dominated by the domestic market will gradually open up the international market; second, the pace of my country’s IVD products entering the international market will gradually accelerate; third, the competitiveness and brand influence of my country’s IVD products will be gained Increased international market share will increase; fourthly, the IVD industry will attract more capital attention, and R&D and innovation power will increase; fifthly, the situation of heavy reliance on imports of diagnostic reagent raw materials will change, and the development and upgrading of biological raw materials by domestic companies will help Promote some raw materials to realize import substitution.

While achieving results, my country's I VD industry still faces many problems and challenges in the process of internationalization. First of all, the high demand of the market will give birth to more I VD companies, and the homogeneity competition will intensify. In fact, starting from the fourth quarter of 2020, price competition has already appeared. Second, multinational companies have obvious advantages and strong competitiveness in the international market. Affected by the new crown pneumonia epidemic in 2020, the sales performance of the world's four largest in vitro diagnostic multinational companies in the Chinese market is mediocre, but their performance in the global market has shown varying degrees of increase. Among them, the molecular diagnostic business represented by Roche and Abbott has the first-mover advantage and sales performance has skyrocketed. Third, in order to respond to the epidemic, various countries and regions have successively issued some emergency, temporary or special authorization regulations to quickly approve epidemic prevention and control products represented by new coronavirus detection reagent products. While striving for orders, enterprises must also pay attention to changes in relevant laws and regulations at any time to enhance their awareness of legal risk prevention. Finally, as the epidemic prevention and control situation stabilizes, various national and regional regulatory agencies have begun to pursue and tighten supervision on some product quality problems, trade violations, etc., and relevant domestic companies must strengthen risk prevention awareness and operate in compliance with laws and regulations. , Adhere to the bottom line of quality and safety, take all trade practices seriously, and avoid unnecessary trouble.