Increased Respiratory Pathogen Incidence in Winter! 233 Diagnostic Device Registrations, Wide Market Prospects

With the arrival of winter and the drop in temperature, the active period of respiratory pathogens has arrived. According to recent surveillance data from the Chinese Center for Disease Control and Prevention, a variety of pathogens are causing acute respiratory infections, including mycoplasma pneumoniae, rhinovirus, common coronavirus, adenovirus, parainfluenza virus and respiratory syncytial virus.

In the treatment of various infections, accurate diagnosis of pathogens is a crucial step, and respiratory pathogen diagnostic reagents are a key product. With the improvement of the public's demand for medical health, respiratory testing as a rigid demand, the market demand for related products continues to grow. At the same time, under the trend of centralized procurement in the in vitro diagnostics (IVD) industry, although respiratory tract detection reagents have not yet been fully included in the scope of centralized procurement, the continuous growth of their demand has also increased the possibility of being included in centralized procurement.

According to the monitoring results of the Chinese Center for Disease Control and Prevention in November, the main positive pathogens in respiratory tract samples of influenza-like cases in outpatient and emergency departments of sentinel hospitals were rhinovirus, mycoplasma pneumoniae and parainfluenza virus. Mycoplasma pneumoniae, rhinovirus and adenovirus were the main positive pathogens in the respiratory samples of hospitalized SARS cases.

By November 2024, 233 in vitro diagnostic reagents related to respiratory pathogens had been registered, including 131 mycoplasma pneumoniae, 51 adenoviruses (excluding enteric adenoviruses), 45 parainfluenza viruses, and 6 rhinoviruses. There are 9 quality control products.

Observing the registration trend, a total of 40 products have been registered in 2020. The number then rose to 58 in 2021, and although it fell back to 48 in 2022, it rose back to 54 in 2023. Overall, the number of product registrations showed an increasing trend.

However, as of November 2024, the number of registrations of these four categories of respiratory pathogen products has decreased significantly compared to 2023. At the same time, the proportion of mycoplasma pneumoniae decreased significantly, while the proportion of other three types of pathogens increased. In particular, rhinoviruses and parainfluenza viruses both increased by nearly 4%.

As of November 2024, according to product methodology analysis, there are 63 products related to fluorescent PCR, 54 products related to colloidal gold, 35 products related to enzyme immunoassay, 15 products related to amplification, 14 products related to chemiluminescence, 13 products related to immunofluorescence, 8 products related to immunochromatography, and 31 other products (including quality control and culture methods, etc.).

According to statistics, as of November 2024, there were 215 domestically registered products, including 122 mycoplasma pneumoniae, 48 adenoviruses, 39 parainfluenza viruses and 6 rhinoviruses. There are 18 imported registered products, including 9 mycoplasma pneumoniae, 3 adenoviruses and 6 parainfluenza viruses.

According to statistics, among the reagents for the in vitro diagnosis of respiratory pathogens with high prevalence (November), there were 216 class III reagents and 17 class II reagents, all of which were used for the classification and identification of mycoplasma pneumoniae and drug susceptibility screening.

As of November 2024, a total of seven provinces in China (excluding Hong Kong, Macao and Taiwan) have completed the registration of respiratory pathogen products (high prevalence in November). Among these provinces, the national Bureau of registration is the main, a total of 217 cases.

Among the products registered by the National Bureau of Commerce, Hunan Province topped the list with 17 registered products, followed by Jiangsu Province with 11 registered products involving four enterprises.

According to statistics, as of November 2024, a total of 75 companies are involved in the development of in vitro diagnostic products for respiratory pathogens. Among these enterprises, the number of registered products ranked first for Beijing Bell Biological Engineering Co., LTD., which registered 22 products; Followed by Zhengzhou Antu Biological Engineering Co., LTD., registered 17; Followed by Wuhan Zhongzhi Biology and Shandong Kanghua Biology, both registered 12; Beijing Innote Biology 10 items, Qingdao Hantang biology 8 items, Ningbo Helsch gene 7 items; Zhuhai Lizhu Reagent, Shengxiang Biological, Shanghai Berger Medical, Guangdong Hexin Health have registered 6 products.

This study deeply analyzed the current market trend and industry status of in vitro diagnostic reagents related to highly prevalent respiratory pathogens, and objectively assessed the development level and quality of diagnostic reagents for mycoplasma pneumoniae, adenovirus, parainfluenza virus and rhinovirus from multiple dimensions such as the overall trend, product information, enterprise distribution and registrant information. The purpose of this study is to provide data support for relevant enterprises in project evaluation, market research and investment decisions. All relevant data are derived from the global medical device big data service platform of the pharmaceutical Intelligence network - pharmaceutical Intelligence medical device data.

Statistics released by the Chinese Center for Disease Control and Prevention show that mycoplasma pneumoniae, adenovirus, parainfluenza virus and rhinovirus have a higher prevalence trend among respiratory pathogens infected by hospital outpatients and inpatients. As the proportion of novel coronavirus decreased, the proportion of these respiratory pathogens, especially mycoplasma pneumoniae and rhinovirus, increased significantly. This phenomenon reminds the public to enhance the awareness of health protection, and also points out a new direction for in vitro diagnostic reagent research and development enterprises.