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Current Situation of Domestic Molecular Diagnosis Market

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(I) molecular diagnosis is developing rapidly, but upstream technological innovation needs to be strengthened.

molecular diagnostic industry includes suppliers of testing instruments, diagnostic reagents, consumables and other products. It is an industrial field with research and development and technological innovation as its main competitiveness. The downstream industry is an institution that provides medical services for patients, including hospitals, third-party medical laboratory service institutions, scientific research institutions, etc., mainly supported by medical services as the main industry, which is greatly restricted by the upstream industry.

the development of upstream high-end original technology is not only the core competitiveness of molecular diagnosis-related enterprises, but also a key factor in the development of my country's genetic testing industry and precision medicine. At present, although the domestic genetic testing market is prosperous, some technologies and products have caught up with the international advanced level, but the phenomenon of foreign technology monopoly is still more prominent, and there are few national enterprises that really have independent innovation core technologies. most institutions are still in the downstream testing service side, the innovation of upstream technology and the development of new technology platform need to be strengthened.

(II) molecular diagnosis is accelerating, and the localization of sequencers has just started.

With the gradual expansion of the molecular diagnostic market and the emergence of large quantities of gene detection-related instruments and equipment, there are currently mainly nucleic acid extraction instruments, PCR amplification instruments, nucleic acid molecular hybridization instruments, gene chip instruments and gene sequencers. In the field of mid-range instruments where technology is relatively easy to break, such as nucleic acid extraction instruments, PCR amplifiers, nucleic acid molecular hybridization instruments, and gene chip instruments, the localization has been formed and gradually occupied the main market, while the localization of gene sequencers has just started. The technical threshold of sequencing equipment and consumables is high, and the mainstream sequencing equipment and technology are basically in the hands of a few European and American companies, illumina and Thermo Fisher together account for about 90% of the global market share and have formed an oligopoly pattern. In 2017, as the first year of domestic sequencer innovation, BGI, Hanhai Gene and other companies have launched their own sequencers. With the emergence of companies that master core technologies, China's high-throughput sequencing companies are developing in the direction of self-sufficiency.

(III) clinical molecular diagnosis items are increasing, infectious disease detection is still the main one.

At present, the domestic molecular diagnostic application mainly focuses on the detection of infectious diseases, such as hepatitis, venereal diseases, hand, foot and mouth, tuberculosis, influenza, blood infectious diseases, etc., and the mainstream technology is fluorescent PCR technology, which is currently the most mature application of clinical molecular diagnostic technology. In terms of genetic disease detection, the current application items are increasing, but they are still mainly concentrated in a few items such as non-invasive prenatal screening and genetic cancer detection; application programs are also increasing in individualized tumor treatment and pharmacogenomic testing.

According to incomplete statistics, from the perspective of the infectious disease screening market in 2017, the number of people tested for viral hepatitis products accounted for 49% of the infectious disease detection. The fastest growing is the HPV testing market, and the detection of sexually transmitted pathogens And the detection of pediatric infectious diseases and respiratory pathogens will also be the main growth points of the future clinical market.

(IV) Major Disease Prevention and Control, Molecular Diagnosis Market Released Further

The number of new cancers in China was 2.8 million in 2008 and 4.29 million in 2015. Nearly 30% of new cancers (cervical cancer, liver cancer, nasopharyngeal cancer, etc.) in my country are caused by viruses and other infections, while developed countries in Europe and the United States have been widely used in clinical and general screening due to molecular diagnostic technology. Drop to 4%.

take cervical cancer (cancer that is completely preventable and controllable through molecular diagnostic screening) as an example. There are more than 130000 new cases in my country every year, accounting for nearly 30% of the world. Although there are more than 70 domestic HPV testing reagents certified products, However, the coverage rate of genetic screening is less than 2% for 0.35 billion of the age-appropriate population in China, while the coverage rate in western developed countries is 30%. Due to the advantages of convenience and popularity of technology, HPV testing will replace traditional cytological methods and become the mainstream technology of cervical cancer screening. In 2015, the State Food and Drug Administration launched the "Guidelines for the Technical Review of Human Papillomavirus (HPV) Nucleic Acid Detection and Genotyping Reagents", which strictly regulated the domestic HPV testing product market. In 2017, it also issued and updated my country's first "Guidelines for Comprehensive Prevention and Control of Cervical Cancer", clearly emphasizing the recommendation of HPV testing as a cervical cancer screening technology for application and popularization. There are nearly 0.35 billion women of the right age for cervical cancer screening in our country. Facing such a large screening population, it is particularly important to be simple, fast and accurate.

(V) Building a Future Without Hepatitis

At the 26th Annual Meeting of the Asia-Pacific Association for the Study of Liver Diseases (APASL) in February 2017, the World Health Organization (WHO) proposed to completely eliminate viral hepatitis by 2030, reduce new chronic hepatitis B and C by 90%, reduce the mortality rate of hepatitis B and C to 65%, and achieve 80% coverage of patients with chronic hepatitis B and C. In November 2017, 11 departments including the National Health and Family Planning Commission and the National Development and Reform Commission jointly formulated and issued the "China Viral Hepatitis Prevention and Control Plan" in order to implement the spirit of the National Health and Health Conference and the "Healthy China 2030" Planning Outline (2017-2020) "to further strengthen the prevention and treatment of viral hepatitis in my country, continuously reduce the epidemic level, and protect the health of the people, the tasks and plans for the prevention and control of viral hepatitis in China have been clarified. As an important part of the prevention and control system, domestic molecular diagnostic enterprises are jointly promoting the public welfare project of eliminating hepatitis C in conjunction with WHO and the Ministry of Civil Affairs (Zoomlion Liver Health Promotion Center). Since the high-sensitivity hepatitis virus quantitative detection project was included in the national clinical detection catalog in 2013, the high-sensitivity hepatitis virus quantitative detection has great value for viral load monitoring, antiviral treatment monitoring, drug resistance monitoring, and treatment plan selection in patients with chronic hepatitis. Domestic manufacturers adopt the internationally leading ultra-paramismatic bead nucleic acid extraction technology to develop high-sensitivity hepatitis B virus nucleic acid quantitative detection reagents that reach the international advanced level of 5-10 IU /mL, and promote the technological innovation of my country's hepatitis B diagnosis and treatment system. Promote the elimination of the hazards of viral hepatitis and contribute to the construction of a future without hepatitis.

(VI) Strengthening Molecular Diagnosis in Blood Safety Detection

In the process of disease transmission, blood transfusion is one of the important links that endanger public health. According to WHO statistics, nearly one million people worldwide are infected with infectious diseases such as AIDS and viral hepatitis due to unhealthy blood or blood products. According to the statistics of the Health Planning Commission, the number of unpaid blood donations in China reached 14 million in 2016, and the total amount of blood collected reached 23.6 million units. Conventional enzyme-linked immunosorbent assay (ELISA) is prone to virus mutation and silent infection missed detection due to long window period. NAT technology can make up for the deficiency of ELISA. In 1997, Germany first began to use NAT technology for blood testing, and then developed countries such as Europe and the United States also adopted NAT technology. Since 2010, China has carried out NAT pilot projects in 16 blood centers in 12 provinces. In 2013, the Health Planning Commission issued the Notice (Plan) on Issuing the Implementation Plan for Comprehensively Promoting Nucleic Acid Detection in Blood Stations (2013-2015), emphasizing that nucleic acid detection will be basically covered nationwide by 2015. By the end of 2016, blood screening nucleic acid testing has covered blood stations nationwide. From the original routine 2-pass ELISA test to the current 2-pass ELISA test plus 1-pass nucleic acid test to ensure blood safety. In November 2017, the "China Viral Hepatitis Prevention and Control Plan (2017-2020)" once again proposed to ensure full coverage of blood hepatitis B virus and hepatitis C virus nucleic acid detection rates in blood stations to ensure blood safety.

blood nucleic acid testing manufacturers are mainly Roche and Gailifu in the world, and the imported products of Roche and Gailifu account for half of the country. The main domestic manufacturers are Kehua Biology, Daan Gene, Huayi Mei and Shanghai Haoyuan. Imported products have obvious advantages in system stability and reagent sensitivity. Now domestic products have begun to catch up with international products in reagent sensitivity, such as the fifth-generation blood sieve products developed by Shengxiang Biology, and the reagent sensitivity has reached the international leading level.

Source: Blue Book on the Development of China's In Vitro Diagnostic Industry

Created on:2020-06-29 13:59