Official definition of in vitro diagnostics

According to the definitions given by the State Food and Drug Administration (CFDA) and the U.S. Food and Drug Administration (FDA), in vitro diagnostics are clinically obtained by testing human samples (blood, body fluids, tissues, etc.) outside the human body. Diagnostic information, and then products and services for judging diseases or body functions.

 

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China has entered an aging society

 

In an aging society, according to the traditional standard of the United Nations, the elderly over 60 years old account for 10% of the total population in a region, and the new standard is that the elderly over 65 years old account for 7% of the total population, that is, the region is regarded as an aging society.

 

According to this standard, my country has entered an aging society. At the end of 2014, the number of people aged 60 and over in my country was 212.42 million, accounting for 15.5% of the total population; the number of people aged 65 and over was 137.55 million, accounting for 10.1%. Breaking through 10% for the first time. It is estimated that the population over 60 years old in my country will exceed 300 million in 2025.

 

 

 

Medical Industry Classification

 

The pharmaceutical industry can be divided into seven sub-sectors: medical services, medical devices, pharmaceutical commerce, raw materials, chemical pharmaceuticals, biopharmaceuticals, and traditional Chinese medicines.

Represented by medicine: medical services, pharmaceutical business, medical equipment; represented by medicine: raw materials, chemical pharmaceuticals, biopharmaceuticals and traditional Chinese medicine.

 

Medical services: provide medical examination and other health examination services and hospitals.

Representative companies: Meinian Health, Ciming Physical Examination, Tongce Medical, Aier Ophthalmology, etc.

 

Medical devices: Medical devices are mainly used to improve the quality of life or improve the efficiency of diagnostic testing.

Representative companies: Yuwell Medical, Mindray Medical, Lepu Medical, etc.

 

Medical business: Pharmaceutical business refers to wholesale and retail channels, mainly including pharmaceutical wholesale, pharmaceutical chain and Internet e-commerce.

Representative enterprises: Yifeng Pharmacy, Common People, Dashenlin, etc.

 

Raw material drug: raw material drug refers to the raw material drug used to produce various preparations, which is the active ingredient in the preparation, various powders, crystals, extracts, etc. used for medicinal purposes prepared by chemical synthesis, plant extraction or biotechnology , but the patient cannot take the substance directly.

Representative companies: Xinhecheng, Yaoshi Technology.

 

Chemical pharmacy: Chemical pharmacy is relatively complicated, and its production process consists of two parts: the production of raw materials and the production of pharmaceutical preparations.

Representative companies: CSPC, Hengrui Medicine.

 

Biopharmaceuticals: Biopharmaceuticals refer to the use of research results in microbiology, biology, medicine, biochemistry, etc., from organisms, biological tissues, cells, organs, body fluids, etc. A class of products used for prevention, treatment and diagnosis made by comprehensively utilizing the principles and methods of microbiology, chemistry, biochemistry, biotechnology, pharmacy and other sciences.

Representative companies: Hualan Biologics, WuXi AppTec, and Changchun Hi-Tech.

 

Traditional Chinese medicine: Chinese medicine refers to substances that are used to prevent, treat, and diagnose diseases under the guidance of the theory of traditional Chinese medicine, and have the functions of rehabilitation and health care.

Representative companies: Yunnan Baiyao, Yiling Pharmaceutical, and Pien Tze Huang.

 

I have always been interested in the classification of the medical industry, the classification of medical devices, and the classification of in vitro diagnostics, because knowing the boundaries of the industry will help me constantly improve my positioning.

 

 

 

As I said, my current positioning in new media is "beginning with IVD, being good at IVD, and not limited to IVD". The last "beyond IVD" is also very important to me. Because this means more possibilities to me, even the top IVD companies will not limit themselves to IVD. If you are a new media company, if you can’t follow the top companies to continuously adjust your positioning, you will have the risk of being eliminated by the market.

 

 

 

Recognize the boundaries of your abilities, but don't set limits on your life. In many cases, it is not hard work and concentration that change destiny, but boldness and seriousness at the right time.

 

 

 

Composition of domestic IVD industry chain

 

The upstream is raw materials, including antigens, antibodies, diagnostic enzymes, etc. in reagents, as well as instrument-related components. Since raw materials directly affect the test results and have high requirements for stability, 90% of raw materials in my country rely on imports.

 

The midstream is IVD manufacturers——outputting instruments, reagents, and services. In my country, the top five overseas giants occupy 50% of the market, while the overall domestic manufacturers present a small and scattered competition pattern. Among the more than 1,300 IVD manufacturers, most of them are small reagent companies, and there are very few companies that have both reagent and instrument R&D capabilities.

 

Downstream are dealers and users: there are more than 20,000 dealers in the industry, who not only provide products to end users, but also export technical support; end users mainly include medical institutions, third-party laboratories, scientific research institutions, and family individuals. Among them, medical institutions are the main users. my country has 33,000 hospitals, 94,000 primary medical institutions, and 18,000 professional public health institutions.

 

 

 

Development of Domestic In Vitro Diagnostic Industry Technology

 

In 1960, the development and production of blood analyzers based on the principle of electrical impedance technology began in China.

 

In 1965, the first domestic blood cell counter was produced in Shanghai.

 

In 1975, Beijing Medical Device Factory also produced a red blood cell counter. However, limited by the scale and level of domestic technology and productivity at that time, these cell counters failed to become commercial products.

 

After the reform and opening up, the domestic in vitro diagnostic industry has developed rapidly, and has gone through a development process from small to large and from weak to strong.

 

In the 1970s, the foundation was weak at the beginning. Until the end of the 1970s, only a few products were launched in the domestic in vitro diagnostic industry. For example, the Shanghai Institute of Medical Chemistry was the first self-contained "two-and-a-half" supplier; Jiangsu Jintan The main products of the medical school reagent station are Wright's stain, white blood cell diluent, liver function turbidimetric tube, jaundice turbidimetric tube and simple conventional manual reagents; the medical test box of Anhui Suzhou Medical Laboratory Center is equipped with a microscope and white blood cell diluent , platelet diluent, etc. At that time, almost all the test reagents carried out by the laboratory were self-prepared by the laboratory.

 

 

 

In the 1960s and 1970s, it was the embryonic stage of my country's in vitro diagnostic industry - small-scale domestic imports, self-made reagents in laboratories, and chaotic management.

 

After the 1980s, especially in the middle and later stages, some workshop-style, non-main in vitro diagnostic reagent manufacturers have emerged across the country, such as Shanghai Hunan Chemical Co., Ltd., which mainly produces rheumatoid latex and Ponceau dye solution for protein electrophoresis. Laboratory (now Shanghai Kehua); Beijing Institute of Biological Products, which mainly produces freeze-dried B-surface antigen diagnostic cells; Zhejiang Military Region Logistics Inspection Institute, which produces microbial micro-fermentation tube culture medium and drug-sensitive paper sheets; production manual There are only a handful of production enterprises such as the Beijing Chemical Factory Reagent Branch of chemical method conventional kits, and the production scale is small and the product is single.

 

 

 

There are only 36 units producing and operating in vitro diagnostic products in the country, and all imported instruments and equipment must be ordered by foreign trade companies due to the control of foreign exchange plans, and there is no legal person company operating imported medical equipment in China. But some experts and entrepreneurs have realized the broad future of the development of in vitro diagnostic industry.

 

In 1980, the first domestically produced micro-fermentation tube with bacterial coding entered the laboratory.

 

In 1981, the first domestic semi-automatic biochemical analyzer (GD211) was born in Shanghai Medical Branch Factory.

 

In 1982, the first domestic kit for the determination of alanine aminotransferase (ALT) by continuous monitoring method was successfully developed.

 

In 1982, the Clinical Laboratory Center of the Ministry of Health was established.

 

Subsequently, clinical testing centers in various provinces and cities were established one after another, which greatly promoted and promoted the formation and development of China's in vitro diagnostic industry. At the same time, the development and introduction of in vitro diagnostic products in China are also rapidly starting.

 

In 1983, Shanghai Blood Center successfully developed blood collection bags and plasma bags, ending the history of using saline bottles for blood collection.

 

In 1986, the first domestically produced automatic blood cell (quasi-automatic) counter (type PC603 and BS615) was launched in Beijing Biochemical Instrument Factory, and the first domestically produced automatic urine analyzer (type MA4210) was born in Guilin Electronic Instrument Factory .

 

In 1988, the National Medical Clinical Laboratory and In Vitro Diagnostic Communication Standardization Technical Committee was established. The clarion call that marks the internationalization of the in vitro diagnostic industry has sounded, which has greatly promoted the progress of the in vitro diagnostic industry and the improvement of product quality. In the same year, the first domestic fully automatic biochemical analyzer (AA880) was born in Beijing Biochemical Instrument Factory.

 

 

 

The 1980s was the initial stage of my country's in vitro diagnostic industry - large-scale imports, and the first batch of local companies in the field of biochemistry and immunology appeared, such as Shanghai Kehua.

 

In the 1990s, during this period, China's in vitro diagnostic industry entered a period of rapid development, and a large number of in vitro diagnostic production companies and import agency companies came into being. The automation of medicine has made a positive contribution.

 

During this period, it has gradually become the consensus of experts, scholars and the in vitro diagnostic industry to go abroad, go to the world, and conduct international exchanges and cooperation. The introduction of foreign advanced in vitro diagnostic instruments and reagents into China and independent research and development of products are carried out simultaneously. In synchronization with international exchanges, domestic regulations and norms related to in vitro diagnostics are gradually being formed and improved, and policies and regulations related to the development of the in vitro diagnostic industry are also emerging.

 

In 1991, the first edition of "National Clinical Inspection Operation Procedures" was published by the Clinical Inspection Center of the Ministry of Health and the Clinical Inspection Center of Jiangsu Province commissioned by the Medical Administration Department of the Ministry of Health. In the same year, the first set of semi-automatic enzyme label washing plate (E960 type) introduced by Beijing Dalong entered the clinic.

 

In March 1991, the first National Association for the Production, Supply and Marketing of Medical Laboratory Products (the predecessor of CACLP) was held in Haikou City. This meeting became a milestone event in the process of building a communication platform for China's in vitro diagnostic industry, and the scale of the meeting has expanded year by year since then. At present, the fraternity has become an important communication platform, a bridge of cooperation and a bond of friendship in the in vitro diagnostic industry.

 

In 1992, the first domestically-made all-inclusive "two-and-a-half" kit developed by Shanghai Kehua entered clinical practice.

 

In 1994, the Ministry of Health issued (1994) No. 10 Document and the Health and Drug Administration (94) No. 365 Document officially began to treat hepatitis B surface antigen, anti-HCV, and anti-human immunodeficiency virus (human immunodeficiency virus, HIV) (ie -HIV, alias anti-AIDS), four reagents for syphilis have been approved by the state and have continued to this day.

 

In July of the same year, the former Ministry of Health