Introduction
"In vitro Diagnostic Reagent Registration Management Measures (Trial)", foreign diagnostic reagents refer to in vitro diagnostic reagents in medical device management, including alone or with instruments, appliances , Equipment or system is used in combination of diseases, prevention, diagnosis, treatment monitoring, prognosis, health status evaluation and prediction of hereditary diseases, for vitro (various body fluids, cells, tissue samples, etc.) Detected reagents, kits, calibrators (objects), quality control (objects), etc.
The national statutory diagnostic reagent for blood source screening, using radionuclide labeling in vitro diagnostic reagent does not belong to the management scope of "In vitro diagnostic reagent registration management method (trial)".
In vitro diagnostic reagent business enterprises must engage in business activities in accordance with the "Regulations" of Drug Business Management.
Classification
According to the high level of product risk, in vitro diagnostic reagents are divided into third categories, second types, first types of products.
(1) Third type:
1. Reagents associated with pathogenic pathogen antigens, antibodies, and nucleic acids, etc.;
2. Reagents associated with blood type, tissue formulation;
3. Reagents associated with human gene detection;
4. Reagents associated with hereditary diseases;
5. Reagents associated with narcotic drugs, psychotropic drugs, medical drug detection;
6. Reagents associated with the treatment of target targets;
7. Reagents associated with tumor markers;
8. Reagents associated with metamorphosis (allergen).
(2) Second Categories: Except for the third class, the first type of product, other second types of products, mainly include:
1. Reagents for protein detection;
2. Reagents for sugar detection;
3. For hormone detection reagents;
4. Reagents for enzyme detection;
5. Reagents for ester detection;
6. Reagents for vitamin detection;
7. Reagents for inorganic ion detection;
8. Reagents for drugs and pharmaceutical metabolites;
9. Reagents for autoantibody detection;
10. Reagents for microbial identification or drug sensitivity;
11. Reagents for other physiological, biochemical or immune function indicators.
(3) The first type of product:
1. Microbial medium (not used for microbial identification and drug sensitivity test);
2. Sample processing products such as hemolysulid, dilution, dyed liquid, etc.
Development History
The development of the in vitro diagnostic reagent industry is extremely similar to the development of the home appliance industry in the early 1990s: on the one hand, the market is large, on the other hand, import reagent And the monopoly advantage of diagnostic instruments is being broken and restricted by national products. "This is a summary of the development status of China in vitro diagnostic reagent. China's in vitro diagnostic reagent industry development has shown a characteristics of developing a big country, that is, there are more market potential. There are more than 18,000 hospitals in China, more than 300 hospitals. Blood stations, at the same time, thousands of medical examination centers and hundreds of independent laboratories are like raining spring army, and some independent medical inspection laboratories are also in the like, which provides a broad market space for the development of in vitro diagnostic reagents.
The Chinese population accounts for 22% of the world's total population, but in vitro diagnostic reagents only account for 2% of the world, and in recent years, various new technologies, new methods have been promoted and integrated. The development and application of in vitro diagnostic reagents. At the same time, with the increase in the income of the people and the improvement of living standards, people have higher demand for health and medical quality. Under the conditions of all kinds of benefits, in vitro The development of the diagnostic reagent industry has welcomed the "Thousands of Rehabilitation" in the history of medical development.
It is to see this broad market prospect, and foreign large medical imaging companies have merged in vitro diagnostic industries. First, in 2006, Siemens successively acquired the US leading immunization diagnostic reagent supplier Derm and German Bayer's diagnostic department, and the GE has taken 8.13 billion acquisition of Abbott pharmaceutical part of the foreign diagnosis and rapid diagnosis reagent business, and several companies The merger operation is gradually "surface out".
Development status status
With the spread of biomedicine technology, the breakthrough and development of the entire diagnostic reagent industry, this will undoubtedly suffer Patients with disease torture brings more freshmen. In the World OECD countries, the largest in vitro diagnostic reagent market is North America. In 2010, the sales of North American markets were $ 18.45 billion, and in 2012nd to $ 22.1 billion. The Western European market is $ 13.7 billion in 2010, reaching 15 billion US dollars in 2012.
in Europe, the largest single market is Germany, 2012 IVD (in vitro diagnostic products) sales is $ 2.9 billion The scale of IVD market in other EU countries see the following data.
After more than 20 years of development, the diagnostic reagent has experienced 4 technical revolutions in chemistry, enzyme, immunoassay, and probe technology. Every revolution, The technology of clinical diagnosis reagents has across a new level, and its business value and investment value are also increasing.
In vitro diagnostic industry is produced with the development of modern inspection medicine, in turn drive The rapid development of medical and basic medicine and other disciplines. 2/3 of the global medical decision is based on diagnostic information, and the diagnosis expenditure only accounts for 1% of medical expenditure, and the diagnostic technology further improves the prevention, diagnosis of the disease. Treatment has a positive significance, the diagnostic reagent industry also has a broad space.
In vitro diagnostic industry has been one of the industries supported by domestic, since 2005, the State Council, the Development and Reform Commission, and the Ministry of Science and Technology. The national department has introduced a number of policies that have positive significance for promoting the development of in vitro diagnostic reagents, diagnostic instruments, diagnosis-related enzyme preparations, and enhance the competitiveness of domestic diagnostic reagents.
data shows that since 2006, the domestic body diagnosis industry has shown a high-speed growth in the year of 15%. In 2008, China's in vitro diagnostic market has reached 9.5 billion yuan, an increase of 12.2 billion yuan in 2010. It is expected that the market size of China's in vitro diagnostic industries will maintain an annual growth rate of about 15%. By 2015, China's in vitro diagnostic market is expected to exceed 30 billion yuan, which is expected to become the third largest market in the world, with an average annual increase between 15% -20%.
The grassroots hospital has brought a huge incremental market for the in vitro diagnostic industry with the in-depth medical reform and concern people's livelihood. The national investment in the grassroots health system is up to 100 billion yuan, and its main benefit segments are mainly a product of common diseases in biochemical reagents. In summary, it can be judged that the diagnostic reagents have investment opportunities, while the chances of family diagnostic reagents will be the focus of attention.
The Chinese diagnosis industry has a small number of small and high growth rates. The size of the external diagnosis market is approximately 3/4 of the entire market, and the size of the diagnostic reagent market accounts for 1/4. In the industry, in 2013, China's in vitro diagnostic market income was 21.5 billion yuan, and the growth rate was 22.9%. China's in vitro diagnostic market is developed in far more than mature markets.
China's in vitro diagnostic reagent market (right side)
China accounts for one-fifth of the world's population, and in vitro diagnostic industry accounts for about 7.8% in the world; the per capita cost is low: China's experience is $ 2.75, far less than $ 25-30 per capita use of developed countries; inspection costs account for low in hospital revenue: foreign clinical practice, check fees generally account for 20-30% of hospital income The Chinese inspection cost accounts for about 11% of total revenue, accounting for low. Adjusting drug prices in the country, canceling the context of drug bonus, more than 50% of the gross profit margin more than 50% is more important in the hospital's important income and harvest.