What Are In Vitro Assays?

In vitro diagnostic reagents and devices are collectively referred to as in vitro diagnostic medical devices abroad. Part of a medical device.

In vitro diagnostic reagents and devices are collectively referred to as in vitro diagnostic medical devices abroad. Part of a medical device.

In China, in vitro diagnostic reagents refer to: can be used alone or in combination with instruments, appliances, equipment or systems. In the process of disease prevention, diagnosis, treatment monitoring, prognostic observation, evaluation of health status and prediction of genetic diseases Reagents, kits, calibrators (substances), quality control substances (substances), etc. for in vitro detection of human samples (various body fluids, cells, tissue samples, etc.).

Chinese name

In vitro diagnostic reagents

Introduction to in vitro diagnostic reagents

The in vitro diagnostic reagent registration management measures (trial) refers to in vitro diagnostic reagents managed according to medical devices, including those that can be used alone or in combination with instruments, appliances, equipment or systems. Reagents, kits, calibrators, substances, etc. used for in vitro detection of human samples (various bodily fluids, cells, tissue samples, etc.) during treatment monitoring, prognostic observation, health status evaluation, and prediction of genetic diseases Controls (things), etc.

The national in vitro diagnostic reagents for blood source screening and in vitro diagnostic reagents labeled with radionuclides do not fall under the scope of the "Administrative Measures for the Registration of In vitro Diagnostic Reagents (Trial)".

An in vitro diagnostic reagent business must engage in business activities in accordance with the "Good Manufacturing Practice for Drugs" ^[1] .

Classification of in vitro diagnostic reagents

According to the level of product risk, in vitro diagnostic reagents are divided into third, second and first products.

(A) the third category of products:

1. Reagents related to the detection of pathogenic pathogen antigens, antibodies and nucleic acids;

2. Reagents related to blood type and tissue matching;

3 Reagents related to human genetic testing;

4 Agents related to hereditary diseases;

5. Reagents related to the detection of narcotic drugs, psychotropic drugs and medical toxic drugs;

6. Reagents related to the detection of the target of the therapeutic drug;

7. Reagents related to tumor marker detection;

8. Reagents related to allergies (allergens).

(2) Category II products: Except products that have been clearly classified as Category III and Category I, others are Category II products, mainly including:

1. Reagents for protein detection;

2. Reagents for sugar detection;

3 Reagents for hormone detection;

4 .Reagents for enzyme detection;

5. Reagents for ester detection;

6. Reagents for vitamin testing;

7. Reagents for inorganic ion detection;

8. Reagents for the detection of drugs and drug metabolites;

9. Reagents for autoantibody detection;

10 Reagents for microbial identification or drug susceptibility testing;

11. Reagents for other physiological, biochemical or immune function indicators.

(3) The first category of products:

1. Microbial culture medium (not used for microbial identification and drug sensitivity tests);

2. Sample processing products, such as hemolytic agents, diluents, staining solutions, etc.

History of in vitro diagnostic reagents

The development status of the in vitro diagnostic reagent industry is very 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, the monopoly advantages of imported reagents and diagnostic equipment are being broken and restricted by national products. "This is a summary of the current status of the development of in vitro diagnostic reagents in China. The overall development of the in vitro diagnostic reagents industry in China shows the characteristics of a large developing country, that is, the market is large and the market potential is greater. China has more than 18,000 hospitals and more than 300 Blood stations, meanwhile, thousands of medical examination centers and hundreds of independent laboratories have sprung up, and some independent medical test laboratories are also in the ascendant, which provides a broad market space for the development of in vitro diagnostic reagents.

China's population accounts for 22% of the world's total population, but the share of in vitro diagnostic reagents accounts for only 2% of the world's population. In recent years, the rise and integration of various new technologies and methods have promoted the development and application of in vitro diagnostic reagents. And replacement. At the same time, with the increase of people's income and the improvement of living standards, people have a higher demand for health and medical quality. Under the favorable conditions, the development of the in vitro diagnostic reagent industry has ushered in a good opportunity in the history of medical development.

It is precisely because of this broad market prospect that large foreign medical imaging companies have begun to merge with companies in the in vitro diagnostics industry. First, in 2006, Siemens successively acquired Depp, the leading supplier of immunodiagnostic reagents in the United States, and the diagnostic department of Bayer AG, and then GE acquired 8.13 billion parts of Abbott Pharmaceutical's in vitro diagnostic and rapid diagnostic reagents business. Merger operations are gradually "surfacing."

Development status of in vitro diagnostic reagents

With the rapid development of biomedical technology and the breakthrough and development of the entire diagnostic reagent industry, all of this will undoubtedly bring more opportunities for new students to suffer from various diseases. Among the OECD countries, the largest market for in vitro diagnostic reagents is North America. In 2010, North American market sales were 18.45 billion U.S. dollars and increased to 22.1 billion U.S. dollars in 2012; while Western European markets were 13.7 billion U.S. dollars in 2010 and 2012 It reached 15 billion U.S. dollars annually.

In Europe, the largest single market is Germany, with IVD (in vitro diagnostic product) sales of US $ 2.9 billion in 2012. The IVD market size of other EU countries is shown in the table below.

After more than 20 years of development, diagnostic reagents have undergone four technological revolutions in chemistry, enzymes, immunoassay and probe technology. Each revolution has brought the technology of clinical diagnostic reagents to a new level, and its commercial value and investment value have become increasingly apparent.

The in vitro diagnostics industry has emerged with the development of modern laboratory medicine, which in turn has led to the rapid development of such disciplines as laboratory medicine and basic medicine. Two thirds of global medical decisions are made based on diagnostic information, and diagnostic expenditures account for only 1% of total medical expenditures. The further improvement of diagnostic technology is of positive significance for disease prevention, diagnosis and treatment, and the diagnostic reagent industry has a broad Expansion capacity.

The in-vitro diagnostic industry has been one of the key industries supported in China. Since 2005, the State Council, the Development and Reform Commission, the Ministry of Science and Technology and other national departments have issued a number of policies to promote in vitro diagnostic reagents, diagnostic instruments, diagnostic related enzymes The development of the diagnostic industry is of positive significance and has strengthened the competitiveness of domestic diagnostic reagent companies.

Data show that since 2006, the domestic IVD industry has shown a rapid growth rate at an annual growth rate of about 15%. The size of China's IVD market in 2008 has reached 9.5 billion yuan, and in 2010 it increased to 12.2 billion yuan. It is estimated that by 2012, the market size of China's IVD industry will maintain an annual growth rate of about 15%. By 2015, the size of China's IVD market is expected to exceed 30 billion yuan, and it is expected to become the third largest market in the world, with an average annual growth rate of 15% -20%.

With the new medical reform and deepening of people's livelihood, primary-level hospitals have brought a huge incremental market to the IVD industry. The state's investment in the primary health system is as high as 100 billion yuan, and its main benefit industries are mainly products for common diseases in biochemical reagents. In summary, it can be judged that there are investment opportunities in several segments of diagnostic reagents, and opportunities such as home diagnostic reagents will be the focus of future attention.

The diagnostic industry in China is characterized by a small base and a high growth rate. Among them, the market size of in vitro diagnostics is about 3/4 of the total market size, and the market size of in vivo diagnostic reagents accounts for 1/4. The industry estimates that China's IVD market revenue in 2013 was 21.5 billion yuan, a growth rate of 22.9%. The Chinese IVD market is growing far beyond the mature market.

China in vitro diagnostic reagents market size (right)

China accounts for one fifth of the world's population, and the IVD industry accounts for only about 7.8% of the world's total; per capita costs are low: in vitro in China

China in vitro diagnostic reagents market size

The annual per capita usage of diagnostic products is US $ 2.75, which is far lower than the per capita usage of US $ 25-30 in developed countries; inspection costs account for a low proportion of hospital revenue: from the perspective of foreign clinical practice, inspection costs generally account for 20-30% of hospital revenue; China Inspection costs account for about 11% of total revenue, a relatively low proportion. In the context of the state's adjustment of drug prices and the elimination of drug markups, clinical departments with a gross profit margin of about 50% have become an important revenue-generating department of hospitals.