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Diagnostic reagents overall development characteristics

Dec 28, 2017

The current development of diagnostic reagents are mainly the following characteristics:

(1) Immunodiagnostic reagents will gradually replace clinical biochemical reagents and become the mainstream of diagnostic reagents.

(2) Diagnostic techniques are evolving to the poles. On the one hand, highly integrated and automated instrument diagnostics, on the other hand are quick and easy diagnostics that are easy and quick to popularize.

(3) The type of product to be tested will rapidly expand.

(4) Accelerated application of product updates Due to the continuous application and development of modern biotechnologies such as genetic engineering, gene recombination and monoclonal antibodies, these precise diagnostic reagents can rapidly enter the clinical stage from the research phase and shorten the development time.

The international clinical diagnostic reagent market annual growth rate of about 3% to 5%, is still in a period of sustained development, the US FDA approved nearly 700 kinds of diagnostic reagents, ranked first in the world, but with the World Health Organization's global disease statistics The demand potential is very high compared to the 12,000 types of diseases that the classification society recently announced that have been identified globally.

After several years of rapid development in the domestic clinical test market, although some important clinical product projects have entered a mature stage, the growth rate of the domestic market has slowed down, but there is still a 15% to 20% growth rate. At present, compared with hundreds of products in the world, the domestic market is still far from being developed. Such as tumor diagnosis and gene chip reagents have great market potential. Even from the current needs of larger, more mature development of several diseases, the market still has great potential for development. At the same time, with the improvement of people's living standards and the reform of the national medical system, the market size will inevitably further expand.


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