Analysis of development trend of diagnostic reagents in China in 2010 2010年我国诊断试剂发展趋势分析

Diagnostic reagents are mostly reagents that are detected by the reaction between antigens and antibodies and can be divided into in vivo diagnostic reagents and in vitro diagnostic reagents. Among them, in vitro diagnostic reagents account for the majority, and it is very useful in the prevention and diagnosis of diseases. As a sub-industry of biopharmaceuticals, diagnostic reagents have expanded in their application in more than 20 years of development. They are playing an increasingly important role in the prevention and detection of diseases, and their commercial value is also increasing.

Two high and one low: China's diagnostic reagent industry has obvious advantages under the new medical reform

The implementation of the new medical reform puts the prevention of diseases into the focus of the reform of the pharmaceutical industry. This obviously brings good opportunities for the development of "prevention-oriented" diagnostic reagent products, in order to reduce the cost of medication for the common people and reduce medical costs, and as much as possible. More efficiency, more accurate prevention and diagnosis will be the top priority. With the complete establishment of a national basic medical system, diagnostic reagent manufacturers will also benefit preferentially.

The advantage of China's diagnostic reagent industry is embodied in “two high and one low”, namely, high growth, high returns, and low risks. The growth rate of the demand for foreign diagnostic reagents is only about 6%, while in China, it can reach nearly 20%. The increasing trend is obvious. In addition, because diagnostic reagents do not require complicated clinical trials, they can yield high returns in the short term. In addition, it takes many years for a new drug to be marketed. During this time, clinical tests are repeated, once clinical trials fail. , the previous work must all be invalidated, while the diagnostic reagent is only used for in vitro testing, the process is simple, and the risk is relatively small.

Because diagnostic reagents refer to the in vitro testing of human samples, including blood, cells, and body fluids, to determine the disease's cognition and diagnosis. Therefore, in this “two high and one low” industrial advantage, plus new with the advancement of medical reform and the tilt of national policies, the diagnostic reagent industry has ushered in the best opportunity for development. This is a big market, especially for manufacturers of diagnostic reagents. This is a rare opportunity for development.

Industrial issues - Lack of self-guided impediments to the healthy development of the industry

The development of the diagnostic reagent industry in China is recent; so many areas have shortcomings and hinder the healthy development of this industry. The primary problem is that the company is small in scale, inefficient, and unable to achieve economies of scale. China's diagnostic reagent industry has a low input, both in basic research and in high-tech research. For China's largest diagnostic reagent manufacturer, the sales per year are not as good as those of foreign companies, and some of their products have poor stability and lack of quality.

Guo Fanli pointed out that, secondly, China has almost no patented technology and intellectual property for its own diagnostic reagents. Because of this, domestic diagnostic reagent products are very weak in competitiveness and have very little exports, making output low. On the other hand, China's lack of new product research and development is also a major reason for the slow growth of the diagnostic reagent industry, because this industry has a characteristic, that is, high investment, high risk, only the companies with strength in order to avoid the risks of the R & D period, otherwise, they choose to directly purchase product production licenses as soon as possible in order to open up new markets; and be under-strength of other companies simply because they do not have the ability to develop new products.

Industry Development - Need to Start with Three Aspects

If the diagnostic reagent industry in China wants to develop, it should start with talents, technology and other aspects, and increase investment to realize the healthy development of the entire industry. First of all, the cultivation of talents is of utmost importance. Diagnostic reagent industry is a technology-intensive industry. The importance of human resources exceeds the cost of production equipment and capital. Therefore, China must not only cultivate the scientific research level of diagnostic reagent product developers, but also it is necessary to raise the technological level of the entire diagnostic reagent industry to a higher level.

Second, China's diagnostic reagent industry needs to vigorously strengthen cooperation with foreign advanced companies. Although China has a leap forward in the development of diagnostic reagents, it is only at an early stage for advanced foreign companies. The gap between R&D and foreign countries is five years, and the production capacity is far from reachable. Therefore, cooperation with foreign countries, establishing research and development centers abroad, and shortening the time for research and development are also important for the moment.

Finally, national support is an indispensable condition. In the field of diagnostic reagents, the Chinese government should increase investment in related policies and the tilt of funds. On the other hand, it should appropriately introduce venture capital and strive to participate in market competition. , Diagnostic reagent companies also need to implement strong alliances to clear the obstacles in the operation of the industry. With the comprehensive establishment of the national basic medical system and the increased alertness for disease prevention, the diagnostic reagent industry will usher in a great opportunity for development. Therefore, China must implement the above development strategy in the development of the diagnostic reagent industry. It is only in this way, we can make China's diagnostic reagent industry invincible.

Future Trends - China's Diagnostic Reagent Industry Will Develop Towards High Integration and Simplification

First of all, in the future, diagnostic reagents in our country will develop toward the direction of highly integrated and automated instrument diagnostics. Nowadays, the global medical diagnostic market has entered a development model with science and technology, automation, and high-tech as the main body, and diagnostic reagents must keep up with the times. The pace must move toward high integration and automation. On the other hand, China's diagnostic reagents will also develop rapidly and simplistically. So, rapid, effective, and simple popular diagnostic reagents have to be made under the new medical reform.

In addition, the types of diagnostic reagent products in China will also rapidly increase, and applications will continue to expand. Due to the continuous application and development of modern biopharmaceutical technologies, China's diagnostic reagent products can also be put into clinical research in the quickest speed. In order to shorten the development time, we can achieve better and faster development of China's diagnostic reagent industry.

The annual growth rate of foreign diagnostic reagents market is about 5%. Benefited from the new medical reforms and national support policies, the annual growth rate of China's diagnostic reagent market can reach about 20%. With the improvement of people’s living standards and the new medical reforms, with continued advancement, the market size of diagnostic reagents in China will inevitably expand and the development prospects will be promising.