IVD market will reach 72.3 billion molecular diagnostics and POCT favored

Nowadays, it is basically not seen by doctors to go to the hospital. Diagnosis comes first. Blood tests and urine tests have long been used to it, and these tests are based on in vitro diagnostic reagents.
In vitro diagnostic reagents also occupy an increasingly important position in the whole medical process with its accuracy, convenience and efficiency. In the modern medical system, it can not only greatly reduce the workload of doctors, but also greatly improve the accuracy of diagnosis and the prevention of diseases. Therefore, in vitro diagnosis has the reputation of "doctor's glasses. Therefore, in vitro diagnostic reagents have a great demand market in major hospitals and clinics, and eventually led to the rapid development of in vitro diagnostic industry (IVD) in China.

According to the statistical analysis of the "China Pharmaceutical Health Blue Book" (hereinafter referred to as the "Blue Book") released by the China Pharmaceutical Industry Information Center: In 2014, the market size of my country's in vitro diagnostic products reached 30.6 billion billion yuan; it is expected that the market size will reach 72.3 billion billion yuan in 2019. The annual compliance growth rate is as high as 18.7.

1. Connotation and market classification

In vitro diagnostic products include reagent instruments and analytical systems for the collection, preparation (directional processing) and detection of human samples (including body fluids, cells, tissue samples, etc.).

The in vitro diagnostics market is generally divided into four main categories: biochemical reagents, immunodiagnostics, molecular diagnostics, and point-of-care testing (POCT). According to the Blue Book data, in 2014, in vitro diagnostics accounted for the top three segments of its overall market: nearly 40% of immunodiagnostics (38%), nearly 20% of biochemical reagents (19%) and 15% of molecular diagnostics. At present, the largest market share is immunodiagnosis.

Among them, biochemical reagent products are mainly domestic brands; immunodiagnostic products are dominated by imports, with domestic brands occupying a certain share; molecular diagnostic products are a mixture of imported and domestic brands; and in POCT products, imports are the main products, and domestic products are still in their infancy.

2. Domestic in vitro diagnostic industry status.

The Blue Book released by the China Pharmaceutical Industry Information Center shows that the total medical device market in my country reached 276 billion yuan in 2014. According to the market share, the top three are: medical imaging equipment with a market share of nearly 20% (19%), in vitro diagnostic products with a market share of 16%, and high-value medical consumables and implants with a market share of 13%. IVD industry has become an important growth pole of the whole medical equipment market.

The data show that the domestic in vitro diagnostic products market has been firmly occupied by several large foreign multinational companies, Roche (Roche), Abbott (Abbott) and other five international industry giants currently occupy more than 37% of the domestic in vitro diagnostic reagents market share. However, domestic in vitro diagnostic product brands are in a relatively weak position. Not only are they well-known and recognized in the international market, but they are also difficult to find in the purchase orders of domestic top three hospitals.

Data from the Food and Drug Administration show that there are many in vitro diagnostic product manufacturers in my country, the scale is also uneven, and the product quality level is even more different. Specifically, at present, the total number of in vitro diagnostic reagent products registered has reached 17000, with about 1000 production enterprises and 9000 operating enterprises. In terms of use, there are nearly 26000 hospitals alone.

At the same time, the "Blue Book" also pointed out: At present, the scale of most domestic in vitro diagnostic manufacturers is very limited, and there are only a handful of companies with annual sales revenue of 0.5 billion yuan. At present, the larger in vitro diagnostic manufacturers in the domestic market are mainly foreign brands such as Roche, Abbott, Siemens Medical Diagnostics.

From the perspective of enterprise gathering areas, the Pearl River Delta, the Yangtze River Delta and the Beijing-Tianjin-Hebei region are still the leaders, especially the two cities of Shenzhen and Zhuhai in Guangdong, which are located in the Pearl River Delta, have well-known domestic industry companies. At present, the province's in vitro diagnostic reagent industry It occupies a considerable share in the country, and ranks among the top in various data indicators such as the number of production and operation enterprises, the gross production value, and supervision and sampling rate.

3. Future development

With the gradual expansion of the medical market and the gradual deepening of health awareness, the future in vitro diagnostic market size is still huge. According to the forecast of China Pharmaceutical Industry Information Center, the market size of in vitro diagnosis in China will reach 72.3 billion billion yuan in 2019.

The huge market is bound to give rise to more intense competition. How to position its own product development in this competition is a difficult problem in front of the practitioners. How to grasp the future direction of market products has become the key to solve this problem.

Professor Kang Xixiong, director of the Experimental Diagnosis Center of Beijing Tiantan Hospital and director of the Department of Clinical Laboratory Diagnosis of Capital Medical University, once pointed out that in vitro diagnosis has six characteristics: large diagnosis, automation, high throughput, simplicity, information flow and bedside, while the mainstream development direction of its products is individualization, rapidity, small sample quantity, equipment integration, bedside, equipment miniaturization, mobile phone, APP software, etc.

In addition, Professor Wu Yong, director of the Clinical Laboratory of the Third Xiangya Hospital of Central South University, pointed out that molecular diagnostic technology has important value in the application of individualized diagnosis, and gene chip is the most promising field in molecular diagnostic technology.

To sum up, it is the development towards individualization, bedside and convenience; that is to say, in the future, the field of molecular diagnosis and POCT are the two fields with the most development potential in vitro diagnosis.

This time, the China Pharmaceutical Industry Information Center also pointed out that from the perspective of the growth potential of the main product categories, the order from low to high is blood testing, clinical biochemistry, other products (including cell diagnosis, microbial diagnosis, coagulation diagnosis, etc.), immunochemistry, molecular diagnosis, bedside testing. It also confirms that molecular diagnosis and POCT will be the focus of development in the future, and it will also be the main field of market competition in the future.

4. Inspiration from the layout of Guangdong IVD industry

In reality, as a large target of IVD product sales, many domestic hospitals still tend to choose imported brands when purchasing inspection reagents, while most domestic brands are still embarrassed to be blocked out of their doors. The emergence of this phenomenon is mainly due to: first, the third-class hospitals are used to introducing expensive imported instruments and think that international brands are more stable and reliable; second, in the IVD industry, instruments and reagents are matched, and many reagents have no domestic production capacity and only purchase imported brand instruments and reagents; third, due to patients' reasons, imported brands have accumulated a certain reputation among patients, faced with low-cost domestic reagents, they prefer to choose more expensive imported brands. This has become the development of the domestic IVD industry is facing difficulties, and the ultimate reason is probably technical problems.

As the lowest-tech ELISA test kit in the industry, the current domestic market is basically localized, and foreign brands are difficult to see in this field. As a product of immune detection method with slightly higher technical content, domestic brands also occupy a certain share in the domestic market at present; and molecular diagnosis, because of its high technical content, has strict requirements on reagents and instrument conditions, especially in the field of gene chips, which are almost monopolized by foreign brands, and there is a similar situation in POCT. It can be said that with the improvement of technical content, domestic brands gradually reduced.

Perhaps we can see something from the industrial layout of Guangdong Province: while seeking breakthroughs in in vitro diagnostic reagents, Zhuhai Deere Biology also insists on independent research and development of supporting testing instruments. The bundling strategy of "reagent-equipment" synchronous development is more conducive to breaking the dual dependence of domestic hospitals on foreign brand reagents and instruments, and is also beneficial to the export of their own products abroad.

In addition to R & D innovation, seeking cross-border cooperation has gradually become an important form of market growth. Zhuhai Lizhu Reagent invested US $10 million in US CYNVENIO companies in 2015. While introducing advanced foreign technology to broaden its own fields, it also better entered foreign markets.

In addition to technological innovation and cooperation mode innovation, group development is also conducive to the development of local enterprises. In February 2015, Shenzhen in vitro diagnostic reagent innovation alliance was established in Shenzhen Institute for Drug Control. The alliance integrates industry production, learning, research, medicine, politics and other resources, promotes effective communication and cooperation among superior enterprises, universities, scientific research institutes, clinical users and regulatory authorities, and provides a basis for the smooth operation of the technological innovation chain of the in vitro diagnostic reagent industry. at the same time, it also makes useful explorations to improve the product quality and independent innovation ability of in vitro diagnostic reagents.

Guangdong food and drug supervision and administration departments at all levels adhere to the construction of a special governance model of "multi-party participation, combination of attack and prevention, combination of attack and construction, public benefit, and industry development" to promote the development of the industry from the regulatory level.

The innovation of enterprises and the promotion of the government have made the IVD industry in Guangdong develop rapidly and occupy a leading position in the IVD industry in various provinces in China. The data shows that in 2014, the output value of medical device manufacturers in Guangdong Province was about 82 billion yuan, and the total export value of foreign trade was 5.1 billion billion US dollars, ranking first in the country, and its in vitro diagnostic reagent industry indicators were also among the best in China.

(Information from small orange lamp network)