Medical network on December 22 - now basically is to go to the hospital did not see the doctor, diagnosis first, blood tests, urinalysis accustomed, but these checks are based on the in vitro diagnostic reagents.
In vitro diagnostic reagents and its precision, easy and efficiency in the whole medical process more and more important position, in the modern medical system not only can greatly reduce the workload of doctors, but also greatly improve the accuracy of the diagnosis and preventive of disease, therefore, in vitro diagnostic and have the reputation of "doctor glasses". Therefore, in vitro diagnostic reagents in each big hospital clinic has a great demand in the market, finally has the the rapid development of in vitro diagnostic (IVD) industry in our country.
According to the Chinese pharmaceutical industry information center released by the Chinese medicine health blue book (hereinafter generally referred to as the "blue book") statistical analysis: in 2014, China has reached 30.6 billion yuan in vitro diagnostic products market scale; The size of the market in 2019 is expected to reach 72.3 billion yuan, the annual average in line with the growth rate is as high as 18.7%.
1. The connotation and classification of market
In vitro diagnostic products including samples to the human body (including body fluids, cells, tissue samples, etc.) are collected, preparation (orientation), detection reagent instrument and analysis system.
Usually in vitro diagnostic market mainly divided into four categories: biochemical reagents, immune diagnosis, molecular diagnosis, real-time testing (POCT). According to the "blue book" data: in 2014, in vitro diagnostic niche three: before its overall market share accounted for nearly forty percent of the immune diagnosis (38%), biochemical reagent (19%) accounted for nearly twenty percent and 15% of molecular diagnosis. The current market share accounted for the largest is the immune diagnosis.
The biochemical reagent products mainly domestic brands; Immune diagnostic products dominated by imports, domestic brand occupies a share; Molecular diagnostic products are imported and domestic brand "; In respect of POCT products, mainly on imports, domestic is still in its infancy.
2. The domestic current situation of the in vitro diagnostic industry
China's pharmaceutical industry information center: according to "the blue book" released in 2014, China's medical equipment market amounted to 276 billion yuan, according to the market share of view, the top three in turn is: market accounted for nearly twenty percent of the medical imaging equipment (19%), the market share of 16% in vitro diagnostic products and market share of 13% high value medical consumables and implants. IVD industry has become an important growth pole of the whole YiXie market.
And statistics show: in vitro diagnostic products market in China has been for several large multinational companies abroad, on top of the Roche (Roche), Abbott laboratories (Abbott), and other five international giant currently occupies more than 37% of the domestic market share in vitro diagnostic reagents. And the domestic brand in vitro diagnostic products is in a relatively weak position, not only low visibility and recognition in the international market is in the country on the purchase order of 3 armour hospital also elusive.
According to data from the food and drug supervision and administration department: in vitro diagnostic products production enterprise in our country is numerous, size also is uneven, the gap between product quality level is obvious. Concrete is currently only in vitro diagnostic reagent products up to 17000, the total number of registered enterprises in around 1000, business in 9000 or so, and in the use process, the hospital alone, nearly 2.6.
At the same time also pointed out in the "blue book" : the size of the current domestic production enterprises most of in vitro diagnostic is very limited, annual sales revenue reached 500 million yuan scale enterprises are numbered. On the domestic market at present is larger in vitro diagnostic manufacturer mainly for foreign brand with roche, abbott laboratories, Siemens medical diagnosis; Domestic brands have a progress of da an gene, biology, mindray medical, etc.
And from the point of enterprise gathering area, is still in the pearl river delta, Yangtze river delta and the beijing-tianjin-hebei region as group leader, especially the two city is located in the pearl river delta of guangdong shenzhen and zhuhai industry with domestic famous enterprises, is the province of in vitro diagnostic reagent industry in make up a significant share of the country, in the production management enterprise quantity, gross and supervision, sampling percent of pass the data indicators are among the top.
3. The future development
Medical market is gradually expanding and health consciousness gradually deepened, in vitro diagnostic market scale is still huge potential in the future. According to the forecast of China's pharmaceutical industry information center, 2019, in vitro diagnostic market scale will reach 72.3 billion yuan in China.
The huge market will inevitably produce more intense competition. How positioning itself in the competition of product development is a difficult problem in front of employees. How to grasp the future market products, becomes the key to resolve this problem.
Test in the diagnosis of Beijing tiantan hospital, capital medical university, director of the center for clinical laboratory diagnostics the dean professor xi-xiong kang has pointed out: in vitro diagnostic with large diagnosis, automation, high flux, facilitation, information flow and bed six characteristics, and its products in the mainstream of development direction is individualized, rapidness, less sample quantization, equipment integration, bed, equipment miniaturization, mobile phone, apps, etc.
In addition, central south university xiangya research and clinical laboratory director professor WuYong that molecular diagnostic technology is of important value in the individualized diagnosis applications, molecular diagnosis of technology and gene chip is one of the most promising fields.
To sum up is toward individualized, next to the bed, the easy development; That is to say, in the future and POCT molecular diagnosis field is the most potential for development in vitro diagnostic two areas.
This time, China's pharmaceutical industry information center also points out that from the perspective of the growth potential of major product categories, from low to high followed by blood tests, clinical, biochemical and other products, including cell diagnostic, microbiological diagnosis, blood coagulation, etc.), immune chemistry, molecular diagnosis and detection by the bed. Also confirmed in this future molecular diagnosis and POCT will be the focus of development, also will be the future market competition main areas.
4. Guangdong IVD industry layout
In reality as a large object of IVD products sales - domestic numerous 3 armour hospital, its test reagents in purchasing still tend to choose imported brand, and most of the domestic brands is still awkward being locked out of the door. The emergence of this phenomenon is mainly because: first, because of 3 armour hospital used to introduce the expensive imported equipment, believe that international brand is more stable and reliable; Second, in IVD industry, instruments and reagents, a lot of reagent no domestic production capacity, only purchase imported brand instrument and reagents; Three reasons are patients, the import brand has piled up a certain reputation in the patients group, in the face of cheap domestic reagent, they prefer to choose more expensive imported brand. This has become the domestic IVD industry development, the problems facing and the ultimate cause or technical problems, I'm afraid.
As the industry technical content of the lowest detection kit, ELISA method on the domestic market at present basically localization, foreign brand in this area is difficult to see. As a slightly higher immune detection method of product technical content, on the domestic market at present domestic brands also occupy a certain share; And molecular diagnosis because of its high technical content, can also more demanding conditions on the reagent and instrument, especially in the field of gene chip, almost all monopoly by foreign brands, and has a similar situation in terms of POCT. Can say with elevated levels of technology, the domestic brands gradually reduced.
Maybe we can see from the industry layout of guangdong province can be anything: zhuhai Deere biological while looking to break on the in vitro diagnostic reagents, also insisted on independent research and development form a complete set of test instruments. "Reagent - equipment" synchronous development of bundling strategy, more conducive to break the domestic hospital dependence on foreign brand reagent and instrument, is also good for their products are exported to overseas.
Seeking international cooperation in research and development innovation, has gradually become an important form to gain market increment. Zhuhai reagent method in 2015 for $10 million investment in the United States CYNVENIO company, involved in the introduction of foreign advanced technology to broaden its field at the same time, also better to enter foreign markets.
In addition to the enterprises in technology innovation, cooperation mode innovation, unity development is conducive to the development of domestic enterprises. In vitro diagnostic reagents in February 2015, shenzhen innovation alliance was established in shenzhen drug inspection. The alliance integration of production, study and research the industry, medicine, politics, such as resources, promote the advantages of enterprises, universities, research institutes, clinical users and regulators of effective communication and collaboration, technology innovation for in vitro diagnostic reagent industry chain to provide smooth running of the foundation, at the same time, to improve product quality and the independent innovation ability in vitro diagnostic reagents and make a beneficial exploration.
Guangdong food and drug supervision and administration departments at all levels adhere to build "participating, predominant combining, built and dealing, public benefit and industry development" of the special governance mode, promote the development of industry from the supervision level.
To promote the innovation of the enterprise and the government made the IVD industry rapid development of guangdong, in the domestic various provinces in IVD industry leading position. Data show that in 2014, the production of medical device manufacturing enterprise of guangdong province about 82 billion yuan, the foreign trade exports of $5.1 billion and the first in the country, and its in vitro diagnostic reagent industry indicators are among the best in domestic also. |
