The IVD market is favored for 72.3 billion molecular diagnostics and POCT

Now go to the hospital to see a doctor is basically not seen, diagnosis first, blood test, urine test has long been accustomed to, and these tests are based on in-body diagnostic reagents.
In-body diagnostic reagents also occupy an increasingly important position in the whole medical process with their precision, ease of convenience and efficiency, which can not only greatly reduce the workload of doctors in the modern medical system, but also greatly improve the accuracy of diagnosis and prevention of diseases, so in-body diagnosis has a reputation as "doctor's glasses". Therefore, in vitro diagnostic reagents in major hospital clinics have a great demand market, and ultimately has long been the rapid development of China's in vitro diagnostic industry (IVD).
According to the "China Pharmaceutical Health Blue Book" (collectively, "Blue Book") released by the China Pharmaceutical Industry Information Center, the market size of China's in-body diagnostic products reached 30.6 billion yuan in 2014;1. Intension and market classification
In-body diagnostic products include the collection, preparation (targeted treatment), testing of reagent instruments and analytical systems for human samples (including body fluids, cells, tissue samples, etc.).
in-body diagnostic market is divided into four main categories: bio-chemical reagents, immunodiagnosis, molecular diagnosis, instant testing (POCT). According to blue book data: In 2014, in-body diagnostic sub-sectors accounted for the top three segments of its overall market: nearly 40% of immunodiagnosis (38%), nearly 20% of bio-chemical reagents (19%) and 15% of molecular diagnostics. At present, the largest share of the market share is immunodiagnosis.
Among them, bio-chemical reagent products are mainly domestic brands, immunodiagnostic products are import-led, domestic brands occupy a certain share, molecular diagnostic products are imported and domestic brands fish and dragon mixed, and IN POCT products, mainly imports, domestic is still in its infancy.2. Status of the domestic in-body diagnostic industry
The Blue Book released by the China Pharmaceutical Industry Information Center shows that china's medical device market reached 276 billion yuan in 2014, according to the market share, the top three are: the market share of nearly 20% of medical imaging equipment (19%), the market share of 16% of in-body diagnostic products and market share of 13% of high-value medical supplies and implants. The IVD industry has become an important growth pole in the entire medical market.
And data show that the domestic in-house diagnostic products market has been firmly occupied by several large foreign multinational companies, Roche, Abbott and other five international industry giants currently occupy more than 37% of the domestic in-body diagnostic reagent market share. However, domestic in-body diagnostic products brand is in a relatively weak position, not only in the international market visibility and recognition is low, that is, in the domestic three hospitals on the purchase order is also difficult to find traces.
from the Food and Drug Administration data show that: China's in-body diagnostic products production enterprises, the size is also uneven, product quality level is a significant gap. Specifically, the total number of in-body diagnostic reagents registered alone has reached 17,000, with about 1,000 production enterprises and about 9,000 operating enterprises, while in the use of the link, there are nearly 26,000 hospitals alone.
also pointed out in the Blue Book: at present, most of the domestic in-body diagnostic production enterprises are very limited in size, annual sales revenue of 500 million yuan of enterprises are few. At present, the domestic market larger in-body diagnostic manufacturers are mainly foreign brands have Roche, Abbott, Siemens medical diagnostics;
And from the enterprise gathering area, still to the Pearl River Delta, Yangtze River Delta and Beijing-Tianjin-Hebei region as the leader, especially in the Pearl River Delta, Guangdong Shenzhen and Zhuhai city has a well-known domestic industry enterprises, the province's in-body diagnostic reagent industry in the country occupies a considerable share, in the number of production and operation enterprises, gross domestic product and supervision of sampling pass rate and other data indicators are ranked in the forefront of the country.3. The future development
the scale of the medical market and the deepening of health awareness, the future in-body diagnostic market size is still huge potential. According to the forecast of The China Pharmaceutical Industry Information Center, the market size of in-body diagnostics in China will reach 72.3 billion yuan in 2019.
huge market is bound to lead to more intense competition. How to position one's own product development in this competition is a difficult problem for practitioners. How to grasp the future market product trend, has become the key to solve this difficult problem.
The director of the experimental diagnostic center of Tiantan Hospital in Beijing and the head of the Department of Clinical Examination and Diagnostics of Capital Medical University, Professor Kang Xixiong, has pointed out that in vitro diagnosis has six characteristics: large diagnosis, automation, high-volume, simplicity, information flow and bedside, and the mainstream development direction of its products is one of integration, rapidization, small samples, equipment integration, bedside, device miniaturization, mobile phone, APP software, etc.
In addition, Professor Wu Yong, Director of the Inspection Department of Xiangya University of Central South China, pointed out that molecular diagnostic technology has important value in the application of individualized diagnostics, and gene chip is the most promising field of molecular diagnostic technology.
summary is towards individualization, bedside, easy development, that is, in the future, molecular diagnostic field and POCT is the two areas with the most potential for in-body diagnosis.
And this time the China Pharmaceutical Industry Information Center also pointed out that from the growth potential of the main product categories, from low to high, blood testing, clinical biochemistry, other products (including cell diagnosis, microbial diagnosis, clotting diagnosis, etc.), immunochemistry, molecular diagnosis, bedside testing. Also here confirmed that the future molecular diagnosis and POCT will be the focus of development, will also be the main area of future market competition.4. The enlightenment of Guangdong IVD industry layout
In reality, as a large target of IVD product sales - many hospitals in China, it is still inclined to choose imported brands when purchasing testing reagents, while most domestic brands are still embarrassed to be shut out. The main reasons for this phenomenon are: First, because of the habit of the introduction of expensive imported equipment, think that international brands are more stable and reliable, second, in the IVD industry, instruments and reagents matching, many reagents have no domestic production capacity, only the purchase of imported brand instruments and reagents; This has become the development of domestic IVD industry is facing difficulties, and its ultimate cause is probably technical problems.
as the industry's lowest technical content ELISA method testing kit, the current domestic market is basically domestic, foreign brands in this area is difficult to see. As a slightly higher-tech immuno-testing method of products, the current domestic market domestic brands also occupy a certain share, and molecular diagnosis because of its high technical content, reagents and instrument conditions are more stringent requirements, especially in the field of gene chips, almost all foreign brands monopolized, and INPOCT has a similar situation. It can be said that with the improvement of technical content, domestic brands gradually reduced.
we can see something from the industrial layout of Guangdong Province: Zhuhai Deere biology in the search for in-body diagnostic reagents breakthrough at the same time, but also adhere to independent research and development of supporting testing equipment. 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 also beneficial to the export of its own products abroad.
in addition to research and development innovation, the search for cross-border cooperation has gradually become an important form of market increment. Zhuhai Lizhu reagent in 2015 with 10 million U.S. dollars to invest in the United States CYNVENIO company, in the introduction of foreign advanced technology to broaden their field of involvement at the same time, but also better into foreign markets.
in addition to enterprises in technological innovation, cooperation model innovation, the development of the group is also good for the development of local enterprises. In February 2015, the Shenzhen In-body Diagnostic Reagent Innovation Alliance was established at the Shenzhen Drug Inspection Institute. The alliance integrates industry production, research, medicine, politics and other resources, promotes effective communication and collaboration between dominant enterprises, universities, research institutes, clinical users and regulatory authorities, provides the basis for the smooth operation of the technology innovation chain of in-body diagnostic reagents industry, and also makes useful explorations to improve the quality of in-body diagnostic reagents and independent innovation capabilities.
Guangdong food and drug supervision and administration departments at all levels adhere to the construction of "multi-participation, anti-combination, construction integration, public benefit, industry development" of the special governance model, from the regulatory level to promote the development of the industry.
innovation and government promotion make Guangdong's IVD industry develop rapidly and occupy a leading position in the IVD industry in various provinces in China. Data show that in 2014, Guangdong Province medical device production enterprises output value of about 82 billion yuan, the total value of foreign trade exports of 5.1 billion U.S. dollars, ranking first in the country, and its in-body diagnostic reagent industry indicators are also among the best in the country. (Medical Innovation Network)