Release date: 2010-05-13
With the development of biotechnology and life sciences, the 21st century has become a century of biotechnology. As a product of biotechnology development, medical in vitro diagnostic reagents are constantly expanding their types with the rapid development of biotechnology. With the development of the global economy, people's awareness of health care, the improvement of medical security policies in most countries, and the rapid development of global health care, led to the rapid development of the in vitro diagnostic industry. The in vitro diagnostic reagent industry has become one of the most active and fastest growing industries in the world. In 2008, the global in vitro diagnostic market was about $55 billion (including instruments and reagents), growing at a compound annual growth rate of 5%-7%.
The development of China's in vitro diagnostic industry began in the 1980s. After more than 20 years of development, from scratch, from weak to strong, it is now in the condition of industrial scale development. The users of in vitro diagnostic products in China mainly include more than 19,700 hospitals, more than 39,000 township health centers, more than 300 blood stations, as well as an ever-changing physical examination center and an emerging independent laboratory for clinical testing. The annual compound growth rate of the market size of the in vitro diagnostic industry in 2006-2012 is expected to reach 15%, showing a rapid growth trend. In 2008, China's in vitro diagnostic market reached 9.3 billion yuan, and the per capita annual usage was 6.64 yuan. In 2008, Japan's per capita annual usage was 227.5 yuan, a wide gap. Overall, China's in vitro diagnostic industry is still in the early stages of growth. Chart 1 China's in vitro diagnostic industry market size and growth
Source: China In vitro Diagnostic System Professional Committee & Han Ding Consulting At present, China's in vitro diagnostic reagent market consists of eight parts, of which the largest amount of immunological diagnostic reagents, market share of 37%, followed by clinical chemistry 29%, blood sugar Detection of 12%, molecular detection of 8%, hematology 5%, microbiology 4%, blood bank 2%, other 3%. Molecular diagnostic reagents were developed in the late 1980s, and are the fastest growing of all diagnostic reagent products, both in technology and in the market. The market size of immunodiagnostic reagents has gradually surpassed that of clinical chemical reagents, but clinical biochemistry will maintain a large share due to differences in the test subjects.
Source: Handing Consulting China's in vitro diagnostic reagent industry is completely market-oriented. Foreign companies rely on stable product quality, high technical content and efficient and accurate instrumentation. The market share in the in vitro diagnostic industry is over 50%. It has a monopoly position in the high-end market of domestic tertiary hospitals. The price is generally higher than domestic similar products. 1-5 times. Leading domestic enterprises basically have agency business in the high-end market, such as Kehua Bio-agent Xisme Kang blood analyzer / urine sediment analyzer, Daan gene agent ABI fluorescence quantitative PCR analyzer, Zhongsheng North control agent Shimadzu Automated biochemical analyzers, etc., the company enriches the company's product line or drives the sales of corporate reagents through agency business.
There are more than 400 in-vitro diagnostic companies in China, with a large number, small scale, low overall quality and technical level, and weak competition. Domestic products have the advantages of low price and good after-sales service. Users are concentrated in the low-end market of secondary hospitals and primary hospitals. With the continuous improvement of the R&D and production technology level of domestic enterprises, the product quality of some enterprises has reached the international advanced level, the market share of domestically produced products is constantly expanding, the market is gradually concentrated to leading enterprises, and the concentration of the industry is continuously improving, but the competition is divided. The pattern has not changed. Leading companies in the industry have diversified into various fields of clinical chemistry, immunity and molecular diagnosis. Below, we will discuss the biochemical reagent market and the immunization market separately. 1. Biochemical reagent market Clinical biochemical reagents mainly include enzymes, sugars, lipids, protein and non-protein nitrogens, inorganic elements, liver function, clinical chemical control serum and other major products. The main purpose is to cooperate with manual, semi-automatic and general automatic biochemical analyzers, such as single reagent, liquid double reagent, dry powder double reagent, chemical reagent, standard and other specifications, and all manufacturers are available for the testing room. Inter- and indoor quality control serum series.
In the biochemical reagent market, foreign reagent sales accounted for 25% of total sales, and sales accounted for 50% of total sales. In the domestic biochemical reagent market, there are mainly enterprises such as Zhongsheng North Control, Kehua Biological, Lidman, and Mike Bio. The country began to purchase rural medical equipment from 2006, and further increased the input of primary health care system in 2009-2011. With the popularization of automatic biochemical analyzers in county-level hospitals and semi-automatic biochemical analyzers in primary hospitals, it is expected that the biochemical reagent market in China will show a rapid growth rate exceeding the average growth rate of the industry in the next few years. According to Han Ding analysis, the market size of biochemical reagents in China reached 2.5 billion yuan in 2009. By 2013, the market size of biochemical reagents in China will reach 5.9 billion yuan.
Data source: Han Ding Consulting 2. Immunodiagnostic reagents Immunodiagnostic reagents are the most widely used in diagnostic kits. According to the diagnostic categories, they can be divided into infectious diseases, endocrine, tumor, drug testing, blood type identification and so on. From the methodological judgment, it can be divided into different types of reagents such as enzyme immunoassay (EIA), colloidal gold, chemiluminescence, and radioimmunoassay. Among them, isotope radioimmunoassay reagents have been contaminated by the environment and are currently in the international market. It has been phased out and there is still a small amount of use in the country
The immune market instruments include automatic chemical luminaires, semi-automatic chemiluminescence analyzers, enzyme-labeled analyzers, and time-resolved fluorescence analyzers. Fully automatic chemical luminescence instruments and reagents are completely imported, concentrated in the domestic tertiary hospital market, mainly based on the products of international famous companies such as Abbott, Roche, and Siemens. They are mainly used to measure thyroid, sex hormones, tumors, infections, and myocardial markers. Wait. Domestically produced immunological instruments are mainly enzyme-labeled analyzers, time-resolved fluorescence analyzers, and semi-automatic chemiluminescence analyzers. Once the introduction of domestic fully automatic chemiluminescence products and the reduction of cost, fully automatic chemiluminescence products will gradually replace enzyme-linked immunosorbent, time-resolved fluorescence and semi-automatic chemiluminescence products.
Colloidal gold is one of the fastest and most convenient immunological detection technologies. It is especially suitable for immediate testing in hospitals including emergency laboratories, intensive care units and outpatient clinics. The hospitals include home, community medical, physician clinics and accident sites. Large-scale time-critical testing and large-scale census, etc., have great development potential.
Source: Han Ding Consulting
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