Biochemical diagnosis is the earliest and most mature segment of in vitro diagnostics. Also known as clinical chemistry, it is often used in basic examination items such as blood glucose, blood lipids, cholesterol, liver function, kidney function, etc., that is, to determine whether the human body is in a healthy state by measuring the content of specific biochemical substances, and to determine what causes it. Today we systematically share all aspects of biochemical testing from a professional point of view.
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The development process of biochemical diagnostics industry
Biochemical analyzer: Since the advent of the first fully automatic biochemical instrument in 1970, the biochemical instrument industry has undergone more than 40 years of development. The first fully automatic biochemical instrument in China was the BS-300 released by Mindray in 2003. At present, Mindray Biochemical Instrument basically covers from 50 speed to 2000 speed, and even to the level of modular combination, basically meeting the needs of domestic hospitals at all levels.
Biochemical testing reagents: from more than 30 years ago hand-formulated, single project situation has developed to no less than 100 registration certificates of major enterprises now. In the future, there will be new markers that will continue to appear, such as the top nine, Meikang, Mike and other companies are still innovating.
How biochemical analyzers work
The automatic biochemical analyzer belongs to the optical analysis instrument, which is essentially equivalent to a spectrophotometer, based on the selective absorption of light by matter, that is, spectrophotometry, the basic measurement principle is still based on Bill's law. Monochromator will be the light source emitted by the complex color light into monochromatic light, a specific wavelength of monochromatic light through the colorimeter containing the sample solution, photoelectric converter will be cast light into an electrical signal and sent to the signal processing system for analysis, the computer and then according to the user's choice of the way of work to process, calculate, analyze, save the measurement data, the printer at the same time print out the corresponding results. Finally, after each set of samples is retested, the cuvette and tubing are clear.
From the structure of the automatic biochemical analyzer, it includes the main components of the spectrophotometer: light source, monochromator, colorimeter, detector, etc.; in addition, it also includes the unique parts required for biochemical analysis, such as the dosing system, reagent system, reaction system, temperature control system, cleaning system, bar code reading system, software system, etc., assembled together through these structures and systems. Through the above explanation, I believe that you should be more clear about how the biochemical analyzer works and then get the results on the report sheet.
Biochemistry Analyzer Market Segmentation
Regarding the classification of biochemical analyzers, there are four main classification methods:
According to the degree of automation of the biochemical analyzer can be divided into: semi-automatic biochemical analyzer and automatic biochemical analyzer, at present, basically all use automatic biochemical analyzer, many of the second and third level hospitals are on the cascade or assembly line.
According to the supporting conditions of reagents and instruments, it can be divided into: closed systems and open systems. With the increasingly fierce competition in the biochemical market, many manufacturers have begun to take the closed route, which is conducive to their own market is not easy to be replaced by open reagents, many mainstream biochemical analysis instrument manufacturers, the main push closed instruments, colleagues open part of the channel.
According to the biochemical analyzer reaction method can be divided into: liquid biochemical analyzer and dry biochemical analyzer, most of the current market is liquid biochemical analyzer, dry biochemical analyzer is relatively few, such as Johnson & Johnson vitro series dry biochemical analyzer, is also very famous, many second- and third-level hospital emergency departments use Johnson & Johnson's dry biochemical. Of course, it's time for Ocendo Medical, a diagnostic company that was spun off from Johnson & Johnson Medical 4 years ago, and dry biochemicals was also split.
According to international velocimetry conventions, it can be divided into: small instruments and medium-sized instruments and large instruments, generally small biochemical analysis instruments belong to 400 speed measurement below, medium-sized biochemical analyzers basically belong to 400 speed to 1200 speed, large biochemical instruments basically belong to more than 1200 speed measurement, such as 1600 speed measurement, 2000 speed measurement. At present, the market is the fastest single module speed is 2000 speed measurement.
If it is sales, we know more about whether the biochemical instrument is open or closed, how much speed measurement, this is the two basic points related to our business, many manufacturers want to open the version and the closed version, the closed version is fully closed, some are open several open channels, mainly afraid of the need for the department on the project and the manufacturer itself does not.
Classification of clinical applications of biochemical testing programs
First of all, to talk about the problem of methodology, the methodology of biochemical reagents is also quite a lot, and the methodology used in different projects of biochemical reagents is mainly determined according to the composition of the reagent and the substances involved in the reaction. Common ones such as fcc rate method, vanadate method, immunoturbidimetry, direct method, ultraviolet endpoint method and so on. These methodologies are determined based on whether they are physical or chemical reactions or biological reactions to antigens and antibodies. The methodology of the biochemical analyzer is basically determined, and the mainstream is mainly the endpoint method, the rate method, and the factor method.
Among the many biochemical reagent analysis methodologies, there are also many immunoturbidimetry items, and immunoturbidimetry items are also easily replaced by potts, chemiluminescent instruments, and specific protein instruments. Such as biochemical projects: homocysteine, myoglobin, troponin, cardioid fatty acid binding protein, immunoglobulins, c-reactive proteins, rheumatoid factors, complement, pepsinogens, etc., these projects in the biochemical project in the biochemical reagents used in the methodology is immunoturbidimetry, and immunoturbidimetry such projects, in the pott, specific protein apparatus, especially in the field of chemiluminescence advantages are also obvious, Many laboratories want to undertake such projects on chemiluminescent instruments mainly based on considerations of accurate results and performance indicators.
Regarding the classification of clinical applications of biochemical reagents, the specific classification is as follows:
l Liver function series:
Alanine aminotransferase abbreviation alt, aspartate aminotransferase abbreviation ast, γ-glutamyl transpeptidase abbreviation r-gt, alkaline phosphatase abbreviation arp, total bilirubin abbreviation t-bil, direct bilirubin abbreviation d-bil, total bile acid abbreviation tba, total protein abbreviation tp, albumin abbreviation alb, prealbumin abbreviation pa, adenosine deamin abbreviation ada, fucoidase abbreviation afu and so on.
l Renal function series:
Uric acid abbreviated ua, urea abbreviated urea, cr abbreviated cr, β2 microglobulin, cystatin abbreviated ccyst-c, urine protein abbreviated up, retinol-binding protein abbreviated rbp and so on.
l Glucose metabolism series:
Blood glucose is referred to as glu, glycosylated hemoglobin is referred to as hba1c, fructosamine is referred to as fmn and so on.
l Blood lipid series:
Total cholesterol is referred to as tc, triglycerides are abbreviated as tg, HDL-c is abbreviated, LDL-C is abbreviated, apolipoprotein is abbreviated as a1, apolipoprotein is abbreviated as b, lipoprotein is abbreviated as alp(a), etc.
l Myocardial:
Creatine kinase is referred to as ck, creatine kinase isoenzyme is referred to as ck-mb, lactate dehydrogenase is referred to as ldh, α-hydroxybutyrate dehydrogenase, myotropin is referred to as myo, troponin is referred to as ictni, etc.
l Immune diseases:
Complement 3, complement 4, immunoglobulin a, immunoglobulin g, immunoglobulin m
l Inflammatory response class:
C-reactive protein abbreviated as crp, anti-streptolysin o abbreviated as ASO, rheumatoid factor abbreviated rf and so on.
l Pancreas:
α- amylase abbreviated as amy, pancreatic amylase abbreviated as pamy, lipase abbreviated as lps, etc.
l Electrolytes:
Calcium, magnesium, iron, chlorine, phosphorus, carbon dioxide, etc.
l Other categories:
Glucose 6 phosphate dehydrogenase is referred to as g6pd et al.
Competition of domestic biochemical diagnostic enterprises
In 2015, the largest revenue of the domestic biochemical industry was Beckman, followed by Roche (912 million, luminescent business of 5.8 billion), the third is Mindray (600 million yuan), followed by Meikang, the top nine, Andemann.
In terms of biochemical instruments:
Only in terms of revenue scale, the first echelon is Hitachi, Beckman, abbott. These three companies are now relatively large in market share, and have a certain amount of technology accumulation, and they all occupy the superior resources of the top three hospitals.
The second echelon, Siemens, Toshiba, Johnson & Johnson (Odyssey), Mindray, Di Rui, Kehua.
The third echelon, Redu, Ulit, Tekang, Xenomet and so on. In recent years, Ulit has entered the market through low prices, especially the basic market, and formed a strong offensive against the domestic manufacturers of the second echelon. Tekang and Raidu entered the list of primary medical care that was the first to be promoted by scientific and technological progress in 2014 and 2015. Synomede has also launched its own 2000 speed measurement instrument.
Biochemical reagents:
Only from the perspective of revenue scale, the first echelon, Beckman, Roche, Meikang, Lidman, and the top nine. The performance of the first echelon has reached a level of more than 450 million yuan.
The second echelon, Siemens, Abbott, Mindray, Mike, Kehua, Zhongsheng North Control. Mindray is mainly in primary hospitals and second-class hospitals. Zhongsheng North Control has also reached the level of 290 million yuan.
Biochemical diagnostic industry development trend
Due to the popularity of foreign medical insurance and the different medical insurance systems and the population covered, the development of the biochemical industry varies greatly. The most extreme are the United States and India. The medical insurance system in the United States is sound, and the biochemical market capacity is huge, which is the earliest market to develop. In contrast, the Indian market is more like China's inspection market situation in 1998-2000. If India can maintain rapid development, the potential of the biochemical market is still very huge.
The Chinese market is between the US and Indian markets. In the next 5 years, the biochemical diagnostics market can continue to exceed GDP growth. The main reason is that at present, it is impossible to see that basic tests such as liver function and kidney function can be replaced, and the biochemical test results still have an irreplaceable market position in the clinic. Although biochemical diagnosis is currently the Red Sea market, new manufacturers have almost no market space, but the industry's leading enterprises still have a lot of room for improvement. The source of growth is mainly the natural growth of the industry and the rapid growth of grass-roots hospitals, among which strong enterprises such as Mike, Meikang, and the top nine still have the possibility of upward or downward penetration and squeezing foreign-funded enterprises or small enterprises. As for whether the biochemical industry has developed to the peak, I personally believe that the biochemical market is still promising. At the same time, with the maturity of antigen antibody biochemical technology, gradually some chemiluminescent projects have been transferred to the biochemical detection platform to complete, thereby reducing the cost of testing, which does solve the needs of the state in terms of medical insurance cost control.
In summary, the increase in registration fees in the biochemical industry from the national level has brought greater cost pressure to the company, and small manufacturers may die. The uneven quality of biochemical instruments and biochemical reagents will gradually rise to the level of national policies, and the access conditions of the market will gradually align with the FDA. The closed tendency of instruments and reagents is inevitable.