At present, China's blood glucose meter market is about 2.5 billion to 4 billion yuan. The market share pattern is: the two foreign giants Johnson & Johnson and Roche have the obvious advantage of the first two market shares, with a total share of more than 60%. And only in China, there are more than 30 different brands, of which Sanno and Yicheng are the big names among domestic manufacturers. Yuyue Medical also wants to start with high cost performance and channel advantages. At present, the profit model of the industry is: the blood glucose meter is almost cost-priced, and the test paper makes money. Taking Sannuo as an example, the company's 2013 annual report showed that the main business income during the reporting period was 448 million yuan, of which the blood glucose tester revenue was 97.121 million yuan, and the blood glucose test strip income was 350 million yuan. The average sales gross margin is about 65%, which is mainly from test paper. From the above data, we can analyze the following characteristics of the blood glucose meter market:
1. Clear, known customer groups
2. High performance, low price customer demand
3. Fully competitive market structure, test strip is the core!
4. Foreign capital also has brand advantages, but the domestic substitution has risen, and the market share of domestic big brands has increased rapidly.
According to the above information analysis of the blood glucose meter industry, what problems have you found? Yes, if the non-invasive blood glucose meter really comes, it will destroy a large existing market of blood glucose meters, because they are all invasive tests, relying on test papers to make money, and non-invasive inspections do not need test papers. Alternatives! But why are these manufacturers not fidgeting like ants on a hot pot, but have little reaction? Here Dr.2 will have to introduce some of the more academic content, briefly summarize it to everyone, trying to explain the hardships of this road.
As early as half a century ago, scientists began to study this issue continuously. The traditional methods of non-destructive testing of blood glucose mainly include:
1. Non-destructive testing method combined with micro-infiltration technology
2. Biosensor (electrochemical sensor and optical sensor) method
3. Spectral spectroscopy: such as Fourier transform near-infrared (FT-NIR) spectroscopy and Fourier transform mid-infrared (FT-IR) spectroscopy.
1. Method for determining blood substitutes and micro-infiltration techniques
A common method is to measure the glucose concentration in blood substitutes (saliva, sweat, urine), but some studies have shown that there is no significant correlation between the measured glucose concentration and blood glucose concentration. Another method is to remove the epidermal barrier by mildly corrosive skin, add negative pressure to extract the sugar concentration of the interstitial fluid, and then inversely estimate the blood glucose concentration by algorithm. However, this is still a slightly lossy detection method. Using micro-infiltration technology combined with in vitro measurement, the correlation between glucose concentration and blood glucose concentration is indeed better, but the operation technology is high in the detection process, and the measurement is complicated. Suitable for general clinical use.
2, biosensor
In the 1960s, enzyme electrodes were first proposed for use as electrochemical sensors, and this was the earliest report of non-destructive testing of blood glucose. Later, optical sensors appeared. After decades of research, biosensors have become a relative. Mature and well-studied areas, and in line with the urgent needs of the clinic.
2.1 Electrochemical sensor
Electrochemical sensors fall into two categories: in vitro sensors (sensors on the skin surface) and implantable subcutaneous sensors that work by measuring physical quantities that vary in proportion to the concentration of the analyte. However, electrochemical sensors can only be used within a limited range and have not yet been used clinically.
2.2 Optical sensor
Divided into light-light sensors, light-thermal sensors and optical-acoustic sensors. The main components of the light-to-light sensor are probes, including a light source fiber (output semiconductor laser) and a light monitoring fiber (introducing an optical signal into a photodiode). Its working principle is divided into three types: light absorption, light reflection and light scattering. However, sensor measurements are generally less than venous blood glucose values, and high energy radiation from the source may cause damage to cells at the molecular level. Therefore, the method of optical sensor is not used in clinical practice.
3. The method of generography
This is a well-established method for the quantitative determination of solutes in liquids. Some predictions can be given by orally administering a certain amount of 13C labeled glucose and measuring its acoustic resonance or magnetic resonance spectrum under an applied magnetic field. However, the equipment is complicated and the computer capacity is huge. In recent years, some research groups have used the Fourier transform Raman spectroscopy to perform non-destructive blood glucose testing.
3.1 Fourier transform near-infrared (FT-NIR) spectroscopy
The most internationally studied is the Fourier transform near-infrared spectroscopy (FT-NIR) therapy. Heise of Germany and Arnold of the United States have done a lot of work and conducted in-depth research. The measurement methods are divided into transmission spectrum and reverse chromatography. Since the thickness of the transmission spectrum measurement sample is very thin, the method of reflection spectrum has great advantages for non-destructive blood glucose detection. For the first time, Heise et al. of Germany measured the concentrations of glucose, protein, cholesterol, urea, uric acid and triglycerides in human plasma and blood using the ATR (Attenuated Total Reflection) technique.
3.2 Fourier transform mid-infrared (FT-IR) spectroscopy
Since the near-infrared calculation is susceptible to changes in other components in the solution, Herise has studied and concluded that the best choice for blood glucose detection is the mid-infrared spectrum. Fourier transform mid-infrared (FT-IR) spectroscopy has strong absorption of fundamental frequency and combined frequency of molecular vibration in the mid-infrared region (400-100000px-1), high spectral information content, good molecular selectivity, and glucose in the mid-infrared region. Characteristic absorption peaks can be applied to in vitro detection, but because the machine is too large, the cost of use is too high, and it cannot be promoted clinically.
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