In vitro diagnostic industry observation

I. Biochemical industry, what is the future

The biochemical industry has been ahead in the process of replacing imported brands, and the replacement rate of domestic biochemical reagents is around 70%. The initial stage is the manual preparation of reagents, spectrophotometer to do help. In 1983, the first semi-automatic biochemical analyzer made in China was put on the market, which made the operators of the laboratory work less tedious. In 1988, the first domestic automatic biochemical analyzer was born, which opened the process of automation development in the field of biochemical analysis in China. Looking back, the automation of biochemical analyzers has been developed for 30 years, and the speed of individual biochemical analysis can now exceed 2000 tests per hour. In the field of biochemical analytical instruments, mindray, Dedray, Kehua and other outstanding listed enterprises have appeared. In the field of biochemical analysis reagents, there have been a large number of excellent reagents open enterprises, such as Jiuqiang, Meikang, Lidman, Ruiyuan, Mike, Bailheng and Zhongyuan. In the field of bio-immune integrated machine, assembly line Mindray, Antu, new industry and other established enterprises are also constantly exploring!

However, at present, there are more than 200 domestic biochemical manufacturers and more than 100 biochemical testing items. The industry has entered the red Sea mode. As the proportion of the biochemical market in IVD market has decreased from the first place to the second place, and has been surpassed by the immune market, after decades of extensive development, it may be necessary to take a deep heart to think about how the biochemical industry should go in the future! At present, the competition in the industry is also fierce, including price war, policy war, intensive purchasing and development mode, as well as the road of enriching product lines. However, in the field of biochemistry, reagent packaging and instrument OEM do not have a good prospect in the future. The enterprise should stick to the route of developing high-quality products, reduce the cost of upstream raw materials, and steadily promote the business in other areas that are easy to enter. Perhaps the enterprise can maintain stable development. Blindly fight price war and policy war, not conducive to the development of the industry!

I communicated with a biochemical manufacturer once and saw the opportunity and crisis of the biochemical manufacturer now. The opportunity is that with the continuous development of regional testing centers, medical consortium and other models, the 80-20 principle will become the industry label more and more obviously. Big brands will be bigger and bigger, small and medium-sized brands will be more and more difficult to survive, this is the survival of the fittest, the law of nature. The crisis is that the technological change in the biochemical industry is not as fast as that in the immune field, and the market share of immune turbiditic biochemical projects will eventually be continuously nibbled by manufacturers of luminescence, specific proteins and POCT. So this is probably something that the industry needs to talk about, what is the future?

Chemiluminescence is the darling of The Times

Speaking of chemiluminescence, we have to talk about the development of immunoassay technology.

In the 1960s, radioimmunoassay was used, with advantages of low cost and high sensitivity, but obvious disadvantages, such as radioactive contamination, short period of validity and complicated operation.

In the 1970s, the colloidal gold technology appeared. Although the operation was simple and fast, the problem of low sensitivity could not be solved, which was also decided by the technology itself

In the 1980s, enzyme-linked immunity and time-resolution methods appeared, such as those represented by Shanghai Kehua. The enzyme-linked immunoassay (ELISA) developed by a domestic company has a low cost and stable nature, which is why the method has been used so far, and its sensitivity and accuracy problems have made it unable to assume the great responsibility. Although the time resolution method has solved the sensitivity problem to some extent, more shortcomings have been exposed, such as complex operation, high cost and long reaction time. However, before chemiluminescence came into being, for example, domestic enterprises, represented by Shanghai New Wave, which mainly focus on the time resolution methodology, gradually developed. Now Shanghai New wave has long been completed by PE strategic acquisition.

Chemiluminescence in the 90 s began to come out, although in the domestic promotion has experienced a long process, with the advent of the 21st century, under the influence of foreign technology, chemiluminescence began to development, especially after 2010, chemiluminescence gradually large, time-resolved methodology replacement process, now in the immune test market, there is no doubt chemiluminescence is unique, the market leading immune detection, become a mainstream immune diagnosis technology.

In the field of chemiluminescence, as in the Spring and Autumn Period, a hundred schools of thought contend. There have been excellent listed companies such as Mindray, New Industries and Antu, which have concentrated most of the domestic chemiluminescence market. With the advance of the biochemical immune assembly line market, as long as the technical breakthrough has reached a certain degree of accumulation, import substitution will also speed up, complete the historical mission!

Third, in the field of blood cells, "who" and contention

Blood cell analyzer, blood cell analysis of the "special funnel". Blood routine as the first of the three routine, almost the majority of patients must check items. As the most popular project, also has a history of hundreds of years. The first routine blood tests in China were basically completed manually. As shown in the figure below:

Now, after decades of development, there are two major blood cell giants, Hisen Mercon and Mindray. Blood cell analysis has been upgraded from manual method to today's blood cell assembly line. As shown in the figure below:

However, there is another potential competitor in the domestic blood cell field: Demai Organisms.

Maybe there will be a big three in the future. Blood cell market competition, not only to fight for the technology, after-sales service, marketing channels, business operations may become an opportunity, may also be a crisis!

Iv. Domestic hemagglutination is expected to rise

When it comes to in vitro diagnosis of the five major components: biochemistry, immunity, blood cells, blood coagulation, molecules, the phrase may be said, just after dinner and tea banter:

Biochemical past "Big brother",

Immune now "Sun Wukong",

The blood cell grew into a "younger brother of the Sand teacher",

The molecules make a big IVD,

The blood clots come and go.

About hemagglutination, the international big three: Hisen Mekon, Wofen, Staco. The hemagglutination market is a segment of IVD that has been developing very fast in recent years, with a compound growth rate of 30% in recent years. In the past five years, the proportion of the hemagglutination market in the rapidly developing IVD sector has gradually increased from about 5% to about 10%. Domestic enterprises such as Mindray, Secco Sid, Shanghai Sun, Redu and other excellent enterprises are also trying to catch up. However, for now: foreign companies in this field have absolute advantage, is expected to occupy more than 90% of the market share.

More do not say, yangguan ancient road is long, domestic blood coagulation will eventually rise!

5. Molecular diagnosis, the prospect is infinite

Speaking of molecular diagnosis, in recent years often appear in our field of vision, it is necessary to popularize it first.

Molecular diagnosis, in the narrow sense, refers to nucleic acid-based diagnosis, that is, the detection of pathogenic mutations in various DNA and/or RNA samples in order to achieve the detection and diagnosis of diseases. Relevant representative enterprises such as: Shengxiang Biology, Daan gene, Shanghai Kehua, etc.

In the broad sense, it includes gene therapy and biological therapy as well as molecular targeted therapy for some signal transduction molecules. Over the past few decades, it has shown unique efficacy in the treatment of certain inherited immunodeficiency diseases, especially neoplastic diseases. Representative enterprises such as: BGI, Boao Biology, Annoroad, etc.

And for molecular diagnosis, you have to have a text and a picture like this:

On April 25, 1953, Watson and Crick published their doomed paper, Molecular Structure of Nucleic Acid: A Structure for Deoxyribose Nucleic Acid.

It has long been known that there are two types of nucleic acid, DNA and RNA, but at the time proteins were more likely to be genetic material. But when the double helix of DNA was discovered, the debate over genetic material was over for good, and the age of molecular biology officially began.

At home, the field of molecular diagnosis. Conventional PCR was halted and resumed in the 1990s. Non-invasive screening has also experienced a moratorium and pilot, which is also the way to explore the development.

With the progress of basic industry and the globalization of downstream industry in China, the automation of clinical molecular diagnosis will be gradually applied in clinical laboratories in China. Automation will be achieved first on the nucleic acid extraction, which is currently manually operated and has the greatest impact on the results, and then on the analysis and judgment of the results, in which software will play the most critical role. Of course, the ultimate goal is to realize the automation of the whole process from nucleic acid extraction to amplification detection and result reporting. Some foreign manufacturers such as Roche and Kaijie have already achieved this, but it still takes quite a long time for domestic enterprises.

It is believed that excellent domestic enterprises in the field of molecular diagnosis will continue to expand the breadth and depth of the market, but it still needs time to accumulate and carry out technical precipitation.