Thoughts on the Development Trend of IVD in 2023

With the end of September, the semi-annual reports of IVD enterprises have been basically announced.

One word: Miserable.. Without the blessing and cover of the new crown testing business, enterprises no longer have an excuse to hide and trick words, only the active layout of the regular business and the persistence of research and development investment.

The decline in performance after the epidemic is not without expectations, but when this expectation comes, instinctive, emotional loss, superimposed on the decline in objective performance, in this industry capital winter, policy adjustment adaptation period catalysis, increased the pessimism of the IVD industry.

This is significantly out of line with the IVD industry's expected annual growth rate of 17%.. At the same time, during this period, we have also seen several high-quality enterprises carrying the banner. At this time of countercurrent, they are always leading and representing the way forward. At least people still remember that IVD is still a sunrise industry, just a periodic rest, and it is preparing for a bright future.

First from the industry's first and second-in-command. A- share medical device leader, which has a market capitalization of more than 300 billion, has continued to grow with an iconic 20% figure. In the first half of the year, operating income was 18.476 billion billion yuan, an increase of 20.32 percent over the same period last year, and net profit was 6.442 billion billion yuan, an increase of 21.83 percent over the same period last year. The double growth of revenue and profit not only comforted the medical device market, but also gave the confidence of the IVD sector. If Meirui is because of life information and support, in vitro diagnosis and medical imaging and other three major sectors, with the advantages of comprehensive synergy, and pure IVD enterprises are different, and the status is different (Meirui is the absolute first brother of medical devices), can not fully represent the IVD industry.

Then there is no reason to look down on the achievements of new industries, Jiuqiang Biology, Pumen Technology, Wanfu and other enterprises.

In the first half of the year, the revenue of the new industry was 1.865 billion yuan (+ 32%), the net profit of the parent company was 0.75 billion yuan (+ 32%), and the net profit of the non-parent company was 0.687 billion yuan (+ 31%);Q2 performed even worse, with revenue of 0.989 billion yuan (+ 47%), net profit of 0.395 billion yuan (+ 51%) and net profit of 0.368 billion yuan (+ 55%). Deep-cultivated chemical luminescence field, finally to the effective moment, heavyweight products MAGLUMI X8 rapid installation, with the proportion of large-scale installed and the number of large-scale end-medical customers continue to increase, the second half of the year to promote performance again brilliant, the logic of confidence is clear. Stepping on the trend of Antu, Mike, Yahuilong in the chemical luminous track, have achieved positive growth, after the outbreak to inject a strong heart needle.

In addition to the trend track's own halo bonus, the nine strong blood coagulation high gross margin in the revenue net profit comparison performance eye-catching. In the first half of the year, its revenue was 0.816 billion yuan, up 14.65 percent from the same period last year, its net profit attributable to its parent was 0.242 billion yuan, up 48.34 percent from the same period last year, and its non-net profit was 0.239 billion yuan, up 53.42 percent from the same period last year. In the countercurrent, the top nine organisms effectively used the diagnosis and treatment recovery cycle, and the proportion of reagent business income was as high as 0.771 billion yuan. Biochemistry, pathology, hemagglutination and other businesses remained resilient in an all-round way. Who said that biochemistry was not promising? The top nine proved with their results that as long as they were hard enough, any card could play the king's spirit.

Pumen Technology, with 0.56 billion revenue in the first half of the year, up 25% year-on-year; Net profit attributable to the parent was 0.135 billion, up 35% year-on-year. Non-net profit was 0.126 billion yuan, up 35% year-on-year. Relying on IVD and treatment and rehabilitation to walk on two legs may be an excuse for some IVD enterprises not to reflect on themselves, but their IVD 0.385 billion income and the complete system of diagnosis, treatment and rehabilitation, there are hundreds of reasons for being lazy in breaking through and innovating. Everyone can imitate the reference. There is only one reason for moving forward, and that is to win.

Immunodiagnosis accounts for nearly 40%, of which 90% is chemiluminescence. Molecular diagnosis and POCT have become the two fastest growing tracks. This is basically the industry consensus. Wanfu, Aotai biological better practice this understanding, its application in POCT force, respiratory tract testing, digestive tract infectious disease testing, blood infectious disease testing, drug testing, eugenics on the increasingly rich, after the epidemic at this stage can not fill the performance vacuum left by the new crown testing, but the same is a static flow, unlimited.

These small or winning companies have more or less emphasized the advantages and plans of entering chemiluminescence in their reports. These all fully illustrate the competitive heights in the next five years. Whoever has a place will be able to maintain operations.

The reason is very simple. Immunodiagnosis accounts for the largest proportion of the domestic market, and the domestic rate is only about 25-30%, while immunodiagnosis will continue to grow by 20% in the next few years. Over the past years of development, the production line, high-end chemiluminescence instruments are gradually replacing imports, has sufficient strength to compete with the performance gap, and is in some areas to achieve beyond. In addition, a new round of scientific and technological innovation such as 5G, AI and big data is giving birth to the change of intelligent automation assembly lines in the whole laboratory,These will become the new advantages of domestic enterprises.

Years of endogenous growth, such as independent innovation, domestic and foreign mergers and acquisitions, and model innovation, have not only created an upgrade window for the assembly line, but alsoHigh-end biochemical instruments, chemiluminescence instrumentsBreakthroughs, these form the basis of domestic substitution, and help the next domestic wind. And the next step of innovative technology has also come into people's field of vision, these conquered, perhaps not as simple as domestic words, but in the international level to compete with Royabessi. These are cutting-edge technologies such as flow-type liquid chip, microfluidic technology, light-activated chemiluminescence technology, single-molecule immunoassay, digital PCR, and third-generation sequencing technology. These domestic enterprises also have a layout, but the current is still relatively scattered.

After chemiluminescence, it must be the turn of molecular diagnosis and POCT diagnosis, and the two are expected to be integrated to effectively solve the shortcomings of the two.

At present, POCT is still based on regular testing, blood sugar testing, cardiovascular testing and other basic products have entered the mature stage, has fallen into the Red Sea, domestic and foreign have the existence of homogenization competition, continue to technological breakthroughs or a broad new application scenario. In these scenarios, new products such as customized demand and new detection of new diseases have become an important breakthrough.

In terms of the possibility of technological breakthroughs, one of the pain points that currently plagues POCT is the problem of stability and accuracy, because POCT products mainly integrate the application of biochemical diagnosis and immunodiagnosis, and more accurate molecular diagnosis has not yet been closer. With the expansion of the market capacity and strong demand, the integration of POCT and molecular diagnosis has become inevitable, and molecular diagnosis itself has the requirement of rapid detection.

Under the trend, new technology platforms have been bred, miniaturized biological diagnostic equipment and microfluidic-based automated immunochip systems have emerged, and the future development will be based on functional nanomaterial-encoded microspheres of liquid biochip technology. Liquid chip can better meet the POCT real-time detection, and multi-detection, high throughput, high sensitivity and other high-performance requirements.

With the development of in vitro diagnostics, into more and more scenarios,It will also promote its development in the direction of miniaturization, fast and convenient, automation and system specialization., respectively, to meet regional central hospitals, primary medical institutions, Junior College rooms, outdoor outside the hospital, etc. And these all depend on the enterprise according to its own characteristics, selective layout, taking into account the current and long-term development strategy.

The domestic in vitro diagnostic industry started in the late 1970 s. Although it developed relatively late, it has also experienced a rapid growth stage of germination, domestic start, disorderly development, industry consolidation, and just ended. Now more and more clearly intoInnovation and integration periodA number of domestic enterprises with strong strength or good prospects, such as Merit, New Industry, Antu, Nine Strong, Pumen, Mike, Yahuilong, Huada Department, etc., have emerged.

The emergence of policies such as collection, medical insurance control fees, medical anti-corruption, LDT and so on, in the middle of three years of new crown detection catalysis, the concentration of the industry accelerated, the initial formation of the Yangtze River Delta, Pearl River Delta, Beijing, Shanghai and other key regions of the development pattern. Therefore, from this perspective, the IVD industry is rolling forward, and the emotional twilight at this stage is precisely the unwillingness to accept the new development model, and the new market demand thinking is at work.

The new stage has already come, but some IVD is not ready yet. What about you?