IVD, the six major forces of the future

The biggest opportunity in the in vitro diagnostics industry comes from the three years of COVID-19, as the market segments accelerate to go overseas and internal circulation accelerates.

01 Biochemical Diagnostics market

From the point of view of the manufacturers that declare the amount of liver work, the manufacturers that enter into the field of biochemical diagnosis are more, not less. The biggest imagination is that in addition to the biochemical diagnosis market still occupies the second place in the market share, the most important reason is that the position of biochemical immune pipeline and cascade will become more and more important in the in vitro diagnosis industry and the needs of channels are more diverse.

Although chemiluminescence is outstanding, but without the biochemical partner, always feel less what, from the layout of many head enterprises can be seen, in the biochemical instruments, reagents, calibration, quality control direction layout, has been accelerating.

The main premise is that the whole macroscopic direction is sinking. The regional medical center and Qianxian project are under comprehensive construction in advance, which means that the biochemical and immune production line and cascade market volume will expand, and automation and intelligence have been more and more popular in the laboratory terminal.

It can be seen that biochemical diagnosis is still indispensable in the age of assembly line.

The application scenarios of the three classic immune technologies, colloidal gold, immunofluorescence and chemiluminescence, have certain differences. As can be seen from the COVID-19 outbreak, colloidal gold technology has unique natural advantages in the rapid screening of infectious diseases. POCT based on immunofluorescence technology has a wide enough customer base in basic medical treatment, private market and clinical laboratories. The chemiluminescence market barrier in medium and large laboratories is very obvious.

Especially the middle and high speed chemiluminescence, has been the top priority of foreign companies and head luminous enterprises in the field of in vitro diagnosis, from the changes in the past few years, foreign companies in the defense of high-end market at the same time, continue to promote the localization strategy for market sinking, and domestic enterprises in vigorously promote the county market into hospitals at the same time, to promote the strength of the third class hospitals can not be ignored.

Visible, chemiluminescence circuit has begun to enter a new stage of domestic attack, foreign defense.

03 Molecular Diagnostics market

Molecular diagnosis is the application of molecular biology methods to detect the genetic material of the tested individual or the genetic structure and type of the virus and pathogen carried, so as to detect and diagnose the disease from the genetic level.

There are four platforms for molecular diagnostics: PCR (amplification), FISH (fluorescence in situ hybridization), gene microarray, and gene sequencing. PCR is mainly used to amplify DNA at very low concentrations :FISH is mainly used to detect specific gene fragments based on probes and fluorescein; gene chips can detect multiple gene targets at one time; gene sequencing is used to detect gene sequences in longer dimensions.

If we want to trace the origin of the application of molecular diagnostic technology, it must be the discovery of DNA double helix structure and the invention of PCR technology. As the field with the most intensive technology innovation in the field of in vitro diagnosis, and also the field with the influx of capital in the past three years, conventional pathogen nucleic acid detection is still the largest segment in the field of molecular diagnosis in terms of market size.

From the perspective of technological innovation and future prospects, the industry has shifted its attention to emerging fields such as tumor early screening mNGS, digital PCR, targeted diagnosis, POCT, pharmacogenomics, etc.

04 Coagulation diagnostics market

Thrombus and hemorrhage is a clinical manifestation caused by the disruption of human coagulation balance, and its causes are related to many diseases, such as cardiovascular and cerebrovascular diseases, malignant tumors, obstetrics, postoperative complications, etc. Thrombus or hemorrhagic diseases are involved in various clinical departments, and the diagnosis, treatment, monitoring and prognosis evaluation of such diseases can not be separated from the coagulation test index. Especially with the development of society and the change of the spectrum of diseases, the aging of the population, the number of people suffering from cardiovascular and cerebrovascular diseases and chronic diseases is increasing year by year, and people's demand for thrombus and hemostatic diagnosis is also growing, which gives rise to more and more new technologies and projects of coagulation detection. At present, the diagnosis of thrombus and hemostasis is in the rapid development stage, so it is paid more and more attention by the capital market.

It can be seen that the clinical application prospect of this subdivision track is very broad. In the past three years, the layout of domestic IVD enterprises in the clotting track is very fast. The reason is that there is a lot of room for domestic alternatives at the track. Another reason is that the application of blood clotting has been amplified after the COVID-19 pandemic.

In addition to routine items, PT, APTT, TT, FIB, DD, FDP, coagulation factor, elastomogram, thrombus new four items also have very promising clinical application prospects.

05 Stream diagnostics market

Flow Cytometry (FCM) is a high-tech technology developed in 1970s, which integrates computer technology, laser technology, fluid mechanics, cytochemistry and cell immunology, and has the function of cell analysis and cell sorting.

Flow cytometry can not only measure cell size, internal particle properties, but also detect cell surface and cytoplasmic antigen, intracellular DNA, RNA content and so on. It can be widely used in the fields of hematology, immunology, oncology, pharmacology, molecular biology and so on.

Different from the closed system of immunoassay instrument, the openness of flow cytometer is relatively high. Some instruments and reagents do not need to be used together, and one instrument can use reagents from different manufacturers.

In recent years, the flow diagnosis technology has become more and more popular in the sinking market. Thanks to the rise of more and more domestic flow platforms, the cost barrier is constantly broken.

According to the latest report, the flow cytoma market is expected to grow at a CAGR of 8.1% from $4.3 billion in 2021 to $6.3 billion in 2026.

06 Clinical Mass spectrometry market

From a global perspective, mass spectrometry has not been applied to clinical field for a long time. It has been less than 40 years since 1988. Compared with biochemical, immune and molecular diagnosis, mass spectrometry has a relatively short development history.

Clinically, mass spectrometry is more sensitive and accurate than biochemical and immune methods, and has the potential to replace many current biochemical and immune tests. Some diseases that cannot be detected by traditional methods can be solved by mass spectrometry.

The global clinical mass spectrometry testing revenue mainly comes from the sales of testing instruments and equipment and the provision of testing reagents (services). At present, the clinical mass spectrometry testing market mainly comes from the sales of mass spectrometers and equipment.

According to the authoritative research institution BCC research forecast, by 2025, the global clinical mass spectrum market output of 4855, the application market will break 10 billion dollars!

Clinical mass spectrometry has been applied in neonatal genetic and metabolic analysis, microbial diagnosis, vitamin detection and drug detection in China, and the market is expected to reach 12.5 billion yuan. At present, the market size of clinical mass spectrometry in China is 3 billion yuan, with four times growth space, and the market is promising in the future.