Clinical mass spectrometry brings new opportunities for IVD under the trend of large price cuts

In 2018 , the biggest change for medicine is the “ price reduction ” shock caused by the purchase of 4+7 . With the purchase of raw materials, the original research manufacturers were squeezed out, and the price of domestic generic drugs was once again depressed. As the largest segment of the pharmaceutical industry, drugs have fallen to the floor price.

The days of medical devices are also not good . IVD as the largest sub-forum of medical devices, over the past two years, many provinces and cities have suffered a “purchase price”, “two votes” system, “the lowest hanging net” and other bidding price pressure. A sharp price cut has inevitably reduced the industry’s profit margin. The road ahead is long, where should IVD people go?

Throughout the development of IVD, every innovation of IVD has a breakthrough in the instrument industry . At present, the penetration of IVD in the instrument industry is still continuing, and the most promising clinical application is clinical mass spectrometry . More and more clinical mass spectrometry products have been approved for listing, which has brought broad opportunities for the majority of IVD people.

Breakthrough in the instrument industry to promote IVD transformation

Let us return to our original heart and re-examine the industry characteristics of IVD.

In the fierce entrepreneurial atmosphere of 2015, the IVD field is booming, and many innovative companies and products have been born.What is the reason?

IVD products can be divided into three major categories : instruments, reagents and software . From the operational point of view, IVD can be divided into detection efficiency and clinical value .

This makes it easy for entrepreneurs to cut into a certain segment to do a good job. Improving the detection efficiency and mining clinical value is the eternal pursuit of the IVD industry. In the context of price cuts, improving detection efficiency will exceed its clinical value.

When it comes to detection efficiency, IVD is the closest department to the hospital in the hospital’s corresponding department—the laboratory and the pathology department. Various large-scale testing equipment, operators, and assembly lines are flooding. Once the specimen leaves the human body, it begins to test in a fixed mode between various instruments, and finally obtains the test result. The process is very similar to that in the factory, where materials travel back and forth between machines to get the finished product. From this perspective, the performance of the instrument can be said to be the most important part of the IVD product.

Domestic IVD companies, doing reagents and making software, seem to be in a good business, but there are not many instruments that are doing well. Many reagent companies also need to use the platform of imported instruments to achieve optimal detection , such as the marriage of the Nine Strong Reagents and Roche Biochemical Instruments, and the marriage of the Permeable Reagents and Abbott Immunoassay.

Why is the instrument so difficult?

The Sino-US trade war in 2018 made everyone understand the importance of the chip. Instrumentation and chips are in similar condition and have long relied on imports . The instrument is not only the cornerstone of IVD. From a larger perspective, it is a battleground for advanced manufacturing competition. To some extent, the instrument industry is the “base of innovation” for advanced manufacturing.

In summary, IVD people pay attention to the development of the instrument industry, whether it is for their own career, or to enhance the national advanced manufacturing capacity, it is very beneficial.

If we raise our sights from IVD to the instrument industry, we will find that IVD is only a part of the medical field, and it is a part of clinical value – effective detection of proteins, nucleic acids, lipids, sugars, inorganic salts, in this field. In addition, there are environmental monitoring, animal and plant inspection and quarantine, quality testing, hazardous chemicals testing, and stimulant testing.

In the IVD industry, some problems seem to have no solution, but from a higher instrument perspective, you can find a solution.

Instrument industry Top20, still no Chinese companies

It can be said that every innovation of IVD has a breakthrough in the instrument industry .

Taking the well-known chemiluminescence as an example, the current industry’s first Roche diagnosis has become the dominant player in the chemiluminescence industry, and it has undergone a twist.

Unlike everyone’s imagination, the world’s first chemiluminescence instrument was not developed by IVD manufacturers .

In the 1980s, Cibo Corning of the United States introduced the ACS-180 automatic chemiluminescence analysis system and announced the world’s first fully automated chemiluminescence analyzer. This company is an instrument company owned by PerkinElmer .

Later, Abbott’s diagnostics acquired chemiluminescence technology and introduced a fully automated chemiluminescence analyzer that is more suitable for clinical use of IVD. It has been leaping forward, and in the early 1990s, Roche’s diagnosis was almost desperate.

In 1996, Roche Diagnostics took Baolingman into the bag and relied on Baolingman’s advanced electrochemiluminescence technology to reverse the situation and develop into the industry leader of IVD.

Last year, the chip was restricted by Europe and the United States, which made many friends care about the industry and formed a certain sense of crisis. In addition to semiconductor equipment, what areas are we still subject to people, and are severely subject to people?

The instrument industry is a heavily regulated industry .

Referring to the international ranking of the analytical instrument industry in 2008, the figures come from the authoritative journal “Instrument Market Outlook” published by the company in the international strategic direction. There is no Chinese company in the list of Top40:

More than half of the US manufacturers , 22 companies on the list , and 5 manufacturers with sales revenue of more than 1.5 billion US dollars are from the United States, such as the top five have the famous Thermo Fisher, Danaher and Agilent;

Japan and Germany each six ;

Britain and Switzerland each of the three ;

There is no Chinese company.

▲Top 40 of the world’s analytical instrument sales (Source: International Strategic Direction Company, Shanghai Science and Technology Information Research)

Looking at the recent data, C&EN, a well-known magazine in 2017, announced the list of global instrument companies. The top few are still a few, Agilent, Danaher, Shimadzu, etc., and there are still no Chinese companies.

Perhaps the statistical caliber and data standards are different, but in this data, it is also intuitive to see the conclusion: After ten years of development, China still has no leading companies in the field of instruments, and developed countries still have absolute control .

From these two rankings, we can also feel that foreign IVD giants such as Roche, Danaher, PerkinElmer, Illumina, Hitachi High-tech, etc., also occupy a certain position in the instrument industry.

If China’s IVD companies want to catch up with and even surpass foreign-invested IVDs, they need to work harder on the development of the instrument and set off their sleeves.

Clinical mass spectrometry brings new dawn to IVD

At the moment, the penetration of IVD in the instrument industry continues. The most promising clinical application is clinical mass spectrometry .

Compared with traditional immunization methods, LC-MS/MS is more accurate, reliable, specific and sensitive. Zhongshan Hospital affiliated to Fudan University has been developed using the Waters mass spectrometry platform:

1) Detection of methoxy-adrenalin, methoxy norepinephrine, 3-methoxytyramine is helpful in the diagnosis of pheochromocytoma;

2) 20 items of adrenal cortex hormones help to diagnose more endocrine diseases;

3) Monitoring of 9 therapeutic drugs such as imatinib, carbamazepine and phenytoin.

LC-MS/MS is highly sensitive, highly specific, targeted for accurate quantitative results, and fast, high-throughput, multi-component analysis for clinical precision medicine.

Take vitamin D test as an example to compare clinical mass spectrometry methods with traditional immunization methods .

Vitamin D has two forms of existence: one is vitamin D3 produced by skin exposure to sunlight, and the other is plant derivative vitamin D2 present in various supplements. Vitamin D is metabolized in the liver to form 25-hydroxyvitamin 25 (OH) VD2, which is further metabolized in the kidney to form the active metabolite 1,25-dihydroxyvitamin D. The level of 25(OH)VD is considered to be the best clinical indicator for assessing vitamin D levels in the body.

The main problem with traditional immunoassays is the inability to distinguish between 25(OH)VD2 and 25(OH)VD3, and the cross-reaction of antibodies with 25(OH)VD 2 to determine the total concentration of 25(OH)VD. If the cross-reaction is below 100%, D2 treatment may not be accurately monitored.

Therefore, the quantitative analysis of 25(OH)VD2 and 25(OH)VD3 by LC-MS/MS method is more popular in terms of improving the quality of detection and reducing cost, and has become the gold standard for 25(OH)VD detection.

Of course, the price of clinical mass spectrometry is relatively high , and whether it can really compete for the mainstream market will also become a difficult point for its future development.

More and more mass spectrometry products are on the market, and IVD people welcome broad opportunities.

Nowadays, more and more instrument companies, Thermo Fisher, Danaher, Shimadzu, Agilent, and Brooke are optimistic about the huge potential of China’s clinical testing market, and more and more domestic clinical mass spectrometry products have been approved for marketing. It also brings a broad opportunity for the majority of IVD people . Below, we summarize the clinical mass spectrometry products that have been approved for marketing.

Domestic clinical mass spectrometry approved product summary table:

Note GIF moving picture simple dividing line

In 2019, medical reform continued and control fees continued. Price cuts remain a problem for the industry. The development of new technologies will bring opportunities.

With the approval of more and more local and foreign clinical mass spectrometers, China’s IVD development will enter a new situation.