Classification of POCT in China

When I first came into contact with this product pipeline, I felt very confused. Because there is too much information related to it, I don't know what industry it belongs to and what field it belongs to. So I compiled this information. Share it here today.

I am explaining this matter from these 8 aspects.

From the picture we can see that poct’s products mainly include: Electrochemical sensor. Later flow assay, Microfluidics, Microarray, surface plasmon resonance-bases detection, surface acoustic wave, Reverse transcription-polymerase chain reaction, loop-mediated isothermal amplification-based detection. Some POCT reagents can be used independently, such as colloidal gold test strips. There are also some reagents that need to be paired with instruments such as Immunofluorescence chromatography assay kits require FIA instruments to read results.

We can roughly divide them into reagents and devices.

So which industry does POCT reagent belong to in China‘s industry classification? Note here that I said reagents，not include device. In China, it belongs to the pharmaceutical manufacturing industry, and the next grade is the biopharmaceutical manufacturing industry. From the figure, we can see that the biomedical manufacturing industry has four fields: vaccines, blood products, diagnostic reagents and antimycin.

Diagnostic reagents are divided into in vitro diagnostics and in vivo diagnostics. POCT belongs to in vitro diagnosis industry. From here we can also see that there are five subdivisions of in vitro diagnostics including biochemical diagnostics, immunodiagnostics, molecular diagnostics, microbiological diagnostics and blood diagnostics.

In the previous PPT, we said that POCT is a division based on application scenarios. All reagents used in POCT scenarios are POCT reagents.

We also need to understand its instruments belong to IVD device. POCT devices and Central laboratory instruments belong to IVD device, and belong to clinical laboratory analytical instruments, and belong to medical instruments. There is a very important conclusion in this part: all medical equipment can be "POCT".

These are POCT instruments that are already on the market. Hope to give you a more intuitive impression.

In vitro diagnostics is divided into these five sub-sectors based on technology. Let's take a little closer look at the methodology involved in these subdivisions.

If your POCT product is going to enter China, it usually needs to be registered with China’s Food and Drug Administration. At this time, you will encounter a problem. Does it belong to Class I, Class II or Class III medical devices?

This table is telling you how to classify POCT products according to the risk factor.

As we learn more about POCT, we know that it’s in the middle of the industry chain. The upstream is the raw material market, including antibodies, antigens, proteins, electronic information industry and chemical synthesis. The downstream market is actually consistent with its application scenarios. In addition to our R & D and production enterprises, the midstream also includes distribution channels and direct sales channels. Testing services are also in this segment.

The picture below shows the companies that have performed well in the Chinese IVD market. Major manufacturers of raw materials for biological products are Merck， Meridian， Sino Biological,? NonoMicro, Roche, Vazyme, Acro, etc. Fine chemical raw material manufacturers include Meihua Group，ExxonMobil，AHB，SELON, and so on. Multiple types of medical coverage areas are Roche, Abbott, Siemens, Mindray,etc. Maccura, Tellgen and snibe are in the immunodiagnosis. Representative companies of POCT are Wondfo, Hotgen and OrientGen. I hope the information in this picture will help you.

As a sales manager of POCT products, when I introduce products to customers, I prefer to classify them by detecting diseases. POCT products are commonly used in testing items such as diabetes, cardiovascular disease, blood gas biochemistry, infection and infectious, reproductive health, cancer and drug abuse.

We also need to pay attention to the market environment of each sector in China. Let's look at diabetes first.

The last page is our company introduction. When you look at this ring diagram, on these tracks are Elabscience, Pricella,Uni-science,DaiAn. They are four subsidiaries of the Elabscience Group.

The subsidiary Elabscience focuses on RUO products in the field of immunoassay. We have twice been named a "Supplier to Watch" by CiteAb. There are over 10,000 citations.

Pricella mainly provides cells and cell-related products. It’s a standard leader in the cell industry of China, owning the largest cell bank in the central area. We initiated a standardization system for STR reports, and there are more than 7,000 citations involving our cells.

DiaAn is the latest member of our family, focusing on antibody development and active protein expression.

Uni-Science is an IVD product manufacturer. Currently, our diagnosis products are based on 3 platforms: colloidal gold immunochromatography platform, fluorescence immunochromatography platform, and pathological diagnosis antibody platform.

Any interest，please contact me.