Data insight into the status and trends of IVD products in my country

As the largest sub-field of medical devices, in vitro diagnosis (IVD) is complicated in terms of product methodology, application scenarios, and indications
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This article mainly reflects the status quo and trends of a part of the IVD field through macro statistics from the perspective of existing products

This article mainly reflects the status quo and trends of a part of the IVD field through macro statistics from the perspective of existing products

Overall analysis

With the iterative upgrading of technology, the in vitro diagnostic industry has formed many sub-fields.
From the perspective of technology branches, immune detection technologies such as chemiluminescence and fluorescence immunity and molecular diagnostic technologies such as gene sequencing and gene chips are in a period of rapid growth
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On the whole, the earliest and most mature biochemical diagnostic products still have a huge product base, but the market is already a red sea, with low barriers to entry and high gross profit margins, resulting in a serious homogeneous competition pattern.
Congested, the market growth rate has been declining, which is lower than that of immunodiagnosis and molecular diagnosis; while the fast-growing immunodiagnosis has come from behind to become the largest segment of the IVD market
.

From overall view,

From the perspective of market size, the three mainstream directions of immunodiagnosis, biochemical diagnosis and molecular diagnosis together account for as high as 72%, of which immunodiagnosis accounts for as high as 38%, followed by biochemical diagnosis and molecular diagnosis at 19% and 15%
.

In terms of market size,

Figure 1: The market share of IVD in China Data source: China Industry Information Network

In terms of products, as of February 28, 2022, there were 31,177 valid registration certificates for Type II and Type III in vitro diagnostic reagents in China, of which immunodiagnosis, biochemical diagnosis and molecular diagnostic products accounted for 38%, 47% and 3% respectively.

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From the product point of view,

Figure 2: Product distribution of China's second and third types of IVD reagents.
Source: Flint Creation Database

The proportion of subdivided products of newly registered IVD reagents in China over the years clearly reflects that the field of immunodiagnosis is catching up with the field of biochemical diagnosis
.

Although in absolute terms, the number of newly registered biochemical diagnostic reagents each year still exceeds that of immunodiagnosis, the proportion of all IVD reagents has continued to decline, and by 2020, it has been completely overtaken by immunodiagnostic reagents

Figure 3: 2015-2021 China’s second and third types of IVD reagent product breakdown data source: Firestone Creation Database

The product data related to the national special review process for innovative medical devices and the priority approval process for medical devices reflects the changing trend of product development and innovation in the above three fields from another perspective
.

Up to now, a total of 79 in vitro diagnostic products have been included in the national innovative medical device special review process and medical device priority approval process, including 11 devices and 68 reagents

02.
Current status of products in three sub-sectors

Current status of products in three sub-sectors

In the field of immunodiagnosis, chemiluminescence has a high technical threshold and difficulty in research and development.
It is the direction of the upgrade and iteration of immunodiagnosis.
It is gradually replacing enzyme-linked immunity and becoming the mainstream technology
.

In 2021, a total of 67 newly registered chemiluminescence diagnostic equipment will be registered nationwide, a record high and an increase of 71.

immunodiagnostics,

Among them, the magnetic particle chemiluminescence technology has become the main research and development direction of chemiluminescence products at home and abroad due to the feature that magnetic particles can fully automatically clean unbound substances under an external magnetic field, thereby greatly improving the detection efficiency
.

Among the approved immunodiagnostic reagents, there are 3451 magnetic particle chemiluminescence reagents, accounting for 66.

Figure 4: Approval status of magnetic particle chemiluminescence reagents Data source: Flint Creation Database

In the field of biochemical diagnosis, automatic biochemical analyzers have been widely used in the market at present.
There are 289 registration certificates for biochemical analyzers in the country (excluding single testing instruments), of which 233 are automatic biochemical analyzer registration certificates, accounting for more than 80%.

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In terms of reagents, there are many products classified according to the testing items, including liver function testing, renal function testing, lipid metabolism testing, glucose metabolism testing, specific proteins, cardiac markers, tumor markers, blood coagulation, trace element testing and other major items corresponding to 2.

the field of biochemical diagnostics,

Figure 5: Proportion of Biochemical Diagnostic Reagents by Subdivision Data Source: Flint Creation Database

Figure 6: TOP10 single-item detection index products of biochemical diagnostic reagents Source: Flint Creation Database

In the field of molecular diagnosis, there are currently 17 registration certificates for domestic gene sequencing equipment in the country.
The reagents are mainly products based on PCR technology, accounting for 83% of all molecular diagnosis reagents.
Other methodologies such as isothermal amplification method only account for 17%
.

molecular diagnostics,

Figure 7: Approval status of molecular diagnostic reagents segmented products Data source: Flint Creation Database

Since the outbreak of the epidemic, the demand for new coronavirus detection kits has surged.
Up to now, a total of 67 new coronavirus (2019-nCoV) detection kits have been approved for marketing across the country, of which 33 are based on molecular diagnostic methods, mainly fluorescent PCR methods, accounting for than 69.
7%
.

03.
Trend Outlook

Trend Outlook

The future technological development of in vitro diagnostics will, on the one hand, continue to add new test items on the basis of the existing test platform due to the endless emergence of new needs, and on the other hand, the upgrade of the original technology or the emergence of new technologies will bring new Inspection technology platform
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POCT ushered in huge development opportunities
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With the continuous growth of demand in many application scenarios such as epidemic prevention and control, emergency first aid, and personal health management, the "instant, local, and convenient" diagnostic method has become one of the important development trends of laboratory medicine, which has promoted the rapid development of POCT.

POCT ushered in huge development opportunities

Precision therapy catalyzes the development of companion diagnostics
.