China's in vitro diagnosis industry began in the 1980s, and has been in existence for under 40 years. From the angle of industrial‐scale and market‐capacity development analysis, China's IVDs industry history is split into three development stages. The initial stage, in the 1980s, was characterized by the production of manual reagents and by low capacity during a small market. future development stage, in the 1990s, was about studying the industry in developed countries primarily. apart from the production of some conventional and hepatitis reagents, most biochemical reagent packages were imported. during this second stage, only semi‐automatic microplate readers, semi‐automatic chemical analyzers, and a few fully automatic instruments, like blood cell analyzers and urine analyzers, can be produced in China. The new century brought about a period of rapid development in China, where all reagents and instruments in various subdivisions came to be produced in‐house. Exports have increased year by year and domestic demand has been met. China's IVD industry has developed from the one and simple reagent‐and‐instrument production to a more complete industrial chain, from a reagent‐instrument system to raw materials, and from the domestic market to the world market. Chinese products now cover various industry segments. China has become a country with one of the foremost complete product lines in the global IVD industry; it's also the country with the strongest market demand. According to Renub Research analysis, China In Vitro Diagnostics Market will be USD 22.3 Billion by 2026.
The Food and Drug Administration (FDA)’s definition of in vitro diagnostics (IVD) refers to the utilization of reagents, instruments, and systems for the gathering, preparation, and testing of human samples to diagnose diseases or other conditions of the body. IVD provide information which will prevent diseases and their complications. Companies engaged in the production, research and development, marketing, service, and application of IVD instruments, reagents, standards, consumables, and quality control products constitute the IVD industry.
Approximately 1000 IVD reagents are in active use in large‐scale comprehensive medical institutions in China, of which approximately 500 are utilized in laboratories; 250‐300 are used in pathology (including flow‐cytometer reagents) and other specialty laboratories, like rheumatology, skin diseases, organ transplants, tissue matching, and more—nearly 100 kinds. It should be noted that China's LDT project has not yet been incorporated into project management.
The major growth drivers for China IVD industry are increasing demand from the middle class for high-quality healthcare products, and rising incidences of lifestyle diseases. In China, there has been massive expenditure in every healthcare segment in the areas of pharmaceuticals, medical devices, and traditional Chinese medicines. The significant barriers for China IVD industry are the local manufacturers lagging by the adoption of advance technology.
In October 2020, Roche diagnostics launched the product "Roche’s Tecentriq" with Avastin which was approved by CFDA for the treatment of liver cancer. The outbreak of Covid-19 has impacted the IVD products by playing a vital role in the diagnosis of the coronavirus symptoms.
Renub Research report titled “China In–Vitro Diagnostics (IVD) Market, By Segment [Clinical Chemistry, Immunoassay, Molecular Testing, Microbiology, Hematology, Self Monitoring of Blood Glucose (SMBG), Point of Care Testing (POCT), Coagulation], Companies (Roche Diagnostics, Sysmex Corporation, Mindray Medical International Limited, Shanghai Kehua Bio-Engineering Co. Ltd., Abbott Laboratories & Others)” studies the China IVD Industry.
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By Segment – The Report Studies the Market of the following 8 Categories:
1. Clinical Chemistry
2. Immunoassay
3. Molecular Testing
4. Microbiology
5. Hematology
6. Self Monitoring of Blood Glucose (SMBG)
7. Point of Care Testing (POCT)
8. Coagulation
Key Players covered in the report which has been studied from 3 viewpoints
• Overview
• Initiatives & Recent Developments
• Revenue
Companies covered in this report
1. Roche Diagnostics
2. Sysmex Corporation
3. Mindray Medical International Limited
4. Shanghai Kehua Bio-Engineering Co. Ltd.
5. Abbott Laboratories
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