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China Diagnostic Reagent Industry Report, 2011-2012

Research In China, Nov 2011, Pages: 60


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Diagnostic reagent can be divided into in vitro diagnostic (IVD) reagent and in vivo diagnostic reagent, wherein the former always holds a larger market share in China, accounting for 92.6% in the overall market for diagnostic reagents in 2010. Despite a late start, China’s IVD reagent industry has achieved fast development, benefiting from the improved medical care spending and the support of national policies.

The market size of China’s IVD industry reached RMB12.1 billion in 2010, with the compound annual growth rate of up to 13.8% from 2007 to 2010, higher than the global growth of 12.6% over the corresponding period. Moreover, considering the large population base and the improved economy, China’s IVD reagent industry possesses huge potential for future growth, which is expected to hit RMB23.2 billion in 2014.

IVD products mainly consist of diagnostic reagents and instruments. In 2010, the market size of IVD reagents climbed 13.3% YoY to RMB9.7 billion in China, occupying 80.2% of the IVD industry. Large-scale diagnostic reagent manufacturers are often good-sized medical test equipment producers as well, but many Chinese enterprises only deal with diagnostic reagents.

In China, the high-end diagnostic instrument market is taken over by foreign brands, such as Hitachi, Toshiba, Olympus, and Sysmex. However, after years of rapid improvement in the field of diagnostic instrument, Kehua Bio-engineering (KHB) has become a leading domestic enterprise of diagnostic reagent and instrument.

As far as market segment is concerned, China’s IVD reagents are still focused on lower-end clinical immunology and clinical chemistry diagnostic reagents for now, with separate market sizes up to RMB3.4 billion and RMB3.1 billion in 2010, taking 35% and 32% of China’s IVD reagent market respectively.

In recent years, along with the launch of nucleic acid blood screening pilot, nucleic acid diagnostics market has been further expanded, as of the end of 2010, there had already been six pharmaceutical factories to declare nucleic acid blood screening reagents to the State Food and Drug Administration (SFDA), namely, KHB, Da An Gene, Haoyuan Biotech, PG Biotech (later acquired by QIAGEN), Roche and Novartis Diagnostics, which will benefit from the nucleic acid blood screening pilot and subsequent marketing.


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China Diagnostic Reagent Industry Report, 2011-2012 (Chinese Version)



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