China represents one of the largest clinical laboratory markets in the Asia-Pacific region and is one of the fastest-growing markets for IVD. Due to the upsurge of the geriatric population and increasing prevalence of chronic diseases, like diabetes, cancer, and CVD, the China In-vitro Diagnostics market is slated to show substantial growth in the future, as all these conditions can be diagnosed and monitored using IVD products. According to the United Nation report of 2017, China is also heading for an elderly population crisis; China’s elderly population is expected to grow to 25% by 2030. Additionally, there is an increasing influence of the China Food and Drug Administration (CFDA), which oversees drugs, medical devices, and IVDs. In October 2014, new regulations were released that imported IVDs to undergo new CFDA requirements. However, lack of expertise in advanced technologies and stringent regulatory framework might hamper the growth of the market.

Key Market Trends

Molecular diagnostics segment dominates the China In-vitro Diagnostics Market

Molecular diagnostic tests detect specific sequences in DNA or RNA (including single nucleotide polymorphism (SNP), deletions, rearrangements, insertions and others) that may or may not be associated with any disease. Molecular diagnostics in China is at a relatively early stage of evolution. Most of the Molecular diagnostic systems in China are “open” with instruments supplied by multinational life science companies, such as Roche and Applied Biosystems [Life Technologies], and reagents provided by local companies, such as Fosun Diagnostics. In July 2016, Thermo Fisher Scientific and HEALTH BioMed, a biotech company in China entered into a collaboration to support HBM’s development of molecular diagnostic kits for infectious disease and pharmacogenomics screening to serve the China market.

In addition, rising approvals by regulatory authorities can be attributed to this growth. For instance, in April 2019, SOPHiA GENETICS received CE-IVD marking for Solid Tumor Solution (STS). It detects and characterizes altered genes in lung, colorectal, brain, and skin cancer. Such collaborations and a rising number of infectious diseases are slated to drive the market growth over the forecast timeframe.

Competitive Landscape

Many players in this market are trying to expand their product portfolio in order to top the global market. The companies focus on strategies, such as mergers and acquisitions, collaborations, and new product developments. In addition, they are aim to expand their businesses in developing regions to increase their market share. For instance, in August 2018, Sysmex Corporation and JVCKENWOOD Corporation agreed to jointly establish a new company Creative Nanosystems Corporation to develop and manufacture biodevices.

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