2    R&D and Production of Instruments and Reagents

The immunoassay market has been the main driven force for the development of the in vitro diagnostics industry in recent years. The market was sensitive to technological innovation, which led to huge market share when new tech was available. Compared with the entire IVD market, the market share occupied by industry giants were much higher in immunoassay market, such as Roche, Abbott, Danaher, Siemens, Sysmex, PerkinElmer Inc., Diasorin, etc. At present, the China's immunoassay market, especially the high-end part, was basically monopolized by worldwide players. However, recently some Chinese manufacturers have achieved breakthroughs in many applications, such as infectious diseases, tumor markers, cardiac markers, and thyroid function markers, in both high-end (3A hospitals) and low-end markets (2A hospitals and below) for replacing the imported systems. 

3    The Market Capacity of In Vitro Diagnostic Immunoassay

In vitro diagnostic products were important tools used in the medical field for diagnosis, monitoring, and prevention of diseases, of which detection principles or methods involved immunology, microbiology, and molecular biology, offering different types of products. Multiple technical fields were involved, such as medicine, machinery, electronics, and composite materials. In recent years, the bioengineering and pharmaceutical industries became one of new booming points, of which the IVD as one of the most branches was boosting with high growth rate in China.

Immunoassay was the largest sub-industry in IVD, in which chemiluminescence technique has become the dominant technology. The following was an estimation of the volume of the IVD market in 2018.

3.1 China IVD Market

1. According to “The Annual Report of China IVD Industry (2022)” released by China Association of In-Vitro Diagnostics, China IVD market size reached $23.7 billion in 2022, up 30% year-on-year. The market is expected to continue its high growth trend in the next 5-10 years, with growth driven by an aging population and increasing healthcare demands.

2. According to the data and report from IQVIA for global IVD market, in 2022, market volume of APAC market reached $40 billion, with more than 20% growth by local currency, which was much higher than worldwide average.

3. According to "The Worldwide Market for In Vitro Diagnostic Tests (15th Edition)"

released by KaloramaInformation, the Chinese market for IVDs is estimated at nearly $6.6 billion in 2022 and is expected to show annual growth of 3.8% to reach $7.9 billion in 2027.

On analysis for structure of China's medical device market in 2018, the China's medical devices had a high share in imaging, in vitro diagnostics, and low-value consumables, accounting for 16%, 14%, and 13 respectively. Top 7 sub-field occupied 68% share of whole market, including cardiovascular equipment. According to the above analysis of various data, China's IVD market capacity in 2018 was about 70 billion CNY.

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