2 Challenges

2.1  Reform of medical service price and change of medical insurance payment mode

At present, there are great differences and discrepancies in medical service prices across the country, including charges for testing items. As the state prepares to advance the reform of medical service prices, it is worth paying close attention to whether a unified national charging standard for test items will be established. If this change occurs, corresponding response requirements and changes to IVD enterprises will definitely emerge. At the same time, with the in-depth and comprehensive operation of DRG and DIP in the country, the operation and arrangement of testing items by medical institutions will certainly have a great impact on the IVD industry, prompting enterprises to conduct in-depth research and actively explore the changes to adapt to this medical payment system.

2.2  Impact of bidding 

The one-size-fits-all bidding policy lacks the standard to judge the quality of reagents, and there is often a tendency for low price to win the bid, which often ignores the demand of medical institutions for services in the process of product application. And ignores the fact that the clinical significance of products with different technical indicators is significantly different and the R&D and production costs of products are high. These may make some enterprises unable to attach importance to quality or performance, which is very disadvantageous for product users or end customers to expect more accurate diagnosis results and satisfactory services, and for promoting technological innovation in industries and enterprises.

2.3  Inadequate innovation ability

In the IVD industry in China, the relatively concentrated product categories, uneven product quality, and serious homogeneous competition in the industry have seriously hindered the healthy development of the IVD industry in China. Although the investment in R&D of enterprises in the industry has been increasing in recent years, the overall proportion is still low, generally below 10%, which is still far behind the international leading enterprises. Although various funds are active, there are few funds willing to invest in early projects and innovative projects. Most funds focus on mature and pre-IPO enterprises and projects. As a result, there are very few original and global leading projects every year.

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