The scale of global In Vitro Diagnostic (IVD) market is expected to increase from USD 84.5 billion in 2020 to USD 96 billion in 2025. At this stage, the demand for IVD device continues to grow, and this trend of rising demand has had a positive impact on the global IVD market.
The constantly updated IVD instrument/equipment is more convenient to use and the testing efficiency is getting higher, which not only reduces the pressure of medical testing, but also increases the reliability of the test. For example, there will be some over-the-counter diagnostic products such as blood glucose monitoring kits on the market. These products are mainly favored by the elderly because these in vitro test kits can help them learn their blood sugar changes in a timely manner at home. Especially in recent years, the incidence of chronic diseases including cancer and diabetes has been increasing, and the importance of IVD products has been increasingly obvious. Even though IVD products are expensive, the demand for IVD products on the market is also increasing as people's disposable income rising.
The United States and European countries have increasingly strict regulatory and legal requirements for IVD.
In the United States, In Vitro Diagnostic market and IVD products are subject to similar guidelines for medical equipment. According to the relevant provisions of the United States Federal Regulations, equipment manufacturers are required to submit an application before they update equipment that produces IVD products, regardless of whether it is to update existing equipment or install new software in existing equipment. And any other updates and modifications to these equipment may require a new application.
In the European Union (EU), there is a separate directive for IVD products, which is regulated separately from other medical equipment. IVD equipment must meet the basic requirements of the directive, and products must have the CE mark before they can be legally sold in the EU.
Nowadays, with the continuous development of the market, new regulations are expected to replace the previous EU directive and there will be more strict requirements for the CE mark of new and existing equipment.