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According to the latest evaluation of surveys among manufacturers of in-vitro diagnostics (IVD), the German Diagnostics Industry Association (VDGH) believes that 2020 will be worse than the years before. According to the forecast, sales and profits are expected to decline this year. In 2019, the company will most likely also see a decrease in sales of 1.3 percent (minus 2.13 billion euros). The IVD market is experiencing a deterioration of the economic situation due to high price pressure and restrictive reimbursements for medical services, the analysis concludes. As the survey shows, 60 percent of all companies surveyed fear this. Poor framework conditions in Germany are exacerbating the situation in the German market, while foreign markets are on the upswing. Innovations that are successful have the potential for growth in the industry, as the example of the diabetics market shows, which is in a state of upheaval because classic blood sugar self-tests have become obsolete. According to experts, new technologies combined with conventional ones can give the market a boost again, as there are now new millions of diabetics in Germany, and the trend is rising. However, diagnostics companies would then have to invest in research and development, something that 80 percent of those surveyed have already done by 2019. Ten percent of the sales volume generated was invested in the development of new technologies and innovations. This puts the IVD sector in second place among all German industrial sectors in terms of investment in this research area. According to the VDGH analysis, however, 80 percent of those surveyed are unable to find qualified personnel, primarily for sales, but also for marketing and in the customer service segment. In addition, there is a lack of personnel with expertise in the area of „implementation of the stricter regulatory requirements stipulated by the new European medical device law“. Here, 70 percent of all companies suffer from the shortage, which will become even worse if the capacities at the Notified Bodies, which are responsible for the „EU-compliant marketing of products“, cannot be increased. New regulations in the regulation of in vitro diagnostics provide that in future, so-called Notified Bodies, as state-authorised bodies, will carry out tests and assessments as part of the conformity assessment to be carried out by the manufacturer, regardless of the risk class of the medical devices, and that their correctness will be assessed according to uniform assessment standards.

Source: Pharmazeutische Zeitung