Compared to the previous year, sales fell by 44%, marking the end of the pandemic-related boom. The highest volume of tests was recorded in 2021 to contain the COVID-19 pandemic.
Ulrich Schmid, Chairman of the VDGH, commented: "The IVD industry is back to normal. For us, the first step is to concentrate on our core business. But we expect strong impetus for laboratory diagnostics from the hopefully advancing digitalization of healthcare and nursing." Corona diagnostics still accounted for 37% of the total market in 2022, compared to 65% in the previous year. Since the end of 2022, coronavirus testing has fallen to a residual level. Routine diagnostics recorded flat growth of 1.3% compared to the previous year.
Outlook for 2023
Expectations for the current year are subdued. Only around a third of companies expect the economic situation to be good or very good. Around 12% expect the economic situation of their company to deteriorate. The reasons for this are the loss of test volumes in corona diagnostics and the generally difficult economic situation. Nevertheless, the IVD industry's willingness to invest remains high, with around 10% of domestic turnover flowing into research and development. This is also reflected in the product range: around 75% of companies plan to launch new products on the market in 2023.
Driving forward the digitalization of the healthcare sector, exploiting innovation potential
VDGH Managing Director Dr. Martin Walger is counting on the German government to implement the digitalization strategy in a timely manner. Although the topic has been on the agenda of the Ministry of Health for around 20 years, the political will to implement it now seems to be there. "It is important that the research industry also has access to anonymized healthcare data in order to be able to further develop products in a patient-centric manner. A uniform interpretation of data protection must be ensured," says Walger.
The bureaucratic hurdles of the EU Regulation on in-vitro diagnostics (IVDR), which has been in force since May 2022, remain a challenge for companies. In particular, the lack of a regulatory infrastructure for notified bodies is causing a bottleneck in the marketing of IVDs. Only 21 percent of current products are certified in accordance with the new requirements. At up to 36 months, the process duration has reached a new high. As a result, every sixth existing product is being withdrawn from the market and fewer manufacturers want to launch their innovations on the European market first.
