Berlin – The Association of the Diagnostics Industry (VDGH) presented the annual balance sheet for 2022 today, Friday. Accordingly, sales in the German in-vitro diagnostics (IVD) market totaled 3.54 billion euros, including corona and routine diagnostics. Compared to the previous year, sales fell by 44 percent, which marks the end of the special boom caused by the pandemic. In 2021, the highest number of tests was recorded to contain the COVID-19 pandemic.
The chairman of the VDGH, Ulrich Schmid, comments: “Everyday life is finding its way back into the IVD industry. For us, it means initially concentrating on our core business. But we expect strong impulses for laboratory diagnostics from the digitization of health care and nursing, which is now hopefully advancing.” Corona diagnostics still made up 37 percent of the total market in 2022, compared to 65 percent in the previous year. Since the end of 2022, corona testing has fallen to a residual level. Routine diagnostics saw flat growth of 1.3 percent year-on-year.
Outlook 2023
Expectations for the current year are muted. Only about a third of the companies expect a good or very good economic situation. Around 12 percent expect the economic situation of their company to deteriorate. The reasons for this are the lack of tests in corona diagnostics and the generally difficult economic situation. Nevertheless, the willingness to invest in the IVD industry remains high, with around 10 percent of domestic sales flowing into research and development. This is also reflected in the product range: Around 75 percent of companies plan to launch new products on the market in 2023.
Advance the digitization of the healthcare system, exploit innovation potential
VDGH Managing Director Dr. Martin Walger is counting on the federal government to implement the digitization strategy in a timely manner. Although the topic has been on the Ministry of Health‘s agenda for around 20 years now, the political will to implement it seems to be there. “It is important that the research-based industry also has access to anonymized data from healthcare 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 regulatory infrastructure of the notified bodies creates a bottleneck when placing IVDs on the market. Only 21 percent of the current products are certified according to the new specifications. With up to 36 months, the length of the process has reached a new high. The result: every sixth existing product is taken off the market and fewer manufacturers want to bring their innovations onto the European market first.
As a trade association, the Association of the Diagnostics Industry (VDGH) represents the interests of more than 120 companies operating in Germany with a total turnover of 6.7 billion euros in 2022. They manufacture examination systems and reagents for the diagnosis of human diseases, with which a turnover of more than 3.5 billion euros, as well as instruments, reagents, test systems and consumables for research in the life sciences, with which a turnover of 3.2 billion euros is generated.
Press kits – VDGH – Verband der Diagnostica-Industrie eV