Corona diagnostics alone account for 65% of sales, which have risen to 6.3 billion euros, according to the latest market survey by the German Diagnostics Industry Association (VDGH).
"Our industry essentially consists of medium-sized companies that have done everything they can to keep the pandemic in check. Research institutions, medical laboratories, hospitals, doctors' surgeries and test centers have been fully supplied with the entire range of test methods. The exceptional boom must not distract us from the fundamental challenges facing our industry," explains VDGH Chairman Ulrich Schmid. Routine in-vitro diagnostics, the actual core of the companies, has been recording stagnating sales in Germany for several years.
For the current year, the members expect a significant decline in corona diagnostics. The comprehensive citizen testing established by the German government will expire in the middle of the year. New bureaucratic challenges are now taking center stage for test manufacturers. The new EU regulation on in-vitro diagnostics (IVDR) comes into force on May 26. Although industry companies are prepared for this, as VDGH Managing Director Dr. Martin Walger emphasizes, important building blocks for the new legal framework are still missing. The industry fears that there will be considerable bottlenecks at the testing institutions: "Currently, only 6 out of 22 bodies have been named that will be allowed to approve our products in the future. The EU Commission has already responded with transitional periods, but the time frame remains very tight."
The testing industry believes it is well prepared for a possible further wave of coronavirus in the fall/winter: "The diagnostics companies are quick to react and remain a reliable partner for the medical profession and politicians," says Walger.
