Market development without growth impetus
The economic development of the industry remains subdued. The German market for in-vitro diagnostics (IVD) reached a volume of 2.38 billion euros in 2025. This corresponds to a decline of 0.8 percent. The life science research (LSR) sector also recorded a slight decline of 0.5% with sales of EUR 3.81 billion.
At the same time, the mood in companies has deteriorated significantly. Expectations for business development in the current year have diminished noticeably, while employment stimuli have largely failed to materialize. At the same time, many companies are increasingly turning their attention to international markets, which are perceived as more dynamic and innovation-friendly than the domestic market.
"Germany is at a crossroads for the diagnostics industry. While other regions are gaining momentum, test manufacturers in this country are facing ever-increasing pressures," explains Dr. Peter Schüßler, Chairman of the VDGH.
In the past year, the so-called laboratory reform in the EBM has resulted in considerable reductions for laboratory tests in statutory health care. The industry is feeling the effects of this. The VDGH therefore reacts with incomprehension to the fact that the announced SHI Contribution Rate Stabilization Act is also intended to reduce the reimbursement for the provision of medical aids by three percent. The planned budgeting of early detection, maternity care and vaccinations is also irritating. These services were previously explicitly excluded from caps, as their use is to be promoted in terms of health policy and social medicine.
Structural reforms are essential
The German government recognized medical technology as a key industry in the coalition agreement and, against this backdrop, launched the pharmaceutical and medical technology dialogue at the end of 2025. In the second half of 2026, concrete measures are to be agreed to improve the framework conditions for the industrial healthcare sector. The VDGH emphatically welcomes this initiative and is involved in the working groups that have been set up. It is already clear that reducing bureaucracy and deregulation are key areas of action. The focus is therefore particularly on Brussels and the framework conditions for product approval. "The VDGH sees many good approaches in the EU Commission's proposal to revise the European IVD Regulation. It is possible to reduce bureaucracy without jeopardizing patient safety. It is now crucial that the Council and the European Parliament enter into discussions quickly and come to decisions," says Schüßler. The VDGH would like to see a continuation of the pharmaceutical and medical technology dialog in Germany. "The cross-departmental dialog between the federal government and the medtech industry is a great benefit for all sides," says the VDGH Chairman.
Further developing healthcare with laboratory diagnostics
The diagnostics industry can make a variety of valuable contributions to the reform approaches of the German healthcare system. For example, patient-oriented immediate diagnostics (point-of-care testing) in ambulance services and emergency departments play a key role in controlling the utilization of care structures. This should be given greater consideration as an efficiency factor in the planned reform of emergency care.
The diagnostics industry provides test concepts for risk factors and early detection of diseases for low-threshold and comprehensive care services in pharmacies and care facilities. Furthermore, pathogen tests enable the rapid diagnosis of infections, particularly of the respiratory tract and gastrointestinal tract. Their application possibilities are to be improved with the planned Pharmacy Supply Further Development Act.
Early and precise laboratory diagnostics safeguard treatment decisions and control care processes. It is therefore of particular importance for the question of how a future primary care system should be designed. The VDGH is in favor of including the potential of AI-based diagnostics and digital health applications in this context.
