The publication "Medical Laboratory Diagnostics in Germany – A Status Report 2024" by Vogeser, Schumacher, and Bühling provides a current and comprehensive overview of laboratory diagnostics in the German healthcare system. The authors emphasize that in-vitro diagnostics (IVD) represent a central pillar of evidence-based medicine and are indispensable for practically all medical specialties. The majority of diagnoses can only be reliably made by considering laboratory-based findings. The aim of the work is to analyze and present the healthcare structures, service spectrum, and development perspectives of laboratory diagnostics in Germany based on publicly available data[1].
The provision of laboratory services in Germany is organized across sectors. It is provided by practicing laboratory physicians, in inpatient facilities, and directly in practices and medical care centers (MVZs) of other specialties. At the end of 2023, according to the German Medical Association, approximately 1,200 specialists in laboratory medicine and 845 in microbiology were active, accounting for about 0.7 percent of all specialists. Two-thirds of laboratory physicians work in private practice. After general practitioners, laboratory physicians are the second most frequently consulted group of doctors, even though their specialty is non-curative. In total, about 108,000 people are employed in medical laboratories, which corresponds to 1.8 percent of the total healthcare personnel. Annual per capita spending on laboratory diagnostics is about 150 euros, with total spending amounting to around 12.9 billion euros per year, representing about 2.6 percent of total healthcare expenditures[1].
The healthcare structures are heterogeneous: only about 17 percent of hospitals, primarily maximum care providers, have their own laboratory infrastructure. The majority of hospitals are supplied by external, mostly large laboratory medicine units, which ensure comprehensive care with complex logistics and data infrastructures. This system is supplemented by point-of-care laboratory diagnostics in practices and MVZs of various disciplines. Laboratory diagnostics are characterized by a high degree of automation. Fully automated analysis systems and IT-supported reporting enable the efficient processing of large sample volumes with comparatively low personnel requirements[1].
In the outpatient sector, specialist laboratories dominate, which are often organized as MVZs and are increasingly part of large, also internationally active, laboratory networks. The largest providers such as Sonic Healthcare, Synlab, Limbach-Gruppe, and amedes together account for more than half of the market volume. Sample transport logistics and electronic report transmission are central elements of the care processes. In addition, there are so-called laboratory communities, in which several doctors jointly operate practice laboratories and offer basic diagnostics. Many specialist practices also perform simple laboratory tests directly on-site (Point-of-Care Testing, POCT)[1].
A central problem area is the increasing shortage of qualified personnel, especially medical laboratory technicians (MTL). While the total number of people employed in laboratories increased slightly between 2012 and 2022, the number of specialists decreased. In clinics, a decline in MTL of almost 30 percent has been recorded. The training and employment of MTL are regulated by the MT-Berufe-Gesetz (Medical Technical Professions Act), which restricts the performance of complex analytics to this professional group, but also provides for openings for academically trained personnel[1].
The annual number of laboratory tests can only be estimated due to a lack of direct data. According to the Professional Association of German Laboratory Physicians, about nine million laboratory reports are generated daily. In the outpatient sector, approximately 1.49 billion laboratory services were billed for statutory insured patients in 2022. The most common tests are automated blood counts, TSH determinations, and HbA1c measurements. Statutory health insurance funds cover a wide range of preventive examinations, especially for adults aged 35 and over and pregnant women[1].
The financing of laboratory diagnostics in the inpatient sector is carried out through flat-rate per-case payments (DRG system), with laboratory services being considered as part of the overall costs. In the outpatient sector, remuneration is based on the Einheitlicher Bewertungsmaßstab (EBM) for statutory insured patients and the Gebührenordnung für Ärzte (GOÄ) for privately insured patients. The remuneration systems are complex and include, among other things, laboratory bonuses for economical behavior. A reform of laboratory remuneration is planned for 2025, which is viewed critically by practicing laboratory physicians, as they expect financial disadvantages[1].
Quality assurance is regulated by the German Medical Association's guideline on quality assurance of laboratory medical examinations (Rili-BÄK), which is considered a binding standard. In addition, there are external and internal quality assurance measures, accreditations according to ISO 15189, and legal requirements for medical devices and IVDs. Supervision is carried out by the medical self-governing bodies and the respective state authorities[1].
The diagnostics industry is strongly represented in Germany. Five major manufacturers dominate the market for large automated laboratories, alongside numerous medium-sized companies. Industry revenue in 2022 was 3.54 billion euros, with a significant pandemic-related decline in revenue after the peak in 2021. Around 31,000 people are employed in the diagnostics industry[1].
In medical education, laboratory diagnostics is anchored in the subjects of clinical chemistry, microbiology, and pathology. Training for MTLs takes place at vocational schools; academic training is being discussed but has not yet been implemented. Further training to become a specialist in laboratory medicine or microbiology follows the guidelines of the state medical associations[1].
Research primarily takes place at university chairs and in industry. The focus is on the development of new analytical techniques, the identification of biomarkers, and the translation of innovative methods into routine practice. Multiparametric "omics" technologies and the use of artificial intelligence are gaining importance[1].
The authors assess laboratory diagnostics as a systemically relevant, highly efficient element of the healthcare system that, despite increasing demands and staff shortages, has so far ensured a high quality of care. However, the sector is characterized by progressive market consolidation and the increasing dominance of large laboratory networks, also supported by financial investors. Ensuring medical independence and sustainable personnel development are identified as key challenges for the future[1].
Source: Vogeser M, Schumacher T, Bühling F. Medical Laboratory Diagnostics in Germany – A Status Report 2024. GMS Ger Med Sci. 2025;23:Doc01. DOI: 10.3205/000337[1].
Sources:
[1] ibid.
