[Potential of bacteriophage therapy in Germany: evidence and clinical relevance].

Bacteriophage therapy (phage therapy) holds great potential in addressing the growing threat of infections caused by multidrug-resistant bacteria. Registry studies and systematic reviews indicate that phage treatments are effective in approximately 80-90% of antibiotic-resistant infections across various indications. In principle, the approximately 62,000 annual cases of infections caused by resistant or difficult-to-treat pathogens in Germany could be treated with phage therapy. Currently, several clinical trials are underway to assess the safety and efficacy of phage therapy for specific indications; however, no product has yet undergone a formal approval process. Furthermore, the timely applicability of phage therapy for individual cases is constrained by high production costs, limited capacities, and regulatory hurdles. The first market approvals in the USA and Europe are expected within the next three to five years, which could significantly strengthen the outlook for phage therapy. Concrete steps to accelerate the implementation of phage therapy in Germany to relieve the healthcare system include establishing a dedicated phage manufacturing facility, reducing regulatory barriers for compassionate use, promoting innovative technologies for production and diagnostics, and supporting clinical approval studies.