The greatest single barrier to the widespread commercialization and adoption of phage therapy in Western markets is the lack of standardized, clear regulatory pathways in the United States (FDA) and the European Union (EMA). Because phages are unique, self-replicating biological agents, they do not fit easily into the established frameworks designed for chemical drugs or simple biologics.

The Compassionate Use Model

Currently, most phage treatments in the US and Europe occur under Expanded Access Investigational New Drug (eIND) or compassionate use protocols. These are emergency pathways for patients with life-threatening infections who have exhausted all other treatment options. While successful case reports (like the landmark 2016 Tom Patterson case) have driven interest, this case-by-case approach is not scalable and cannot form the basis of a commercial market.

Signs of Evolving Frameworks

The regulatory situation is beginning to evolve under pressure from the AMR crisis. The EMA has held workshops to explore regulatory flexibility, recognizing that the "one-size-fits-all" drug approval process must adapt to accommodate the highly personalized nature of phages. In Europe, the development of a Magistral Phage Framework (notably in Belgium) allows pharmacies to prepare and dispense phages under certain quality controls, providing a middle ground between emergency use and full approval. In 2024, significant progress was made with the implementation of harmonized quality criteria for phage therapy medicinal products in the European Pharmacopoeia, a key step toward standardization. For full commercialization, however, phages must be manufactured under strict Good Manufacturing Practice (GMP) standards and demonstrate unequivocal efficacy through randomized controlled clinical trials—a costly and complex endeavor that will shape the market's long-term success. For detailed analysis of the regulatory constraints and regional policy developments, consult the comprehensive Bacteriophage Market Report.