Growing evidence indicates that imbalances in bacteria living in the human microbiome can lead to a range of diseases that can potentially be treated by restoring harmonious bacterial populations. This connection between the microbiome and human health shows the potential of the microbiome as a prime therapeutic target and has inspired the development of several microbiome-based therapies that are currently progressing through pre-clinical and clinical trials. Of these, probiotic therapies are the most advanced. With several probiotic therapies progressing towards commercialisation, the high growth potential of the microbiome therapeutics market is clear.
However, there are several barriers hindering the development and commercialisation of microbiome-based therapies and the willingness of other companies to enter the sector. In this European Pharmaceutical Review article, we describe how manufacturers must address and overcome three key challenges hindering progress in the sector and the optimal strategies needed to demonstrate the value of microbiome-based therapies in successful commercialisation.