This white paper examines the evolving scientific, clinical, and commercial landscape of microbiome-based therapies. It discusses advances in understanding host–microbiome interactions and their implications for disease treatment and prevention. The report highlights development challenges, including variability, regulatory uncertainty, and manufacturing complexity. It also explores emerging business models, clinical trial design considerations, and the importance of biomarkers and companion diagnostics. By charting current progress and future opportunities, the paper provides a framework for organizations seeking to navigate innovation, investment, and commercialization in the rapidly maturing microbiome therapeutics space.

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