Market Challenges And Opportunities
Global Human Microbiome Market– Drivers
- Emergence of the newly advanced microbiome based therapies like live biotherapeutic products (LBPs): Emergence of the newly advanced microbiome based therapies like live biotherapeutic products (LBPs) are expected to drive the human micro biome market growth. For instance, in Nov 2022, Ferring B.V., a global pharmaceutical company, receivedapproval from the U.S. Food and Drug Administration (FDA) for REBYOTA (fecal microbiota, live-jslm), a novel drug based on microbiota-based live biotherapeutic, that is indicated for the prevention of recurrence of Clostridioides difficile (C. difficile) infection in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.
- Increasing awareness about probiotics and their role in preventive health and in balancing gut microbiome: Increasing choice of adapting to healthy lifestyle, owing to increased awareness about prebiotics and probiotics and their role in preventive health measures and in balancing gut Microbiome in North America region. For instance, according to the article published by Gastrointestinal Society in Decmber, 2022 to manage dysbiosis, “if bacterial infection the antibiotic treatment might destroy the offending bacteria, The probiotics and prebiotics can help in microbiota restoration or simply adding back bacteria to help improve an individual’s microbiome”.
Global Human Microbiome Market: Restraint
- Stringent regulatory requirements for approval of new products: To launch a drug, it has go through all the regulation procedures by the regulatory authorities. For instance, The European Union has strict requirements for nutritional claims and specifies them in the Claims-Regulation (European Directive 1924/2006) appendix [7]. The U.S. Food and Drug Administration (FDA) classifies items based on the claims made by the marketer, not on the ingredients or any other characteristics of the products themselves. As a drug is developed, it has to go through costly investigational new drug (IND) application procedure.