Microbiome Market Size, Share, Growth Analysis, By Product(Probiotics, Prebiotics, Symbiotics, Others), By Application(Therapeutics, Diagnostics, Nutrition and Dietics, Others), By Distribution Channel(Retail Pharmacies, Online Pharmacies, Supermarkets and Hypermarket), By Region - Industry Forecast 2025-2032

Microbiome Market Driver

• Increasing focus on human microbiome therapeutics development

Human gut microbiomes play a significant impact in the efficacy of medicinal drugs. Several studies have demonstrated that the appropriate balance of microorganisms in the human body can help treat a variety of illnesses. This link between bacteria and specific disease states could open up new avenues for medication development (or vaccine manufacturers). Because microbes are rich in enzymes, they can be exploited in a variety of therapeutic applications, such as the search for novel medicines.

Microbiome treatment has grown in popularity. Over a ten-year period, the National Institutes of Health (NIH) spent USD 215 million on the Human Microbiome Project (HMP) and USD 728 million on extramural human microbiome research initiatives outside of the HMP. Similarly, the European Commission established the Metagenomics of the Human Intestinal Tract (MetaHIT) initiative, which is primarily concerned with gut microbes. This project received USD 15 million investments from 2008 - 2012. MetaCardis (Metagenomics in Cardiometabolic Disorders), a large EU-funded research project that explored the function of gut bacteria in cardiometabolic diseases, received a USD 14 million (EUR 12 million) investment from 2012 to 2018. (CMDs). Similarly, Horizon 2020 is one of the largest EU R&I projects, with about USD 96.9 million (€80 billion) available over seven years (2014 to 2020).

Microbiome Market Restraint

• Government Regulations Restricting the Market Growth

Probiotics have not been approved by the FDA as a live biotherapeutic product (a biological product other than a vaccine that contains live organisms used to prevent or treat a disease or condition in humans). Nonetheless, FDA-regulated foods containing probiotics, including dietary supplements, are legally available; however, these items cannot be legitimately advertised to cure, mitigate, treat, or prevent any diseases.

Probiotic supplements are heavily promoted in retail stores and on the Internet. Although no probiotic has been licenced by the FDA for therapeutic reasons as of yet, some are now undergoing clinical trials and may be sold as biologics or other medications in the near future. The existing FDA regulatory regulations do not apply to probiotics. Given the future market potential for probiotics, it is possible that the FDA will issue regulations requiring research/clinical studies. It has been suggested that probiotics with drug claims be subjected to the same standards as other medications under the Abbreviated New Drug Application (ANDA) procedure. This will also allow probiotics to be exempted from Phase I studies, the first step in the research process. This may hamper the growth of the human microbiome market since big investors will have to invest more in R&D.