Harnessing the power of the human microbiome: An introduction to a nascent market

Microbes have long been perceived by the general public as being harmful and something to be avoided. Many household products claim to be antibacterial, antiseptic or antimicrobial as a selling argument.
However, recent advancements in microbiome research changed this perception as scientists describe numerous health advantages that are conferred by some bacterial populations colonizing the human body.

Based on these findings, health-promoting products containing probiotics or prebiotics have arrived on the market and see broad adoption, be it fermented food, dietary supplements or cosmetics.

In clinical settings, fecal microbiota transfers (FMTs) have long been the unique treatment to address microbiome-related pathologies. This is changing with the recent approval of the first Live Biotherapeutic Product (LBP) as medicinal product by the FDA. It opens a new era in the microbiome field, and looking at current clinical pipelines, we expect new products to be approved for a wide range of indications.

Roger van den Heuvel

Partner, EMA Life Sciences Strategy Lead

KPMG Switzerland

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What to expect from this article

What the microbiome is
The impact of a disbalanced microbiome on health
The different microbiome-based products
Trends in the microbiome market and resulting challenges
Success factors to pioneer in the microbiome industry

Harnessing the power of the human microbiome

Introduction to a nascent market

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Investing in the microbiome market

Companies willing to take part in the microbiome market face a few challenges.

First, despite a surge of scientific evidence, the field is relatively new and the complex interactions between microorganisms and the human hosts have not yet been completely deciphered. Related regulatory hurdles await companies trying to get their microbiome products approved as the regulatory landscape in Europe remains nascent:

A limited microbiome expertise within competent authorities, complex requirements for biological medicinal products and lengthy assessment procedures have hindered the translation of these products from academia to industry.
There is a trend towards increasing and harmonizing regulation in the space. In 2016, the US FDA issued its Chemistry, Manufacturing and Controls guidance for early clinical trials, followed by the European Directorate for the Quality of Medicines and Healthcare (EDQM) defining quality requirements through the publication of a European Pharmacopoeia monograph for LBPs in 2019.
Nevertheless, the absence of clear European guidelines spanning quality, pre-clinical and clinical considerations poses a challenge for biotechnology companies seeking to develop and launch these innovative products. Variability can exist in assessment requirements between different competent authorities and the differing classification of microbiome products in different regions.

Beyond the scientific and regulatory challenges, there is a lack of standardization in the industry, mainly due to its novelty, but also because a multitude of different microbial strains are used and are difficult to differentiate.

There is a limited understanding by the general public and a need for education to explain the potential far-reaching health benefits conferred by these bacteria-containing products. Increased awareness and comprehension would in turn support the growth of the market for microbiome-based products.

How to protect your innovation?

How to strategically position yourself in this growing market and make sure you are not missing out?

How to maneuver and equip yourself in this very specific microbiome manufacturing area?

How to navigate through and be compliant with the microbiome regulatory process?

How we can support

In such a dynamic but uncertain environment, our KPMG Life Sciences Strategy team can assist you with:

Navigating regulatory requirements in key markets such as the EU
Identifying partnering opportunities and supporting the valuation, due diligence and deal execution
Supporting the preparation of a go-to-market strategy driven by competitive and market insights
Designing an appropriate, efficient and compliant operating model

Our team combining scientific and medical experts with seasoned strategy and operations practitioners gives us a unique perspective on Life Sciences companies.

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