The microbiome field is currently at the beginning of the third wave with ongoing development of therapeutic solutions, an increasing number of products in clinical phases, and the creation of several CROs/microbiome platforms providing various dedicated services such as study design, sequencing, bioanalyses, and bioinformatics for clients from the Food, Pharma, and Cosmetics industries.
During clinical trials, biotechs are subcontracting several steps of their study to contract research organisations (CROs) such as the volunteers’ recruitment, the biological sampling, or the bioanalysis. CROs follow stringent protocols defined during the study design by biotechs as the outcome of a study relies heavily on their capacity to all perform precisely the same tests under the same conditions.
The standardisation of protocols remains a burning issue in the microbiome field. There are currently no universal standards for microbiome bioanalysis leading to a problem of replicability of the results. Indeed, risks of contamination are high and could occur at several stages. The highest risk appears during sampling procedures nonetheless samples integrity could be threatened during the transportation or the extraction of the DNA from complex matrices ahead of the sequencing. Long term storage stability of microbiome samples is also an open question. Institutes like the IBBL (Integrated BioBank of Luxembourg) are conducting research on finding the best way to process microbiome samples.
Additionally, there is a growing demand for microbiome biobanks. Theses biobanks will provide researchers access to data covering a large panel of the population. Big Pharma and biotechs would use biobanks for biomarkers discoveries through big data analysis or as providers of characterised faecal microbiota ahead of a faecal transplantation. For instance, OpenBiome, a US non-profit stool bank, is developing the FMT under the Investigational New Drug framework of the FDA and provides clinicians with ready to use faecal transplants.
Biotechs are currently subcontracting only a small part of their clinical studies to microbiome specialised CROs; mostly services around sequencing but there is a growing need for players able to offer a wider range of services from the study design and the kit preparation to data treatment and bioinformatics services. The development of these additional services is conditional on the emergence of standardised protocols.
Many public institutions are solicited as subcontractors in microbiome clinical trials like BioAster, TNO, or Metagenopolis, yet there is a growing number of private players. We distinguish three categories of private subcontractors: pure-player sequencers, bioinformatic companies, and microbiome service providers. Pure-player are equipped with several different sequencing technologies, like BGI or Fasteris, and provide Sanger and NGS sequencing services at competitive prices in short delays. On the other hand, some life science bioinformatics companies deliver data analytics services for various applications with an increase development of tools toward microbiome. Finally, dedicated microbiome platforms can either offer some partial services (uBiome, Microsynth, etc) while others are more diversified with a full-service offer from study design to report (Biofortis Mérieux NutriSciences, Nizo, Atlantia).
Private microbiome CROs (Contract Research Organization) are emerging both in the USA and Europe and the demand for microbiome subcontractors is expected to increase at a faster rate in the coming years. Food, pharma, cosmetic industries and biotechs need their services for subcontracting them several steps of their study. There is clearly a growing need of CROs offering a wider range of services from the study design, the kit preparation, microbiome analysis to bioinformatics and biostatistics analysis. The standardization of protocols remains an important issue in the microbiome field. In parallel, there is an increasing need for microbiome biobanks for biomarkers discoveries.
To conclude those three human microbiome market chapters, we have identified and analysed a diversity of players ranging from academics to dedicated microbiome platforms.
Marc-Olivier Bévierre (Cepton Strategies), Etienne Casal (Biofortis – Mérieux NutriSciences), Murielle Cazaubiel (Biofortis – Mérieux NutriSciences), Françoise Le Vacon (Biofortis – Mérieux NutriSciences), Charles Savoie (Cepton Strategies), Alessandra De Martino (Biofortis – Mérieux NutriSciences)
Our expertise: Pharmaceuticals & Biotechnology, Medtech & Diagnostics, Healthcare Services, Infrastructures, Automobile & Process Industries
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Biofortis – Mérieux NutriSciences:
As part of Mérieux NutriSciences, Biofortis supports the food and health industries by conducting research projects with a unique nutrition and analytical service. A one-stop shop CRO offering innovative services including clinical assessments and microbiota-related research for Pharma, Biotech and Food industries. Over the last 15 years, Biofortis has developed a unique and extended expertise in the Microbiome area, enjoying a very strong market recognition.