WITHIN ADM THERE IS A WEALTH OF EXPERIENCE IN THE MICROBIOME SPACE AND THE AMBITION TO BECOME A WORLD LEADER IN THIS FIELD.
Interestingly, one of the biggest challenges faced by the microbiome industry is actually not scientific, but one of regulation. In Europe, microbiome interventions are regulated in the same way (and by the same agency) as foods. Even though a microbiome intervention might be shown in clinical trials to have certain health benefits or mitigate certain symptoms, it is not currently possible to communicate this to consumers. In fact, even the word “probiotic” cannot be used in consumer-facing communications; for instance you may have seen products referred to as “live bacterial cultures”. Why is the regulatory framework restricting the way that consumers can be told about the benefits of these novel treatments? Surely it implies that the evidence is weak or lacking? As with all scientific research, microbiome research occurs on a spectrum: some is ground-breaking, some is poorly-designed or executed, and most falls somewhere in-between. Interestingly, one of the main problems arises because most research is carried out in individuals with a known illness, when the European regulations require that health claims are supported by data from healthy populations.2 Also, because the full mechanistic workings of the microbiome are yet to be fully understood, rarely can the researchers conducting clinical trials say with confidence exactly how a particular microbiome modulating intervention works. Inherent in this picture is a tension: are probiotics foods or are they medicines? Or do they fall somewhere in between? Currently probiotics are regulated as foods, but frequently researched as if they were medicines.
Despite these regulatory hurdles, the microbiome sector is growing rapidly, both in terms of the science that underpins it and in terms of commercial value – globally the microbiome industry is valued at approximately USD 15 billion per year and growing at around 7% annually.3 Within ADM there is a wealth of experience in the microbiome space and the ambition to become a world leader in this field. ADM Biopolis provides a world-leading research facility in Valencia, Spain, with a vast library of scientific research, including publications on microbiome interventions for atopic dermatitis, psoriasis, male fertility and weight management. And in the UK, ADM Protexin produces a number of market-leading consumer microbiome solutions, including Bio-Kult, one of the world’s leading probiotic brands as well as a hugely successful range of probiotics for companion animals and livestock.
Microbiome research has advanced enormously in recent years – both in the techniques used and the scope of diagnoses included. As the research base has matured, so too the market has grown. There are many competitors currently operating in the microbiome space, and the challenge going forward is to ensure that ADM microbiome solutions stand out from the crowd. Continued investment in both pre-clinical and clinical programmes will be key to developing the scientifically robust and novel solutions our customers demand. In subsequent articles we will explore ADM’s microbiome research portfolio in greater depth and consider where our research should be focused to meet the challenges of tomorrow.
Richard Day E:
richard.day@
protexin.com
References:
1 Lenoir-Wijnkoop I, Merenstein D, Korchagina D, Broholm C, Sanders ME, Tancredi D. Probiotics reduce health care cost and societal impact of flu-like respiratory tract infections in the USA: An economic modeling study. Front Pharmacol 2019; 10: 1–9.
2 Salminen S, van Loveren H. Probiotics and prebiotics: health claim substantiation. Microb Ecol Health Dis 2012; 23: 40–2.
3 van den Nieuwboer M, van de Burgwal LHM, Claassen E. A quantitative key-opinion-leader analysis of innovation barriers in probiotic research and development: Valorisation and improving the tech transfer cycle. PharmaNutrition 2016. DOI:10.1016/
j.phanu.2015.09.003.
22 | ADMISI - The Ghost In The Machine | Q2 Edition
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