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Gut Feeling
The microbiome, probiotics and the gut health opportunity
Dr Volker Spitzer, VP, Global Consumer Health R&D/RWE, IQVIA Consumer Health
May 09, 2023

Digestive health is big business. As health maintenance - over just treating symptoms - has gained in importance for an increasingly health-conscious and mindful consumer base, gut health has appeared as a key wellness trend.

Microbiome-based products are already a viable business as food supplements or OTC products in the consumer health space – most commonly in the probiotics sub-category. Despite controversies around efficacy and clinical health benefits in certain indications, probiotics that positively affect the gut microbiome have outperformed the total consumer health market long-term and saw double-digit growth rates during the COVID-19 pandemic between 2020-2021.1

Probiotics are part of a wider digestive products category which is the 4th largest OTC category as measured by IQVIA Consumer Health with sales of $18 billion globally. This category is expected to outperform the OTC market as a whole, with a forecasted CAGR of 7% from 2022-2025.2

Within the wider digestives category, the probiotics sub-category is showing potential for growth and innovation. Defined by IQVIA as OTC products that contain live microorganism either alone or in combination with other ingredients, probiotic-based products posted global value sales of $4.6 billion in 2021 with — as expected — probiotic digestive remedies accounting for 75% of that total, followed by vitamins (10%) and skin treatments (3%). Long-term market growth is positive with 7% CAGR (2017-21) and recovered after a dip during the first year of the COVID-19 pandemic with 12% year-over-year (YoY) growth in 2021. It is a similar picture from a volume perspective — slight decline at -1% in 2020 followed by a 5% recovery in 2021. We expect the growth trend to continue. Comparing the first three quarters of 2022 to the previous period shows an 11% value and 3% volume increase (Figure 1).

Figure 1: Probiotics Market Development (Source: IQVIA Consumer Health Global Consumer Health Insights)


Probiotic products in the consumer health space are mostly marketed as food supplements or food products. Given the long experience developing and marketing these products, it is worthwhile looking at some learnings that will also apply to microbiome innovators wanting to successfully commercialise their future prescription-bound assets (Figure 2).

Figure 2: Key Learnings from the Probiotics market (Source: IQVIA EMEA Thought Leadership)


Regulation presents challenges

The use of the word “probiotics” for advertising and on food supplement packaging is not allowed in most EU countries due to EU health regulations categorizing it as an unauthorised health claim without relevant scientific evidence. No health claims for probiotics have been granted by the European Commission (EC) after evaluation by the European Food and Safety Agency (EFSA), however France recently allowed label claims around “probiotics” for food supplements that meet specific conditions, highlighting a lack of harmonization in the EU around this product class.

Like probiotics, prebiotic products are also important in the food supplement area and are generally accepted to have a positive impact on health, but only few health claims have been granted. The claim “Inulin contributes to the growth of bifidobacteria in the gut” for example was allowed by the EC after review of the scientific evidence by EFSA.

The dietary supplement category itself has a challenging claims situation, leading some companies to adopt different regulatory strategies. The German brand “Kijimea” categorises itself as a substance-based medical device due to its heat-deactivated Bifidum bacterium strain, which has physical properties that provide benefits for bloating, pain and diarrhoea. Its efficacy is backed by clinical studies published in peer-reviewed journals.3

Stronger evidence for a stronger category

The gut microbiome has been implicated in a number of health problems, including digestive health, obesity, diabetes, and various diseases. While advances have been made in analysing the composition of the microbiome, the abundance of data generated from comparing healthy and diseased individuals can lead to misleading claims about the link between bacteria and disease. Other factors, such as diet, drug treatments, and stool consistency, also play a role.

Currently, most clinical evidence of the health benefits of probiotics and prebiotics is limited, often conducted by manufacturers to promote their products. The quality of studies is often low, with small sample sizes and limited understanding of individual differences in microbiome and immune response, making it difficult to draw firm conclusions.4

Numerous companies promote their products by combining probiotics with vitamins and minerals to make health claims that align with the authorised claims for vitamins and minerals, such as boosting immune health. Although this complies with regulatory guidelines, consumers might perceive such a strategy as misleading and ultimately resulting in distrust of future microbiome-based medicines in general.

A better approach would be running hybrid studies and leveraging RWE for marketing and regulatory purposes. Pharmaceutical companies will need to fill this evidence gap by running large-scale clinical trials and tackle the inherent variability amongst patients when running those studies.

The consumer health microbiome market will be characterised by a balancing act between innovation and regulation. New approaches to microbiotic products meet a growing consumer interest in and demand for therapies; claims about benefits must be tempered with scientific evidence.

Explore the potential of microbiome therapeutics further by downloading Bigger on the Inside: The Expanding World of Microbiome Therapeutics whitepaper here 


  1. IQVIA Consumer Health Consulting
  2. IQVIA Global Consumer Health Insights – Local Currency Dollars (LC$) based on MNF Price $M, MAT 09/2022, IQVIA OTC audits (Excluding Venezuela).
  3. https://pubmed.ncbi.nlm.nih.gov/32277872/; https://kijimea.de/
  4. https://gut.bmj.com/content/67/9/1716

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