The Probiotics Supplement Market
This Slide Show has been adapted from the SupplySide West 2016 Workshop: Tapping the Growing Probiotics Supplement Market. The workshop addressed the market growth of probiotics globally in recent years as well as projected growth, while also examining the health benefits of probiotics and the importance of substantiating product claims. In addition, the workshop looked at what the revised New Dietary Ingredient (NDI) Draft Guidance could mean for probiotics.
The workshop “Tapping the Growing Probiotics Supplement Market,” featured experts including Ewa Hudson, global head of health and wellness, nutrition and ethical labels research, Euromonitor International; Maria Marco, associate professor, UC Davis, Food Science and Technology; Josh Baisley, associate director, Nutrasource; and Ivan Wasserman, partner, Amin Talati Upadhye.
Supplement Retail Sales
Ewa Hudson, global head of health and wellness, nutrition and ethical labels research, Euromonitor, discussed the retail sales growth of a variety of supplements, spanning the years 2006-2021. Probiotics supplements are predicted to grow 249 percent, globally, outpacing other dietary supplements such as protein and calcium. This shows consumer demand has increased and will continue to increase.
Hudson looked at the shift in probiotics consumption, by form, from 2002 projected out to 2020, even as we have seen an increase in retail value of probiotics in North America. From 2002 to 2005, there was a decisive shift among consumers between different consumption forms of probiotics: probiotic supplements, probiotic yogurt and sour milk products. Between 2015 and 2016, the gap between yogurt and supplements began narrowing as North American consumers began embracing probiotic supplements. In 2015, the retail value of probiotic supplements in the Americas was US$1.9 billion, with North America making up 96 percent of retail value.
Global Probiotic Market
According to Euromonitor’s data, five countries hold 77 percent of the global share in probiotic retail value: the United States, Italy, Japan, Russia and Taiwan. The highest expected growth rate from 2016 to 2021 is for the United States at 57 percent. Interestingly, Taiwan has the lowest retail value among the top five countries with the global share of retail value, yet its predicted growth percentage will be 27 percent, with Italy falling not too far behind at 25 percent.
Companies looking to target consumers have myriad paths with marketing. Hudson explained that the advice from the pharmacist and the connected consumer will shape future trends of probiotic supplements. Between North America and Latin America, there are many ways to market the benefits of probiotics. Examples include gastroenterologist recommendation claim, infomercials via ambassadors, improving digestive health and sponsoring editorial content in mass media.
Probiotics and the Microbiome
In the next portion of the presentation, the workshop turned to the science behind probiotics. Mario Marco, associate professor, UC Davis, Food Science and Technology, discussed gut microbes and the advancements in probiotics and microbiome research. Gut microbes are associated with multiple functions of the body, from food digestion and immune system development to vitamin synthesis, and are even associated with autism and allergies.
Probiotics for All Ages
Studies suggest probiotics have beneficial effects for consumers at different ages. For instance, probiotics are being used in infants to address colic, and in children with diarrhea. For adults, probiotics can help treat IBS or vaginal infections. Probiotics may also reduce the risk for ulcerative colitis in adults, and lactose maldigestion in both children and adults.
Marco noted each probiotic strain possesses distinct traits that are not shared by many other members of the species. Strains and formulations are frequently grouped in meta-analyses. For instance, probiotics in food or supplements without a claim are species for which general benefits are known to contain probiotics; extrapolated evidence reasonably assumes that the strains would perform the same function.
Labeling and Claims
Josh Baisley, associate director, Nutrasource, encouraged marketers to consider the entire label when including a claim on a product. For instance, the claimed effect must be supported with clinical evidence. Evidence should identify the specific strain or proprietary blend, as well as the minimum effective dose. The label also needs to include the duration of use.
Baisley discussed evidence required in studies to substantiate claims. He explained the importance of the endpoints in a study, and how they should be formulated in correspondence with the claim, considering acceptable biomarkers and validated questionnaires. They must also be clearly defined and measured in clinical studies to prevent misestimating sample size or failure of hypothesis. For example, measuring IBS symptoms, the appropriate measurement would be the Irritable Bowel Syndrome Symptom Score (IBSSS).
New Dietary Ingredient Draft Guidance
Ivan Wasserman, partner, Amin Talati Upadhye, focused a good portion of his comments on the revised New Dietary Ingredient (NDI) Draft Guidance. He noted companies must confirm Old Dietary Ingredient (ODI) documentation. FDA considers each strain of a bacterial or yeast species to be a separate ingredient, and if a particular probiotic is an ODI, it is important to assess whether there have been any manufacturing changes that could change that status.
Decoding NDI Draft Guidance
Wasserman noted FDA did not revise its assessment that not all bacterial microorganisms are dietary ingredients, therefore per the NDI Draft Guidance, “Bacteria that have never been consumed as food are unlikely to be dietary ingredients.” Examples would be Salmonella or E. Coli.
Chemically Altered Ingredients
Wasserman stressed it is imperative to assess whether an ingredient has been chemically altered and if it is an NDI. The Revised Draft Guidance provided the following as an example a of process that chemically altered an ingredient:
- Changing agricultural or fermentation conditions to alter the chemical or molecular composition or structure of the ingredient. Examples: sprouting garlic or fermenting yeast using a medium containing large amounts of sodium selenite to create large amounts of organic selenium compounds.