What will it take to grow the U.S. probiotic market?

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Probiotics have been such a supplement success story that it’s hard to believe they were downright esoteric not long ago-familiar mainly to researchers, health professionals, culture ingredient suppliers, and the occasional “nutrition nerd.”

What a difference a few years makes. Thanks to praiseworthy press, mounting scientific support, and consumers’ embrace of healthy living, probiotic supplementation is now a regular part of even average Americans’ wellness routines-as de rigueur as juicing or joining a gym.

To put that normalization into numbers, consider that market research firm Euromonitor International (Chicago) tracked the retail value of the domestic probiotic supplement market as shooting from $950.2 million in 2012 to $2.263 billion in 2017, with a total value of $3.511 billion looking likely by 2022; meanwhile, U.S. probiotic yogurt sales went from $3.301 billion to $4.354 billion during the same period, and could hit $4.870 billion in 2022.

But despite this rising profile, probiotics have yet to reach their full potential with Americans, whether as supplements, functional-food ingredients, or scientifically substantiated tools for improving their own health. In other words, there’s room to grow.

Or, as John Quilter, vice president and general manager, Wellmune and GanedenBC30, Kerry Functional Ingredients and Actives (Mayfield Heights, OH), puts it, “The U.S. adoption of probiotics occurred somewhat later than other markets, so this state of affairs simply speaks to the future possibilities the U.S. market offers manufacturers of probiotic products.”

Playing Catchup-and Winning

As Quilter concedes, “The U.S. probiotics market is still playing catchup with other regions”-namely, with Asia, which remains the world’s largest market for probiotic food and beverages, and Europe, which comes in second.

But judging from the results of an online survey that Chr. Hansen (Milwaukee) recently conducted with a representative sample of 2,246 U.S. consumers, the domestic market appears to be making up for lost time.

To wit, nine out of 10 U.S. consumers surveyed are familiar with probiotics, with 41% consuming them daily, or at least often. Consumption is higher among women, parents, urban consumers, Millennials, and Gen Xers and-crucially-consumers who pay attention to health and carefully monitor what they eat. And 42% of the probiotic consumers surveyed purchase more than one probiotic product weekly or more often, choosing everything from capsules and powders to dairy beverages, nondairy beverages, yogurts, and other fermented products.

Beyond the Gut

Among those who consume probiotics daily or often, the survey found, digestive health/bowel function, overall wellbeing, immune function, and a healthier microbiome were the top-four factors for selecting probiotic supplements or foods.

And the fact that consumers turn to probiotics to address such a spectrum of health concerns-and not solely gut health-illustrates how far these beneficial bacteria have come, both in consumers’ minds and with the scientific community.

As Elodie Ruffin, probiotics marketing manager, Lesaffre Human Care (Marcq en Baroeul, France), says, while consumers approach probiotic supplementation for their own unique reasons, their approaches in general are “starting to shift as they begin to understand how daily probiotic supplementation can enhance their overall wellness, or specific problem areas.”

The evidence supporting that notion is increasingly solid. “Digestive and immune health are still the main drivers of today’s probiotic market,” Ruffin notes, “however, skin health, obesity management, cardiovascular health, stress management, and cognitive health as well as female health are definitely among the wellness conditions beyond the gut that probiotic supplementation can improve, according to ongoing research.”

For example, one area the possibilities of which excite Ruffin and her colleagues is women’s health-a “market that seems to be gaining interest,” she says. Managing vaginal infections with probiotics would represent a breakthrough because current pharmacological therapies, though efficient, “aren’t designed to prevent recurrences and can cause undesirable side effects as well as antifungal resistance,” Ruffin says. Her company’s Saccharomyces cerevisiae-based Florigyn Biotic ingredient has undergone several studies^{1, 2, 3} investigating its role in the day-to-day management of vaginal infections and “provides a safe and natural solution that can help protect the vaginal flora against pathogenic yeasts and bacteria and prevent recurrences in the long term,” she says.

Bérengère Feuz, marketing director, Lallemand Health Solutions (Montreal), notes that probiotic supplementation has also demonstrated “promising outcomes” with respect to mood, citing two recent studies that examine the effect of her company’s proprietary Lactobacillus helveticus Rosell-52 and Bifidobacterium longum Rosell-175 probiotics on mood and anxiety as mediated by brain-gut and microbiota communication. In one-a double-blind human clinical trial⁴ involving 110 patients with major depressive disorder-researchers determined that relative to either placebo or a prebiotic, eight weeks of probiotic supplementation improved scores on the Beck Depression Inventory of depression severity. And in a pilot study⁵, results of which were presented at Probiota Americas in June, researchers from Queen’s University, Canada, evaluated the efficacy, safety, and tolerability of the same probiotic formula on depression symptoms in treatment-naïve patients. “Such studies,” Feuz says, “are positive and reinforce the scientific backing of a probiotic formulation already proven to alleviate both physiological and psychological symptoms of chronic stress in the general population.”

John Deaton, vice president, science and technology, Deerland Probiotics & Enzymes (Kennesaw, GA), points out that some probiotics have shown a capacity to maintain a healthy mouth and throat, “which is linked to many health benefits,” he says. “For example, specific strains of Streptococcus salivarius BLIS K12 and BLIS M18 are supported by more than 40 clinical trials in the areas of strep sore throat and tonsillitis, otitis media-inner ear infection-halitosis, periodontal disease, and dental health.”

And a study⁶ published in 2016 found a relationship between Ganeden’s BC30 Bacillus coagulans GBI-30, 6086, product and the body’s more efficient use of protein. Specifically, consumption of 1 billion CFU of the probiotic with one serving of protein helped reduce muscle soreness and enhance recovery post-exercise-making the ingredient, Quilter says, “great for high-protein meal-replacement and sports-nutrition products.”

Similarly, weight management is a focal point for probiotic inquiry, and Johanna Maukonen, global health and nutrition science leader, DuPont Nutrition & Health (Madison, WI), notes that her company published results of a weight-management trial⁷ showing that 10 billion CFU of its Howaru Shape probiotic (Bifidobacterium animalis subsp. lactis B420) administered either alone or in synbiotic combination with 12 g of their prebiotic Litesse Ultra polydextrose fiber controlled body fat mass, core fat mass, waist circumference, and energy intake in overweight and obese adults. “Moreover,” Maukonen continues, “the unique results were obtained with no changes to diet or exercise habits, and there were no stimulants added, so participants felt like themselves while controlling body fat mass and improving body composition.”

Long Road Ahead

The researchers postulate that mechanisms of action likely involve improvements in intestinal integrity, anti-inflammatory effects, and, potentially, beneficial changes in the composition of gut microbiota. “And what’s especially intriguing with the human study,” Maukonen notes, “is that we also assessed the microbiota composition before and after the trial and found that supplementation with the synbiotic product was associated with an increase in the relative abundance of Akkermansia, Christensenellaceae, and Methanobrevibacter”-bacteria well-represented in lean individuals-“while relative abundance of Paraprevotella spp.”-which can be opportunistic pathogens-“was reduced in fecal samples. Moreover, B420 alone was shown to increase the relative abundance of beneficial microbes Lactobacillus spp. and Akkermansia spp. in overweight and obese subjects, with the changes in microbiota composition correlating with benefits shown in obesity-related clinical outcomes.”

That’s heady news for those excited to reap dividends from research not only into probiotics, but into their relationship with the human microbiome. And indeed, says Mirjana Curic-Bawden PhD, principal scientist, application manager, fermented milk and probiotics, Chr. Hansen, “There’s more evidence showing the gut microbiome’s effect on cognition, stress reduction, anxiety, obesity, diabetes, inflammation, chronic fatigue, IBS, and more. Ongoing research is aimed at elucidating details on the mechanism of action, as well as how probiotics react with the rest of the gut microflora.”

We have a ways to go before those dividends start landing in R&D bank accounts as newly developed products. And, adds Feuz, while “the development of novel strains and even new bacterial species with different characteristics and modes of actions allows us to explore new health applications for probiotics and contributes to the credibility of the category,” probiotic watchers would be wise to practice patience as they wait for those advances to translate into on-the-shelf products.

“Isolation of new strains is just the beginning,” Curic-Bawden cautions. “Actual documentation of the health effects is a lengthy and complex process. And some of the new beneficial species or strains targeting balance of the gut microbiome might not be appropriate or feasible to use in fermented milk or food, and will be available only as supplements.”

Special Delivery

But because consumers have shown an affinity for eating or drinking their probiotics, brands would do better to focus on applying the strains we’ve already commercialized to a wider sample of the products most consumers eat, or drink.

“Traditionally,” Curic-Bawden notes, “probiotics have been relegated to fermented dairy as well as nondairy products. And from a global perspective, fermented products are, by far, the most popular category for probiotic delivery.” After all, they already harbor live bacteria, so the presence of additional beneficial species “makes sense to consumers.”

But the development of probiotic strains that not only thrive outside fermented dairy but actually survive the otherwise-lethal extremes of the gastrointestinal tract, harsh manufacturing, and long-term storage has opened up whole new environments for fortification, including breakfast cereals, baking mixes and baked goods, instant hot and iced coffee, fruit and vegetable juices and smoothies, enhanced waters, trail mixes, savory snacks and puffs, nut butters, infant formulas, chocolate, and cereal bars-even hot tea and soup.

The strains that make this possible tend to be spore formers. Quilter describes Ganeden’s BC30 B. coagulans probiotic as “a hardy strain of bacteria equipped with a natural protective shell” that leaves it more resistant than vegetative cells to the extremes of pH, heat, cold, shear, and pressure common to food and beverage production processes like HTST and HPP pasteurization. The same shell also shields it from stomach acids.

Deerland’s Bacillus subtilis DE111 probiotic forms spores that protect it from the digestive tract’s harsh conditions and suit it to challenging applications like pasteurized beverages, hot tea, and baked goods, says Scott Ravech, Deerland’s CEO. What’s more, the company’s DE111 HS allows for formulation in applications that require solubility. It “mixes easily with liquid and still maintains a high count of colony-forming units in the finished product,” Ravech says. And it opens doors for inclusion in “high-growth natural product markets” like hot beverages, functional drinks, and nutritional supplement gummies.

Speaking of which, Sarah Hansen, scientist, probiotics R&D, DuPont Nutrition & Health, is fielding more requests for gummies and chewable tablets. “Interest in nondairy milks and fermented beverages has increased dramatically over the last year, too,” she continues. “Other delivery systems include food in general-for the ease of use and ability to feed it to people who can’t swallow a pill-and chocolate is a perfect system for this and can deliver a higher dose.”

Ravech agrees. “Research suggests that chocolate and probiotics really do go well together,” he says. “This is because the beneficial bacteria that live toward the end of the digestive tract ferment both the antioxidants and the fiber in cocoa, creating anti-inflammatory compounds. Combining certain probiotics with chocolate multiplies its health benefits because the probiotics work best at the end of the digestive tract, where they set up shop and kick out bad or irrelevant bacteria. More friendly bacteria aid the cocoa fermentation process.”

Trust but Verify

Ravech believes that “continuing to introduce probiotic supplements in fun and innovative delivery systems like this will increase the products’ ‘stickiness’ or brand loyalty as consumers search for more enjoyable ways to consume their supplements.”

But also enhancing their stickiness will be the continued pursuit of reliable, legitimate probiotic science. As Quilter cautions, “Trust is hard won and easily lost.” The straightest path he sees to maintaining it is “to investigate the quality of the scientific substantiation supporting a probiotic strain’s efficacy and benefits. Without good-quality clinical evidence, a probiotic strain can’t be relied on to deliver on its promises. And safety data is certainly important, as well.”

Ruffin notes that most testing methods for probiotic counts are highly specific and sometimes even species-dependent. Because not every lab can perform these analyses, she advises manufacturers “to discuss analytical methods and testing with their supplier and learn more about their level of expertise, which can be an indication of the quality of the documentation received.”

And because we can’t effectively measure probiotics the same way we do vitamin and mineral supplements-that is, in terms of mass-the number of CFUs is the “scientifically sound way to measure their potency,” Ravech adds. Thus, in September, FDA released new draft guidance in which the agency acknowledged the advantages of labeling probiotic content in CFUs.

And because today’s consumers expect full transparency, “It’s important to label the probiotic strain’s identity and scientific name, as well as cell count,” Curic-Bawden says. “It allows consumers to do their own research and make educated decisions.”

In the end, “The main rule still stands,” she believes: “A documented dose should be delivered in one serving, and the cell count should be present at the end of shelf life. And it goes without saying that the strain has to be backed up by clinical documentation.” 

References:

1. Sabbatini S et al. “Saccharomyces cerevisiae-based probiotic as novel anti-microbial agent for therapy of bacterial vaginosis.” Virulence, vol. 9, no. 1 (December 31, 2018): 954-966
2. Cayzeele-Decherf A et al. “Saccharomyces cerevisiae CNCM I-3856 as a natural breakthrough for vaginal health: A clinical study.” Medical Journal of Obstetrics and Gynecology, vol. 5, no. 4 (December 21, 2017): 1112
3. Gabrielli E et al. “Saccharomyces cerevisiae-based probiotic as novel anti-fungal and anti-inflammatory agent for therapy of vaginal candidiasis.” Beneficial Microbes, vol. 9, no. 2 (2018): 219-230
4. Kazemi A et al. “Effect of probiotic and prebiotic versus placebo on psychological outcomes in patients with major depressive disorder: A randomized clinical trial.” Clinical Nutrition. Published online ahead of print April 24, 2018.
5. Menayang A. “Pilot study sheds light on probiotics’ potential as novel therapy for depression symptoms.” Nutraingredients.com. www.nutraingredients-usa.com/article/2018/06/18/pilot-study-sheds-light-on-probiotics-potential-as-a-novel-therapeutic-for-depression-symptoms
6. Jäger R et al. “Probiotic Bacillus coagulans GBI-30, 6086 reduces exercise-induced muscle damage and increases recovery.” PeerJ, vol. 4 (2016): e2276
7. Stenman LK et al. “Probiotic with or without fiber controls body fat mass, associated with serum zonulin, in overweight and obese adults-randomized controlled trial.” EBioMedicine. Published online October 26, 2016.