Digestive well-being is a foremost health concern for consumers, as one in three people around the world struggle with gut-related symptoms, according to the World Gastroenterology Organisation. 
 
With such high prevalence, many consumers are recognizing the value of probiotic and prebiotic supplementation to help cultivate a healthier digestive system. Data from the International Food Information Council (IFIC) Foundation’s 2016 Food & Health Survey indicated a third of Americans said they were trying to consume probiotics, and 10% were working to incorporate prebiotics in their diet. 
 
“While consumers’ understanding of the role of probiotics, prebiotics, and digestive health is still in its infancy, the concept dovetails with desires for more natural approaches to overall well-being,” said Taylor Halstead, product manager for specialty carbohydrates, Cargill, Minneapolis, MN.  
 
Barri Sigvertsen, marketing manager, Lonza Consumer Health & Nutrition, Morristown, NJ, noted that consumer awareness of the term “friendly bacteria” has increased in the U.S “year on year as consumers have access to more information online and more products featuring pre- and probiotics reach the shelves.” However, she suggested there is still progress to be made in terms of educating consumers on the difference between pre- and probiotics, and what she called “their complementary roles in digestive wellness.”
 
Despite the fact that consumers may not fully understand pre- and probiotics, their piqued curiosity has led these ingredients to become a powerful force within the global nutrition market. Future earnings for probiotic supplements and foods/beverages are set to reach $64 billion by 2023, according to a 2016 report from Global Market Insights. Meanwhile, the global prebiotics market accounted for approximately $3.5 billion in 2017, according to Transparency Market Research, with an anticipated 10.3% CAGR in the next seven years, leading to $7.7 billion by 2025.
 
The Basics
The benefits of probiotic bacteria can only be conferred if they are properly “fed” by sustaining prebiotic fiber. 
 
Describing the role of prebiotics in promoting digestive health, Anke Sentko, vice president of regulatory affairs & nutrition communication for Belgium-based BENEO explained this fiber promotes “health and well-being from the inside by supporting naturally present good bacteria.” She called prebiotics “food components” that when introduced to the large intestine are not absorbed, but rather “function there as preferred feed for a few specific beneficial microorganisms.”
 
Well established prebiotics like inulin, oligofructose (FOS), and galacto-oligosaccharides (GOS) fuel the human gastrointestinal tract, which contains trillions of microbes. The gut contains both good and bad bacteria that “require a delicate balance to maintain a healthy microbiome,” said Samantha Ford, business development director, AIDP, City of Industry, CA. Meanwhile, probiotics are the “good bacteria” known for their important role in maintaining many of the body’s mechanisms, she noted, including “immunity, metabolism, inflammation, skin health, cardiovascular health, and more.”
 
Probiotic bacteria naturally exist within the body, but can also be found in yogurt and fermented foods like sauerkraut or kimchi. “In addition, one can take a probiotic supplement to further boost healthy bacteria in the gut,” said Ford. “In supplements and functional foods, probiotics are taken as ‘live bugs.’ Prebiotics, on the other hand, are non-digestible carbohydrates and fibers that stimulate the growth of good bacteria, acting like a fertilizer to enhance the benefits of probiotics.” 
 
The synergistic effect of this fiber and these bacteria has led to the emergence of a category referred to as “synbiotics”—combined pre- and probiotic formulas that work together to promote digestive health and overall wellness.
 
“In many cases, prebiotics in foods, beverages, or supplements interact within the microbiome, often, but not always feeding beneficial bacteria,” explained Len Monheit, executive director, Global Prebiotic Association, Spring, TX. “A broader description of their activity would be to say that they interact to ultimately trigger biochemical pathways, often impacting specific species and even strains of probiotics, native or added through ingestion. This leads to the principle of synbiotics, which is a combination of prebiotics and probiotics that synergistically has demonstrable positive impact on health.”
 
Careful consideration must be given to which prebiotics are selected to promote bacterial growth, cautioned Sam Michini, vice president of marketing and strategy, Deerland Probiotics & Enzymes, Kennesaw, GA. He suggested “it is not as simple as just combining a prebiotic and a probiotic. Some prebiotics are indiscriminate and feed everyone—harmful bacteria included.”
 
Synbiosis, he explained, occurs when “the correct prebiotics are provided in the exact proportions necessary to maximize the desired health effects of the specific probiotic strains through stimulating the growth and activating the metabolism of health-promoting bacteria. True synbiotic products are those that improve the survival of live microbial supplements in the gastrointestinal tract, optimizing the health-promoting activities of the probiotics.”
 
Shaheen Majeed, president worldwide for Sabinsa, East Windsor, NJ, also pointed to synbiotic formulas as a growing category within the nutraceutical market. “According to a Mordor Intelligence report in September 2018, the global synbiotic market is projected at a CAGR of 9.8% during the forecast period 2018-2023,” he said.
 
Interest & Usage
Citing a MARS Consumer Health Study, the International Probiotics Association (IPA) reported recognition of beneficial bacteria is pervasive in the U.S., with 76% of healthy consumers saying they were aware of the benefits of probiotics in 2017. Discussing this data, Michini of Deerland Probiotics & Enzymes called the U.S. market unique in that “nearly 30% of probiotic consumers choose supplements over natural foods like yogurt.” In comparison, just 14% of EU participants said they chose to consume probiotics in a supplement format, he said.
 
The same MARS Consumer Health Study found there are approximately 33 million probiotic consumers who range between 25 and 65 years old; and 65% are middle-aged women, Michini added. The demographic “sweet spot,” however, is parents aged 25-34 who make more than $100,000 per year. “Nearly 75% of these parents reported interest in or regular purchasing of probiotics,” he said.
 
Steve Hanson, executive vice president, global sales, for Prenexus Health, Inc., Gilbert, AZ, pointed to data from the Global Prebiotic Association, suggesting regular users of prebiotics have higher income, are younger than the average supplement user, and are more likely to be female. “Regular users are also more conscious of eating healthy foods and regularly purchase natural and organic foods,” he observed. 
 
Monheit further explained that the main concerns driving dietary supplement users to prebiotic formulas are gut health and digestion. “Over 770 million consumers every day suffer from some form of digestive disorder and the number of visits to physician offices with diseases of the digestive system as the primary diagnosis was 32.3 million in 2017 [according to the CDC].” The second most pressing issue leading consumers to consider prebiotics is immunity.
 
Proprietary market research from Lonza Consumer Health & Nutrition conducted by the Natural Marketing Institute (NMI), Harleysville, PA, found that 23% of the U.S. general population are currently managing digestive health issues via dietary supplements, over-the-counter (OTC) options, or medical prescriptions, and 38% of U.S. consumers are very concerned about maintaining digestive health, up 24% since 2009. The survey of 2,000 participants also uncovered that almost half of U.S. consumers said they would be very likely to use supplements to help manage digestive health issues, up 17% since 2009. Analyzing the top nutritional ingredients for digestive health, Lonza’s Sigvertsen noted “78% of supplements users are taking digestive enzymes for digestive health, while 64% use fiber, 63% probiotics, 58% prebiotics, and 43% Boswellia.”
 
Halstead, from Cargill, referred to HealthFocus International’s 2018 Global Topic Report, which indicated improving digestion was the top functional health benefit that shoppers were seeking in foods and beverages, among a list of 30 health benefits. 
 
“The same study found a strong connection between gut health and overall health in the minds of shoppers, with more than 70% of consumers linking digestive health with their overall physical health,” he said. 
 
Beyond Digestion
While digestive health is a key concern leading consumers to consider pre- and probiotics, continued research on the microbiome is exposing the vast potential for these ingredients to offer benefits beyond the gut. 
 
“On a fundamental level, good gut health can contribute to an overall sense of day-to-day well-being,” said John Quilter, vice president and general manager, GanedenBC30, Kerry Functional Ingredients & Actives, Mayfield Heights, OH. However, he added that clinical evidence now suggests probiotics can help strengthen the immune system, indicating “that our gut is indeed at the very heart of the mechanisms the body uses to fight off illness.” He cited a controlled study (Postgraduate Medicine, 2009) that found GanedenBC30 probiotic (Bacillus coagulans GBI-30, 6086) helped increase immune response to a viral challenge. “Early research (Beneficial Microbes, 2017) also shows a connection of the probiotic with protein utilization,” he added. “This is a promising area of research and one
to watch.”
 
Julie Impérato, marketing manager with France-based Nexira also spoke to the strong connection between digestive health and immunity. “The gut barrier is one of the most important components of the immune system,” she explained. “Actually, 70% of the immune system is located in the digestive tract. Its main role is to absorb nutrients and to serve as one of our body’s most important barriers. It protects us from potential allergic reactions, as well as microbiological and chemical threats.”
 
Challenges for the immune system, such as infection, trauma from burns and surgery, and the use or overuse of many medications, are linked to the condition referred to as Leaky Gut Syndrome (LGS), Impérato said. “Inflammation and damage to the intestinal lining results in a disruption of the tight junctions, resulting in poor nutrient absorption and unwanted substances entering the bloodstream. The incidence of impaired and increased gut permeability, also known as Leaky Gut Syndrome, is increasingly studied because of its potential involvement in many health issues and diseases, such as Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), and others. The possibility of modulating the composition and activity of gut microbiota is considered to be a way to improve LGS and thus improve overall health and well-being.”
 
Nexira has conducted several studies to understand how acacia fiber ferments in the colon. “These experiments confirm that Fibregum fermentation helps to improve the gut impermeability by reinforcing the tight junctions and by providing anti-inflammatory effect. Supported with these studies, Fibregum is the only fiber with a patent pending on gut barrier restoration.” 
 
BENEO has also invested in research examining how prebiotic fiber can help bolster the immune system. A 2018 study conducted at the University of Pécs, Hungary, utilized a composition of chicory root fiber (a variant of BENEO’s Orafti inulin) with kindergarten children and found it supported the gut microbiota by increasing Bifidobacteria and Lactobacilli, resulting in lower numbers of fever episodes requiring a physician’s consultation and sinusitis.  
 
Other research has demonstrated a link between digestive health and weight wellness. Sabinsa’s Majeed pointed to a study published in the Journal of Chiropractic Medicine in 2013 that showed the benefits of B. coagulans MTCC 5856 (branded as LactoSpore) for weight loss and lipid profile management. “In a 21-day weight loss program with pre-post intervention design, regimented supplementation with B. coagulans MTCC 5856 (2x109 CFU/day) demonstrated a clinically significant decrease in body weight, BMI, and waist circumference.” Additionally, Majeed said pre-post intervention decreased the levels of total cholesterol, LDL cholesterol, and triglycerides.
 
The research community is exploring the use of probiotics for health challenges ranging from migraines to eczema as well as for applications in infant formulas, according to Michini. Deerland has been focusing primarily on probiotics in the area of sports and fitness nutrition. Specifically, he referenced two human clinical trials dedicated to the impact of B. subtilis DE111 consumption and athletic and fitness performance and recovery. “The first study looked at performance parameters in female collegiate athletes during offseason training,” he said. “The researchers found that DE111 (1 billion CFU) helped improve body composition and indices of athletic performance (the study used a deadlift). Compared to placebo, DE111 produced statistically significant improvements in the reduction of body fat percentage, and improved performance of the deadlift exercise,” (Journal of Strength and Conditioning Research, 2018).
 
Additionally, another recent study of DE111 (1 billion CFU) showed that the probiotic produced a statistically significant reduction of the pro-inflammatory compound tumor necrosis factor alpha (TNA-a), which accelerates recovery in male collegiate athletes who engaged in post-season training (Sports, 2018).
 
Research surrounding the biochemical signaling between the GI tract and the central nervous system—known as the “gut/brain axis”—is a strong area of exploration for both pre- and probiotics. 
 
A 2019 study published in Nature Microbiology found that gut bacteria Coprococcus and Dialister were capable of producing neurotransmitters, including dopamine and serotonin, which help control mood and behavior. In the study of 2,000 European participants, researchers also found those lacking these two bacterial strains had a higher incidence of depression. While more research is needed, scientists believe these bacteria could be good candidates as supplemental “psychobiotics,” or probiotics used to support mental health. 
 
Likewise, Nicole Durch, senior technical service specialist at Cargill, cited a 2015 human study on prebiotics that suggests it may impact brain function, affecting both emotional processing and stress hormone (e.g., cortisol) levels (Psychopharmacology, 2015).
 
A number of studies have also focused on the impact of prebiotics in the early markers of cardiovascular and metabolic diseases. “For example, scientists in France and Belgium, using an original mouse model, demonstrated that inulin-type fructans may improve host endothelial dysfunction, an early key marker of cardiovascular disease, through changes in the gut microbiota [Gut, 2017]. These findings, if replicated in humans, could support positioning prebiotics as a novel dietary approach to the management of metabolic disorders related to cardiovascular disease.”
 
Additionally, Durch pointed to the discovery of the role of prebiotics in enhancing calcium absorption and improving bone mineral density (Journal of the American College of Nutrition, 2017). 
 
Market Abundance
A broad range of pre- and probiotic products—including supplements, bars, teas, and snacks—have been expanding within the nutraceuticals market, with these ingredients popping up in new and novel formats.
 
“Within this space, there is a growing emphasis on diversity and personalization—a recognition of the importance of individual needs and preferences and, in turn, the satisfaction of these with tailored solutions,” said Kerry’s Quilter. “From cars to clothing, music to movies, travel to TV shows, companies are recognizing consumers’ right to ‘self-express’—respecting the idea that, better than anyone else, they know what’s best for them.” In response, there are a seemingly endless supply of new products designed to give consumers customized ways to consume their prebiotic and probiotic ingredients of choice. 
 
For example, just a few of the new products utilizing Kerry’s shelf-stable GanedenBC30 include: Lola Bars, a range of plant protein and probiotic snack bars; Vegan Rob’s Probiotic Cauliflower Puffs; herbal hot probiotic teas from Bigelow; Flapjacked’s Mighty Muffin with Probiotics; Betty Lou’s Probiotic Bites nutritional bars; Purely Elizabeth probiotic granola; and Good Spread, a probiotic unsweetened peanut butter. 
 
“These products speak to the type of consumers looking for probiotic foods and beverages,” said Quilter. “For example, certain demographic groups are particularly keen on probiotics and their benefits. Among adults, meanwhile, probiotics elicit the most interest from consumers aged 25-34, with significant interest also shown by those aged 35-44. In fact, research shows consumers are willing to pay at least 10% more for a food or beverage containing probiotics.” Further, according to a consumer survey from Kerry, 87% of families are more likely to purchase a product for their children because it is fortified with a probiotic. Additionally, 87% of parents and 61% of millennials said they would pay more for the added benefit of probiotics in beverages. 
 
Many companies are set to capitalize on this interest. Lifeway Foods, Inc., which offers kefir and other dairy products, has partnered with TruFusion Fitness Studios to launch a co-branded probiotic-protein smoothie, TruEnergy fueled by Lifeway. TruEnergy is an 8-oz. kefir drink that contains 21 grams of protein and 12 live and active probiotic cultures designed to meet consumers’ workout recovery needs. The companies said TruEnergy fueled by Lifeway was developed to address the need for a clean and convenient functional fitness grab-and-go offering for members of TruFusion’s boutique fitness studios.
 
While Lifeway and TruFusion’s offering is hyper-specific, a new probiotic chew from Israel-based Anlit, Ltd. is designed for consumers of all ages. Anlit has developed an innovative technology called ProBites LLP, “Long-Life Probiotic” that allows for the high stability of live bacteria in ambient conditions. The company’s probiotic chew line is designed for the whole family, suitable for ages three and up. The chews are available in chocolate, vanilla, and a variety of fruit flavors. 
 
On the confectionery front, Unilever launched its new brand Culture Republick, which the company has called the first premium light ice cream with probiotics. Each pint contains 3 billion live active cultures, 400-500 calories, 16-18 grams of protein, 11-12 grams fiber, and no artificial sweeteners. The product is available in unique flavors such as Macha Chocolate, Turmeric Chai & Cinnamon, and Cold Brew & Chocolate Chip, among others. 
 
Several new products are bringing synbiotic formulas to consumers in a variety of formats. The wellness brand HI! Happy Inside from Kellogg’s delivers prebiotics, probiotics, and fiber in an all-in-one cereal. The three-in-one formula targets digestive wellness by providing 1 billion CFU of live probiotics from active strains, 2.5 grams of prebiotics, in addition to 8-9 grams of indigestible fiber. The cereal includes fruit and yogurt pieces, is made with 100% whole grains, and is available in three flavors: Simply Strawberry, Bold Blueberry, and Coconut Crunch. 
 
On the dietary supplement front, Enviromedica has introduced Terraflora, a broad spectrum synbiotic featuring soil-based probiotic strains and diverse prebiotics. The spore-based microbes in Terraflora are designed “to nurture and support the center of wellness—the human gut,” according to the company. Terraflora contains Ribospore (Bacillus pumilus) and Bacillus megaterium EM144—novel, spore-forming microorganisms shown to generate highly bioavailable, gastric stable antioxidant carotenoids. Bacillus subtilis, Bacillus clausii, and Bacillus coagulans complete Terraflora’s multi-strain probiotic complex. The company also added certified organic prebiotics designed to support healthy intestinal flora, with naturally-occurring food-based polyphenols and polysaccharides sustainably sourced from wild-harvested seaweeds, mushroom fruiting bodies, and humic acid.
 
Dannon’s Activia brand includes Probiotic Dailies—a line of dairy yogurt shots. A new addition to the line includes a variety featuring prebiotics and real ginger. Available in Lemon Ginger and Honey Ginger, each Activia Probiotic Dailies with Prebiotic Fiber includes chicory root fiber, “billions of live active cultures,” and cultured Grade A reduced fat milk. 
 
A relatively new product called Regular Girl uses Taiyo’s prebiotic Sunfiber along with a Bifidobacteria lactis probiotic that utilizes the regulating effects of prebiotics and probiotics to promote digestive balance. The product consists of a powder format, and is available in bulk or single serving sachets. 
 
Country Life has introduced Gut Connection, containing 630 mg of EpiCor, a clinically-studied whole food fermentate prebiotic shown to balance and support the gut by boosting levels of good bacteria. Made using a fermented whole food yeast, it captures a complex array of beneficial nutrients through the process of fermentation. Documented benefits include supporting a shift in healthy gut microbiota (flora) composition, helping maintain the gut lining, maintaining gut barrier function, and supporting the overall gut microbiome. 
 
The line’s eight SKUs include: Digestive Balance, Immune Balance, Sleep Balance, Mood Balance, Cognitive Balance, Stress Balance, Energy Balance, and Weight Balance. Each product comprises easy-to-swallow capsules that are individually formulated with scientifically studied ingredients, depending on the consumer’s needs.
 
Touting itself as an organic prebiotic snack, Gutzy offers fruit and botanical blends in refrigerated pouches featuring 5-6 grams of prebiotic acacia fiber per serving. The pouches contain plant-based ingredients, are dairy- and gluten-free, and have no added sugar. 
 
ISOThrive is a novel bacterial “microfood” in a powdered format, which was recently found to reduce acid reflux. A study published in Integrative Medicine reported that 88% of patients supplemented with the prebiotic formula experienced symptom improvement, while 17% experienced complete symptom resolution. “Resolving chronic heartburn/acid reflux using ‘food’ for bacteria is a novel solution,” said Jack Oswald, ISOThrive co-founder, CEO and CTO. “We have developed a ‘microfood’ that nourishes specific bacteria in the digestive tract to address bacterial imbalances that are at the root of many chronic health issues including acid reflux.” 
 
Closing Thoughts…
Looking ahead, emerging research will solidify pre- and probiotics as critical components for human health, according to Lonza’s Sigvertsen. “We’re only just beginning to understand the human gut microbiota and the role of probiotics and prebiotics in overall health and wellness,” she said. 
 
The Global Prebiotic Association’s Monheit expects growth of prebiotic supplements will outpace the continued growth of synbiotics. “While there are consistent and solid benefits to the synbiotic approach, more research is being conducted on prebiotic mechanisms of action. The challenge is individuality. You need a broad enough responder set in order to be able to demonstrate significance, but we expect that the next couple of years will see new approaches to pre-screening for responders, enabling prebiotic research to encompass the two critical aspects—specificity and then tie that specificity of interaction within the microbiome to an identified health benefit.”
 
Quilter, from Kerry, stressed that branded ingredients have a big role to play in terms of educating consumers and earning trust in order to keep the digestive health category thriving. “Just giving an ingredient a fancy name is nowhere near sufficient,” he warned. “Consumers attracted to a branded ingredient tend to be more informed and curious about the story behind the brand—specifically, what benefits it offers and information supporting its safety and efficacy. It’s no secret that, because information is now at their fingertips, consumers are smarter, more skeptical and much more selective than they used to be. They now expect transparency of information from manufacturers about the products they choose to buy.”