size of the gastrointestinal support category in 2021

The human body is host to a complex ecosystem of some 40 trillion bacteria, viruses, fungi, and yeast. Researchers estimate that these microbes outnumber human cells an average of 10 to 1, and this collection of microorganisms, known as the microbiome, has been shown to have a major impact on our overall health and wellbeing. 

“The role of the gut microbiome in human health and disease has received increasing attention over the last 20 years, and this increase in interest can be attributed to the invention of next-generation sequencing technologies—the completion of the Human Genome Project, the launch of the Human Microbiome Project, and the Metagenomics of The Human Intestinal Tract,” notes Nirmal Nair, CEO, Sempera Organics. “Articles and papers on gut biome supported by private and public funds have been increasing for the past 26 years and are up by 80% in recent five years.” 

What scientists have discovered is that the microbiome has a direct influence on everything from digestion to immune function to mood and hormone balance. “Thanks in part to microbiome sequencing and other scientific advances, we have a much greater understanding of how gut microbiota and associated metabolites contribute to gastrointestinal diseases, immune dysfunction, neuropsychiatric conditions, and obesity,” explains Brandy Webb, ND, Scientific Affairs Manager, Probi USA, Inc. “Intestinal microbiota help regulate the production and activity of hormones, neurotransmitters, cytokines, and other key compounds that affect virtually every biological pathway.” 

This biological influence of the microbiome has far-reaching effects on many facets of health, says Anurag Pande Ph.D., VP Scientific Affairs, Sabinsa. Gut microbiome has been implicated in shaping our immune system, training our immune cells, and inhibiting autoimmune disorders. The microbiome’s role in digestion is well known: aiding absorption of micronutrients and macronutrients, allowing the body to receive nutrition from food. The gut-brain axis discovery led to investigation into the role of the microbiome on cognitive performance, as well conditions such as depressive disorders. Chronic health conditions affecting the microbiome have been linked with occurrence of cognitive health problems like depression and anxiety. The microbiome is also implicated in healthy metabolism and healthy weight management; obesity has been linked with poor diversity of certain microbes. Skin health is another area where research is showing a connection between the gut microbiome, as well as the skin microbiome, on skin health.” 

The impact of the microbiome may extend still further, muses Miquel Bonachera, Co-Founder and Executive Director, AB-Biotics. “Interestingly, several recent papers have noted the influence of gut microbiota on the modulation of sex hormones, noting the influence of the gut on oestrogen, progesterone, and corticosterone levels. This is a subject that will keep gaining popularity in the following months, since it opens the doors to microbiota-modulating treatments developed for women or men specifically to alleviate conditions caused by hormonal disbalances such as menopause.”

There also is speculation that the microbiome plays a role in the body’s circadian rhythms and sleep cycles, points out Jay Levy, Director of Sales, Wakunaga of America. “Because the gut microbiome is incredibly complex, these findings may just scratch the surface of how it can either help or hurt overall health. According to the University of Chicago, researchers are currently investigating how the microbiome might impact other health conditions, including acne, Alzheimer’s disease, asthma, celiac disease, colon cancer, heart disease, kidney stones, liver disease, multiple sclerosis, psoriasis, rheumatoid arthritis, and stroke.”

Keys to Fostering a Healthy Microbiome

“The microbiome’s role on human health is so significant that it’s now considered an organ, on account of the biochemical interactions between the microorganisms and their hosts, and their systemic integration into the host biology,” says Bonachera.

Researchers working to develop targeted microbiome medicine to treat specific health conditions have started to formulate recommendations for what a healthy microbiome should look like, reports Dr. Pande. “It’s important to note that the composition of a healthy microbiome does vary from person to person. There is still much we don’t know about what constitutes an ideal microbiome, but there are some general characteristics of a healthy microbiome such as microbial diversity, healthy balance of good bacteria, as well as resilience of microbiome towards health disturbances.” 

As with other organs in the body, nutrition and lifestyle choices and other environmental factors can make or break the health of the microbiome. “Diet and lifestyle play a huge role in determining the composition of the gut microbiome,” notes Webb. “A high-fiber diet is essential, since fiber serves as a prebiotic food source to help probiotic strains colonize and produce beneficial metabolites. Emerging research suggests that different microbiota prefer specific prebiotic forms, so it is important to consume a variety of fiber-rich foods. Regular exercise has also been linked to greater microbial diversity and is an essential part of maintaining a healthy gut microbiome.” 

Similarly, certain factors can deplete populations of beneficial bacteria and allow bad bugs to flourish, creating an imbalance in bacteria known as dysbiosis. Brian Terry, Director of Sales, Retail, Nordic Naturals, cautions, “Many factors including stress, aging, diet, environmental toxins, medications such as antibiotics, and a sedentary lifestyle can result in the loss of microbial abundance and/or a lack of microbial diversity.” 

That’s a problem because if dysbiosis is left unchecked, it can trigger health issues. Lizbeth Cabigas, Business Manager, AIDP, explains, “In the short term, and perhaps of immediate interest to the general consumer, is the way dysbiosis shows up symptomatically, starting with perhaps some GI distress, food intolerances, bloating and so on [and] eventually leading to issues like fatigue and poor immune responses.” 

Over time, microbiome imbalances can leave people vulnerable to leaky gut and other complications. “Absence of a healthy microbial composition can also lead to degradation of the protective barrier provided by the single layer of cells forming the intestinal lining,” says Terry. “Undesirable substances can then enter the bloodstream through small breaks in the gut wall, known as increased intestinal permeability or leaky gut. This can set off a cascade of initially low-grade inflammatory immune activities in the gut wall, as the body tries to seal the leaks and re-establish the protective barrier.” 

Consumers are becoming increasingly aware of the impact of the microbiome on their health, and they are turning to supplements to support and nourish their gut flora. “Consumers are looking to the microbiome for whole-body health, prompting solid growth for the gastrointestinal support category, which hit $3.5 billion in 2021, according to Nutrition Business Journal,” says Justin Green, Ph.D., Director of Scientific Affairs for Cargill’s health technologies business. “Though probiotics still make up the lion’s share of the market at 58.9%, new products featuring prebiotics and postbiotics are emerging with strong clinical evidence that could lead the category to new heights. In fact, proprietary research from Cargill finds nearly half of shoppers are familiar with postbiotics.” 

3 Strategies to Maximize Microbiome Sales 

This emerging category can quickly become confusing for consumers and retail employees.   Stocking shelves with the highest quality products will help ensure that your customers see tangible benefits from their purchases, which will make them more likely to become repeat buyers. Smart strategies:  

1. Get creative with education: Most consumers are familiar with the microbiome and its impact on health; however, helping them understand the basics, like which strains to look for and their suggested health claims, can help them make more educated purchasing decisions,” says Rob Brewster, President, Ingredients by Nature. “One way to do this is to include this information in the store’s newsletters, magazines, and apps. Educational signage within the supplement aisle can also be helpful as they shop.” Setting up an in-store educational workshop or expert lecture on the microbiome may also be helpful. 

When it comes to probiotics, Brittany Gordon, MBA, Marketing Manager, Probi USA, says there are steps retailers can take to ensure they offer only high-quality products to their customers. “The first step is to look for strain designation on labels and avoid products that list only genus and species. Next, retailers should perform their own research on strains using online resources such as PubMed. Retailers should also consider factors like clinical testing, potency, shelf life, and CFU count. Finally, retailers can ensure efficacy by purchasing exclusively from reputable manufacturers or suppliers with rigorous validation methods and stability data.”

2. Make it personal: Probiotic and prebiotic formulas have gotten more targeted, so it’s a good idea to stock products that address a wide range of health issues, age groups, and gender. “Recently, we’ve had special requests to develop specific formulas to aid women’s health, including perimenopause and menopausal symptoms,” notes Brewster.  

“It is also important to tailor messaging based on the values of the intended audience according to market analysts,” adds Gordon. “For example, younger generations value sustainability while older demographics favor familiarity when purchasing supplements.” 

3. Stock up on fresh delivery formats: “New delivery formats for probiotics and other microbiome-supporting products are expected to gain popularity,” says Allison Chandler, Brand Head and B2B Marketing Head, Novozymes OneHealth North America. “Traditional capsules and tablets are being supplemented or even replaced by more user-friendly formats like stick packs, gummies, and functional foods and beverages. Probiotics, prebiotics, and postbiotics can be incorporated into everyday foods and drinks, like yogurts, energy bars, or kombucha, providing an easy and seamless way to improve gut health.” 

As much as consumers want products that are efficacious, they also want products that are appealing and easy to use, adds Auke Zeilstra, Managing Director for North America at FrieslandCampina Ingredients. "As we all juggle increasingly busy work, family, and social lives, tasty and convenient products hit a consumer sweet spot – and these are the products that retailers should focus on. Snacks and drinks that pack multiple different benefits are great for giving consumers a quick nutritional hit, but supplements are also a popular choice – in the U.S., 58.5% of adults use at least one nutritional supplement daily. This is especially true of novel formats like fruit-flavored gummies, which can offer a moment of enjoyment as well as a nutritional boost. Of course, retailers must also be cognizant of balancing these benefits with efficacy. Seeking products that leverage scientifically proven ingredients – and clearly communicating their benefits – is a must. When it comes to prebiotic supplements, it can be hard to find products that get the balance between convenience, experience, and efficacy exactly right. This is because prebiotics typically require a high dose to be effective, making smaller formats a challenge." 


The Latest in -Biotics 

The field of probiotics, prebiotics, synbiotics, and postbiotics is becoming more specialized and targeted as science continues to explore the intricate relationship between the microbiome and various aspects of human health, Chandler points out. Here, some of the emerging strains and fibers with study-backed benefits. 

Probiotics: “There are hundreds if not thousands of different strains that live in the gut microbiome, with each impacting the body in different ways. Science has just scratched the surface on how to deliver specific strains in targeted supplements,” according to Levy. For instance, Wakunaga signature probiotics supplement feature a clinically studied proprietary blend of three biocompatible human strain probiotics, Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, and Bifidobacterium longum MM-2 to support a healthy digestive and immune system. “We also offer our Max Probiotic, with 50 billion CFU as a recovery probiotic for those that need to replenish and restore their microbiome after medication use, or while traveling, or under stress as these conditions can deplete the balance of good bacteria in
  our system.” 

Other clinically studied strains include Sabinsa’s LactoSpore, says Dr. Pande. “This shelf-stable probiotic strain of Weizmannia coagulans MTCC 5856, has been clinically studied for its role in overcoming depressive disorder resulting from chronic gut conditions such as irritable bowel syndrome.” 

Probi USA offers two science-backed strains with proven immune benefits as well. “Lactiplantibacillus plantarum HEAL9 and Lacticaseibacillus paracasei 8700:2, which comprise Probi Defendum, have been clinically proven to have a measurable impact on immunity within two weeks,” says Webb. “In addition to immune benefits, HEAL9 has been shown through preclinical and clinical trials to improve health parameters related to cognition, mood, and stress responses.” 

Customers looking for mood support may also want to consider bifidobacterium longum 1714 strain, found in Novozymes OneHealth ProbioBrain, notes Chandler. “It has shown in two placebo-controlled clinical trials to help adults handle the psychological and physical responses to stress and to significantly reduce cortisol output in response to stress.” 

Bonachera points out that AB-Biotics offers their i3.1 probiotic blend (P. acidilactici KABP 021 and L. plantarum KABP 022 and KABP 02), which was shown to reduce diarrhea and boost mental health and productivity in healthy Japanese volunteers under stressful conditions. 

Prebiotics: “Prebiotics are not new, but scientific advances in our understanding of their connection to many aspects of human health have made it one of the fastest-growing nutritional supplement categories,” asserts Ruud Albers, Ph.D.,  founder and Chief Scientific Officer of NutriLeads. “Prebiotics are fibers and oligosaccharides that nourish and promote the growth of specific beneficial microorganisms already present in the GI tract. However, the effectiveness of these special fibers can vary greatly due to interpersonal differences in gut microbiome composition. Competition among microbial communities for resources is fierce. Low specificity fibers with a simple structure can be utilized by numerous different microorganisms and their effect is thus highly dependent on one’s preexisting microbiota. Very complex or rare fibers have extreme specificity and can only be utilized in those subjects that have the rare microorganisms that can utilize it. The sweet spot—fibers of medium to high complexity—can be used to target specific beneficial microorganisms present in virtually all people with precision, thus supporting different aspects of human physiology resulting in distinct health benefits.” 

This new science has led to the development of “precision prebiotics,” which cultivate the growth of specific beneficial gut bacteria. AIDP offers precision prebiotics. “Our BeautyOligo is a high-purity galactooligosaccharide prebiotic with unique human clinical data on skin health: reduction in wrinkle appearance, improved skin hydration and evening skin tone,” says Cabigas. “And our Actazin green kiwi powder not only supports gut motility and regularity, but benefits protein digestion and amino acid absorption—a huge benefit in the sports market.” 

On the topic of sports nutrition, Zeilstra notes, "The gut-muscle axis is a particularly exciting development, as it could unlock the potential for a brand-new category of sports nutrition solutions which provide multiple benefits. It’s even more pertinent when you take into consideration that intensive exercise, stress, and dietary habits associated with heavy training have been shown to cause gut discomfort – in fact, as many as 86% of athletes suffer from gastro-intestinal issues. And with more Americans exercising to improve their health – a third are more physically active than they were pre-pandemic – it’s possible we could see this become an even bigger issue among consumers. Ultimately, this is a previously untapped area of nutritional science that could level up sports nutrition NPD as we know it in the coming years. To help brands leverage this emerging space, we recently launched Biotis Fermentis – a first-of-its-kind solution which combines the benefits of whey protein, prebiotic galacto-oligosaccharides (Biotis GOS) and probiotic cultures by fermenting them together, creating a unique formulation that targets the gut-muscle axis and enhances sports performance."

Another ingredient with support from clinical trials: NutriLeads’ signature ingredient BeniCaros, a prebiotic fiber derived from carrots, shown to consistently increased the abundance of 30 beneficial bacterial species, including Bifidobacteria (B. longum and B. adolescentis) as well as anti-inflammatory species (e.g., F. prautnizii, A. halii, R. hominis) independent of starting microbiota composition.

Stratum Nutrition’s prebiotics fiber Bimuno has clinically proven benefits to support cognitive wellbeing and help cope with stress by reducing cortisol levels, according to Collins. “Bimuno can help balance the gut microbiome by raising levels of bifidobacteria in as little as seven days.” 

Synbiotics: “These are combinations of prebiotics and probiotics that work synergistically,” says Chandler. “As the understanding of the complex interactions within the microbiome improves, there might be a greater emphasis on products that combine various components to enhance overall microbiome health.” One such example: Wakunaga offers Pro+ Synbiotic, a berry-flavored chewable tablet packaged in daily serving packets. This unique combination of two grams of prebiotic and 20 billion CFU of nine clinically studied strains, provides convenient and effective digestive support.  

Postbiotics: “In the colon, probiotic bacteria ferment dietary fibers and polyphenols, which results in the production of postbiotic metabolites,” explains Ross Pelton, RPh, CCN, Ph.D., Science Director for Essential Formulas, Dr. Ohhira’s Probiotics. “Postbiotic metabolites are increasingly recognized as health-
 regulating compounds that influence all organ systems throughout the body, including the brain and the immune system. They are critical regulators of the gut microbiome ecosystem and overall human health.” 

One advantage of postbiotics, defined as heat-treated or dead probiotics and their metabolites, is that they offer similar health-promoting benefits as probiotics without the stability concerts. “This has big ramifications on product development because these postbiotics are inherently easier to keep stable during processing and storage as they do not need to be kept alive,” says Dr. Green. “There is still much to learn about the gut-immune connection and postbiotics are quite new to our lexicon. Nonetheless, given the science-backed benefits these ingredients provide and consumers’ increasing interest in immune support, products containing postbiotics are well-positioned for steady growth.”

One such example: Cargill’s EpiCor postbiotic, which has eight published clinical trials and seven pre-clinical studies demonstrating a wide range of health benefits, including nasal comfort, daily immune balance,, and gut microbiome support. 

Stratum offers the postbiotic LBiome. “LBiome has some exciting new research that was just published that shows it is able to extend its gut microbiome support to our canine pals,” says Collins. “In addition, the new LBiome pet research shows that LBiome was able to attenuate the oxidative stress response dogs can get when traveling in a car.” 

 More microbiome supports 

“Research has shown certain nutritional supplements encourage the growth of healthful organisms in our gut,” says Dr. Pande. He notes that Livinol, a proprietary extract derived from the fruit rind of Garcinia indica, has been shown to increase the population of intestinal dwelling commensal Akkermancia muciniphila, a mucin dependent organism associated with healthy weight loss. “In addition, A muciniphila increases the cellular energy regulator AMPK. Promotion of Akkermancia also increases gut barrier providing support from the onslaught of toxins.” 

Curcumin, found in Sabinsa’s CurCousin and Curcumin C3 Complex, has also been shown to improve the populations of certain good bacteria. “CurCousin decreased the obesity associated Ruminococcaceae and Butyricicoccus genera as additional mechanisms of moderating obesity. And a human clinical study on Curcumin C3 Complex found prebiotic-like activity was demonstrated. Unlike prebiotics, which are necessarily driven by catabolism of sugar components, researchers attribute the prebiotic-like effects of curcuminoids to ‘suitable alterations of host physiology congenial to the growth of beneficial

To help remedy a leaky gut and help restore balance to the microbiome, Hank Cheatham, Vice President, Daiwa Health Development, recommends supplementing with ImmunoLin, a powder form of serum-derived immunoglobulin concentrate, found in Daiwa GastroImmune. “Daiwa GastroImmune contains the highest concentration of naturally sourced immunoglobulins and is shown to help restore gut homeostasis, support healthy GI barrier function, bind and to neutralize bacterial toxins in the gut, and aid in uptake and utilization of nutrients.” 

Gut flora health benefits also come from mushrooms, adds Nair. “This is an important area of research for us as we continue to develop bio-active ingredients for nutraceuticals and functional food and beverage applications.”

Black seed oil extract, branded as ThymoQuin, also shows promising microbiome benefits, adds Dr. Liki von Oppen-Bezalel, Business Development Director, TriNutra. “In clinical studies, ThymoQuin has been shown to contribute to a healthy microbiome, immune health, and overall mental well-being in endurance athletes. Another study revealed that B’utyQuin, TriNutra’s standardized BSO, helps to balance the skin and gut microbiome through inhibitory effect of growth of pathogens, and thereby improves skin conditions and appearance. In multiple placebo-controlled clinical studies, ThymoQuin as a stand-alone as well as in synergistic combinations with omega 3 or astaxanthin, showed significantly fewer upper-respiratory tract complaints such as cough, sore throat, and sinus congestion, and better overall well-being, such as lower stress and increased energy, as well as lower levels of the stress hormone cortisol and superior microbiome diversity, including increased populations of S. thermophilus.” 


Mastering the Microbiome Market

There’s so much more to know about the microbiome, and world-class experts took a deep dive into the expanding category at the education conference Microbiome: Mastering the Market, which was held virtually in May. Researchers and industry leaders discussed the latest science, consumer trends, regulatory guidance, marketing and messaging strategies, and more. Sessions topics include:

• Dietitians and ‘Biotics – Driving the Discussion

• Mechanistic Mining of the Microbiome for Metabolic and Mental Health

• The Next Generation of Immune Health – A Postbiotic with Real Clinical Research

• Abundant Biotics: Engaging brands and consumers on the definitions and diverse benefits of pre- and postbiotics

• Insights into ‘Biotic’ Supplement Consumers  – Deep Dive into Gut/Brain and Inflammation Targets

• SIBO: A Common Imbalance in the Gut Microbiome – Clinical Pearls for Diagnosis and Treatment

• Actionable Microbiome Insights for Health, Disease, Aging, and Drug Responses

• Targeting Science to Meet Consumer’s Digestive Needs

• Awakening New Perspectives: Enzymes for Digestion and Microbiome Health

• The Kitchen Prescription: How to Revolutionize Your Gut Health with the Food You Eat

• Case Studies: Microbiome Entrepreneurship

•Challenges in Postbiotic Communication: Are consumers ready for postbiotics?

• These Folks can Really Shut You Down (a look at class action activity)

All of these sessions are available to view on demand, at no cost, on NaturallyInformed.net (scan the ELi Code for access). WF


Helping Customers Heal:

The 5 “R’s” of Gut Health 

“New research is showing that taking just any brand/strain of probiotics boasting 1M+ CFU is not the right choice for everyone. Every person’s microbiome is different, in differing stages of dysbiosis, and requires different tools to get them back on track,” cautions Brian Kaufman, RN, Vice President of Global Sales, Proliant Health and Biologicals. “Many people quit using probiotics because they feel they are not working, or make them feel worse, when the truth is that they just introduced them at the wrong stage. Starting your gut health journey with a standard probiotic is a recipe for ‘die-off’ disaster and a big reason why many don’t consistently take them.”

To help your customers get better results from gut health products, Kaufman suggests encouraging people to consider, “What stage of dysbiosis am I in?” From there, use the five “Rs” of gut health set forth by the Institute of Functional Medicine to select the appropriate gut health tool: Remove, Replace, Reinoculate, Repair, and Rebalance.

“As an example, you want to start by Removing bad bacteria with an immunoglobulin,” Kaufman explains. “Then Replacing deficient enzymes in the gut needed to help break down foods. This is followed by Reinoculating or rebuilding the microbiome through use of pre- and probiotics which feed good bacteria. Next is Repairing the gut lining by nourishing it with great things like bone broth and L-glutamine. Lastly, these factors culminate together to Rebalance which is all about lifestyle. Work-life balance, choosing anti-inflammatory foods, and managing stress in combination with the other 4 Rs lead to gut homeostasis and living that best life we always talk about.”