As global demand for health products rises, the market for prebiotics and probiotics will grow stronger, in spite of regulatory challenges, thanks in part to broadening scientific research and increased consumer understanding, industry experts believe.
 
Publication of clinical studies evaluating probiotics continues to accelerate and uncover new health indications—outside of the traditionally recognized digestive health benefits—to include immune support, anti-inflammation, oral and skin care and women’s health.
 
However, to date, the European Food Safety Authority (EFSA) has rejected all applications for health claims related to probiotics, establishing a strict environment that has handcuffed marketers at times. Meanwhile, increased regulatory oversight in the U.S. led to false advertising charges from FTC against The Dannon Company for claims that its Activia product relieves irregularity and that DanActive helps prevent colds and flu. Dannon agreed to a $21 million settlement in December, but admitted no wrongdoing.
 
According to FTC, Dannon may not claim that Activia yogurt will relieve temporary irregularity or help with slow intestinal transit time, unless the ad conveys that three servings of Activia yogurt must be eaten each day to obtain those benefits. Dannon may claim that eating fewer than three servings a day provides these benefits only if the company is relying on two well-designed human clinical studies substantiating the claim.
 
More recently, in February, FDA issued a warning letter to Lifeway Foods, Morton Grove, IL, for what the agency considered disease claims related to its Lifeway Kefir and other probiotic-containing products.
 
Still Selling
 
Despite the tension between regulators and marketers, consumers’ buying habits speak for themselves. The global probiotics market, still in its infancy stage, could reach nearly $29 billion in revenue by 2015, according to a report from Global Industry Analysts, Inc. (GIA) titled “Probiotics: A Global Strategic Business Report.” The market is set to witness impressive growth as consumers become more conscious about their health and switch to preventative healthcare due to rising costs, the report said. Enhanced efficiency of ingredients and increasing scientific evidence on the benefits of probiotics are the other major factors facilitating market growth.
 
GIA also predicts the market for prebiotics in Europe and the U.S. will reach nearly $1.2 billion and $225 million, respectively, by 2015. Popularity is rising within the functional food market due to various applications in dairy products, beverages, nutrition bars, breakfast cereals, bakery products, mineral supplements, weight loss products, infant formula and pet food.
 
U.S. sales of prebiotic and probiotic food and dietary supplements exceeded $1.5 billion across natural supermarkets and Food, Drug and Mass channels for the 52-week period ending in February, representing an impressive 28% growth over the previous year, according to SPINS, a market research and consulting firm for the natural products industry based in Schaumburg, IL.
 
Awareness
 
Consumers are accepting the concept that live microorganisms can offer health benefits when consumed in adequate amounts.
 
“Over the last few years in the U.S., more consumers have become familiar with the word ‘probiotics,’ however, a deeper understanding of how probiotics actually work and the differences between specific strains and products are still needed,” said Lauren Weidelman, corporate communications manager, Yakult U.S.A, Torrance, CA, a subsidiary of Tokyo, Japan-based Yakult Honsha, Co., Ltd. “Our company focuses on educating healthcare professionals through annual scientific symposiums and regular probiotic seminars for dietitians. We believe that it is the role of the healthcare professional to educate and guide consumers as to the use of probiotics.”
 
Increased awareness of probiotics and their health benefits has positioned the category alongside the most popular products on the market today, including vitamins and omega 3 fish oils, said Tim Gamble, senior vice president, Sales and Marketing, Nutraceutix, Redmond, WA. “Probiotics, with increased academic and scientific support, are now regularly recommended to consumers by practitioners in traditional medicine, not just integrative or alternative medicine.”
 
Perhaps indicating the mainstream acceptance of probiotics, Ganeden Biotech, Inc., Cleveland, OH, recently launched its enLiven brand of all-natural yogurt exclusively in Wal-Mart stores. The low-fat yogurt contains GanedenBC30 probiotics and is available in four flavors: Vanilla, Blueberry, Strawberry and Peach.
 
Mike Bush, vice president of business development, Ganeden, said the product has been selling very well and Ganeden’s website saw increased traffic, and more downloads of clinical trials, immediately after enLiven’s launch. The product doesn’t make any health claims, simply featuring “with Probiotics” and the Ganeden BC30 logo on the package.
 
It seems, then, a strict regulatory environment hasn’t been a barrier to engaging consumers, Mr. Bush noted, as consumers are taking the initiative to investigate products and research themselves. “I think consumers understand some of the benefits without shoving claims down their throat.”
 
Yakult’s Ms. Weidelman agreed, saying, “I think once consumers experience the benefits of probiotics for themselves, they will understand how and why probiotics can be helpful and important in a healthy diet.”
 
Indications & Research
 
Digestive health continues to represent one of the greatest needs among consumers and, in turn, one of the largest opportunities for companies in the health and wellness arena, according to New Nutrition Business, which ranked digestive health as the top heath and wellness trend for 2011.
 
The overall digestive health market in the U.S. continues to show steady growth, due in part to increased awareness of prebiotics and probiotics, noted Sarah Staley, vice president of business development at FrieslandCampina Domo, Chicago, IL.
 
“While consumer understanding of prebiotics has lagged behind the awareness of probiotics, market surveys show there is sustained interest in the benefits of prebiotic fermentation, particularly prebiotics that increase the level of beneficial probiotic bacteria, like Bifidobacteria,” she said. “In addition, these ingredients can now be found in everyday foods and beverages that fit into consumer’s lifestyles.”
 
Neel Varde, Nutriose product manager, Roquette America, Keokuk, IA, said prebiotics are often bundled with fiber, and consumers recognize their deficiencies in that area. “The recommended daily value for fiber is 25 grams per day, and most adults only get half of this amount,” he said. “In general, a good prebiotic should increase the levels of good bacteria in the gut, decrease the levels of bad bacteria and provide some sort of physiological benefit.”
 
Shaheen Majeed, marketing director, Sabinsa Corporation, East Windsor, NJ, also discussed the unique relationship between pre- and probiotics, saying prebiotic (non-digestible) foods are vital to encourage probiotic organisms to survive and thrive in the human gut. “Probiotic bacteria taken together with prebiotics that support their growth are called ‘synbiotics.’ LactoWise is a synbiotic proprietary composition containing Bacillus coagulans, a probiotic marketed by Sabinsa Corporation under the brand LactoSpore, and soluble Fenumannan from fenugreek seeds as the prebiotic component. Both work together in a synergistic way, more efficiently promoting the probiotic benefits.”
 
Backed by sound scientific documentation, gut health remains the primary indication for pre- and probiotics, said Isabelle Champié, deputy manager and global marketing director for Institut Rosell-Lallemand, Montreal, Quebec, Canada. “Based on today’s clinical proofs, probiotics are particularly effective and recommended to help in the prevention and management of antibiotic-associated and acute diarrhea, lactose intolerance, gastroenteritis, intestinal infection, traveler’s diarrhea, inflammatory bowel disease (IBD), irritable bowel syndrome (IBS) and transit regulation.”
 
Recent years have witnessed a proliferation of published clinical studies involving probiotics. “According to the research database Pubmed.gov, the number of probiotic studies has significantly increased around the world in the last decade,” said Yakult’s Ms. Weidelman. “In the 1990s there were 456 published probiotic studies versus in the 2000s there were upward of 6260 published studies. The numbers are climbing significantly year over year.”
 
For Yakult’s exclusive strain, Lactobacillus casei Shirota, the most compelling study in 2010 was a double-blind, randomized, controlled field trial conducted in the urban slums of India involving 3758 children, Ms. Weidelman noted. “These children were given one bottle of Yakult (65 ml) per day over a period of weeks. The study results indicated that Lactobacillus casei Shirota was significantly effective in reducing incidence of diarrhea in children. This is an important finding since there is a high rate of infectious diarrhea leading to mortality in children in developing countries or areas.”
 
Ms. Champié said that other health indications beginning to emerge include immune support, based on the notion the gut is a primary immune site in the human body. “A growing number of studies show the effects of certain probiotic strains in the prevention of common infectious disease,” she said. “For example, ProbioKid, a synbiotic formula from Institut Rosell-Lallemand has been shown to decrease the risks of common winter infections in children (Cazzola et al., Therapeutic Advances in Respiratory Disease 2010). These results were presented in September 2010 at the European Respiratory Society congress in Barcelona.” She also noted potential benefits for women’s health with respect to the maintenance and protection of the urogenital microflora.
 
Dr. S. K. Dash, president, UAS Laboratories, Eden Prairie, MN, agreed that probiotics have gained momentum from research that demonstrates clear health benefits. “Consumers are concerned about the antibiotic residues in milk, meat and eggs and are more concerned about antibiotic resistant bacteria,” he added. “This has made consumers prefer probiotics instead of antibiotics.”
 
UAS Labs has completed a study on IBS that it expects will be published in June. Another clinical trial on urinary tract infections is underway and expected to be completed by the end of May, Dr. Dash added.
 
Among other areas of research, Scott Bush, vice president of marketing, Health & Nutrition, Danisco, Madison, WI, said inflammation represents an interesting direction that probiotic research is starting to explore. “As medical science continues to better understand diseases and outcomes related to inflammation, the ability of probiotics to modulate inflammatory responses may be very significant. I expect we’ll see more research in that area.”
 
Application Issues
 
Logically, different probiotic strains behave differently. As a result, manufacturers must assess their needs before formulating, either with dietary supplements or functional foods and beverages.
 
In the case of the latter, stability of probiotics in different food matrices depends on the specific strain, said Joanie Dion, technical representative, Lallemand Nutritional Food Ingredients. “Particular strains better resist acidic conditions, like in beverages, or osmolarity shock, like in chocolate, or even to heat treatment, like in bread and muffins. The challenge is to maintain adequate concentration through the shelf-life depending on storage conditions of the finished product.”
 
While yogurt and dairy products have been the traditional vehicles for probiotic-fortified foods and beverages—due to a typically short shelf-life and refrigeration—better technologies have expanded potential applications to other food areas, including chocolate, juices and baked goods.
 
For example, NextFoods, Boulder, CO, has added Probiotic Coconut Water to its GoodBelly line of probiotic fruit drinks, which contain the patented Lp299v strain. The new product contains 20 billion live and active probiotic cultures and 80 calories per serving.
 
Michael Shahani, director of operations for Nebraska Cultures, Inc., Walnut Creek, CA, said that improvements in understanding how probiotics can be stabilized in food and beverage applications, has led to more successful product launches. “We are getting numerous inquiries about putting probiotics in dried meal replacement and energy beverage mixes, infant formula, frozen yogurt mixes, chocolate and other foods,” he said. “We expect quite a bit of new business for these applications.”
 
Lorraine Niba, business development manager, Nutrition, National Starch, Bridgewater, NJ, said bars and other more trendy products like shots and chews are gaining popularity among consumers. “Ingredient suppliers who can offer functional ingredients that can be easily incorporated in multiple food, beverages and supplement categories will be at an advantage in this attractive market.”
 
Sabinsa’s Mr. Majeed said his company’s LactoSpore could be used in powder form in ready-to-drink mixes suitable for use in room temperature liquids, dry suspensions, tablets, capsules, chewable tablets and dispersible tablets. Fenumannan can also be used in dry soup mixes.
 
After some hesitancy to launch new products in an unstable economy, Ganeden’s Mr. Bush said he believes more companies have regained confidence. “Food companies have such long development cycles but we’re starting to see some acceleration now.” He also noted growth in the animal health and personal care markets. “On both fronts, we’re starting to see more aggressive research and development.”
 
While improvements in food and beverage formulation have proffered growth for the category overall, dietary supplements continue to offer better viability and higher potency than other forms, according to Mr. Gamble, of Nutraceutix. “Probiotic chewables oral health products, probiotics in combination with vitamins and other top selling active ingredients are being formulated and produced at a heightened pace as brands seek ways to capture the attention of increasingly educated consumers.”
 
Danisco’s Mr. Bush said the potency of probiotic supplements continues to increase. “It’s not a short-term trend. It’s been going on for some time, but the numbers are getting significantly higher. Ten years ago a lot of the counts were single digit billions—10-20 billion live bacteria would have been a very high count—now we’re seeing products with 40, 60, 80 and 100 billion counts.”
 
He also noted VSL#3, marketed as a medical food for the dietary management of patients with ulcerative colitis (UC), an ileal pouch (IP) and irritable bowel syndrome (IBS), has a bacteria count of 450 billion.
 
“While part of the drive to higher counts may be marketing driven, we have sponsored clinical studies in which a dose response is shown to exist with the higher count proving more efficacious.”
 
In order to preserve viability of probiotic counts, Capsugel, Peapack, NJ, has developed a series of capsules that provide for flexible and targeted delivery of probiotics. All the capsules use hydroxypropyl methylcellulose (HPMC), which is lower in moisture (4-6% in 50% relative humidity) than regular gelatin (12-14%) and thus protects the moisture-sensitive probiotics from activating in the package and/or before it reaches the intestines, where they are most effective for digestive health.
 
Recently, the company introduced DRcaps, vegetarian capsules with properties that slow down capsule opening after swallowing and are particularly suited for probiotics. In vitro studies show the capsule contents are protected for at least 30 minutes at a gastric pH of 1.2 and release fully at an intestinal pH of 6.8.
 
Capsugel also offers Pre-Pro Combo, which is designed to contain a combination of prebiotic and probiotic ingredients. It utilizes the company’s Moisture Defense System (MDS), which includes the use of capsule-in-a-capsule technology. The inner capsule of the Pre-Pro Combo contains L. acidophilus, which is then suspended in a liquid-based prebiotic formula containing fructo-oligosaccharide (FOS).
 
“Prebiotics and probiotics can work together to improve the ultimate nutritional effectiveness of probiotic ingredients,” said Mark Vieceli, director of sales, marketing and business development for Capsugel, Americas Region. “However, prebiotic regimens are less common because they are new to the market and more difficult to find on store shelves. The Pre-Pro Combo gives manufacturers a distinctive way to efficiently offer consumers additional benefits within one unique product.”
 
Pre-Pro Combo is designed so that the inner capsule containing the probiotic culture takes longer to fully dissolve, helping to improve its ability to reach the digestive system where it is most effective. “The natural-delayed dissolution properties of Pre-Pro Combo reduce the need for enteric coatings,” said Mr. Vieceli. “Such coating processes add an extra step in manufacturing, and the heat and moisture involved can affect the viability of the live bacteria.”
 
Regulations & Differentiation
 
While the pre- and probiotics market seems to be thriving in spite of a restrictive regulatory environment, Danisco’s Mr. Bush noted a lack of approvals has negated a significant point of differentiation for companies that have invested in research.
 
“The types of claims we see on products with science behind them are often no different than the statements made on products with no science,” he said. “It’s really hard to differentiate a documented product from an undocumented product at the consumer level. Researchers and physicians can spend the time to read the literature and see what is supported by good science. But the consumer walks into a health food store, picks up 10 products and reads the labels, and they can all sound remarkably similar.”
 
Nebraska Culture’s Mr. Shahani said that as the market progresses, it’s important to educate both manufacturers and consumers about the benefits and limitations of probiotics. “We have already seen that some manufacturers making unsubstantiated claims about the efficacy or stability of their probiotic products has tarnished the reputation of the industry as a whole. As a result, regulatory agencies such as the FDA and the FTC are beginning to take a closer look at the probiotics industry.”
 
Nebraska Cultures supports efforts of organizations like the International Probiotic Association to work with companies and regulatory agencies to ensure that probiotics are promoted and regulated in a responsible and effective manner, he added.