Consumers are seeking targeted, functional benefits in their immune health products.

Call it a gut reaction or call it a change in direction. As more people seek products that promote immune health, the shelves of the wellness marketplace are getting stocked as much with enriched drinks and foods as with jars of supplements.

Developers and manufacturers in the field of wellness/health foods believe the state of the immune health market has been shifting gears dramatically.

“The market for functional beverages has exploded during the past decade,” noted Richard G. Mueller, chief executive officer of Minnesota-based Biothera, the Immune Health Company. “According to a Euromonitor International study, the global market for functional and fortified beverages has more than doubled in the past decade to $86 billion last year.”

Deanne Dolnick, science director for TR Nutritionals in Georgia, pointed to another Euromonitor study–one indicating a decrease in the immune health supplement category by 29 percent from 2009 to 2014. “For many years consumers were boosting their immunity by taking mega-doses of vitamins and other dietary supplements,” she said.

The fact that consumers have moved away from boosting immune health through dietary supplements “doesn’t mean that the consumer no longer cares about boosting their immunity,” Dolnick said. “The healthy/organic food category has grown exponentially during the same time period that dietary supplement sales have fallen.”

Most people would find it almost impossible to get all their micronutrients solely through their diets, Dolnick added. “Vitamin supplements will always be necessary, but should be used as an adjunct to a healthy diet.”

Pro-active Approach

Mueller described “consumers’ embrace of food, beverage and supplements created to provide immune health benefits” as “a recent phenomenon.” He explained that 20 years ago “consumers were focused on the absence of nutritional negatives in beverages (low sodium, refined sugar, artificial sweeteners). They’ve since come to accept the presence of nutritional positives (calcium, fiber) but now are seeking targeted functional benefits (immune health, digestion).”

It is a shift driven by consumers “taking a long-term approach to their health, moving from reactive, short-term fixes to a more pro-active, preventative approach,” Mueller said.

Dan Lifton, president of Proprietary Branded Ingredients Group of Maypro Industries (New York), pointed to the most recent Consumer Survey on Dietary Supplements survey published in October 2014, by the Council for Responsible Nutrition (CRN). “Twenty-five percent of consumers take immune-health supplements, with immune support consistently among the top five health concerns among consumers,” he said. “Not only that—immune health supplement sales were predicted to reach nearly $2.5 billion in 2014.”

Sales of single vitamins are down, but up are “innovative, whole-food-based vitamins,” Pete Maletto, founder and CEO of PTM Food Consulting in New Jersey, said. “It’s big businesses. People don’t buy soy but they buy whey. Vegan protein exploded over past year.”

Perceptions of Immune Health

Recognition of the importance of immune health is increasing. “It has improved over past three or four years, even doubled,” Maletto said. “People see what they are ingesting as important to the immune system. I only see it growing from here.”

Like Maletto, Dr. John Deaton, vice president of technology at Georgia-based Deerland Enzymes, said a properly functioning digestive system is the key to immune health and noted that more immune cells reside in the intestines than anywhere else in the human body. He described probiotics as “beneficial bacteria” playing “a crucial role in the development and operation of the mucosal immune system in the digestive tract.”

Deaton explained, “In many cases, immune dysfunction begins with a ‘failure to communicate’ in the human gut. Considering 80 percent of the immune system is located in the digestive tract, maintaining a healthy gut is becoming a major focal point in the pursuit to support overall health and immunity. When the digestive system is functioning properly it serves as a barrier to bacteria, viruses and pathogens.”

Deaton added, “poor digestion leaves the body and the immune system with a lack of nutritional factors that support immune function and the function of the entire body.”

Categorizing Immune Health

Immune health has always been one of the largest categories within the nutrition category and has recently passed heart health as the No. 1 condition-specific category, according to Karen E. Todd, a registered dietitian and senior director for global brand marketing with New York-based Kyowa Hakko U.S.A., Inc. “Our research has shown that over 70 percent of adults are making some effort to strengthen their immune system,” she said. “Immune health is clearly a large category, and the size and growth will only expand.”

The changes are in the ingredients and not in how people perceive immune health, Todd continued. “What have changed recently in the immune health category are all the new ingredients jumping into the category to gain consumer interest, making it extremely difficult for a consumer to overlook the ones making the most ‘noise’ and look to the ones with the best support,” she said. “Consumers are educating themselves more and are looking for the actual research and information to support their lifestyle choices.”

Mueller noted that Biothera believes “the next big driver of market growth will be immune health.”

As Michael Bush, senior vice president for Ganeden, Inc. in Ohio, said, “It’s an evolving marketplace with new and interesting immune support types.”

In the Marketplace

Bush explained that Ganeden makes one primary ingredient, Probiotic Ganaden BC30, which he described as a Probiotic “starter culture kept in purified strains in a deep freeze.” Ganeden markets BC30 in “various forms and formats” to manufacturers of more than 100 finished products, including probiotic teas by Bigelow and Yogi; a cereal by Post, and a host of sparkling beverages and dairy products.

“In all cases, the organism itself is exactly the same and genetically the same with lots of QC (quality control),” he said. “We produce it; it’s patented by us, and we have about 115 patents.”

According to Bush, Ganeden’s clinical studies have been run by outside firms. Founded in 1997, Ganeden launched a line of supplements in approximately 60,000 stores in 2007 and sold that business when it shifted roles and became an ingredient supplier in 2011. Ganeden has a worldwide presence. “In the last quarter we shipped to 16 different countries all around world,” Bush said.

Maypro’s AHCC (Active Hexose Correlated Compound) is the top-selling immune support ingredient in Japan. Lifton described AHCC as “a cultured extract of mushroom mycelia that is rich in immune-supportive alpha glucans” and its’ manufactured as a “patented, extended liquid culturing process that makes its active components different from other mushroom extract products.” He added that one of the attributes of AHCC is “superior absorption and strong clinical efficacy.”

AHCC is supported by more than 20 human clinical studies and is used in more than 1,000 clinics across the globe, Lifton noted. Studies on the compound have been conducted “at some of the finest research institutions in the world, including highly regarded Ivy League universities. It is unique, in that it modifies both the innate and adaptive immune response.”

Mueller said beverage, food and supplement products utilize Biothera’s Wellmune, a natural immune health ingredient, around the world. It is the active ingredient in the MRM Immune Sport, a new beverage sachet supporting the special immune needs of hard-training athletes. Wellmune also is being used in Enfagrow & Enfakid toddler formula sold in Thailand and Mexico by Mead Johnson Nutrition, in Emergen-C Immune dietary supplements, and in FruitActiv Immuniboost bars from Sun-Rype Products Ltd., based in British Columbia.

“Numerous published, peer-reviewed clinical studies support the ingredient’s ability to help safely and naturally support the immune system,” Mueller said. Studies involving marathon runners, women, aging populations, and individuals under stress have demonstrated that Wellmune can enhance key immune functions; improve overall physical health; help consumers maintain healthy energy levels; provide immune support as people age, and keep people healthy during times of stress.

Kyowa’s major immune health ingredient is called Setria Glutathione, and the brand name, according to Todd, came about by the root of the words “set,” meaning balance, and “tria,” short for tripeptide, a protein made up of a chain of three amino acids. “Setria,” she explained, is Kyowa’s “branded form of glutathione–the body’s master or most important antioxidant.”

Clinical studies show Setria increases blood glutathione levels and supports the immune system, Todd said. “Glutathione levels should be replenished every morning when levels are at their lowest and oxidative risk is high.” She listed Setria’s three important benefits: providing antioxidant protection; promoting detoxification, and fortifying the immune system. Setria is a supplement intended for healthy aging and for the “effective use of vitamins C and E.”

Vitamins

Standard to the wellness market are vitamins.

Since its inception in 2005, TR Nutritionals has supplied vitamins to the dietary supplement industry in the United States and throughout the world, offering nine essential in its portfolio: C, biotin, cyanocobalamin/methylcobalamin, K1, niacin, pyridoxine, riboflavin and thiamine and Pyridoxal-5-Phosphate (P5P). Dolnick explained that P5P is the metabolically active (co-enzyme) form of B6 (pyridoxine) and has recently been gaining attention. “This form of B6 can set apart a multivitamin from the competition,” she said. “P5P is required by various enzymes to carry out reactions in the body. It is vital for a healthy immune system, formation of glucose and niacin, red blood cell metabolism and synthesis of several neurotransmitters including serotonin and GABA. P5P is involved in more than 100 individual reactions, and when taken in supplemental form is readily utilized by the body.”

TR is the No. 1 supplier of Pyridoxal-5-Phosphate in the world, “purchasing its material from one of the most respected manufacturing facilities in China. The production process yields P5P that consistently meets purity levels of no less than 98.5 percent,” Dolnick added.

In May, Pennsylvania-based Genestra Brands introduced a new product, Cor Defense, a once-daily capsule, free of dairy and gluten, that contains European elderberry flower extract, vitamins C and D, and zinc combined with EpiCor, a clinically tested, dried fermentate of Saccharomyces cerevisiae (baker’s yeast) manufactured by Iowa-based Embria Health Sciences.

In a press release, Genestra noted that, “a double-blind, placebo-controlled crossover study by Jenson et al. found that within just two hours, 500 mg of EpiCor supplementation enhanced activation of natural killer (NK) cells and significantly increased antioxidant protection. EpiCor’s fast-acting antioxidant power is just one possible way in which it provides respiratory, immune, and healthy sinus support.”

Probiotics

Maletto called probiotics “the first line of attack in the immune system,” noting the importance of “good bacteria in your gut.”

Among Deerland’s products is DE111, termed as “a highly effective strain of Bacillus subtilis, a probiotic spore that works as a complement to many of the non-spore strains on the market today” by Deaton. DE111 has been fully genome-sequenced and uploaded to GenBank, the National Institutes of Health genetic sequencing database. DE111, Deaton added, “supports digestive and general health by producing enzymes that aid in the digestion of dietary fats and complex carbohydrates into beneficial small chain fatty acids such as omega-3 and omega-6.”

“Physiological testing and a human clinical study have been performed to demonstrate the strain’s ability to control microbial populations in the gut and maintain general health,” Deaton said. “Stability studies show that this spore-forming probiotic remains viable under a wide temperature range and doesn’t require refrigeration.”

Deaton pointed to “a randomized, double-blind, placebo controlled” human clinical study that showed the ability of DE111 “to support healthy gut microflora by controlling microbial populations.” The same study also demonstrated the strain’s ability to maintain healthy levels of cholesterol, glucose and triglycerides.

Consumers

The consumer base for immune health products specifically and for supplements is varied.

Lifton of Maypro noted that approximately 70 percent of women and 65 percent of men take supplements. He described those consumers as predominantly college educated and over the age of 35, who regularly read supplement labels and who have household incomes above $50,000.

“Consumers are looking beyond echinacea and are today much more sophisticated and practical in terms of immune-health products they are purchasing at retail,” Lifton said. “By sophisticated, I mean that they are looking beyond traditional botanicals and vitamin and mineral supplement selections and increasingly—from what we see at Maypro in terms of what ingredients are more and more popular—choosing products with effective, proprietary ingredients that have a compelling story and are supported by published research.”

He added, “By practical, I mean that they want more bang for their buck, and seem to be increasingly buying products with key ingredients that offer multiple structure-function benefits, in addition to immune health.”

Todd said that Kyowa’s top consumers “are interested in strengthening their immune system overall and take a proactive approach to their diet and nutrition versus waiting until it is too late.” Typically, such consumers have been in the habit of taking supplements or eating functional foods to support their immunity.

Mueller reported that Biothera sees a high interest in immune health products among three main groups: mothers and children; athletes, whose immune systems can be temporarily weakened by intense exercise, and older adults taking a proactive approach to healthy aging.

“A Gallup study found that immunity is the most sought after health benefit by moms for their children,” Mueller said. “Biothera research found that 77 percent of moms with young children would probably buy or definitely buy a food or beverage containing Wellmune.”

Prominent Ingredients for Immune Health

In addition to probiotics, the team at Genestra Brands listed the following ingredients as gaining prominence in the development of immune health products: yeast beta-glucans, mushroom extracts, vitamin D, magnesium and omega-3 fatty acids. Public relations account executive Gabriella Gasparich also noted that year-round immune health support is an increasing concern among their clients.

Maletto made note of echinacosdes, natural phenols, which he described as “a mainstay from the 70s.” And he named goldenseal “a big one” especially because of the alkaloid it contains, berberine. “The raw herb doesn’t do as much,” Maletto said. “It needs to be concentrated, extracted. I actually work on delivery systems, using coding, emulsification, nano technology and the micronizing of ingredients.” He also recommended citrus bergamot in the form of an essential oil for reducing cholesterol as well as turmeric in soft gel capsules for its anti-inflammatory properties.

Lifton said that in addition to AHCC, probiotics and polyphenols are attracting a good deal of interest.

Research Interests

Mueller of Biothera noted that, “successful functional products start with safe, efficacious ingredients supported by numerous peer-reviewed clinical studies. Quality clinical research can earn credibility among consumers and support compelling marketing claims that can help better define the product, withstand regulatory scrutiny, and ultimately drive consumer value.”

Mueller also said that Biothera has conducted immune health research that shows consumers attribute a variety of positive benefits to a healthy immune system, including wellness, productivity, energy, mood, mental clarity, stress management, athletic performance and quality of life.

Dolnick of TR Nutritionals pointed to the need to follow a “gold standard” for research, which she described as “a double-blind, placebo-controlled study with enough participants to achieve statistically significant results.”

Lipkin of Maypro weighed in on the importance of clinical research—“proprietary ingredients backed up by human clinical studies, as is the case with AHCC for immune health. While research showing benefits to fruit flies and cultured cells may be intriguing, ingredients supported by a portfolio of human clinical data ultimately spell ‘efficacy,’ and immune health products that work make manufacturers happy and consumer end-users coming back for more.”

Todd of Kyowa also made note of the “gold standard. At Kyowa, we are providing the scientific support through our clinical studies, but are taking it a step further and have data on the immune health category as a whole and tie it back to claims that can be made to support consumer’s interest,” she noted.

Maletto said that when a manufacturer client asks him to explore “every single aspect of immunity” on a product he is developing, he would test for a “footprint.” He also makes use of existing clinical research such as that published in National Institutes of Health peer-reviewed journals.

Bush said Ganeden has 21 published clinical trials, most looking at digestive function and some at protein utilization. “Sports nutrition work,” he concluded, “is very interesting to us. There’s a lot going on.” NIE

For More Information:
Deerland Enzymes, (800) 697-8179
Ganeden, Inc., (440) 229-5200
Ganestra Brands, (888) 737-6925
Kyowa Hakko USA, Inc., (212) 319-5353
Maypro Industries, (914) 251-0701
PTM Foods Consulting, (888) 736-6339
TR Nutritionals, (404) 935-5761

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