Powerful Pairings For Digestive Wellness

As digestive health interests rise, tried-and-true ingredient combinations and innovative delivery methods drive the category.

for Digestive Wellness

The market dynamics and trends among the three digestive health ingredient segments—probiotics, prebiotics and enzymes— are very different, according to MarketsandMarkets.com. Prebiotics and probiotics are growing at double- digit growth rates as compared to digestive enzymes, which are experiencing a relatively lower growth rate..

But make no mistake: all are growing. “The market for digestive wellness products has grown rapidly in recent years, since there is more demand for natural products and the movement for better health, and the realization of the damage that fast foods and artificial ingredients can cause our health, especially our digestive health,” added Ron Yaffe, ND, chief science officer with Novel Creation Dietary Supplements (Neve Yarak, Israel). “People are realizing that better health starts with better digestion. There are some studies showing that almost 60 percent of the population suffers from some sort of digestive problem.”

In fact, patients suffering from inflammatory bowel disease and irritable bowel syndrome (IBS)—an estimated 1. 4 million in the United States alone— are driving domestic sales, according to Mark Cieceli, director of sales, marketing and business development with Capsugel, Americas Region (Greenwood, SC). “They view probiotics as a ‘natural’ alternative to prescription drugs and look to their gastroenterologist or health practitioner for advice.”

In addition, Sarah Staley, vice president business development with FrieslandCampina Domo (Paramus, NJ), shared that consumer awareness has increased due to the recognition of the link between digestive wellness and a balanced immune system. “With the rising cost of health care, consumers appear more open to considering preventative measures to benefit their long-term health. While the rest of the world has embraced products aimed at digestive health for a number of years, it is only very recently that the U.S. consumer has become more comfortable in discussing digestive health and considering consumption of products that could assist digestive wellness,” she said. “Since it is estimated that 70 percent of your immunity derives from your digestive system, improper digestion or poor digestive health can indeed lead to larger problems. The adult human gut contains approximately 10 to the 14 microorganisms or, to express as weight about 1–1.5 kilos or approximately 2. 2–3.3-lbs. of live bacteria. It is vital that the micro-flora present are in balance; if pathogenic or harmful microorganisms proliferate then problems can occur including illness and disease, hence the reason it really all starts with a healthy digestive system.”

But as the market is growing and consumers’ needs are evolving, Yaffe pointed out that it’s often not a single ingredient or product that’s in demand. “Most consumers are looking for as few products as possible, therefore are looking for a combination of ingredients,” he said. “As far as ingredient combinations that work well, they are usually a combination of herbal extracts or active herbal ingredients that has a synergistic Effect such as anti-inflammatory, antiparasitic, anti-fungal, antibacterial herbal combination. Another combination that works well is probiotic supplements that combine various species and other ingredients that can support the production of the beneficial bacteria such as FOS [fructooligosacchides].” 

Probiotics

MarketsandMarkets.com’s November 2010 report showed the probiotics market in the U.S. is at an emerging stage. With reference to the awareness level among the U.S. consumers against European consumers, the U.S. consumers are still becoming more aware. In the U.S. market, the consumption of probiotics through dietary supplement products is high. However, in Europe probiotics are often consumed in a more diluted form through dairy and other food and beverage products.

A point concurred by Euromonitor International statistics, which showed in 2009, probiotics were the No.1 nonherbal dietary supplement in Japan and Western Europe, while they ranked the sixth best seller of non-herbal dietary supplements in the U.S. By 2010, however, the U.S. emerged as the No. 1 individual market for the sale of probiotic Supplements with Italy and Japan following in second and third places, respectively, according to a July 2011 Euromonitor report on probiotic supplement trends. Of the $2.2 billion of global probiotic supplement sales in 2010, the U.S. logged $567 million, Italy registered $493.5 million and Japan reported $454 million in supplement sales.

“Clearly the growth of probiotic supplements in the United States speaks to our desire for convenience and portability,” said Capsugel’s Cieceli. “However, manufacturers must look for ways to improve the survivability of probiotics to help grow this market. We see many supplement companies educating their consumers that capsules are a better delivery alternative for both the convenience as well as the stability and effectiveness of the active.” 

This is one of the reasons Manufacturers seek out Redmond, WA-based Nutraceutix, Inc. with its now U.S. patented BIO-tract® technology. “There is increased awareness of and expectation for properly delivered viable probiotics. Putting a quality probiotic product on a store shelf, and one that will stand up under scrutiny, requires specialized expertise in formulation, handling, production, packaging and delivery,” said Tim Gamble, the company’s president and CEO. “With patented processes to create probiotic caplets with extended shelf life, even at room temperature, and an unmatched intestinal delivery technology, BIO-tract, that has just recently added a U.S. patent to its collection of international patents and patents-pending, we are helping quality conscious brands bring their probiotic offerings up to the state-of-the-art in potency and quality.”

Gamble explained that, particularly in probiotics, his company is seeing a continued interest in formulations and reformulations to strengthen existing product offerings. “Companies want to meet new labeling requirements and potency claims,” he said. “There is a bit of a reset occurring in the space, as many established brands realize that their existing products may not hold up well under increasing scientific and regulatory scrutiny.” 

Beyond that, there has been an increased interest in probiotic combination products. “For many active ingredients, this makes a great deal of sense, as probiotics can assist with the assimilation of nutrients in the body,” said Gamble. “However, not all combina- Tions are synergistic, in spite of their potential attractiveness to marketers or consumers. So, in the case of probiotic combination products, some real consideration has to be given to how the ingredients will combine both in the delivery form and in the body.” 

Prebiotics

Capsugel’s Cieceli noted that research shows that probiotics work best when combined with prebiotics, also known as synbiotics. Sourced primarily from nondigestible carbohydrate fibers, prebiotics help promote The growth and activity of friendly bacteria, feeding the probiotics for greater effectiveness. “In other words,” he said, “prebiotics prepare the environment for probiotics to flourish and work at their best.” 

To this end, Capsugel introduced its Pre-Pro Combo in 2009. It was the first probiotic product to be Generally marketed as a combination liquid product.

It was also created to Respond to consumer awareness of how digestive health can be enhanced when prebiotics are taken before a probiotics. Another key advantage for Pre-Pro Combo is the delivery technology’s protective “moisture defense system” (MDS). The MDS helps to keep the probiotic’s beneficial bacteria stable and inactive until it reaches the digestive system.

“The unique capsule- in-acapsule delivery design of Pre-Pro Combo promotes synergy by allowing targeted release of the ingredients,” said Cieceli. “The liquid prebiotic outer layer is released first to prepare the environment for the probiotic, the active in the inner capsule dissolves later in the intestinal tract where the probiotic is most effective. The inherent, natural delayed-release properties prevent the need for enteric coatings typically used for probiotic tablets.”

From there, Capsugel released its Drcaps™ capsules in late 2010. A vegetarian capsule with unique acid-protective properties that slow down the capsule opening after swallowing, Drcaps are made of HPMC, creating a capsule that disintegrates more slowly than conventional gelatin capsules, helping protect the capsule contents from opening in stomach acid after swallowing. The capsules delay opening without adding synthetic chemicals, solvents or other coating ingredients, Cieceli explained, adding that 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.

“Doing away with the coating step could reduce production time and cost for manufacturers, and make it easier for our customers to launch products rapidly,” said Cieceli. “It is also appealing to nutritional health companies whose customers often perceive coatings as ‘unnatural.’” 

Friesland’s Staley shared that prebiotic supplementation can be very helpful in supporting a positive microflora balance, and a prebiotic is defined as a non-digestible food ingredient that beneficially affects the host by selectively stimulating the growth and/or activity of one or a limited number of potentially health-promoting bacterial species already resident in the colon. “By nondigestible we mean that it travels intact to the colon where it can Become food for the beneficial bacteria,” she said. “It is worth noting that to be considered a prebiotic, the component should be food for the beneficial bacteria and not the harmful microorganisms, thus allowing the beneficial bacteria to grow well and keeping a healthy balance in the gut.” 

Vivinal GOS® is a prebiotic offered by Friesland that provides “a great food source for the growth of these beneficial bacteria they can then do their job and ultimately help your body help itself by optimizing the natural processes.” The company’s Vivinal GOS range—available as Vivinal GOS Syrup, a clear syrup with a prebiotic activity at low dosage and excellent heat and acid stability; Vivinal GOS Powder WPC, a co-spray dried product of Vivinal GOS syrup and whey protein concentrate; and Vivinal GOS Powder Maltodextrin, co-spray dried product of Vivinal GOS syrup and maltodextrin— is halal certified.

Enzymes

Rich Mihalik, director of innovation and product development with National Enzyme Company (NEC, Forsyth, MO), expressed that the market for enzymes is also growing. “More consumers are coming to the realization that the OTC acid blockers and proton pump inhibitors can have significant side effects when used longterm,” he said. “They are looking for safer alternatives to support digestive health, and are realizing that enzymes are suitable for this purpose with a very low incidence of side effects.”

Mihalik explained that digestive enzymes work particularly well in combination, and they are also complementary to probiotics for digestive support. “Internationally, we are noticing a trend toward combining probiotics and digestive enzymes to provide comprehensive digestive support,” he said. “This can be in a single capsule or as two separate capsules and/or tablets taken together.” NEC offers formulas that combine both probiotics and enzymes, or convenience packaging that allows a probiotic and an enzyme to be packaged together for ease of dosing.

“Multi-component formulations have become the norm with consumers looking more toward multi-functional, enzyme-based formulations to help reduce the number of supplements they are taking,” said Scott Ravech, CEO of Deerland Enzymes, Inc. (Kennesaw, GA). “As a result, it is our belief that off-the-shelf, fixed formulas simply are too limiting in being able to Satisfy the diverse needs of our customers, who sell directly to consumers.” 

To address this diverse set of needs, Deerland created a service offering called YourBlendSM. YourBlendSM was specifically designed to provide customers with a platform to customize their formulations to the specific performance benefit(s) they seek in an enzyme-based supplement, according to Ravech.

“It is for this reason that we (Deerland Enzymes) invest a considerable amount of time and effort at the early concept stages to collaborate with each customer to better understand the specific performance needs they have and create a product that is more in line with their definition of an effective enzyme based formulation,” he said. “By embracing and building a strategy around customization, we have been able to clearly grow the overall market segment and differentiate ourselves in the market.”

While Deerland is still at the research level, one of the more promising areas it is focusing its research is in regards to functional bowel disease. A significant advance, Ravech said, is the finding of small intestinal bacterial overgrowth in patients with IBS.

“In the past decade, clinical investigators have revealed that over 50 percent of the individuals with the functional diagnosis of IBS are afflicted by an overgrowth of bacteria in the proximal small intestine, thereby causing alterations in the structure and function of the absorptive small intestine. And there are approximately 60 million people (20 percent of the population) with IBS,” he said. “Deerland Enzymes has conducted in vitro cultures on its proprietary blend to identify components that suppress the growth of colonic microorganisms. We are currently working with Dr.

Theodore Hersh former head of Gastroenterology for Emory Medical School on products that improve digestive wellness along these lines.” 

“Enzymes and probiotics are known to be ‘must haves’ to restore digestive health,” said Hersh, who is also the founder/CEO of Thione International (Atlanta, GA). “The addition of other products (botanical, herbals, probiotics and vitamins) to our enzyme blends has significantly increased the diversity of available digestive blend formulations.” 

Hersh said that when choosing an enzyme supplement, consumers need to understand differences in the activity (potency) of the various enzymes. “As most consumers are familiar with weight as a measure of potency, far fewer understand the various activity units which are used in the industry. Activity is one of the prime differences you will see when comparing price and performance differences of the various products,” he said. “For example, a 500mg enzyme supplement may be far less effective than a 200mg product, if the enzyme concentration/activity is higher in the lower weight product.”

Shelf Stir

According to Research and Markets’ “The Future of Digestive Food and Drinks” report, among all new functional Food and drink products recorded by Product Launch Analytics during 2007-10, 21.2 percent were claimed to impart digestive health benefits to the consumer.

As the market continues to flood with products touting digestive benefits, how can manufacturers ensure their products are catching the consumer’s eye?

“Our most successful customers get their message heard through a variety of market channels,” said NEC’s Mihalik. “The marketing models are well proven, it simply requires a good product to go along with those models, such as probiotics or digestive enzymes, in which people feel a difference in their digestive health almost immediately.”

“Today there are numerous options available to the consumer claiming to improve digestive health,” added Deerland’s Ravech. “Brand marketers are partnering with their channels to provide in-store information that provide simple messages on the performance benefit of their supplements. Additionally, easy access to customer service personnel has also found favor for companies that market their products online. 

“Forward thinking retailers are investing more time and resources in training their employees so they can be knowledgeable and assist the consumers in isolating an option that may work best for their individual circumstance(s),” he added. “As a result, the industry must respect the fact that today’s consumers are taking more control of their digestive health and will not be motivated by which ‘angle’ companies try to move them in; but instead, [focus on] products that really work and are safe.”