Known for aiding in regulating digestive health, probiotics are proving that they can do much more..

The probiotics market is on the rise. Once considered a smaller, lesser-known category in the U.S., it is now growing as Americans increasingly understand that probiotics are a “good bacteria” that their bodies need. While probiotics have been gaining popularity in Europe and Asia for some time now, Americans are starting to catch on. According to Business Insights, in 2010, total sales of probiotic supplements reached almost $800 million in the U.S. and European Union (E.U.). Further, through 2015, sales will rise by 6.9 percent per year in the U.S. and 6.1 percent per year in the E.U., for an overall market growth of 6.4 percent annually.

With health care costs rising rapidly, some consumers are looking for preventative measures that may help them avoid an excessive amount of doctor visits.

“News/developments are ongoing in the industry as probiotics are gaining interest and commercial appeal,” said Luc Monbourquette, strategic sales manager for Chr. Hansen Inc. (Milwaukee, WI). “We are seeing an increase in well-designed clinical studies in the area which is critical in driving the category forward.”

Growing Benefits

Probiotics are most well-known for helping regulate the digestive system. The standard American diet (i.e., SAD), age and stress all factor in to the array of digestive issues Americans face. But in recent years, studies have found a connection between digestive and immune health. In fact, 70 percent of the Immune system is located in the digestive tract. Probiotics can help restore healthy bacterial levels in the gut while regulating the digestive system and boosting the immune system.

“As the gastrointestinal system has become increasingly recognized as an active immune center, and as digestive stress amongst consumers worldwide accelerates, the focus on probiotics has grown,” said Dr. Gregory Leyer, business development director for Danisco USA Inc. (Madison, WI).

Danisco has recently launched HOWARU® Balance, a new series of probiotic supplements that target the digestive and immune health needs for people of all ages. According to the company, each of the supplements in the series contains targeted combinations of two highly documented probiotic strains, accommodating the differing intestinal microflora of children, adults and seniors. The digestive and immuneenhancing effects of Bifidobacterium lactis HN019 and Lactobacillus acidophilus NCFM® have been extensively evaluated in multiple clinical studies.

Studies have shown that probiotics can go beyond digestive and immune health conditions. Oral health, urinary tract health, vaginal health, stress and anxiety Are just a few of the areas being evaluated for the benefits of probiotics. Often, studies show that one strain can do a plethora of different things.

The mouth is an entry point for pathogens as it comes into contact with billions of bacteria. To that end, Frutarom, USA, Inc. (North Bergen, NJ) offers two probiotics for oral health, BLIS K12™ and BLIS M18™. According to the Company, BLIS K12 is the world’s first advanced probiotic for the oral cavity and upper respiratory tract. A specific strain of Streptococcus salivarius, BLIS K12 helps provide a natural defense against bacterial sore throat and ear infections as well as promote fresh breath and boost the immune system’s defenses.

BLIS M18 is a patented oral probiotic providing advanced protection for teeth and gums. Developed from a specific strain of S. salivarius, BLIS M18 has been clinically proven to promote the health of the oral cavity by continuously supporting and promoting the health of teeth and gums.

Chr. Hansen’s Probio-Tec® strains are supported by more than 100 human studies. The BB-12® strain in particular, is identified as Bifidobacterium animalis ssp. Lactis and has been tested in a number of clinical trials from newborn preterm infants to the elderly. The studies indicate that BB-12 can relieve constipation, restore the intestinal microbiota after an antibiotic treatment and can have an impact on colic in infants.

The Institut Rosell-Lallemand (Montreal, Canada) is focusing its research and development efforts on products that direct attention to the following health areas: gut health, women’s health and immune support (ProbioKid for children and ProbioStim, for adults and seniors). In addition, the company’s Product, ProbioStick, has been developed for the reduction of chronic stressinduced gastro-intestinal symptoms.

“Of course, digestive health is the primary area for probiotic applications, but other areas are gaining scientific support (immunity, stress, etc.), and we are focusing our research on developing products to address other health issues,” said Isabelle Champié, deputy manager and global marketing director for Institut Rosell-Lallemand. “We have developed a product for immune support (ProbioKid), and this has shown Clinical efficacy in children. Another very innovative area is stress and anxiety management for which we have a documented formula that was the first study to show actual benefits of a probiotic product on psychological distress.”

In addition to expanding the benefits of probiotics to being something more than just for digestive health, some manufacturers are discovering the benefits of combining probiotics with other ingredients to increase the health benefits. “Our most successful probiotic ingredient has been Lactobacillus acidophilus DDS®-1,” said Dr. S.K. Dash, president of UAS Laboratories, Inc. (Eden Prarie, MN). “This patented and trademarked strain remains a leading probiotic with broad-spectrum applications. Our newest ingredient innovation has been the combination of DDS probiotics with spirulina for excellent antioxidant properties. Our spirulina has been shown to have excellent prebiotic effects by enhancing the growth of both probiotic bacteria and beneficial commensal bacteria.”

From Species to Strain

Now that probiotics have been gaining in popularity, a shift has begun to occur. While strain-specific products used to be the norm, species-specific products are now gaining momentum. “We are seeing a shift from species- to strainspecific products, which is an important trend for this category,” explained Monbourquette. “According to the World Health Organization (WHO), a product can only be considered a true probiotic if it consists of one or various strains that have been documented to show a positive effect. So strains that have good science associated to them are seeing increased interest, while those that don’t are not.”

Obstacles

Although the probiotic category continues to grow, it has not been immune to experiencing a few setbacks. When Dannon introduced Activia yogurt, the product was launched with the “Activia Challenge” commercial, which brought immediate attention to the category. “Sales have soared because of the rise in consumer knowledge,” said Missy Lowery, marketing manager for Capsugel (Greenwood, SC). “In the United States, in particular, awareness of prebiotics and probiotics have risen steadily over the last five years; U.S. consumer awareness of the term ‘probiotics’ was 48 percent in 2008, up from 31 percent in 2007, according to an NMI Health & Wellness Trends survey.”

However, the claims that Dannon made in the commercial caught the attention of the U.S. Food and Drug Administration (FDA). Dannon was fined $21 million by the FDA and was ordered to scale back on the health claims they were making on their products. “The category challenges include demonstration of health benefits and the ability to make health claims,” said Dash.

And the regulations on probiotics have not stopped there. Regulators overseas have also targeted probiotics. “In Europe, the latest news concerns the European Food Safety Authority (EFSA) health claim regulation, which affects the whole dietary supplements industry, not just probiotic, and we expect other territories to follow the lead,” explained Champié. “It can be seen as a positive and negative factor: if it represents a hindrance for the food supplement industry and certainly slows down innovation, it is positive for the consumers, giving them clear information about the true benefits of a product, it will help regulate the market, whereby only documented products will remain.”

“Regulatory questions, most notably in Europe, have brought the evaluation of clinical data to the forefront,” added Leyer. “The interpretation of what claims are allowed and the corresponding accurate package claim language continues to be an area of focus.”

Stability, Delivery & Research

Probiotics can be dispensed in just about every delivery method one could think; however, there can be issues when it comes to stability. “Manufacturing is one of the challenges because you are dealing with live organisms,” said Eden Somberg, technical specialist of the health business unit for Frutarom USA, Inc. “[It is important] that during the manufacturing process, they are maintaining the viability of the organisms.”

“Because probiotics are live bacteria,Manufacturing a finished product with probiotics is a bit more difficult to do,“ explained Dash. “Some of the strains with the best health benefits can be fragile. [Manufacturers should] select food systems and/or processing systems that limit heat, pressure and moisture, or add probiotics at a post-processing point.”

While probiotic bars, yogurts, juices, cereals and other functional probiotic foods are growing more popular with consumers, some believe that the supplement form still reigns supreme. “Consumers are drawn to probiotics in supplement form. In addition to being low in calories, supplements have a longer shelf life than dairy products and don’t usually require refrigeration to keep their active status,” said Lowery. “They may also be an alternative for those with lactose intolerance. Supplements have the added benefit of being portable and convenient to take.”

Then there are the issues of potency and shelf stability. “Supplements also offer a greater assurance of live bacteria,” added Lowery. “In general for the supplement industry, a good quality supplement will contain a minimum of billions of live bacteria and one billion CFUs at the time of consumption. Consumers might not know how much beneficial bacteria is in their yogurt or other food product.”

While communicating with manufacturers and marketers, Capsugel learned of the specific challenges associated with the manufacturing of consumer health care products containing probiotics. The supplements needed capsules with lower moisture as well as a way to provide some protection from stomach acid. The company created new capsule technologies to address those issues: Drcaps™ low moisture capsules and Vcaps® Plus capsules. The company now offers a number of capsules that provide for flexible and targeted delivery of moisture-sensitive probiotics.

Research and proven data can also help the confused consumer. “There are so many strains and different levels. Are they alive when they reach your gut?

Backing it up with clinical research is really a No. 1 [priority],” said Somberg.

The Dannon Activia lawsuit can make consumers hesitant to try probiotics if all they hear are negative things about probiotics in general, but research and data backing up claims can ease an unsure customer. “Concerning probiotics, at least we can say that the best documented products, the ones which are backed by scientific and clinical studies published in peer-reviewed journals, are the ones which are endorsed by medical doctors and thus are accepted by consumers,” explained Champié.

“Educating consumers about the benefits of probiotics is increasingly important given the growing trend toward self care,” added Leyer.

The Future of Probiotics

With the probiotics market continuing to grow larger and research discovering more benefits, what does the future hold for this developing category? While branded products are not the standard just yet, Laurent Leduc, vice president of the health business unit for Frutarom USA, Inc., believes that it is just a matter of time before they are. “It is a new category for the health industry, but it is growing.”

“With the emergence of probiotics for skin and weight management it may soon be a case of ‘feel and see’ the benefit,” concluded Michael Randle, senior analyst for Business Insights. “It’s a time for change for probiotics in the current market. Marketing and brand positioning will hold the key to success in the future.”