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The Live Market

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CapsCanada

While growth is certainly strong for probiotics, suppliers and manufacturers stay focused on quality and stability to ensure future success.
ACcording to a research report, “Probiotics Market (2009-2014)” published in September 2009 by MarketsandMarkets, the global probiotics market is expected to be worth $32.6 billion by 2014, with Europe and Asia accounting for nearly 42 percent and 30 percent of the total revenues, respectively.

Manufacturers are certainly experiencing this growth and don’t expect it to subside anytime soon. What’s driving the market, they said, is increased consumer knowledge and the fact that many are taking charge of their own health.

“The probiotic market in the US, as well as globally, continues to grow at attractive rates despite recent economic conditions,” noted Kevin Mehring, global market manager—dietary supplements with Danisco USA (New Century, KS). “Consumers are interested in maintaining their digestive and immune health in good or even bad economies. Proactive and personal health maintenance is an increasing focus of more enlightened consumers.” Jay Levy, director of sales with Wakunaga (Mission Viejo, CA), added that with increasing published research and awareness of the benefits of probiotics, the category is continuing to be one of the fastest growing in the dietary supplement segment. “In fact, we are seeing a lot of movement into functional foods as well. The category is still young, and has potential to continue to grow over the next five years.” And that is true for Brian Peeters, strategic sales manager in the Human Health Division of Chr. Hansen Inc. (Milwaukee, WI), who agreed that the growth of all probiotic products is faster than ever, from dietary supplements to functional foods to probiotic yogurts.

“We are witnessing unprecedented growth in all categories. We believe that the double-digit growth that we are seeing in the probiotic dietary supplement category will continue for at least several more years before leveling out.” Product Development Standout probiotic manufacturers offer high quality standards, stringent production and stabilization guidelines, and industrial microbiological expertise.

Beneficial probiotics are living organisms and have to be stabilized very carefully and uniformly on a carrier, said Levy. “When companies try to rapidly stabilize bacteria or over-concentrate (trying to produce cheaper blends), this injures or kills the bacteria, or significantly decreases their viability. There is a lot of buzz on high potency probiotics, but in reality it’s not how many bacteria you consume, but rather how many implant and colonize.

“Another important feature is the source of the strain,” Levy added.

“Human strains are indigenous to the human intestinal tract and, according to several specialists in the field of microbiology, human strains are a better choice for supplementation by humans than nonhuman strains. They seem to have better integrity during the manufacturing process, can withstand lower stom.

Ach acid pH conditions after oral intake, and have superior stability on shelf.” Also to be considered is that probiotics can be sensitive to several factors, including manufacturing conditions and processes, other actives they are combined with and the packaging components, Levy said. “Manufacturers that don’t have enough experience in manufacturing probiotics, or don’t take prudent measures to protect the probiotics, will produce very unstable products which will degrade more rapidly over time.” A relative newcomer, Joe Stout Bsc, MS, director of product development with the Chehalis WA-based Mt. Capra Products, said the company began offering a probiotic line near the beginning of 2000 with a proprietary blend of probiotics cultured in all natural goat milk. “We wanted to offer to consumers a probiotic line that was truly different and superior to the vast probiotic supplements available on grocery store shelves.” Danisco has been active in probiotics for several years with its first dietary supplement customer purchasing freeze dried probiotics in 1984. Ten years prior to that, Lactobacillus acidophilus NCFM(R) was incorporated in a frozen format into Sweet Acidophilus Low Fat Milk.

Kyo-Dophilus probiotics are the results of more than 90 years of manufacturing experience the company’s Japanese side, Levy noted. They are friendly, human strain probiotics ideal for adherence and colonization, are stable at room temperature (and hence don’t require refrigeration) and can maintain viability in lower stomach acid pH conditions. Additionally, they provide sufficient numbers of cells for implantation and are distributed throughout the intestinal tract after oral intake.

“In manufacturing Kyo-Dophilus probiotics, great care is taken to use a primary stock strain and to cultivate the bacteria properly so that it grows healthily,” Levy said. “The separation and drying stages are also critical to produce a pure bacteria strain, and to carefully dry it without impacting the viability. This takes a lot of experience and proprietary know-how.

Finally, the stabilization on the carrier is most important because the bacteria need to be distributed evenly in the mixed powder, and be viable throughout the post-production process.” For those suppliers and supplement manufacturers doing probiotics right, Mehring said the future remains bright.

“‘Doing it right’ means selling stable and efficacious probiotic-containing products that benefit our customer’s health and well being,” he added.

“Documentation will increasingly become a focus for the industry as the regulations evolve. Consumers now have more access than ever to information on supplement products on the market and the functional ingredients contained within.” Government Watch With the FDA warning companies making misleading claims, probiotics as well as other dietary supplement ingredients and finished products are affected, said Peeters. “As a leader in documented probiotic strains, Chr. Hansen is vigilant when it comes to ensuring that our products perform to the standards set forth in our clinical documentation.” Other manufacturers agree product claims must be made clear in all aspects of marketing and product quality must be high to avoid government, as well as consumer, scrutiny. “The FDA seems to be focusing most of its concern (warnings) toward companies that tie specific health claims (prevention, treatment, diagnosis, etc.) to their products,” explained Stout. “When it comes to probiotics, the FDA seems to flag companies using non-strain specific claims for probiotic benefits. For example, a specific strain of L. acidophilus may be found to have health benefits, but the company that makes the same health claim for a different strain of L. acidophilus comes under scrutiny and may even get a warning letter.” “I think we will see the FDA start to look at the probiotic market more closely, both with respect to labeling of probiotics (shelf life and strain identification) as well as claims,” Levy predicted.

“Hopefully the FDA will eliminate the use of statements listing probiotic viability ‘at the time of manufacture.’ These poor stability products have very little, if any, efficacy, and consumers.
Who purchase these products and do not get benefits will be skeptical to return to the category.” Danisco’s Mehring speculated that certainly some probiotic dietary supplement manufacturers and retailers were among those receiving warning letters recently. “This has lead to some manufacturers in the industry taking a proactive look at their own websites and marketing collateral in general to ensure claims are substantiated and based on health support/maintenance (digestive and immune health especially in the case of probiotics) versus treating, curing or mitigating a disease.” Advancing the Category There has been much technological advancement within the field of probiotic supplementation. One new technology developed by Ganedan Labs is spore formed probiotics, noted Stout.

The company developed a probiotic, encased in a protective spore, which can withstand the low pH of the stomach and reach the intestinal tract with almost no loss in CFU (colony forming unit) count. “This is certainly impressive since the vast majority of health benefits occur when the probiotics reach the intestines,” Stout added. Ensuring the survival of probiotic organisms from production to consumption to final delivery to the GI tract is and has always been the biggest challenge for probiotic manufacturers and marketers, agreed Peeters. “The goal is to eventually get to the point where probiotics can have extended shelf life (24 months) at room temperature in a basic packaging system, such as a standard HDPE bottle. Right now, however, Chr.

Hansen is able to achieve this type of stability with the proper packaging system.

Marketers would like to put probiotics (e.g. lactobacillus and bifidobacterium strains) into more functional foods and beverages, but this type of application is limited due to the high water activity and thus shortened live span for the probiotics in such a product,” he explained.

Danisco is also focused on continuing to expand its stability expertise across more probiotic strains and throughout more application areas in not only supplements, but also functional foods and beverages. “Stability is absolutely critical because even the most efficacious probiotic strain will not do much good if it is not live (an important qualification to fit the official definition of a probiotic according to the World Health Organization). Stability is an area in which Danisco invests a lot of time and money,” Mehring said.

Addressing Health Concerns The ability of probiotics to stimulate immune function and improve digestive health are two main reasons the friendly microorganisms have become so popular.

Marketers see the demand from consumers for relief from minor sickness/ digestive issues and are fulfilling this need to a great extent.

In addition, oral health, colitis, stomach ulcers, hospital-acquired infections and diarrhea (due to Clostridium difficile) are some examples of health concerns for which probiotics are currently being studied.

Combination products involving pro.

Biotics are being seen more globally.

These products include not only cranberry in combination, but also prebiotics and fibers. This synbiotic approach will continue to grow as the science supports the added benefit of combining one or more nutraceuticals, and if consumers feel the products are more effective for them than taking one functional ingredient alone. Certain applications will be aimed toward convenience (e.g. Yo-Quick™ instant yogurt).

“There will always be product development going on, and especially combining ingredients which have a synergistic effect,” said Peeters.“There will certainly be more of this to come as probiotic manufacturers and marketers look for new ways to add value to, while at the same time simplifying, a user’s experience with dietary supplements.

Science Watch The main focus areas for suppliers and manufacturers remain digestive health and immune health. These broad health areas cover a lot of specific health conditions where probiotic supplementation can positively impact consumer health. “In addition,” Mehring noted, “there is some exciting new work being done in emerging areas such as metabolic syndrome. Danisco recently announced its growing progress in investigating this area. In the US alone, more than 50 million are believed to have this condition with risk factors such as obesity, elevated blood pressure and insulin resistance all leading to an increased risk of coronary heart disease as well as other serious health conditions.” Though a promising start for Danisco, the barrier for most companies is that studies are expensive to conduct and take more time than most companies are willing to wait, Peeters noted.

“Suppliers and marketers want solid science, meaning double-blind, placebocontrolled clinical trials with a large sample size (high number of subjects), published in a reputable scientific journal,” he said. “These are the gold standard studies which every company wants to have in their clinical substantiation portfolio.” Chr. Hansen considers itself the leader in clinically documented probiotics because it has taken a methodical approach when it comes to product documentation, Peeters added. “It’s been a slow process with high costs, but the payoff comes later in the form of new customers who want to ensure that their finished products are supported by strong and significant clinical data.” NIE 

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