The boundless opportunities of the microbiome and the power of prebiotics and probiotics have given rise to intense focus from researchers, investors and companies working in both the nutraceutical and pharmaceutical space. However, what is becoming clear is the importance that claims stay rooted in science and not consumer hype. This is according to Stephen O’Hara, OptiBiotix CEO, who notes the emerging research on prebiotics and probiotics and the rising role they will have in the food and nutraceuticals industry in 2019.

“Research is rapidly unveiling the way we understand the human body’s mechanisms of action and the extent of the impact of the health of the intestinal tract on overall wellness, which is estimated to represent almost 70 percent of a human’s immune system,” says O’Hara. “This connection, combined with the increasing understanding of the role of prebiotics and probiotics in human health, is creating a demand for natural foods and supplements that provide tangible health benefits and contain both prebiotics and probiotics.”

The body of research demonstrating the function pre and probiotics have on human health is rapidly increasing. As we enter 2019, new clinical trials, including some from OptiBiotix, will uncover the role of the microbiome in digestive health, immune support, cardiovascular health, weight management and cognitive function, for example.

Which market categories will see the most fruitful NPD?
Most probiotic strains are developed to focus on immunity and gastrointestinal health and thus these markets are generally saturated, notes O’Hara. 

According to US supermarket Whole Foods, probiotics are expected to expand beyond the chilled foods categories, such as yogurts, over the next few years. New strains of probiotics, such as Bacillus coagulans GBI-30 and Bacillus coagulans MTCC 5856, are making more shelf-stable applications possible and resulting in their incorporation in pantry staples such granola, oatmeal, nut butters, soups and nutrition bars. 

A key example of a shelf-stable innovative application includes Kellog’s HI! Happy Inside launch from last year, which delivers pre and probiotics and fiber in an all-in-one cereal. 

It’s also likely that more probiotic-containing shelf-stable products in the household and personal care sectors will crop up in the next year, shares O’Hara.

Last month, DSM Venturing, the venture investment arm of DSM Nutrition, made an equity investment in skin microbiome company S-Biomedic NV to further its “new approach to the cosmetic and therapeutic potential of the skin microbiome.” While Symrise and bioengineering company Probi are cooperating to deliver probiotic-based cosmetic ingredients, seeking to develop cosmetic products with the Lactobacillus strain which could hold particular potential for the sensitive and dry skin market.

Probiotics for pharma
Further to innovations on the supermarket shelves, technological advances are opening new doors to “next generation” precision engineered solutions via targeted strains, broadening the market’s scope for health management in the pharmaceutical space.

OptiBiotix’s LPLDL, a “next-generation” probiotic that uses a naturally-occurring strain of the bacterial species Lactobacillus Plantarum, has been shown in randomized controlled human studies to deliver “tangible health benefits.” This includes reducing total cholesterol by up to 36.7 percent, LDL cholesterol by 13.9 percent and lowering systolic blood pressure by 5.1 percent.” 

“Cardiometabolic health, for example, is showing great potential and OptiBiotix’s LPLDL probiotic strain demonstrates the capacity to boost heart fitness, making it a valuable ingredient in functional food products,” O’Hara says.

Late last year, OptiBiotix launched CholBiome, a cholesterol management range that harnesses the LPLDL probiotic for heart health. The company developed the biotherapeutic pharmaceutical product for the first time following a deal with an unnamed US-based pharmaceutical company. 

Most strains do not have known mechanisms of action, wheras it is known that LPLDL influences and reduces cholesterol levels in a number of ways, including breaking apart bile salt molecules, increasing the loss of cholesterol in the intestine. This mechanism of action results in reduced cholesterol absorption in the gut and subsequently less harmful LDL in the blood, he explains.

“Knowing the mechanism of action is key to NPD because the combination of active ingredients can be designed rationally. By its mechanism of action, LPLDL shows great potential for rational NPD, meaning it can be applied to many different categories such as food supplements and dairy products.”

Regarding development in the pipeline, OptiBiotix is studying several potential applications for LPLDL, as its mechanism of action through the microbiome-liver axis is involved in many physiological processes, including diabetes, weight management, vitamin absorption and liver function. 

What barriers may companies face in this space?
For companies looking to incorporate pre and probiotics into products, regulatory challenges can vary with geography, notes O’Hara.

In Europe, claims can be the primary challenge. Research and science must back up any claim made for a product so that consumers can clearly understand a product’s intended use. In other geographies, product registration can also be a challenging and time-consuming issue.

The issue of probiotic stability in foods and beverages is also a “troubling” barrier. Almost no probiotic can stand the temperatures required in certain food manufacturing processes. In food processing, which generally involves high temperatures and mixing with certain ingredients, this can present a significant operational challenge.

Moving forward
“As we learn more about the role of the gut microbiome, prebiotics, probiotics and their impact on physiological wellbeing, manufacturers and ingredient suppliers will continue to develop new products and expand a marketplace that has been evolving during the past decade,” says O’Hara.

One area to watch will be precision engineered prebiotics which modify specific elements of the microbiome and can provide new novel solutions to help sustain a healthy lifestyle and reduce the risk of chronic illnesses such as diabetes and cardiovascular disease. 

The rise of prebiotics is bound to feature heavily in this space in the coming year. “Prebiotics also look to be finally making inroads in a category dominated by fiber and probiotic ingredients to dent the food and beverage industry’s use of sugar and aid with issues such as obesity,” OHara concludes.