Industry eyes HMOs beyond infant formula as gut health evidence leads

Interest in the role of human milk oligosaccharides (HMOs) in health beyond infancy is growing, with potential wider benefits, although most launches remain in infant formula. Filed patents point to product innovation activity in the fields of brain, muscles, and skin. 

Nutrition Insight speaks with Novonesis Human Health Biosolutions about regulatory and scientific challenges that must be addressed before mainstream adoption. Morinaga Milk outlines where evidence is strongest outside of infant nutrition, while Innova Market Insights reveals which regions lead in toddler, child, and adult innovation. 

“HMOs remain overwhelmingly a formula ingredient, with more than nine in 10 of the HMO launches we tracked being infant formula or growing-up milks,” says Marieke Bokkes, market analyst at Innova Market Insights.

“The patents show that companies increasingly see HMOs as more than an early-life gut health ingredient. Most filings build on the role of HMOs in the gut, but they extend it to benefits elsewhere in the body. This points to a shift from HMOs as a prebiotic for babies toward HMOs as a platform for lifelong health.”

However, she points out that a patent is not a product, so what will matter is whether the ideas will reach the market. According to Bokkes, that will depend on scientific evidence and regulation. Meanwhile, she highlights the market itself is changing in “sophistication rather than size.”

“Brands continue to launch new HMO products every year, but our launch data shows that activity has held broadly steady over the past five years rather than accelerating,” she highlights. “More HMOs have been approved in more markets during this period, but this hasn’t yet translated into HMOs spreading across a much wider range of products.”

Formulation and clinical nutrition

The bigger change is in formulation, Bokkes points out. She adds that brands are moving beyond single HMOs toward more complex recipes, combining several HMOs and pairing them with other gut and immune ingredients. “So the market is becoming more sophisticated rather than bigger.”

Bokkes says that beyond formula, pediatric clinical nutrition is leading, followed by supplements for children and adults. At the moment, HMO use in everyday foods, such as dairy, is still in its early stages, she adds.

“Adult products are a small niche, but they already exist. In the US, specialist brands led by Layer Origin sell HMO supplements for adults, positioned for digestive health, IBS support, immunity, and weight management. These are mostly sold online and through practitioner channels, and mainstream food and beverage brands haven’t entered the space yet.”

Kids’ products typically carry broad “healthy development” messaging with HMOs mostly linked to immunity and, to a lesser extent, gut health, Bokkes finds.

“Growth and brain development claims on these packs are usually credited to other ingredients, such as DHA or protein, and in many products the HMO is listed without any specific benefit claimed for it,” she adds.

For adult products, mostly supplements, Bokkes says: “Brands typically present [them] as a next-generation prebiotic for gut health, with immunity as a secondary benefit.”

Asia leading in toddler and kids’ launches

According to Innova Market Insights data, Asia leads HMO launches — around two in five tracked in the first half of 2026. Bokkes adds that the region also leads in launches outside infant formula, such as toddlers and kids’ nutrition. “In most other regions, launch activity has been broadly flat, although Latin America and Africa show early signs of growth.”

“Asia’s lead in HMO launches reflects the bigger role formula plays in children’s nutrition there.”

“In North America, around eight in 10 HMO launches are aimed at infants. In Asia, more than half target toddlers and older children, mainly through growing-up milks that often continue into the preschool years,” Bokkes details.

In kids’ formats, powdered milk remains the core focus globally, she adds, including growing-up milks and pediatric nutrition formulas, where HMOs are one ingredient among a broader nutrition package.

“Ready-to-drink kids’ milks have appeared since 2022 and are the most established of these newer formats, followed by fruit-flavored toddler milk drinks and, more recently, dairy desserts and baby cereals and porridges. These formats bring HMOs out of the formula tin and into daily snacks and meals.”

“Supplement-style formats are still largely missing. We have not seen any HMO gummies, and chewables remain very rare,” shares Bokkes.

In Asia, adult launches remain rare, per Innova data, and where they do exist, HMOs are mainly found in specialized nutrition milks, such as for people with diabetes.

“Regulation is an important part of this story. Rules differ widely across Asia, and in most markets, HMO use is still focused on infant and young child nutrition,” explains Bokkes.

“However, approvals are expanding. China is a good example. After approving its first two HMOs, 2’-FL and LNnT, in 2023, it added a third, 3’-SL, in 2026, with more under review.”

Gut health comes first, systemic benefits follow

HMO evidence beyond infancy is strongest in gut and microbiome health, according to Nicola Procházková, Ph.D., global scientific advisor of Early Life and Specialized Nutrition at Novonesis Human Health Biosolutions.

“Adult clinical studies have demonstrated good tolerability across a wide range of doses and have provided encouraging results in areas such as digestive comfort and microbiome modulation, making gut health the most substantiated opportunity for HMOs in adults today.”

“Emerging clinical and preclinical data point toward opportunities in cardiometabolic health, healthy aging, cognition, bone and muscle health, and immune resilience,” details Procházková. “While these areas still require larger, indication-specific clinical trials, they represent some of the most promising innovation spaces for the future of functional nutrition.”

Beyond infancy, Saki Yamashita, global marketing manager of Functional Food Ingredients at Morinaga Milk, says evidence is strongest for gut microbiota modulation and digestive health, with ongoing research into how HMO effects depend on an individual’s gut microbes.

“At the same time, recent research suggests that certain undesirable bacteria may also utilize specific HMOs under some conditions, highlighting the importance of overall microbiome balance,” explains Yamashita.

“This has shifted attention from HMOs alone to how they interact with the microbiota. Evidence for immunity, healthy aging, and other systemic outcomes is promising, but remains an emerging area.”

Patents expand beyond gut health

According to Bokkes, most patent filings are on HMOs’ role in the gut; however, these are extending to other benefits that link gut health to the brain, muscles, and skin.

“Several filings connect HMOs to some of the biggest trends in nutrition today. Muscle health stands out, including for people using GLP-1 weight-loss medications, alongside weight management, healthy aging, sleep and stress, and beauty from within, covering skin and hair.”

“Others look at earlier life stages from a new angle, such as HMO supplements for pregnant women to support the baby’s health, and early-life HMO intake that may benefit brain development into adulthood.”

She underscores that scientific evidence is one factor that will determine whether products reach the market, since research in adults is still limited and mostly focused on gut health.

“The second is regulation, since most Asian markets still focus HMO use on infant and young child nutrition, and in Europe, brands cannot communicate a health benefit without an approved claim,” states Bokkes. “Until both move forward, many of these applications are likely to remain on paper.”

Navigating HMO health claims

Regulations are shaping how HMOs are advancing. Bokkes shares that in the US, HMOs are recognized as safe in infant formula alongside a range of everyday foods and drinks. She adds: “Brands can make general health statements such as ‘supports digestive health’ without prior approval, which can help specialist adult brands grow.”

“In the EU, HMOs are authorized in a wide range of foods, drinks, and supplements, including for adults, but every health claim must be approved in advance, and none has yet been approved for HMOs,” explains Bokkes.

“As a result, brands can use HMOs in adult products but cannot tell consumers what they do. Most Asian markets, meanwhile, still focus HMO use on infant and young child nutrition.”

Meanwhile, Novonesis’ probiotics and synbiotics global regulatory partner, Han Youl Lee, points out that “claim wording and scientific substantiation” are essential when communicating health benefits to consumers.

“With some exceptions, supplements are generally regulated as foods rather than drugs; therefore, gut health and immunity claims must comply with food claim regulations and should not imply that the supplement can cure, mitigate, treat, or prevent disease.”

“Regulatory authorities generally consider high-quality clinical trials to be the primary basis for claim substantiation, with greater emphasis placed on study quality than on the quantity of studies,” details Lee. “In addition, clinical trials used to support claims should be relevant to the target population.”

He points out that in most countries, regulatory authorities require pre-market approval for health claims. Exceptions exist, such as in the US, where some claims must be adequately substantiated but are not required to go through pre-market review, notes Lee.

Reaching mainstream production

Production of the most established HMOs has reached meaningful technological and commercial maturity, says Joey Zhu, global commercial development manager of early life and specialized nutrition at Novonesis Human Health Biosolutions. Precision fermentation, purification, and large-scale manufacturing are now established for key structures, supporting broad use in infant nutrition. 

“Further expansion depends on various factors, such as improving strain performance, fermentation yields, downstream processing, and regulatory access, particularly for more complex and less common HMOs that remain costly to manufacture,” shares Zhu.

“HMOs are getting closer to applications beyond premium infant formula, especially in adult gut health and microbiome-focused nutrition. But becoming mainstream will require more than manufacturing scale. It will require competitive cost-in-use, clear application-specific benefits, clinical evidence and regulatory pathways that allow those benefits to be communicated.”

Novonesis forcasts that HMO adoption will first expand through premium, targeted functional nutrition, followed by broader F&B categories, says Zhu.

However, Bokkes shares that Innova’s social listening suggests that consumer awareness is still low. “Online conversation about HMOs is limited and mostly driven by news and trade media rather than parents, so explaining what HMOs do will be just as important as the formulation itself.”