Human Milk Oligosaccharides Market - Forecast(2025 - 2031)

Human Milk Oligosaccharides Market Overview

The Human Milk Oligosaccharides Market size is estimated to reach $X Billion by 2030, growing at a CAGR of 21.9% during the forecast period 2024-2030. Human Milk Oligosaccharides (HMOs) are a group of complex carbohydrates naturally found in human breast milk, known for their numerous health benefits, particularly in infant nutrition. They play a crucial role in the development of the immune system, gut health, and overall growth of infants by promoting the growth of beneficial gut bacteria and acting as prebiotics. The market for HMOs is primarily driven by the increasing demand for infant formula and nutritional supplements that replicate the benefits of breast milk. Rising awareness among parents and healthcare professionals about the health benefits of HMOs, along with the growing trend of premium infant nutrition products, is propelling market growth. Additionally, advancements in HMO production technologies, such as biotechnological methods for synthesizing these oligosaccharides, are making them more accessible and cost-effective, further boosting their adoption in both infant formula and functional foods. Moreover, the increasing prevalence of gastrointestinal and immune-related disorders in infants is encouraging the use of HMOs to support healthy development, driving the market across various regions.

Advances in Human Milk Oligosaccharide (HMO) research are expanding the HMO market, revealing broader health benefits like gut health, immunity, and inflammation reduction. These discoveries open opportunities for HMOs to be incorporated into functional foods, Food Supplements, and products targeting adults.  For example, a September 2024 article from Nutrition Ingredients highlights preliminary findings from an ongoing trial showing that infant formula mimicking the lipid structure of breast milk can enhance calcium absorption, modulate gut microbiota, and strengthen immunity. These innovations further support the growing demand for HMO-based products in infant nutrition and other health-focused applications. Synthetic biology production is rapidly advancing in the HMO space, offering more sustainable and cost-effective ways to manufacture these beneficial compounds. A June 2024 The Guardian article highlights a breakthrough where scientists have genetically engineered a close relative of the tobacco plant, Nicotiana benthamiana, to produce human milk oligosaccharides (HMOs), complex sugars found in breast milk. This development could lead to infant formula that more closely replicates the health benefits of breastfeeding, including promoting healthy gut bacteria and supporting the infant immune system. The breakthrough in synthetic biology may revolutionize infant nutrition by making HMO production more accessible and sustainable.

Market Snapshot: 

 Human Milk Oligosaccharides Market- Report Coverage:

The “Human Milk Oligosaccharides Market Report - Forecast (2024-2030)” by IndustryARC, covers an in-depth analysis of the following segments in the Human Milk Oligosaccharides Market.
Attribute    Segment
Type 

COVID-19 / Ukraine Crisis - Impact Analysis:  

The COVID-19 pandemic heightened global awareness about the importance of immune health, particularly in infants and young children, which led to a surge in demand for nutrition products enriched with HMOs. As a result of increased health concerns, parents were more focused on providing the best nutritional support for their children, and HMOs, known for their ability to support gut health, improve immunity, and foster overall growth, became highly sought after. This shift in consumer behavior positively influenced the market, as more parents turned to infant formulas containing HMOs, viewing them as an essential tool in protecting their babies during uncertain times. Additionally, the rising interest in preventive healthcare and fortified foods further fueled the demand for HMOs in both infant formulas and other Food Supplements.

During Russia-Ukraine conflict as both Russia and Ukraine are key players in the global agricultural and chemical industries, providing vital raw materials such as corn, wheat, and certain bio-based chemicals, the disruptions have resulted in the scarcity and increased cost of these essential components, directly impacting the production of HMOs. Furthermore, Europe, a major market for HMO products, has been particularly affected due to the direct proximity of the conflict, causing supply chain bottlenecks, rising transportation costs, and limited access to key resources. This has led to a domino effect, where manufacturers are facing higher production costs, and the overall cost of end-products, including infant formula enriched with HMOs, has increased. As a result, both manufacturers and consumers are under financial strain, which may slow down the adoption of such premium products in certain markets.

Key Takeaways:

•    North America is Leading the Market:

North America accounted for largest market share of 21.9% in 2023 by significant research along with investments from leading industry players, facilitating rapid innovation in infant nutrition. The region also benefits from a supportive regulatory environment, ensuring the safety and efficacy of HMO-based products. As consumer demand for functional and specialized nutrition grows, North American companies are leading the way in developing new products that address specific needs, such as food allergies and formula shortages, further cementing the region's position as the market leader. For instance, In March 2023, Danone North America, alongside its Specialized Nutrition business Nutricia, launched Pepticate in the U.S. to support families dealing with food allergies amidst a formula shortage. Pepticate is an extensively hydrolyzed powdered formula designed for infants aged 0 to 12 months, providing relief from cow milk allergy (CMA) symptoms and sold in over 75 countries.This product addresses both food allergies and the ongoing formula need in the U.S., showcasing North America's ability to respond quickly to market needs. Also regarding approvals,  in August 2023, the U.S. FDA issued Good Day Letters to DSM-Firmenich for three Generally Recognized as Safe (GRAS) notices concerning specific human milk oligosaccharides (HMOs), including LNFP-l/2'-FL, hypoallergenic grade LNnT, and 2'-FL. This regulatory approval underscores North America's leadership in HMO development, fostering confidence in the safety and efficacy of these ingredients for infant nutrition and other applications. The approval is a significant step in advancing HMO-based products in the market.

•    3’-Fucosyllactose (3’-FL) to Register the Fastest Growth

3’-Fucosyllactose (3’-FL) is poised for the fastest growth in the HMO market due to its well-documented health benefits and increasing regulatory acceptance. As one of the most abundant human milk oligosaccharides, 3’-FL is known for its prebiotic properties, which help promote the growth of beneficial gut bacteria like bifidobacteria. This aids in maintaining a balanced gut microbiome, which is crucial for infant health. Additionally, 3’-FL has immunomodulatory and antimicrobial effects, making it a valuable ingredient in infant formulas and functional foods . As per the August 2023 article by the Food Standards Agency, 3’-Fucosyllactose (3’-FL) has been approved as a novel food. The total saccharide content of 3’-FL is ≥ 92% by dry weight, with other saccharides present in smaller quantities. Additionally, in September 2024, DSM-Firmenich, a leading nutritional ingredients supplier, announced that the United Kingdom and European Union had approved its human milk oligosaccharide (HMO) ingredients—3-FL and a mixture of LNFP-I and 2'-FL—as novel food ingredients. This approval is a significant milestone in the growing acceptance and use of HMOs in various food and nutrition products. These regulatory approval highlights the growing recognition of 3’-FL's safety and nutritional value, reinforcing its potential in food and nutrition applications, particularly in infant formulas and other health-focused products. Its prebiotic, immunomodulatory, and antimicrobial properties make it a valuable ingredient in infant formulas and functional foods. As more research confirms its positive effects on neonatal brain development and overall health, demand for 3’-FL is anticipated to rise, driving rapid market expansion.

•    Infant Formula is Leading the Market

Infant formula is currently the leading sector in the HMO market due to its increasing demand for products that replicate the benefits of breast milk. According to a WHO 2023 article, undernutrition is estimated to be associated with 2.7 million child deaths annually, accounting for 45% of all child deaths. Infant and young child feeding is a critical area to improve child survival and promote healthy growth and development, emphasizing the importance of improving formula nutrition and access for infant well-being. Human milk oligosaccharides (HMOs), which are vital for infant health, particularly in supporting the gut microbiome, immune system, and brain development, are now being added to formula products. This trend is driven by growing awareness of the health benefits of HMOs, and as research continues to support their effectiveness, the incorporation of HMOs into infant formula. Infant formula is specifically designed to meet the full nutritional needs of babies under 12 months, traditionally containing higher protein levels than breast milk. However, advancements in formula composition have led to the inclusion of ingredients like specific carbohydrates previously unique to human milk. In the future, human proteins and lipids may also be added, further enhancing the nutritional profile to more closely replicate the benefits of breastfeeding. This shift is fueling the demand for advanced formula products that utilize HMOs and other ingredients to better support infant health and development. In support of this growing demand, in November 2023, Nestlé debuted a new infant formula in Hong Kong containing a proprietary blend designed to support multiple growth areas, including digestive, bone, and cognitive health.

•    Focus on Digestive and Immune Health of Infants Drives the Market

The growing focus on digestive and immune health of infants is driving the HMO market by promoting beneficial bacteria and reducing harmful bacteria. They also play a crucial role in enhancing immune function, helping to protect infants from infections and illnesses. According to a May 2024 article by the CDC, about 1 in 200 babies are born with congenital CMV, and 1 in 5 of those babies will experience long-term health issues like hearing loss. Human cytomegalovirus (CMV) is a prevalent herpesvirus that can be transmitted to neonates through breast milk. While postnatal CMV transmission can negatively impact preterm or immunocompromised infants, healthy term infants typically experience benign effects. Human milk oligosaccharides (HMOs) support the gradual maturation of the microbiome in an infant's digestive system and nasal cavity, aiding in immune health and helping protect against infections, including CMV. Also, as per a December 2024 article from Imperial College London, a study led by researchers found an association between women’s exposure to emissions from municipal waste incinerators (MWIs) and elevated levels of polychlorinated biphenyls (PCBs) and dioxins in their breast milk. hese findings underscore the potential environmental risks to maternal and infant health, emphasizing the importance of improving infant nutrition, particularly through formulas enriched with human milk oligosaccharides (HMOs). HMOs support the infant's immune system and gut health, offering a safer alternative to reduce the impact of such environmental pollutants.As parents become more aware of the importance of these health benefits, the demand for HMOs in infant formulas continues to rise, leading to their increased inclusion in product formulations to support overall infant well-being.

•    Ethical and Cultural Concerns to Hamper the Market

Ethical and cultural concerns are significant hurdles for the HMO market, particularly regarding the use of human milk-derived ingredients in infant formulas. Many cultures and individuals may feel uncomfortable with the idea of incorporating human milk components into products, fearing it challenges the sanctity of breastfeeding. There is also apprehension around the commercialization of breastfeeding, which is considered a natural and vital bonding experience. While breast milk is crucial for infant health, its consumption by adults, particularly from unregulated commercial sources, raises significant health risks and ethical questions. Global regulations on human milk (HM) are inconsistent or entirely absent, complicating the issue. Key ethical concerns include informed consent, medical decision-making, and the potential overexploitation of limited milk supplies. Additionally, containers used to store human milk must be food-grade to avoid chemical contamination, as repeated use of polycarbonate containers could lead to the migration of bisphenol-A (BPA) into the milk, further increasing safety concerns.
 

Key Market Players: 

Product/Service launches, approvals, patents and events, acquisitions, partnerships, and collaborations are key strategies adopted by players in The Human Milk Oligosaccharides Market. The top 10 companies in this industry are listed below:
1.    BASF SE
2.    Dsm-Firmenich
3.    KYOWA HAKKO BIO CO. LTD.
4.    Inbiose N.V
5.    Novonesis
6.    zuChem, Inc.
7.    Elicityl SA
8.    Nestlé S.A.
9.    Abbott
10.    Royal FrieslandCampina N.V

Scope of the Report: 

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