According to experts, breastfeeding is the gold standard of infant nutrition. Despite the known benefits of breast milk, some women consciously choose not to breastfeed due to existing medical conditions, economic barriers like lack of paid leave and hence the need to return to work, or simply as a lifestyle choice. About 2%-5% of women cannot breastfeed due to low milk supply, certain medications, infectious diseases (e.g., HIV, tuberculosis), or babies born with genetic conditions who cannot tolerate breast milk. According to the World Health Organization, only 41% of infants under 6 months of age are exclusively breastfed. Fortunately, women today have multiple choices for alternatives to breast milk.
Development and growth of breast milk substitutes:
Our knowledge about the complexities of human milk has evolved over the years. Apart from providing complete essential nutrition, breast milk also protects against infections, trains the infant’s immune system, and even evolves to meet the baby’s needs. In 1865, a German scientist named Justus von Liebig first marketed infant formula that consisted of cow’s milk, wheat and malt flour, and potassium bicarbonate. Infant formula has come a long way since then and is now strictly regulated by the nutrition and food safety requirements of the Food and Drug Administration in the United States, the European Food Safety Authority in Europe, and most other markets.
The global infant formula market size is expected to reach USD $45,348 million by 2025, at a compound annual growth rate (CAGR) of 9.5%.
The changing nature of the infant nutrition substitution market:
The different types of commercially available infant formula can be grouped into the following categories:
- Cow milk–based: These offer complete nutrition, but about 5%-7% of formula-fed babies develop allergies to cow’s milk.
- Soy–based: Choosing soy-based formula for babies who are allergic to a milk-based formula is not recommended since about 8%-14% of babies allergic to milk are known to react to soy.
- Protein hydrolysate–based: The proteins in the milk are broken down to ease digestion in babies. These are further classified according to the level of decomposition of milk proteins as partially hydrolyzed, where the whey protein is broken down into large chunks; extensively hydrolyzed (hypoallergenic), where caseins are broken down into small pieces; and amino acid–based (elemental), which are completely broken down into basic protein building blocks.
The International Code of Marketing of Breast Milk Substitutes was adopted by the World Health Assembly and UNICEF in 1981 to protect breastfeeding. Yet, the infant formula market is teeming with multiple brands sold by manufacturers like Nestlé, Danone S.A., Reckitt Benckiser, Abbott, FrieslandCampina, Bellamy’s Organic, and others that often confuse the average consumer struggling to make a choice based on claims like “tummy-friendly” and “brain-building nutrition.” Adding to the complexity is the dynamic nature of the infant nutrition market, with innovations in the areas of novel ingredients, smart packaging, plant-based products, and the production of breast milk from cells!
Most commercial infant formulas sold today are prepared from cow’s milk by adding some of the micronutrients found in breast milk, including nucleotides, lutein, vitamin E, minerals, probiotics, prebiotics, and fatty acids such as docosahexaenoic acid (DHA) and arachidonic acid (ARA). In striving to provide a composition closest to breast milk, infant formula manufacturers are constantly adapting to include ingredients that are continuously emerging as crucial for warding off diseases and building immunity in the newborn.
Recent years have seen the reduction of protein quantity while improving quality in infant formula to mimic what happens with breastfed infants and reduce obesity. One method is by adding alpha-lactalbumin to keep similar tryptophan content but reduce the caseins (predominant cow milk proteins) and replace them with whey (predominant human milk proteins).
Arla Foods Ingredients recently obtained FDA approval to supply its whey protein concentrate Lacprodan ALPHA-10, containing 41% alpha-lactalbumin, to the US formula market.
Massachusetts-based biotech company, Conagen, recently announced the development of lactoferrin, the main iron-binding protein in milk. Using synthetic biology and fungal systems for fermentation, they have found a cost-effective solution to create the engineered protein with similar nutritional properties to lactoferrin found in breast milk. The company is currently looking to commercialize their product with support from formula manufacturers.
Since the 2000s, researchers have found that apart from lactose and fat, human milk also has hundreds of oligosaccharides called HMOs that feed the infant’s gut bacteria. Of these HMOs, the two most abundant are tetrasaccharide lacto-N-neotetraose (LNnT) and 2′-fucosyllactose (2′-FL), accounting for 40% of all HMOs. The HMOs are known to help prevent multiple bacterial infections and inhibit inflammation. Backed by decades of research, Nestlé first introduced the mix of these two HMOs in its unique formula in 2017, closely followed by Abbott’s introduction of 2’-FL into its infant formula Similac in 2018. Studies have shown that these HMOs may confer health benefits by preventing infections and diseases such as necrotizing enterocolitis and allergies.
With the plant-based product market predicted to grow with a CAGR of 9% over the period of 2019-2025, we are recently seeing some innovation in plant-based infant formulas. Since the development of infant and toddler formula, 90% of the market consists of dairy-based products. The rest are soy-based formulas that have long been the mainstay for fulfilling the protein needs of infants who cannot consume dairy. Though not life threatening, soy-based infant formula is known to cause certain allergies. Moreover, most babies who are allergic to milk are also allergic to soy. Hence there is a gap in the infant formula market that is only starting to be filled with products from other plant-based sources.
The formula manufacturer Nature’s One recently introduced the first-ever organic pea protein–based baby formula with the hope of eliminating the sources of sensitive foods like soy and dairy in early childhood. The company claims that it uses ingredients like organic DHA and ARA that are obtained from sources devoid of insecticides, pesticides, and neurotoxins.
Else Nutrition, an Israel-based food and nutrition company that focuses on innovative and clean plant-based products, is set to launch its 100% plant-based organic toddler formula made from almonds, buckwheat, and tapioca that is free of gluten, hormones, and antibiotics.
PROTEIN2FOOD is a unique project focusing on plant-based protein-rich food prototypes consisting of a team of 18 partner institutions from 13 countries that is led by the University of Copenhagen and funded by the European Union. In a European Commission–led conference in Belgium, they recently showcased a lentil-based infant formula created by isolating protein ingredients from crops and legumes that they validated on a pilot scale.
The growing consumer need to maintain hygiene and safety of products is driving innovation in the infant and toddler formula packaging industry. In the United States, the FDA strictly regulates packaging designs and the acceptable solutions are plastic containers, metal cans, tubs, cartons, and pouches. Recently, low carbon-impact packaging and biodegradable materials are gaining traction. For ensuring food safety, packaging companies are adopting technology to support traceability and authentication in consumer packaged goods.
When it comes to smart packaging, a couple of the early adopters in the infant formula sector are Danone and FrieslandCampina’s formula brand FRISO. Danone now offers Track & Connect service on its infant formula in China and plans to launch soon in France, Germany, Australia, and Switzerland. The tracking relies on a dual QR code system in the packaging. The code on the outer packaging reveals the time of production and the factory location, while the code inside the seal when scanned on a smartphone validates the authenticity of the product.
Similarly, FRISO has integrated secure traceable codes by the Norway-based tech company Kezzler to ensure authenticity and transparency of its infant formula made in the Netherlands and sold in China. These smart packaging solutions can definitely be extended across all consumer products to ensure safety and traceability.
Creating breast milk from human cells:
Though infant formulas are primarily the only breast milk substitutes until now, the advanced tools of genetic engineering and synthetic biology are likely going to change this soon. Scientists are currently working on producing breast milk in the lab by keeping human mammary cells alive through controlled environment and nutrient supply. The proteins and sugars found in the cultured breast milk will perhaps be better suited to infants’ tummies as opposed to formula. Notably, two companies are working in this space with the promise of commercialization in the near future.
The Singaporean startup TurtleTree Labs announced the launch of its lab-grown breast milk in 2021. With the initial mission of disrupting the dairy industry with lab-grown cow’s milk for sustainable development, the company later pivoted to make breast milk that will surely revolutionize the infant nutrition industry. The company is using a unique way of creating breast milk by redirecting stem cells from human volunteers to create mammary glands in the lab that can lactate.
As TurtleTree targets the Asian market, the startup Biomilq, which targets the Western world, is on a similar mission. Utilizing a patent-pending technology, the company is leveraging the natural ability of human mammary cells to produce milk by keeping them alive in a controlled environment with a constant supply of nutrients. The founders recently claimed to have made human casein and lactose and are confident of their ability to make a product that is at least nutritionally similar to breast milk.
There is definitely a lot to keep an eye out for in the infant nutrition sector. For instance, microRNA (miRNA), which are short RNA strands of 20-22 nucleotides, have been found in mother’s milk and while researchers are still trying to find the health benefits they offer, formula manufacturers are already considering supplementing infant formula with miRNA. Whether the new initiatives to produce plant-based alternatives and lab-cultured breast milk will ultimately lead to products that are closer to human breast milk, be approved by the regulatory authorities, and be readily adopted by consumers are yet to be seen.
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