Bringing HMOs to market –2′-Fucosyllactose

Case Study 3 – Bringing HMOs to market –2′-Fucosyllactose

2’-Fucosyllactose (2’-FL) is an oligosaccharide (made up of the 3 sugar units fucose, glucose, and, galactose) and is the most abundant HMO in breast milk. It is believed to play a role in preventing infections by blocking pathogens and toxins. It is of interest as an ingredient for infant formula milk. 

The infant formula ingredients market was valued at $13.99 bn in 2016 and is projected to reach around $23.79 bn by 2022, at a compound annual growth rate of 9.4% from 2017 to 2022.

In 2017, Jennewein, a German biotechnology company, was granted the first EU approval of a HMO as a novel food ingredient for their bacterial fermentation production of 2’-FL. Although 2’-FL is a natural product, production via chemical or biotechnology methods requires it to be assessed for safety prior to regulatory approval.

This regulatory milestone has paved the way for other companies to produce 2’-FL and bring other HMOs to market, a major hurdle given commercialisation of the first HMOs (2’-FL and Lacto-N-neotetraose (LNnT)) took a similar timescale to an innovative pharmaceutical product (8-10 years).

Further reading:

Infant Formula Ingredients Market by Type (Carbohydrates, Oils & fats, proteins, Vitamins & minerals, Prebiotics), Application (Growing-up milk, Standard infant formula, Follow-on formula, Specialty), Form, Source, and Region – Global Forecast to 2022 Markets & Markets. Available from www.marketsandmarkets.com.

Jennewein press release: EU approval for 2’-fucosyllactose http://jennewein-biotech.de/en/eu-approval-for-2-fucosyllactose-2/ (Accessed July 2018).

Inbiose press release: DuPont and Inbiose Celebrate EU Regulatory Approval of Their First Human Milk Oligosaccharide Ingredient for Infant Formula http://www.inbiose.com/fucosyllactose-eu-approval/ (Accessed March 2018)

BASF Press Release: BASF advances capabilities in infant nutrition with launch of 2’-fucosyllactose https://www.basf.com/en/company/news-and-media/news-releases/2018/07/p-18-259.html (July 2018).

Bode, L., Contractor N., Barile, D., Pohl, N., Prudden, A. R., Boons, G.-J., Jin, Y.-S., Jennewein, S. Overcoming the limited availability of human milk oligosaccharides: challenges and for research and application Nutrition reviews, 2016, 74 (10), 635-644.