Clasado Biosciences has announced that its prebiotic ingredient Bimuno® GOS is now available for use in Therapeutic Goods Administration (TGA)-listed products in Australia, including dietary supplements intended for therapeutic purposes.

The development allows dietary supplements marketed under the TGA framework to include Bimuno GOS and reference a range of permitted health effects.

David Mharakurwa, Regional Director APAC at Clasado, commented: "This is a major step forward for Bimuno GOS in Australia. Formulators now have the opportunity to include the most studied GOS on the market, in therapeutic products that align with consumer demand for credible, gut-focused health solutions. And with permitted claims available under TGA regulation for products containing Bimuno GOS, it makes it easier to communicate those benefits clearly and confidently to consumers."

This move into the TGA category builds on the ingredient’s existing success within the FSANZ (Food Standards Australia New Zealand) category, where 29 self-substantiated food-health relationship claims are available, further strengthening its regulatory position in the region.

Australia represents one of the world’s most progressive supplement markets, valued at USD $13.74 billion in 2023. Prebiotics are seeing a strong growth curves in particular according to Grand View Research data, with the category expected to triple in value to USD $708 million by 2030, at an impressive 17.6% compound annual growth rate (CAGR).

With a clinically proven low dose starting from just 1.37g, Bimuno GOS combines formulation flexibility with a strong scientific profile backed by more than 125 publications and over 20 clinical trials.

Lucie Nagy, General Counsel at Clasado, said: “Entering the TGA category is a key milestone for Bimuno GOS in the APAC region.  This reinforces the trusted safety and quality of Bimuno GOS, while creating new opportunities for our partners to innovate in the growing therapeutic product space.”

David added: “This development supports our broader ambition – to make better gut health accessible to more people, in more markets, through scientifically validated ingredients that are easy to formulate and trusted by the industry. With Bimuno now available for use within TGA-listed products now, we're proud to be giving Australian formulators the tools to deliver next-generation prebiotic gut health products that meet the highest consumer and regulatory expectations”.