As a business opportunity, nutraceuticals has great potential. It ticks the box for 'innovative medicine' but also wears the consumer mantle of 'health and wellbeing' well too.  The world of nutrition-based products – particularly for 'preventative' and/or therapeutic care – is predicted to enter a new and dynamic era.

Listen to our latest podcast to get some insight into where the world of nutraceuticals could be heading. Will the likes of Nestlé and Danone create alliances with pharma (as Proctor & Gamble and Teva did in 2011) – or pitch against pharma companies, such as Abbott, GSK and Aventis, in the mergers and acquisitions market?

Some commentators say the prospect for pharma of adding value to an existing line of treatment by bolting on a nutritional product is a strong enough enticement as it faces patent expiries. But questions remain over whether what may be seen as exclusive territory for pharma in developing science-based, nutritional products that pair with, for example, an existing portfolio of oncology treatments will really prove commercially viable.

There's also the possibility that pharma continues to spin off its interests in nutrition – as Pfizer and BMS have done – perhaps finding that it distracts them from their drugs portfolio.

And not least of all, the divide between 'nutraceuticals' and 'medical foods' is one that needs clarity.

One thing is for sure; with national healthcare organisations in developed countries looking to reduce the long-term financial impact of ageing populations and modern-day epidemics such as obesity on their systems, interest in the science-based nutritional market is clearly one to watch.

Abbott Nutrition is no newcomer to this business area of course. The division held a symposium at the end of last year on new insights on ageing and preserving muscle mass and its Ensure family of products is well established.

Nestlé Health Science has hit the ground running since its inception in 2011. At the time Luis Cantarell, president and CEO said: “...this will pioneer a new industry between food and pharma”.

But how will evidence for efficacy of these products evolve, as surely it must?

'You are what you eat' goes back to the days of Hippocrates but what we see now is the growth of a much more refined approach towards clinically-proven medical foods. And with it, will proxy measurements (which can be misinterpreted by the media and others) become a thing of the past and new protocols for clinical-based trials devised?

I asked Patrick Coppens, director of the International Food and Health Law and Scientific Affairs at EAS Strategic Advice (regulatory advisers in the food and nutritional area) whether we could expect more stringent, evidence-based outcomes put in place for 'nutraceuticals'?

“Definitely yes,” said Coppens. “The EU nutrition and health claims regulation is being implemented in such a way that it is only possible to have a claim approved for well-defined substances on well-defined and measurable outcomes and (mostly disease-related) end points, as demonstrated by randomised controlled trials in the healthy population.”

So with 'the global nutraceutical event', Vitafoods Europe, just around the corner in May it's anyone's guess what sponsors such as Royal DSM and Natural Alternatives International, as well as visitors looking to grow their businesses, are thinking about stricter regulatory processes. Particularly in light of Coppens' comment: “This [the new EU nutrition and health claims regulation] has been judged by many to be unfeasible for many foods and food components in relation to the maintenance of health functions of the body.”

It's a topic that raises so many questions. So I turned to the Across Health team in the US to seek their thoughts, with Bryan Russiano and Pat Thistlethwaite (former Pfizer consumer communications and marketing men) providing their forecast for the market in the PMLiVE article 'Nutraceuticals – Big Pharma or Big Food's next Big Growth area?'. 

Additional resources that can help overcome the complexities of the topic and keep a a consumer audience up to date on nutraceuticals include NHS Choices' Behind the Headlines and its 2011 report Miracle foods – myths and the media (pdf).

In any case, whether pharma or food giant, for medical foods, nutraceuticals or however we define them, there's a huge amount of interest, and a huge amount to play for.

Listen to the PMLiVE podcast about nutraceuticals