The Blurring Lines of Pharma & Nutrition 

The pharmaceutical and nutrition sectors are undergoing significant change as the boundaries between the two are becoming blurred for both manufacturers and consumers.

With increasing consumer health education and recent innovation in both the pharma and nutrition markets, industry convergence has emerged resulting in the creation of new sectors such as functional foods, nutritional supplements and medical nutrition

Functional foods can be viewed as encompassing a very broad range of products or are developed around a particular functional ingredient; for example, foods containing probiotics, prebiotics, or plant stanols and sterols. Other functional foods and drinks can be fortified with a nutrient that would not usually be present to any great extent e.g. folic acid fortified cereals for pregnant women. Essentially they deliver additional or enhanced benefits over the basic nutritional value and can contribute to a varied and balanced diet and healthy lifestyle.

Examples of functional foods

• Probiotics are defined as live microorganisms – mostly bacteria – which when taken in adequate amounts confer a health benefit
• Prebiotics promote the growth of particular bacteria in the large intestine that are beneficial to intestinal health and can also support the inhibition of bacteria that are potentially harmful to intestinal health
• Stanols and sterols, which occur naturally in small amounts in plants and fruits, are thought to have a cholesterol lowering effect and are added to products such as reduced/low fat spreads

Nutritional supplements are added to diets to provide nutrients that may not be otherwise consumed in sufficient quantities such as vitamins, minerals and proteins and in medical nutrition, products with specific nutritional compositions are created and used for symptom alleviation and the intervention of disease progression.

The areas on the border between food nutrition and pharmaceuticals are often not well defined as they can both contain bioactive compounds such as friendly bacteria, fatty acids and probiotics, amongst other contributions.

Several pharmaceutical drugs are also derived from natural products, including those that we are exposed to in our everyday diets. A good example is Souvenaid, a natural supplement drink that is used in the management of the early stages of Alzheimer’s disease.

With all this overlapping of definition, consumers and even professionals can become easily confused about the opportunity, so here is a guide to looking at these exciting converging sectors.

Which way is the market heading?

At present, the growing trend is for the pharmaceutical industry to try and enter the probiotics and food nutrition markets by using strains that have been researched with an understood mechanism of action, and specific health benefits that have been proven in human research trials.

The industry is aiming to enable self-modulation of the human microbiome and essentially has two strategic options to be available to move into the probiotics sector. The common approach is to acquire or partner with food supplement companies to enter the market and operate at the industry standard. Alternatively, it can leverage pharmaceutical brands and quality standards to produce a probiotic strain under GMP (Good Manufacturing Practice) conditions with the finished supplement created in house or contracted out to qualified manufacturers.

The second key area making progress is the biotherapeutic approach. This term refers to any treatment that is produced by, or involves, living cells rather than synthesised chemicals. Several products are currently in development and going through legal approval. However, due to the embryonic nature of the market, there isn’t a significant legal framework in place to manage its positioning and commercialisation. The FDA has recently released a guidance document on the market sector and legal developments are anticipated due to the fast-moving nature of this part of the pharmaceutical industry.

Market Drivers

With a globally ageing and health-conscious population, alongside a U.S. health system that has extortionate costs, there is an ever-growing interest in the restorative, preventative and therapeutic benefits of food and nutrition.

More than a third of people now self-diagnose using online resources which in turn results in self-medication rather than a visit to the local doctor. This is leading to a trend in consumers seeking functional nutritional products with health benefits. Again the pharmaceutical industry needs to find a way to capitalise on this new market opportunity, and there are four options emerging in the food and drink sector where they could play

• Better-for-you foods – smaller portions of everyday foods containing less salt, fat and sugar. This includes ‘free from’ foods.
• Functional foods – these support overall health such as bread and cereals with boosted fibre, as well as probiotic yoghurts.
• Nutraceuticals – supplements in liquid or powder form that is ‘taken’ rather than eaten but are still derived from foods.
• Pharma Foods – This is the new frontier where the lines are blurred. It involves an element of preventative or curative functions for diseases.

Pharma Foods seem to present an excellent opportunity for both food and pharmaceutical companies due to its vastly untouched innovative nature and the opportunity for higher profit margins due to the unique and low regulatory landscape of the sector to date.

Emerging Issues

With the pharma industry heading into the nutrition sector, it begs the question, why won’t the nutrition sector head the other way?

Historically, the food and drink sector has avoided the vast NPD costs and regulations associated with pharmaceuticals product development. The regulatory landscape related to pharmaceuticals is very different from the food and drink sector and comes with a lot more complexity and expense to ensure compliance and commercialisation.

Both pharmaceutical and nutrition companies also find themselves firmly out of their comfort zones when it comes to the new ‘pharma foods’, with many different barriers present on each side of the sector. Nutrition companies must improve their research and development to enhance their scientific capabilities, as well as building key relationships with drug companies and practitioners. Pharmaceutical companies on the other hand must learn to compete on taste with competitors in the field and develop strategic relationships with the big retailers; an unknown territory compared with their usual pharmaceutical retail and distribution channels.

So how can companies profit from the growing health focus?

First, the health-conscious consumer is increasingly more likely to read labels when purchasing innovative nutritional products. Today’s food and drink companies must therefore strive towards a healthy balance of the ‘less-good-for-you’ ingredients used in their products, as well as segmenting their products with healthier versions, comprising less sodium, fat and salts, to attract the savvy body-conscious consumer.

Secondly, the focus on marketing the health properties of the foods/supplements they are producing has to increase. For example, beetroot has become a go-to superfood for lowering blood pressure and increasing blood flow after being promoted by recent research studies. If this is included in a product, the brand has a new marketing angle to boost sales

Finally, companies need to think carefully about whether they should approach supplement or pharma food sectors when pitching their product. Understanding research and development costs and barriers associated with each industry is key to getting the right distribution and financial results.

The Future

Moving forward, we will undoubtedly see more pharmaceutical and food and drink companies working alongside each other to produce new brands aimed at the changing consumer market.

With consumers becoming ever more health conscious and wary of what products they are using to treat themselves, it is becoming more important to provide treatments that move away from the more traditional chemically synthesised formulations. Nutritionally based remedies and functional foods are becoming the treatment of choice, and it is vitally important for the two industries to collaborate and innovate to ensure businesses can keep up with the changing market trends.

Currently, the regulatory landscape surrounding pharmaceuticals is a daunting thought for those involved in nutrition NPD. Similarly, pharmaceutical companies face a tough uphill challenge to enter the food and drink sector and work with, or indeed compete against, the large retailers already dominating the sector.

In the future, we can expect to see new regulatory bodies established to cover the products created by both industries that sit along the aforementioned blurred lines. It will also become a more common practice to see companies collaboratively working together to breach the barriers and drive growth in these new exciting product sectors.