Medical Food: Bedside Manna

September 19, 2011
Paul Gander

Today, the term clinical nutrition seems to stretch from intensive care to products that would not look out of place in a supermarket. What unites them is science, hard-health economics, and attractive margins.

When Nestlé announced its 2010 results in February, there was one small but positive detail that was almost lost in the welter of mostly negative reporting about divestments and rising costs: the company is planning to channel some of its CHF34.2 billion net profits into small-scale acquisitions in the medical food area. This is a logical extension of growth strategies followed by Nestlé and rival Danone over recent years in competing for this lucrative and increasingly sophisticated market.

Why lucrative? The well-documented aging of the general population in developed markets would in itself be enough to indicate that health-related expenditure-including nutrition-is likely to rise steadily for the foreseeable future.

But the term developed markets is a relative one. As a professor of clinical nutrition and metabolism at the University of Southampton in the UK, Marinos Elia has led many research projects examining nutrition in the community. “A substantial amount of malnutrition goes unrecognized and untreated,” he says.

Fighting Malnutrition

Elia quotes estimates putting the cost of malnutrition to the UK’s National Health Service at £13 billion, partly accounted for by longer hospital stays. Clinical services provider Fresenius puts the additional costs of malnutrition to healthcare insurers in Germany at about €9 billion. “The cost of tube feeding, on the other hand, would only be a couple of percent of that total cost,” Elia states.

At the specialist ingredients development company Provexis plc (Windsor, UK), chief executive Stephen Moon paints a bigger picture. “The cost of healthcare in the United States is around 15% of gross domestic product, and is forecast to double by the end of the decade,” he says. “The Nestlés and Danones know that if they can help to reduce this burden, they will be welcomed with open arms.”

And what of the growth in sophistication? Developments in medical nutrition have followed a relatively steep trajectory over the past four decades, says former chair of the European Society for Clinical Nutrition and Metabolism (ESPEN), professor Simon Allison.

Feeding patients via a tube has been practiced for some 300 years. “But it really took off in the late 1970s and the 1980s thanks to developments in technology,” he says. “The tubes and pumps were able to deliver a precise amount of liquid over a precise period of time.”

Allison himself was involved in the development of parenteral products (fed directly into the blood stream to bypass the digestive system) at the time.

Nutritional science has also improved, of course. German company B. Braun, with the majority of its products in the parenteral area, says there is, for instance, an increasing amount of research-but also still plenty of discussion-regarding the optimal omega-3 to omega-6 fatty acid profile, and the sources of those fatty acids.

“Studies and clinical trials show that certain lipid components can improve outcomes in patients in intensive care,” says Karsten Kluetsch, vice president of project management, critical care, global marketing and sales, of B. Braun’s hospital care division.

Enteral nutrition (for those whose gastrointestinal condition allows normal digestion) has developed at an equally rapid rate, but at the same time, it has diversified.

Estimates quoted by Provexis forecast sales growth in all types of enteral products of more than 7% year-on-year, to reach a value of $2.7 billion in 2013. Parenterals will grow at rates closer to 10%, to hit a value of $1 billion. However, definitions are increasingly being stretched, and Moon says that some estimates put the value of a broader “clinical food” category as high as $20 billion.

Condition Specific

On one level, enteral nutrition is about fairly standardized products. However, many developments in this segment have been in the area of foods for special medical purposes (FSMP).

Manufacturers such as Nutricia (Danone) claim that disease-specific nutrition is where the most exciting future developments are most likely. Examples include Nutricia’s Diasip diabetes and FortiCare cancer products.

But the brand owners are at pains to emphasize the fact that, while such products may help specialists manage a condition or reduce the severity of symptoms, they are not pharmaceuticals and do not actually treat the condition.

Put like that, the contrast seems clear, although in the future there may be examples of products that blur this distinction to an even greater extent. For now, though, they exist in a sort of hybrid regulatory area. “There are rules regarding FSMP in Europe,” says Elia. “They are less stringent than those for pharmaceuticals, and more so than those for mainstream foods.”

Moon at Provexis explains some of the differences. “You avoid the three-stage process required in pharmaceuticals,” he says. “You could base a clinical nutrition product on two very good trials. The whole process could take just three to four years-more or less the time it takes to get a functional food to market.”

Revenues may be more modest than for functional foods, says Provexis, but gross margins in this industry can be above 70%. And, of course, an evidence-based clinical nutrition product can have a “second life” in the nutraceuticals sector. [Editor’s note: In the United States, whether the road from clinical nutrition to nutraceutical is smooth depends on FDA’s viewpoint.]

On the other hand, there is a clear regulatory contrast between enteral and parenteral products. “We operate in a pharmaceutical environment, with the same requirement for safety studies and development times for new products of up to seven to eight years,” says Kluetsch at B. Braun.

There is another important distinction to be made here-between tube-fed enteral products and orally administered “sip” products. When it comes to the latter, packaged and clearly branded in bottles and cartons, the food multinationals are on a firmer-or at least more familiar-footing.

Provexis is not alone in attaching importance to this distinction. “There are some well-entrenched companies focusing on the tube-feed and drip-feed area,” says Moon. “We’re trying to get into more accessible products, and I think that’s where companies such as Danone and Nestlé are coming from.”

Provexis is currently working on the use of non-starch plantain polysaccharides in foods for Crohn’s and other inflammatory bowel disease patients. According to Moon, the company plans to get the same ingredient into trials in Clostridium difficile applications later this year.

The management of high blood sugar levels as a precursor to metabolic syndrome and, potentially, type 2 diabetes, is an area where several manufacturers, including Nestlé and Abbott Nutrition in the United States, are active, Moon says. Provexis, too, is now investigating an as-yet undisclosed ingredient in this area.

This is not to say that the more niche, well-entrenched nutrition providers are not alive to the opportunities of the sip-feed segment. Indeed, B. Braun’s Nutricomp range of enteral products includes sip as well as tube feeds.

Fresenius’s Kabi division saw the value of its international clinical nutrition sales grow by 10% to €924 million between 2008 and 2009. That same year, it launched a high-calorie sip product, Fresubin 2kcal, in several flavors, especially suitable for tumor patients. Since then, it has launched dessert-style Fresubin Crème, also in multiple flavors.

Elia sees the choice between tube-feed and sip-feed products as contextual. “Of course, there are conditions where patients cannot take liquids or feed themselves,” he says. “Strokes, for instance, are a common indication for long-term tube-feeding in the community. It may not be easy to implement, but it is estimated that up to 15% of patients could be weaned off tube feeding.” On this basis, there is a case to be made for periodical assessment, he believes.

Dairy Proteins

At Dutch-based dairy ingredients supplier FrieslandCampina Domo (Amersfoort, The Netherlands), global marketing manager Leonard Mallée goes further. “Up to about five years ago, the majority of enteral products were tube-fed,” he says. Since then, he claims, there has been a tendency-largely cost-driven-to move patients to orally administered products as soon as patients are physically able to make the change.

“With this shift in emphasis, taste has become much more important,” Mallée explains. “The protein of choice used to be caseinates, but milk protein concentrate (MPC) has increasingly been used for products where flavor matters.”

Part of this shift has been a move towards more protein-dense finished products. At its factory in the east of the Netherlands, recently opened as a joint venture between FrieslandCampina’s Domo and DMV businesses, the company is producing MPC. It also started up production of micellar casein isolate (MCI) at the end of 2010.

“When you move to higher densities, you get into issues of viscosity, and MCI is known to be less viscous in higher concentrations,” says Mallée. This is new and patented technology, says Domo, and was still in the validation phase in February.

Clinical nutrition manufacturers look for dairy proteins that meet the same safety and stability criteria as caseinates, with the same lack of contamination and lactose-free credentials.

In terms of future developments, Provexis believes there are two trends within the broader definition of enteral clinical nutrition. “Companies will pick off major therapeutic areas, such as Danone has already done with digestive health, or Abbott with blood sugar,” says Moon. “But others will find smaller ‘creases’ where demand is narrow but very deep.”

Just as interesting will be to see to what extent these innovations feed down into mainstream functional foods in the years to come-and what the consumer and clinical sectors can learn from each other.

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