Nutraceuticals: Emphasis on Medical Foods

 

Introduction:

 

The market for targeted health and wellness foods and beverages is a dynamic and promising one, driven largely by the growing recognition—among scientists, government, practitioners, and consumers alike—of the instrumental role diet plays in a wide range of health conditions. Diseases that are linked to eating habits, including heart disease, high blood pressure, stroke, some types of cancer, and diabetes, are among the leading causes of death in the United States.

The risk of developing diet-related chronic diseases increases with age, so the aging population is a key factor in this market. In addition, escalating healthcare costs are causing consumers to seek ways of managing their health. Consumers today are living longer and are more active, but they may still suffer from a chronic condition that needs treatments.

Although the term "nutraceutical" is not a term recognized by the FDA, this term is often used to describe the various products of dietary supplements, homeopathics, functional foods, and medical foods. The popularity of dietary supplements and medical foods, resulting in a billion-dollar market in the US, reflects not only the social trend away from what is sometimes considered "artificial" pharmaceutical drugs and toward "natural" ingredients, but also the lack of satisfactory drugs that are both effective and safe. The field of candidates for development of nutraceuticals is expanding continuously due to advances in the understanding of nutrition and disease.

 

Nutraceutical Comparisons:

Medical Foods:

 

Medical Foods are a unique space between dietary supplements and pharmaceuticals.

The medical foods category is poised to play a role in health and quality of life beyond prescription drug therapies. Recent research has shown that a number of diseases are associated with metabolic imbalances and that patients in treatment have specific nutritional requirements, including osteoporosis and osteopenia, insomnia, IBS, Alzheimer's disease, and heart disease.

These metabolic syndrome diseases are continuously being targeted in medical food development. Age-related digestive tract diseases as well as general digestive issues and absorption of nutrients are additional areas of focus for many companies.

Medical foods are an attractive yet misunderstood pathway, as companies can take advantage of the shorter time to market and lower regulatory risk. Although medical foods are in fact regulated by the Food and Drug Administration (FDA), the pathway to bring a medical food to market is quicker and less costly than the pathway to bring a pharmaceutical drug to the market. However, unlike dietary supplements, medical foods require strong scientific support to meet the medical food criteria. This means the benefits of the medical foods must be proven in clinical trials.

 

Medical Foods Criteria

Medical Food Requirements to Launch:

The companies that are succeeding with medical foods are those that demonstrate a commitment to real science and evidence-based medicine.

Medical foods represent a growing market opportunity, as large pharmas are competing in the space and investing in its growth potential. Global sales are projected at just under $9 billion (Kalorama, 2010; Global Industry Analysts, 2011)

The big players in the field include Abbott Laboratories (e.g., Glucerna, Nepro, Ensure), Nestlé Health Science, Nestlé SA (e.g., Boost Glucose Control, Novasource Renal) and Nutricia, Groupe Danone (e.g., Fortifit, Souvenaid).

However, the main innovation is coming from smaller biotech and nutrition companies.

In February 2013, Nestlé Health Science, a subsidiary of Nestlé, bought U.S. medical food company Pamlab who produces medical foods for a wide variety of indications. Nestlés commitment in this field is illustrated by a series of other acquisitions and partnerships, including Accera (launched a medical food for the dietary management of Alzheimer's patients); Vitaflo (provides nutritional solutions for those effected by genetic disorders influencing how the body processes foods); and Prometheus Laboratories (specializing in diagnostics and pharmaceuticals in gastrointestinal and oncology).

 

Medical Food Marketing:

 

Although there is a requirement for medical foods to be used under medical supervision, medical foods can be launched as a prescription or as an over-the- counter (OTC). This is a business decision, and clearly will affect the marketing plan for the product. Marketing to healthcare practitioners will provide the most penetration, as consumers become the final decision makers regarding the purchase of these products but are often guided by the advice and recommendations of healthcare professionals.

Due to the lack of knowledge by healthcare practitioners regarding medical foods (and their confusion with dietary supplements), a solid pre-education strategy, rigorous data, and well-controlled clinical trials are the best way to obtain practitioner engagement, acceptance, and recommendations to their patients.

The call points for marketing include: primary care physicians, specialist MDs and prescribing nurses, registered dietitians, mail order pharmacies, long-term care (corporate and/or local), hospitals (corporate and/or local) and home care services. Main distribution channels include retail and mail order pharmacies, doctors' offices, Internet, hospitals, home care services and specialized disease clinics.

At the moment, coverage by insurance is dependent upon many factors. However, reimbursement efforts are making great strides to include medical foods.

Below are some of the medical food-specific marketing activities that well help penetrate the market:

 

 

Closing:

 

Overall, the opportunities for nutraceuticals are growing as science is defining nutritional components of diseases, consumers are demanding more natural treatments, and healthcare costs are increasing and allow alternative treatments to flourish. Companies should take advantage of this pathway as a way to bring treatments to the patients that need them most.

 

To learn more, please call:

 

Mark Creswell
President & CEO
International Discovery Services and Consulting, LLC
markcreswell@idscbiotechnetwork.com
1.734.433.9670 Ext. 11

 

 

Lauren C.

 

Lauren is an advisor to emerging life science and medical technology companies. She has 20+ years developing therapeutics for several indications, with an emphasis on neurodegenerative diseases. Her experience includes leading products from research through clinical, regulatory, and commercialization stages. She also plays a key role connecting her early-stage companies with potential partners, venture capital, and angel investors, as well as directing due diligence for in- and out-licensing activities. She is currently Vice President of Therapeutics and Device Development for CID4, and holds board seats in several companies and non-profits. Previously she was Vice President at Accera where her team developed and launched an Alzheimer's therapeutic, she was on faculty at Harvard Medical School, and was voted "Business Advisor of the Year" 2011 by U Colorado TTO.

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