Rx Medical Food Market Analysis by Leading Manufacturers Abbott Laboratories, Danone, Mead Johnson & Company, Fresenius Kabi AG, Nestle, Primus Pharmaceuticals

The U.S. FDA amended regulations related to formulation and marketing of medical food in 2013, the category, which was previously ill-defined. The new additions clarified some issues associated with marketing and branding of medical food products. Furthermore, the U.S. FDA also states that medical food does not require prescription, rather requires to be consumed under the supervision of a medical practitioner. Furthermore, the medical food market is expected to gain traction, owing to major investments by players such as Nestlé and Danone in research and development of medical foods along with widening scope of applications such as chronic pain, and personalized medicine. Medical food currently available in the market include Axona (Accera), Limbrel, Deplin, Lofenalac, Ensure, Vasculera, and Vascazen.

The global Rx medical food market was valued at US$ 14,504.6 million in 2016 and is expected to witness a robust CAGR of 7.0% over the forecast period (2017-2025).

Medical food is a category of products for dietary management or supportive therapy for specific disease or medical conditions such as pulmonary and metabolic disorders. Ingredients used in medical foods must have generally recognized as safe (GRAS) status, which is assigned to naturally found food materials. Medical food is different from nutritional food, dietary supplements, and prescription drugs. Medical food is protein-based, nutrient-based (Omega 3 fatty acids, chelated zinc, and isoflavones), and may contain minerals and vitamins such as folic acid and thiamine. These products are prescribed by physicians or taken under their supervision. The U.S. Food & Drug Administration (FDA) has classified medical foods into four major categories namely, nutritional complete products, nutritionally incomplete products, formulas for metabolic disorders, and oral rehydration solutions. The U.S. FDA separately regulates medical food category under Orphan Drug Act (1988) to ensure safety of populace and curb presence of products falsely claiming to cure medical conditions. Medical food does not require premarket approval, specification as an Investigational New Drug (IND), and individual registration with the FDA. However, they are required to support all their health claims with proper laboratory and clinical studies.

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North America accounts for the largest share in the Rx medical food market, followed by Europe and Asia-pacific. The regulatory authorities in North America and Europe have clearly defined and distinguished the medical food category. Furthermore, medical food is also being regulated in Australia and New Zealand, under Food Standards Code 2.9.5. Asia-Pacific region holds major untapped market potential with strengthening regulations in the region. The Council for Responsible Nutrition (CRN), U.S., the leading trade association for the dietary supplement and functional food industry, announced to explore and include medical food as part of its mission, in 2017. The CRN will provide a common platform for major players in the industry to work together towards the advancement of medical food and to increase awareness about medical food among healthcare practitioners and consumers. Nestlé has set out a US$ 500 Mn budget to support medical food research by 2021, which is expected to boost growth of the Rx medical food market over the forecast period.

Medical food is consumed or enterally administered under the supervision of a physician for treatment of a disease or specific dietary management. Medical food is used for various purposes such as healthy aging, maintaining brain health, and for treating chronic medical conditions, irritable bowel syndrome, and metabolic disorders. Medical food mimics therapeutic agents used in the treatment of clinical conditions such as pain, sleep disorders, and cognitive disorders. It provides relief to pain or helps treat the condition without exhibiting any risk or side effects that are usually associated with the pharmaceutical drugs. Medical food products claiming treatment of such medical conditions or any other diseases are required to support their claim with proper scientific and clinical study results. Although medical food products do not require adherence to any particular labeling requirements, any false claims or misbranding may result in legal action by the Food, Drug & Cosmetic Act (FD & C Act). Medical food varies in forms of dosage such as powders, pills, and solutions, which allows for wider availability and reach. Advancement in nutritional therapies is a result of robust support of medical food products and their wide variety of therapeutic applications, which, to a certain extent is expected to offset prescription drugs usage.

Market Dynamics

Medical food, although a prescribed product, offers various advantages over prescription drugs such as lesser side effects, lower product costs, and nutritional benefits. Leveraging the preference for convenience food formats is expected to favor long-term growth of the medical food market. Besides, personalized medicine is a developing field, wherein the patient’s genetic makeup is used to guide the prevention, diagnosis, and treatment of diseases. Medical food is expected to gain a strong foothold in the personalized medicine sector. According to a report by Personalized Lifestyle Medicine Institute, in 2013, 70% of all chronic diseases were fundamentally the results of nutrition deficiencies or imbalances, in the U.S. Such nutrition-based etiologies could be directly addressed with the help of medical foods in the initial stages of diseases, preventing further loss. Thus, management of diseases by treating individual nutritional deficiencies, increases the demand for personalized medicines. The awareness regarding medical food and its benefits, among healthcare professionals and patients is critical for growth of the market.

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