Rx Medical Food Market Application with Its Leading Manufacturers Abbott Laboratories, Danone, Mead Johnson & Company, Fresenius Kabi AG, Nestle

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).

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Manufacturers are developing medical food products with improved therapeutic effects and different dosage forms for ease of administration and patient convenience. Abbott laboratories introduced science-based nutrition drinks, Ensure Surgery Immunonutrition Shake, and Ensure Pre Surgery Clear Nutrition in 2016, to help patients recover from surgeries. Cera Products, Inc. launched Ceralyte oral rehydration salt to treat dehydration and diarrhea in 2017. Cambrooke announced the launch of Tylacti COMPLETE Bars, a nutritionally complete medical food available in a convenient format, for the dietary management of Tyrosinemia (TYR) in 2017. The company launched medical food line Phenactin AA Plus, Vilactin AA Plus, Isovactin AA Plus, Homactin AA Plus, and Promactin AA Plus for inborn errors of metabolism in 2015. Nutricia Metabolics launched Anamix Next for Tyrosinemia, Methylmalonic Acidemia, and Isovaleric Acidemia in 2015. Moreover, the company launched PhenylAde GMP, a new formula for Phenylketonuria (PKU) in the same year.

Key players are investing in research and development activities of pipeline products for the development of novel medical food that can be used in various medical conditions. For instance, in 2012, Targeted Medical Pharma reported preliminary data of its new amino acid-based oral formulation called PERCURA, which can be used for reducing symptoms of pain and numbness associated with peripheral neuropathy, in an open-label pilot study. In 2015, Enzymotec Ltd announced investigator initiated clinical trial of Vayarin, which is capable of managing attention deficit hyperactivity disorder (ADHD) in children suffering from epilepsy. Moreover, scientists at Nestlé Institute of Health Science are studying human DNA for the development of personalized programs for epilepsy and intestinal disorders, thereby leading to development of medical food products that contain natural compounds.

Major players are adopting strategies such as mergers and acquisitions to expand their product portfolio and enter into the medical food industry. Nestlé is adding medical foods such as prescription-based powders and drinks that can be used for treatment of diseases to its existing product portfolio for business expansion, which will in turn help the company to enter the nutrition sector. In 2017, AlfaSigma, an Italy-based company completed the acquisition of the U.S. medical food maker Pamlab from Nestlé, to strengthen the company’s operations in North America. The U.S. Food & Drug Administration (FDA) awarded grants through the Orphan Products Clinical Trials Grants Program, to encourage clinical development of products, which includes medical food to treat rare diseases or conditions.

Some major players operating in the Rx medical food market are Abbott Laboratories, Danone, Mead Johnson & Company, LLC, Fresenius Kabi AG, Nestle, Primus Pharmaceuticals, Inc., Targeted Medical Pharma, Enzymotec ltd., AlfaSigma, and Pivotal Therapeutics.

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