Medical food is a category of food products for dietary management or preventive therapy for specific disease or medical conditions such as pulmonary, gastrointestinal, and metabolic disorders. Ingredients used in medical foods must have ‘generally recognized as safe’ (GRAS) status. 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; nutritionally complete products, nutritionally incomplete products, formulas for metabolic disorders, and oral rehydration solutions. The U.S. FDA separately regulates medical food 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.
Rx Medical Food Market - Impact of Coronavirus (Covid-19) Pandemic
The coronavirus pandemic has negatively impacted the development, production, and supply of Rx medical food worldwide during the coronavirus pandemic. Many production and manufacturing facilities and transport departments have suspended activities in their Rx medical food factories to stop the spread of coronavirus. Thus, this pandemic has affected both demand and supply of Rx medical food market.
Since December 2019, a novel coronavirus spread throughout China and across the world, causing a continuous increase in confirmed cases within a short period of time. The disease has spread to more 100 countries around the globe with the World Health Organization declaring it a public health emergency.
For instance, according to the World Health Organization Coronavirus Disease (COVID-19) Dashboard (WHO) report, the manifestation of the coronavirus disease (COVID-19) has resulted in more than 11 million infected individuals worldwide as of July 2020.
The global Rx Medical Food Market is estimated to be valued at US$ 19,387.3 million in 2020 and is expected to exhibit a CAGR of 6.8 % during the forecast period (2020-2027).
Figure 1. Rx Medical Food Market Share (%) Analysis, By Region, 2020
Factors such as the increasing regulatory support and awareness about medical food among healthcare professionals are expected to drive growth of the Rx medical food market.
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. 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 Rx medical food market is expected to witness significant growth, 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.
Rx Medical Food Market - Restraints
The major factors restraining growth of the Rx medical food market are side effects and complications caused by Rx medical food products if they are consumed in excess amount. Food products or dietary supplements can often cause adverse effects on the user, if not taken under supervision of a physician or any specialist. Many health problems such as cardiovascular, gastrointestinal conditions can arise owing to its adverse effects.
For instance, according to the New England Journal of Medicine, in 2015, around 23,000 emergency department visits in the U.S. were attributed to adverse events related to dietary supplements. According to the study, many such visits involve cardiovascular problems arising from weight-loss or energy products.
Similarly, according to a study published in the Annals of Internal Medicine journal, in December 2013, vitamin use increased among older Americans, with regular use climbing higher than 50% in the 50 to 64 age group. According to the report, excessive vitamins do not provide health benefits and may even cause harm, and most supplements do not prevent chronic disease or death.
|Base Year:||2019||Market Size in 2019:||US$ 19,387.3 Mn|
|Historical Data for:||2016 to 2019||Forecast Period:||2020 to 2027|
|Forecast Period 2020 to 2027 CAGR:||6.8 %||2027 Value Projection:||US$ 30,757.3 Mn|
Abbott Laboratories, Danone S.A., Mead Johnson & Company, LLC, Fresenius Kabi AG, Nestle S.A., Primus Pharmaceuticals, Inc., Targeted Medical Pharma Inc., Pivotal Therapeutics Inc., VAYA Pharma, Inc., and AlfaSigma S.P.A.
|Restraints & Challenges:||
Rx Medical Food Market– Regional Analysis
On the basis of region, the global Rx Medical Food market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America is expected to account for the largest share in the Rx medical food market, followed by Europe and Asia Pacific. The regulatory authorities in North America – U.S. Food and Drug Administration (FDA) and in Europe – European Medicine Agency (EMA) 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. For instance, 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. For instance, in 2010, Nestlé started a US$ 500 Million budget to support nutritional medical food research by 2021, which is expected to boost growth of the Rx medical food market over the forecast period.
Figure 2. Rx Medical Food Market Value (US$ Mn) & Y-o-Y Growth (%), 2017-2027
Rx Medical Food Market- Competitive Landscape
Key players operating in the Rx Medical Food Market are Abbott Laboratories, Danone S.A., Mead Johnson & Company, LLC, Fresenius Kabi AG, Nestle S.A., Primus Pharmaceuticals, Inc., Targeted Medical Pharma Inc., Pivotal Therapeutics Inc., VAYA Pharma, Inc. and AlfaSigma S.P.A.
Medical food is consumed or enterally administered under the supervision of a physician for the 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 such as irritable bowel syndrome and metabolic disorders. Medical food imitates therapeutic agents used in the treatment of clinical conditions such as pain, sleep disorders, and cognitive disorders. It provides relief from pain or helps treat the condition without exhibiting any risk or side effects that are usually associated with 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.
Medical food is a category of prescribed products which offer various advantages over prescription drugs such as lesser side effects, lower product costs, and nutritional benefits..
Although, medical food products do not require adherence to any particular labelling requirements, any false claims or misbranding may result in legal action from the Food, Drug & Cosmetic Act (FD & C Act). Medical food varies in forms of dosage such as powders, pills, and solutions, which offer a wider range of products to the patients’. Technical advancements in nutritional therapies for different disorders is a result of robust support of medical food research and approved products and their various therapeutic applications, which, to a certain extent is expected to diminish the use of prescription drugs usage.
Personalized medicine is a developing field, and gaining medical industry’s attention for its therapeutic application, where 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 owing to innovative developments.
According to a report by the Personalized Lifestyle Medicine Institute, in 2013, 70% of all chronic diseases in the U.S. were due to nutrition deficiencies or imbalances. Such nutrition-based disease conditions could be directly addressed with the help of medical foods in the initial stages of the disease and prevent further loss. Thus, management of diseases by treating individual nutritional deficiencies is expected to favor demand for personalized medicines. The awareness about medical food and its benefits among healthcare professionals and patients is expected to drive growth of the market.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.