Table of Contents
•The global medical foods market generated a revenue of $xxbillion in 2013. It is estimated to grow at a CAGR of xx% to reach $xx billion in 2018.
•Increasing number of disease targets, increasing healthcare expenditure, and increasing public health consciousness are likely to be the key drivers for market growth. A poor regulatory environment and low medical adherence among patients restrain market growth.
•The market is well-consolidated with the top xx participants accounting for about xx%– % of the market. Increasing merger and acquisition (M&A) activities are set to impact the market dynamics.
•A robust R&D set-up, regional product differentiation, and focus on product innovation are the key competitive factors in the Asia-Pacific (APAC) medical foods market.
•The APAC market (including Australia, New Zealand, and Southeast Asia) still accounts for a very small share of the global medical foods market. Considering the region’s population and disease prevalence rates, this region continues to have a significant growth potential.
•Diabetes, oncology, and metabolic health are the most significant application areas in the APAC region, while immune health and cardiovascular health are promising applications for future growth.
•Different growth factors have been evaluated for their significance in market growth and product-related trends have been identified to have the highest impact, followed by promotional efforts by medical food manufacturers.
•The pricing and product functionality of medical foods are largely influenced by the ingredients. Nutritional proteins and nutritional lipids account for a majority of the revenue of the ingredients market for APAC medical foods.
•Medical foods is a loosely coined and an often-misunderstood term for a special category of disease-specific foods administered to sick patients.
•Medical foods are specially formulated and processed foods that are targeted to meet specific nutritional requirements arising out of a disease condition, and are meant for oral or enteral administration to patients receiving active and ongoing medical supervision.
•Medical foods are a part of clinical nutrition, which also includes parenteral nutrition. Parenteral nutrition is excluded from the scope of this research.
•Medical foods are well-regulated in the United States (US) by the Food and Drug Administration (FDA).
Criteria for Medical Food Classification—US FDA
Under regulation xx CFR 101.9(j)(8), the US FDA has established the criteria to clarify the statutory definition of medical foods as outlined below.
Criteria for Medical Food Classification
•It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube.
•It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone.
•It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation.
•It is intended to be used under medical supervision; and
•It is intended only for a patient receiving active and ongoing medical supervision, wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.
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