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Diet-Based Therapies and Regulatory Pathways Driving Growth in the Global Medical Foods Market: Clinical Utility and Reimbursement Challenges
The Medical Foods Market occupies a distinct and often misunderstood niche in the healthcare industry, separate from dietary supplements and conventional foods. Defined and regulated in the U.S. under the Orphan Drug Act, medical foods are specially formulated to be consumed or administered enterally under a physician's supervision, and are intended for the dietary management of a disease or condition for which distinctive nutritional requirements exist. This market is primarily driven by the rising prevalence of chronic conditions, such as Alzheimer's disease, diabetes, inborn errors of metabolism (e.g., Phenylketonuria), and Crohn's disease, that cannot be managed by diet modification alone. Products include elemental and polymeric formulas, and specialized formulations containing specific amino acids, vitamins, or lipids designed to correct metabolic imbalances or meet the elevated nutritional needs of a particular disease state.…