분야별 정보자료/식품·건강기능식품

특수의료용도식품 (medical food)

식품 및 건강기능식품 인허가 컨설팅 2025. 8. 21. 11:17

A Food for Special Medical Purposes (FSMP) refers to food that is manufactured or processed to be consumed orally or via enteral feeding as a partial or total replacement of a regular diet. It is intended for individuals whose ability to ingest, digest, absorb, or metabolize nutrients is limited, or who, due to clinical conditions such as illness or surgery, have nutritional requirements that differ physiologically from the general population and therefore require sufficient nutritional support, restriction, or supplementation of certain nutrients.

Korea is expected to enter a super-aged society in 2025. Six metropolitan cities and provinces, including Busan, have already reached this stage, with people aged 65 or older accounting for more than 20% of their total population. Food is regarded as one of the most critical areas in a super-aged society. Since the elderly often suffer from chronic conditions such as hypertension and diabetes, as well as diseases including cancer and dementia, they may find it difficult to consume ordinary meals or may face nutrient deficiencies. As a result, demand for FSMPs is projected to rise.

Globally, the FSMP market is steadily expanding. In Korea, the market size has shown sharp growth, increasing more than threefold from KRW 81.1 billion in 2019 to KRW 269.6 billion in 2023. As of 2024, 61 domestic companies are producing 876 FSMP products.