OTC drugs 8K↓·health functional foods 25K↑ over 10 years

The number of over-the-counter (OTC) drug items decreased to nearly half over 10 years…one out of every two products has no production record

The number of health functional food items increased robustly…2.5↑ times than last year's OTC drugs

The gap between the number of registered health functional foods and over-the-counter (OTC) drugs in South Korea has widened significantly. Over the past 10 years, health functional foods have more than doubled, and just nine years after overtaking OTC drugs, the number of health functional foods items has reached five times that of OTC products. OTC drugs have decreased to nearly half their previous level over the past 10 years, indicating that the movement to enter the market has been greatly restricted. It was also found that one out of every two approved OTC products has no production record.

According to the '2025 Food and Drug Statistical Annual Publication' released by the Ministry of Food and Drug Safety (MFDS) on the 31st, the number of OTC drug items was calculated at 8,630 last year. This is a decrease of 490 items from 9,120 in 2023.

The downward trend in the number of domestically approved OTC drug items is continuing. From 16,717 items in 2014, the count has shrunk to nearly half over the course of 10 years. The number of OTC items dropped by 5,797, from 14,175 in 2018 to 8,378 in 2019, and although it recovered to the 10,000 level in 2020, the decline has persisted since 2021. The number of OTC drug items rose by 307, from 8,813 in 2022 to 9,120 the following year, but returned to a downward trend within a year.

The number of over-the-counter (OTC) drugs and health functional foods registered in South Korea by year (unit: number, source: MFDS)

The report indicates that more products have withdrawn from the domestic OTC market than new ones have entered. In the pharmaceutical market, many products disappear due to safety management systems such as the continuous renewal of product licenses. The requirements of the drug product license renewal system is that drugs approved by health authorities must re-verify their efficacy and safety every five years for the license to be maintained. For many products, if marketability is determined to have declined at the time of expiration, the renewal is abandoned and the product is withdrawn from the market.

This is a stark contrast to the continuous annual increase in health functional food.

Last year, the number of manufactured health functional food items was 41,896, an increase of 4,622 from the previous year. Over the 10 years since 2014, when there were 16,632 items, the count has increased by 25,264, expanding by approximately 2.5 times.

In 2014, health functional foods had 85 fewer items than OTC drugs. In 2015, the number of health functional food items rose to 18,956, overtaking the 14,892 OTC drug items by a margin of 4,064, and the gap has gradually widened since then. Last year, the number of health functional food items was found to be about five times greater than that of OTC drugs..  

The gap becomes even larger when considering only those OTC drugs with actual production records. Last year, the number of OTC drugs with production records was 4,631, compared to 4,873 in 2023. This means that about half of the OTC drugs currently maintaining MFDS approval have no production records. The number of OTC items with production records has decreased by 1,444 over the 10 years since 2014, when it was 6,075.

Analysis suggests that as the health functional food market size continues to grow and market entry barriers are relatively lower than those for OTC drugs, new entry activities are more active.  

Last year, the health functional food market was valued at KRW 4.0131 trillion, a 1.9% decrease from the previous year. It has decreased for two consecutive years from KRW 4.1695 trillion in 2022. The industry analyzes that as new entries into the health functional food market have become active and low-price competition has intensified, it has affected the reduction in market size. However, compared to KRW 2.4130 trillion in 2014, the market size has increased by 146.1%, showing rapid growth recently.

The health functional food market size and _over-the-counter (OTC) drug production size by year (unit: KRW 100 million, source: MFDS)

Following the enactment of the Health Functional Food Act in 2003, the health functional food system was implemented. The purpose of introducing the Act was to contribute to the promotion of public health and consumer protection by ensuring the safety and improving the quality of health functional foods and fostering sound distribution and sales. The domestic health functional food market surpassed KRW 1 trillion for the first time in 2010 and exceeded KRW 2 trillion in 2016. The market size grew to the KRW 3 trillion range in 2020 and has remained above KRW 4 trillion since 2021.

While the number of OTC drug items continued to decline, production performance showed a brief upward trend.

Last year, the production size of OTC drugs was KRW 4.2357 trillion, a 9.9% increase from the previous year. Last year's OTC production amount was the largest in history.

The production size of OTC drugs decreased from KRW 3.1779 trillion in 2020 to KRW 3.0692 trillion in 2021 but returned to an upward trend in 2022. In 2022, the OTC production record was KRW 3.5848 trillion, a 16.8% increase from the previous year, and in 2023, it recorded KRW 3.8554 trillion, a 7.5% increase year-on-year. Last year's OTC production scale increased by 38.0% in three years compared to 2021, surpassing KRW 4 trillion for the first time.

Analysis suggests that the recent expansion of OTC production records was most heavily influenced by the COVID-19 pandemic and endemic.

Since the end of 2021, when hundreds of thousands of COVID-19 cases were reported daily, sales of antipyretics, analgesics, and cold medicines used for symptom relief significantly increased. It is analyzed that the boom in the OTC market has continued as the number of flu and cold patients surged since the transition to the COVID-19 endemic phase in 2023.