South Korea’s Medical Device Production Records Surplus for Third Consecutive Year with 22.2% Growth in Domestic Production, 425% Increase in COVID-19 Self-Test Kits production, and 30.0% Domestic Market Size Increase

3 consecutive years of surplus, 22.2% growth in domestic medical device production
425% increase in production of COVID-19 self-test kits, 2 trillion won in production ↑ 2 manufacturers

South Korea’s 2022 medical device trade surplus was tallied at $2.99 ​​billion. In Korean currency, 3.8593 trillion won. After the first surplus in 2020, it has been in the black for three consecutive years.

The Ministry of Food and Drug Safety disclosed the trade balance of medical devices on the 24th. Korea’s medical device trade balance has been showing deficits at -280 million dollars in 2018 and -450 million dollars in 2019. However, after 2020, the results have changed. It received three consecutive ‘surplus’ report cards, including $2.21 billion in 2020, $3.28 billion in 2021, and $2.99 ​​billion in 2022.

The amount of medical device production in 2022 was tallied at 15,737.4 billion won. This is an increase of 22.2% compared to 2021, the highest growth rate ever.

Exports ($7.88 billion) and imports ($4.89 billion) decreased (8.7%, 8.6%) compared to 2021. In terms of won, it increased slightly (3.0%, 3.1%) due to the rise in the exchange rate. The Bank of Korea standard exchange rate rose from 1144.42 won in 2021 to 1291.95 won in 2022.

The size of the domestic medical device market in 2022 also reached 11,878.2 billion won, an increase of 30.0% compared to 2021, the highest growth rate ever. The domestic medical device market has grown by 159% over the past 10 years. Market size is the sum of production and imports minus exports.

The Ministry of Food and Drug Safety recently cited the spread of Corona 19 as the main cause of the increase in domestic medical device production and market size. Among them, he pointed out that demand for self-diagnosis kits for COVID-19 in Korea has skyrocketed due to the spread of Omicron mutations.

The government also helped mass-produce and supply test kits by implementing distribution improvement measures, such as responding to the demand and increasing production and supporting the supply of raw materials.

The production of Corona 19 self-test kits increased by more than 400% from 274.4 billion won in 2021 to 1441.5 billion won in 2022. Exports also increased by 100% from 42.2 billion won in 2021 to 84.3 billion won in 2022.

Following COVID-19 test kits, dental implants and biomaterials for tissue repair showed a high rate of increase in production compared to the previous year. Biomaterials for tissue repair refer to biomaterials used for replacement, restoration, and reconstruction, such as human tissue.

Dental implants are analyzed to be influenced by the aging population, expanded application of health insurance, and increased demand for bioplastics for tissue repair.

photo-layout image photo_114113 max-width-348 float-center" data-idxno="114113" data-type="photo" style="display:inline-block">

The market share of domestic medical devices recorded a record high of 46.8%.

Also, the increase in production of domestic medical devices such as Corona 19 test kits had an impact. The share of imported medical devices naturally recorded an all-time low.

The share of domestic medical devices is the value obtained by subtracting exports from output, dividing by market size, and then multiplying by 100. It recorded 37.2% in 2018, 37.9% in 2019, 30.6% in 2020, 32.9% in 2021, and 46.8% in 2022.

A total of two medical device manufacturers exceeded 2 trillion won in production last year. The companies concerned are SD Biosensor Co., Ltd. and Osstem Implant Co., Ltd.

In 2012, there were only two manufacturers with an output value of more than 200 billion won. This is a huge growth in 10 years. The top two companies in terms of production accounted for 30.4% of total production. The top 1 exporter accounted for 23.6% of total exports. This means that the polarization of manufacturers has deepened.

Production and export of digital medical devices are also steadily increasing.

Digital medical device production was tallied from 688.1 billion won in 2020 to 862.2 billion won in 2021 and 1.167 trillion won in 2022. In the case of exports, they recorded $520 million in 2020, $690 million in 2021, and $740 million in 2022.

On May 24, the Ministry of Food and Drug Safety will operate a comprehensive support center for licensing and licensing of software and medical devices. The purpose is to support the rapid development of domestic digital medical devices and promote entry into overseas markets.

The Center provides intensive support for the export of 30 items from three product groups with product competitiveness for three years to advance domestic medical devices into the global market. The K-Medical device Go Abroad (MEGA) project 3 project).

The project is a project that supports the entire life cycle of product development, from the approval/permission stage to overseas market entry, to support the strategic export of domestic medical devices.

The Ministry of Food and Drug Safety said, “We plan to provide comprehensive technical support throughout the entire product development cycle, from clinical trials and approvals to overseas market entry, for companies developing software and medical devices.”

Copyright © Uihyup Newspaper Unauthorized reproduction and redistribution prohibited