Invest KOREA

The Ministry of Food and Drug Safety analyzed the data on the clinical trials registration system of the US National Institutes of Health (ClinicalTrials.gov) and found that Korea’s share in the industry-led clinical trial market ranked no. 5 in 2022, compared to no. 6 in 2021. Seoul, in particular, has continued to rank first in global clinical trial city rankings for three consecutive years. Its multinational clinical trial ranking was no. 11, which is still the highest among Asian countries.

Korea is standing out globally in the biosimilar category: as of December 2022, nine out of forty biosimilar products approved by the United Sates Food and Drug Administration were developed by Korea, and the number of approved products was the second highest following the United States. With the joining of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) in 2014 and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 2016, Korea is recognized as a global leader in pharmaceuticals regulation.

In May 2019, Korea became the seventh country to be listed on the EU Whitelist. Korea is now exempt from the GMP written confirmation of drug substances, which the EU demands to exporters. The World Health Organization has been working towards installing the Global Training Hub for Biomanufacturing (GTH-B) to help develop the bio capabilities of low and middle income countries having difficulties procuring vaccines. In February 2022, Korea was solely designated as the GTH-B and is championing efforts to resolve the global inequality in vaccines supply and build the global healthcare safety net.

According to IQVIA, a global pharmaceutical market research agency, Korea's pharmaceutical market is the 13th largest in the world and is expected to record high growth rates between 4.5 and 7.5% until 2027.

According to the Ministry of Food and Drug Safety (MFDS), the size of Korea's pharmaceutical market exceeded KRW 25 trillion won (USD 21 billion) in 2021 by growing at an average annual growth rate of 4% over the past five years, supported by increased production and imports of COVID-19 vaccines and treatments.

As of 2021, the domestic pharmaceutical production reached KRW 25.4906 trillion won (about USD 21 billion), up 3.8% year-on-year and recorded an average annual growth rate of 5.8% over the past five years. Of the total pharmaceutical production value, finished pharmaceutical products accounted for 88.0% and raw materials for 12.0%. In 2021, pharmaceutical exports reached KRW 11.3642 trillion (about USD 9.9 billion), up 14.0% year-on-year. During the same period, imports reached KRW 11.2668 trillion (about USD 9.6 billion), up 31.5% year-on-year.

The Korean government with a vision to "emerge as a global leader of pharmaceutical and bio industries" announced in March 2023 the 3rd Master Plan for Fostering and Supporting Pharmaceutical and Bio Industries to Emerge as a Global Leader of Bio and Healthcare (Draft) (2023-2027) with related ministries.

Across Korea, eighteen clusters are operating in full-scale, including Songdo Bio Complex specializing in biopharmaceuticals and CMO, and Osong Medical Industrial Complex specializing in biopharmaceuticals and BT-based medical devices. The government plans to add two clusters to strengthen expertise and support new high-tech industries.

COVID-19 pandemic triggered increases in production and R&D investments in vaccines and biopharmaceuticals Cytiva, a subsidiary of US-based Danaher decided to invest in Songdo, Incheon, to establish a disposable culture bag production facility to meet growing demand in the vaccine production process. Sartorius, a German manufacturer of raw materials and equipment for biotechnology research and vaccine production, is in the process of building a production facility in Songdo, Incheon, to produce biopharmaceuticals and raw materials for biotechnology R&D in Korea. Prestige Biopharma based in Singapore continued to expand its investment in Prestige Biopharma, a vaccine and biopharmaceutical CDMO facility in Osong, Chungcheongbuk-do, and decided to establish Prestige Biopharma Korea to operate the Innovation Discovery Center for advanced biopharmaceutical R&D and global cooperation.