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7th Largest Clinical Trial Market in the World Close7th Largest Clinical Trial Market in the WorldThe market share of industry-led clinical trials in Korea was ranked 7th in the world in 2018.
The share of Seoul (number of clinical trial laboratories) out of all cities around the world ranked first in 2018.
Korea stands out in the global biosimilar field, and 7 out of 23 biosimilar products approved by the FDA were developed in Korea (August 2019).In May 2019, Korea became the seventh country to make the EU’s drug whitelist (GMP written confirmation exemption).
According to the agreement signed with the WHO in December 2016,
Korean vaccines supplied to international organizations are exempted from undergoing site inspections for the WHO-GMP area.According to IQVIA, a global medical market research institution, the Korean medicine and medical supplies market ranked 12th in the world in 2019,
showing a high growth rate at 7.3% for the five years from 2014 to 2019, and is expected to show a growth rate as high as 5 to 8% over the next five years from 2020 to 2024."EU Whitelist (GMP written confirmation exemption)"7th country in the world to make the EU whitelist- Switzerland listed : 2012.11
- Australia listed: 2013.04
- Japan listed: 2013.06
- US listed: 2013.06
- Israel listed: 2015.07
- Brazil listed: 2015.07
- Korea listed: 2019.05
- No. 1 – 2018 city’s market share in clinical trial market (Seoul) * Source: Korea National Enterprise for Clinical Trials
- No. 7 – 2018 national clinical trial market share (Korea) * Source: Korea National Enterprise for Clinical Trials
- 7 – Korean biosimilar products approved by the FDA (August 2019)
- 7.3% - High growth rate at 7.3% for the most recent five years in the Korean medical market
※ Source: Korea National Enterprise for Clinical Trials -
World-class Biomedicine Contract Manufacturing Facility CloseWorld-class Biomedicine Contract Manufacturing FacilityKorea has been raising its status as a contract manufacturing base for biomedicine products.
In August 2020, Samsung Biologics announced its plan in to build its fourth plant with a capacity of 256,000 liters.
Celltrion also is promoting the construction of a third plant with a 200,000 liter capacity."Contract Manufacturing Capacity of the Korean Biomedical Industry"-
Samsung Biologics 364,000 liters+
- plant 1: 30,000 liters
- plant 2: 154,000 liters
- plant 3: 180,000 liters
- plant 4: 256,000 liters planning
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CELLTRION 190,000 liters+
- plant 1: 100,000 liters
- plant 2: 90,000 liters
- plant 3: 200,000 liters planning
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Samsung Biologics 364,000 liters+
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Growth Led by Drug Products OpenGrowth Led by Drug ProductsAccording to the Ministry of Food and Drug Safety, the domestic medicine and medical supplies market in 2019 reached USD 20.9 billion (KRW 24.31 trillion), up 5.2% YoY.
The total output of medicine and medical supplies in 2019 was USD 19.2 billion (KRW 22.31 trillion), up 5.7% YoY,
and the CAGR over the past five years reached 7.1%. Drug products accounted for 88.9% of all medical products,
and 83.7% of those drug products were prescription drugs.In addition, exports of medicine and medical supplies in 2019 reached USD 5.2 billion, up 11.2% YoY,
the largest increase in history, and imports also increased by 6.2% YoY to reach USD 7 billion.(Unit: KRW trillion, %, USD 100 million, USD)Bio Industrial Trend Category, year Source: 2018 Korean Bio Industry Factual Survey -
Increasing Clinical Research and Joint Research in Korea by Global Pharmaceutical Companies OpenIncreasing Clinical Research and Joint Research in Korea by Global Pharmaceutical CompaniesAccording to the Korean Research-based Pharma Industry Association, 35 global pharmaceutical companies that entered Korea invested USD 400 million (KRW 483.7 billion) in R&D in 2019, showing a steady increase.
These companies conducted 1,536 clinical research studies in Korea in 2019.Various joint R&D projects have also been continuously conducted, such as basic research support, non-clinical trials,
license-in of domestically developed substances, joint development of domestic pharmaceutical companies and
research institutes, and agreements for research with domestic hospitals and groups."Joint Research between Multinational Pharmaceutical Companies and Korean Companies"Joint Research between Multinational Pharmaceutical Companies and Korean Companies Foreign-invested Companies, Korean Companies/Institutes, Cooperation Foreign-invested Companies Korean Companies/Institutes Cooperation Abbott CorePharm Bio Joint development of incrementally modified drug Kolon Pharma Joint development of incrementally modified drug AstraZeneca Dong-A ST Three joint research studies on immune-oncology precursors Korea Health Industry Development Institute Select and support four translational research projects in the anticarcinogenic area Bayer KOTRA Support Korean digital healthcare startups Bristol-Myers Squibb Samsung Biologics Produce raw material medicines Hospitals Sign a master clinical trial agreement GlaxoSmithKline Yonsei University College of Medicine Joint research on next generation new anti-cancer drugs Hospitals Sign a master clinical trial agreement Lilly Korea Research Institute of Chemical Technology Sign a partnership on open innovative new drug development LK Global PS Phase 1 clinical research on candidate substances for new drugs for gastric cancer and lung cancer MSD Korea Drug Development Fund Joing R&D programs on anti-cancer drugs Pharmabcine Joint research on combined therapy on recurrent brain tumors and metastatic breast cancer Genexine Joint research on combined therapy on cervix squamous cell carcinoma sanofi aventis Asan Medical Center Joint research on bio informatics for liver cancer patients Seoul National University/KAIST Joint research on platform development of next generation immuno-anti-cancer drugs Institut Pasteur Korea Joint research on antibiotic candidate substances and new drugs for hepatitis B SANOFI PASTEUR SK Chemicals Global joint research on next generation protein-conjugate pneumococcus vaccines Global license for producing universal flu vaccines ※ Source: Korea Research-based Pharma Industry Association “2019 R&D Investment in Korea” -
Manufacturing Foundation for Advanced Bio Medical Products OpenManufacturing Foundation for Advanced Bio Medical ProductsUnder the restrictions of the Special Taxation Act, the Korean government offers income tax, acquisition tax, and property tax reductions or exemptions to foreign investors in the medical and bio industries if certain requirements are met.
Capital goods designated in the enforcement ordinance are exempted from customs duties, special consumption tax, and value added tax.Meanwhile, the Act on the Safety and Support for Advanced Regenerative Medicine and Advanced Biomedicine was enforced in September 2020.
Advanced biomedicine refers to biomedicine manufactured by using living cells, tissues, or genes as substances, and it includes cell therapy products, gene therapy products,
and tissue engineered products. A reasonable approval and evaluation system was established to manufacture
and control quality of advanced biomedicine that is different from traditional synthetic drugs. -
Regional Bio Clusters OpenRegional Bio ClustersBio clusters are established across the country, and specialized clusters for medical products are located in Osong, Daegu, Incheon, and Hwasun.
Bio clusters are a combination of universities, companies, hospitals, and research institutes that are closely connected through networks.
Foreign pharmaceutical companies aiming to enter the Korean market can receive various incentives, such as tax benefits,
and networking support from universities, companies, hospitals, and research institutes, if they choose to be located in these cities."Bio Clusters in Korea"- Hongneung, Seoul : Startup incubation and commercialization support hub
- Gyeonggi : Companies-focused, company support institutions, infrastructure, and service (Hyangnam Pharmaceutical Industrial Complex, Gwanggyo/Pangyo Techno Valley)
- Songdo, Incheon : Manufacture biomedicine
- Chuncheon : Natural substances, medicine and medical supplies, health supplements, cosmetics companies
- Osong, Chungcheongbuk-do (High-tech Composite Medical Complex) : Bio clinical and non-clinical
- Wonju : Medical devices
- Seosan : Green bio convergence
- Jecheon : Oriental bio
- Daedeok, Daejeon (R&D special zone) : Venture companies and R&D-focused
- Chungju : Diabetes bio
- Okcheon : Medical devices
- Andong, Gyeongsangbuk-do : Vaccine bio
- Daegu, Gyeongsangbuk-do (High-tech Composite Medical Complex) : Chemical medicines, medical companies
- Iksanm Jeollabuk-do : Food microorganisms
- Gimhae (Biomedical, Medical Device Gangso Special Zone) : Biomedical, medical devices, electroceutical
- Hwasun : Biomedical
- Jinju : Bio
- Jeju : Natural beauty, health, waters
※ Source: Ministry of Health and Welfare, Local governments
※ Source Provider: Korea Biotechnology Industry Organization
Invest KOREA
Medical/Healthcare PM
Park Beum Joon
New Industry Promotion Team
T.+82-2-3460-7883
Recommendation on Locations
Industrial complex information
[Incheon Metropolitan City Michuhol-gu] Incheon General Industrial Complex
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Complex nameIncheon General Industrial Complex
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Initial designation date1973.04.01
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Designated area(m2)1,136,269
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ManagementIncheon Metropolitan City Corporation
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Nearby RailwayBupyeong Station
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Distance from station(km)7
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Nearby AirportGimpo International Airport
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Distance from airport(km)29
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Industrial water Supply capacity(ton/day)-
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Affiliation local governmentIncheon Metropolitan City Michuhol-gu
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Population2,943,491
Industrial complex information
[Chungcheongbuk-do Cheongju City] Osong Life Science Complex
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Complex nameOsong Life Science Complex
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Initial designation date1997.09.23
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Designated area(m2)4,833,314
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ManagementKorea Industrial Complex Corporation
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Nearby RailwayCheongju Station
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Distance from station(km)9
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Nearby AirportCheongju International Airport
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Distance from airport(km)21
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Industrial water Supply capacity(ton/day)25000(㎥/day)
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Affiliation local governmentChungcheongbuk-do Cheongju City
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Population843,782
Industrial complex information
[Gyeongsangbuk-do Andong City] Gyeongbuk Bio 2nd General Industrial Complex
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Complex nameGyeongbuk Bio 2nd General Industrial Complex
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Initial designation date2016.02.29
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Designated area(m2)299,829
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ManagementGyeongsangbuk-do Andong City
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Nearby RailwayAndong Station
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Distance from station(km)19
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Nearby AirportDaegu International Airport
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Distance from airport(km)111
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Industrial water Supply capacity(ton/day)1863(㎥/day)
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Affiliation local governmentGyeongsangbuk-do Andong City
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Population158,867
Industrial complex information
[Gyeongsangbuk-do Andong City] Gyeongbuk Bio General Industrial Complex
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Complex nameGyeongbuk Bio General Industrial Complex
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Initial designation date2004.07.05
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Designated area(m2)941,431
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ManagementGyeongsangbuk-do Andong City
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Nearby RailwayYecheon Station
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Distance from station(km)15
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Nearby AirportDaegu International Airport
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Distance from airport(km)111
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Industrial water Supply capacity(ton/day)5287(㎥/day)
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Affiliation local governmentGyeongsangbuk-do Andong City
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Population158,867
Industrial complex information
[Gyeonggi-do Hwaseong-sity] Gyeonggi Hwaseong Bio Valley General Industrial Complex
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Complex nameGyeonggi Hwaseong Bio Valley General Industrial Complex
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Initial designation date2012.07.04
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Designated area(m2)0
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ManagementHwaseong City Corporation
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Nearby RailwaySuwon Station
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Distance from station(km)27
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Nearby AirportGimpo International Airport
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Distance from airport(km)52.5
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Industrial water Supply capacity(ton/day)3154(㎥/day)
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Affiliation local governmentGyeonggi-do Hwaseong-sity
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Population842,864
Industrial complex information
[Jeollabuk-do Iksan City] Iksan 4th Industrial Complex [formerly: Iksan General Medical Science]
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Complex nameIksan 4th Industrial Complex [formerly: Iksan General Medical Science]
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Initial designation date2008.03.14
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Designated area(m2)502,825
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ManagementJeollabuk-do Iksan City
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Nearby RailwayHwangdeung Station
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Distance from station(km)4
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Nearby AirportGunsan Airport
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Distance from airport(km)47
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Industrial water Supply capacity(ton/day)4,540(㎥/day)
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Affiliation local governmentJeollabuk-do Iksan City
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Population283,496