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7th Largest Clinical Trial Market in the World Close
7th Largest Clinical Trial Market in the World

The 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 Close
World-class Biomedicine Contract Manufacturing Facility

Korea 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
- CELLTRION 190,000 liters+
  
  plant 1: 100,000 liters
  
  plant 2: 90,000 liters
  
  plant 3: 200,000 liters planning
  
  Celltrion Third Plant 60,000 liters (Total capacity 190,000-> 250,000 liters)
Growth Led by Drug Products Open

Growth Led by Drug Products

According 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

e-Nation Indicator Shortcuts

Increasing Clinical Research and Joint Research in Korea by Global Pharmaceutical Companies Open

Increasing Clinical Research and Joint Research in Korea by Global Pharmaceutical Companies

According 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
Abbott	Kolon Pharma	Joint development of incrementally modified drug
AstraZeneca	Dong-A ST	Three joint research studies on immune-oncology precursors
AstraZeneca	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
Bristol-Myers Squibb	Hospitals	Sign a master clinical trial agreement
GlaxoSmithKline	Yonsei University College of Medicine	Joint research on next generation new anti-cancer drugs
GlaxoSmithKline	Hospitals	Sign a master clinical trial agreement
Lilly	Korea Research Institute of Chemical Technology	Sign a partnership on open innovative new drug development
Lilly	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
SANOFI PASTEUR	SK Chemicals	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 Open

Manufacturing Foundation for Advanced Bio Medical Products

Under 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 Open
Regional Bio Clusters

Bio 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

BEST1

[Incheon Metropolitan City Michuhol-gu]

Incheon General Industrial Complex

Designated area(m2) : 1,136,269
Management : Incheon Metropolitan City Corporation
Nearby Railway : Bupyeong Station (7km)
Nearby Airport : Gimpo International Airport (29km)

BEST2

[Chungcheongbuk-do Cheongju City]

Osong Life Science Complex

Designated area(m2) : 4,833,314
Management : Korea Industrial Complex Corporation
Nearby Railway : Cheongju Station (9km)
Nearby Airport : Cheongju International Airport (21km)

BEST3

[Gyeongsangbuk-do Andong City]

Gyeongbuk Bio 2nd General Industrial Complex

Designated area(m2) : 299,829
Management : Gyeongsangbuk-do Andong City
Nearby Railway : Andong Station (19km)
Nearby Airport : Daegu International Airport (111m)

BEST4

[Gyeongsangbuk-do Andong City]

Gyeongbuk Bio General Industrial Complex

Designated area(m2) : 941,431
Management : Gyeongsangbuk-do Andong City
Nearby Railway : Yecheon Station (15km)
Nearby Airport : Daegu International Airport (111km)

BEST5

[Gyeonggi-do Hwaseong-sity]

Gyeonggi Hwaseong Bio Valley General Industrial Complex

Designated area(m2) : 0
Management : Hwaseong City Corporation
Nearby Railway : Suwon Station (27km)
Nearby Airport : Gimpo International Airport (52.5km)

BEST6

[Jeollabuk-do Iksan City]

Iksan 4th Industrial Complex [formerly: Iksan General Medical Science]

Designated area(m2) : 502,825
Management : Jeollabuk-do Iksan City
Nearby Railway : Hwangdeung Station (4km)
Nearby Airport : Gunsan Airport (47km)