CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – South Korea

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The South Korean medical device market was valued at $9.95 billion in 2020 and is expected to grow at a CAGR of over 4% during the period 2021-2027. South Korea is the world’s 10th largest pharmaceutical market and considers the pharmaceutical industry a potential growth engine for the country’s future economic growth. South Korea’s pharmaceutical manufacturing industry is accelerating its transformation due to increased support from government policies such as the five-year comprehensive plan and the steadily rising coronavirus-related deals.

In 2020, the Advanced Regenerative Bio Act was passed to encourage biopharma innovation. The Act is a law that relaxes screening criteria in regenerative medicine research when certain conditions are met which allows companies to market products in phase 2 development provided phase 3 clinical trials are conducted. The Ministry of Food and Drug Safety (MFDS) has established a goal of responding to clinical trial applications within 30 days of submission. The emphasis on speed has contributed to a 152-day average time frame for starting a clinical trial in South Korea.

South Korean medical device market overview

South Korean medical device market overview

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What are the market dynamics in South Korean pharmaceutical market?

South Korea has many domestic pharmaceutical manufacturers with advanced R&D facilities. According to the Korea International Trade Research Institute (KITRI) report, South Korea’s biopharmaceutical exports increased by 139% year on year, and it ranked seventh across the globe during 2020. The aging population will sustain demand for pharmaceuticals given its high burden of non-communicable diseases, such as heart disease, obesity, cancer and diabetes. In May 2020, the government announced a joint medical devices R&D project with a target budget of $0.98 billion between 2020 and 2025. The project aims to support the strengthening of the medical devices industry by taking the opportunity of increased trust in Korean-made medical devices and health services in the fight against COVID-19.

Which are the key segments in the South Korean pharmaceutical market?

The key segments in the South Korea pharmaceutical market are generics, biologics, biosimilars, and OTC.

Generics pharmaceutical market in South Korea: The Korean Ministry of Food and Drug Safety (MFDS) has improved the quality of generic drug products and ensured an efficient and competitive generics market. South Korea’s generics market was expected to increase further due to the government’s significant investment in the generics market. Another contributing factor was that many original drugs were set to lose their patents by 2020, thus opening the market for generics. In July 2021, the KPBMA announced the revision of the Pharmaceutical Affairs Act (PAA) to restrict generic drugs. The act was amended to include a 1+3 restriction regulation, limiting the number of generic drugs that can be approved with a single bioequivalence test set to a maximum of four.

Biologics and Biosimilars pharmaceutical market in South Korea: In 2020, 20 biologics were approved in South Korea, of which 18 were domestically manufactured and two were imported biologics. As of October 2021, MFDS had approved 13 biosimilars within the product classes of HER2-inhibitor, insulin, tumor necrosis factor (TNF)-inhibitor, and monoclonal antibody, for use in South Korea. The top 10 companies producing drugs in South Korea in 2020 were Celltrion, Hanmi Pharmaceutical, Chong Kun Dang, GC Pharma, inno.N, Daewoong Pharmaceutical, Yuhan, LG Chem Dong-A ST, and JW Pharmaceutical. All these companies are involved in the production or distribution of biosimilars.

Over-the-Counter Medicines (OTC) pharmaceutical market in South Korea: The sale of OTC drugs such as cold and digestive medicines, antipyretics, analgesics, and pain relief patches in stores other than a pharmacy has been legal in South Korea. Convenience stores sell around a dozen OTC drugs. Regional associations of Korean pharmacists began boycotting imported Japanese over-the-counter drugs in 2019. Takeda’s Actinium, Kobayashi’s Eyebon, and Nichiban’s Careleaves were among them. This was done in order to protect South Korea’s national interestsfrom Japan’s newly imposed trade restrictions. According to in-house sales data, in 2020, the cumulative over-the-counter drug sales for the past nine months amounted to $1.5 billion, with an increase of 0.2% as compared to a similar time period of 2019.

South Korean pharmaceutical market, by segment type

South Korean pharmaceutical market, by segment type

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Who are the key players in the South Korean healthcare market?

In the South Korean pharmaceutical market, Celltrion is the leading company by net sales followed by Pfizer GSK and Chong Kun Dang Pharmaceutical Corp. Chong Kun Dang Pharmaceutical Corp is expected to grow during the forecast period. Whereas the major players in South Korea’s medical devices market are Abbott, Medtronic, GE Healthcare, Canon Medical Systems Corp, and i-Sens.

South Korean Pharmaceutical Market, by key players

South Korean Pharmaceutical Market, by key players

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Market report scope

Market value (Year – 2020) $9.95 billion (Medical devices)
Growth rate (CAGR) >4%
Base year for estimation 2020
Forecast period 2021-2027
Key Segment Generics, Biologics, Biosimilars, and OTC
Key Players Celltrion, Pfizer GSK and Chong Kun Dang Pharmaceutical Corp. Abbott, Medtronic, GE Healthcare, Canon Medical Systems Corp, and i -Sens

Scope:

The report provides information on the healthcare, regulatory, and reimbursement landscape in South Korea, and includes:

  • An overview of the pharmaceutical and medical device markets, comprising market size, segmentation, and key drivers and barriers.
  • Profiles and SWOT analyses of the major players in the pharmaceutical market: Roche, Pfizer, Sanofi, CSL, and Sonic Healthcare.
  • Profiles and SWOT analyses of the major players in the medical device market: Medtronic, Stryker, Boston Scientific, Ansell, and Nanosonics.
  • An insightful review of the COVID-19 epidemiology, COVID-19 impact and developments in healthcare market, HealthTech landscape, reimbursement and regulatory landscape, with analysis covering details of the country’s healthcare reimbursement process, regulatory agencies and the approval processes for new drugs and medical devices.
  • Detailed analysis of the country’s healthcare policy highlights, demographics, healthcare infrastructure and healthcare expenditure.
  • An overview of the opportunities for and challenges to growth in the South Korea healthcare market.

Reasons to Buy

This report will enhance your decision-making capability by allowing you to:

  • Develop business strategies by understanding the trends shaping and driving the South Korea healthcare market.
  • Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact the South Korea healthcare market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing competitors’ performance.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment and strategic partnership.

Table of Contents

1 Table of Contents

1.1 List of Figures

1.2 List of Tables

2 Executive Summary

2.1 Executive Summary

2.2 Key Highlights – Facts about the South Korea Healthcare Market

2.3 Key Highlights: Healthcare Startups in South Korea

2.4 Key Events: South Korea Pharmaceutical News, 2015–2021

2.5 Key Events: South Korea Pharmaceutical Market

2.6 Key Events: M&As, VC & PE Deals, Global Pharmaceutical Market, 2020–2021

2.7 Key Events: Mergers and Acquisitions

2.8 Country Profile, South Korea, 2021

3 Overview of Pharmaceutical Market

3.1 Pharmaceutical Market – Overview

3.2 Pharmaceutical Market – Exports

3.3 Pharmaceutical Market – Imports

3.4 Pharmaceutical Market – Supply Channels, South Korea

3.5 Pharmaceutical Market – Market Segments

3.6 COVID-19 Epidemiology, South Korea

3.7 COVID-19 Impact and Developments in the Healthcare Market, South Korea

3.9 Pharmaceutical Market – Major Players

4 Overview of Medical Devices Market

4.1 Medical Device Market – Overview

4.2 Medical Devices Market – Major Players

5 Pharmaceutical and Medical Devices Market – Drivers and Barriers

5.1 Drivers

5.2 Barriers

6 Deal Analysis

6.1 Deal Analysis: Pharmaceutical Market, South Korea, 2019–2021

6.2 Deal Analysis: Medical Device Market, South Korea, 2019–2021

7 HealthTech Landscape

7.1 HealthTech Landscape, South Korea

7.2 HealthTech Deals Landscape, South Korea

7.3 Adoption of Technology in Healthcare, South Korea

7.4 Key HealthTech Deals, South Korea

7.5 Digital Statistics, South Korea

7.6 HealthTech Landscape, South Korea

7.7 Digital Regulations, South Korea

7.8 COVID-19 Impact on Digital Health, South Korea

7.9 HealthTech Landscape: Benefits and Risks, South Korea

8 Market Access

8.1 Overview of Healthcare System, South Korea

8.2 Reimbursement Process, South Korea

8.3 Overview of Insurance Providers, Public Insurance, South Korea

8.4 Out-of-Pocket Spending and Pharmaceutical Price Index, South Korea

8.5 Pricing Policies, South Korea

8.6 Regulatory Landscape, South Korea

8.6.1 Marketing Authorization for Pharmaceutical Products, South Korea

8.6.2 Marketing Authorization for Generic Medicines, South Korea

8.6.3 Marketing Authorization for OTC, South Korea

8.6.4 Marketing Authorization for Biologics and Biosimilars, South Korea

8.6.5 Pharmaceutical Market – Drug Approvals

8.6.6 Marketing Authorization for Medical Devices, South Korea

8.6.7 Pharmaceutical Export and Import, South Korea

8.6.8 Intellectual Property Rights, South Korea

8.6.9 Intellectual Property Rights, Patent, South Korea

8.6.10 Intellectual Property Rights, Trademark, South Korea

8.6.11 Clinical Trial Regulation Process, South Korea

8.6.12 Pharmaceutical Clinical Trials Landscape, South Korea

8.6.13 Medical Device Clinical Trials Landscape, South Korea

8.6.14 Pharmaceutical Advertising Regulations, South Korea

8.6.15 Pharmacy Regulations, South Korea

8.6.16 Labeling and Packaging Regulations, South Korea

9. Country Healthcare Landscape

9.1 South Korean Healthcare Policy Highlights

9.2 Healthcare Facilities, South Korea

9.3 Life Expectancy and Immunization Rate, South Korea

9.4 Environmental Health, South Korea

9.5 Healthcare Personnel, South Korea

9.6 Disease Burden, South Korea

9.7 Healthcare Expenditure, South Korea

10 Trade Associations, South Korea

11 Trade Fairs, South Korea

12 Opportunities and Challenges

13 Appendix

13.1 Research Methodology

13.1.1 Coverage

13.1.2 Secondary Research

13.1.3 Forecasts

13.2 Bibliography

13.3 About GlobalData

13.4 Contact Us

13.5 Disclaimer

Table

Table 1: Approved Biosimilars, South Korea, 2020

Table 2: Key Approved Biologics, South Korea, 2020–2021

Table 3: Top 5 Imported Products, OTC Market ($M), South Korea, 2020

Table 4: COVID-19 Indicators, Global and South Korea, 2020–2021

Table 5: COVID-19-Related Travel Restrictions, South Korea, 2020–2021

Table 6: Authorized COVID-19 Vaccines, South Korea, 2020–2021

Table 7: Available COVID-19 IVD Products, South Korea, 2020–2021

Table 8: Pipeline COVID-19 IVD Products, South Korea, 2020–2021

Table 9: Medical Devices Market, South Korea, Major Segments ($M), 2020

Table 10: Hospital Supplies Market, South Korea, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 11: General Surgery Market, South Korea, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 12: Dental Devices, South Korea, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 13: Cardiovascular Devices, South Korea, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 14: Orthopedic Devices, South Korea, Revenue ($M) and Market Share (%) of Major Companies, 2020

Table 15: Insurance Contribution Rates, South Korea, 2021

Table 16: Co-payment Ceiling System, South Korea, 2021

Table 17: National Long-Term Care Insurance System vs. Previous Elderly Benefit Service System, South Korea, 2021

Table 18: Pricing by Drug Type, South Korea, 2018

Table 19: OTC Monograph Therapeutic Categories, South Korea, 2021

Table 20: MFDA Gap Analysis of Biosimilar Guidelines for the Extrapolation of Indications, South Korea, 2021

Table 21: Medical Devices Classification, South Korea, 2021

Table 22: Patent Fees, South Korea, 2021

Table 23: Trademark Application Fee, South Korea, 2021

Table 24: Drug Container and Package Information, South Korea, 2021

Table 25: Package Insert Information, South Korea, 2021

Table 26: Conferences and Trade Fairs, South Korea

Figures

Figure 1: Pharmaceutical Market, South Korea, Revenue ($B and KRWM), 2013–2020

Figure 2: Medical Devices Market, South Korea, Revenue ($M), 2016–2021

Figure 3: Healthcare Start-Ups in South Korea, 2021

Figure 4: Country Profile, South Korea, 2021

Figure 5: Pharmaceutical Market, South Korea, Revenue ($B), 2013–2020

Figure 6: Pharmaceutical Market, South Korea, Revenue Forecast ($B), 2021–2026

Figure 7: Pharmaceutical Exports ($B), South Korea, 2011–2020

Figure 8: Top Export Partners, South Korea, 2020

Figure 9: Pharmaceutical Imports ($B), South Korea, 2011–2020

Figure 10: Top Import Partners, South Korea, 2020

Figure 11: Process of Assigning the Korea Drug Code, South Korea, 2021

Figure 12: Drug Supply and Reporting Process of Drug Transaction Records, South Korea, 2021

Figure 13: Major Bio-health Clusters, South Korea, 2021

Figure 14: Number of Biosimilar and Biologics Drug Approvals, South Korea, 2016–2020

Figure 15: Top Biopharma Companies (by Sales, $M), South Korea, Jan 2021–Jun 2021

Figure 16: Patent Expirations of Major Biologics, South Korea, 2021

Figure 17: OTC Medicines Market, (per Capita Expenditure [$B]), South Korea, 2010–2020

Figure 18: OTC Medicines Market, Market Value ($M), South Korea, 2012–2020

Figure 19: OTC Medicines Market, Major Market Value Segmentation (%), South Korea, 2019

Figure 20: Therapeutic Area by Sales per Capita ($/person), South Korea, 2019

Figure 21: Therapeutic Area by Pharmaceutical Consumption (DDD/1,000 person/day), South Korea, 2018

Figure 22: COVID-19 (Number of Deaths), South Korea, 2020–2021

Figure 23: COVID-19 (Number of Cases), South Korea, 2020–2021

Figure 24: COVID-19 Fiscal Stimulus Timeline, South Korea, 2020–2021

Figure 25: COVID-19 Vaccine Dose Administration, Number of Vaccine Doses Administered, South Korea, 2021

Figure 26: COVID-19 Clinical Trials Sponsors by Count, South Korea, 2020–2021

Figure 27: COVID-19 Clinical Trials Count by Phase, South Korea, 2020–2021

Figure 28: COVID-19 Clinical Trials Count by Trial Status, South Korea, 2020–2021

Figure 29: Medical Devices Market, South Korea, Revenue ($B), 2016–2020

Figure 30: Medical Devices Market, South Korea, Revenue Forecast ($B), 2021–2026

Figure 31: Medical Devices Market, South Korea, Major Segments (%), 2020

Figure 32: Hospital Supplies Market, South Korea, Revenue ($M), 2016–2024

Figure 33: Hospital Supplies Market, South Korea, Market Share of Major Players (%), 2020

Figure 34: General Surgery Market, South Korea, Revenue ($M), 2016–2023

Figure 35: General Surgery Market, South Korea, Market Share of Major Players (%), 2020

Figure 36: Dental Devices, South Korea, Revenue ($M), 2016–2023

Figure 37: Dental Devices, South Korea, Market Share of Major Players (%), 2020

Figure 38: Cardiovascular Devices, South Korea, Revenue ($M), 2016–2023

Figure 39: Cardiovascular Devices, South Korea, Market Share of Major Players (%), 2020

Figure 40: Orthopedic Devices, South Korea, Revenue ($M), 2016–2023

Figure 41: Orthopedic Devices, South Korea, Market Share of Major Players (%), 2020

Figure 42: Diagnostic Market, South Korea, Revenue ($M), 2016–2021

Figure 43: Diagnostic Market, South Korea, Revenue ($M), 2022–2027

Figure 44: Deals Value and Deal Count, Pharmaceutical Market, South Korea, 2019–2021

Figure 45: Deals Value and Deal Count Subtypes, Pharmaceutical Market, South Korea, 2019–2021

Figure 46: Deals Value and Deal Count, Quarterly, Pharmaceutical Market, South Korea, 2019–2021

Figure 47: Top Therapy Areas by Deal Value ($M), Pharmaceutical Market, South Korea, 2019–2021

Figure 48: M&A Deals by Quarter, Pharmaceutical Market, South Korea, 2019–2021 (by Value and by Number)

Figure 49: Top Therapy Areas by Deal Count, Pharmaceutical Market, South Korea, 2019–2021

Figure 50: Private Equity Deals by Quarter, Pharmaceutical Market, South Korea, 2019–2021 (by Value and by Number)

Figure 51: Deals Value and Deal Count, Medical Devices Market, South Korea, 2019–2021

Figure 52: Deals Value and Deal Count Subtypes, Medical Devices Market, South Korea, 2019–2021

Figure 53: Deals Value and Deal Count, Quarterly, Medical Devices Market, South Korea, 2019–2021

Figure 54: Top Equipment Sectors by Deal Value ($M), Medical Devices Market, South Korea, 2019–2021

Figure 55: M&A Deals by Quarter, Medical Devices Market, South Korea, 2019–2021 (by Value and by Number)

Figure 56: Top Equipment Sectors by Deal Count, Medical Devices Market, South Korea, 2019–2021

Figure 57: VF Deals by Quarter, Medical Devices Market, South Korea, 2019–2021 (by Value and by Number)

Figure 58: Deals Value ($M), HealthTech, South Korea, 2019–2021

Figure 59: Deal Count (Number of Deals), HealthTech, South Korea, 2019–2021

Figure 60: Digital Statistics, South Korea

Figure 61: Key Goals: Digital New Deal, South Korea, 2021

Figure 62: Key Policy Highlights: Digital New Deal, South Korea, 2021

Figure 63: COVID-19 impact on Digital Health, South Korea

Figure 64: Organizational Structure of the Healthcare System, South Korea, 2021

Figure 65: Organization Structure of the National Health Insurance Services, South Korea, 2021

Figure 66: Positive and Negative List, Health Insurance Review and Assessment Service, South Korea, 2021

Figure 67: Drug Reimbursement Process, South Korea, 2021

Figure 68: Medical Devices Reimbursement Process, South Korea, 2021

Figure 69: Medical Devices Reimbursement Approval Process, South Korea, 2021

Figure 70: Structure of National Health Insurance, South Korea, 2021

Figure 71: NHIS Beneficiaries (Million Person), South Korea, 2010–2019

Figure 72: NHIS Benefits by Disease (%), South Korea, 2019

Figure 73: Out-of-Pocket Spending ($ per Capita), South Korea, 2011–2020

Figure 74: Annual Rate of Change (%), Health Price Index, South Korea, 2010–2019

Figure 75: Drug Pricing, South Korea, 2021

Figure 76: Ministry of Food and Drug Safety, Organization Chart, 2021

Figure 77: National Institute of Food and Drug Safety Evaluation, Organization Chart, 2021

Figure 78: New Drug Approval Process, South Korea, 2021

Figure 79: Generic Drug Approval Process, South Korea, 2021

Figure 80: Drug Approvals and Notifications (Number), South Korea, 2010–2018

Figure 81: Drug Approvals by Therapeutic Class, South Korea, 2018

Figure 82: Premarket Approval Process, Medical Devices, South Korea, 2021

Figure 83: Starting Date of UDI, South Korea, 2021

Figure 84: Implementation of Integrated Medical Device Information System (IMDIS), South Korea, 2021

Figure 85: Medical Devices Approval Process, South Korea, 2021

Figure 86: Patent Approval Process, South Korea, 2021

Figure 87: Trademark Registration Process, South Korea, 2021

Figure 88: Number of Clinical Trials Registered, South Korea, 2010–2020

Figure 89: Clinical Trial Approval Process, South Korea, 2021

Figure 90: Pharmaceutical Clinical Trials Count by Trial Status, South Korea, 2019–2021

Figure 91: Pharmaceutical Clinical Trials Count by Indication, South Korea, 2019–2021

Figure 92: Pharmaceutical Clinical Trials Count by Phase, South Korea, 2019–2021

Figure 93: Pharmaceutical Clinical Trials Count by Sponsors, South Korea, 2019–2021

Figure 94: Medical Devices Clinical Trials Count by Trial Status, South Korea, 2019–2021

Figure 95: Medical Devices Clinical Trials Count by Device Category, South Korea, 2019–2021

Figure 96: Medical Devices Clinical Trials Count by Indication, South Korea, 2019–2021

Figure 97: Top Five Medical Devices Clinical Trials Sponsors by Count, South Korea, 2019–2021

Figure 98: Healthcare Policy Highlights, South Korea, 2021

Figure 99: Number of Hospitals, South Korea, 2013–2021

Figure 100: Number of Diagnostic Equipment Units (per 100,000 Population), South Korea, 2013–2020

Figure 101: Number of Hospital Beds (per 1,000 Population), South Korea, 2010–2019

Figure 102: Number of Acute Care Beds (per 1,000 Population), South Korea, 2010–2019

Figure 103: Number of Psychiatric Care Beds (per 1,000 Population), South Korea, 2010–2019

Figure 104: Life Expectancy at Birth (Years), South Korea, 2010–2019

Figure 105: Immunization Rate (%), South Korea, 2010–2018

Figure 106: PM2.5 (µg per m3), South Korea, 2010–2017

Figure 107: CO2 Emissions (Mt CO2), South Korea, 2010–2019

Figure 108: Physicians (per 1,000 Population), South Korea, 2010–2019

Figure 109: Pharmacists (per 1,000 Population), South Korea, 2010–2019

Figure 110: Dentists (per 1,000 Population), South Korea, 2010–2019

Figure 111: Nurses (per 1,000 Population), South Korea, 2010–2019

Figure 112: Major Causes of Mortality (Number of Deaths), South Korea, 2019

Figure 113: Major Causes of Male Mortality (Number of Deaths), South Korea, 2019

Figure 114: Major Causes of Female Mortality (Number of Deaths), South Korea, 2019

Figure 115: Disability-Adjusted Life Years by Major Disease (‘000), South Korea, 2019

Figure 116: Healthcare Expenditure as Percentage of GDP (%), South Korea, 2010–2020

Figure 117: Public–Private Share (%), South Korea, 2010–2020

Figure 118: Healthcare Expenditure Components by Function (% of Total Health Expenditure), South Korea, 2020

Figure 119: Pharmaceutical Spending ($ per Capita), South Korea, 2010–2020

Figure 120: Opportunities and Challenges, South Korea, 2021

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