CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - South Korea

  • ID: 2785158
  • Report
  • Region: South Korea
  • 144 pages
  • GlobalData
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South Korean Pharmaceutical Market to Grow Slowly to $20.4 Billion by 2020
CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - South Korea

Summary

The "CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - South Korea" report is an essential source of information and analysis on the healthcare, regulatory and reimbursement landscape in South Korea. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure of South Korea. Most importantly, the report provides valuable insights into the trends and segmentation of the pharmaceutical and medical device markets. It is built using data and information sourced from proprietary databases, secondary research, and in-house analysis by the author’s team of industry experts.

South Korea is a growing pharmaceutical market with a strong focus on biosimilars and domestic pharmaceutical manufacturing. The value of the pharmaceutical market increased from $16.7bn in 2010 to $18.7bn in 2016, at a Compound Annual Growth Rate (CAGR) of 2%. It is forecast to reach $23.2bn by 2022. The medical device market was valued at $4.4bn in 2010, which increased to $7bn in 2017. It is expected to grow at a CAGR of 8.8% from $7.5bn in 2018 to $10.5bn in 2022. South Korea has free trade agreements with the US, EU and India. These agreements help in eliminating trade barriers and attracting foreign investment. In 2017, foreign companies invested $352m in pharmaceutical manufacturing in South Korea.

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 (Pfizer, Merck, Novartis, AstraZeneca, Daewoong Pharmaceutical and Celltrion) and profiles and SWOT analyses of the major players in the medical device market (GE Healthcare, Stryker, Boston Scientific, Alcon and i-Sens)
  • Detailed analysis about recent completed deals in the pharmaceutical and medical device market of South Korea
  • Porter’s five forces analysis for pharmaceutical and medical devices market of South Korea
  • An insightful review of the reimbursement and regulatory landscape, of which analysis includes details of the healthcare reimbursement process, the regulatory agencies and the approval processes for new drugs and medical devices
  • Information regarding recent healthcare policies along with healthcare infrastructure and healthcare expenditure
  • An overview of the opportunities for and challenges to growth in the South Korean 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 Korean healthcare market
  • Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to impact the healthcare market in the future
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors
  • Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment, and strategic partnership
  • Identify, understand, and capitalize on the opportunities and challenges in the South Korean healthcare market.
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Executive Summary
Overview of Pharmaceutical Market
Overview of Medical Device Market
Deals Analysis
Porter’s Five Forces Model
Market Access
Country Healthcare Landscape
Opportunities and Challenges
Appendix

List of Tables
Table 1: Approved Biosimilars. South Korea, 2018 22
Table 2: Pharmaceutical Market, South Korea, Therapeutic Area by Production Amount ($bn), 2016 23
Table 3: Diagnostic Imaging Devices Market, South Korea, Revenue ($m) and Market Share (%) of Major Companies, 2015 47
Table 4: Ophthalmic Devices Market, South Korea, Revenue ($m) and Market Share (%) of Major Companies, 2015 48
Table 5: Cardiovascular Devices Market, South Korea, Revenue ($m) and Market Share (%) of Major Companies, 2017 49
Table 6: Dental Devices Market, South Korea, Revenue ($m) and Market Share (%) of Major Companies, 2017 50
Table 7: Orthopedic Devices Market, South Korea, Revenue ($m) and Market Share (%) of Major Companies, 2017 51
Table 8: Merger and Acquisition Deals, Medical Device Market, South Korea, 2017-2018 77
Table 9: Private Equity, Deals, Medical Device Market, South Korea, 2017-2018 77
Table 10: National Insurance Contribution Rates, South Korea, 2016 88
Table 11: Long-Term Care Insurance System vs Previous Elderly Benefit Service System, South Korea, 2016 91
Table 12: Co-payments, South Korea, 2015 94
Table 13: Medical Device Classification, South Korea, 2015 103
Table 14: Patent Fees, South Korea, 2017 109
Table 15: Trademark Fees, South Korea, 2017 111
Table 16: Drug Container and Package Information, South Korea, 2017 116
Table 17: Package Insert Information, South Korea, 2017 116
Table 18: Trade Fairs, South Korea, 2018-2019 129

List of Figures
Figure 1: Pharmaceutical Market, South Korea, Revenue ($bn), 2010-2017 8
Figure 2: Medical Device Market, South Korea, Revenue ($bn), 2010-2017 8
Figure 3: Country Profile, South Korea, 2017 14
Figure 4: Pharmaceutical Market, South Korea, Revenue ($bn), 2010-2017 16
Figure 5: Pharmaceutical Market, South Korea, Revenue Forecast ($bn), 2018-2022 16
Figure 6: Pharmaceutical Exports ($bn), South Korea, 2010-2016 17
Figure 7: Top Export Partners, South Korea, 2016 17
Figure 8: Pharmaceutical Imports ($bn), South Korea, 2010-2016 18
Figure 9: Top Import Partners, South Korea, 2016 18
Figure 10: Process of Assigning KD code, South Korea, 2018 19
Figure 11: Drug Supply and Report Process of Drug Transaction Records, South Korea, 2016 20
Figure 12: Pharmaceutical Market, South Korea, Therapeutic Area by Production Amount($bn), 2016 23
Figure 13: Pharmaceutical Market, South Korea, Major Players 25
Figure 14: Medical Device Market, South Korea, Revenue ($bn), 2010-2017 45
Figure 15: Medical Device Market, South Korea, Revenue Forecast ($bn), 2018-2022 45
Figure 16: Medical Device Market, South Korea, Revenue by Segment ($m), 2017 46
Figure 17: Diagnostic Imaging Devices Market, South Korea, Revenue ($m), 2010-2017 47
Figure 18: Diagnostic Imaging Devices Market, South Korea, Market Share of Major Players (%), 2015 47
Figure 19: Ophthalmic Devices Market, South Korea, Revenue ($m), 2010-2017 48
Figure 20: Ophthalmic Devices Market, South Korea, Market Share of Major Players (%), 2015 48
Figure 21: Cardiovascular Devices Market, South Korea, Revenue ($bn), 2010-2017 49
Figure 22: Cardiovascular Devices Market, South Korea, Market Share of Major Players (%), 2017 49
Figure 23: Dental Devices Market, South Korea, Revenue ($m), 2010-2017 50
Figure 24: Dental Devices Market, South Korea, Market Share of Major Players (%), 2017 50
Figure 25: Orthopedic Devices Market, South Korea, Revenue ($m), 2010-2017 51
Figure 26: Orthopedic Devices Market, South Korea, Market Share of Major Companies (%), 2017 51
Figure 27: Diagnostic Market, South Korea, Revenue ($m), 2010-2017 52
Figure 28: Diagnostic Market, South Korea, Revenue ($m), 2018-2022 52
Figure 29: Medical Device Market, South Korea, Revenue ($bn) of Major Companies, 2017 54
Figure 30: Deal Value and Deal Count, Pharmaceutical Market, South Korea, 2017-2018 74
Figure 31: Deal Value and Deal Count Quarterly, Pharmaceutical Market, South Korea, 2017-2018 74
Figure 32: Deal Value and Deal Count Sub-types, Pharmaceutical Market, South Korea, 2017-2018 74
Figure 33: Pharmaceutical Market, South Korea, Top Five Therapy Areas by Deal Value ($m), 2017-2018 75
Figure 34: Pharmaceutical Market, South Korea, Top Five Therapy Areas by Deal Number, 2017-2018 75
Figure 35: Pharmaceutical Market, South Korea, Venture Financing Deals by Therapy Area, 2017-2018 75
Figure 36: Medical Device Market Deals (by deal value, $m), South Korea, 2017-2018 76
Figure 37: Medical Device Market Deals (by deal count), South Korea, 2017-2018 76
Figure 38: Medical Device Market Deals Share (by deal count), South Korea, 2017-2018 76
Figure 39: Medical Device Market Deals Share (by deal value), South Korea, 2017-2018 76
Figure 40: Health Care System, South Korea, 2018 82
Figure 41: Organization Structure of the NHIS, South Korea, 2018 83
Figure 42: Positive and Negative List, South Korea, 2018 84
Figure 43: Drug Reimbursement Process, South Korea, 2018 85
Figure 44: Medical Device Reimbursement, South Korea, 2018 87
Figure 45: National Insurance Contribution Score Calculation, South Korea, 2016 89
Figure 46: Structure of National Health Insurance, South Korea, 2016 90
Figure 47: Out-of-Pocket Expenditure (% of total expenditure on health), South Korea, 2010-2017 93
Figure 48: Annual Rate of Change (%), Health Price Index, South Korea, 2010-2017 93
Figure 49: New Drug Pricing, South Korea, 2015 96
Figure 50: Ministry of Food and Drug Safety, Organization Chart, 2017 98
Figure 51: National Institute of Food and Drug Safety Evaluation, Organization Chart, 2017 99
Figure 52: New Drug Approval Process, South Korea, 2017 101
Figure 53: Generic Drug Approval Process, South Korea, 2017 102
Figure 54: Premarket Approval Process, South Korea, 2017 104
Figure 55: Medical Device Approval Process, South Korea, 2017 106
Figure 56: Patent Approval Process, South Korea, 2016 110
Figure 57: Trademark Process, South Korea, 2016 112
Figure 58: Clinical Trial Regulation, South Korea, 2017 113
Figure 59: Hospitals (Number), South Korea, 2010-2017 120
Figure 60: Hospitals by Type (Number), South Korea, 2010-2017 120
Figure 61: Diagnostic Equipment (per million population), South Korea,2010-2017 120
Figure 62: Hospital Beds (per 1,000 population), South Korea, 2010-2017 121
Figure 63: Acute Care Hospital Beds (per 1,000 population), South Korea, 2010-2017 121
Figure 64: Psychiatric Hospital Beds (per 1,000 population), South Korea, 2010-2017 121
Figure 65: Life Expectancy (in years), South Korea, 2010-2017 122
Figure 66: Immunization Rate (%), South Korea, 2010-2017 122
Figure 67: PM2.5 (µg per m3), South Korea, 2010-2017 123
Figure 68: CO2 Emissions (metric tons per capita), South Korea, 2010-2017 123
Figure 69: Physicians (per 1,000 population), South Korea, 2010-2017 124
Figure 70: Nurses (per 1,000 population), South Korea, 2010-2017 124
Figure 71: Dentists, (per 1,000 population), South Korea, 2010-2017 124
Figure 72: Pharmacists, (per 1,000 population), South Korea, 2010-2017 124
Figure 73: Major Causes of Mortality (number of deaths, ‘000), South Korea, 2015 125
Figure 74: Major Causes of Male Mortality (number of deaths, ‘000), South Korea, 2015 125
Figure 75: Major Causes of Female Mortality (number of deaths, ‘000), South Korea, 2015 125
Figure 76: Disability-Adjusted Life Years by Major Disease (‘000), South Korea, 2015 125
Figure 77: Healthcare Expenditure as Percentage of GDP (%), South Korea, 2010-2017 126
Figure 78: Public-Private Share (%), South Korea, 2010-2017 126
Figure 79: Healthcare Expenditure by Providers (%), South Korea, 2016 127
Figure 80: Healthcare Expenditure by Function (%), South Korea, 2016 127
Figure 81: Opportunities and Challenges, South Korea 131
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South Korean Pharmaceutical Market to Grow Slowly to $20.4 Billion by 2020, says Analyst

The pharmaceutical market in South Korea will rise from approximately $18.6 billion in 2016 to $20.4 billion in 2020, representing Compound Annual Growth Rate (CAGR) of 2.4%, as the government increasingly focuses on generics in order to reduce healthcare expenditure.

The company’s latest report* states that the country’s generics market increased from $3.5 billion in 2008 to around $5.8 billion in 2015, growing at a CAGR of 7%, as the government has invested significantly in the generics market in recent years. Many novel drugs are set to lose their patents by 2020, meaning South Korea’s generics market is expected to increase significantly.

Adam Dion, MSc, Senior Industry Analyst, says: “Overall market growth is expected to be influenced by burgeoning treatment populations and various government initiatives to encourage Research and Development (R&D) and sustain growth in the pharmaceutical industry, such as the Korean Small Business Innovation Research program.”

Other government initiatives will also aid businesses, such as lifting the ban on advertisements for medical services, which has enabled hospitals to hire advertising agencies to help them attract medical tourists.

Dion explains: “The Free Trade Agreement with the US, which began in March 2012, has had the effect of lowering tariffs for imports up to 80%, and nearly 95% of bilateral trade in consumer and industrial products has become duty-free for up to five years, making investment in the South Korean pharmaceutical industry easier for multinational companies.”

*CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - South Korea

This report provides analysis of the pharmaceutical market landscape in South Korea, and the impact of the current and emerging market access strategies used by the pharmaceutical industry for new and existing drugs. It includes annualized market data from 2008 to 2015 and forecast to 2020, and discusses the regulatory requirements, key health insurance trends, recent government healthcare reforms, and general industry trends.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by a team of industry experts.
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