Japan – Healthcare, Regulatory and Reimbursement Landscape

Pages: 167 Published: April 30, 2019 Report Code: GDHC0077CHR

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GlobalData, the industry analysis specialist, has released its latest report, "Japan – Healthcare, Regulatory and Reimbursement Landscape". The report is an essential source of information on analysis of the healthcare, regulatory and reimbursement landscape in Japan. It identifies the key trends in the country’s healthcare market and provides insights into its demographic, regulatory and reimbursement landscape, and healthcare infrastructure. Most importantly, the report provides valuable insights into the trends and segmentation of its pharmaceutical and medical device markets. It uses data and information sourced from proprietary databases, secondary research, and in-house analysis by GlobalData’s team of industry experts.

The Japanese pharmaceutical market is the third largest in the world in terms of value. Japan’s pharmaceutical market, based on production value, increased from ¥6,894B in 2013 to ¥9,281B in 2020 at a Compound Annual Growth Rate (CAGR) of 4.34%. In terms of US Dollars, the market increased from $70.64B in 2013 to $86.96B in 2020 at a CAGR of 3.01%. It is forecast to reach about $100.88B in 2025. The increasing elderly population, chronic and lifestyle diseases, incentives for innovation, and short regulatory approval timelines are the main factors driving the growth of the Japanese pharmaceutical market.

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in Japan, 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, Novartis, GSK, Takeda, and Astellas Pharma

Profiles and SWOT analyses of the major players in the medical device market: Medtronic, Siemens Healthineers, DePuy Synthes, Olympus, and Terumo

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 Japanese 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 Japan’s healthcare market

Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to impact Japan’s 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

1.1List of Figures

1.2 List of Tables

2. Executive Summary

2.1 Executive Summary

2.2 Key Highlights – Facts about the Japanese Healthcare Market

2.3 Key Highlights: Healthcare Startups in Japan

2.4 Key Events: Japanese Healthcare Timeline, 2014-2020

2.5 Key Events: Japanese Pharmaceutical Market

2.6 Key Events: M&As, VC & PE Deals, Global Pharmaceutical Market, 2019-2020

2.7 Key Events: Mergers and Acquisitions

2.8 Country Profile, Japan, 2020

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, Japan

3.5 Pharmaceutical Market – Market Segments

3.6 Major Therapeutic Areas, Japan

3.7 COVID-19 Epidemiology, Japan

3.8 COVID-19 Impact and Developments in the Healthcare Market, Japan

3.9 COVID-19 Clinical Trials Landscape, Japan

3.10 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, Japan, 2020-2021

6.2 Deal Analysis: Medical Device Market, Japan, 2020-2021

7. HealthTech Landscape

7.1 HealthTech Landscape, Japan

7.2 HealthTech Deals Landscape, Japan

7.3 Key HealthTech Deals, Japan

7.4 Adoption of Technology in Healthcare, Japan

7.5 Key Development Technologies, Japan

7.6 Regulatory Scenario Covering Use of Technology in Healthcare, Japan

7.7 HealthTech Landscape: Benefits and Risks, Japan

8. Market Access

8.1 Overview of Healthcare System, Japan

8.2 Reimbursement Process, Japan

8.3 Overview of Insurance Providers, Japan

8.4 Healthcare Spending and Prescription Drug Price Trend, Japan

8.5 Pricing Policies, Japan

8.6 Regulatory Landscape, Japan

8.6.1 Overview of Regulatory Agencies

8.6.2 Marketing Authorization for Pharmaceutical Products, Japan

8.6.3 Marketing Authorization for Medical Devices, Japan

8.6.4 Marketing Authorization for Regenerative Medical Products, Japan

8.6.5 Intellectual Property Rights, Patent, Japan

8.6.6 Intellectual Property Rights, Trademark, Japan

8.6.7 Clinical Trial Regulation Process, Japan

8.6.8 Pharmaceutical Clinical Trials Landscape, Japan

8.6.9 Medical Devices Clinical Trials Landscape, Japan

8.6.10 Market Authorization for Pharmaceutical Manufacturing, Japan

8.6.11 Market Authorization for Medical Devices Manufacturing, Japan

8.6.10 Pharmaceutical Export and Import, Japan

8.6.13 Pharmaceutical Advertisement Regulations, Japan

8.6.14 Pharmacy Regulations, Japan

8.6.15 Labeling and Packaging Regulations, Japan

9. Country Healthcare Landscape

9.1 Japanese Healthcare Policy Highlights

9.2 Healthcare Facilities, Japan

9.3 Healthcare Parameters, Japan

9.4 Life Expectancy and Immunization Rate, Japan

9.5 Environmental Health, Japan

9.6 Healthcare Personnel, Japan

9.7 Disease Burden, Japan

9.8 Healthcare Expenditure, Japan

10 Trade Associations, Japan

11 Trade Fairs, Japan

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

List of Tables

Table 1: Biopharmaceuticals Composition Ratio (%), Japan, 2019

Table 2: Approved Biosimilars, Japan, 2017-2021

Table 3: Major Therapeutic Areas by Production Value ($B), Japan, 2019

Table 4: COVID-19 Indicators (Number of Cases), Global and Japan, 2020-2021

Table 5: COVID-19-Related Travel Restrictions, Japan, 2020-2021

Table 6: COVID-19 Vaccines Development Landscape, Japan, 2020-2021

Table 7: Approved Medical Products for COVID-19, Japan, 2020-2021

Table 8: Approved Medical Devices for COVID-19, Japan, 2020-2021

Table 9: COVID-19 IVD Products (April ‘20- April ‘21), Japan, 2020-2021

Table 10: Medical Device Market, Japan, Major Segments ($B), 2020

Table 11: General Surgery Market, Japan, Revenue ($M) and Market Share (%) of Major Companies, 2019

Table 12: Orthopedic Devices Market, Japan, Revenue ($M) and Market Share (%) of Major Companies, 2019

Table 13: Cardiovascular Devices Market, Japan, Revenue ($M) and Market Share (%) of Major Companies, 2019

Table 14: Wound Care Management Market, Japan, Revenue ($M) and Market Share (%) of Major Companies, 2019

Table 15: Nephrology and Urology Devices Market, Japan, Revenue ($M) and Market Share (%) of Major Companies, 2019

Table 16: Medical Device Reimbursement Assessment Categories, Japan, 2018

Table 17: Public Insurance Schemes, Japan, 2019

Table 18: Types of Premiums, Japan, 2020

Table 19: Classification and Regulation Regarding Medical Devices, Japan, 2021

Table 20: Classification of Regenerative Medical Products, Japan, 2021

Table 21: Patent Fees, Japan, 2021

Table 22: Trademark Fees, Japan, 2021

Table 23: Headings and their Sequence in Package Inserts, Japan, 2021

List of Figures

Figure 1: Pharmaceutical Market, Japan, Revenue ($B and ¥B), 2013-2020

Figure 2: Medical Device Market, Japan, Revenue ($B), 2015-2020

Figure 3: Healthcare Startups in Japan, 2021

Figure 4: Number of Deals (2019-2020)

Figure 5: 2019-2020 Deal Overview by Region

Figure 6: Country Profile, Japan, 2020

Figure 7: Pharmaceutical Market, Japan, Revenue ($B and ¥B), 2013-2020

Figure 8: Pharmaceutical Market, Japan, Revenue Forecast ($B and ¥B), 2021-2025

Figure 9: AMED Projects, Japan, 2019

Figure 10: Pharmaceutical Exports ($B), Japan, 2013-2020

Figure 11: Top Export Partners, Japan, 2020

Figure 12: Pharmaceutical Imports ($B), Japan, 2013-2020

Figure 13: Top Import Partners, Japan, 2020

Figure 14: Pharmaceutical Supply Channel, Japan, 2021

Figure 15: Generic Drugs Penetration Rate, Japan, 2005-2018

Figure 16: Pharmaceutical, Biotechnology, and Healthcare Clusters, Japan, 2021

Figure 17: OTC Medicines Market, Revenue ($B), Japan, 2013-2020

Figure 18: OTC Medicines Market, Major Distribution Channels ($B), Japan, 2020

Figure 19: OTC Medicines Market, Major Categories ($B), Japan, 2020

Figure 20: Major Therapeutic Areas by Production Value, Japan, 2019

Figure 21: COVID-19 Cases, Japan, 2020-2021

Figure 22: COVID-19 Deaths, Japan, 2020-2021

Figure 23: COVID-19 Fiscal Stimulus Timeline, Japan, 2020-2021

Figure 24: COVID-19 Vaccination Progress, Japan, 2021

Figure 25: COVID-19 Clinical Trials Count by Phase, Japan, 2020-2021

Figure 26: COVID-19 Clinical Trials Count by Trial Status, Japan, 2020-2021

Figure 27: Top Five COVID-19 Clinical Trials Sponsors by Trial Count, Japan, 2020-2021

Figure 28: Medical Devices Market, Japan, Revenue ($B), 2015-2020

Figure 29: Medical Devices Market, Japan, Revenue Forecast ($B), 2021-2025

Figure 30: AMED Projects for Medical Device, Japan, 2020

Figure 31: Medical Device Market, Japan, Major Segments (%), 2020

Figure 32: General Surgery Market, Japan, Revenue ($B), 2017-2025

Figure 33: General Surgery Market, Japan, Market Share of Major Players (%), 2019

Figure 34: Orthopedic Devices Market, Japan, Revenue ($B), 2017-2025

Figure 35: Orthopedic Devices Market, Japan, Market Share of Major Players (%), 2019

Figure 36: Cardiovascular Devices Market, Japan, Revenue ($B), 2017-2025

Figure 37: Cardiovascular Devices Market, Japan, Market Share of Major Players (%), 2019

Figure 38: Wound Care Management Market, Japan, Revenue ($B), 2017-2025

Figure 39: Wound Care Management Market, Japan, Market Share of Major Players (%), 2019

Figure 40: Nephrology and Urology Devices Market, Japan, Revenue ($B), 2017-2025

Figure 41: Nephrology and Urology Devices Market, Japan, Market Share of Major Players (%), 2019

Figure 42: Diagnostics Market, Japan, Revenue ($B), 2015-2020

Figure 43: Diagnostics Market, Japan, Revenue Forecast ($B), 2021-2025

Figure 44: Medical Devices Market, Revenue ($B) of Major Companies, Japan, 2019

Figure 45: Deal Value and Deal Count, Pharmaceutical Market, Japan, 2020-2021

Figure 46: Deal Value and Deal Count Sub-types, Pharmaceutical Market, Japan, 2020-2021

Figure 47: Deal Value and Deal Count, Quarterly, Pharmaceutical Market, Japan, 2020-2021

Figure 48: Top Five Therapy Areas by Deal Value, Pharmaceutical Market, Japan, 2020-2021

Figure 49: Top Five Therapy Areas by Deal Count, Pharmaceutical Market, Japan, 2020-2021

Figure 50: M&A Deals by Therapy Area, Pharmaceutical Market, Japan, 2020-2021 (by Value ($M) and by Number)

Figure 51: VC Deals by Therapy Area, Pharmaceutical Market, Japan, 2020-2021 (by Value ($M) and by Number)

Figure 52: Medical Devices Market Deals by Deal Value ($M), Japan, 2020-2021

Figure 53: Medical Devices Market Deals by Deal Count, Japan, 2020-2021

Figure 54: Medical Devices Market Deals Share by Deal Value, Japan, 2020-2021

Figure 55: Medical Devices Market Deals Share by Deal Count, Japan, 2020-2021

Figure 56: Top Therapy Area by Deal Value and Deal Count, Medical Devices Market, Japan, 2020-2021

Figure 57: M&A Deals by Therapy Area, Medical Devices Market, Japan, 2020-2021 (by Value ($M) and by Number)

Figure 58: VC Deals by Therapy Area, Medical Devices Market, Japan, 2020-2021 (by Value ($M) and by Number)

Figure 59: PE Deals by Therapy Area, Medical Devices Market, Japan, 2020-2021 (by Value ($M) and by Number)

Figure 60: Development of AI in the Field of Health and Medical Care, Japan, 2019

Figure 61: Deal Value ($M), HealthTech, Japan, 2019-2021

Figure 62: Deal Count (No. of Deals), HealthTech, Japan, 2019-2021

Figure 63: Organization of the Health System, Japan, 2020

Figure 64: Reimbursement Pricing for New Drugs, Japan, 2020

Figure 65: Public Insurance Coverage (% of Population), Japan, 2019

Figure 66: Overview of Medical Service Regime, Japan, 2020

Figure 67: Number of Health Insurance and Cancer Insurance Policies (millions), Japan, 2015-2019

Figure 68: Number of Policies for Hospitalization and Surgery Coverage (millions), Japan, 2014-2019

Figure 69: OOP Expenditure (% of Total Expenditure on Health), Japan, 2013-2020

Figure 70: Reduction in Average Price of Prescription Drugs (%), 2010-2019

Figure 71: New Drug Price Determination Method, Japan, 2020

Figure 72: MHLW, Organization Chart, 2020

Figure 73: Organization of PSEHB and PMDA, Japan, 2020

Figure 74: Drug Approval Process, Japan, 2020

Figure 75: Drug Approval Process Timeline, Japan, 2020

Figure 76: Regenerative Medical Products Approvals, Japan, 2021

Figure 77: Review Pathway of Regenerative Medical Products, Japan, 2021

Figure 78: Patent Approval Process, Japan, 2021

Figure 79: Trademark Approval Process, Japan, 2021

Figure 80: Clinical Trial Notification Process, Japan, 2021

Figure 81: Pharmaceutical Clinical Trials Count by Trial Status, Japan, 2020-2021

Figure 82: Pharmaceutical Clinical Trials Count by Indication, Japan, 2020-2021

Figure 83: Pharmaceutical Clinical Trials Count by Phase, Japan, 2020-2021

Figure 84: Top Five Pharmaceutical Clinical Trials Sponsors by Count, Japan, 2020-2021

Figure 85: Medical Devices Clinical Trials Count by Trial Status, Japan, 2020-2021

Figure 86: Medical Devices Clinical Trials Count by Indication, Japan, 2020-2021

Figure 87: Medical Devices Clinical Trials Count by Category, Japan, 2020-2021

Figure 88: Top Five Medical Devices Clinical Trial Sponsors by Count, Japan, 2020-2021

Figure 89: Drug Manufacturing/Marketing Approvals, Japan, 2021

Figure 90: Medical Device Manufacturing/Marketing Approvals, Japan, 2021

Figure 91: Japan Vision: Health Care 2035, Japan, 2021

Figure 92: Number of Hospitals, Japan, 2012-2018

Figure 93: Number of Diagnostic Equipment, Japan, 2015-2020

Figure 94: Hospital Beds (per 1,000 population), Japan, 2012-2018

Figure 95: Acute Care Hospital Beds (per 1,000 population), Japan, 2012-2018

Figure 96: Psychiatric Care Hospital Beds (per 1,000 population), Japan, 2012-2018

Figure 97: Life Expectancy at Birth (Years), Japan, 2012-2019

Figure 98: Immunization Rate (%), Japan, 2013-2019

Figure 99: PM2.5 (µg per m3), Japan, 2013-2019

Figure 100: CO2 Emissions (Billion Tons), Japan, 2013-2019

Figure 101: Physicians (per 1,000 population), Japan, 2012-2018

Figure 102: Dentists (per 1,000 population), Japan, 2012-2018

Figure 103: Pharmacists (per 1,000 population), Japan, 2012-2018

Figure 104: Nurses (per 1,000 population), Japan, 2012-2018

Figure 105: Major Causes of Mortality (per 100,000 population), Japan, 2019

Figure 106: Major Causes of Male Mortality (per 100,000 population), Japan, 2019

Figure 107: Major Causes of Female Mortality (per 100,000 population), Japan, 2019

Figure 108: Disability-Adjusted Life Years by Major Disease (per 100,000 population), Japan, 2019

Figure 109: Healthcare Expenditure as Percentage of GDP (%), Japan, 2013-2019

Figure 110: Health Expenditure Share (% of total health spending), Japan, 2013-2019

Figure 111: Healthcare Expenditure Components by Function (% of Total Health Expenditure), Japan, 2017

Figure 112: Pharmaceutical Spending (% of total health spending), Japan, 2011-2017

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