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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape-Japan

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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape-Japan

Summary

GlobalData, the industry analysis specialist, has released its latest report,"CountryFocus: Healthcare, Regulatory and Reimbursement Landscape-Japan". T

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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape-Japan

Summary

GlobalData, the industry analysis specialist, has released its latest report,"CountryFocus: Healthcare, Regulatory and Reimbursement Landscape-Japan". This report is an essential source of information on and 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 the 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.

In 2009, Japan's pharmaceutical market was worth $68.9 billion. It is projected to reach $72.0 billion in 2021, increasing at a Compound Annual Growth Rate (CAGR) of 0.3%. The medical device market was valued at $56 billion in 2016 and is projected to grow at a CAGR of 7.4% to $80 billion in 2021. These positive growth trends can be primarily attributed to

An increasingly elderly population

Universal health coverage

Government initiatives

In 2016, Japan's population was approximately 126.3 million, having declined at a negative CAGR of 0.1% from 2009. Its public healthcare expenditure accounted for 84% of total healthcare expenditure in 2016, and the government spent approximately $14.75 billion on pharmaceutical R&D in 2015.

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, including market size, segmentation, and key drivers and barriers

Profiles and SWOT analysis of the major players in the pharmaceutical market (Astellas Pharma, Otsuka, Chugai Pharmaceutical, Taisho Pharma and Mitsubishi Tanabe) and medical device market (Terumo Medical, NIPRO, Olympus Medical Systems, Toshiba Medical Systems and Hitachi Medical Corporation)

A review of the 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 political and economic environment, covering economic indicators, demographics, healthcare infrastructure and healthcare expenditure

An overview of the opportunities for and challenges to growth in the 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 revenue by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to affect Japan's healthcare market

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 best opportunities for consolidation, investment, and strategic partnerships

Identify, understand, and capitalize on the opportunities and challenges in Japan's healthcare market

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Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 7

2 Executive Summary 9

3 Introduction 15

3.1 GlobalData Report Guidance 15

4 Overview of the Pharmaceutical and Medical Device Markets 16

4.1 Pharmaceutical Market 16

4.1.1 Market Overview 16

4.1.2 Pharmaceutical Exports and Imports 18

4.1.3 Supply Channels 19

4.1.4 Market Segments 20

4.1.5 Major Therapeutic Areas 24

4.1.6 Major Companies 30

4.2 Medical Device Market 57

4.2.1 Overview of the Top Five Segments 59

4.2.2 Diagnostic Market 68

4.2.3 Major Players 70

4.3 Market Drivers and Barriers 93

4.3.1 Drivers 93

4.3.2 Barriers 93

5 Market Access 95

5.1 Reimbursement and Payer Landscape 95

5.1.1 Overview of Healthcare System 95

5.1.2 Reimbursement Process 96

5.1.3 Overview of Insurance Providers 98

5.1.4 Patient Share in Healthcare Spending 100

5.1.5 Price Trends in the Healthcare Sector 101

5.1.6 Pricing Policies 102

5.2 Regulatory Landscape 104

5.2.1 Overview of Regulatory Agencies 104

5.2.2 Market Authorization Procedure for Pharmaceutical Products 105

5.2.3 Approval Process of Biological Products as Biosimilar or Interchangeable 110

5.2.4 New Medical Device Approval Process 111

5.2.5 Intellectual Property Rights 113

5.2.6 Clinical Trial Regulations 117

5.2.7 Pharmaceutical Advertising Regulations 117

5.2.8 Pharmacy Regulations 118

5.2.9 Labeling and Packaging Regulations 119

6 Country Analysis 124

6.1 Political Environment 124

6.1.1 Political Structure 124

6.1.2 Analysis of the Current Political Environment 126

6.1.3 Healthcare Policy Initiatives 128

6.2 Economic Landscape 129

6.3 Economic Indicators 132

6.3.1 Gross Domestic Product 132

6.3.2 Gross National Income 135

6.3.3 Inflation 136

6.3.4 Currency Exchange Rate 140

6.3.5 Foreign Direct Investment 141

6.3.6 Foreign Exchange Reserves 142

6.3.7 Trade Balance 142

6.3.8 General Government Structural Balance 144

6.3.9 General Government Net Debt 145

6.3.10 Major Industries 147

6.4 Demographics 149

6.4.1 Population 149

6.4.2 Education and Literacy 163

6.4.3 Employment 164

6.4.4 Disease Burden 165

6.5 Healthcare Infrastructure 167

6.5.1 Healthcare Facilities 167

6.5.2 Healthcare Parameters 172

6.5.3 Environmental Health 174

6.5.4 Healthcare Personnel 176

6.6 Healthcare Expenditure 179

6.6.1 Overview 179

6.6.2 Major Components of Healthcare Spending 180

6.6.3 Public and Private Sector Share 181

6.6.4 Spending in Healthcare R&D 182

6.7 Trade Associations 182

6.7.1 Japan Pharmaceutical Manufacturers Association 182

6.7.2 Federation of Pharmaceutical Manufacturers' Associations 183

6.7.3 Japan Pharmaceutical Traders Association 183

6.7.4 Japan Pharmaceutical Equipment and Machinery Association 183

6.7.5 Japan Federation of Medical Devices Associations 183

6.7.6 The Federation of Japan Pharmaceutical Wholesalers Association 184

6.8 Trade Fairs 184

7 Opportunities and Challenges 185

7.1 Opportunities 185

7.2 Challenges 185

8 Appendix 187

8.1 Abbreviations 187

8.2 Bibliography 189

8.3 Research Methodology 198

8.3.1 Coverage 198

8.3.2 Secondary Research 198

8.3.3 Forecasts 199

8.3.4 Expert Panel 199

8.4 Contact Us 199

8.5 Disclaimer 200


List Of Figure

1.2 List of Figures

Figure 1: Pharmaceutical Market, Japan, Revenue ($bn), 2009-2021 10

Figure 2: Medical Device Market, Japan, Revenue ($m), 2009-2021 11

Figure 3: Pharmaceutical Market, Japan, Country Profile, 2017 14

Figure 4: Pharmaceutical Market, Japan, Revenue ($bn), 2009-2016 17

Figure 5: Pharmaceutical Market, Japan, Revenue ($bn), 2017-2021 18

Figure 6: Pharmaceutical Market, Japan, Exports and Imports ($bn), 2009-2016 19

Figure 7: Pharmaceutical Market, Japan, Supply Channels, 2016 20

Figure 8: Pharmaceutical Market, Japan, Generics Share by Volume (%), 2009-2015 21

Figure 9: Pharmaceutical Market, Japan, Biologics Production (%), 2014 22

Figure 10: Pharmaceutical Market, Japan, OTC Drug Market Revenue ($bn), 2009-2015 24

Figure 11: Pharmaceutical Market, Japan, Major Therapeutic Areas, Production Value ($bn), 2014 25

Figure 12: Pharmaceutical Market, Japan, Cardiovascular Agents, Production Share (%), 2014 26

Figure 13: Pharmaceutical Market, Japan, CNS Agents, Production Share (%), 2014 27

Figure 14: Pharmaceutical Market, Japan, Digestive Organ Agents, Production Share (%), 2014 28

Figure 15: Pharmaceutical Market, Japan, Blood and Body Fluid Agents, Production Share (%), 2014 29

Figure 16: Pharmaceutical Market, Japan, Blood and Body Fluid Agents, Production Share (%), 2014 30

Figure 17: Medical Device Market, Japan, Revenue ($bn), 2009-2016 57

Figure 18: Medical Device Market, Japan, Revenue ($bn), 2017-2021 58

Figure 19: Medical Device Market, Japan, Revenue by Segment ($bn), 2016 59

Figure 20: Medical Device Market, Japan, Ophthalmic Devices Market, Revenue ($bn), 2009-2016 60

Figure 21: Medical Device Market, Japan, Orthopedic Devices Market, Sales Share for Major Players (%), 2015 61

Figure 22: Medical Device Market, Japan, Nephrology and Urology Devices Market, Revenue ($bn), 2009-2016 62

Figure 23: Medical Device Market, Japan, Nephrology and Urology Devices Market, Sales Share for Major Players (%), 2012 63

Figure 24: Medical Device Market, Japan, Healthcare IT Market, Revenue ($bn), 2009-2016 64

Figure 25: Medical Device Market, Japan, Healthcare IT, Sales Share for Major Players (%), 2015 65

Figure 26: Medical Device Market, Japan, Hospital Supplies Market, Revenue ($bn), 2009-2016 66

Figure 27: Medical Device Market, Japan, Hospital Supplies Market, Sales Share for Major Players (%), 2015 66

Figure 28: Medical Device Market, Japan, Diagnostic Imaging Market, Revenue ($bn), 2009-2016 67

Figure 29: Medical Device Market, Japan, Diagnostic Imaging Market, Sales Share for Major Players (%), 2015 68

Figure 30: Medical Device Market, Japan, Diagnostic Market, Revenue ($bn), 2009-2016 69

Figure 31: Medical Device Market, Japan, Diagnostic Market, Revenue ($bn), 2017-2021 70

Figure 32: Healthcare Market, Japan, Drivers and Barriers, 2017 94

Figure 33: Healthcare System, Organizational Structure, Japan, 2015 96

Figure 34: Healthcare System, Reimbursement Pricing for New Drugs, 2015 97

Figure 35: Healthcare System, Public Health Insurance System, 2015 99

Figure 36: Market Access, Japan, Out-of-Pocket Payment (% of Healthcare Expenditure), 2009-2016 101

Figure 37: Market Access, Japan, Change in Average Price of Prescription Drugs (%), 2004-2014 102

Figure 38: Market Access, Japan, Organizational Structure of PMDA and PFSB, 2015 105

Figure 39: Market Access, Japan, New Drug Development and Approval Process, 2015 107

Figure 40: Market Access, Japan, Approval Review Process, 2015 109

Figure 41: Market Access, Japan, New Generic Drug Approval Process, 2015 110

Figure 42: Market Access, Japan, Patent Approval Process, 2016 114

Figure 43: Market Access, Japan, Trademark Process, 2016 116

Figure 44: Economic Indicators, Japan, Gross Domestic Product per Capita ($), 2009-2016 132

Figure 45: Economic Indicators, Japan, Gross Domestic Product per Capita ($), 2017-2021 133

Figure 46: Economic Indicators, Japan, Gross Domestic Product Annual Growth (%), 2009-2016 134

Figure 47: Economic Indicators, Japan, Gross Domestic Product Annual Growth (%), 2017-2021 135

Figure 48: Economic Indicators, Japan, Gross National Income per Capita ($), 2009-2016 136

Figure 49: Economic Indicators, Japan, Consumer Price Index, 2009-2016 137

Figure 50: Economic Indicators, Japan, Consumer Price Index, 2017-2021 138

Figure 51: Economic Indicators, Japan, Consumer Price Annual Change (%), 2009-2016 139

Figure 52: Economic Indicators, Japan Currency Exchange Rate ($/JPY), 2009-2016 140

Figure 53: Economic Indicators, Japan, Foreign Direct Investment ($bn), 2009-2016 141

Figure 54: Economic Indicators, Japan, Foreign Exchange Reserves ($bn), 2009-2016 142

Figure 55: Economic Indicators, Japan, Imports of Goods and Services ($bn), 2009-2016 143

Figure 56: Economic Indicators, Japan, Exports of Goods and Services ($bn), 2009-2016 144

Figure 57: Economic Indicators, Japan, Government Structural Balance ($bn), 2009-2016 145

Figure 58: Economic Indicators, Japan, General Government Net Debt ($bn), 2009-2016 146

Figure 59: Economic Indicators, Japan, General Government Net Debt ($bn), 2017-2021 147

Figure 60: Economic Indicators, Japan, Major Industries, Output ($bn), 2013 148

Figure 61: Demographics, Japan, Population (million), 2009-2016 149

Figure 62: Demographics, Japan, Population (million), 2017-2021 150

Figure 63: Demographics, Japan, Population, Urban-Rural Population Share (%), 2009-2016 151

Figure 64: Demographics, Japan, Population, Urban-Rural Population Share (%), 2017-2021 152

Figure 65: Demographics, Japan, Population Distribution by Age Group (%), 2009-2016 153

Figure 66: Demographics, Japan, Population Distribution by Age Group (%), 2017-2021 154

Figure 67: Demographics, Japan, Births (per 1,000 population), 2009-2016 155

Figure 68: Demographics, Japan, Mortality (per 1,000 population), 2009-2016 156

Figure 69: Demographics, Japan, Number of Deaths, 2014 157

Figure 70: Demographics, Japan, Mortality Rate in Children under Five (per 1,000 live births), 2009-2016 158

Figure 71: Demographics, Japan, Immunization Rate (%), 2009-2016 159

Figure 72: Demographics, Japan, Major Causes of Mortality in Males, Number of Deaths, 2014 160

Figure 73: Demographics, Japan, Major Causes of Mortality in Females, Number of Deaths, 2014 161

Figure 74: Demographics, Japan, Gender Ratio (M/F), 2009-2016 162

Figure 75: Demographics, Japan, Life Expectancy at Birth (years), 2009-2016 163

Figure 76: Demographics, Japan, Gross Enrollment by Level of Education (%), 2009-2016 164

Figure 77: Demographics, Japan, Unemployment Rate (%), 2009-2016 165

Figure 78: Demographics, Japan, Disability-Adjusted Life Years by Major Disease ('000), 2014 166

Figure 79: Healthcare Infrastructure, Japan, Hospitals, 2009-2016 167

Figure 80: Healthcare Infrastructure, Japan, Hospitals by Service, 2009-2016 168

Figure 81: Healthcare Infrastructure, Japan, Clinics by Type, 2009-2016 169

Figure 82: Healthcare Infrastructure, Japan, Hospital Beds, 2009-2016 170

Figure 83: Healthcare Infrastructure, Japan, Diagnostic Units (per million population), 2009-2016 171

Figure 84: Healthcare Infrastructure, Japan, Hospital Beds (per 1,000 population), 2009-2016 172

Figure 85: Healthcare Infrastructure, Japan, Doctors (per 1,000 population), 2009-2016 173

Figure 86: Healthcare Infrastructure, Japan, PM2.5 Emissions (

List Of Table

1.1 List of Tables

Table 1: Pharmaceutical Market, Japan, Revenue ($bn), 2009-2016 16

Table 2: Pharmaceutical Market, Japan, Revenue ($bn), 2017-2021 17

Table 3: Pharmaceutical Market, Japan, Exports and Imports ($bn), 2009-2016 18

Table 4: Pharmaceutical Market, Japan, Generics Share by Volume (%), 2009-2015 20

Table 5: Pharmaceutical Market, Japan, Biologics Production, 2014 21

Table 6: Pharmaceutical Market, Japan, OTC Drug Market Revenue ($bn), 2009-2015 23

Table 7: Pharmaceutical Market, Japan, Top Five Therapeutic Areas, Production Value, 2014 24

Table 8: Pharmaceutical Market, Japan, Cardiovascular Agents, Production, 2014 25

Table 9: Pharmaceutical Market, Japan, CNS Agents, Production, 2014 26

Table 10: Pharmaceutical Market, Japan, Digestive Organ Agents, Production, 2014 27

Table 11: Pharmaceutical Market, Japan, Blood and Body Fluid Agents, Production, 2014 28

Table 12: Pharmaceutical Market, Japan, Blood and Body Fluid Agents, Production, 2014 29

Table 13: Pharmaceutical Market, Astellas Pharma, Major Products, 2016 30

Table 14: Pharmaceutical Market, Astellas Pharma, Global, Late-Stage Pipeline, 2016 31

Table 15: Pharmaceutical Market, Otsuka, Late-Stage Pipeline, 2016 37

Table 16: Pharmaceutical Market, Chugai Pharmaceuticals, Global, Major Products, 2015 42

Table 17: Pharmaceutical Market, Chugai Pharmaceuticals, Global, Late-Stage Pipeline, 2016 43

Table 18: Pharmaceutical Market, Mitsubishi Tanabe, Global, Late-Stage Pipeline, 2016 52

Table 19: Medical Device Market, Japan, Revenue ($bn), 2009-2016 56

Table 20: Medical Device Market, Japan, Revenue ($bn), 2017-2021 57

Table 21: Medical Device Market, Japan, Revenue by Segment ($bn), 2016 58

Table 22: Medical Device Market, Japan, Ophthalmic Devices Market, Revenue ($bn), 2009-2016 59

Table 23: Medical Device Market, Japan, Ophthalmic Devices Market, Sales Share for Major Players, 2015 60

Table 24: Medical Device Market, Japan, Nephrology and Urology Devices Market, Revenue ($bn), 2009-2016 61

Table 25: Medical Device Market, Japan, Nephrology and Urology Devices Market, Sales Share for Major Players, 2012 62

Table 26: Medical Device Market, Japan, Healthcare IT Market, Revenue ($bn), 2009-2016 63

Table 27: Medical Device Market, Japan, Healthcare IT, Sales Share for Major Players, 2015 64

Table 28: Medical Device Market, Japan, Hospital Supplies Market, Revenue ($bn), 2009-2016 65

Table 29: Medical Device Market, Japan, Hospital Supplies Market, Sales Share for Major Players, 2015 66

Table 30: Medical Device Market, Japan, Diagnostic Imaging Market, Revenue ($bn), 2009-2016 66

Table 31: Medical Device Market, Japan, Diagnostic Imaging Market, Sales Share for Major Players, 2015 67

Table 32: Medical Device Market, Japan, Diagnostic Market, Revenue ($bn), 2009-2016 68

Table 33: Medical Device Market, Japan, Diagnostic Market, Revenue ($bn), 2017-2021 69

Table 34: Medical Device Market, Terumo, Major Products, 2016 70

Table 35: Medical Device Market, Nipro, Major Products, 2016 76

Table 36: Medical Device Market, Olympus, Global, Major Products, 2016 80

Table 37: Market Access, Japan, Types of Health Insurance, 2014 99

Table 38: Market Access, Japan, Out-of-Pocket Payment (% of Healthcare Expenditure), 2009-2016 100

Table 39: Market Access, Japan, Change in Average Price of Prescription Drugs (%), 2004-2014 101

Table 40: Market Access, Japan, Requirements for Applying Premiums for Drug Prices, 2015 102

Table 41: Regulatory Landscape, Japan, Patent Fees, 2016 114

Table 42: Regulatory Landscape, Japan, Trademark Fees, 2016 116

Table 43: Economic Indicators, Japan, Gross Domestic Product per Capita ($), 2009-2016 132

Table 44: Economic Indicators, Japan, Gross Domestic Product per Capita ($), 2017-2021 132

Table 45: Economic Indicators, Japan, Gross Domestic Product Annual Growth (%), 2009-2016 133

Table 46: Economic Indicators, Japan, Gross Domestic Product Annual Growth (%), 2017-2021 134

Table 47: Economic Indicators, Japan, Gross National Income per Capita ($), 2009-2016 135

Table 48: Economic Indicators, Japan, Consumer Price Index, 2009-2016 136

Table 49: Economic Indicators, Japan, Consumer Price Index, 2017-2021 137

Table 50: Economic Indicators, Japan, Consumer Price Annual Change (%), 2009-2016 138

Table 51: Economic Indicators, Japan Currency Exchange Rate ($/JPY) 2009-2016 139

Table 52: Economic Indicators, Japan, Foreign Direct Investment ($bn), 2009-2016 140

Table 53: Economic Indicators, Japan, Foreign Exchange Reserves ($bn), 2009-2016 141

Table 54: Economic Indicators, Japan, Imports of Goods and Services ($bn), 2009-2016 142

Table 55: Economic Indicators, Japan, Exports of Goods and Services ($bn), 2009-2016 143

Table 56: Economic Indicators, Japan, Government Structural Balance ($bn), 2009-2016 144

Table 57: Economic Indicators, Japan, General Government Net Debt ($bn), 2009-2016 145

Table 58: Economic Indicators, Japan, General Government Net Debt ($bn), 2017-2021 146

Table 59: Economic Indicators, Japan, Major Industries, Output ($bn), 2013 147

Table 60: Demographics, Japan, Population (million), 2009-2016 148

Table 61: Demographics, Japan, Population (million), 2017-2021 149

Table 62: Demographics, Japan, Population, Urban-Rural Population Share (%), 2009-2016 150

Table 63: Demographics, Japan, Population, Urban-Rural Population Share (%), 2017-2021 151

Table 64: Demographics, Japan, Population Distribution by Age Group (%), 2009-2016 152

Table 65: Demographics, Japan, Population Distribution by Age Group Forecast (%), 2017-2021 153

Table 66: Demographics, Japan, Births (per 1,000 population), 2009-2016 154

Table 67: Demographics, Japan, Mortality (per 1,000 population), 2009-2016 155

Table 68: Demographics, Japan, Number of Deaths, 2014 156

Table 69: Demographics, Japan, Mortality Rate in Children under Five (per 1,000 live births), 2009-2016 157

Table 70: Demographics, Japan, Immunization Rate (%), 2009-2016 158

Table 71: Demographics, Japan, Major Causes of Mortality in Males, Number of Deaths, 2014 159

Table 72: Demographics, Japan, Major Causes of Mortality in Females, Number of Deaths, 2014 160

Table 73: Demographics, Japan, Gender Ratio (M/F), 2009-2016 161

Table 74: Demographics, Japan, Life Expectancy at Birth (years), 2009-2016 162

Table 75: Demographics, Japan, Gross Enrollment by Level of Education (%), 2009-2016 163

Table 76: Demographics, Japan, Unemployment Rate (%), 2009-2016 164

Table 77: Demographics, Japan, Disability-Adjusted Life Years by Major Disease ('000), 2012 165

Table 78: Healthcare Infrastructure, Japan, Hospitals, 2009-2016 166

Table 79: Healthcare Infrastructure, Japan, Hospitals by Services, 2009-2016 167

Table 80: Healthcare Infrastructure, Japan, Clinics by Type, 2009-2016 168

Table 81: Healthcare Infrastructure, Japan, Hospital Beds, 2009-2016 169

Table 82: Healthcare Infrastructure, Japan, Diagnostic Units (per million population), 2009-2016 170

Table 83: Healthcare Infrastructure, Japan, Hospital Beds (per 1,000 population), 2009-2016 171

Table 84: Healthcare Infrastructure, Japan, Doctors (per 1,000 population), 2009-2016 172

Table 85: Healthcare Infrastructure, Japan, PM2.5 (

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