CountryFocus: Healthcare, Regulatory and Reimbursement Landscape –Japan

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

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

3 Introduction

3.1 GlobalData Report Guidance

4 ...

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

3 Introduction

3.1 GlobalData Report Guidance

4 Overview of the Pharmaceutical and Medical Device Markets

4.1 Pharmaceutical Market

4.1.1 Market Overview

4.1.2 Pharmaceutical Exports and Imports

4.1.3 Supply Channels

4.1.4 Market Segments

4.1.5 Major Therapeutic Areas

4.1.6 Major Companies

4.2 Medical Device Market

4.2.1 Overview of the Top Five Segments

4.2.2 Diagnostic Market

4.2.3 Major Players

4.3 Market Drivers and Barriers

4.3.1 Drivers

4.3.2 Barriers

5 Market Access

5.1 Reimbursement and Payer Landscape

5.1.1 Overview of Healthcare System

5.1.2 Reimbursement Process

5.1.3 Overview of Insurance Providers

5.1.4 Patient Share in Healthcare Spending

5.1.5 Price Trends in the Healthcare Sector

5.1.6 Pricing Policies

5.2 Regulatory Landscape

5.2.1 Overview of Regulatory Agencies

5.2.2 Market Authorization Procedure for Pharmaceutical Products

5.2.3 Approval Process of Biological Products as Biosimilar or Interchangeable

5.2.4 New Medical Device Approval Process

5.2.5 Intellectual Property Rights

5.2.6 Clinical Trial Regulations

5.2.7 Pharmaceutical Advertising Regulations

5.2.8 Pharmacy Regulations

5.2.9 Labeling and Packaging Regulations

6 Country Analysis

6.1 Political Environment

6.1.1 Political Structure

6.1.2 Analysis of the Current Political Environment

6.1.3 Healthcare Policy Initiatives

6.2 Economic Landscape

6.3 Economic Indicators

6.3.1 Gross Domestic Product

6.3.2 Gross National Income

6.3.3 Inflation

6.3.4 Currency Exchange Rate

6.3.5 Foreign Direct Investment

6.3.6 Foreign Exchange Reserves

6.3.7 Trade Balance

6.3.8 General Government Structural Balance

6.3.9 General Government Net Debt

6.3.10 Major Industries

6.4 Demographics

6.4.1 Population

6.4.2 Education and Literacy

6.4.3 Employment

6.4.4 Disease Burden

6.5 Healthcare Infrastructure

6.5.1 Healthcare Facilities

6.5.2 Healthcare Parameters

6.5.3 Environmental Health

6.5.4 Healthcare Personnel

6.6 Healthcare Expenditure

6.6.1 Overview

6.6.2 Major Components of Healthcare Spending

6.6.3 Public and Private Sector Share

6.6.4 Spending in Healthcare R&D

6.7 Trade Associations

6.7.1 Japan Pharmaceutical Manufacturers Association

6.7.2 Federation of Pharmaceutical Manufacturers’ Associations

6.7.3 Japan Pharmaceutical Traders Association

6.7.4 Japan Pharmaceutical Equipment and Machinery Association

6.7.5 Japan Federation of Medical Devices Associations

6.7.6 The Federation of Japan Pharmaceutical Wholesalers Association

6.8 Trade Fairs

7 Opportunities and Challenges

7.1 Opportunities

7.2 Challenges

8 Appendix

8.1 Abbreviations

8.2 Bibliography

8.3 Research Methodology

8.3.1 Coverage

8.3.2 Secondary Research

8.3.3 Forecasts

8.3.4 Expert Panel

8.4 Contact Us

8.5 Disclaimer

List of tables

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

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

Table 3: Pharmaceutical Market, Japan, Exports and ...

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Table 78: Healthcare Infrastructure, Japan, Hospitals, 2009–2016

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

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

Table 81: Healthcare Infrastructure, Japan, Hospital Beds, 2009–2016

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

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

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

Table 85: Healthcare Infrastructure, Japan, PM2.5 (µg/m3), 2009–2016

Table 86: Healthcare Infrastructure, Japan, CO2 Emissions (metric tons per capita), 2009–2016

Table 87: Healthcare Infrastructure, Japan, CO2 Emissions by Sector (%), 2014

Table 88: Healthcare Infrastructure, Japan, Nurses (per 1,000 population), 2009–2016

Table 89: Healthcare Infrastructure, Japan, Dentists (per 1,000 population), 2009–2016

Table 90: Healthcare Infrastructure, Japan, Pharmacists (per 1,000 population), 2009–2016

Table 91: Healthcare Expenditure, Japan, Healthcare Expenditure (percentage of GDP), 2009–2016

Table 92: Public Healthcare Expenditure, Japan, Share of Major Components (%), 2015

Table 93: Healthcare Expenditure, Japan, Healthcare Expenditure, Public–Private Share (%), 2009–2016

Table 94: Healthcare Expenditure, Japan, R&D Expenditure ($bn), 2009–2016

Table 95: Healthcare Expenditure, Japan, Major Healthcare Trade Fairs, 2017

List of figures

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

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

Figure 3: Pharmaceutical Market, Japan, Country ...

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Figure 79: Healthcare Infrastructure, Japan, Hospitals, 2009–2016

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

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

Figure 82: Healthcare Infrastructure, Japan, Hospital Beds, 2009–2016

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

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

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

Figure 86: Healthcare Infrastructure, Japan, PM2.5 Emissions (µg/m3), 2009–2016

Figure 87: Healthcare Infrastructure, Japan, CO2 Emissions (metric tons per capita), 2009–2016

Figure 88: Healthcare Infrastructure, Japan, CO2 Emissions by Sector (%), 2014

Figure 89: Healthcare Infrastructure, Japan, Nurses (per 1,000 population), 2009–2016

Figure 90: Healthcare Infrastructure, Japan, Dentists (per 1,000 population), 2009–2016

Figure 91: Healthcare Infrastructure, Japan, Pharmacists (per 1,000 population), 2009–2016

Figure 92: Healthcare Expenditure, Japan, Healthcare Expenditure (percentage of GDP), 2009–2016

Figure 93: Public Healthcare Expenditure, Japan, Share of Major Components (%), 2015

Figure 94: Healthcare Expenditure, Japan, Public–Private Share of Healthcare Expenditure (%), 2009–2016

Figure 95: Healthcare Expenditure, Japan, R&D Expenditure ($bn), 2009–2016

Figure 96: Healthcare Market, Japan, Opportunities and Challenges, 2017

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