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Japan Healthcare, Regulatory and Reimbursement Landscape – CountryFocus

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 and analysis on the healthcare, regulatory and reimbursement landscape in Japan. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure of Japan. 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 GlobalData’s team of industry experts.

In 2010, the Japanese pharmaceutical market was worth $67.5B, which decreased to an estimated $61.8B in 2017 at a negative Compound Annual Growth Rate (CAGR) of 2%. The Japanese medical devices market was valued at $48.3B in 2015, which increased to $52.2B in 2017. The market is expected to grow at a CAGR of 4.1% from $54.5B in 2018 to $59.4B in 2020. Regulatory reforms have led to faster and more efficient drug approval processes. This has led to international pharmaceutical companies establishing R&D centers and increasing their investments in Japan.

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in the 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 (Daiichi Sankyo, Astellas, Roche, Takeda, and Otsuka) and profiles and SWOT analyses of the major players in the medical device market (Medtronic, Abbott, Roche, Terumo and Fujitsu)

• Detailed analysis about recent completed deals in the pharmaceutical and medical device market of Japan

• Porter’s five forces analysis for pharmaceutical and medical devices market of Japan

• 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 opportunitiesand challenges to growth in the Japanese healthcare market

Reasons to buy

The report provides information on the healthcare, regulatory, and reimbursement landscape in the 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 (Daiichi Sankyo, Astellas, Roche, Takeda, and Otsuka) and profiles and SWOT analyses of the major players in the medical device market (Medtronic, Abbott, Roche, Terumo and Fujitsu)

• Detailed analysis about recent completed deals in the pharmaceutical and medical device market of Japan

• Porter’s five forces analysis for pharmaceutical and medical devices market of Japan

• 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 Japanese healthcare market

Table of Contents

1 Table of Contents

1.1 List of Figures

1.2 List of Tables

2 Executive Summary

2.1 Executive Summary – Overview

2.2 Key Highlights

2.3 Key Events: Japanese Pharmaceutical History, 2007–2019

2.4 Key Events: Japanese Pharmaceutical Market

2.5 Key Events: M&A, VF & PE Deals, Global Pharmaceutical Market, 2017–2018

2.6 Key Events: Mergers and Acquisitions

2.7 Country Profile, Japan, 2018

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

3.5 Pharmaceutical Market – Market Segments

3.6 Pharmaceutical Market – Top Five Disease Areas

3.7 Pharmaceutical Market – Major Players

4 Overview of Medical Devices Market

4.1 Medical Device Market – Overview

4.2 Medical Device Market – Top Five Segments

4.3 Medical Device Market – Diagnostic Market

4.4 Medical Device Market – Major Players

5 Pharmaceutical and Medical Device Market – Drivers and Barriers

5.1 Drivers

5.2 Barriers

6 Deal analysis

6.1 Deal Analysis: M&A, VF and PE Deals, Pharmaceutical Market, Japan

6.2 Deal Analysis: M&A, VF and PE Deals, Medical Device Market, Japan

7 Pharmaceutical and Medical Device Market – Porter’s Five Forces Analysis

7.1 Pharmaceutical Market, Japan – Porter’s Five Forces Analysis

7.2 Medical Device Market, Japan – Porter’s Five Forces Analysis

8 Market Access

8.1 Overview of Healthcare System, Japan

8.2 Reimbursement Process, Japan

8.2.1 Overview of Insurance, Japan

8.2.2 Healthcare Spending and Medicines and Health Fortification Price Index, Japan

8.2.3 Pricing Policies, Japan

8.3 Regulatory Landscape, Japan

8.3.1 Market Authorization for Pharmaceutical Drugs, Japan

8.3.2 Market Authorization for Medical Devices, Japan

8.3.3 Intellectual Property Rights, Patent, Japan

8.3.4 Intellectual Property Rights, Trademark, Japan

8.3.5 Clinical Trial Regulations, Japan

8.3.6 Pharmaceutical Advertising Regulations, Japan

8.3.7 Labeling and Packaging Regulations, Japan

9 Country Healthcare Landscape

9.1 Healthcare Policy Highlights

9.2 Healthcare Facilities

9.3 Healthcare Parameters

9.4 Environmental Health

9.5 Healthcare Personnel

9.6 Disease Burden

9.7 Healthcare Expenditure

9.7.1 Healthcare Expenditure – Overview

9.7.2 Share of Public and Private Sectors

10 Trade Associations

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

13.1.4 Expert Panel

13.2 Bibliography

13.3 Contact Us

13.4 Disclaimer

List of Tables

Table 1: Approved Biosimilars, Japan, 2018

Table 2: Top Five Therapeutic Areas by Drug Production Value ($B), Japan, 2017

Table 3: Ophthalmic Devices Market, Japan, Revenue ($M) and Market Share (%) of Major Companies, 2015

Table 4: Nephrology and Urology Devices Market, Japan, Revenue ($M) and Market Share (%) of Major Companies, 2016

Table 5: In Vitro Diagnostics Market, Japan, Revenue ($M) and Market Share (%) of Major Companies, 2017

Table 6: Diagnostic Imaging Market, Japan, Revenue ($B), 2015–2022

Table 7: Hospital Supplies Market, Japan, Revenue ($M) and Market Share (%) of Major Companies, 2017

Table 8: Medical Device Classification, Japan, 2016

Table 9: Patent Fees, Japan, 2019

Table 10: Trademark Fees, Japan, 2019

Table 11: Trade Fairs, Japan, 2019

List of Figures

Figure 1: Pharmaceutical Market, Japan, Revenue ($B), 2010–2017

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

Figure 3: Country Profile, Japan, 2018

Figure 4: Pharmaceutical Market, Japan, Revenue ($B), 2010–2017

Figure 5: Pharmaceutical Market, Japan, Revenue Forecast ($B), 2018–2022

Figure 6: Pharmaceutical Exports ($B), Japan, 2010–2018

Figure 7: Top Export Partners, Japan, 2018

Figure 8: Pharmaceutical Imports ($B), Japan, 2010–2018

Figure 9: Top Import Partners, Japan, 2018

Figure 10: Pharmaceutical Supply Chain, Japan, 2019

Figure 11: Generic Drugs Market (% share), Japan, 2009–2017

Figure 12: Major Approved Biopharmaceuticals in Japan, Japan, 2016

Figure 13: Breakdown of Approved Biopharmaceuticals, Japan, 2016

Figure 14: Top 5 Therapeutic Areas by Annual Turnover ($B), Japan, 2017

Figure 15: Pharmaceutical Market, Major Players, 2017

Figure 16: Medical Device Market, Japan, Revenue ($B), 2015–2020

Figure 17: Medical Device Market, Japan, Revenue Forecast ($B), 2021–2025

Figure 18: Medical Device Market, Japan, Revenue by Segment ($B), 2018

Figure 19: Ophthalmic Devices Market, Japan, Revenue ($B), 2015–2022

Figure 20: Ophthalmic Devices Market, Japan, Market Share of Major Players (%), 2015

Figure 21: Nephrology and Urology Devices Market, Japan, Revenue ($B), 2015–2022

Figure 22: Nephrology and Urology Devices Market, Japan, Market Share of Major Companies (%), 2016

Figure 23: In Vitro Diagnostics Market, Japan, Revenue ($B), 2015–2022

Figure 24: In Vitro Diagnostics Market, Japan, Market Share of Major Players (%), 2017

Figure 25: Diagnostic Imaging Market, Japan, Revenue ($B), 2015–2022

Figure 26: Diagnostic Imaging Market, Japan, Market Share of Major Players (%), 2016

Figure 27: Hospital Supplies Market, Japan, Revenue ($B), 2015–2022

Figure 28: Hospital Supplies Market, Japan, Market Share of Major Players (%), 2017

Figure 29: Diagnostic Market, Japan, Revenue ($B), 2015–2020

Figure 30: Diagnostic Market, Japan, Revenue ($B), 2021–2025

Figure 31: Medical Device Market, Japan, Revenue ($B) of Major Companies, 2017

Figure 32: Deal Value and Deal Count, Pharmaceutical Market, Japan, 2018–2019

Figure 33: Deal Value and Deal Count Quarterly, Pharmaceutical Market, Japan, 2018–2019

Figure 34: Deal Value and Deal Count Sub-Types, Pharmaceutical Market, Japan, 2018–2019

Figure 35: Top Five Therapy Areas by Deal Value, Pharmaceutical Market, Japan, 2018–2019

Figure 36: Top Five Therapy Areas by Deal Number, Pharmaceutical Market, Japan, 2018–2019

Figure 37: M&A Deals by Therapy Area, Pharmaceutical Market, Japan, 2018–2019 (by value and by number)

Figure 38: Venture Financing Deals by Therapy Area, Pharmaceutical Market Japan, 2018–2019(by value and by number)

Figure 39: Medical Device Market Deals (by deal value, $M), Japan, 2018

Figure 40: Medical Device Market Deals (by deal count), Japan, 2018

Figure 41: Medical Device Market Deals Share (by deal count), Japan, 2018

Figure 42: Medical Device Market Deals Share (by deal value), Japan, 2017–2018

Figure 43: Medical Device Market Deals, Japan, Top Therapy Area by Deal Value, 2018

Figure 44: Medical Device Market Deals, Japan, Top Therapy Area by Deal Number, 2018

Figure 45: Medical Device Market Deals, Japan, M&A Deals by Therapy Area, 2018

Figure 46: Medical Device Market Deals, Japan, Venture Financing Deals by Therapy Area, 2018

Figure 47: Medical Device Market Deals, Japan, Private Equity Deals by Therapy Area, 2018

Figure 48: Organization of the Health System, Japan, 2018

Figure 49: Reimbursement Pricing for New Drugs, Japan, 2018

Figure 50: Public Insurance Schemes, Japan, 2016

Figure 51: Public Insurance Schemes, People Insured by Scheme (%), Japan, 2016

Figure 52: Financial flow based on insurance flows, Japan, 2016

Figure 54: Out-of-Pocket Expenditure (% of total expenditure on health), Japan, 2010–2017

Figure 55: Annual Rate of Change (%), Medicines and health fortification Price Index, Japan, 2010–2018

Figure 56: Types of Premiums, Japan, 2016

Figure 57: Pricing Policies, Japan, 2017

Figure 58: Ministry of Health, Labour and Welfare, Organization Chart, 2018

Figure 59: Organization of PSEHB and PMDA, Japan, 2018

Figure 60: Drug Approval Process, Japan, 2018

Figure 61: Drug Approval Process Timeline, Japan, 2018

Figure 62: Patent Approval Process, Japan, 2016

Figure 63: Trademark Process Timeline, Japan, 2017

Figure 64: Clinical Trial Notification Process, Japan, 2018

Figure 65: Layout of Package Insert Based on Revised Guidelines for Preparation, Japan, 2018

Figure 66: Health Care 2035, Japan, 2019

Figure 67: Health Care 2035, Japan, 2019

Figure 68: Hospitals (number), Japan, 2010–2017

Figure 69: Hospitals by Type (number), Japan, 2010–2017

Figure 70: Diagnostic Equipment (installed base), Japan, 2015–2022

Figure 71: Hospital Beds (per 1,000 population), Japan, 2010–2017

Figure 72: Acute Care Hospital Beds (per 1,000 population), Japan, 2010–2017

Figure 73: Psychiatric Care Hospital Beds (per 1,000 population), Japan, 2010–2017

Figure 74: Life Expectancy (in years), Japan, 2010–2017

Figure 75: Immunization Rate (%), Japan, 2010–2016

Figure 76: PM2.5 (µg per m3), Japan, 2010–2017

Figure 77: CO2 Emissions (metric tons per capita), Japan, 2010–2017

Figure 78: Physicians (per 1,000 population), Japan, 2010-2017

Figure 79: Nurses (per 1,000 population), Japan, 2010-2017

Figure 80: Dentists, (per 1,000 population), Japan, 2010-2017

Figure 81: Pharmacists, (per 1,000 population), Japan, 2010-2017

Figure 82: Major Causes of Mortality (Death rate [per 100,000 population]), Japan, 2016

Figure 83: Major Causes of Male Mortality (Death rate [per 100,000 population]), Japan, 2016

Figure 84: Major Causes of Female Mortality (Death rate [per 100,000 population]), Japan, 2016

Figure 85: Disability-Adjusted Life Years by Major Disease (‘000), Japan, 2016

Figure 86: Healthcare Expenditure as Percentage of GDP (%), Japan, 2011–2017

Figure 87: Health Expenditure Share (% of total health spending), Japan, 2011–2017

Figure 88: Healthcare spending as per providers (%), Japan, 2015

Figure 89: Pharmaceutical Spending (% of total health spending), Japan, 2010–2015

Figure 90: Opportunities & Challenges, Japan

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