Japan Pharmaceutical Market Outlook - Deregulation and More Efficient New Drug Approval Process Attract Foreign Investment and Improve the Competitiveness of Japanese Players



Summary



GBI Research, the leading business intelligence provider, has released its latest research “Japan Pharmaceutical Market Outlook - Deregulation and More Efficient New Drug Approval Process Attract Foreign Investment and Improve the Competitiveness of Japanese Players”. Japan’s pharmaceutical industry is the second largest in the world, worth $89 billion in 2011 or 10% of the world market. The industry grew from $62.8 billion in 2005 to its current value at a Compound Annual Growth Rate (CAGR) of 5.1%.

Growth of the domestic pharmaceutical industry has recently been hampered by biennial drug price reductions, which are expected to continue as the government attempts to cut healthcare expenditure. Price reviews are also constrained by a national health budget, which limits the increase of drug prices. In addition, the gradual increase in market share and competition from generics has depressed market value and will continue to do so as government policy promotes their use.

However, easing of regulatory guidelines, an aging population and a strong product pipeline will provide a strong impetus for growth in the pharmaceutical industry. Although the increasing market share of generics may dampen market value, this represents a great deal of opportunity for generic manufacturers.

Historically, the Japanese pharmaceutical market has favored domestic companies. However, since the 1990s, deregulation has promoted investment from abroad and increased the presence of foreign firms.



Scope


- The report assesses characteristics of the Japanese pharmaceutical market, detailing recent regulatory changes, supply chain and competitive landscape. It also draws on macroeconomic and demographic factors and the implications on healthcare policy.
- A macroeconomic analysis of Japan, focusing on key economic parameters such as Gross Domestic Product (GDP), inflation and unemployment. The implications of the global financial crisis in 2008 and natural disaster in 2011 are considered.
- The changing demographic landscape and implications on health economics and policy-making.
- The industry characteristics section presents an overview of pricing policies, the regulatory landscape, new drug approval process and pharmaceutical supply chain in Japan. Notable changes that have occurred over recent years, in an attempt to improve the regulatory system and reduce drug review times, are highlighted.
- The report then analyzes the competitive landscape in Japan, including the major domestic companies and M&A. The discussed regulatory reforms and cooperation between government and industry have improved the international competitiveness of Japan’s pharmaceutical market. Coupled with a number of mergers, the industry now consists of well-known multinationals. The competitive landscape section confirms the top five Japanese pharmaceutical companies by revenue, according to GBI Research data.
- The report concludes by providing an overview of the drivers and barriers currently facing the Japanese pharmaceutical industry.



Reasons to buy


- Primarily, the report will allow clients to gain a strong understanding of the economic and healthcare challenges facing Japan.
- In addition, the report will assist in identifying opportunities within Japan’s pharmaceutical market, including:
- Potential for market growth - A number of factors could provide strong potential for sales growth in the Japanese pharmaceutical market. Examples include the world leading life expectancy and associated increase in lifestyle diseases, and government initiatives to prevent such diseases, which provides opportunities for healthcare and pharmaceutical companies, who often carry out the work.
- The report provides a source of information covering Japan’s regulatory landscape, and importantly, recent deregulation, to help identify the reasons Japan has become an attractive market for big pharma.
- The report will provide new market entrants with a comprehensive overview of the leading Japanese pharmaceutical companies, and the specific therapeutic indications they are currently targeting.
- Overall, allowing clients to determine whether the Japanese pharmaceutical market will provide them with commercially viable opportunities for growth.

Table Of Contents

Table of Contents

1 Table of Contents 6
1.1 List of Tables 8
1.2 List of Figures 8
2 Introduction 10
3 Market Overview 11
3.1 Introduction 11
3.2 Economic Landscape 11
3.3 Economic Indicators 12
3.3.1 Gross Domestic Product 12
3.3.2 GDP Composition by Sector 15
3.3.3 Consumer Price Index 16
3.3.4 Unemployment 18
3.3.5 Exchange Rate 20
3.3.6 Foreign Direct Investment 21
3.3.7 Trade Balance 23
3.3.8 Value of Exports/Imports 24
3.3.9 Exports and Imports Forecast 25
3.3.10 Trading Partners 26
3.3.11 Government Debt 27
3.3.12 Gross National Income 28
3.3.13 Gross National Savings 31
3.3.14 Labor Force 32
3.3.15 Employment 34
3.3.16 Current Account Balance 36
3.3.17 Foreign Exchange Reserves 37
3.4 Demographic Analysis 38
3.4.1 Population 38
3.4.2 Population Distribution 39
3.4.3 Urban-Rural Share 40
3.5 Healthcare 41
3.5.1 Healthcare Expenditure 41
3.5.2 Public and Private Expenditure 43
3.5.3 Healthcare Infrastructure 46
3.5.4 Alcohol Consumption 49
3.5.5 Tobacco Consumption 50
3.5.6 Obesity 52
3.5.7 Life Expectancy 53
3.5.8 Leading Causes of Death 54
3.5.9 Pharmaceutical Expenditure 55
3.5.10 Insurance and Reimbursement 55
3.5.11 Reimbursement Process 57
3.6 Market Segments 58
3.6.1 Generics 58
3.6.2 Over-the-Counter Drugs 59
4 Industry Characteristics 60
4.1 Introduction 60
4.2 Pricing Policy 60
4.2.1 Reimbursement Prices for New Drugs 60
4.3 Regulatory Landscape 62
4.3.1 Pharmaceutical and Food Safety Bureau 64
4.3.2 Pharmaceutical and Medical Devices Agency 65
4.3.3 New Drug Approval Process 66
4.3.4 Drug Manufacture 68
4.3.5 Clinical Trials - Basic Requirements 68
4.3.6 Advertising 68
4.3.7 Licensing 69
4.3.8 Orphan Drugs 69
4.4 Pharmaceutical Supply Chain 70
4.4.1 Leading Companies 71
5 Competitive Landscape 72
5.1 Introduction 72
5.2 Major Domestic Companies 72
5.2.1 Major Players by Revenue 72
5.2.2 Takeda 73
5.2.3 Product Portfolio 73
5.2.4 Research and Development 73
5.2.5 Otsuka 76
5.2.6 Product Portfolio 76
5.2.7 Research and Development 77
5.2.8 Astellas 78
5.2.9 Product Portfolio 79
5.2.10 Research and Development 80
5.2.11 Daiichi Sankyo 81
5.2.12 Product Portfolio 81
5.2.13 Research and Development 82
5.2.14 Eisai 83
5.2.15 Research and Development 84
5.3 Major Foreign Players 85
5.4 Acquisitions and Collaboration 86
5.4.1 MandA 86
5.4.2 Licensing Agreements and Co-development Deals 89
6 Drivers and Barriers 92
6.1 Drivers 92
6.1.1 World-Leading Life Expectancy - Increased Disease Burden 92
6.1.2 Deregulation - Easing of Regulatory Guidelines 92
6.1.3 Government Initiatives to Prevent Lifestyle Diseases 92
6.1.4 Continued Growth of the Generics Market 92
6.2 Barriers 93
6.2.1 Time Lag in Drug Approval Process 93
6.2.2 Political Instability 93
6.2.3 High Cost of Clinical Trials 93
6.2.4 High Value of the Yen 93
7 Japan Pharmaceutical Market Outlook - Appendix 94
7.1 Market Definitions 94
7.2 Abbreviations 94
7.3 Bibliography 95
7.4 Research Methodology 96
7.5 Coverage 96
7.6 Secondary Research 97
7.7 Competitive Landscape 97
7.7.1 Expert Panel Validation 97
7.8 Contact Us 97
7.9 Disclaimer 97



List of Tables

Table 1: Pharmaceutical Market, Japan, Health Insurance, 1922-2008 55
Table 2: Pharmaceutical Market, Japan, Insurance and Reimbursement, 2009 56
Table 3: Pharmaceutical Market, Japan, Premium Rates and Requirements, 2012 61
Table 4: Pharmaceutical Market, Japan, Pharmaceutical Supply Chain, Leading Companies, Revenue ($bn), 2012 71
Table 5: Takeda, Japan, Major Product Portfolio, Revenue ($bn), 2011 73
Table 6: Takeda, Japan, Product Pipeline, 2012 74
Table 7: Otsuka, Japan, Major Product Portfolio, Revenue ($m), 2010 76
Table 8: Otsuka, Japan, Product Pipeline, 2012 77
Table 9: Astellas, Japan, Major Product Portfolio, Revenue ($m), 2011 79
Table 10: Astellas, Japan, Product Pipeline, 2011 80
Table 11: Daiichi Sankyo, Japan, RandD Pipeline, Revenue ($bn), 2012 81
Table 12: Daiichi Sankyo, Japan, RandD Pipeline, 2012 82
Table 13: Eisai, Japan, Major Product Portfolio, Revenue ($bn), 2011 83
Table 14: Eisai, Japan, Product Pipeline, 2012 84
Table 15: Pharmaceutical Market, Japan, Licensing Agreements by Company, 2005-2012 90



List of Figures

Figure 1: Pharmaceutical Market, Japan, Gross Domestic Product ($tn), 2005-2017 12
Figure 2: Pharmaceutical Market, Japan, Gross Domestic Product Growth (%), 2005-2017 13
Figure 3: Pharmaceutical Market, Japan, Gross Domestic Product Per Capita ($), 2005-2017 14
Figure 4: Pharmaceutical Market, Japan, Gross Domestic Product by Sector (%), 2011 15
Figure 5: Pharmaceutical Market, Japan, Annual Consumer Price Index, 2005-2017 16
Figure 6: Pharmaceutical Market, Japan, Average Consumer Price Change (%), 2005-2017 17
Figure 7: Pharmaceutical Market, Japan, Unemployment (%), 2005-2017 18
Figure 8: Pharmaceutical Market, Japan, Youth Unemployment (%), 2005-2010 19
Figure 9: Pharmaceutical Market, Japan, Currency Exchange Rate (JPY/$), 2005-2011 20
Figure 10: Pharmaceutical Market, Japan, Foreign Direct Investment Outflows ($bn), 2005-2011 21
Figure 11: Pharmaceutical Market, Japan, Foreign Direct Investment Inflows ($bn), 2005-2011 22
Figure 12: Pharmaceutical Market, Japan, Trade Balance ($bn), 2005-2011 23
Figure 13: Pharmaceutical Market, Japan, Exports and Imports ($bn), 2005-2010 24
Figure 14: Pharmaceutical Market, Japan, Exports and Imports Forecast (%), 2010-2017 25
Figure 15: Pharmaceutical Market, Japan, Exports by Trading Partner (%), 2011 26
Figure 16: Pharmaceutical Market, Japan, General Government Gross Debt (% of GDP), 2005-2017 27
Figure 17: Pharmaceutical Market, Japan, Gross National Income (PPP $tn), 2005-2011 28
Figure 18: Pharmaceutical Market, Japan, Gross National Income Growth (%), 2005-2010 29
Figure 19: Pharmaceutical Market, Japan, Gross National Income Per Capita (PPP $), 2005-2011 30
Figure 20: Pharmaceutical Market, Japan, Gross National Savings (% of GDP), 2005-2017 31
Figure 21: Pharmaceutical Market, Japan, Labor Force (Millions), 2005-2011 32
Figure 22: Pharmaceutical Market, Japan, Labor Force by Occupation (%), 2010 33
Figure 23: Pharmaceutical Market, Japan, Employment to Population Ratio, Age 15+ (%), 2005-2010 34
Figure 24: Pharmaceutical Market, Japan, Employment to Population Ratio by Gender, Age 15+ (%), 2005-2010 35
Figure 25: Pharmaceutical Market, Japan, Current Account Balance ($bn), 2005-2011 36
Figure 26: Pharmaceutical Market, Japan, Foreign Exchange Reserves ($bn), 2005-2011 37
Figure 27: Pharmaceutical Market, Japan, Crude Birth and Death Rate (Per 1,000 Population), 2005-2010 38
Figure 28: Pharmaceutical Market, Japan, Population by Age Group (%), 2000-2020 39
Figure 29: Pharmaceutical Market, Japan, Urban-Rural Share (%), 2005-2010 40
Figure 30: Pharmaceutical Market, Japan, Healthcare Expenditure, Percentage of GDP (%), 2005-2010 41
Figure 31: Pharmaceutical Market, Japan, Healthcare Expenditure Per Capita ($), 2005-2010 42
Figure 32: Pharmaceutical Market, Japan, Public and Private Expenditure (%), 2005-2010 43
Figure 33: Pharmaceutical Market, Japan, Expenditure as Percentage of Government Expenditure (%), 2005-2010 44
Figure 34: Pharmaceutical Market, Japan, Out-of-Pocket Expenditure (%), 2005-2010 45
Figure 35: Pharmaceutical Market, Japan, Hospital Beds (Per 1,000 Population), 2005-2010 46
Figure 36: Pharmaceutical Market, Japan, Physicians (Per 1,000 Population), 2002-2010 47
Figure 37: Pharmaceutical Market, Japan, Average Hospital Stay (Days), 2005-2010 48
Figure 38: Pharmaceutical Market, Japan, Alcohol Consumption (Liters Per Capita), 2005-2010 49
Figure 39: Pharmaceutical Market, Japan, Tobacco Consumption (%), 2005-2010 50
Figure 40: Pharmaceutical Market, Japan, Tobacco Consumption by Gender (%), 2005-2010 51
Figure 41: Pharmaceutical Market, Japan, Obesity (%), 2005-2010 52
Figure 42: Pharmaceutical Market, Japan, Life Expectancy at Birth (Years), 2005-2010 53
Figure 43: Pharmaceutical Market, Japan, Death Rate by Leading Causes (Per 100,000 Population), 2011 54
Figure 44: Pharmaceutical Market, Japan, Financial Source of Healthcare Insurance (%), 2008 57
Figure 45: Pharmaceutical Market, Japan, Generic Market, Volume and Value (%), 2005-2011 58
Figure 46: Pharmaceutical Market, Japan, Over-the-Counter Drugs, Revenue Forecast ($bn), 2008-2016 59
Figure 47: Pharmaceutical Market, Japan, Ministry of Health, Labor and Welfare, Structure, 2012 63
Figure 48: Pharmaceutical Market, Japan, Pharmaceutical and Food Safety Bureau, Structure, 2012 64
Figure 49: Pharmaceutical Market, Japan, Pharmaceutical and Medical Devices Agency, Structure, 2012 65
Figure 50: Pharmaceutical Market, Japan, New Drug Approval Process, 2012 67
Figure 51: Pharmaceutical Market, Japan, Pharmaceutical Supply Chain. 2012 70
Figure 52: Pharmaceutical Market, Japan, Major Domestic Companies, Revenue ($bn), 2012 72
Figure 53: Pharmaceutical Market, Japan, MandA, 2005-2012 86
Figure 54: Pharmaceutical Market, Japan, MandA Deals by Country, 2005-2012 87
Figure 55: Pharmaceutical Market, Japan, MandA, Aggregate Deal Value ($bn), 2005-2012 88
Figure 56: Pharmaceutical Market, Japan, Licensing Agreements, 2005-2012 89
Figure 57: Pharmaceutical Market, Japan, Co-development Deals, 2005-2012 90



Companies Mentioned

Takeda Pharmaceutical Ltd.
Otsuka Holdings Ltd.
Astellas Pharma Inc.
Daiichi Sankyo Ltd.
Eisia Ltd.

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