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.

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

2. 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
1 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
Japan Pharmaceutical Market Outlook - Deregulation and More Efficient New Drug Approval Process Attract Foreign Investment and Impro

3. 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
Japan Pharmaceutical Market Outlook - Deregulation and More Efficient New Drug Approval Process Attract Foreign Investment and Impro

4. 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 M&a 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
Japan Pharmaceutical Market Outlook - Deregulation and More Efficient New Drug Approval Process Attract Foreign Investment and Impro

5. 7.9 Disclaimer 97
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Japan Pharmaceutical Market Outlook - Deregulation and More Efficient New Drug Approval Process Attract Foreign Investment and Impro