Japan pharmaceutical market outlook deregulation and more efficient new drug approval process attract foreign investment - Reports Corner

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

DescriptionDescription
Reports Cornerwww.reportscorner.com
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.

Brief SummaryBrief Summary
The Declining and Rapidly Aging Population Presents Significant
Challenges to the Healthcare System and Economy as a
WholeJapan had a population of 127,817,277 in 2011, making it the
10th most populated country in the world (The World Bank, 2012).
However, since 2005, as the number of deaths exceeded that of
births, the population has declined. Without significant
government intervention, the depopulation process is expected to
continue.The proportion of people aged 65 or over is 23.3% and
projected to reach 29.1% by 2020 and almost 40% by 2050
(Statistical Research and Training Institute, 2012).These
demographic changes will present further challenges to a
stagnating economy, which, as the data in this report confirms, is
already struggling with reduced economic growth. A diminishing
workforce and falling productivity levels will likely add to the
economic difficulties Japan is experiencing.

The associated increase in disease burden has also had
implications for the healthcare system. Healthcare expenditure
has risen, and is set to rise further as the population continues to
age.In 2010, Japan’s healthcare spending per capita was $4,065.4,
a significant increase from 2005.Japan’s universal healthcare
system may therefore prove unsustainable as the government
looks to control spending. A combination of pro-generic policies,
government initiatives to prevent lifestyle diseases, and higher
copayments should help to keep healthcare expenditure under
control.Regulatory Reform will Continue to Attract Foreign
Pharmaceutical CompaniesThe ongoing deregulation of the
Japanese pharmaceutical industry has made it an attractive
market for big pharma. Improvements to the new drug approval
process have significantly shortened the approval time.
Consultation services provided by approval bodies have been
expanded and improved, approval standards have been clarified

and the number of trained personnel involved in the review
process has increased.Many of these changes have occurred
following the introduction of a number of plans and government
policies. Plans are currently being implemented to shorten the
review period and improve cooperation with other countries,
particularly Western and other Asian nations, such as the Second
Medium Range Plan (2009–2014), which includes the International
Strategic Plan.In April 2007, the government introduced the 5-Year
Strategy for the Creation of Innovative Pharmaceuticals and
Medical Devices, which contributed towards the reduction in lag
time associated with new product approvals.In addition to
attracting foreign investment, deregulation has also improved the
competitiveness of Japan’s pharmaceutical companies. The
market now consists of multinational players such as Takeda and
Daiichi Sankyo, who market leading products globally. Takeda
Maintains its Position as the Leading Company in the Japanese
Pharmaceutical

IndustryTakeda maintained its position as the leader in Japan’s
pharmaceutical industry in 2012, with revenues of $18.9 billion.
This was followed by Otsuka Holdings, Astellas, Daiichi Sankyo
and Eisai.M&A activity has become a common theme within the
global pharmaceutical industry. This is often a strategic response
to patent expirations, reduced R&D productivity and the need to
cut costs.The Japanese pharmaceutical industry has followed this
trend. Although historically dependent on domestic R&D, the
recent globalization of Japanese companies has been driven by
enhanced M&A activity. Significant deals have been completed in
the US, Europe and developing nations, such as China, India and
Brazil.With a total of 20 M&A, including two recently announced,
Takeda has been the most active Japanese company.The M&A
strategy is seen as necessary for pharmaceutical companies keen
to expand product pipelines following patent expirations and gain
access to untapped markets. It is hoped that such strategic
measures will help develop or maintain growth and revenue.

Table of ContentsTable 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
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
5.2.8 Astellas 78
5.2.11 Daiichi Sankyo 81

5.2.14 Eisai 83
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
7.9 Disclaimer 97

For more informationFor more information
For more information please visit our website
https://www.reportscorner.com/reports/15625/Japan-Pharmaceutical-Market-
Outlook---Deregulation-and-More-Efficient-New-Drug-Approval-Process-Attract-
Foreign-Investment-and-Improve-the-Competitiveness-of-Japanese-Players/

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Japan pharmaceutical market outlook deregulation and more efficient new drug approval process attract foreign investment - Reports Corner

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Japan pharmaceutical market outlook deregulation and more efficient new drug approval process attract foreign investment - Reports Corner