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The Japanese pharmaceutical market outlook for 2014: environmental policy, market structure, competitive environment, growth opportunities, Aarkstore

Japan has been an active industrial nation since the adoption of Western technology and industrial supremacy won in the early 20th century. In 2008, services sector (72.1%) contributed to the majority of GDP growth in Japan, followed by industry (26.4%) and agriculture (1

The regulatory framework which is the Japanese pharmaceutical market has changed significantly in the last decade. Many of the Japanese pharmaceutical companies had a considerable experience a string of recent high-profile acquisitions. Moreover, with strong cash reserves and the recent dramatic rise in the yen's value (especially compared the euro), this appetite for acquisitions is likely to remain in the coming years.

Foreign companies are now in full expansion with presence in Japan especially in the field of R & D and marketing. In terms of domestic sales of prescription drugs, foreign firms have increased its market share with Pfizer, Roche, Novartis and GSK takes the top 10. This expansion in the Japanese pharmaceutical market has suffered occasional setbacks, such as Pfizer and Merck & Co. decision to close research facilities in 2006. In addition, in 2008, U.S. biotech giant Amgen (In U.S. $ 1.2bn agreement with Takeda) also gave the rights of 13 drugs to Takeda. But more recently, foreign multinationals are seeking to expand its presence in Japan above all to preserve rights that previously had been Japanese domestic companies.

The main features of this report

• The macroeconomic environment in Japan includes the profile of the population, the disease burden, economic outlook and health expenditures

• The Japanese health system share the recent developments in the health sector, social security system, system of Japanese drug regulatory (Covering IP protection, pricing and reimbursement, drug and health care reforms approval system) and future prospects of prices and system reimbursement in Japan

• Overview of the Japanese pharmaceutical market covering Japanese domestic pharmaceutical market, generic drug market, biotechnological challenges, mergers and acquisitions and key attractions pipeline until 2014

• Forecasting and Analysis leading products in the Japanese pharmaceutical market during the period from 2008 to 1914 spread over the main indications and types of treatments

Scope implementation of this report

• Develop ideas for the Japanese pharmaceutical market, prices and regulation and the epidemiological situation detailed indications or risk factors common in the country

• Quickly understand how recent events are affecting the performance main product, and how their vendors are facing competitive challenges in the Japanese market

• Earn up to date competitive intelligence across a wide range of products sold, R & D, market share data, sales forecasts and the competitive landscape for the major players in the Japanese pharmaceutical market

• Understand the indications have the greatest potential to provide franchise growth and how pharmaceutical companies are attempting to exploit these opportunities in Japan

Key Market Issues

• The biosimilar somatropin formed BS first to launch in Japan
Novartis Sandoz generics division became the first company to launch a biosimilar therapeutic BS somatropin (recombinant form of the growth hormone Genotropin) in Japan. Initially approved in June 2009 in Japan for the treatment of deficiency of growth hormone in children, growth disturbance associated with Turner syndrome and chronic renal failure, and is marketed by Sandoz as Omnitrope in the EU, U.S. and a number of other markets.

• Cervarix, Prevenar and drug Januvia most anticipated formed to receive approval in Japan in 2009
In October 2009, GSK Cervarix (vaccine against cervical cancer), Wyeth / Pfizer 's Prevenar (pediatric pneumococcal conjugate vaccine) and Merck & Co inhibitor DPP-IV Januvia (sitagliptin) received final marketing approval in Japan. Moreover, also formed the first Cervarix vaccine products Japanese receive approval from the human papilloma virus (HPV). Januvia was notable among other clearances from the ministry, which will be co-marketed by Ono as Glactiv in Japan.

The main conclusions of this report

• The Japanese pharmaceutical market was valued at $ 68.6bn in 2008, registering a sales growth of 17.2% over 2007, and is expected to grow at a CAGR of 4.8% during 2008-14. According to estimates Economic Insights, Targeted therapies and antineoplastic and immunomodulating agents have the greatest growth with CAGR of 19.8% and 10.1% respectively over the forecast period.

• Cardiovascular disorders, digestive tract and general metabolism and anti-infectives is still the best sellers in Japan, therapeutic categories, 2008 record sales of U.S. $ 14.6bn, $ 6.5bn and $ 9.6bn respectively.

• Leading brands in the Japanese pharmaceutical market had a prevalence of cardiovascular drugs (up to six products in the top 10). The 10 products in this market is a very small market with only 11.4% share in 2008. Takeda drug inhibitor of angiotensin-II Blopress led the market with 2008 sales of $ 1.1bn, a growth of 13.3% over 2007.

Key questions answered

• What information will increase significantly in the Japanese pharmaceutical market during the period 2008-14?

• Which companies (multinational and national) will become the key players in the Japanese pharmaceutical market during the period 2008-14?

• What products are affected by generic competition during the period 2008-14?

• What products will be the drivers of future growth of the Japanese pharmaceutical market?

• What therapeutic categories are forecast to higher levels of trade potential during the period from 2008 to 1914

Contents
The Japanese perspective Pharmaceutical Market to 2014
10 Executive summary
The macroeconomic environment in Japan 10
The Japanese healthcare system 11
Market analysis 12 Japanese pharmaceutical
competitive landscape of the Japanese pharmaceutical market 13
Scope and Methodology 14
Scope 14
Methodology 14
Chapter 1 The macroeconomic environment in Japan 16
Summary 16
Introduction 17
Economic scenario 17
Environmental scenario 20
Population profile 20
Burden of disease 22
24th Medical
Chapter 2 The Japanese healthcare system 28
Summary 28
Introduction 29
Health insurance system 30
drug regulatory system 32 Japanese
Intellectual property rights 33
Prices and reimbursement of 36
The health system reform in Japan 41
Future perspectives of pricing and reimbursement in Japan 41
Increased absorption of drugs generic 41
The changes in the type of drugs that are reimbursable 42
Reference prices can be more restrictive 42
The government should try to provide innovative drug manufacturers 42
Chapter 3 The analysis of Japanese pharmaceutical market 44
Summary 44
Introduction 45
The domestic pharmaceutical market in Japan 46
Japanese market for generic drugs 47
biotechnological challenges in Japan 49
Key mergers and acquisitions in Japan 50
M & A deals in 2007 and 2008 52
offerings and key partnerships in 2009 53
Pipeline attractions Japanese pharmaceutical market 53
key drugs to enter the Japanese market in 2009-10 55
Therapy area analysis 57
Unmet medical needs in Japan 60
Therapy Area Forecast sales 61
62 Main output dynamics
Blopress – Takeda 63
Diovan – Novartis 64
Norvasc – Pfizer 64
Lipitor – Pfizer 65
Aricept – Eisai 65
Mohrus – 66 Hisamitsu
Takepron – Takeda 66
Leuplin – Takeda 66
Micardis – Boehringer Ingelheim 67
Amlodin – Dainippon Sumitomo 67
Main product sales forecasts 68
Chapter 4 Competitive Landscape of the Japanese pharmaceutical market 70
Abstract 70
Introduction 71
competitive positioning of the best players in the Japanese pharmaceutical market 72
The detailed analysis of key market players 74 Japanese pharmaceutical
74 Takeda
74 Overview
Sales main therapeutic area focus 75
marketed product portfolio 77
80 Takeda pipe approach
83 Strategic Analysis of growth
Daiichi Sankyo 85
85 Overview
Sales main focus therapeutic area 86
marketed product portfolio 88
Daiichi Sankyo approach 90 pipelines
91 Strategic Analysis of growth
94 Pfizer
Information 94 general
Sales main therapeutic area focus 94
marketed product portfolio 96
98 pipe approach Pfizer
Strategic Growth analysis 100
103 Mitsubishi Tanabe
Overview 103
Main focus therapeutic area sales 103
marketed product portfolio 104
approach Mitsubishi Tanabe line 107
Strategic growth analysis 108
Roche 110
Overview 110
Sales main focus therapeutic area 110
marketed product portfolio 112
Roche pipeline approach 114
115 Strategic Growth analysis
117 Otsuka
Overview 117
Main focus therapeutic area sales 118
marketed product portfolio 119
Otsuka pipe approach 121
Strategic Growth analysis 123
Novartis 125
Overview 125
Main focus therapeutic area sales 125
marketed product portfolio 127
Novartis approach 129 pipe
130 Strategic Growth analysis
Chapter 5 Appendix 133
Anatomical Therapeutic Classification (ATC) 133
R: digestive system and metabolism 133
B: blood and blood forming-133
C: Cardiovascular System 133
D: 134 dermatological
G: System Genitourinary and sex hormones 134
H: Systemic hormonal preparations 134
J: Systemic anti-infective General 134
K: 134 Hospital Solutions
L: antineoplastic and immunomodulating 134
M: Musculoskeletal System 135
N: Nervous System 135
P: 135 Parasitology
A: The respiratory system 135
S: sense organs 135
T: 135 diagnostic agents
V: Miscellaneous 135
Prognostic factors 136
137 Glossary
Index 138

List of Figures
Figure 1.1: Japanese GDP distribution across sectors, 2008 19
Figure 1.2: Comparison health expenditure in the seven major pharmaceutical markets 25
Figure 2.3: provision of healthcare in Japan 29
Figure 2.4: Organization of MHLW 33
Figure 2.5: Number of patent applications and records for the Japanese, 2003-08 35
Figure 2.6: Process for approval of pricing and reimbursement of 40 new drugs
Figure 3.7: Top 10 classes of drugs in the Japanese pharmaceutical market ($ millions), 2008 60
Figure 3.8: medical needs not covered by major therapeutic areas in Japan 61
Figure 4.9: Japan's Takeda sales market by therapy area ($ m), 2008 76
Figure 4.10: Daiichi Sankyo is Japan market sales by therapy area ($ m), 2008 87
Figure 4.11: Pfizer's Japanese sales market by therapeutic area ($ M), 2008 95
Figure 4.12: Mitsubishi Tanabe Japanese market sales by therapy area ($ millions), 2008 104
Figure 4.13: Sales Roche Japanese market by therapy area ($ millions), 2008 111
Figure 4.14: Otsuka Japanese sales market therapy area ($ m) 2008 119
Figure 4.15: Japanese sales by Novartis market therapy area ($ millions), 2008 126

List of Tables
Table 1.1: Key financial metrics in Japan, 2008 18
Table 1.2: Japanese demographic scenario 21
Table 1.3: Forecast epidemiology of common risk factors or conditions in Japan, 2008-14 23
Table 2.4: The latest on laws related to drug pricing in Japan 38
Table 2.5: Revision of prices of the product reimbursement rates during 2000-2008 in Japan 39
Table 3.6: Key mergers and acquisitions of pharmaceutical companies Japanese in 2007 and 2008 52
Table 3.7: Keys and offers of alliances involving Japanese pharmaceutical companies in 2009 53
Table 3.8: List of key drugs to enter the Japanese market in 2009 a October 1956
Table 3.9: Japanese pharmaceutical sales by therapy area, 2008 58
Table 3.10: Japanese pharmaceutical market sales forecast by ATC code, 2008-2014 62
Table 3.11: leading brands in the Japanese pharmaceutical market, 2008 63
Table 3.12: major products sales forecast, 2008-14 68
Table 4.13: Leading companies in the Japanese pharmaceutical market, 2008 73
Table 4.14: leading brands Takeda in the Japanese market, 2008 78
Table 4.15: Takeda compounds pipeline in Japan, 82 July 2009
Table 4.16: leading brands in Daiichi Sankyo Japanese market 2008 89
Table 4.17: Compounds of Daiichi Sankyo pipeline in Japan, 91 July 2009
Table 4.18: Pfizer's leading brands in the Japanese market 2008 97
Table 4.19: Major Brands Mitsubishi Tanabe in the Japanese market, 2008 105
Table 4.20: Mitsubishi Tanabe product pipeline in Japan, July 2009 108
Table 4.21: Roche's leading brands in the Japanese market, 2008 112
Table 4.22: Roche / Chugai 's new products in Japan, July 2009 115
Table 4.23: Otsuka leading brands in the Japanese market, 2008 120
Table 4.24: Otsuka / Taiho 's new products in Japan, 2009 122
Table 4.25: Novartis' leading brands in the Japanese market, 2008 127