Reportlinker Adds The Japanese Pharmaceutical Market Outlook to 2014: Policy Environment, Market Structure, Competitive Landscape, Growth Opportunities
NEW YORK, Jan. 19 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Japan, the second single largest drug market in the world (historically known to be a land of innovation) is a leading nation in terms of scientific research, technology, machinery and medical research. Japan has been an industrially active nation ever since it adopted Western technology and gained industrial supremacy in the early years of the 20th century. In 2008, the services sector (72.1%) contributed the major portion of GDP growth in Japan followed by industries (26.4%) and agriculture (1.5%).
The regulatory environment that shaped the Japanese pharmaceutical market has changed significantly over the past decade. Many of the Japanese pharma companies had a considerable experience from a string of recent high profile acquisitions. Moreover, with strong cash reserves and the recent dramatic increase in the value of the yen (particularly against euro), this appetite for international acquisitions looks set to continue in the coming years.
Foreign companies are now increasingly developing a presence in Japan mostly in the field of R&D and marketing. In terms of domestic sales of prescription drugs, foreign companies have boosted their market share with Pfizer, Roche, Novartis and GSK making it to the top 10 list. This expansion into the Japanese pharmaceutical market has suffered occasional reversals such as Pfizer and Merck & Co. decision to close research facilities in 2006. Moreover in 2008, US biotech giant Amgen (in a $1.2bn deal with Takeda) also handed over the rights of 13 drugs to Takeda. But more recently, foreign multinationals are seeking to expand their presence in Japan mostly by retaining Japanese rights that formerly would have gone to domestic firms.
Key features of this report
- The macroeconomic environment in Japan includes the population profile, disease burden, economic landscape and healthcare spending
- Japanese healthcare system involving the recent developments in healthcare sector, health insurance system, Japanese drug regulatory system (covering IP protection, pricing and reimbursement, drug approval system and healthcare reforms) and future prospects of pricing & reimbursement system in Japan
- Overview of the Japanese pharmaceutical market covering Japanese domestic pharmaceutical market, generic drug market, biotechnological challenges, key mergers & acquisitions and pipeline attractions through 2014
- Forecasts and analysis of the leading products in the Japanese pharma market over the period 2008–14 spread across major indications and classes of treatments
Scope of this report
- Develop insights for the Japanese pharmaceutical market, pricing & regulation and detailed epidemiological status of the common indications/risk factors in the country
- Quickly understand how recent events are affecting the performance of major products, and how their marketers are confronting competitive challenges in the Japanese market
- Gain up-to-date competitive intelligence across a wide-range of marketed products, R&D pipeline, market share data, sales forecast and competitive landscape for the major players in the Japanese pharmaceutical market
- Understand which indications have the greatest potential to provide franchise growth, and how pharmaceutical companies are attempting to exploit these opportunities in Japan
Key Market Issues
- Somatropin BS formed the first biosimilar to launch in Japan
Novartis's generic division Sandoz became the first company to launch a therapeutic biosimilar Somatropin BS (a recombinant form of human growth hormone Genotropin) in Japan. Initially approved in June 2009 in Japan, for the treatment of growth hormone deficiency in children, growth disturbance associated with Turner's syndrome and chronic renal insufficiency, Sandoz already markets this product as Omnitrope in the EU, the US and a number of other markets.
- Cervarix, Prevenar and Januvia formed the most awaited drugs to receive Japanese approval in 2009
In October 2009, GSK's Cervarix (cervical cancer vaccine), Wyeth/Pfizer's Prevenar (a pediatric pneumococcal conjugate vaccine) and Merck & Co's DPP-IV inhibitor Januvia (sitagliptin) received the final marketing approval in Japan. Moreover, Cervarix also formed the first vaccine product to receive Japanese approval against human papillomavirus (HPV). Januvia was notable among the ministry's other clearances, which will be co-marketed by Ono as Glactiv in Japan.
Key findings from this report
- The Japanese pharmaceutical market was valued at $68.6bn in 2008, registering sales growth of 17.2% over 2007, and is forecast to grow at a CAGR of 4.8% during 2008–14. According to Business Insights estimates, targeted therapies and antineoplastics & immunomodulating agents will have the highest growth with CAGR of 19.8% and 10.1%, respectively, over the forecast period.
- Cardiovascular disorders, alimentary canal & metabolism and general anti-infectives remained the top selling therapeutic categories in Japan, registering 2008 sales of $14.6bn, $9.6bn and $6.5bn respectively.
- The leading brands in the Japanese pharmaceutical market had a predominance of cardiovascular drugs (with as many as 6 products in top 10). The top 10 products in this market constituted a very small portion of the market with only 11.4% share in 2008. Takeda's angiotensin-II inhibitor drug Blopress led the market with 2008 sales of $1.1bn, a growth of 13.3% over 2007.
Key questions answered
- Which indications will see major growth in the Japanese pharmaceutical market over the period 2008–14?
- Which companies (both multinational and domestic) will become the key players in the Japanese pharma market over the period 2008–14?
- Which products will be impacted by generic competition over the period 2008–14?
- Which products will be the future growth drivers for the Japanese pharmaceutical market?
- Which therapeutic categories are forecast to have the highest levels of commercial potential over the period 2008–14?
Table of Contents
The Japanese Pharmaceutical Market Outlook to 2014
Executive summary 10
The macroeconomic environment in Japan 10
The Japanese healthcare system 11
The Japanese pharmaceutical market analysis 12
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
Disease burden 22
Healthcare spending 24
Chapter 2 The Japanese healthcare system 28
Summary 28
Introduction 29
Health insurance system 30
Japanese drug regulatory system 32
Intellectual property rights 33
Pricing and reimbursement 36
Reforming the healthcare system in Japan 41
Future prospects of pricing and reimbursement in Japan 41
Increase in the uptake of generic drugs 41
Changes to the type of drugs that are reimbursable 42
Reference pricing may become more restrictive 42
The government should aim to make it easier for innovative drug makers 42
Chapter 3 The Japanese pharmaceutical market analysis 44
Summary 44
Introduction 45
Domestic pharmaceutical market in Japan 46
Japanese generic drug market 47
Biotechnological challenges in Japan 49
Key mergers and acquisitions in Japan 50
M&A deals in 2007 and 2008 52
Key deals and alliances in 2009 53
Pipeline attractions of Japanese pharmaceutical market 53
Key drugs to enter the Japanese market during 2009–10 55
Therapy area analysis 57
Unmet medical needs in Japan 60
Therapy area sales forecast 61
Leading product dynamics 62
Blopress – Takeda 63
Diovan – Novartis 64
Norvasc – Pfizer 64
Lipitor – Pfizer 65
Aricept – Eisai 65
Mohrus – Hisamitsu 66
Takepron – Takeda 66
Leuplin – Takeda 66
Micardis – Boehringer Ingelheim 67
Amlodin – Dainippon Sumitomo 67
Leading product sales forecast 68
Chapter 4 Competitive landscape of the Japanese pharmaceutical market 70
Summary 70
Introduction 71
Competitive positioning of top players in the Japanese pharma market 72
Detailed analysis of key players in the Japanese pharmaceutical market 74
Takeda 74
Overview 74
Sales focus by leading therapeutic area 75
Marketed product portfolio 77
Takeda's pipeline focus 80
Strategic growth analysis 83
Daiichi Sankyo 85
Overview 85
Sales focus by leading therapeutic area 86
Marketed product portfolio 88
Daiichi Sankyo's pipeline focus 90
Strategic growth analysis 91
Pfizer 94
Overview 94
Sales focus by leading therapeutic area 94
Marketed product portfolio 96
Pfizer's pipeline focus 98
Strategic growth analysis 100
Mitsubishi Tanabe 103
Overview 103
Sales focus by leading therapeutic area 103
Marketed product portfolio 104
Mitsubishi Tanabe's pipeline focus 107
Strategic growth analysis 108
Roche 110
Overview 110
Sales focus by leading therapeutic area 110
Marketed product portfolio 112
Roche's pipeline focus 114
Strategic growth analysis 115
Otsuka 117
Overview 117
Sales focus by leading therapeutic area 118
Marketed product portfolio 119
Otsuka's pipeline focus 121
Strategic growth analysis 123
Novartis 125
Overview 125
Sales focus by leading therapeutic area 125
Marketed product portfolio 127
Novartis' pipeline focus 129
Strategic growth analysis 130
Chapter 5 Appendix 133
Anatomical therapeutic classification (ATC) 133
A: Alimentary tract and metabolism 133
B: Blood and blood-forming organs 133
C: Cardiovascular system 133
D: Dermatologicals 134
G: Genitourinary system and sex hormones 134
H: Systemic hormonal preparations 134
J: General anti-infectives systemic 134
K: Hospital solutions 134
L: Antineoplastic and immunomodulating agents 134
M: Musculoskeletal system 135
N: Nervous system 135
P: Parasitology 135
R: Respiratory system 135
S: Sensory organs 135
T: Diagnostic agents 135
V: Various 135
Forecast factors 136
Glossary 137
Index 138
List of Figures
Figure 1.1: Japanese GDP distribution across different sectors, 2008 19
Figure 1.2: Comparison of healthcare expenditure across the seven major pharmaceutical markets 25
Figure 2.3: Healthcare provision in Japan 29
Figure 2.4: Organization of MHLW 33
Figure 2.5: Number of patent applications and registrations during the in Japan, 2003–08 35
Figure 2.6: Approval process for pricing and reimbursement of new drugs 40
Figure 3.7: Top 10 drug classes in the Japanese pharma market ($m), 2008 60
Figure 3.8: Unmet medical needs by key therapeutic areas in Japan 61
Figure 4.9: Takeda's Japanese market sales by therapy area ($m), 2008 76
Figure 4.10: Daiichi Sankyo's Japanese market sales by therapy area ($m), 2008 87
Figure 4.11: Pfizer's Japanese market sales by therapy area ($m), 2008 95
Figure 4.12: Mitsubishi Tanabe's Japanese market sales by therapy area ($m), 2008 104
Figure 4.13: Roche's Japanese market sales by therapy area ($m), 2008 111
Figure 4.14: Otsuka's Japanese market sales by therapy area ($m), 2008 119
Figure 4.15: Novartis' Japanese market sales by therapy area ($m), 2008 126
List of Tables
Table 1.1: Key economic metrics in Japan, 2008 18
Table 1.2: Japanese demographic scenario 21
Table 1.3: Forecast epidemiology of common risk factors/disorders in Japan, 2008–14 23
Table 2.4: Latest developments on drug pricing-related laws in Japan 38
Table 2.5: Revision rates of product reimbursement prices during 2000–08 in Japan 39
Table 3.6: Key mergers and acquisitions involving Japanese pharmaceutical companies in 2007 and 2008 52
Table 3.7: Key deals and alliances involving Japanese pharmaceutical companies in 2009 53
Table 3.8: List of key drugs to enter Japanese market during 2009–10 56
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: Leading products sales forecast, 2008–14 68
Table 4.13: Leading companies in the Japanese pharmaceutical market, 2008 73
Table 4.14: Takeda's leading brands in the Japanese market, 2008 78
Table 4.15: Takeda's pipeline compounds in Japan, July 2009 82
Table 4.16: Daiichi Sankyo's leading brands in the Japanese market, 2008 89
Table 4.17: Daiichi Sankyo's pipeline compounds in Japan, July 2009 91
Table 4.18: Pfizer's leading brands in the Japanese market, 2008 97
Table 4.19: Mitsubishi Tanabe's leading brands in the Japanese market, 2008 105
Table 4.20: Mitsubishi Tanabe's pipeline products in Japan, July 2009 108
Table 4.21: Roche's leading brands in the Japanese market, 2008 112
Table 4.22: Roche/Chugai's pipeline products in Japan, July 2009 115
Table 4.23: Otsuka's leading brands in the Japanese market, 2008 120
Table 4.24: Otsuka/Taiho's pipeline products in Japan, 2009 122
Table 4.25: Novartis' leading brands in the Japanese market, 2008 127
To order this report:
Pharmaceutical Industry: The Japanese Pharmaceutical Market Outlook to 2014: Policy environment, market structure, competitive landscape, growth opportunities
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