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:

The Japanese Pharmaceutical Market Outlook to 2014: Policy environment, market structure, competitive landscape, growth opportunities

http://www.reportlinker.com/p0172208/The-Japanese-Pharmaceutical-Market-Outlook-to-2014-Policy-environment-market-structure-competitive-landscape-growth-opportunities.html

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

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Pharmaceutical Industry: The Japanese Pharmaceutical Market Outlook to 2014: Policy environment, market structure, competitive landscape, growth opportunities

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