Narco Non Victims

The Japanese Pharmaceutical Market Outlook To 2014: Policy Environment, Market Structure, Competitive Landscape, Growth Opportunities -Aarkstore

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

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 JapanNovartis’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 2009In 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 ContentsThe Japanese Pharmaceutical Market Outlook to 2014Executive summary 10The macroeconomic environment in Japan 10The Japanese healthcare system 11The Japanese pharmaceutical market analysis 12Competitive landscape of the Japanese pharmaceutical market 13Scope and methodology 14Scope 14Methodology 14Chapter 1 The macroeconomic environment in Japan 16Summary 16Introduction 17Economic scenario 17Environmental scenario 20Population profile 20Disease burden 22Healthcare spending 24Chapter 2 The Japanese healthcare system 28Summary 28Introduction 29Health insurance system 30Japanese drug regulatory system 32Intellectual property rights 33Pricing and reimbursement 36Reforming the healthcare system in Japan 41Future prospects of pricing and reimbursement in Japan 41Increase in the uptake of generic drugs 41Changes to the type of drugs that are reimbursable 42Reference pricing may become more restrictive 42The government should aim to make it easier for innovative drug makers 42Chapter 3 The Japanese pharmaceutical market analysis 44Summary 44Introduction 45Domestic pharmaceutical market in Japan 46Japanese generic drug market 47Biotechnological challenges in Japan 49Key mergers and acquisitions in Japan 50M&A deals in 2007 and 2008 52Key deals and alliances in 2009 53Pipeline attractions of Japanese pharmaceutical market 53Key drugs to enter the Japanese market during 2009–10 55Therapy area analysis 57Unmet medical needs in Japan 60Therapy area sales forecast 61Leading product dynamics 62Blopress – Takeda 63Diovan – Novartis 64Norvasc – Pfizer 64Lipitor – Pfizer 65Aricept – Eisai 65Mohrus – Hisamitsu 66Takepron – Takeda 66Leuplin – Takeda 66Micardis – Boehringer Ingelheim 67Amlodin – Dainippon Sumitomo 67Leading product sales forecast 68Chapter 4 Competitive landscape of the Japanese pharmaceutical market 70Summary 70Introduction 71Competitive positioning of top players in the Japanese pharma market 72Detailed analysis of key players in the Japanese pharmaceutical market 74Takeda 74Overview 74Sales focus by leading therapeutic area 75Marketed product portfolio 77Takeda’s pipeline focus 80Strategic growth analysis 83Daiichi Sankyo 85Overview 85Sales focus by leading therapeutic area 86Marketed product portfolio 88Daiichi Sankyo’s pipeline focus 90Strategic growth analysis 91Pfizer 94Overview 94Sales focus by leading therapeutic area 94Marketed product portfolio 96Pfizer’s pipeline focus 98Strategic growth analysis 100Mitsubishi Tanabe 103Overview 103Sales focus by leading therapeutic area 103Marketed product portfolio 104Mitsubishi Tanabe’s pipeline focus 107Strategic growth analysis 108Roche 110Overview 110Sales focus by leading therapeutic area 110Marketed product portfolio 112Roche’s pipeline focus 114Strategic growth analysis 115Otsuka 117Overview 117Sales focus by leading therapeutic area 118Marketed product portfolio 119Otsuka’s pipeline focus 121Strategic growth analysis 123Novartis 125Overview 125Sales focus by leading therapeutic area 125Marketed product portfolio 127Novartis’ pipeline focus 129Strategic growth analysis 130Chapter 5 Appendix 133Anatomical therapeutic classification (ATC) 133A: Alimentary tract and metabolism 133B: Blood and blood-forming organs 133C: Cardiovascular system 133D: Dermatologicals 134G: Genitourinary system and sex hormones 134H: Systemic hormonal preparations 134J: General anti-infectives systemic 134K: Hospital solutions 134L: Antineoplastic and immunomodulating agents 134M: Musculoskeletal system 135N: Nervous system 135P: Parasitology 135R: Respiratory system 135S: Sensory organs 135T: Diagnostic agents 135V: Various 135Forecast factors 136Glossary 137Index 138

List of FiguresFigure 1.1: Japanese GDP distribution across different sectors, 2008 19Figure 1.2: Comparison of healthcare expenditure across the seven major pharmaceutical markets 25Figure 2.3: Healthcare provision in Japan 29Figure 2.4: Organization of MHLW 33Figure 2.5: Number of patent applications and registrations during the in Japan, 2003–08 35Figure 2.6: Approval process for pricing and reimbursement of new drugs 40Figure 3.7: Top 10 drug classes in the Japanese pharma market ($m), 2008 60Figure 3.8: Unmet medical needs by key therapeutic areas in Japan 61Figure 4.9: Takeda’s Japanese market sales by therapy area ($m), 2008 76Figure 4.10: Daiichi Sankyo’s Japanese market sales by therapy area ($m), 2008 87Figure 4.11: Pfizer’s Japanese market sales by therapy area ($m), 2008 95Figure 4.12: Mitsubishi Tanabe’s Japanese market sales by therapy area ($m), 2008 104Figure 4.13: Roche’s Japanese market sales by therapy area ($m), 2008 111Figure 4.14: Otsuka’s Japanese market sales by therapy area ($m), 2008 119Figure 4.15: Novartis’ Japanese market sales by therapy area ($m), 2008 126

List of TablesTable 1.1: Key economic metrics in Japan, 2008 18Table 1.2: Japanese demographic scenario 21Table 1.3: Forecast epidemiology of common risk factors/disorders in Japan, 2008–14 23Table 2.4: Latest developments on drug pricing-related laws in Japan 38Table 2.5: Revision rates of product reimbursement prices during 2000–08 in Japan 39Table 3.6: Key mergers and acquisitions involving Japanese pharmaceutical companies in 2007 and 2008 52Table 3.7: Key deals and alliances involving Japanese pharmaceutical companies in 2009 53Table 3.8: List of key drugs to enter Japanese market during 2009–10 56Table 3.9: Japanese pharmaceutical sales by therapy area, 2008 58Table 3.10: Japanese pharmaceutical market sales forecast by ATC code, 2008–2014 62Table 3.11: Leading brands in the Japanese pharmaceutical market, 2008 63Table 3.12: Leading products sales forecast, 2008–14 68Table 4.13: Leading companies in the Japanese pharmaceutical market, 2008 73Table 4.14: Takeda’s leading brands in the Japanese market, 2008 78Table 4.15: Takeda’s pipeline compounds in Japan, July 2009 82Table 4.16: Daiichi Sankyo’s leading brands in the Japanese market, 2008 89Table 4.17: Daiichi Sankyo’s pipeline compounds in Japan, July 2009 91Table 4.18: Pfizer’s leading brands in the Japanese market, 2008 97Table 4.19: Mitsubishi Tanabe’s leading brands in the Japanese market, 2008 105Table 4.20: Mitsubishi Tanabe’s pipeline products in Japan, July 2009 108Table 4.21: Roche’s leading brands in the Japanese market, 2008 112Table 4.22: Roche/Chugai’s pipeline products in Japan, July 2009 115Table 4.23: Otsuka’s leading brands in the Japanese market, 2008 120Table 4.24: Otsuka/Taiho’s pipeline products in Japan, 2009 122Table 4.25: Novartis’ leading brands in the Japanese market, 2008 127 For More information please contact :

http://www.aarkstore.com/reports/The-Japanese-Pharmaceutical-Market-Outlook-to-2014-Policy-environment-market-structure-competitive-landscape-growth-opportunities-36779.html