Last year, the Japanese pharmaceutical market was the second largest in the world, with a value of $58.5bn. However, Japan’s market has experienced growth at a much lower rate than the other major pharmaceutical markets. It is at a key stage in its development.

For many years the market has been dominated by the pricing and reimbursement policy of the Japanese government, which is arguably the most stringent of all the major governments. A determination to maintain tight cost controls on healthcare in Japan has resulted in the cost of drugs being tightly controlled. The government imposes limits on the price of drugs, and these are reduced every two years. This situation has caused concern to the international pharma industry, which remains eager to make further inroads into that large market.

It is this imposed price control that is the key determining factor in influencing the shape, size and potential of the Japanese pharmaceutical market. The Japanese pharmaceutical market should have greater growth. However, the expansion of that market is influenced by several factors, including:

• Biennial National Health Insurance drug price reductions
• Increasing R&D expenses
• Intensifying competition between domestic companies and foreign international pharmaceutical companies, especially market leaders
• Restructuring within the pharmaceutical industry in Japan and worldwide
• Non-availability of many leading international products
• Relatively low use of generics
• A regulatory system that has recently become more accessible to international pharma companies.

The Japanese pharmaceutical market is at the start of a cycle that will see an increasing number of mergers and overall consolidation. The extent of the mergers involving a global pharmaceutical company buying out a smaller Japanese company will depend largely on the pipeline of the Japanese company involved. Global pharmaceutical companies, such as Pfizer, are already establishing a major presence in Japan.

The Japanese Pharmaceutical Market 2008-2023 examines that leading market critically, through a comprehensive review of available information. Sources include in-depth interviews, primary research, industrial databases, commercial news, in-house reports and economic research. Visiongain also applied financial forecasting, qualitative analyses and the assessment of unmet needs to provide a comprehensive market report with detailed analysis and informed opinion. This information is not available anywhere else.

In particular, this Japanese pharmaceutical market report concentrates on the following essential aspects of that market:

• Discussion of the current Japanese pharmaceutical market in the context of the global pharma market
• Forecast of the overall Japanese pharmaceutical market from 2008 to 2023
• Drivers and restraints facing the Japanese market
• Opportunities and threats facing the Japanese market
• Commercial prospects for the market-leading drugs, with sales forecasts from 2008 to 2023
• Individual forecasts of the leading drug classes from 2008 to 2023
• The potential of generics manufacturers to penetrate this market
• Relevant pipeline developments with blockbuster potential
• Currently marketed drugs with blockbuster potential
• Discussion of unmet therapeutic needs

Why you should buy this report:

• To receive a comprehensive analysis of the prospects for the Japanese pharmaceutical market from 2008 to 2023
• To discover predicted revenues, growth rates and other key metrics for leading pharmaceutical treatments from 2008 to 2023, both by major therapeutic area and leading products
• To determine prospects of leading companies in that market
• To discover "hot" pipeline developments and up-and-coming products
• To determine the forces that influence the Japanese market: drivers, restraints, strengths, weaknesses, opportunities and threats
• To find out where the market is heading - both technologically and commercially from 2008 onwards

1 Executive Summary

• 1.1 The Japanese Pharmaceutical Market Has Entered a Key Stage in its Development
• 1.2 Aims, Scope and Format

2 Introduction to Japan’s Pharmaceutical Sector

• 2.1 Japan Remains a Key Market for Pharmaceuticals
• 2.2 Features of the World’s Second Largest Economy
• 2.3 The Japanese Drug Regulatory Authorities
• 2.4 The Pharmaceutical Affairs Law (PAL) Has Been Important in Shaping the Japanese Pharma Market
• 2.5 Disease Epidemiology
• 2.6 Top 10 Leading Pharma Companies in Japan, 2007
• 2.7 The Top 10 Selling Products in the Japanese Pharma Market, 2007
• 2.8 The Top 10 Therapy Classes in the Japanese Pharma Market, 2007

3 An Overview of the Japanese Pharmaceutical Market

• 3.1 Japan's Position in the World Pharmaceutical Market
  • 3.1.1 The Japanese Pharma Market Faces Numerous Challenges
  • 3.1.2 Strategy to Overcome the Challenges and Increase Value in the Japanese Market
• 3.2 The Japanese Pharmaceutical Market Set to Expand Despite Considerable Changes
  • 3.2.1 Japanese Pharma Companies - Strategy and Outlook
  • 3.2.2 Blopress Currently Leads the Japanese Pharma Market
  • 3.2.3 Angiotensin II Antagonists Class Currently Dominates – But Will it Last?
• 3.3 The Japanese Wholesale Industry Has Shown No Growth But High Consolidation
• 3.4 Changes in the Japanese Approval System – How Advantageous are These?

4 The Leading Therapy Classes - Market Forecast 2008-2013, 2018 & 2023

• 4.1 The Top 10 Therapy Classes - Analysis & Forecasts
• 4.2 Angiotensin II Antagonists Class
• 4.3 Antiulcerants
• 4.4 Calcium Antagonists
• 4.5 Cholesterol & Trigly. Regulator Class
• 4.6 The Platelet Aggr. Inhibitors Class
• 4.7 Antirheumatics Topical Class
• 4.8 Oral Antidiabetics Class
• 4.9 Antihistamines Systemic Class
• 4.10 Cephalosporins & Combined Products Class
• 4.11 All Other Antineoplastics Group
• 4.12 Top 10 Therapy Classes Summary

5 Top 10 Leading Products, Analysis and Forecasts

• 5.1 The Japanese Pharmaceutical Market Showed Impressive Revenues in 2007
• 5.2 The Top Ten Selling Drugs of 2007 in the Japanese Market
• 5.3 The Top Five Products of 2007 in the Japanese Market
• 5.4 Blopress Forecast
• 5.5 Norvasc Forecast: Will it Reach Blockbuster Revenues in Japan?
• 5.6 Diovan Forecast
• 5.7 Lipitor Forecast: Product Still to Peak in Japan
• 5.8 Epogin Forecast
• 5.9 Mohrus Forecast
• 5.10 Leuplin Forecast
• 5.11 Aricept Forecast
• 5.12 Amlodin Forecast
• 5.13 Mevalotin Forecast: Generic Competition
• 5.14 Top 10 Leading Products Summary

6 SWOT Analysis – Key Issues Affecting the Japanese Pharma Market

• 6.1 A SWOT Analysis for the Japanese Pharma Market
  • 6.1.1 Important Drivers for the Japanese Pharma Market
  • 6.1.2 Important Restraints for the Japanese Pharma Market
• 6.2 The Japanese Pharmaceutical Industry is a Large/Growing Market
• 6.3 Lifecycle Management Strategies Will Become More Prominent to Protect Soon-to-be off-Patent Drugs
• 6.4 Additional Indications for Currently Available Brands May be an Advantage
• 6.5 M&A Activity in the Japanese Pharma Market will Increase
• 6.6 Drug Approval Time in Japan to Get Shorter
• 6.7 Generic Penetration in the Japanese Pharma Market
  • 6.7.1 The Key Reason for Low Generic Adoption
  • 6.7.2 Teva and Kowa to Partner in Establishment of a Generic Pharmaceutical Company in Japan
• 6.8 New Pharmaceutical Affairs Law (PAL) Will Affect the Japanese Pharma Market
• 6.9 Reliance on Revenues from the Japanese Market Only is a Weakness

7 Top Ten Companies in the Japanese Pharmaceutical Market

• 7.1 Further Pharmaceutical Consolidation Expected
• 7.2 Takeda Currently Leads the Japanese Market
  • 7.2.1 Takeda Increases its R&D Investment
  • 7.2.2 Takeda and Millennium Pharmaceuticals
• 7.3 Pfizer
  • 7.3.1 COPD - A Key Area of Interest for Pfizer
• 7.4 Daiichi Sanko: Background to the Latest Merger
  • 7.4.1 Six Key Areas of Therapeutic Research
• 7.5 Mitsubishi Pharma - a Conglomerate with Potential Financial Backing
• 7.6 Chugai and Roche - The First Major Japanese/Global Merger
• 7.7 Astellas Pharma - A Merger of Two Complimentary Companies
  • 7.7.1 Complimentary Regional Revenue Streams for Astellas
• 7.8 Novartis Continues to Divest
• 7.9 Eisai Dissolves Agreement with Sanofi-Aventis
• 7.10 GSK Reorganises its Medical Sales Force
• 7.11 Otsuka Has a Diverse Portfolio of Drugs
• 7.12 Summary of Chapter

8 The Japanese Patent System

• 8.1 A Patent System of Constant Change
• 8.2 An Improved Patent System Encourages R&D
• 8.3 US Patent System Determining Japanese R&D
• 8.4 Patent Licensing for Genetic Material is Becoming More Important
• 8.5 Changes in Approval Times Will Aid Non-Domestic Companies’ Entry into the Japanese Pharmaceutical Market
• 8.6 Summary

9 Pricing and Reimbursement in Japan

• 9.1 The Japanese Healthcare System
• 9.2 Revisions to the Health Insurance Law Saw an Increase in Co-Payments
• 9.3 Japanese Drug Pricing
• 9.4 New Developments: Changes to the Pharmaceuticals Affairs Law
• 9.5 New Drug Approval and License System Will Cut Drug Approval Time
• 9.6 The Japanese Reference System
• 9.7 The Re-examination and Re-evaluation Drug Systems are used to Predict Drug Safety
• 9.8 Japan Has Reduced Healthcare Spending Including That for Drugs
• 9.9 Generic Drug Pricing
• 9.10 Generic Substitution in Japan
• 9.11 The Japanese Wholesale Market in Consolidation
• 9.12 Bungyo: the Separation of Dispensing and Prescribing is Rapidly Increasing
• 9.13 Bungyo Separation Has Dramatic Effect on Retail Pharmacies
• 9.14 Conclusion: The Japanese Government Directly Controls Drug Prices through Price Cuts

10 Pipeline Products for the Leading Japanese Companies

• 10.1 Increased R&D Investment Enhances Takeda's Pipeline
• 10.2 Limited Pipeline with Low US Focus
• 10.3 Mitsubishi Tanabe Late-Stage Pipeline
• 10.4 Chugai’s Late-Stage Pipeline
• 10.5 Astellas’ Late-Stage Pipeline Products Through Co-development
• 10.6 Eisai’s Late-Stage Pipeline
• 10.7 Otsuka’s Late-Stage Pipeline

11 Conclusions

• 11.1 The Japanese Pharmaceutical Market Set for Considerable Change
• 11.2 The Top 5 Japanese Products of 2007 Will Remain Stable to 2013
  • 11.2.1 Top 10 Leading Products Ranking - 2007 and 2013 Comparison
• 11.3 Angiotensin II Antagonists Class Currently Dominates – But Will it Last?
  • 11.3.1 Top 10 Therapy Classes Ranking - 2007 and 2013 Comparison
• 11.4 Will Takeda Remain at the Forefront of the Japanese Pharma Industry?
• 11.4.1 Japanese Pharmaceutical Companies’ Strategy in the Pharma Industry

List of Tables

• Table 2.1 The Top 10 Leading Pharma Companies in Japan, 2007
• Table 2.2 The Top 10 Leading Products in Japan, 2007
• Table 2.3 The Top 10 Leading Therapy Classes in Japan, 2007
• Table 3.1 Pharmaceutical Sales ($m) of Top 10 Nations, 2007
• Table 3.2 Japanese Pharmaceutical Market Forecast ($m) 2008-2013, 2018 & 2023
• Table 4.1 Revenues ($m) for the Top Ten Therapy Classes', 2008-2013, 2018 & 2023
• Table 4.2 Revenues ($m), 6-Year CAGR (%) and Market Share (%) for Top Ten Therapy Classes, 2007 & 2013
• Table 4.3 Top 10 Therapy Classes Rank Comparison, 2007 and 2013
• Table 5.1 Top 10 Leading Drugs Revenue ($m) Forecast 2008-2013, 2018 & 2023
• Table 5.2 Top 10 Drugs 6-Year CAGR (%) and Market Share (%), 2007 & 2013
• Table 5.3 Top 10 Products Market Share (%) Comparison 2007 & 2013
• Table 5.4 Blopress Revenues ($m) 2008-2013, 2018 & 2023
• Table 5.5 Norvasc Revenues ($m) 2008-2013, 2018 & 2023
• Table 5.6 Diovan Revenues ($m) 2008-2013, 2018 & 2023
• Table 5.7 Lipitor Revenues ($m) 2008-2013, 2018 & 2023
• Table 5.8 Epogin Revenues ($m) 2008-2013, 2018 & 2023
• Table 5.9 Mohrus Revenues ($m) 2008-2013, 2018 & 2023
• Table 5.10 Leuplin Revenues ($m) 2008-2013, 2018 & 2023
• Table 5.11 Aricept Revenues ($m) 2008-2013, 2018 & 2023
• Table 5.12 Revenues ($m) for Amlodin 2008-2013, 2018 & 2023
• Table 5.13 Revenues ($m) for Mevalotin 2008-2013, 2018 & 2023
• Table 5.14 Top 10 Products Rank Comparison, 2007 and 2013
• Table 6.1 A SWOT Chart for the Japanese Pharma Market
• Table 7.1 Revenue ($m) and Market Share (%) of the Top Ten Pharmaceutical Companies in Japan, 2007
• Table 10.1 Takeda’s Late-Stage Pipeline Products, 2008
• Table 10.2 Daiichi’s Late-Stage Pipeline Products, 2008
• Table 10.3 Mitsubishi’s Late-Stage Pipeline Products, 2008
• Table 10.4 Chugai’s Late-Stage Pipeline Products, 2008
• Table 10.5 Astellas’ Late-Stage Pipeline Products, 2008
• Table 10.6 Eisai’s Late-Stage Pipeline Products, 2008
• Table 10.7 Otsuka’s Late-Stage Pipeline Products, 2008
• Table 11.1 Japanese Pharma Market Forecast ($m) 2008-2013, 2018 & 2023
• Table 11.2 Top 10 Products Rank Comparison, 2007 and 2013
• Table 11.3 Top 10 Therapy Classes Rank Comparison, 2007 and 2013

List of Figures

• Figure 3.1 Pharmaceutical Revenues ($m) of Top 10 Nations, 2007
• Figure 3.2 Countries Ranked by Pharmaceutical Market Share in 2007
• Figure 3.3 Japanese Pharma Market Revenue Forecast 2008-2013, 2018 & 2023
• Figure 4.1 Top Ten Therapy Classes Revenue ($m) Comparison, 2007 & 2013
• Figure 4.2 Top Ten Therapy Classes Market Share (%), 2007
• Figure 4.3 Top Ten Therapy Classes Market Share (%), 2013
• Figure 4.4 Angiotensin II Antagonists Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
• Figure 4.5 Antiulcerants Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
• Figure 4.6 Calcium Antagonists Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
• Figure 4.7 Cholesterol & Triglyceride Regulator Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
• Figure 4.8 Platelet Aggregation Inhibitors Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
• Figure 4.9 Antirheumatics Topical Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
• Figure 4.10 Oral Antidiabetics Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
• Figure 4.11 Antihistamines Systemic Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
• Figure 4.12 Cephalosporins & Combs Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
• Figure 5.1 Japanese Pharmaceutical Market Sales Breakdown ($m) 2008-2013, 2018 & 2023
• Figure 5.2 Top 10 Products Market Share (%) 2007
• Figure 5.3 Top 10 Products Market Share (%) 2013
• Figure 5.4 Revenues ($m) for Blopress 2008-2013, 2018 & 2023
• Figure 5.5 Revenues ($m) for Norvasc 2008-2013, 2018 & 2023
• Figure 5.6 Revenues ($m) for Diovan 2008-2013, 2018 & 2023
• Figure 5.7 Revenues ($m) for Lipitor 2008-2013, 2018 & 2023
• Figure 5.8 Revenues ($m) for Epogin 2008-2013, 2018 & 2023
• Figure 5.9 Revenues ($m) for Mohrus 2008-2013, 2018 & 2023
• Figure 5.10 Revenues ($m) for Leuplin 2008-2013, 2018 & 2023
• Figure 5.11 Revenues ($m) for Aricept 2008-2013, 2018 & 2023
• Figure 5.12 Revenues ($m) for Amlodin 2008-2013, 2018 & 2023
• Figure 5.13 Revenues ($m) for Mevalotin 2008-2013, 2018 & 2023
• Figure 7.1 Market Share (%) of the Top Ten Pharmaceutical Companies in Japan, 2007
• Figure 11.1 Total Revenue ($m) of the Japanese Pharmaceutical Market 2008-2013, 2018 & 2023