The Japanese Pharmaceutical Market 2008-2023

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. You need to take notice of these changes.

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. Are you achieving the success you should in Japan?
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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
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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

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





Altana Pharma AG
Astellas Seiyaku
Boehringer Ingelheim
Bristol-Myers-Squibb
Celgene
Chugai Seiyaku
Colorado Biotech Pharmion
Daiichi Sankyo
Dainippon Sumitomo
EFPIA
Eisai
Eli Lilly
FDA
Fujisawa Pharmaceutical
GSK
Health Policy Bureau (HPB)
Japan Pharmaceutical Manufacturers Association (JPMA)
Japan Pharmaceutical Wholesalers Association (JPWA)
Japanese Patent Office (JPO)
Japan's Drug Organisation (KIKO)
Kissei
Metabasis Therapeutics
Millennium Pharmaceuticals
Ministry of Health, Labour and Welfare (MHLW)
Mitsubishi Tanabe
National Institute of Health Sciences (NIH)
Novartis
Otsuka
Pfizer
Pharmaceutical and Food Safety Bureau (PFSB)
Pharmaceutical and Medical Devices Agency (PMDA)
Pharmaceuticals and Medical Devices Evaluation Centre (PMDEC)
PhRMA
Roche
Sanofi-Aventis
Sanwa Kagaku Kenkyusho
Taisho Pharmaceutical
Takeda
Yamanouchi Pharmaceutical
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