1. Executive Summary
1.1 Crucial Aspects of This Report
1.1.1 Japan is World's Second-Largest Pharmaceutical Market
1.1.2 The Content of Forecasts
1.1.3 Growth Rate Terms
1.1.4 Japan's Population Aging Rapidly
1.2 Aims, Scope and Format of This Report
1.2.1 Chapter Breakdown
1.3 Research Methods
2. Overview of Japanese Pharmaceutical Conditions
2.1 The Ministry of Health, Labor, and Welfare (MHLW, Koseirodosho)
2.1.1 Breakdown of the MHLW's Independent, Pharmacy-Related Divisions
2.1.2 Divisions of the Pharmaceutical and Food Safety Bureau (PFSB)
2.1.3 Divisions of the Health Policy Bureau
2.1.4 Divisions of the Pharmaceuticals and Medical Devices Agency (PMDA, Kiko)
2.1.4.1 Office of New Drug I
2.1.4.2 Office of New Drug II
2.1.4.3 Office of New Drug III
2.1.4.4 Office of Biologics
2.1.4.5 Office of Compliance and Standards
2.1.4.6 Office of Safety
2.1.5 The Pharmaceutical Affairs and Food Sanitation Council (PAFSC): Advisory Body to the MHLW
2.2 Drug Approvals
2.2.1 Approval Times
2.2.2 2004 Increase in Application Fees
2.2.3 Application Prioritisation and Restricted Approval
2.3 Patent Life
2.4 Pricing System
2.4.1 Price-Bundling Procedures
2.4.2 The National Health Insurance Drug Price List
2.4.3 Standard Reimbursement Formula
2.4.4 Reimbursement Premiums for New Drugs
2.4.5 Generics Pricing
2.5 Number of Prescriptions Increasing Steadily
2.6 Doctors Can Make Money from Prescriptions
2.7 Bungyo: The Separation of Dispensing and Prescribing Functions
2.7.1 Bungyo Ratios Rising: Up to 57.2% in 2007
2.7.2 Effects of Bungyo: Costs Not Falling as Experts Predicted
2.7.3 Effects of Bungyo: Not Necessarily Beneficial for the Healthcare System
2.8 Japan Pharmaceutical Association (JPA)
2.8.1 JPA Engaged in International Cooperation
2.8.2 Changes from a 4-year to a 6-Year Pharmacy Degree
2.8.2.1 Two-Year Pharmacist Shortage Coming?
2.8.3 Previous Pharmacist Pass Rates
2.8.4 JPA Involved in Healthcare Awareness
2.9 New Legislation Regarding Over-the-Counter Drugs to Come Online in 2009
2.10 Japan Pharmaceutical Manufacturers Association (JPMA): Coordinating and Harmonising
2.11 Japan's Aging Demographics
2.11.1 Highest Life Expectancy in the World
2.11.2 Very Low Fertility Rate Since 1989
2.11.3 Population Predicted to Drop to 90 Million by 2055
2.11.4 United Nation's Dependency Predictions: Dependency Could Reach 85% by 2050
2.11.5 Can Immigration Help?
2.12 Leading Causes of Death and Morbidity
2.12.1 Death Rate Rising to 8.5% in 2005/6
2.13 Brief Summary of the Healthcare System
2.14 Healthcare Expenditures
2.15 OECD Economic Outlook for Japan
2.15.1 Slow or Negative Economic Growth, but Increasing Demand for Pharmaceuticals
3. Japanese Total Market Forecasts, 2009-2024
3.1 Total Market Summary: Forecasts 2009-2024
3.1.1 Market Growth Increasing Significantly over 15-Year Forecast Period
3.1.2 Top Markets: Tables 2009-2024
3.1.3 Market Forecast Figures, 2009-2024
3.2 Cardiovascular Treatments Forecasts, 2009-2024
3.2.1 Medicines Comprising the Cardiovascular Treatments Category
3.2.2 Cardiovascular Sub-Division Forecasts
3.2.3 Angiotensin-II Antagonists Forecast Discussion
3.2.4 Cholesterol and Triglyceride Regulators Forecast Discussion
3.2.5 Calcium Antagonists Forecast Discussion
3.2.6 Platelet Aggregation Inhibitors Forecast Discussion
3.3 Antiulcerants Forecasts, 2009-2024
3.4 Cancer Treatments (Antimetabolites and Antineoplastics) Forecasts, 2009-2024
3.4.1 Cancer Rates in Japan
3.5 Antidepressants and Antipsychotics Forecasts, 2009-2024
3.5.1 Depression and Psychological States: Relatively New Focus for Discussion
3.6 Topical Antirheumatics Forecasts, 2009- 2024
3.6.1 Daiichi Sankyo Files for Topical Antirheumatic Approval
3.7 Systemic Antihistamines Forecasts, 2009-2024
3.7.1 Post-War Cedar Trees: a Reason Why Japan's Antihistamines Market is Growing
3.8 Cephalosporins Forecasts, 2009-2024
3.8.1 Many Cephalosporins Discovered in Japan
3.8.2 Stopping Antibiotics Misuse: One Reason Japan's Cephalosporins Market is Declining
3.9 Antivirals (minus HIV products) Forecasts, 2009-2024
3.9.1 Japan: Avian Flu and SARS
3.10 Others (Including Traditional Chinese Medicines and Immunosuppressive Agents) Forecasts, 2009-2024
3.10.1 2008-2009 Growth Rates of Traditional Chinese Medicines and Immunosuppressive Agents
3.11 Summary of Categories' Relative Growths, CAGRs, and Market Shares, 2009-2024
3.11.1 Antivirals and Cancer Treatments Showing Greatest 15-Year Increase
3.11.2 Cephalosporins Losing Value from 2009-2024
3.11.3 Market Share Forecasts: Summary Figure
3.12 Important Economic Indicators
3.12.1 Is Japan Out of its Recession?
3.12.2 2008-2009 Economic Stimulus Packages
3.12.3 Pharmaceutical Spending Higher than Commodities Consumption
4. Generics in Japan
4.1 Generic Penetration by Volume and Value: Forecasts 2009-2024
4.1.1 Generics Growth: Forecast Discussion
4.1.2 Branded Drugs: Growth Forecast Discussion
4.2 Generics and Branded Drugs: Sales Volume Forecasts, 2009-2024
4.3 Generics and Branded Drugs: Sales Value Percentage Forecasts, 2009-2024
4.3.1 Value and Volume: Comparative Summary Figure for 2009, 2014, 2019 and 2024
4.4 Government Determined to Increase Use of Generics
4.4.1 2007 Action Plan to Promote Generic Adoption
4.4.2 Promoting Generic Substitution: Efficacy Doubtful
4.4.3 Will Generic Substitution Become Mandatory?
4.4.4 Generics Added to the Reimbursement Price List Twice Per Year
4.5 Scepticism about Generics is Prevalent
4.5.1 Generics and the Placebo Effect
4.6 Combating Anti-Generic Attitudes: the Japan Generic Medicines Association
4.6.1 Generics' Active Pharmaceutical Ingredients: a Source of Concern
4.6.2 Generics Hindered by Supply Chain
4.7 Collaborations: Solving Perception Problems?
4.7.1 Daiichi Sankyo Bought Generics Manufacturer Ranbaxy
4.7.2 Kowa Pharma Ltd and Teva: 2008 Agreement
5. Top Domestic Companies
5.1 Takeda
5.1.1 Financial Information
5.1.2 Impending Patent Expiries on Four Key Products
5.1.3 Gaining Pipeline Through Acquisitions and Licenses: Millennium Pharma and Amgen Japan
5.1.3.1 Takeda and Millennium Pharma
5.1.3.2 Takeda and Amgen
5.1.3.3 Takeda and Cell Genesys
5.1.4 Takeda and Cancer Segment - Visiongain's Analysis
5.2 Daiichi Sankyo
5.2.1 Financial and Pipeline Information
5.2.2 Daiichi Sankyo Takes Control of Ranbaxy
5.2.2.1 Leveraging the Power of Generics
5.2.2.2 The US FDA Banned 30 Ranbaxy Generics in 2008 and Rejected 2 Dozen in 2009
5.2.2.3 The 1980s: Generic Drug Problems
5.2.3 Daiichi Sankyo's Successful Anti-Influenza Trial
5.2.4 Can Daiichi Sankyo Manage a Global Business? Visiongain's Analysis
5.3 Astellas
5.3.1 Financial Information
5.3.2 Reorganising Drug Discovery Research Functions: Effective 1 October 2009
5.3.3 Astellas and Pfizer: Partners in Selling Lipitor and Caduet
5.3.4 Astellas and AstraZeneca to Sell Symbicort Asthma Inhaler
5.3.5 Astellas and Maxygen: Seeking New Technology
5.3.6 Astellas Investing in India: Anti-Rejection Drug Programme
5.3.6.1 Small Number of Transplants Performed in Japan, but the Number is Growing
5.3.7 Astellas in Brazil as of 2009: Now In all BRIC Countries
5.4 Mitsubishi Tanabe Pharma
5.4.1 Financial Information
5.4.2 Top Products and Pipeline Goals
5.4.2.1 Generics Subsidiary
5.4.2.2 International Expansion
5.4.3 Will Mitsubishi Tanabe Reach its 2015 Goals? Visiongain's Analysis
5.5 Eisai Co.
5.5.1 Specialties and Top Drugs
5.5.2 Financial Information
5.5.3 Eisai, Alzheimer's, and TorreyPines Therapeutics
5.5.4 Working on Oncology: Eisai, MGI Pharma and Morphotek
5.5.5 Will Eisai Be Able to Compete with Takeda in Oncology? Visiongain's Analysis
5.6 Shionogi
5.6.1 Financial Information
5.6.2 Crestor Losing Patent Protection in 2016
5.6.3 Shionogi's Antiviral Trials
5.6.4 Shionogi Acquired Sciele
5.6.5 Shionogi/Sciele Acquisition of Victory Pharma Cancelled
5.6.6 Will Shionogi Buy Another Anti-Pain Specialist? Visiongain's Analysis
5.7 Dainippon Sumitomo Pharma Co., Ltd.
5.7.1 Financial Information
5.7.2 Acquisition of Sepracor Inc.
5.7.3 Dainippon Sumitomo's Antipsychotics: Can They Survive Generic Zyprexa?
5.7.4 Will Dainippon Sumitomo License Out Fewer Drugs? Visiongain's Analysis
6. The Japanese Healthcare System
6.1 Healthcare Costs Have Been Rising Unsustainably
6.1.1 2006 Emphasis on Preventative Care
6.2 Insurance: Social and National Health Insurance Schemes
6.3 Hospitals Required to be Non-Profit
6.4 Co-Pays and How Payments are Made and Calculated
6.4.1 Payments for Care Nationally Standardised
6.4.2 Doctors' Incentives to Address Multiple Health Problems
6.5 Number of Physicians, Dentists and Pharmacists
6.5.1 Breakdown of Physicians, Dentists and Pharmacists by Gender
6.6 Sustainability and Satisfaction: The Major Healthcare Concerns of the 2000s
6.7 Provision for the Elderly: Under Periodic Reassessment
6.7.1 Replacing Nursing Homes
6.8 Relatively Little Emphasis on Preventative Care: To Be Changed by Reforms?
6.9 Decentralised Healthcare: Too Many Hospitals, Not Enough Quality Control?
6.9.1 Allocation Inefficiencies Make the System Financially Unsustainable
6.9.2 Absent Accreditation Standards
6.9.3 Cost-Sharing Schemes Do Not Reduce Demand
6.9.4 Forcibly Reducing Costs Compromises Care
6.9.5 Hospitals Commonly in Debt
6.10 Earnings of Doctors in Japan
6.10.1 Salary Caps
6.10.2 Doctors Have Few Incentives to Specialise
6.11 Japan Has a Shortage of Doctors
6.11.1 The Tiered Hospital System Causing Problems
6.11.2 Patients Turned Away from Emergency Rooms
6.11.3 No Foreign Doctors In Japan (And Very Few Foreign Nurses)
6.12 Organisation for Economic Co-Operation and Economic Development (OECD): Healthcare Statistics Summary
6.12.1 OECD Statistics: Summary Discussion
6.12.2 Other Healthcare Indicators: HIV Rates
7. Near- and Long-Term Development Factors: SWOT
7.1 Strengths: 2009-2014
7.1.1 An Aging Population Needs More Medicine
7.1.2 The Strong Yen: Making Medicines Affordable
7.1.3 The Strong Yen: Facilitating Mergers and Acquisitions
7.1.4 Strength or Weakness? Branded Drugs Benefit at the Expense of Generics
7.2 Weaknesses: 2009-2014
7.2.1 The Strong Yen: Slowing Economic Growth
7.2.2 Government Seeking to Curb Spending
7.2.3 Not Enough Doctors or Pharmacists
7.3 Opportunities: 2014-2024
7.3.1 International Expansion: A Major Opportunity
7.3.2 Generics: An Opportunity and a Threat
7.4 Threats: 2014-2014
7.4.1 Corrections to Over-Prescription
7.4.2 Long-Term Effects of Doctor and Pharmacist Shortage
8. Conclusions
8.1 Key Data from This Report
8.2 International Expansion: The Way Forward for Japanese Pharmaceutical Companies
8.3 The Domestic Market: Growing Slowly
8.3.1 Age-Related Medicines: The Major Drivers
8.3.2 The Doctor Shortage Will Become an Increasingly Restraining Factor
8.3.3 Assessing the Effects of Bungyo
8.4 A Definite Trend Towards Generics
List of Tables
Table 2.1 Crucial Independent Bureaus in Pharmaceutical Oversight, by Title and Function (2007)
Table 2.2 Offices of the PMDA
Table 2.3 Details of Premium Drug Pricing Characteristics (2007)
Table 2.4 Number of Prescriptions, 1990-1998 (in increments of 100m)
Table 2.5 Number of Prescriptions, 1998-2007 (in increments of 100m)
Table 2.6 Bungyo Ratios, 1990-1998 (%)
Table 2.7 Bungyo Ratios, 1998-2007 (%)
Table 2.8 Functions of the Japan Pharmaceutical Association
Table 2.9 Number of Passing Pharmacy Examinees, 2002-2008
Table 2.10 Demographic Percentages by Age (2007)
Table 2.11 Dependency Percentages, 1995 through 2050 (2008 Forecasts)
Table 2.12 Major Causes of Death, 2005 (Number per 100,000)
Table 2.13 Death Rates per 1000 Population, from 2000-2006 (%)
Table 3.1 Total Market and Categories Forecasts, 2009-2019 ($m)
Table 3.2 Total Market and Categories Forecasts, 2019-2024 ($m)
Table 3.3 Cardiovascular Treatments Forecast, 2009-2019 ($m)
Table 3.4 Cardiovascular Treatments Forecast, 2019-2024 ($m)
Table 3.5 Cardiovascular Treatments Forecasts, by Subdivision, 2009-2019 ($m)
Table 3.6 Cardiovascular Treatments Forecasts, by Subdivision, 2019-2024 ($m)
Table 3.7 Marketed Angiotensin-II Antagonists, with Chemical, Drug, and Company Names
Table 3.8 Antiulcerants Forecast, 2009-2019 ($m)
Table 3.9 Antiulcerants Forecast, 2019-2024 ($m)
Table 3.10 Cancer Treatments Forecast, 2009-2019 ($m)
Table 3.11 Cancer Treatments Forecast, 2019-2024 ($m)
Table 3.12 Cancer Deaths in Japan in 2006, by Cancer Type
Table 3.13 Antidepressants and Antipsychotics Forecast, 2009-2019 ($m)
Table 3.14 Antidepressants and Antipsychotics Forecast, 2019-2024 ($m)
Table 3.15 Topical Antirheumatics Forecast, 2009-2019 ($m)
Table 3.16 Topical Antirheumatics Forecast, 2019-2024 ($m)
Table 3.17 Systemic Antihistamines Forecast, 2009-2019 ($m)
Table 3.18 Systemic Antihistamines Forecast, 2019-2024 ($m)
Table 3.19 Cephalosporins Forecast, 2009-2019 ($m)
Table 3.20 Cephalosporins Forecast, 2019-2024 ($m)
Table 3.21 Antivirals Forecast, 2009-2019 ($m)
Table 3.22 Antivirals Forecast, 2019-2024 ($m)
Table 3.23 Others Forecast, 2009-2019 ($m)
Table 3.24 Others Forecast, 2019-2024 ($m)
Table 3.25 Categories' 15-Year Growth and CAGR Percentages 2009-2024, (Highest to Lowest by CAGR %)
Table 4.1 Branded and Generic Drugs Forecasts, 2009-2019 ($bn and %)
Table 4.2 Branded and Generic Drugs Forecasts, 2019-2024 ($bn and %)
Table 4.3 Branded and Generic Drugs Volume Percentages Forecasts, 2009-2019 (%)
Table 4.4 Branded and Generic Drugs Volume Percentages Forecasts, 2019-2024 (%)
Table 4.5 Branded and Generic Drugs Value Percentages Forecasts, 2009-2019 (%)
Table 4.6 Branded and Generic Drugs Value Percentages Forecasts, 2019-2024 (%)
Table 6.1 Three Types of Japanese Health Insurance and Their Defining Characteristics
Table 6.2 Total Number of Physicians, Dentists and Pharmacists and Number per 100,000 Population, 2008
Table 6.3 Number of Male and Female Physicians, Dentists and Pharmacists, 2008
Table 6.4 Modifications to the Healthcare Services Programme for the Elderly, 1983-2012
Table 6.5 Comparison of Japanese Statistics with OECD Average Statistics, 2009
Table 7.1 Strengths and Weaknesses in the Japanese Pharmaceutical Market, 2009-2014
Table 7.2 Opportunities and Threats in the Japanese Pharmaceutical Market, 2014-2024
List of Figures
Figure 2.1 Number of Prescriptions, 1990-2007 (x 100m)
Figure 2.2 Bungyo Ratios, 1990-2007 (%)
Figure 2.3 Number of Passing Pharmacy Examinees, 2002-2008
Figure 2.4 Death Rates from 2000-2006 (%)
Figure 3.1 Total Market Forecast, 2009-2024, ($bn)
Figure 3.2 Total Market, Cardiovascular Treatments and Others Forecasts, 2009-2024 ($m)
Figure 3.3 7 Top-Selling Drugs Categories Forecasts, 2009-2024 ($m)
Figure 3.4 Cardiovascular Treatments Forecast, 2009-2024 ($m)
Figure 3.5 Therapies in the Cardiovascular Treatments Category: 2009 Values and Relative Percentages
Figure 3.6 All Cardiovascular Treatments Forecasts, 2009-2024 ($m)
Figure 3.7 Antiulcerants Forecast, 2009-2024 ($m)
Figure 3.8 Cancer Treatments Forecast, 2009-2024 ($m)
Figure 3.9 Antipsychotics and Antidepressants Forecast, 2009-2024 ($m)
Figure 3.10 Topical Antirheumatics Forecast, 2009-2024 ($m)
Figure 3.11 Systemic Antihistamines Forecast, 2009-2024 ($m)
Figure 3.12 Cephalosporins Forecast, 2009-2024 ($m)
Figure 3.13 Antivirals Forecast, 2009-2024 ($m)
Figure 3.14 Others Forecast, 2009-2024 ($m)
Figure 3.15 Growth Over 2009 Value, By Category, 2009-2024 (%)
Figure 3.16 Market Share Forecasts for 7 Categories, 2009-2024 (%)
Figure 4.1 Branded and Generic Drugs Value Forecasts, 2009-2024 ($bn)
Figure 4.2 Branded and Generic Drugs Forecasts by Sales Volume, 2009-2024 (%)
Figure 4.3 Branded and Generic Drugs Forecasts by Sales Value, 2009-2024 (%)
Figure 4.4 Branded and Generic Drugs Volume and Value Forecasts Summary Figure, 2009-2024 (%)
Figure 6.1 Number of Male and Female Physicians, Dentists and Pharmacists, 2008