The report builds on 10 face-to-face interviews with industry experts
to provide a balanced and comprehensive understanding of the
development and prospects for the generics sector in Japan. Japan's
healthcare system, regulatory environment, generics market, and future
development are covered in detail.
Features and benefits
No. of Pages: 145
: Single User License - US$3835 Corporate User License - US$14381
Your key questions answered
Features and benefits
- Evaluate the future potential of the generics market in Japan.
- Understand why generics were slow to develop, the government’s response and how successful it is likely to be.
- Learn which strategies foreign generics companies have used to enter Japan and originator companies strategies to defend their brands.
- Assess Japan's regulatory environment and evaluate changes which are in the pipeline.
- Analyze attitudes of doctors, patients, and pharmacists towards generic drugs.
Japan Generics Industry Report
Published: January 2012No. of Pages: 145
: Single User License - US$3835 Corporate User License - US$14381
Your key questions answered
- Why has generic penetration been low to date in Japan?
- What measures have the government introduced in an attempt to stimulate greater generic use?
- Who are the main established and emerging generic companies in Japan and what are their strategies?
- What changes are likely to take place on April 1st 2012 when the NHI pricing rules and medical fees are next reformed that will impact generic use?
- What are attitudes towards generics among pharmacists, patients, and physicians?
Table of Contents
About the author
Disclaimer
EXECUTIVE SUMMARY
Organization and funding of Japan’s healthcare system
Regulatory environment
Pharmaceutical business environment
Generics market
Attitudes toward generics
Generics industry
Generics company strategies and generics defense
Market prospects
Organization and funding of Japan’s healthcare system
Summary
Introduction
Key actors
Health insurance
Schemes managed by the government
Schemes managed by large companies
Schemes managed by the municipalities
Health insurance for the elderly
Private insurance
Healthcare providers
Healthcare benefits
Remuneration of providers
Fee-for-service
DPC hospital funding
Dispensing fees
Patient co-payment
Healthcare expenditure
Regulatory environment
Summary
Intellectual property protection
Marketing approval
(Untitled sub-section)
NHI drug tariff
NHI price setting
NHI price revision processes
Biennial revision
Repricing
Long-listed brands
Correction premiums
Overall impact
Generic encouragement measures by government
(Untitled sub-section)
Inconsistent government policies
Pharmaceutical business environment
Summary
Pharmaceutical market
Research-based pharmaceutical industry
Generic industry
Wholesalers
Pharmacies
Foreign exchange rates
Generics market
Summary
Introduction to generics
Market size
Generic inclusion in NHI drug tariff
Introductory pricing of generics
Price revision of generics
Distribution of generics
Attitudes toward generics
Summary
Insurers
Physicians
Hospitals
Pharmacists
Wholesalers
Patients
Generics industry
Summary
Traditional domestic generic companies
Domestic R&D company presence
Distributor presence
Multinational presence
Indian companies
Company profiles
Fujifilm
Nichi-Iko
Sandoz
Sawai
Teva
Towa
Exports
Generics company strategies and generics defense
Summary
By generic sector
Generic companies
Generic industry associations
Counterstrategies by innovative manufacturers
Molecule case studies
Amlodipine
Clarithromycin
Donepezil
Famotidine
Lopamidol
Pioglitizone
Pravastatin
Risperidone
Market prospects
Summary
Introduction
Generic opportunities
Further incentives needed
Likely changes affecting generics from April 2012
Long-listed brands
Reference pricing
Fixed-dose combinations
Premium for new drug creation
Other reform measures
Other factors influencing generic prospects
Conclusions
Appendix
Scope
Methodology
Primary research
Secondary research
Currency exchanges rates
Glossary/Abbreviations
Bibliography/References
List of Tables
Table: Japan’s healthcare in perspective, 2009 (or latest available year)
Table: Main health insurance schemes
Table: Penetration of DPC in hospitals, 2008
Table: DPC hospitals by bed numbers, 2008
Table: Specimen outpatient hospital bill
Table: Growth in national medical costs, 1990–2008
Table: Number (million) and share (%) of population older than 65 years, 2012-22
Table: Specifications required for generics by type of formulation
Table: PMDA review times for new generic applications, 2005–09
Table: Share of product portfolio of Japanese R&D companies accounted for by long-listed brands
Table: Additional price cuts for long-listed brands, 2002–10
Table: NHI drug price revisions since 1981
Table: Market share evolution (%) by customer type, 1992–2009
Table: Forecast sales of leading wholesalers, FY2011
Table: Top 10 chain pharmacies, 2008
Table: Breakdown of the NHI drug tariff by product type, 2007
Table: Specimen brand names of popular generics
Table: Generic penetration in Japan, 2002–10
Table: Numbers of new tariff-listed generics, 2003–11
Table: Examples of new generics first listed in NHI tariff, 1999–2007
Table: Examples of new generics first listed in NHI tariff, 2008–2011
Table: Calculation of initial NHI prices for generics, 1992–2010
Table: Results of biennial NHI price revisions: Overall average price cuts versus those for generics
Table: Japan Generics Association companies by size, 2007
Table: Consolidated results of leading listed domestic generic manufacturers, forecast for FY2011
Table: Other data on leading listed domestic generic manufacturers, forecast for FY2011
Table: Generic sales of innovative Japanese manufacturers, FY2010
Table: Generic market entrants from overseas: evolution and current status
Table: Generic market entrants from overseas: evolution and current status (continued)
Table: Representative value-added innovations from Sawai
Table: Examples of combination products launched around the time of patent expiry of one component
Table: Change in NHI prices of selected first wave generics of amlodopine 5mg tablets, 2008–10
Table: Change in NHI prices of selected first wave generics of famotidine 20mg tablets, 2002–10
Table: Change in NHI prices (¥) of Iopamiron (150 strength, 50ml) and leading generic version, Oipamiron, 1996-2010
Table: Recent NHI price erosion with Mevalotin and generic pravastatin, 10mg tablet
Table: Examples of major molecules expected soon to go off-patent in Japan, 2012–2013
Table: Average exchange rates, 2007–11
List of Figures
Figure: NHI drug list by route of administration, 2010
Figure: Top 10 therapeutic classes in Japan by 2010 sales
Figure: Top 10 best selling prescription brands in Japan by 2010 sales
Figure: Top 20 pharmaceutical companies in Japan by 2010 sales to wholesalers
Figure: JGA member companies
Figure: Breakdown of generic listing in the NHI tariff by product nomenclature, 2010
Figure: Generic volume penetration by country, 2009
About the author
Disclaimer
EXECUTIVE SUMMARY
Organization and funding of Japan’s healthcare system
Regulatory environment
Pharmaceutical business environment
Generics market
Attitudes toward generics
Generics industry
Generics company strategies and generics defense
Market prospects
Organization and funding of Japan’s healthcare system
Summary
Introduction
Key actors
Health insurance
Schemes managed by the government
Schemes managed by large companies
Schemes managed by the municipalities
Health insurance for the elderly
Private insurance
Healthcare providers
Healthcare benefits
Remuneration of providers
Fee-for-service
DPC hospital funding
Dispensing fees
Patient co-payment
Healthcare expenditure
Regulatory environment
Summary
Intellectual property protection
Marketing approval
(Untitled sub-section)
NHI drug tariff
NHI price setting
NHI price revision processes
Biennial revision
Repricing
Long-listed brands
Correction premiums
Overall impact
Generic encouragement measures by government
(Untitled sub-section)
Inconsistent government policies
Pharmaceutical business environment
Summary
Pharmaceutical market
Research-based pharmaceutical industry
Generic industry
Wholesalers
Pharmacies
Foreign exchange rates
Generics market
Summary
Introduction to generics
Market size
Generic inclusion in NHI drug tariff
Introductory pricing of generics
Price revision of generics
Distribution of generics
Attitudes toward generics
Summary
Insurers
Physicians
Hospitals
Pharmacists
Wholesalers
Patients
Generics industry
Summary
Traditional domestic generic companies
Domestic R&D company presence
Distributor presence
Multinational presence
Indian companies
Company profiles
Fujifilm
Nichi-Iko
Sandoz
Sawai
Teva
Towa
Exports
Generics company strategies and generics defense
Summary
By generic sector
Generic companies
Generic industry associations
Counterstrategies by innovative manufacturers
Molecule case studies
Amlodipine
Clarithromycin
Donepezil
Famotidine
Lopamidol
Pioglitizone
Pravastatin
Risperidone
Market prospects
Summary
Introduction
Generic opportunities
Further incentives needed
Likely changes affecting generics from April 2012
Long-listed brands
Reference pricing
Fixed-dose combinations
Premium for new drug creation
Other reform measures
Other factors influencing generic prospects
Conclusions
Appendix
Scope
Methodology
Primary research
Secondary research
Currency exchanges rates
Glossary/Abbreviations
Bibliography/References
List of Tables
Table: Japan’s healthcare in perspective, 2009 (or latest available year)
Table: Main health insurance schemes
Table: Penetration of DPC in hospitals, 2008
Table: DPC hospitals by bed numbers, 2008
Table: Specimen outpatient hospital bill
Table: Growth in national medical costs, 1990–2008
Table: Number (million) and share (%) of population older than 65 years, 2012-22
Table: Specifications required for generics by type of formulation
Table: PMDA review times for new generic applications, 2005–09
Table: Share of product portfolio of Japanese R&D companies accounted for by long-listed brands
Table: Additional price cuts for long-listed brands, 2002–10
Table: NHI drug price revisions since 1981
Table: Market share evolution (%) by customer type, 1992–2009
Table: Forecast sales of leading wholesalers, FY2011
Table: Top 10 chain pharmacies, 2008
Table: Breakdown of the NHI drug tariff by product type, 2007
Table: Specimen brand names of popular generics
Table: Generic penetration in Japan, 2002–10
Table: Numbers of new tariff-listed generics, 2003–11
Table: Examples of new generics first listed in NHI tariff, 1999–2007
Table: Examples of new generics first listed in NHI tariff, 2008–2011
Table: Calculation of initial NHI prices for generics, 1992–2010
Table: Results of biennial NHI price revisions: Overall average price cuts versus those for generics
Table: Japan Generics Association companies by size, 2007
Table: Consolidated results of leading listed domestic generic manufacturers, forecast for FY2011
Table: Other data on leading listed domestic generic manufacturers, forecast for FY2011
Table: Generic sales of innovative Japanese manufacturers, FY2010
Table: Generic market entrants from overseas: evolution and current status
Table: Generic market entrants from overseas: evolution and current status (continued)
Table: Representative value-added innovations from Sawai
Table: Examples of combination products launched around the time of patent expiry of one component
Table: Change in NHI prices of selected first wave generics of amlodopine 5mg tablets, 2008–10
Table: Change in NHI prices of selected first wave generics of famotidine 20mg tablets, 2002–10
Table: Change in NHI prices (¥) of Iopamiron (150 strength, 50ml) and leading generic version, Oipamiron, 1996-2010
Table: Recent NHI price erosion with Mevalotin and generic pravastatin, 10mg tablet
Table: Examples of major molecules expected soon to go off-patent in Japan, 2012–2013
Table: Average exchange rates, 2007–11
List of Figures
Figure: NHI drug list by route of administration, 2010
Figure: Top 10 therapeutic classes in Japan by 2010 sales
Figure: Top 10 best selling prescription brands in Japan by 2010 sales
Figure: Top 20 pharmaceutical companies in Japan by 2010 sales to wholesalers
Figure: JGA member companies
Figure: Breakdown of generic listing in the NHI tariff by product nomenclature, 2010
Figure: Generic volume penetration by country, 2009
