Japan Generic Drug Market - Industry Trends, Competitive Landscape, Opportunities and Outlook
Japan represents the world’s eighth biggest market for generic drugs in terms of value. Generic drugs, however, have traditionally enjoyed a relatively lower penetration in Japan compared to other developed markets such as the United States and Europe. Historically, the lower penetration of generic drugs in japan was due to several reasons. These included – the perception of inferior quality of generic drugs, the preference of branded drugs among physicians and patients and the limited profits to be made by physicians from pharmaceutical price differentials by prescribing low priced generics. Generic drugs also remained less popular in Japan because of the lack of generic substitution rights by Japanese pharmacists, slower review times in the drug approval process and difficulties working with major pharmaceutical distributors – many of whom were closely tied to major branded drug manufacturers.
The landscape of the generic market in Japan, however, has changed noticeably over the last decade. The Japanese government has identified growth of the country’s generic drug market as imperative to Japan’s long-term economic health. The Japanese government, recognizing the country’s increasing aging population as well as rising costs of branded drugs has begun instituting healthcare policy changes to cut their expenditures on medical costs. Drug costs account for around a fifth of the country’s total medical expenses and reducing this burden has become a cornerstone of Japan’s health administration policy. Substitution of low-cost generic drugs for innovator products has been identified as a strategy where major savings are possible. Driven by these initiatives, the penetration of generics has grown robustly over the past few years. The government has also made a target towards achieving a generic penetration of 60% by 2017. This is expected to create huge opportunities for both domestic and foreign generic manufacturers in Japan.
The report entitled “Japan Generic Drug Market - Industry Trends, Competitive Landscape, Opportunities and Outlook” represents an in-depth analysis on the historical, current and future trends in the generic drug market in Japan. This research report serves as an exceptional tool to understand the drivers, sales trends, prescription trends, market structure, competitive landscape, regulations, key players, key drugs, manufacturing and the outlook of generic drug market in Japan. This report can serve as an excellent guide for investors, researchers, consultants, marketing strategists and all those who want to gain an insight into the market for generic drugs in Japan.
Key Questions Answered:
The landscape of the generic market in Japan, however, has changed noticeably over the last decade. The Japanese government has identified growth of the country’s generic drug market as imperative to Japan’s long-term economic health. The Japanese government, recognizing the country’s increasing aging population as well as rising costs of branded drugs has begun instituting healthcare policy changes to cut their expenditures on medical costs. Drug costs account for around a fifth of the country’s total medical expenses and reducing this burden has become a cornerstone of Japan’s health administration policy. Substitution of low-cost generic drugs for innovator products has been identified as a strategy where major savings are possible. Driven by these initiatives, the penetration of generics has grown robustly over the past few years. The government has also made a target towards achieving a generic penetration of 60% by 2017. This is expected to create huge opportunities for both domestic and foreign generic manufacturers in Japan.
The report entitled “Japan Generic Drug Market - Industry Trends, Competitive Landscape, Opportunities and Outlook” represents an in-depth analysis on the historical, current and future trends in the generic drug market in Japan. This research report serves as an exceptional tool to understand the drivers, sales trends, prescription trends, market structure, competitive landscape, regulations, key players, key drugs, manufacturing and the outlook of generic drug market in Japan. This report can serve as an excellent guide for investors, researchers, consultants, marketing strategists and all those who want to gain an insight into the market for generic drugs in Japan.
Key Questions Answered:
- What are generic drugs? How are they different from branded drugs?
- How has Japan’s generic drug market performed in recent years?
- How have generic drugs performed compared to branded drugs?
- What were the total sales and prescriptions for generic drugs in Japan?
- Who are the key players in the Japanese generic drug market? How have they performed?
- What is the structure of the Japanese generic drug market?
- What is the pricing mechanism of generic drugs in Japan?
- What is the value chain of generic drugs in Japan?
- What are the regulations for generic drugs in Japan?
- How are generic drugs distributed in Japan?
- How are generic drugs manufactured?
- What are the raw material and machinery requirements to manufacture generic drugs?
- What are the drivers and challenges in the Japanese generic drug market?
1 RESEARCH METHODOLOGY AND MARKET DEFINITIONS
2 REPORT SUMMARY
3 JAPAN GENERIC DRUG MARKET - INTRODUCTION
3.1 What are Generic Drugs?
3.2 Unbranded and Branded Generic Drugs
3.3 Authorized Generic Drugs
4 WHY IS THE JAPANESE GENERIC DRUG MARKET SO LUCRATIVE
4.1 Blockbuster Drugs Going Off-Patent
4.2 Rising Healthcare Costs Coupled with an Increasing Ageing Population
4.3 Japan Has One of the Lowest Penetration of Generics
4.4 Incentives for Dispensing Generics
4.5 Significant Savings For Payers and Providers
4.6 Biosimilars
5 GLOBAL GENERIC DRUG MARKET
5.1 Current and Historical Market Trends
5.2 Market Breakup by Country
5.3 Market Forecast
5.4 Most Prescribed Generic and Branded Drugs
6 JAPAN GENERIC DRUG MARKET
6.1 Japan Pharmaceutical Market – Current, Historical and Future Market Trends
6.2 Japan Pharmaceutical Market - Share of Branded and Generic Drug
6.3 Japan Generic Drug Market – Current, Historical and Future Sales Trends
6.4 Japan Generic Drug Market – Current, Historical and Future Volume Trends
7 JAPAN GENERIC DRUG MARKET- COMPETITIVE LANDSCAPE
7.1 Japan Generic Drug Market - Competitive Structure
7.2 Japan Generic Drug Market - Sales Breakup of Key Players
7.3 Japan Generic Drug Market – Distribution Breakup by Channels
8 JAPAN GENERIC DRUG MARKET - VALUE CHAIN ANALYSIS
8.1 Research and Development
8.2 Manufacturing
8.3 Marketing
8.4 Distribution
9 REGULATIONS IN JAPAN GENERICS INDUSTRY
9.1 Approval Pathway of a Generic Drug in Japan
9.1.1 Master File Scheme for Active Ingredients
9.1.2 Equivalency Review
9.1.3 Conformity Audit
9.2 Certifications
9.2.1 MAH (Market Authorization Holder) License for Product Approval
9.2.2 FMA (Foreign Manufacturer Accredited) Certification for Product Approval
9.2.3 DMF (Drug Master File) Registration
9.2.4 GMP (Good Manufacturing Practices) Certification
9.2.5 Manufacturer’s License
10 JAPAN GENERIC DRUG MARKET: KEY SUCCESS FACTORS
11 JAPAN GENERIC DRUG MARKET: ROAD BLOCKS
12 REQUIREMENTS FOR SETTING UP A GENERIC DRUG MANUFACTURING PLANT
12.1 Manufacturing Process
12.2 Raw Material Requirements
12.3 Machinery and Infrastructure Requirements
13 JAPAN GENERIC DRUG MARKET - KEY COMPANY PROFILES
13.1 Teva Pharmaceutical Ltd.
13.2 Sawai Pharmaceutical Co., Ltd.
13.3 Nichi-Iko Pharmaceutical Co., Ltd.
13.4 Pfizer Japan Inc.
13.5 Meiji Seika Pharma
13.6 Towa Pharmaceutical
13.7 Nipro Pharma Corporation
13.8 Fuji Pharma Co., Ltd.
13.9 Daiichi Sankyo Espha Co., Ltd.
13.10 Nihon Generic Co. Ltd.
2 REPORT SUMMARY
3 JAPAN GENERIC DRUG MARKET - INTRODUCTION
3.1 What are Generic Drugs?
3.2 Unbranded and Branded Generic Drugs
3.3 Authorized Generic Drugs
4 WHY IS THE JAPANESE GENERIC DRUG MARKET SO LUCRATIVE
4.1 Blockbuster Drugs Going Off-Patent
4.2 Rising Healthcare Costs Coupled with an Increasing Ageing Population
4.3 Japan Has One of the Lowest Penetration of Generics
4.4 Incentives for Dispensing Generics
4.5 Significant Savings For Payers and Providers
4.6 Biosimilars
5 GLOBAL GENERIC DRUG MARKET
5.1 Current and Historical Market Trends
5.2 Market Breakup by Country
5.3 Market Forecast
5.4 Most Prescribed Generic and Branded Drugs
6 JAPAN GENERIC DRUG MARKET
6.1 Japan Pharmaceutical Market – Current, Historical and Future Market Trends
6.2 Japan Pharmaceutical Market - Share of Branded and Generic Drug
6.3 Japan Generic Drug Market – Current, Historical and Future Sales Trends
6.4 Japan Generic Drug Market – Current, Historical and Future Volume Trends
7 JAPAN GENERIC DRUG MARKET- COMPETITIVE LANDSCAPE
7.1 Japan Generic Drug Market - Competitive Structure
7.2 Japan Generic Drug Market - Sales Breakup of Key Players
7.3 Japan Generic Drug Market – Distribution Breakup by Channels
8 JAPAN GENERIC DRUG MARKET - VALUE CHAIN ANALYSIS
8.1 Research and Development
8.2 Manufacturing
8.3 Marketing
8.4 Distribution
9 REGULATIONS IN JAPAN GENERICS INDUSTRY
9.1 Approval Pathway of a Generic Drug in Japan
9.1.1 Master File Scheme for Active Ingredients
9.1.2 Equivalency Review
9.1.3 Conformity Audit
9.2 Certifications
9.2.1 MAH (Market Authorization Holder) License for Product Approval
9.2.2 FMA (Foreign Manufacturer Accredited) Certification for Product Approval
9.2.3 DMF (Drug Master File) Registration
9.2.4 GMP (Good Manufacturing Practices) Certification
9.2.5 Manufacturer’s License
10 JAPAN GENERIC DRUG MARKET: KEY SUCCESS FACTORS
11 JAPAN GENERIC DRUG MARKET: ROAD BLOCKS
12 REQUIREMENTS FOR SETTING UP A GENERIC DRUG MANUFACTURING PLANT
12.1 Manufacturing Process
12.2 Raw Material Requirements
12.3 Machinery and Infrastructure Requirements
13 JAPAN GENERIC DRUG MARKET - KEY COMPANY PROFILES
13.1 Teva Pharmaceutical Ltd.
13.2 Sawai Pharmaceutical Co., Ltd.
13.3 Nichi-Iko Pharmaceutical Co., Ltd.
13.4 Pfizer Japan Inc.
13.5 Meiji Seika Pharma
13.6 Towa Pharmaceutical
13.7 Nipro Pharma Corporation
13.8 Fuji Pharma Co., Ltd.
13.9 Daiichi Sankyo Espha Co., Ltd.
13.10 Nihon Generic Co. Ltd.
LIST OF FIGURES
Figure 3 1: Structure of the Pharmaceutical Industry
Figure 3 2: Classification of Generic Drugs
Figure 4 1: Penetration of Generic Drugs Across Various Developed Markets
Figure 5 1: Global: Generic Drug Market: Sales Value (in Billion US$), 2010-2015
Figure 5 2: Global: Generic Drug Market: Sales Volume (in Billion Units), 2010-2015
Figure 5 3: Global: Generic Drug Market: Sales Value Breakup by Country (in %), 2015
Figure 5 4: Global: Generic Drug Market: Sales Volume Breakup by Country (in %), 2015
Figure 5 5: Global: Generic Drug Market Forecast: Sales Value (in Billion US$), 2016-2021
Figure 5 6: Global: Generic Drug Market: Sales Volume (in Billion Units), 2016-2021
Figure 6 1: Japan: Pharmaceutical Market: Sales Value (in Billion JPY), 2010-2015
Figure 6 2: Japan: Pharmaceutical Market: Sales Volume (in Billion Units), 2010-2015
Figure 6 3: Japan: Pharmaceutical Market Forecast: Sales Value (in Billion JPY), 2016-2021
Figure 6 4: Japan: Pharmaceutical Market: Sales Volume (in Billion Units), 2016-2021
Figure 6 5: Japan: Pharmaceutical Market: Sales Volume Breakup of Branded and Generic Drugs (in %), 2010 and 2015
Figure 6 6: Japan: Pharmaceutical Market: Sales Value Breakup of Branded and Generic Drugs (in %), 2010 and 2015
Figure 6 7: Japan: Generic Drug Market: Sales Value (in Billion JPY), 2010-2015
Figure 6 8: Japan: Generic Drug Market Forecast: Sales Value (in Billion JPY), 2016-2021
Figure 6 9: Japan: Generic Drug Market: Sales Volume (in Billion Units), 2010-2015
Figure 6 10: Japan: Generic Drug Market Forecast: Sales Volume (in Billion Units), 2016-2021
Figure 7 1: Japan: Generic Drug Market: Sales Share of Top Players (in %), 2015
Figure 8 1: Japan: Generic Drug Market: Value Chain Analysis
Figure 9 1: Japan: Approval Pathway for a Generic Drug
Figure 3 1: Structure of the Pharmaceutical Industry
Figure 3 2: Classification of Generic Drugs
Figure 4 1: Penetration of Generic Drugs Across Various Developed Markets
Figure 5 1: Global: Generic Drug Market: Sales Value (in Billion US$), 2010-2015
Figure 5 2: Global: Generic Drug Market: Sales Volume (in Billion Units), 2010-2015
Figure 5 3: Global: Generic Drug Market: Sales Value Breakup by Country (in %), 2015
Figure 5 4: Global: Generic Drug Market: Sales Volume Breakup by Country (in %), 2015
Figure 5 5: Global: Generic Drug Market Forecast: Sales Value (in Billion US$), 2016-2021
Figure 5 6: Global: Generic Drug Market: Sales Volume (in Billion Units), 2016-2021
Figure 6 1: Japan: Pharmaceutical Market: Sales Value (in Billion JPY), 2010-2015
Figure 6 2: Japan: Pharmaceutical Market: Sales Volume (in Billion Units), 2010-2015
Figure 6 3: Japan: Pharmaceutical Market Forecast: Sales Value (in Billion JPY), 2016-2021
Figure 6 4: Japan: Pharmaceutical Market: Sales Volume (in Billion Units), 2016-2021
Figure 6 5: Japan: Pharmaceutical Market: Sales Volume Breakup of Branded and Generic Drugs (in %), 2010 and 2015
Figure 6 6: Japan: Pharmaceutical Market: Sales Value Breakup of Branded and Generic Drugs (in %), 2010 and 2015
Figure 6 7: Japan: Generic Drug Market: Sales Value (in Billion JPY), 2010-2015
Figure 6 8: Japan: Generic Drug Market Forecast: Sales Value (in Billion JPY), 2016-2021
Figure 6 9: Japan: Generic Drug Market: Sales Volume (in Billion Units), 2010-2015
Figure 6 10: Japan: Generic Drug Market Forecast: Sales Volume (in Billion Units), 2016-2021
Figure 7 1: Japan: Generic Drug Market: Sales Share of Top Players (in %), 2015
Figure 8 1: Japan: Generic Drug Market: Value Chain Analysis
Figure 9 1: Japan: Approval Pathway for a Generic Drug
LIST OF TABLES
Table 4 1: Japan: Sales (in Billion JPY) and Patent Expiry of Major Drugs Expected to Lose Patent Protection
Table 4 2: Japan: History of Major Government Policies to Encourage the Use of Generic Drugs
Table 5 1: Global: Generic Drug Market: Sales Volume and Growth of Major Markets, 2014
Table 5 2: Global: Generic Drug Market: Volume Performance of Top Generic Drugs (in Million Prescriptions), 2015
Table 5 3: Global: Branded Drug Market: Volume Performance of Top Branded Drugs (in Million Prescriptions), 2015
Table 7 1: Japan: Generic Drug Market: Sales Values of Key Manufacturers (in Million JPY), 2015
Table 4 1: Japan: Sales (in Billion JPY) and Patent Expiry of Major Drugs Expected to Lose Patent Protection
Table 4 2: Japan: History of Major Government Policies to Encourage the Use of Generic Drugs
Table 5 1: Global: Generic Drug Market: Sales Volume and Growth of Major Markets, 2014
Table 5 2: Global: Generic Drug Market: Volume Performance of Top Generic Drugs (in Million Prescriptions), 2015
Table 5 3: Global: Branded Drug Market: Volume Performance of Top Branded Drugs (in Million Prescriptions), 2015
Table 7 1: Japan: Generic Drug Market: Sales Values of Key Manufacturers (in Million JPY), 2015
