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 japan generic drug market, 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 2018. 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, Share, Size, Growth, Opportunity and Forecast 2019-2024” represents an in-depth analysis on the historical, current and future market 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 generic drug market in Japan.
Key Questions Answered:
| 1 Preface 2 Scope and Methodology 2.1 Objectives of the Study 2.2 Stakeholders 2.3 Data Sources 2.3.1 Primary Sources 2.3.2 Secondary Sources 2.4 Market Estimation 2.4.1 Bottom-Up Approach 2.4.2 Top-Down Approach 2.5 Forecasting Methodology 3 Executive Summary 4 Japan Generic Drug Market – Introduction 4.1 What are Generic Drugs? 4.2 Unbranded and Branded Generic Drugs 4.3 Authorized Generic Drugs 5 Why is the Japanese Generic Drug Market So Lucrative 5.1 Blockbuster Drugs Going Off-Patent 5.2 Rising Healthcare Costs Coupled with an Increasing Ageing Population 5.3 Japan Has One of the Lowest Penetration of Generics 5.4 Incentives for Dispensing Generics 5.5 Significant Savings for Payers and Providers 5.6 Biosimilars 6 Global Generic Drug Market 6.1 Market Performance 6.1.1 Value Trends 6.1.2 Volume Trends 6.2 Market Breakup by Country 6.2.1 Market Breakup by Volume 6.2.2 Market Breakup by Value 6.3 Market Forecast 6.4 Most Prescribed Generic and Branded Drugs 7 Japan Generic Drug Market 7.1 Japan Pharmaceutical Market Performance 7.1.1 Value Trends 7.1.2 Volume Trends 7.1.3 Market Breakup by Type 7.1.4 Market Forecast 7.2 Japan Generic Drug Market Performance 7.2.1 Value Trends 7.2.2 Volume Trends 7.2.3 Market Forecast 8 SWOT Analysis 8.1 Overview 8.2 Strength 8.3 Weakness 8.4 Opportunities 8.5 Threats 9 Pricing Mechanism and Profit Margins at Various Levels of Supply Chain 10 Porter’s Five Forces Analysis 10.1 Overview 10.2 Bargaining Power of Buyers 10.3 Bargaining Power of Suppliers 10.4 Degree of Competition 10.5 Threat of New Entrants 10.6 Threat of Substitutes 11 Japan Generic Drug Market- Competitive Landscape 11.1 Japan Generic Drug Market – Competitive Structure 11.2 Japan Generic Drug Market – Breakup by Key Players 11.3 Japan Generic Drug Market – Breakup by Distribution Channel 12 Japan Generic Drug Market- Value Chain Analysis 12.1 Research and Development 12.2 Manufacturing 12.3 Marketing 12.4 Distribution 13 Regulations in Japan Generics Industry 13.1 Approval Pathway of a Generic Drug in Japan 13.1.1 Master File Scheme for Active Ingredients 13.1.2 Equivalency Review 13.1.3 Conformity Audit 13.2 Certifications 13.2.1 MAH (Market Authorization Holder) License for Product Approval 13.2.2 FMA (Foreign Manufacturer Accredited) Certification for Product Approval 13.2.3 DMF (Drug Master File) Registration 13.2.4 GMP (Good Manufacturing Practices) Certification 13.2.5 Manufacturer’s License 14 Japan Generic Drug Market: Key Success Factors 15 Japan Generic Drug Market: Road Blocks 16 Requirements for Setting up a Generic Drug Manufacturing Plant 16.1 Manufacturing Process 16.2 Raw Material Requirements 16.3 Raw Material Pictures 16.4 Land and Construction Requirements 16.5 Machinery and Infrastructure Requirements 16.6 Machinery Pictures 16.7 Plant Layout 16.8 Packaging Requirements 16.9 Utility Requirements 16.10 Manpower Requirements 17 Japan Generic Drug Market – Key Company Profiles |
Global Generic Drug Market
Japan Generic Drug Market