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Japan Generic Drug Market: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2019-2024

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:

  • 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 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


List of Figures

Figure 1: Structure of the Pharmaceutical Industry
Figure 2: Classification of Generic Drugs
Figure 3: Penetration of Generic Drugs Across Various Developed Markets
Figure 4: Global: Generic Drug Market: Sales Value (in Billion US$), 2011-2018
Figure 5: Global: Generic Drug Market: Sales Volume (in Billion Units), 2011-2018
Figure 6: Global: Generic Drug Market: Sales Value Breakup by Country (in %), 2018
Figure 7: Global: Generic Drug Market: Sales Volume Breakup by Country (in %), 2018
Figure 8: Global: Generic Drug Market Forecast: Sales Value (in Billion US$), 2019-2024
Figure 9: Global: Generic Drug Market Forecast: Sales Volume (in Billion Units), 2019-2024
Figure 10: Japan: Pharmaceutical Market: Sales Value (in Billion JPY), 2011-2018
Figure 11: Japan: Pharmaceutical Market: Sales Volume (in Billion Units), 2011-2018
Figure 12: Japan: Pharmaceutical Market Forecast: Sales Value (in Billion JPY), 2019-2024
Figure 13: Japan: Pharmaceutical Market Forecast: Sales Volume (in Billion Units), 2019-2024
Figure 14: Japan: Pharmaceutical Market: Sales Volume Breakup of Branded and Generic Drugs (in %), 2011 and 2018
Figure 15: Japan: Pharmaceutical Market: Sales Value Breakup of Branded and Generic Drugs (in %), 2011 and 2018
Figure 16: Japan: Generic Drug Market: Sales Value (in Billion JPY), 2011-2018
Figure 17: Japan: Generic Drug Market Forecast: Sales Value (in Billion JPY), 2019-2024
Figure 18: Japan: Generic Drug Market: Sales Volume (in Billion Units), 2011-2018
Figure 19: Japan: Generic Drug Market Forecast: Sales Volume (in Billion Units), 2019-2024
Figure 20: Japan: Generic Drug Market: Breakup by Key Players (in %)
Figure 21: Japan: Generic Drug Market: Breakup by Distribution Channel (in %)
Figure 22: Japan: Generic Drug Market: SWOT Analysis
Figure 23: Pricing Mechanism and Profit Margins at Various Levels of the Supply Chain 
Figure 24: Japan: Generic Drug Market: Porter’s Five Forces Analysis 
Figure 25: Japan: Generic Drug Market: Value Chain Analysis
Figure 26: Japan: Generic Drug Manufacturing: Detailed Process Flow
Figure 27: Japan: Generic Drug Manufacturing: Raw Material Requirements
Figure 28: Japan: Generic Drug Manufacturing Plant: Proposed Plant Layout
Figure 29: Japan: Generic Drug Manufacturing: Packaging Requirements
Figure 30: Japan: Approval Pathway for a Generic Drug

List of Tables

Table 1: Japan: Sales (in Billion US$) and Patent Expiry of Major Drugs Expected to Lose Patent Protection (in Billion US$)
Table 2: Japan: History of Major Policies to Encourage the Use of Generic Drugs    
Table 3: Japan: Expenses of Generic and Branded Drug Manufacturers (in %)    
Table 4: Major Biosimilar Product Under Development as of March 2018    
Table 5: Global: Generic Drug Market: Key Industry Highlights, 2018 and 2024    
Table 6: Global: Generics Market: Volume Performance of Top Molecules (in Million Prescriptions)
Table 7: Global: Branded Drug market: Volume Performance of Top Branded Drugs (in Million Prescriptions)
Table 8: Japan: Generic Drug Industry: Market Structure
Table 9: Generic Drug Manufacturing Plant: Machinery Costs (in US$)    
Table 10: Generic Oncology Drug Manufacturing Plant: Costs Related to Salaries and Wages (in US$)
Table 11: Japan: Data Requirements for a New Generic Drug Application
Table 12: Japan: Various Bioequivalence Guidelines for Generic Drugs    
Table 13: Japan: Timeline for New Generic Drug Approval    
Table 14: Japan: Review Time of the Application for Partial Change Approval    
Table 15:  Nichi-Iko Pharmaceutical Co., Ltd: Key Financials (in US$ Million)    
Table 16:  Sawai Pharmaceutical Co., Ltd: Key Financials (in US$ Million)
Table 17:  Towa Pharmaceutical: Key Financials (in US$ Million)
Table 18:  Teva Pharmaceutical Ltd: Key Financials (in US$ Million)
Table 19: Fuji Pharma Co Ltd: Key Financials (in US$ Million)

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