Japan 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 Impact of COVID-19
        7.2.4 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$), 2019-2024
Figure 5: Global: Generic Drug Market: Sales Volume (in Billion Units), 2019-2024
Figure 6: Global: Generic Drug Market: Sales Value Breakup by Country (in %), 2024
Figure 7: Global: Generic Drug Market: Sales Volume Breakup by Country (in %), 2024
Figure 8: Global: Generic Drug Market Forecast: Sales Value (in Billion US$), 2025-2033
Figure 9: Global: Generic Drug Market Forecast: Sales Volume (in Billion Units), 2025-2033
Figure 10: Japan: Pharmaceutical Market: Sales Value (in Billion JPY), 2019-2024
Figure 11: Japan: Pharmaceutical Market: Sales Volume (in Billion Units), 2019-2024
Figure 12: Japan: Pharmaceutical Market Forecast: Sales Value (in Billion JPY), 2025-2033
Figure 13: Japan: Pharmaceutical Market Forecast: Sales Volume (in Billion Units), 2025-2033
Figure 14: Japan: Pharmaceutical Market: Sales Volume Breakup of Branded and Generic Drugs (in %), 2018 and 2023
Figure 15: Japan: Pharmaceutical Market: Sales Value Breakup of Branded and Generic Drugs (in %), 2018 and 2023
Figure 16: Japan: Generic Drug Market: Sales Value (in Billion US$), 2019-2024
Figure 17: Japan: Generic Drug Market Forecast: Sales Value (in Billion US$), 2025-2033
Figure 18: Japan: Generic Drug Market: Sales Volume (in Billion Units), 2019-2024
Figure 19: Japan: Generic Drug Market Forecast: Sales Volume (in Billion Units), 2025-2033
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 Industry: SWOT Analysis
Figure 23: Pricing Mechanism and Profit Margins at Various Levels of the Supply Chain 
Figure 24: Japan: Generic Drug Industry: Porter’s Five Forces Analysis 
Figure 25: Japan: Generic Drug Industry: 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 2023
Table 5: Japan: Generic Drug Market: Key Industry Highlights, 2024 and 2033
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)