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Japan Generic Drug Market: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2018-2023

Japan Generic Drug Market: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2018-2023

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 2018-2023” 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 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 Current and Historical Market Trends
6.1.1 Value Trends
6.1.2 Volume Trends
6.2 Market Breakup by Country
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 Strength
8.2 Weakness
8.3 Opportunities
8.4 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 - Sales Breakup of Key Players
11.3 Japan Generic Drug Market – Distribution Breakup by Channels
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 Machinery and Infrastructure 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$), 2010-2017
Figure 5: Global: Generic Drug Market: Sales Volume (in Billion Units), 2010-2017
Figure 6: Global: Generic Drug Market: Sales Value Breakup by Country (in %), 2017
Figure 7: Global: Generic Drug Market: Sales Volume Breakup by Country (in %), 2017
Figure 8: Global: Generic Drug Market Forecast: Sales Value (in Billion US$), 2018-2023
Figure 9: Global: Generic Drug Market Forecast: Sales Volume (in Billion Units), 2018-2023
Figure 10: Japan: Pharmaceutical Market: Sales Value (in Billion ), 2010-2017
Figure 11: Japan: Pharmaceutical Market: Sales Volume (in Billion Units), 2010-2017
Figure 12: Japan: Pharmaceutical Market Forecast: Sales Value (in Billion JPY), 2018-2023
Figure 13: Japan: Pharmaceutical Market Forecast: Sales Volume (in Billion Units), 2018-2023
Figure 14: Japan: Pharmaceutical Market: Sales Volume Breakup of Branded and Generic Drugs (in %), 2010 and 2017
Figure 15: Japan: Pharmaceutical Market: Sales Value Breakup of Branded and Generic Drugs (in %), 2010 and 2017
Figure 16: Japan: Generic Drug Market: Sales Value (in Billion JPY), 2010-2017
Figure 17: Japan: Generic Drug Market Forecast: Sales Value (in Billion JPY), 2018-2023
Figure 18: Japan: Generic Drug Market: Sales Volume (in Billion Units), 2010-2017
Figure 19: Japan: Generic Drug Market Forecast: Sales Volume (in Billion Units), 2018-2023
Figure 20: Japan: Generic Drug Market: Sales Share of Top Players (in %), 2017
Figure 21: Japan: Generic Drug Market: SWOT Analysis
Figure 22: Pricing Mechanism and Profit Margins at Various Levels of the Supply Chain
Figure 23: Japan: Generic Drug Market: Porter’s Five Forces Analysis
Figure 24: Japan: Generic Drug Market: Value Chain Analysis
Figure 25: Japan: Generic Drug Market: Detailed Process Flow
Figure 26: Japan: Generic Drug Market: Raw Material Requirements
Figure 27: Japan: Generic Drug Market: Plan Layout
Figure 28: Japan: Generic Drug Market: Packaging Requirements
Figure 29: Japan: Approval Pathway for a Generic Drug
List of Tables
Table 1: Japan: Sales (in Billion JPY) and Patent Expiry of Major Drugs Expected to Lose Patent Protection
Table 2: Japan: History of Major Government Policies to Encourage the Use of Generic Drugs
Table 3: Global: Generic Drug Market: Sales Volume and Growth of Major Markets, 2017
Table 4: Global: Generic Drug Market: Volume Performance of Top Generic Drugs (in Million Prescriptions), 2017
Table 5: Global: Branded Drug Market: Volume Performance of Top Branded Drugs (in Million Prescriptions), 2017
Table 6: Generics Manufacturing Plant: Land and Construction Requirements
Table 7: Generics Manufacturing Plant: Machinery and Infrastructure Requirements
Table 8: Generics Manufacturing Plant: Utility Requirements
Table 9: Generics Manufacturing Plant: Manpower Requirements
Table 10: Japan: Generic Drug Market: Sales Values of Key Manufacturers (in Million JPY), 2017

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