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

  • ID: 4763077
  • Report
  • April 2019
  • Region: Japan
  • 98 pages
  • IMARC Group
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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?
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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 Tables and Figures are available on enquiry
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