日本のジェネリック医薬品市場：産業動向・競合状況・機会・展望

日本は金額ベースで世界第8位のジェネリック医薬品市場となっています。しかし、これまでの日本におけるジェネリック医薬品の普及率は、米国や欧州といった他の先進市場と比較して比較的低くなっています。政府は2017年までにジェネリック医薬品の普及率が60%を達成するという目標を定めています。これは国内および外国のジェネリック医薬品メーカーにとって、巨大な機会を生み出すと見込まれています。

当レポートでは、日本のジェネリック医薬品市場における過去・現在・将来の市場動向を詳細に分析し、市場の促進因子、売上動向、処方動向、市場構造、競合状況、規制、主要企業、主要医薬品、製造および展望など、体系的な情報を提供しています。

第1章 調査手法・市場定義

第2章 調査サマリー

第3章 日本のジェネリック医薬品市場：イントロダクション

• ジェネリック医薬品とは？
• ノーブランド・ブランドジェネリック医薬品
• 認定ジェネリック医薬品

第4章 日本のジェネリック医薬品市場が非常に収益が大きい理由

• 特許期限切れとなるブロックバスター医薬品
• 人口高齢化の拡大に伴う医療費の増加
• 日本はジェネリック医薬品の普及率が最も低い国のひとつ
• 調剤ジェネリック医薬品のインセンティブ
• 企業・プロバイダーの大幅な節約
• バイオシミラー

第5章 世界のジェネリック医薬品市場

• 現在・過去の市場動向
• 市場分類：国別
• 市場予測
• 最も処方されたジェネリック医薬品・ブランド医薬品

第6章 日本のジェネリック医薬品市場

• 現在・これまでの市場動向
• ブランド医薬品・ジェネリック医薬品のシェア
• 現在・過去・将来の売上動向
• 現在・過去・将来の売上 (数量) 動向

第7章 日本のジェネリック医薬品市場：競合状況

• 競合構造
• 主要企業の売上分析
• 流通分析：チャネル別

第8章 日本のジェネリック医薬品市場：バリューチェーン分析

• 研究・開発
• 製造
• マーケティング
• 流通

第9章　日本のジェネリック医薬品産業における規制

• 日本におけるジェネリック医薬品の認可手順
• 仕様

第10章　日本のジェネリック医薬品市場：主な成功要因

第11章　日本のジェネリック医薬品市場：

第12章　ジェネリック医薬品製造工場の設立要件

• 製造工程
• 原材料の要件
• 機械・インフラの要件

第13章　日本のジェネリック医薬品市場：主要企業のプロファイル

• Teva Pharmaceutical Ltd.
• 沢井製薬
• 日医工
• Pfizer Japan Inc.
• Meiji Seika ファルマ
• 東和薬品
• ニプロ
• 富士薬品
• 第一三共エスファ
• 日本ジェネリック

図表

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)

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, XXXXXCompetitive LandscapeYYYYY, 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?

Table of Contents

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