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1347359

日本學名藥市場：2023-2028 年行業趨勢、佔有率、規模、成長、機遇和預測

Japan Generic Drug Market: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028

出版日期: 2023年09月04日 | 出版商:

IMARC | 英文 115 Pages | 商品交期: 2-3個工作天內

價格

簡介目錄圖表

市場概況：

2022年日本學名藥市場規模達到107億美元。展望未來，IMARC Group預計到2028年市場規模將達到169億美元，2023-2028年復合年成長率（CAGR）為7.8%。

按價值計算，日本是全球第八大學名藥市場。然而，與美國和歐洲等其他發達市場相比，學名藥在日本的滲透率傳統上相對較低。從歷史上看，日本學名藥的滲透率較低有幾個原因。其中包括：對學名藥品質較差的看法、醫生和患者對品牌藥的偏好以及醫生通過開低價學名藥從藥品價格差異中獲得的利潤有限。由於日本藥劑師缺乏學名藥替代權、藥品核准過程的審查時間較慢以及與主要藥品經銷商合作的困難（其中許多經銷商與主要品牌藥品製造商關係密切），學名藥在日本仍然不太受歡迎。

然而，日本學名藥市場的格局在過去十年中發生了顯著變化。日本政府已確定該國學名藥市場的成長對於日本的長期經濟健康至關重要。日本政府認知到該國人口老齡化加劇以及品牌藥品成本不斷上漲，已開始改變醫療保健政策，以削減醫療費用支出。藥品費用約佔日本醫療總費用的五分之一，減輕這一負擔已成為日本衛生行政政策的基石。用低成本學名藥替代創新產品已被確定為一種可以節省大量資金的策略。在這些舉措的推動下，學名藥的滲透率在過去幾年中強勁成長。預計這將為日本國內外學名藥製造商創造巨大的機會。

這份題為《日本學名藥市場：2023-2028年行業趨勢、佔有率、規模、成長、機遇和預測》的報告對日本學名藥市場的歷史、當前和未來市場趨勢進行了深入分析。該研究報告是了解日本學名藥市場的促進因素、銷售趨勢、處方趨勢、市場結構、競爭格局、法規、主要參與者、關鍵藥物、製造和前景的特殊工具。該報告可以為投資者、研究人員、顧問、行銷策略師以及所有想要深入了解日本學名藥市場的人提供出色的指南。

回答的關鍵問題：

什麼是學名藥？它們與品牌藥有何不同？

近年來日本學名藥市場表現如何？

COVID-19 對日本學名藥市場有何影響？

與品牌藥相比，學名藥的表現如何？

日本學名藥的總銷售額和處方量是多少？

誰是日本學名藥市場的主要參與者？他們的表現如何？

日本學名藥市場結構如何？

日本學名藥的定價機制是怎樣的？

日本學名藥的價值鍊是怎樣的？

日本對學名藥有哪些規定？

日本的學名藥是如何銷售的？

學名藥是如何生產的？

生產學名藥對原料和機械有哪些要求？

日本學名藥市場的促進因素和挑戰是什麼？

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. 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 2023-2028" 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?

What has been the impact of COVID-19 on the Japan generic drug market?

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 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

簡介目錄圖表

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$), 2017-2022
Figure 5: Global: Generic Drug Market: Sales Volume (in Billion Units), 2017-2022
Figure 6: Global: Generic Drug Market: Sales Value Breakup by Country (in %), 2022
Figure 7: Global: Generic Drug Market: Sales Volume Breakup by Country (in %), 2022
Figure 8: Global: Generic Drug Market Forecast: Sales Value (in Billion US$), 2023-2028
Figure 9: Global: Generic Drug Market Forecast: Sales Volume (in Billion Units), 2023-2028
Figure 10: Japan: Pharmaceutical Market: Sales Value (in Billion JPY), 2017-2022
Figure 11: Japan: Pharmaceutical Market: Sales Volume (in Billion Units), 2017-2022
Figure 12: Japan: Pharmaceutical Market Forecast: Sales Value (in Billion JPY), 2023-2028
Figure 13: Japan: Pharmaceutical Market Forecast: Sales Volume (in Billion Units), 2023-2028
Figure 14: Japan: Pharmaceutical Market: Sales Volume Breakup of Branded and Generic Drugs (in %), 2017 and 2022
Figure 15: Japan: Pharmaceutical Market: Sales Value Breakup of Branded and Generic Drugs (in %), 2017 and 2022
Figure 16: Japan: Generic Drug Market: Sales Value (in Billion US$), 2017-2022
Figure 17: Japan: Generic Drug Market Forecast: Sales Value (in Billion US$), 2023-2028
Figure 18: Japan: Generic Drug Market: Sales Volume (in Billion Units), 2017-2022
Figure 19: Japan: Generic Drug Market Forecast: Sales Volume (in Billion Units), 2023-2028
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 2021
Table 5: Japan: Generic Drug Market: Key Industry Highlights, 2022 and 2028
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)