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1729645

日本學名藥市場：產業趨勢、佔有率、規模、成長、機會及預測（2025-2033）

Japan Generic Drug Market: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2025-2033

出版日期: 2025年05月01日 | 出版商:

IMARC | 英文 118 Pages | 商品交期: 5-7個工作天內

價格

簡介目錄圖表

2024年日本學名藥市場規模達123億美元。展望未來， IMARC Group預計到2033年市場規模將達到225億美元，2025-2033年期間的成長率（CAGR）為6.55%。政府擴大推行具有成本效益和負擔得起的醫療保健政策、人口老齡化加劇、醫療保健成本上升以及醫療保健提供者和患者對學名藥的接受度不斷提高，這些都是推動市場成長的主要因素。

日本學名藥市場分析：

主要市場驅動力：政府不斷推出的旨在降低醫療成本的政策是市場的主要驅動力。政府透過激勵措施和優惠法規積極推動學名藥的使用，使其成為品牌藥物的經濟有效的替代品。醫療保健支出的上漲進一步推動了日本市場的發展。
主要市場趨勢：國內外製藥公司之間日益加強的合作代表了日本學名藥市場的主要趨勢。這些合作旨在利用全球專業知識和資源，加強學名藥的開發和分銷。另一個值得注意的趨勢是學名藥製造技術的進步。
競爭格局：該報告也對市場競爭格局進行了全面分析。報告涵蓋了市場結構、關鍵參與者定位、最佳制勝策略、競爭儀表板和公司評估象限等競爭分析。此外，也提供了所有主要公司的詳細資料。
挑戰與機會：市場面臨多重挑戰，包括嚴格的監管要求，可能會延遲學名藥的批准和上市。然而，市場也面臨著各種機遇，包括人口老化和醫療成本上漲推動了對廉價藥物的需求。

日本學名藥市場趨勢：

不斷成長的政府政策和舉措

日本政府積極推動使用學名藥，以降低醫療成本。激勵措施、優惠法規和公眾意識運動鼓勵採用學名藥，使其成為國家醫療保健策略的重要組成部分。根據《日本時報》2024年發表的一篇文章稱，日本衛生部的一個小組正在敦促小型製藥商與大型製藥商合併，以確保日本在學名藥持續短缺的情況下實現學名藥的穩定供應。目前，該產業中約有四分之一的主要生產學名藥的公司，每家公司生產的產品種類超過51種。這極大地促進了日本學名藥市場的成長。

人口老化加劇

日本人口快速老化增加了對平價藥物的需求。老年患者通常需要長期治療慢性病，因此需要具有成本效益的學名藥來減輕醫療保健系統的財務負擔。據行業報告稱，日本是世界上出生率最低的國家之一，長期以來一直在為如何養老人口而苦苦掙扎。根據聯合國報告，以 65 歲以上人口比例衡量，中國是全球人口老化程度最高的國家。根據日本國立社會保障人口問題研究所的預測，到2040年，日本65歲以上人口將佔總人口的34.8%。這可能會推動未來幾年日本學名藥市場的發展。

醫療成本上漲

隨著醫療支出的不斷上升，患者和醫療保健提供者都在尋求更經濟的治療選擇。據 Ubie Health 稱，日本的醫療費用在過去 30 年裡一直穩步上升，政府估計預計到 2040 年醫療費用將達到約 4,450 億美元。由於學名藥在不影響療效的情況下提供了一種比品牌藥更具成本效益的替代品，因此它們越來越受到患者和醫療保健提供者的青睞，使其成為管理醫療預算的一個有吸引力的選擇。根據明治發表的文章稱，目前，日本藥局出售的處方藥中約有 80% 是學名藥，預計這一比例還會繼續上升，以應對日本日益成長的醫療成本。

競爭格局：

日本學名藥市場的主要參與者受到政府激勵措施等因素的驅動，這些措施包括推廣使用學名藥來降低醫療成本以及提供有利的監管環境。日本人口老化大大增加了對可負擔的長期藥物選擇的需求，鼓勵製藥公司擴大其學名藥組合。此外，不斷上漲的醫療成本促使醫療服務提供者和患者尋求更經濟的治療方案，從而增加了學名藥的採用。藥品製造和配方技術的進步也使主要參與者能夠生產高品質的學名藥，確保市場競爭力並遵守嚴格的監管標準。

日本學名藥市場新聞：

2024年6月，澤井製藥株式會社宣布將兩種三種強度的學名藥列入國民健康保險（NHI）藥品價格表。 Sawai 的產品線目前包括 327 種化合物，具有 776 種強度。
2023年8月，朝日化成製藥宣布，其從瑞典Orphan Biovitrum Japan Co., Ltd.（Sobi Japan）獲得的補體蛋白C3抑製劑Empaveli(R)皮下注射液1080毫克（通用名：pegcetacoplan）在日本的獨家經銷權已列入日本國民藥品保險標準。該產品最終於2023年9月4日上市。

本報告回答的關鍵問題：

日本學名藥市場目前表現如何？未來幾年又將如何表現？
新冠疫情對日本學名藥市場有何影響？
日本學名藥市場的價值鏈分為哪些階段？
日本學名藥市場的主要促進因素和挑戰是什麼？
日本學名藥市場的結構是怎麼樣的？主要參與者有哪些？
市場的競爭結構是怎麼樣的？
日本學名藥市場的主要參與者/公司有哪些？

本報告回答的關鍵問題：

日本學名藥市場目前表現如何？未來幾年又將如何表現？
新冠疫情對日本學名藥市場有何影響？
日本學名藥市場的價值鏈分為哪些階段？
日本學名藥市場的主要促進因素和挑戰是什麼？
日本學名藥市場的結構是怎麼樣的？主要參與者有哪些？
市場的競爭結構是怎麼樣的？
日本學名藥市場的主要參與者/公司有哪些？

The Japan generic drug market size reached USD 12.3 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 22.5 Billion by 2033, exhibiting a growth rate (CAGR) of 6.55% during 2025-2033. The growing government policies promoting cost-effective and affordable healthcare, the increasing ageing population, the rising healthcare costs, and the growing acceptance of generics among healthcare providers and patients are some of the major factors propelling the growth of the market.

Japan Generic Drug Market Analysis:

Major Market Drivers: The rising government policies aimed at reducing healthcare costs represent the major drivers of the market. the government actively promotes the use of generic drugs through incentives and favorable, regulations, making them a cost-effective alternative to branded medications. The rising healthcare expenditures further propel the market in Japan.
Key Market Trends: The increasing collaboration between domestic and international pharmaceutical companies represents the key Japan generic drug market trends. These partnerships aim to enhance the development and distribution of generic medications, leveraging global expertise and resources. Another notable trend is the technological advancement in generic drug manufacturing.
Competitive Landscape: The report has also provided a comprehensive analysis of the competitive landscape in the market. Competitive analysis such as market structure, key player positioning, top winning strategies, competitive dashboard, and company evaluation quadrant has been covered in the report. Also, detailed profiles of all major companies have been provided.
Challenges and Opportunities: The market faces several challenges including strict regulatory requirements, which can delay the approval and launch of generic medications. However, the market also faces various opportunities including an aging population and rising healthcare costs driving demand for affordable medications.

Japan Generic Drug Market Trends:

Growing Government Policies and Initiatives

The Japanese government actively promotes the use of generic drugs to reduce healthcare costs. Incentives, favorable regulations, and public awareness campaigns encourage the adoption of generics, making them a key component of the national healthcare strategy. According to an article published by the Japan Times in 2024, a health ministry panel is urging small drugmakers to merge with their bigger counterparts to ensure a stable supply of generic drugs in Japan amid an ongoing shortage. At present, around a quarter of the companies in the industry that primarily manufacture generic drugs, each produce more than 51 products. This is boosting the Japan generic drug market growth significantly.

Increasing Aging Population

Japan's rapidly aging population increases the demand for affordable medications. Elderly patients often require long-term treatment for chronic conditions, driving the need for cost-effective generic drugs to manage the financial burden on the healthcare system. According to the industry report, Japan has one of the lowest birth rates in the world and has long struggled with how to provide for its aging population. It has the world's oldest population, measured by the proportion of people aged 65 or up, as per the United Nations report. In Japan, those aged over 65 years are expected to account for 34.8% of the population by 2040, according to the National Institute of Population and Social Security Research. This is likely to fuel the Japan generic drug market forecast over the coming years.

Rising Healthcare Costs

As healthcare expenditures continue to rise, both patients and healthcare providers seek more economical treatment options. According to Ubie Health, Japan's healthcare expenses have been on a steady rise since the past 30 years with the government estimates predicting healthcare expenses to be approximately 445 billion dollars in the year 2040. Since generic drugs offer a cost-effective alternative to branded medications without compromising efficacy, they are increasing gaining traction among both the patients and healthcare providers, making them an attractive choice in managing healthcare budgets. According to an article published by Meiji, at present, about 80% of the prescribed drugs available at pharmacies in Japan are generic drugs, which is expected to only witness a rise to cope with the increasing healthcare costs in the country.

Competitive Landscape:

Key players in the Japan generic drug market are driven by factors such as government incentives promoting the use of generics to reduce healthcare costs and providing a favorable regulatory environment. The aging population in Japan significantly boosts demand for affordable, long-term medication options, encouraging pharmaceutical companies to expand their generic drug portfolios. Additionally, rising healthcare costs push both providers and patients towards more economical treatment alternatives, increasing the adoption of generic drugs. Technological advancements in drug manufacturing and formulation also enable key players to produce high-quality generics, ensuring market competitiveness and compliance with stringent regulatory standards.

Japan Generic Drug Market News:

In June 2024, Sawai Pharmaceutical Co., Ltd. announced the listing of two generic drugs with three strengths in the National Health Insurance (NHI) drug price list. Sawai's product line now includes 327 compounds with 776 strengths.
In August 2023, Asahi Kasei Pharma announced that Empaveli(R) Subcutaneous Injection 1080 mg (generic name: pegcetacoplan), a complement protein C3 inhibitor, for which it obtained exclusive distribution rights in Japan from Swedish Orphan Biovitrum Japan Co., Ltd. (Sobi Japan), has been listed on Japan's National Health Insurance (NHI) drug price standard. The product was finally launched in September 4, 2023.

Key Questions Answered in This Report:

How has the Japan generic drug market performed so far, and how will it perform in the coming years?
What has been the impact of COVID-19 on the Japan generic drug market?
What are the various stages in the value chain of the Japan generic drug market?
What are the key driving factors and challenges in the Japan generic drug market?
What is the structure of the Japan generic drug market, and who are the key players?
What is the competitive structure of the market?
Who are the key players/companies in the 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

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 USD), 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 USD), 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 %), 2019 and 2024
Figure 15: Japan: Pharmaceutical Market: Sales Value Breakup of Branded and Generic Drugs (in %), 2019 and 2024
Figure 16: Japan: Generic Drug Market: Sales Value (in Billion USD), 2019-2024
Figure 17: Japan: Generic Drug Market Forecast: Sales Value (in Billion USD), 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 USD) and Patent Expiry of Major Drugs Expected to Lose Patent Protection (in Billion USD)
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 USD)
Table 10: Generic Oncology Drug Manufacturing Plant: Costs Related to Salaries and Wages (in USD)
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 USD Million)
Table 16: Sawai Pharmaceutical Co., Ltd: Key Financials (in USD Million)
Table 17: Towa Pharmaceutical: Key Financials (in USD Million)
Table 18: Teva Pharmaceutical Ltd: Key Financials (in USD Million)
Table 19: Fuji Pharma Co Ltd: Key Financials (in USD Million)