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2009429

日本學名藥市場：產業趨勢、市場佔有率、市場規模、成長、機會與預測（2026-2034）

Japan Generic Drug Market: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2026-2034

出版日期: 2026年04月01日 | 出版商:

IMARC | 英文 144 Pages | 商品交期: 2-3個工作天內

價格

簡介目錄圖表

2025年，日本學名藥市場規模達131億美元。展望未來，IMARC Group預測，到2034年，該市場規模將達到231億美元，2026年至2034年的複合年成長率為6.29%。市場成長的主要促進因素包括：政府推行旨在提高醫療保健成本效益和可負擔性的政策、人口老化、醫療保健成本上升以及醫療專業人員和患者對學名藥的接受度不斷提高。

日本學名藥市場趨勢：

政府政策和措施的擴展

日本政府正積極推廣使用學名藥，旨在降低醫療成本。獎勵、優惠政策和宣傳宣傳活動正在推動學名藥的普及，學名藥是日本醫療保健策略的關鍵組成部分。根據《日本時報》2024年發表的報導，厚生勞動省的一個專家小組正強烈敦促中小製藥企業與大型企業合併，以確保在學名藥持續短缺的情況下，國內供應穩定。目前，約四分之一的學名藥生產商生產的產品種類超過51種，這大大促進了日本學名藥市場的成長。

人口老化的進程

隨著日本人口老化加劇，對價格適中的藥品的需求日益成長。老年患者往往需要長期治療慢性疾病，因此，為了減輕醫療系統的經濟負擔，對經濟實惠的學名藥的需求也日益迫切。根據產業報告顯示，日本是世界上出生率最低的國家之一，長期以來一直難以應對人口老化問題。聯合國的報告指出，以65歲以上人口比例計算，日本是世界上老化程度最高的國家。日本國立人口與社會保障研究所的研究預測，到2040年，65歲以上人口將佔總人口的34.8%。這一趨勢很可能在未來幾年推動日本學名藥市場的成長。

醫療保健成本不斷上漲

隨著醫療保健支出持續成長，患者和醫療服務提供者都在尋求更經濟的治療方案。根據Ubie Health報道，日本的醫療保健支出在過去30年中穩步成長，政府預計到2040年，醫療保健支出將達到約4,450億美元。學名藥因其在不降低療效的前提下提供品牌藥的成本效益替代方案，正日益受到患者和醫療服務提供者的青睞，成為管理醫療保健預算的理想選擇。明治製藥發表的報導指出，目前日本藥局處方藥中約80%為學名藥，預計這一比例還將繼續上升，以應對該國不斷成長的醫療保健成本。

報告範圍：

IMARC Group發布的這份市場報告全面分析了日本學名藥市場的趨勢。該研究詳細闡述了2026年至2034年日本學名藥市場規模（價值和銷售）的變化趨勢、新冠疫情的影響以及市場預測。

競爭格局：

日本學名藥市場的主要企業正受惠於政府的各項政策，例如推廣使用學名藥以降低成本，以及創造有利的法規環境。日本人口老化顯著增加了對價格適中、長期服用藥物的需求，促使製藥公司擴大學名藥的供應。此外，不斷上漲的醫療成本也推動了學名藥的普及，因為醫療服務提供者和患者都在尋求更經濟的治療方案。製藥生產和製劑技術的進步也使主要企業能夠生產高品質的學名藥，從而確保市場競爭並符合嚴格的監管標準。

本報告解答的主要問題

日本學名藥市場至今發展狀況如何？未來幾年預計又將如何發展？
新冠疫情對日本學名藥市場產生了哪些影響？
日本學名藥市場價值鏈包含哪些環節？
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？主要企業有哪些？
該市場的競爭結構是怎麼樣的？
日本學名藥市場的主要企業有哪些？

The Japan generic drug market size reached USD 13.1 Billion in 2025. Looking forward, IMARC Group expects the market to reach USD 23.1 Billion by 2034, exhibiting a growth rate (CAGR) of 6.29% during 2026-2034. 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.

REPORT COVERAGE:

The market report by IMARC Group provides extensive coverage of the performance of the generic drug market in Japan. The study provides in-depth information about the value and volume trends, COVID-19 impact, and market forecast from 2026-2034.

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.

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), 2020-2025
Figure 5: Global: Generic Drug Market: Sales Volume (in Billion Units), 2020-2025
Figure 6: Global: Generic Drug Market: Sales Value Breakup by Country (in %), 2025
Figure 7: Global: Generic Drug Market: Sales Volume Breakup by Country (in %), 2025
Figure 8: Global: Generic Drug Market Forecast: Sales Value (in Billion USD), 2026-2034
Figure 9: Global: Generic Drug Market Forecast: Sales Volume (in Billion Units), 2026-2034
Figure 10: Japan: Pharmaceutical Market: Sales Value (in Billion JPY), 2020-2025
Figure 11: Japan: Pharmaceutical Market: Sales Volume (in Billion Units), 2020-2025
Figure 12: Japan: Pharmaceutical Market Forecast: Sales Value (in Billion JPY), 2026-2034
Figure 13: Japan: Pharmaceutical Market Forecast: Sales Volume (in Billion Units), 2026-2034
Figure 14: Japan: Pharmaceutical Market: Sales Volume Breakup of Branded and Generic Drugs (in %), 2020-2025
Figure 15: Japan: Pharmaceutical Market: Sales Value Breakup of Branded and Generic Drugs (in %), 2020-2025
Figure 16: Japan: Generic Drug Market: Sales Value (in Billion USD), 2020-2025
Figure 17: Japan: Generic Drug Market Forecast: Sales Value (in Billion USD), 2026-2034
Figure 18: Japan: Generic Drug Market: Sales Volume (in Billion Units), 2020-2025
Figure 19: Japan: Generic Drug Market Forecast: Sales Volume (in Billion Units), 2026-2034
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, 2025 and 2034
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)