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市场调查报告书
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2009429

日本学名药市场:产业趋势、市场占有率、市场规模、成长、机会与预测(2026-2034)

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

出版日期: | 出版商: IMARC | 英文 144 Pages | 商品交期: 2-3个工作天内

价格

2025年,日本学名药市场规模达131亿美元。展望未来,IMARC集团预测,到2034年,该市场规模将达到231亿美元,2026年至2034年的复合年增长率为6.29%。市场成长的主要驱动因素包括:政府推行旨在提高医疗保健成本效益和可负担性的政策、人口老化、医疗保健成本上升以及医疗专业人员和患者对学名药的接受度不断提高。

日本学名药市场趋势:

政府政策和措施的扩展

日本政府正积极推广使用学名药,旨在降低医疗成本。奖励、优惠政策和宣传宣传活动正在推动学名药的普及,仿製药是日本医疗保健策略的关键组成部分。根据《日本时报》2024年发表的报导,厚生劳动省的一个专家小组正强烈敦促中小製药企业与大型企业合併,以确保在学名药持续短缺的情况下,国内供应稳定。目前,约四分之一的学名药生产商生产的产品种类超过51种,这大大促进了日本学名药市场的成长。

人口老化的进程

随着日本人口老化加剧,对价格适中的药品的需求日益增长。老年患者往往需要长期治疗慢性疾病,因此,为了减轻医疗系统的经济负担,对经济实惠的学名药的需求也日益迫切。根据产业报告显示,日本是世界上出生率最低的国家之一,长期以来一直难以应对人口老化问题。联合国的报告指出,以65岁以上人口比例计算,日本是世界上老化程度最高的国家。日本国立人口与社会保障研究所的研究预测,到2040年,65岁以上人口将占总人口的34.8%。这一趋势很可能在未来几年推动日本学名药市场的成长。

医疗保健成本不断上涨

随着医疗保健支出持续成长,患者和医疗服务提供者都在寻求更经济的治疗方案。根据Ubie Health报道,日本的医疗保健支出在过去30年中稳步增长,政府预计到2040年,医疗保健支出将达到约4,450亿美元。学名药因其在不降低疗效的前提下提供品牌药的成本效益替代方案,正日益受到患者和医疗服务提供者的青睐,成为管理医疗保健预算的理想选择。明治製药发表的报导指出,目前日本药局处方药中约80%为学名药,预计这一比例还将继续上升,以应对该国不断增长的医疗保健成本。

报告范围:

IMARC集团发布的这份市场报告全面分析了日本学名药市场的趋势。该研究详细阐述了2026年至2034年日本仿製药市场规模(价值和销售)的变化趋势、新冠疫情的影响以及市场预测。

竞争格局:

日本学名药市场的主要企业正受惠于政府的各项政策,例如推广使用学名药以降低成本,以及创造有利的法规环境。日本人口老化显着增加了对价格适中、长期服用药物的需求,促使製药公司扩大学名药的供应。此外,不断上涨的医疗成本也推动了学名药的普及,因为医疗服务提供者和患者都在寻求更经济的治疗方案。製药生产和製剂技术的进步也使主要企业能够生产高品质的学名药,从而确保市场竞争并符合严格的监管标准。

本报告解答的主要问题

  • 日本学名药市场至今发展状况如何?未来几年预计又将如何发展?
  • 新冠疫情对日本学名药市场产生了哪些影响?
  • 日本学名药市场价值链包含哪些环节?
  • 日本学名药市场的主要驱动因素和挑战是什么?
  • 日本学名药市场的结构是怎么样的?主要企业有哪些?
  • 该市场的竞争结构是怎么样的?
  • 日本学名药市场的主要企业有哪些?

目录

第一章:序言

第二章:调查方法

  • 调查目的
  • 相关利益者
  • 数据来源
    • 主要讯息
    • 二手资讯
  • 市场估值
    • 自下而上的方法
    • 自上而下的方法
  • 预测方法

第三章执行摘要

第四章:日本学名药市场:简介

  • 什么是学名药?
  • 没有品牌名称的学名药和有品牌名称的学名药
  • 核准的学名药

第五章:为什么日本学名药市场如此盈利?

  • 专利即将到期的重磅药物
  • 医疗保健成本不断上涨和人口老化
  • 日本是世界上学名药渗透率最低的国家之一。
  • 奖励分发学名药
  • 为支付方和医疗服务提供者大幅降低成本
  • 生物相似药

第六章:全球学名药市场

  • 市场表现
  • 市场细分:按国家/地区
  • 市场预测
  • 最常开立的学名药和品牌药

第七章:日本学名药市场

  • 日本医药市场趋势
  • 日本学名药市场趋势

第八章 SWOT 分析

第九章:供应链各阶段的定价机制与利润率

第十章:波特五力分析

第十一章 日本学名药市场:竞争格局

  • 日本学名药市场:竞争格局
  • 日本学名药市场:主要企业市占率细分
  • 日本学名药市场:按分销管道分類的市场细分

第十二章:日本学名药市场:价值链分析

  • 研究与开发
  • 製造业
  • 行销
  • 分配

第十三章 日本学名药产业的规章制度

  • 日本学名药核准流程
    • 活性成分主檔案系统
    • 等效性审查
    • 符合性审核
  • 认证
    • 产品核可上市核准持有人(MAH)许可证
    • FMA(外国製造商认证)产品核可认证
    • DMF(药品主文件)註册
    • GMP(良好生产规范)认证
    • 生产许可证

第十四章:日本学名药市场:成功的关键

第十五章:日本学名药市场:障碍

第十六章学名药生产厂的设立要求

  • 製造过程
  • 原料需求
  • 原料照片
  • 场地和施工要求
  • 对机械、设备和基础设施的要求
  • 机器照片
  • 工厂布局
  • 包装要求
  • 公用设施要求
  • 所需人员

第十七章 日本学名药市场:主要企业概况

Product Code: SR112026A698

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?

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 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

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)