日本仿製药市场：产业趋势、份额、规模、成长、机会及预测（2025-2033）

2024年日本仿製药市场规模达123亿美元。展望未来， IMARC Group预计到2033年市场规模将达到225亿美元，2025-2033年期间的成长率（CAGR）为6.55%。政府越来越多地推行具有成本效益和负担得起的医疗保健政策、人口老龄化加剧、医疗保健成本上升以及医疗保健提供者和患者对仿製药的接受度不断提高，这些都是推动市场增长的主要因素。

日本仿製药市场分析：

• 主要市场驱动力：政府不断推出的旨在降低医疗成本的政策是市场的主要驱动力。政府透过激励措施和优惠法规积极推动仿製药的使用，使其成为品牌药物的经济有效的替代品。医疗保健支出的上涨进一步推动了日本市场的发展。
• 主要市场趋势：国内外製药公司之间日益加强的合作代表了日本仿製药市场的主要趋势。这些合作旨在利用全球专业知识和资源，加强仿製药的开发和分销。另一个值得注意的趋势是仿製药製造技术的进步。
• 竞争格局：该报告也对市场竞争格局进行了全面分析。报告涵盖了市场结构、关键参与者定位、最佳制胜策略、竞争仪表板和公司评估象限等竞争分析。此外，也提供了所有主要公司的详细资料。
• 挑战与机会：市场面临多重挑战，包括严格的监管要求，可能会延迟仿製药的批准和上市。然而，市场也面临着各种机会，包括人口老化和医疗成本上涨推动了对廉价药物的需求。

日本仿製药市场趋势：

不断增长的政府政策和倡议

日本政府积极推动使用仿製药，以降低医疗成本。激励措施、优惠法规和公众意识运动鼓励采用仿製药，使其成为国家医疗保健策略的重要组成部分。根据《日本时报》2024年发表的一篇文章称，日本卫生部的一个小组正在敦促小型製药商与大型製药商合併，以确保日本在仿製药持续短缺的情况下实现仿製药的稳定供应。目前，该产业中约有四分之一的主要生产仿製药的公司，每家公司生产的产品种类超过51种。这极大地促进了日本仿製药市场的成长。

人口老化加剧

日本人口快速老化增加了对平价药物的需求。老年患者通常需要长期治疗慢性病，因此需要具有成本效益的仿製药来减轻医疗保健系统的财务负担。据行业报告称，日本是世界上出生率最低的国家之一，长期以来一直在为如何养老人口而苦苦挣扎。根据联合国报告，以 65 岁以上人口比例衡量，中国是全球人口老化程度最高的国家。根据日本国立社会保障人口问题研究所的预测，到2040年，日本65岁以上人口将占总人口的34.8%。这可能会推动未来几年日本仿製药市场的发展。

医疗成本上涨

随着医疗支出的不断上升，患者和医疗保健提供者都在寻求更经济的治疗选择。据 Ubie Health 称，日本的医疗费用在过去 30 年里一直稳步上升，政府估计预计到 2040 年医疗费用将达到约 4,450 亿美元。由于仿製药在不影响疗效的情况下提供了一种比品牌药更具成本效益的替代品，因此它们越来越受到患者和医疗保健提供者的青睐，使其成为管理医疗预算的一个有吸引力的选择。根据明治发表的文章称，目前，日本药局出售的处方药中约有 80% 是仿製药，预计这一比例还会继续上升，以应对日本日益增长的医疗成本。

竞争格局：

日本仿製药市场的主要参与者受到政府激励措施等因素的驱动，这些措施包括推广使用仿製药来降低医疗成本以及提供有利的监管环境。日本人口老化大大增加了对可负担的长期药物选择的需求，鼓励製药公司扩大其仿製药组合。此外，不断上涨的医疗成本促使医疗服务提供者和患者寻求更经济的治疗方案，从而增加了仿製药的采用。药品製造和配方技术的进步也使主要参与者能够生产高品质的仿製药，确保市场竞争力并遵守严格的监管标准。

日本仿製药市场新闻：

• 2024年6月，泽井製药株式会社宣布将两种三种强度的仿製药列入国民健康保险（NHI）药品价格表。 Sawai 的产品线目前包括 327 种化合物，具有 776 种强度。
• 2023年8月，朝日化成製药宣布，其从瑞典Orphan Biovitrum Japan Co., Ltd.（Sobi Japan）获得的补体蛋白C3抑製剂Empaveli(R)皮下注射液1080毫克（通用名：pegcetacoplan）在日本的独家经销权已列入日本国民药品保险标准。该产品最终于2023年9月4日上市。

本报告回答的关键问题：

• 日本仿製药市场目前表现如何？未来几年又将如何表现？
• 新冠疫情对日本仿製药市场有何影响？
• 日本仿製药市场的价值链分为哪些阶段？
• 日本仿製药市场的主要驱动因素和挑战是什么？
• 日本仿製药市场的结构是怎么样的？主要参与者有哪些？
• 市场的竞争结构是怎么样的？
• 日本仿製药市场的主要参与者/公司有哪些？

本报告回答的关键问题：

• 日本仿製药市场目前表现如何？未来几年又将如何表现？
• 新冠疫情对日本仿製药市场有何影响？
• 日本仿製药市场的价值链分为哪些阶段？
• 日本仿製药市场的主要驱动因素和挑战是什么？
• 日本仿製药市场的结构是怎么样的？主要参与者有哪些？
• 市场的竞争结构是怎么样的？
• 日本仿製药市场的主要参与者/公司有哪些？

目录

第一章：前言

第二章：范围与方法

• 研究目标
• 利害关係人
• 资料来源
  • 主要来源
  • 次要来源
• 市场评估
  • 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：日本仿製药市场－简介

• 什么是仿製药？
• 非品牌和品牌仿製药
• 授权仿製药

第五章：日本仿製药市场为何利润丰厚

• 重磅药物专利到期
• 医疗成本上涨和人口老化加剧
• 日本是仿製药渗透率最低的国家之一
• 配发仿製药的激励措施
• 为付款人和提供者节省大量成本
• 生物相似药

第六章：全球仿製药市场

• 市场表现
• 市场区隔：依国家
• 市场预测
• 处方最多的仿製药和品牌药

第七章：日本仿製药市场

• 日本医药市场表现
• 日本仿製药市场表现

第 8 章：SWOT 分析

• 概述
• 力量
• 弱点
• 机会
• 威胁

第九章：供应链各层级的定价机制与利润率

第 10 章：波特五力分析

• 概述
• 买家的议价能力
• 供应商的议价能力
• 竞争程度
• 新进入者的威胁
• 替代品的威胁

第 11 章：日本仿製药市场-竞争格局

• 日本仿製药市场－竞争结构
• 日本仿製药市场 - 细分：按关键参与者
• 日本仿製药市场-细分：按配销通路

第十二章：日本仿製药市场-价值链分析

• 研究与开发
• 製造业
• 行销
• 分配

第十三章：日本仿製药产业的监管

• 日本仿製药审批途径
  • 活性成分主文件方案
  • 等效性审查
  • 合规审核
• 认证
  • MAH（市场授权持有人）产品核准许可证
  • FMA（外国製造商认可）产品认证
  • DMF（药品主文件）註册
  • GMP（良好生产规范）认证
  • 製造商许可证

第 14 章：日本仿製药市场：关键成功因素

第十五章：日本仿製药市场：障碍

第十六章：设立仿製药生产厂的要求

• 製造过程
• 原料需求
• 原料图片
• 土地和建设要求
• 机械和基础设施需求
• 机械图片
• 工厂布局
• 包装要求
• 实用要求
• 人力需求

第十七章：日本仿製药市场－主要公司简介

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?

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), 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)