日本生物相似药市场报告（按分子、适应症、製造类型和地区）2025-2033

2024年，日本生物相似药市场规模达4.758亿美元。展望未来， IMARC Group预计到2033年，该市场规模将达到34.196亿美元，2025-2033年期间的复合年增长率（CAGR）为22.7%。慢性病盛行率的上升、政府简化审批的措施、人口老化的需求、製药公司的大力参与、成本控制措施、认知度的提高以及产品线的不断扩展，是推动市场发展的一些关键因素。

生物相似药是一种与现有的、已核准的参考生物製剂高度相似且无临床意义差异的生物製品。与小分子仿製药（与品牌药完全相同）相比，生物相似药是源自生物体的大型复杂分子，例如蛋白质或抗体。生物相似药的开发涉及与参考生物製剂的全面比较，涵盖结构、功能和功效等方面。由于生物製剂固有的复杂性，不可能生产出完全相同的复製品；然而，透过严格的测试和监管审批流程，生物相似药在安全性和功效方面已被证明与参考生物製剂高度相似。生物相似药提供了一种比昂贵生物製剂更经济实惠的替代品，并在全球范围内作为应对医疗成本上涨的一种手段而备受推崇，它为医疗系统、从业人员和患者提供了既经济实惠又不损害治疗效果的治疗方案。

日本生物相似药市场趋势：

癌症和糖尿病等慢性病的日益流行，使得具有成本效益的治疗方案成为必要，这主要推动了日本生物相似药市场的成长。同时，日本政府推动使用生物相似药的倡议以及引入监管框架以加快审批流程，大大推动了市场的成长。此外，日本老年人口的增加凸显了对生物相似药等可负担得起的医疗保健解决方案的需求，从而加强了市场的成长。除此之外，大批老牌製药公司在生物相似药研发 (R&D) 方面的大力投资，正在为市场成长提供动力，因为这些公司利用其专业知识和资源来加快生物相似药产品的生产和商业化。同时，国内外製药公司之间的广泛合作与伙伴关係刺激了创新，拓宽了生物相似药产品的范围，这有助于市场的成长。此外，受经济因素驱动，日本对医疗成本控制的追求进一步提振了生物相似药市场，因为这些产品提供了一种在不影响疗效的情况下大幅节省成本的途径。此外，医疗专业人员和患者对生物相似药的认知度和接受度不断提高，对这些替代方案形成了积极的认知，这为市场扩张带来了丰厚的利润。此外，对个人化医疗和标靶治疗的日益重视，以及涵盖众多治疗领域的生物相似药产品线的不断扩展，也为市场成长创造了积极的前景。

日本生物相似药市场细分：

分子洞察：

• 英夫利西单抗
• 甘精胰岛素
• 依泊汀阿尔法
• 依那西普
• 非格司亭
• 生长激素
• 利妥昔单抗
• 促卵泡激素阿尔法
• 阿达木单抗
• 培非格司亭
• 曲妥珠单抗
• 贝伐单抗
• 其他的

指示见解：

• 自体免疫疾病
• 血液疾病
• 糖尿病
• 肿瘤学
• 生长缺陷
• 女性不孕症
• 其他的

製造类型洞察：

• 内部製造
• 合约製造

竞争格局：

市场研究报告也对竞争格局进行了全面的分析。报告涵盖了市场结构、关键参与者定位、最佳制胜策略、竞争仪錶板和公司评估象限等竞争分析。此外，报告还提供了所有主要公司的详细资料。

本报告回答的关键问题：

• 日本生物相似药市场迄今表现如何？未来几年将如何表现？
• COVID-19 对日本生物相似药市场有何影响？
• 日本生物相似药市场依分子划分是怎样的？
• 日本生物相似药市场根据适应症的划分是怎样的？
• 根据製造类型，日本生物相似药市场是如何分類的？
• 日本生物相似药市场的价值链分为哪些阶段？
• 日本生物相似药的关键驱动因素和挑战是什么？
• 日本生物相似药市场的结构是怎么样的？主要参与者是谁？
• 日本生物相似药市场的竞争程度如何？

本报告回答的关键问题：

• 日本生物相似药市场迄今表现如何？未来几年将如何表现？
• COVID-19 对日本生物相似药市场有何影响？
• 日本生物相似药市场依分子划分是怎样的？
• 日本生物相似药市场根据适应症的划分是怎样的？
• 根据製造类型，日本生物相似药市场是如何分類的？
• 日本生物相似药市场的价值链分为哪些阶段？
• 日本生物相似药的关键驱动因素和挑战是什么？
• 日本生物相似药市场的结构是怎么样的？主要参与者是谁？
• 日本生物相似药市场的竞争程度如何？

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：日本生物相似药市场 - 简介

• 概述
• 市场动态
• 产业趋势
• 竞争情报

第五章：日本生物相似药市场格局

• 历史与当前市场趋势（2019-2024）
• 市场预测（2025-2033）

第六章：日本生物相似药市场-细分：依分子

• 英夫利西单抗
  • 概述
• 甘精胰岛素
  • 概述
• 依泊汀阿尔法
  • 概述
• 依那西普
  • 概述
• 非格司亭
  • 概述
• 生长激素
  • 概述
• 利妥昔单抗
  • 概述
• 促卵泡激素阿尔法
  • 概述
• 阿达木单抗
  • 概述
• 培非格司亭
  • 概述
• 曲妥珠单抗
  • 概述
• 贝伐单抗
  • 概述
• 其他的

第七章：日本生物相似药市场-细分：按适应症

• 自体免疫疾病
  • 概述
• 血液疾病
  • 概述
• 糖尿病
  • 概述
• 肿瘤学
  • 概述
• 生长缺陷
  • 概述
• 女性不孕症
  • 概述
• 其他的

第 8 章：日本生物相似药市场 - 细分：按製造类型

• 内部製造
  • 概述
• 合约製造
  • 概述

第九章：日本生物相似药市场-竞争格局

• 概述
• 市场结构
• 市场参与者定位
• 最佳获胜策略
• 竞争仪錶板
• 公司评估象限

第十章：关键参与者简介

• Company A
• Business Overview
• Product Portfolio
• Business Strategies
• SWOT Analysis
• Major News and Events
• Company B
• Business Overview
• Product Portfolio
• Business Strategies
• SWOT Analysis
• Major News and Events
• Company C
• Business Overview
• Product Portfolio
• Business Strategies
• SWOT Analysis
• Major News and Events
• Company D
• Business Overview
• Product Portfolio
• Business Strategies
• SWOT Analysis
• Major News and Events
• Company E
• Business Overview
• Product Portfolio
• Business Strategies
• SWOT Analysis
• Major News and Events

第 11 章：日本生物相似药市场 - 产业分析

• 驱动因素、限制因素和机会
  • 概述
  • 驱动程式
  • 限制
  • 机会
• 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
• 价值链分析

第 12 章：附录

Japan biosimilar market size reached USD 475.8 Million in 2024. Looking forward, IMARC Group expects the market to reach USD 3,419.6 Million by 2033, exhibiting a growth rate (CAGR) of 22.7% during 2025-2033. The increasing chronic disease prevalence, government initiatives for streamlined approvals, aging population demands, strong pharmaceutical company involvement, cost containment efforts, heightened awareness, and expanding product pipelines represent some of the key factors driving the market.

A biosimilaris a biological product that is highly similar to and has no clinically meaningful differences from an existing, already approved reference biologic drug. Compared to generic versions of small-molecule drugs, which are identical replicas of their branded counterparts, biosimilars are large, complex molecules derived from living organisms, such as proteins or antibodies. The development of biosimilars involves a comprehensive comparison with the reference biologic, encompassing aspects like structure, function, and efficacy. Due to the inherent complexity of biologics, it is impossible to produce exact replicas; however, biosimilars are demonstrated to be highly similar in terms of safety and efficacy through rigorous testing and regulatory approval processes. Biosimilars offers a more affordable alternative to expensive biological drug and have gained prominence globally as a means to address the rising costs of healthcare, providing healthcare systems, practitioners, and patients with cost-effective options without compromising therapeutic benefits.

Japan Biosimilar Market Trends:

The increasing prevalence of chronic diseases, such as cancer and diabetes, necessitating cost-effective treatment options is primarily driving the growth of the Japan biosimilar market. In line with this, the Japanese government's initiatives to promote the use of biosimilars, and the introduction of a regulatory framework to expedite the approval process, are significantly fueling the market growth. Moreover, the rising geriatric population in Japan underscores the demand for affordable healthcare solutions, such as biosimilars, strengthening the market growth. Besides this, the strong presence of established pharmaceutical companies investing in biosimilar research and development (R&D) is providing an impetus to the market growth as these companies leverage their expertise and resources to expedite the production and commercialization of biosimilar products. Concurrently, extensive collaborations and partnerships between domestic and international pharmaceutical firms stimulate innovation and widen the scope of biosimilar offerings, which is contributing to the market's growth. Along with this, the push for healthcare cost containment, driven by economic factors, further bolsters the biosimilar market in Japan, as these products provide an avenue for achieving significant cost savings without compromising on treatment efficacy. Additionally, the increasing awareness and acceptance of biosimilars among healthcare professionals and patients, fostering a positive perception of these alternatives, is presenting lucrative opportunities for the market expansion. Furthermore, the growing emphasis on personalized medicine and targeted therapies and the expanding pipeline of biosimilar products encompassing a diverse range of therapeutic areas are creating a positive outlook for the market growth.

Japan Biosimilar Market Segmentation:

Molecule Insights:

• Infliximab
• Insulin Glargine
• Epoetin Alfa
• Etanercept
• Filgrastim
• Somatropin
• Rituximab
• Follitropin Alfa
• Adalimumab
• Pegfilgrastim
• Trastuzumab
• Bevacizumab
• Others

Indication Insights:

• Auto-Immune Diseases
• Blood Disorder
• Diabetes
• Oncology
• Growth Deficiency
• Female Infertility
• Others

Manufacturing Type Insights:

• In-House Manufacturing
• Contract Manufacturing

Competitive Landscape:

The market research report has also provided a comprehensive analysis of the competitive landscape. 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.

Key Questions Answered in This Report:

• How has the Japan biosimilar market performed so far and how will it perform in the coming years?
• What has been the impact of COVID-19 on the Japan biosimilar market?
• What is the breakup of the Japan biosimilar market on the basis of molecule?
• What is the breakup of the Japan biosimilar market on the basis of indication?
• What is the breakup of the Japan biosimilar market on the basis of manufacturing type?
• What are the various stages in the value chain of the Japan biosimilar market?
• What are the key driving factors and challenges in the Japan biosimilar?
• What is the structure of the Japan biosimilar market and who are the key players?
• What is the degree of competition in the Japan biosimilar 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 Biosimilar Market - Introduction

• 4.1 Overview
• 4.2 Market Dynamics
• 4.3 Industry Trends
• 4.4 Competitive Intelligence

5 Japan Biosimilar Market Landscape

• 5.1 Historical and Current Market Trends (2019-2024)
• 5.2 Market Forecast (2025-2033)

6 Japan Biosimilar Market - Breakup by Molecule

• 6.1 Infliximab
  • 6.1.1 Overview
  • 6.1.2 Historical and Current Market Trends (2019-2024)
  • 6.1.3 Market Forecast (2025-2033)
• 6.2 Insulin Glargine
  • 6.2.1 Overview
  • 6.2.2 Historical and Current Market Trends (2019-2024)
  • 6.2.3 Market Forecast (2025-2033)
• 6.3 Epoetin Alfa
  • 6.3.1 Overview
  • 6.3.2 Historical and Current Market Trends (2019-2024)
  • 6.3.3 Market Forecast (2025-2033)
• 6.4 Etanercept
  • 6.4.1 Overview
  • 6.4.2 Historical and Current Market Trends (2019-2024)
  • 6.4.3 Market Forecast (2025-2033)
• 6.5 Filgrastim
  • 6.5.1 Overview
  • 6.5.2 Historical and Current Market Trends (2019-2024)
  • 6.5.3 Market Forecast (2025-2033)
• 6.6 Somatropin
  • 6.6.1 Overview
  • 6.6.2 Historical and Current Market Trends (2019-2024)
  • 6.6.3 Market Forecast (2025-2033)
• 6.7 Rituximab
  • 6.7.1 Overview
  • 6.7.2 Historical and Current Market Trends (2019-2024)
  • 6.7.3 Market Forecast (2025-2033)
• 6.8 Follitropin Alfa
  • 6.8.1 Overview
  • 6.8.2 Historical and Current Market Trends (2019-2024)
  • 6.8.3 Market Forecast (2025-2033)
• 6.9 Adalimumab
  • 6.9.1 Overview
  • 6.9.2 Historical and Current Market Trends (2019-2024)
  • 6.9.3 Market Forecast (2025-2033)
• 6.10 Pegfilgrastim
  • 6.10.1 Overview
  • 6.10.2 Historical and Current Market Trends (2019-2024)
  • 6.10.3 Market Forecast (2025-2033)
• 6.11 Trastuzumab
  • 6.11.1 Overview
  • 6.11.2 Historical and Current Market Trends (2019-2024)
  • 6.11.3 Market Forecast (2025-2033)
• 6.12 Bevacizumab
  • 6.12.1 Overview
  • 6.12.2 Historical and Current Market Trends (2019-2024)
  • 6.12.3 Market Forecast (2025-2033)
• 6.13 Others
  • 6.13.1 Historical and Current Market Trends (2019-2024)
  • 6.13.2 Market Forecast (2025-2033)

7 Japan Biosimilar Market - Breakup by Indication

• 7.1 Auto-Immune Diseases
  • 7.1.1 Overview
  • 7.1.2 Historical and Current Market Trends (2019-2024)
  • 7.1.3 Market Forecast (2025-2033)
• 7.2 Blood Disorder
  • 7.2.1 Overview
  • 7.2.2 Historical and Current Market Trends (2019-2024)
  • 7.2.3 Market Forecast (2025-2033)
• 7.3 Diabetes
  • 7.3.1 Overview
  • 7.3.2 Historical and Current Market Trends (2019-2024)
  • 7.3.3 Market Forecast (2025-2033)
• 7.4 Oncology
  • 7.4.1 Overview
  • 7.4.2 Historical and Current Market Trends (2019-2024)
  • 7.4.3 Market Forecast (2025-2033)
• 7.5 Growth Deficiency
  • 7.5.1 Overview
  • 7.5.2 Historical and Current Market Trends (2019-2024)
  • 7.5.3 Market Forecast (2025-2033)
• 7.6 Female Infertility
  • 7.6.1 Overview
  • 7.6.2 Historical and Current Market Trends (2019-2024)
  • 7.6.3 Market Forecast (2025-2033)
• 7.7 Others
  • 7.7.1 Historical and Current Market Trends (2019-2024)
  • 7.7.2 Market Forecast (2025-2033)

8 Japan Biosimilar Market - Breakup by Manufacturing Type

• 8.1 In-House Manufacturing
  • 8.1.1 Overview
  • 8.1.2 Historical and Current Market Trends (2019-2024)
  • 8.1.3 Market Forecast (2025-2033)
• 8.2 Contract Manufacturing
  • 8.2.1 Overview
  • 8.2.2 Historical and Current Market Trends (2019-2024)
  • 8.2.3 Market Forecast (2025-2033)
  • 8.2.3 Market Forecast (2025-2033)

9 Japan Biosimilar Market - Competitive Landscape

• 9.1 Overview
• 9.2 Market Structure
• 9.3 Market Player Positioning
• 9.4 Top Winning Strategies
• 9.5 Competitive Dashboard
• 9.6 Company Evaluation Quadrant

10 Profiles of Key Players

• 10.1 Company A
  • 10.1.1 Business Overview
  • 10.1.2 Product Portfolio
  • 10.1.3 Business Strategies
  • 10.1.4 SWOT Analysis
  • 10.1.5 Major News and Events
• 10.2 Company B
  • 10.2.1 Business Overview
  • 10.2.2 Product Portfolio
  • 10.2.3 Business Strategies
  • 10.2.4 SWOT Analysis
  • 10.2.5 Major News and Events
• 10.3 Company C
  • 10.3.1 Business Overview
  • 10.3.2 Product Portfolio
  • 10.3.3 Business Strategies
  • 10.3.4 SWOT Analysis
  • 10.3.5 Major News and Events
• 10.4 Company D
  • 10.4.1 Business Overview
  • 10.4.2 Product Portfolio
  • 10.4.3 Business Strategies
  • 10.4.4 SWOT Analysis
  • 10.4.5 Major News and Events
• 10.5 Company E
  • 10.5.1 Business Overview
  • 10.5.2 Product Portfolio
  • 10.5.3 Business Strategies
  • 10.5.4 SWOT Analysis
  • 10.5.5 Major News and Events

11 Japan Biosimilar Market - Industry Analysis

• 11.1 Drivers, Restraints, and Opportunities
  • 11.1.1 Overview
  • 11.1.2 Drivers
  • 11.1.3 Restraints
  • 11.1.4 Opportunities
• 11.2 Porters Five Forces Analysis
  • 11.2.1 Overview
  • 11.2.2 Bargaining Power of Buyers
  • 11.2.3 Bargaining Power of Suppliers
  • 11.2.4 Degree of Competition
  • 11.2.5 Threat of New Entrants
  • 11.2.6 Threat of Substitutes
• 11.3 Value Chain Analysis

12 Appendix