日本のバイオシミラー市場レポート：分子、適応症、製造タイプ、地域別、2025年～2033年

日本のバイオシミラー市場規模は2024年に4億7,580万米ドルに達しました。今後、IMARC Groupは、同市場が2033年までに34億1,960万米ドルに達し、2025年から2033年にかけて22.7%の成長率（CAGR）を示すと予測しています。慢性疾患の増加、承認の合理化を目指す政府の取り組み、高齢化社会の需要、製薬会社の強力な関与、コスト抑制の取り組み、意識の高まり、製品パイプラインの拡大などが市場を牽引する主な要因となっています。

本レポートで扱う主な質問

• 日本のバイオシミラー市場はこれまでどのように推移し、今後どのように推移するのか？
• COVID-19が日本バイオシミラー市場に与えた影響は？
• 日本のバイオシミラー市場の分子別区分は？
• 日本のバイオシミラー市場の適応症別の区分は？
• 日本のバイオシミラー市場の製造タイプ別区分は？
• 日本のバイオシミラー市場のバリューチェーンにおける各段階とは？
• 日本のバイオシミラーの主要な促進要因と課題は何か？
• 日本のバイオシミラー市場の構造と主要プレーヤーは？
• 日本のバイオシミラー市場における競合の程度は？

目次

第1章 序文

第2章 調査範囲と調査手法

• 調査の目的
• ステークホルダー
• データソース
• 市場推定
• 調査手法

第3章 エグゼクティブサマリー

第4章 日本のバイオシミラー市場- イントロダクション

• 概要
• 市場力学
• 業界動向
• 競合情報

第5章 日本のバイオシミラー市場情勢

• 過去および現在の市場動向（2019～2024年）
• 市場予測（2025～2033年）

第6章 日本のバイオシミラー市場- 分子別の内訳

• インフリキシマブ
• インスリングラルギン
• エポエチンアルファ
• エタネルセプト
• フィルグラスチム
• ソマトロピン
• リツキシマブ
• フォリトロピンアルファ
• アダリムマブ
• ペグフィルグラスチム
• トラスツズマブ
• ベバシズマブ
• その他

第7章 日本のバイオシミラー市場- 適応症別の内訳

• 自己免疫疾患
• 血液疾患
• 糖尿病
• 腫瘍学
• 成長不全
• 女性の不妊症
• その他

第8章 日本のバイオシミラー市場- 製造タイプ別の内訳

• 社内製造
• 契約製造

第9章 日本のバイオシミラー市場-競合情勢

• 概要
• 市場構造
• 市場企業のポジショニング
• 主要成功戦略
• 競合ダッシュボード
• 企業評価象限

第10章 主要企業のプロファイル

第11章 日本のバイオシミラー市場- 業界分析

• 促進要因・抑制要因・機会
• ポーターのファイブフォース分析
• バリューチェーン分析

第12章 付録

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