バイオシミラーの市場規模、シェア、成長分析、薬剤クラス別、適応症別、地域別 - 産業予測 2025年～2032年

バイオシミラーの世界市場規模は2023年に243億米ドルと評価され、2024年の283億8,000万米ドルから2032年には983億1,000万米ドルに成長し、予測期間（2025～2032年）のCAGRは16.8%で成長する見通しです。

世界のバイオシミラー市場は、主にヒュミラやレミケードなどの確立された生物学的製剤の特許が失効し、費用対効果の高い代替品への道が開かれたことにより、加速度的な成長が見込まれています。これらのバイオシミラーは、標準品に比べ通常15～30％低い価格で提供されるため、これまで十分なサービスが提供されていなかった市場での採用を後押ししています。各国政府は、有利な償還政策を通じてバイオシミラー医薬品の導入を促進し、アクセシビリティをさらに高めています。FDAやEMAなどの規制機関は、承認プロセスを合理化し、時間とコストを削減し、市場競争を促進しています。さらに、AIの進歩は、生物学的特性評価と製造効率を改善することにより、バイオシミラー開発に革命をもたらし、研究開発サイクルの短縮と費用の削減につながっています。バイオジェンとインシリコ・メディシンのようなコラボレーションは、AIが業界に変革的な影響を与え、最終的に患者の転帰と市場の実行可能性を高めることを例証しています。

目次

イントロダクション

• 調査の目的
• 調査範囲
• 定義

調査手法

• 情報調達
• 二次と一次データの方法
• 市場規模予測
• 市場の前提条件と制限

エグゼクティブサマリー

• 世界市場の見通し
• 供給と需要の動向分析
• セグメント別機会分析

市場力学と見通し

• 市場概要
• 市場規模
• 市場力学
  • 促進要因と機会
  • 抑制要因と課題
• ポーターの分析

主な市場の考察

• 重要成功要因
• 競合の程度
• 主な投資機会
• 市場エコシステム
• 市場の魅力指数（2024年）
• PESTEL分析
• マクロ経済指標
• バリューチェーン分析
• 価格分析
• 特許分析
• 規制分析
• ケーススタディ

バイオシミラー市場規模：薬剤クラス別& CAGR（2025-2032）

• 市場概要
• モノクローナル抗体
  • インフリキシマブ
  • リツキシマブ
  • トラスツズマブ
  • アダリムマブ
  • その他のモノクローナル抗体
• 顆粒球コロニー刺激因子
• インスリン
• エリスロポエチン
• 組み換えヒト成長ホルモン
• エタネルセプト
• フォリトロピン
• テリパラチド
• インターフェロン
• 抗凝固薬
• その他の薬物クラス

バイオシミラー市場規模：適応症別& CAGR（2025-2032）

• 市場概要
• 腫瘍学
• 炎症性疾患および自己免疫疾患
• 慢性疾患
• 血液疾患
• 成長ホルモン欠乏症
• 感染症
• その他の適応症

バイオシミラー市場規模：地域別& CAGR（2025-2032）

• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • スペイン
  • フランス
  • 英国
  • イタリア
  • その他欧州地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• ラテンアメリカ
  • ブラジル
  • その他ラテンアメリカ地域
• 中東・アフリカ
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ

競合情報

• 上位5社の比較
• 主要企業の市場ポジショニング（2024年）
• 主な市場企業が採用した戦略
• 最近の市場動向
• 企業の市場シェア分析（2024年）
• 主要企業の企業プロファイル
  • 企業の詳細
  • 製品ポートフォリオ分析
  • 企業のセグメント別シェア分析
  • 収益の前年比比較（2022-2024年）

主要企業プロファイル

• Biocon Biologics（India）
• Celltrion（South Korea）
• Sandoz（Switzerland）
• Fresenius Kabi（Germany）
• Teva Pharmaceuticals（Israel）
• Amgen（USA）
• Mylan（USA）
• Coherus BioSciences（USA）
• Alvotech（Iceland）
• Polpharma Biologics（Poland）
• Accord Healthcare（United Kingdom）
• Formycon（Germany）
• Pfizer（USA）

結論と提言

Global Biosimilars Market size was valued at USD 24.3 billion in 2023 and is poised to grow from USD 28.38 billion in 2024 to USD 98.31 billion by 2032, growing at a CAGR of 16.8% during the forecast period (2025-2032).

The global biosimilars market is poised for accelerated growth, primarily fueled by the expiration of patents on established biologic drugs such as Humira and Remicade, paving the way for cost-effective alternatives. These biosimilars provide significant affordability, typically 15-30% less than their reference counterparts, thereby boosting adoption in previously underserved markets. Governments are promoting biosimilar uptake through favorable reimbursement policies, further enhancing accessibility. Regulatory bodies like the FDA and EMA have streamlined approval processes, reducing time and costs, and encouraging market competition. Moreover, advancements in AI are revolutionizing biosimilar development by improving biologic characterization and manufacturing efficiency, leading to shorter R&D cycles and lower expenses. Collaborations, such as that between Biogen and Insilico Medicine, exemplify the transformative impact of AI on the industry, ultimately enhancing patient outcomes and market viability.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Biosimilars market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Biosimilars Market Segments Analysis

Global Biosimilars Market is segmented by Drug Class, Indication and region. Based on Drug Class, the market is segmented into Monoclonal Antibodies, Granulocyte Colony-Stimulating Factor, Insulin, Erythropoietin, Recombinant Human Growth Hormone, Etanercept, Follitropin, Teriparatide, Interferons, Anticoagulants and Other Drug Classes. Based on Indication, the market is segmented into Oncology, Inflammatory & Autoimmune Diseases, Chronic Diseases, Blood Disorders, Growth Hormone Deficiency, Infectious Diseases and Other Indications. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Biosimilars Market

The increasing incidence of chronic illnesses such as cancer, diabetes, and autoimmune disorders is driving the demand for cost-effective biologic therapies. Biosimilars offer affordable alternatives to expensive biologic drugs, thereby improving patient access to essential treatments that can sustain life. As more individuals seek long-term therapeutic options, the uptake of biosimilar medications continues to rise significantly. This trend highlights the vital role that biosimilars play in addressing the healthcare needs of patients while also alleviating financial burdens associated with traditional biologic medicines, thereby fueling the growth of the global biosimilars market.

Restraints in the Global Biosimilars Market

The global biosimilars market faces significant challenges due to stringent regulatory evaluations required to demonstrate safety, efficacy, and quality in comparison to reference biologics. Variations in approval processes across different countries create delays and increase compliance costs for manufacturers. This complex regulatory landscape poses obstacles for biosimilar companies, impacting their ability to launch products effectively and ultimately restricting their market presence. As a result, the growth potential of the biosimilars market may be hindered by these regulatory hurdles, which require substantial time and resources to navigate, thus affecting overall accessibility and competitiveness within the industry.

Market Trends of the Global Biosimilars Market

The global biosimilars market is experiencing significant growth, driven by increasing demand for affordable biologic therapies and advancements in biotechnology. As companies like Arven Pharmaceuticals, established in 2013, enhance their portfolio with complex biosimilars such as Fraven, a Filgrastim biosimilar, the market is poised for further expansion. The rising prevalence of conditions like neutropenia, especially among cancer patients undergoing chemotherapy, has accelerated the adoption of biosimilars, which offer similar efficacy at lower costs. Furthermore, regulatory advancements in regions like the EU and U.S. are facilitating market entry, making biosimilars a fundamental component of the global healthcare landscape.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis
• Patent Analysis
• Regulatory Analysis
• Case Studies

Global Biosimilars Market Size by Drug Class & CAGR (2025-2032)

• Market Overview
• Monoclonal Antibodies
  • Infliximab
  • Rituximab
  • Trastuzumab
  • Adalimumab
  • Other Monoclonal Antibodies
• Granulocyte Colony-Stimulating Factor
• Insulin
• Erythropoietin
• Recombinant Human Growth Hormone
• Etanercept
• Follitropin
• Teriparatide
• Interferons
• Anticoagulants
• Other Drug Classes

Global Biosimilars Market Size by Indication & CAGR (2025-2032)

• Market Overview
• Oncology
• Inflammatory & Autoimmune Diseases
• Chronic Diseases
• Blood Disorders
• Growth Hormone Deficiency
• Infectious Diseases
• Other Indications

Global Biosimilars Market Size & CAGR (2025-2032)

• North America (Drug Class, Indication)
  • US
  • Canada
• Europe (Drug Class, Indication)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Drug Class, Indication)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Drug Class, Indication)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Drug Class, Indication)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• Biocon Biologics (India)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Celltrion (South Korea)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sandoz (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Fresenius Kabi (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Teva Pharmaceuticals (Israel)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Amgen (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Mylan (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Coherus BioSciences (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Alvotech (Iceland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Polpharma Biologics (Poland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Accord Healthcare (United Kingdom)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Formycon (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pfizer (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations