生物相似藥市場規模、佔有率、成長分析（按藥品類別、適應症和地區）—2025 年至 2032 年產業預測

2023 年全球生物相似藥市場規模為 243 億美元，預計將從 2024 年的 283.8 億美元成長到 2032 年的 983.1 億美元，預測期內（2025-2032 年）的複合年成長率為 16.8%。

全球生物相似藥市場預計將加速成長，這主要歸因於Humira和Remicade等成熟生物製藥的專利到期，為具有成本效益的替代品鋪平了道路。這些生物相似藥的價格通常比參考藥物低 15-30%，從而刺激了它們在先前服務不足的市場中的應用。各國政府正透過優惠的報銷政策促進生物相似藥的引進，進一步提高其可及性。 FDA 和 EMA 等監管機構正在簡化核准流程，減少時間和成本，並增加市場競爭。此外，人工智慧的進步正在透過改善生物特性和製造效率徹底改變生物相似藥的發展，從而縮短研發週期並降低成本。 Biogen 和In Silico Medicine 等合作體現了人工智慧可以對產業產生的變革性影響，最終改善患者的治療效果和市場可行性。

目錄

介紹

• 調查目的
• 研究範圍
• 定義

調查方法

• 資訊採購
• 二次資料和一次資料方法
• 市場規模預測
• 市場假設與限制

執行摘要

• 全球市場展望
• 供需趨勢分析
• 細分機會分析

市場動態與展望

• 市場概覽
• 市場規模
• 市場動態
  • 促進因素和機會
  • 限制與挑戰
• 波特的分析

關鍵市場考察

• 關鍵成功因素
• 競爭程度
• 主要投資機會
• 市場生態系統
• 市場吸引力指數（2024年）
• PESTEL分析
• 總體經濟指標
• 價值鏈分析
• 定價分析
• 專利分析
• 監管分析
• 案例研究

生物相似藥市場規模（按藥物類別和複合年成長率） (2025-2032)

• 市場概覽
• 單株抗體
  • Infliximab
  • Rituximab
  • 曲妥珠單抗
  • Adalimumab
  • 其他單株抗體
• 顆粒細胞增生因子
• 胰島素
• 促紅血球生成素
• 重組人體生長荷爾蒙
• Etanercept
• 促濾泡素
• 特立帕肽
• 干擾素
• 抗凝血劑
• 其他藥物類別

生物相似藥市場規模（按適應症和複合年成長率） (2025-2032)

• 市場概覽
• 腫瘤學
• 發炎與自體免疫疾病
• 慢性病
• 血液系統疾病
• 生長激素缺乏症
• 感染疾病
• 其他適應症

生物相似藥市場規模（按地區）及複合年成長率（2025-2032）

• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 西班牙
  • 法國
  • 英國
  • 義大利
  • 其他歐洲國家
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 其他亞太地區
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲
• 中東和非洲
  • 海灣合作理事會國家
  • 南非
  • 其他中東和非洲地區

競爭資訊

• 前五大公司對比
• 主要企業市場定位（2024年）
• 主要市場參與者所採取的策略
• 近期市場趨勢
• 公司市場佔有率分析（2024年）
• 主要企業簡介
  • 公司詳情
  • 產品系列分析
  • 公司分部佔有率分析
  • 收益與前一年同期比較對比（2022-2024 年）

主要企業簡介

• 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）

結論和建議

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