バイオシミラーモノクローナル抗体市場 - 世界の産業規模、シェア、動向、機会、予測、製品別、用途別、地域別、競合別、2020年～2030年

バイオシミラーモノクローナル抗体の世界市場規模は2024年に54億7,000万米ドル、2030年までには108億3,000万米ドルに達し、CAGR12.03％で拡大すると予測されています。

バイオシミラーモノクローナル抗体（mAbs）は、その費用対効果の高さとオリジネーター生物製剤に匹敵する有効性により、バイオ医薬品業界において変革をもたらすセグメントです。がん、自己免疫疾患、炎症性疾患などの治療において生物学的製剤がますます不可欠となる中、バイオシミラーmAbsは、特にその手頃な価格と入手しやすさから、有望な代替品となります。バイオシミラーは参照生物学的製剤と同一ではありませんが、安全性、有効性、品質において密接に一致するように設計されています。生きた細胞内での高度な組換えDNA技術によって開発されたバイオシミラー医薬品は、患者への幅広いアクセスを可能にし、ヘルスケア支出の軽減に貢献します。ヘルスケアシステムが世界的に高い生物学的製剤コストと闘う中、バイオシミラーmAbsは、治療成績を維持しながら経済的負担を軽減する可能性があるとして、支持を集めています。

主要な市場促進要因

がんと自己免疫疾患の増加

主要な市場課題

製造の複雑さ

主要市場動向

技術の進歩

目次

第1章 製品概要

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 顧客の声

第5章 世界のバイオシミラーモノクローナル抗体市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • 製品別（インフリキシマブ、リツキシマブ、アブシキシマブ、トラスツズマブ、アダリムマブ、ベバシズマブ、その他）
  • 用途別（腫瘍学、慢性疾患・自己免疫疾患、その他）
  • 企業別（2024年）
  • 地域別
• 市場マップ

第6章 北米のバイオシミラーモノクローナル抗体市場展望

• 市場規模・予測
• 市場シェア・予測
• 北米：国別分析
  • 米国
  • メキシコ
  • カナダ

第7章 欧州のバイオシミラーモノクローナル抗体市場展望

• 市場規模・予測
• 市場シェア・予測
• 欧州：国別分析
  • フランス
  • ドイツ
  • 英国
  • イタリア
  • スペイン

第8章 アジア太平洋のバイオシミラーモノクローナル抗体市場展望

• 市場規模・予測
• 市場シェア・予測
• アジア太平洋：国別分析
  • 中国
  • インド
  • 韓国
  • 日本
  • オーストラリア

第9章 南米のバイオシミラーモノクローナル抗体市場展望

• 市場規模・予測
• 市場シェア・予測
• 南米：国別分析
  • ブラジル
  • アルゼンチン
  • コロンビア

第10章 中東・アフリカのバイオシミラーモノクローナル抗体市場展望

• 市場規模・予測
• 市場シェア・予測
• 中東・アフリカ：国別分析
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦

第11章 市場力学

• 促進要因
• 課題

第12章 市場動向と発展

• 合併と買収
• 製品上市
• 最近の動向

第13章 ポーターのファイブフォース分析

• 業界内の競合
• 新規参入の可能性
• サプライヤーの力
• 顧客の力
• 代替品の脅威

第14章 競合情勢

• Abbott
• Pfizer
• Novartis AG
• AbbVie, Inc.
• Coherus BioSciences
• Biocon Limited
• Allergan plc.
• Accord Healthcare limited.
• Amgen inc.
• Dr. Reddy's Laboratory

第15章 戦略的提言

第16章 調査会社について・免責事項

The Global Biosimilar Monoclonal Antibodies Market was valued at USD 5.47 billion in 2024 and is projected to reach USD 10.83 billion by 2030, expanding at a CAGR of 12.03%. Biosimilar monoclonal antibodies (mAbs) represent a transformative segment in the biopharmaceutical industry due to their cost-effective nature and comparable efficacy to originator biologics. As biologic drugs become increasingly essential in treating conditions like cancer, autoimmune, and inflammatory diseases, biosimilar mAbs offer a promising alternative, especially given their affordability and accessibility. Though biosimilars are not identical to reference biologics, they are engineered to closely match in safety, efficacy, and quality. Their development through advanced recombinant DNA technology in living cells enables broader patient access and helps mitigate healthcare expenditures. As healthcare systems globally grapple with high biologic costs, biosimilar mAbs are gaining traction for their potential to alleviate economic burdens while maintaining therapeutic outcomes.

Key Market Drivers

Rising Cancer and Autoimmune Disorders

The global upsurge in cancer and autoimmune diseases has led to a growing demand for effective and affordable therapies, thereby propelling the biosimilar monoclonal antibodies (mAbs) market. Cancer, characterized by abnormal cell growth, continues to be a major cause of mortality, with the European Union reporting a 2.3% rise in new cases and a 2.4% increase in cancer-related deaths in 2022 compared to 2020. Similarly, autoimmune diseases are becoming more prevalent, heightening the necessity for targeted and cost-efficient treatments. Biosimilar mAbs have emerged as a valuable solution by providing therapeutic efficacy comparable to reference biologics at reduced costs. This market segment is increasingly crucial in balancing patient needs and healthcare affordability, driving its expansion in the global pharmaceutical landscape.

Key Market Challenges

Manufacturing Complexity

The production of biosimilar monoclonal antibodies (mAbs) is fraught with complexity due to their biological origins. These therapies are derived from living cells, introducing inherent variability in expression systems, cell lines, and culture conditions. Such variability can lead to slight differences between biosimilars and their reference biologics, complicating efforts to maintain consistent quality and biological performance. Ensuring equivalence in physicochemical properties, biological activity, and immunogenicity requires robust quality control and advanced analytical tools. Minor changes in the manufacturing process can significantly affect clinical outcomes, presenting a regulatory and developmental hurdle. This complexity results in higher development costs and prolonged timelines, emphasizing the need for substantial investments to achieve regulatory compliance and maintain product consistency.

Key Market Trends

Technological Advancements

Technological innovation is driving the evolution of biosimilar monoclonal antibodies (mAbs), transforming them into precision therapeutic tools. Advances in biotechnology and research have facilitated the development of biosimilars that closely replicate the safety and efficacy of originator biologics. These breakthroughs support the rise of personalized medicine by enabling therapies tailored to individual genetic and disease profiles. Concurrently, innovations in bioprocessing, such as enhanced cell culture methods and purification techniques, have significantly improved production efficiency and product quality. These developments not only reduce manufacturing costs but also ensure better patient outcomes. As a result, biosimilar mAbs are increasingly integrated into treatment regimens, bolstered by their improved accessibility, affordability, and alignment with modern medical strategies.

Key Market Players

• Abbott
• Pfizer
• Novartis AG
• AbbVie, Inc.
• Coherus BioSciences
• Biocon Limited
• Allergan plc.
• Accord Healthcare limited.
• Amgen inc.
• Dr. Reddy's Laboratory

Report Scope: In this report, the Global Biosimilar Monoclonal Antibodies Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Biosimilar Monoclonal Antibodies Market, By Product:

• Infliximab
• Rituximab
• Abciximab
• Trastuzumab
• Adalimumab
• Bevacizumab
• Others

Biosimilar Monoclonal Antibodies Market, By Application:

• Oncology
• Chronic & Autoimmune Diseases
• Others

Biosimilar Monoclonal Antibodies Market, By Region:

• North America
• Asia-Pacific
• Europe
• Middle East & Africa
• South America

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Biosimilar Monoclonal Antibodies Market.

Available Customizations:

Global Biosimilar Monoclonal Antibodies Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, and Trends

4. Voice of Customer

5. Global Biosimilar Monoclonal Antibodies Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Product (Infliximab, Rituximab, Abciximab, Trastuzumab, Adalimumab, Bevacizumab, Others)
  • 5.2.2. By Application (Oncology, Chronic & Autoimmune Diseases, Others)
  • 5.2.3. By Company (2024)
  • 5.2.4. By Region
• 5.3. Market Map

6. North America Biosimilar Monoclonal Antibodies Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Product
  • 6.2.2. By Application
  • 6.2.3. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Biosimilar Monoclonal Antibodies Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Product
      • 6.3.1.2.2. By Application
  • 6.3.2. Mexico Biosimilar Monoclonal Antibodies Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Product
      • 6.3.2.2.2. By Application
  • 6.3.3. Canada Biosimilar Monoclonal Antibodies Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Product
      • 6.3.3.2.2. By Application

7. Europe Biosimilar Monoclonal Antibodies Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Product
  • 7.2.2. By Application
  • 7.2.3. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. France Biosimilar Monoclonal Antibodies Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Product
      • 7.3.1.2.2. By Application
  • 7.3.2. Germany Biosimilar Monoclonal Antibodies Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Product
      • 7.3.2.2.2. By Application
  • 7.3.3. United Kingdom Biosimilar Monoclonal Antibodies Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Product
      • 7.3.3.2.2. By Application
  • 7.3.4. Italy Biosimilar Monoclonal Antibodies Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Product
      • 7.3.4.2.2. By Application
  • 7.3.5. Spain Biosimilar Monoclonal Antibodies Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Product
      • 7.3.5.2.2. By Application

8. Asia-Pacific Biosimilar Monoclonal Antibodies Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Product
  • 8.2.2. By Application
  • 8.2.3. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Biosimilar Monoclonal Antibodies Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Product
      • 8.3.1.2.2. By Application
  • 8.3.2. India Biosimilar Monoclonal Antibodies Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Product
      • 8.3.2.2.2. By Application
  • 8.3.3. South Korea Biosimilar Monoclonal Antibodies Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Product
      • 8.3.3.2.2. By Application
  • 8.3.4. Japan Biosimilar Monoclonal Antibodies Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Product
      • 8.3.4.2.2. By Application
  • 8.3.5. Australia Biosimilar Monoclonal Antibodies Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Product
      • 8.3.5.2.2. By Application

9. South America Biosimilar Monoclonal Antibodies Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Product
  • 9.2.2. By Application
  • 9.2.3. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Biosimilar Monoclonal Antibodies Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Product
      • 9.3.1.2.2. By Application
  • 9.3.2. Argentina Biosimilar Monoclonal Antibodies Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Product
      • 9.3.2.2.2. By Application
  • 9.3.3. Colombia Biosimilar Monoclonal Antibodies Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Product
      • 9.3.3.2.2. By Application

10. Middle East and Africa Biosimilar Monoclonal Antibodies Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Product
  • 10.2.2. By Application
  • 10.2.3. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Biosimilar Monoclonal Antibodies Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Product
      • 10.3.1.2.2. By Application
  • 10.3.2. Saudi Arabia Biosimilar Monoclonal Antibodies Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Product
      • 10.3.2.2.2. By Application
  • 10.3.3. UAE Biosimilar Monoclonal Antibodies Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Product
      • 10.3.3.2.2. By Application

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Porters Five Forces Analysis

• 13.1. Competition in the Industry
• 13.2. Potential of New Entrants
• 13.3. Power of Suppliers
• 13.4. Power of Customers
• 13.5. Threat of Substitute Products

14. Competitive Landscape

• 14.1. Abbott
  • 14.1.1. Business Overview
  • 14.1.2. Company Snapshot
  • 14.1.3. Products & Services
  • 14.1.4. Financials (As Reported)
  • 14.1.5. Recent Developments
  • 14.1.6. Key Personnel Details
  • 14.1.7. SWOT Analysis
• 14.2. Pfizer
• 14.3. Novartis AG
• 14.4. AbbVie, Inc.
• 14.5. Coherus BioSciences
• 14.6. Biocon Limited
• 14.7. Allergan plc.
• 14.8. Accord Healthcare limited.
• 14.9. Amgen inc.
• 14.10. Dr. Reddy's Laboratory

15. Strategic Recommendations

16. About Us & Disclaimer