モノクローナル抗体治療薬市場- 世界の産業規模、シェア、動向、機会、予測、製品タイプ別、用途別、生産源別、エンドユーザー別、地域別、競合別、2020～2030年

モノクローナル抗体治療薬の世界市場は、2024年には2,430億2,000万米ドルとなり、2030年には4,182億8,000万米ドルに達すると予測され、予測期間中のCAGRは9.43%です。

近年、世界のヘルスケア部門は、医学研究と技術の画期的な進歩によって大きな変貌を遂げています。その中でも、治療薬におけるモノクローナル抗体（mAb）の開発と応用は大きな注目を集めています。モノクローナル抗体は様々な疾患の治療に革命をもたらし、低分子モノクローナル抗体治療薬セグメントはこのダイナミックな分野における重要なプレーヤーとして台頭しています。

モノクローナル抗体は、体内の特定のタンパク質や抗原を標的として設計されたバイオ医薬品の一種です。モノクローナル抗体は、B細胞として知られる1種類の免疫細胞をクローン化し、同一の抗体を産生させることによって作製されます。これらの抗体は、がん細胞、病原体、自己免疫誘発物質の表面に見られる分子など、特定の分子と結合するように設計されています。この標的化アプローチにより、さまざまな疾患に対する的確な治療が可能になります。

世界の低分子モノクローナル抗体治療薬市場は、幅広い治療用途を網羅し、近年目覚ましい成長を遂げています。がん、自己免疫疾患、感染症などの慢性疾患は、依然として世界の健康上の大きな課題であり、モノクローナル抗体は有望な治療オプションとして台頭してきています。バイオテクノロジー、特に抗体工学の進歩は、より特殊で効果的なモノクローナル抗体の創製につながり、治療への応用範囲を拡大し、市場需要を増大させています。さらに、モノクローナル抗体は、個人の遺伝的体質や疾患プロファイルに合わせて治療を行う個別化医療の中心的存在であり、治療成績と患者満足度の両方を向上させています。

世界各国の政府は、革新的なプロジェクトに資金を提供し支援することで、モノクローナル抗体治療薬を含むバイオテクノロジーの研究開発を積極的に支援しています。これは市場の成長を加速させる上で極めて重要です。

主な市場促進要因

慢性疾患の有病率の上昇

適応症と承認の拡大

個別化医療への注目の高まり

バイオ医薬品への投資の増加

主な市場課題

高額な開発コスト

バイオシミラーとの競合

主な市場動向

技術の進歩

戦略的パートナーシップと協働

目次

第1章 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 世界のモノクローナル抗体治療薬市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • 製品タイプ別（ネイキッド、融合タンパク質、抗体フラグメント、コンジュゲート、多特異性）
  • 用途別（がん、自己免疫疾患、感染症、その他）
  • 生産源別（ヒト、ヒト化、キメラ、その他）
  • エンドユーザー別（病院、専門センター、研究機関）
  • 地域別
  • 企業別（2024年）
• 市場マップ

第6章 北米のモノクローナル抗体治療薬市場展望

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

第7章 欧州のモノクローナル抗体治療薬市場展望

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

第8章 アジア太平洋地域のモノクローナル抗体治療薬市場展望

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

第9章 南米のモノクローナル抗体治療薬市場展望

• 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・アフリカのモノクローナル抗体治療薬市場展望

• 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（ある場合）
• 製品の発売（ある場合）
• 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

• F. Hoffmann-La Roche Ltd
• Novartis AG
• Merck & Co. Inc.
• Pfizer Inc.
• Eli Lilly and Co.（Lilly）
• Sanofi S.A.
• AstraZeneca Plc
• Bayer AG
• Regeneron Pharmaceuticals Inc.
• GSK Plc

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 monoclonal antibody therapeutics market was valued at USD 243.02 billion in 2024 and is projected to reach USD 418.28 billion by 2030, reflecting a compound annual growth rate (CAGR) of 9.43% during the forecast period. Recent years have seen a significant transformation in the global healthcare sector, driven by groundbreaking advancements in medical research and technology. Among these, the development and application of monoclonal antibodies (mAbs) in therapeutics has garnered significant attention. Monoclonal antibodies have revolutionized the treatment of various diseases, with the lower monoclonal antibody therapeutics segment emerging as a key player within this dynamic field.

Monoclonal antibodies are a class of biopharmaceuticals designed to target specific proteins or antigens in the body. They are created by cloning a single type of immune cell, known as a B cell, to produce identical antibodies. These antibodies are engineered to bind with particular molecules, such as those found on the surface of cancer cells, pathogens, or autoimmune triggers. This targeted approach enables precise treatment for a wide array of diseases.

The global lower monoclonal antibody therapeutics market encompasses a broad spectrum of therapeutic applications and has experienced impressive growth in recent years. Chronic diseases, such as cancer, autoimmune disorders, and infectious diseases, remain a significant global health challenge, with monoclonal antibodies emerging as a promising treatment option. Advancements in biotechnology, particularly in antibody engineering, have led to the creation of more specialized and effective monoclonal antibodies, expanding the range of therapeutic applications and increasing market demand. Furthermore, monoclonal antibodies are central to personalized medicine, where treatments are tailored to an individual's genetic makeup and disease profile, improving both treatment outcomes and patient satisfaction.

Governments worldwide are actively supporting research and development in biotechnology, including monoclonal antibody therapeutics, by providing funding and support for innovative projects. This has been pivotal in accelerating market growth.

Key Market Drivers

The rising prevalence of chronic diseases has been a major driver for the global monoclonal antibody therapeutics market. Over recent years, there has been a notable increase in the prevalence of chronic diseases, including cancer, autoimmune disorders, and infectious diseases. This surge has amplified the demand for effective and advanced treatment options, spurring growth in the monoclonal antibody therapeutics market. Monoclonal antibodies, with their targeted approach, offer promising biopharmaceutical therapies for these chronic conditions.

Chronic diseases, characterized by their long-term duration and slow progression, now account for a substantial portion of the global disease burden. Contributing factors include an aging population, sedentary lifestyles, poor dietary habits, and increased exposure to risk factors such as tobacco and alcohol. Environmental, genetic, and infectious factors also play significant roles in the development of these illnesses. As the incidence of chronic diseases rises, the demand for innovative and effective treatments is more pressing than ever.

The monoclonal antibody therapeutics market has witnessed remarkable growth, driven by the increasing acceptance of these therapies in clinical practice. Pharmaceutical companies and research institutions are heavily investing in developing novel monoclonal antibody therapies for chronic diseases, resulting in a robust pipeline of potential treatments. Additionally, regulatory agencies like the U.S. Food and Drug Administration (FDA) are approving more monoclonal antibody drugs, expanding their clinical use.

Key Market Challenges

A significant challenge facing the monoclonal antibody therapeutics market is the high cost of research, development, and clinical trials. The process of discovering and designing monoclonal antibodies is both time-consuming and expensive, requiring substantial financial investment. From early-stage research to clinical trials, these therapies undergo rigorous testing to meet safety and efficacy standards set by regulatory authorities. Compliance with regulatory requirements and the extensive documentation required for approval further increases costs. These high development costs often pose a barrier to entry for smaller biotech companies, limiting their ability to introduce new therapeutic options to the market.

Additionally, continuous research efforts to improve existing therapies and develop next-generation monoclonal antibodies further strain financial resources. As a result, larger, well-funded companies tend to dominate the market, consolidating industry power among the major players.

Key Market Trends

Technological advancements have significantly propelled the growth of the monoclonal antibody therapeutics market. In recent years, progress in genomics, proteomics, and bioinformatics has revolutionized the identification of disease-related targets, enabling more accurate development of monoclonal antibody therapies. Technologies such as phage display allow rapid screening of large antibody libraries to identify the most effective candidates for therapeutic purposes.

Moreover, advancements in antibody engineering have led to the creation of humanized and fully human antibodies, minimizing the risk of immune responses and expanding the potential patient population. Innovations in bioprocessing and cell culture techniques have enhanced the scalability and efficiency of monoclonal antibody production, reducing manufacturing costs and increasing accessibility to these therapies. The development of bioconjugation techniques has further enhanced the market, enabling the creation of antibody-drug conjugates (ADCs) that show promise in treating cancer and other diseases.

Key Market Players

• F. Hoffmann-La Roche Ltd.
• Novartis AG
• Merck & Co., Inc.
• Pfizer Inc.
• Eli Lilly and Co. (Lilly)
• Sanofi S.A.
• AstraZeneca Inc.
• Bayer AG
• Regeneron Pharmaceuticals Inc.
• GSK Plc.

Market Segmentation

The global monoclonal antibody therapeutics market is segmented as follows:

By Product Type:

• Others
• Naked
• Fusion Protein
• Antibody Fragment
• Conjugate
• Multi-specific

By Application:

• Cancer
• Autoimmune Diseases
• Infectious Diseases
• Others

By Production Source:

• Human
• Humanized
• Chimeric
• Others

By End User:

• Hospitals
• Specialty Centers
• Research Institutes

By Region:

• North America: United States, Canada, Mexico
• Europe: France, United Kingdom, Italy, Germany, Spain
• Asia-Pacific: China, India, Japan, Australia, South Korea
• South America: Brazil, Argentina, Colombia
• Middle East & Africa: South Africa, Saudi Arabia, UAE

Competitive Landscape

The report also provides a detailed analysis of the major companies in the monoclonal antibody therapeutics market, with the option for further customization based on specific business needs.

Available Customizations

TechSci Research offers the following customization options for the global monoclonal antibody therapeutics market report:

• 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 & Validations
• 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, Trends

4. Voice of Customer

5. Global Monoclonal Antibody Therapeutics Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Product Type (Naked, Fusion Protein, Antibody Fragment, Conjugate, Multi-specific)
  • 5.2.2. By Application (Cancer, Autoimmune Diseases, Infectious Diseases, Others)
  • 5.2.3. By Production Source (Human, Humanized, Chimeric, Others)
  • 5.2.4. By End User (Hospital, Specialty Centers, Research Institutes)
  • 5.2.5. By Region
  • 5.2.6. By Company (2024)
• 5.3. Market Map

6. North America Monoclonal Antibody Therapeutics Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Product Type
  • 6.2.2. By Application
  • 6.2.3. By Production Source
  • 6.2.4. By End User
  • 6.2.5. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Monoclonal Antibody Therapeutics 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 Type
      • 6.3.1.2.2. By Application
      • 6.3.1.2.3. By Production Source
      • 6.3.1.2.4. By End User
  • 6.3.2. Canada Monoclonal Antibody Therapeutics 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 Type
      • 6.3.2.2.2. By Application
      • 6.3.2.2.3. By Production Source
      • 6.3.2.2.4. By End User
  • 6.3.3. Mexico Monoclonal Antibody Therapeutics 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 Type
      • 6.3.3.2.2. By Application
      • 6.3.3.2.3. By Production Source
      • 6.3.3.2.4. By End User

7. Europe Monoclonal Antibody Therapeutics Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Product Type
  • 7.2.2. By Application
  • 7.2.3. By Production Source
  • 7.2.4. By End User
  • 7.2.5. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Monoclonal Antibody Therapeutics 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 Type
      • 7.3.1.2.2. By Application
      • 7.3.1.2.3. By Production Source
      • 7.3.1.2.4. By End User
  • 7.3.2. United Kingdom Monoclonal Antibody Therapeutics 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 Type
      • 7.3.2.2.2. By Application
      • 7.3.2.2.3. By Production Source
      • 7.3.2.2.4. By End User
  • 7.3.3. Italy Monoclonal Antibody Therapeutics 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 Type
      • 7.3.3.2.2. By Application
      • 7.3.3.2.3. By Production Source
      • 7.3.3.2.4. By End User
  • 7.3.4. France Monoclonal Antibody Therapeutics 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 Type
      • 7.3.4.2.2. By Application
      • 7.3.4.2.3. By Production Source
      • 7.3.4.2.4. By End User
  • 7.3.5. Spain Monoclonal Antibody Therapeutics 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 Type
      • 7.3.5.2.2. By Application
      • 7.3.5.2.3. By Production Source
      • 7.3.5.2.4. By End User

8. Asia-Pacific Monoclonal Antibody Therapeutics Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Product Type
  • 8.2.2. By Application
  • 8.2.3. By Production Source
  • 8.2.4. By End User
  • 8.2.5. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Monoclonal Antibody Therapeutics 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 Type
      • 8.3.1.2.2. By Application
      • 8.3.1.2.3. By Production Source
      • 8.3.1.2.4. By End User
  • 8.3.2. India Monoclonal Antibody Therapeutics 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 Type
      • 8.3.2.2.2. By Application
      • 8.3.2.2.3. By Production Source
      • 8.3.2.2.4. By End User
  • 8.3.3. Japan Monoclonal Antibody Therapeutics 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 Type
      • 8.3.3.2.2. By Application
      • 8.3.3.2.3. By Production Source
      • 8.3.3.2.4. By End User
  • 8.3.4. South Korea Monoclonal Antibody Therapeutics 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 Type
      • 8.3.4.2.2. By Application
      • 8.3.4.2.3. By Production Source
      • 8.3.4.2.4. By End User
  • 8.3.5. Australia Monoclonal Antibody Therapeutics 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 Type
      • 8.3.5.2.2. By Application
      • 8.3.5.2.3. By Production Source
      • 8.3.5.2.4. By End User

9. South America Monoclonal Antibody Therapeutics Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Product Type
  • 9.2.2. By Application
  • 9.2.3. By Production Source
  • 9.2.4. By End User
  • 9.2.5. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Monoclonal Antibody Therapeutics 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 Type
      • 9.3.1.2.2. By Application
      • 9.3.1.2.3. By Production Source
      • 9.3.1.2.4. By End User
  • 9.3.2. Argentina Monoclonal Antibody Therapeutics 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 Type
      • 9.3.2.2.2. By Application
      • 9.3.2.2.3. By Production Source
      • 9.3.2.2.4. By End User
  • 9.3.3. Colombia Monoclonal Antibody Therapeutics 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 Type
      • 9.3.3.2.2. By Application
      • 9.3.3.2.3. By Production Source
      • 9.3.3.2.4. By End User

10. Middle East and Africa Monoclonal Antibody Therapeutics Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Product Type
  • 10.2.2. By Application
  • 10.2.3. By Production Source
  • 10.2.4. By End User
  • 10.2.5. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Monoclonal Antibody Therapeutics 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 Type
      • 10.3.1.2.2. By Application
      • 10.3.1.2.3. By Production Source
      • 10.3.1.2.4. By End User
  • 10.3.2. Saudi Arabia Monoclonal Antibody Therapeutics 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 Type
      • 10.3.2.2.2. By Application
      • 10.3.2.2.3. By Production Source
      • 10.3.2.2.4. By End User
  • 10.3.3. UAE Monoclonal Antibody Therapeutics 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 Type
      • 10.3.3.2.2. By Application
      • 10.3.3.2.3. By Production Source
      • 10.3.3.2.4. By End User

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. Porter's 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. F. Hoffmann-La Roche Ltd
  • 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. Novartis AG
• 14.3. Merck & Co. Inc.
• 14.4. Pfizer Inc.
• 14.5. Eli Lilly and Co. (Lilly)
• 14.6. Sanofi S.A.
• 14.7. AstraZeneca Plc
• 14.8. Bayer AG
• 14.9. Regeneron Pharmaceuticals Inc.
• 14.10. GSK Plc

15. Strategic Recommendations

16. About Us & Disclaimer