二重特異性抗体治療薬の受託製造市場- 世界の産業規模、シェア、動向、機会、予測、適応症別、投与経路別、最終用途別、地域別、競合別、2020～2030年

二重特異性抗体治療薬の受託製造の世界市場は、2024年には73億2,000万米ドルと評価され、2030年には187億4,000万米ドルに達し、CAGR 16.92％で成長すると予測されています。

二重特異性抗体は、2つの異なる抗原を同時に標的とする能力により、がんや自己免疫疾患のような複雑な疾患に対する新規治療戦略を提供し、バイオ医薬品業界で大きな支持を得ています。製造受託機関（CMO）は、このような複雑な生物製剤の製造に必要なインフラ、技術的専門知識、拡張性を提供することで、このような状況において重要な役割を果たしています。この市場を牽引しているのは、急速に拡大する二重特異性抗体候補のパイプラインであり、多くのバイオファーマ企業が外部委託を好む専門的な製造能力の必要性です。企業が革新的な二重特異性抗体フォーマットや治療アプリケーションを開発し続ける中、柔軟で高品質な製造サポートに対する需要は着実に増加し、次世代生物学的療法の推進におけるCMOの役割が強化されると予想されます。

市場促進要因

二重特異性抗体治療薬の継続的な調査活動

主な市場課題

二重特異性抗体治療薬の製造に関連する課題

主な市場動向

二重特異性抗体に対する需要の増加

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 世界の二重特異性抗体治療薬の受託製造市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • 適応症別（がん、感染症、自己炎症性および自己免疫性疾患、中枢神経系疾患、その他）
  • 投与経路別（静脈内、皮下、その他）
  • 最終用途別（製薬会社、バイオ医薬品会社、その他）
  • 企業別（2024）
  • 地域別
• 市場マップ

第6章 北米の二重特異性抗体治療薬の受託製造市場展望

• 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 欧州の二重特異性抗体治療薬の受託製造市場展望

• 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 アジア太平洋地域の二重特異性抗体治療薬の受託製造市場展望

• 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
  • 韓国
  • 日本
  • オーストラリア

第9章 南米の二重特異性抗体治療薬の受託製造市場展望

• 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・アフリカの二重特異性抗体治療薬の受託製造市場展望

• 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

• 最近の動向
• 製品上市
• 合併と買収

第13章 PESTEL分析

第14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15章 競合情勢

• Lonza Group AG
• Creative Biolabs Inc
• Amgen Inc
• Johnson & Johnson
• Wuxi Biologics Cayman Inc
• Roche Holding AG
• Sino Biological Inc
• IQVIA Inc
• Janssen Pharmaceuticals Inc
• AbbVie Inc.

第16章 戦略的提言

第17章 調査会社について・免責事項

The Global Bispecific Antibody Therapeutics Contract Manufacturing Market was valued at USD 7.32 billion in 2024 and is projected to reach USD 18.74 billion by 2030, growing at a CAGR of 16.92%. Bispecific antibodies have gained significant traction in the biopharmaceutical industry for their ability to target two different antigens simultaneously, offering novel therapeutic strategies for complex diseases such as cancer and autoimmune disorders. Contract manufacturing organizations (CMOs) play a crucial role in this landscape by providing the infrastructure, technical expertise, and scalability required to manufacture these complex biologics. The market is being driven by a rapidly expanding pipeline of bispecific antibody candidates and the need for specialized manufacturing capabilities that many biopharma companies prefer to outsource. As companies continue to develop innovative bispecific formats and therapeutic applications, the demand for flexible, high-quality manufacturing support is expected to rise steadily, reinforcing the role of CMOs in advancing next-generation biologic therapies.

Key Market Drivers

Ongoing Research Activities in Bispecific Antibody Therapeutics

The Global Bispecific Antibody Therapeutics Contract Manufacturing Market is experiencing strong growth due to intensifying research and development efforts. As of early 2025, there are more than 200 bispecific antibody candidates in various stages of development, with over 50 undergoing clinical trials targeting oncology, autoimmune conditions, and infectious diseases. The structural diversity of bispecific formats-such as BiTEs, DVD-Igs, and tandem diabodies-requires advanced design and production capabilities. CMOs with expertise in bispecific antibody manufacturing are increasingly in demand as they provide essential services like high-throughput analytics, improved purification processes, and scalable production systems. With more than 60% of biologics-focused CMOs having expanded capabilities tailored to bispecifics, the sector is seeing a surge in specialized offerings aimed at supporting the growing complexity and volume of these novel therapeutics.

Key Market Challenges

Challenges Associated with Manufacturing of Bispecific Antibody Therapeutics

Manufacturing bispecific antibody therapeutics presents a unique set of challenges that differentiate them from traditional monoclonal antibodies. The complexity of these molecules-arising from their dual-target structure-necessitates precise control over manufacturing to ensure consistency and efficacy. Post-translational modifications such as glycosylation and oxidation introduce further heterogeneity, requiring robust analytical oversight. Scale-up remains a critical hurdle, as production must transition smoothly from development to commercial levels without compromising quality. Custom purification strategies are often required due to the distinct molecular properties of each bispecific antibody, complicating downstream processing. Additionally, the need for specialized equipment, such as bioreactors and chromatography systems suited for bispecifics, results in higher capital investment. Regulatory compliance adds another layer of complexity, as evolving global guidelines demand rigorous quality and safety controls, further elevating the operational demands for CMOs in this field.

Key Market Trends

Increasing Demand for Bispecific Antibodies

The rising demand for bispecific antibodies is a dominant trend shaping the Global Bispecific Antibody Therapeutics Contract Manufacturing Market. These molecules offer the ability to engage two targets simultaneously, providing novel mechanisms of action in diseases like cancer, autoimmune disorders, and infections. In oncology, bispecific T-cell engagers (BiTEs) have shown strong therapeutic potential by redirecting immune responses toward cancer cells, prompting further clinical exploration. The trend toward personalized medicine is also driving demand for customizable bispecific formats tailored to specific disease subtypes or patient groups. As biopharmaceutical companies seek contract partners capable of delivering precision-engineered therapeutics at scale, the market for CMOs offering flexible and advanced bispecific antibody manufacturing continues to grow. This rising demand, coupled with innovations in therapeutic design, is positioning bispecific antibodies as a key area of growth within the broader biologics manufacturing ecosystem.

Key Market Players

• Lonza Group AG
• Creative Biolabs Inc
• Amgen Inc
• Johnson & Johnson
• Wuxi Biologics Cayman Inc
• Roche Holding AG
• Sino Biological Inc
• IQVIA Inc
• Janssen Pharmaceuticals Inc
• AbbVie Inc

Report Scope:

In this report, the Global Bispecific Antibody Therapeutics Contract Manufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Bispecific Antibody Therapeutics Contract Manufacturing Market, By Indication:

• Cancer
• Infectious Diseases
• Autoinflammatory and Autoimmune Diseases
• CNS Conditions
• Others

Bispecific Antibody Therapeutics Contract Manufacturing Market, By Route of Administration:

• Intravenous
• Subcutaneous
• Others

Bispecific Antibody Therapeutics Contract Manufacturing Market, By End Use:

• Pharmaceutical Companies
• Biopharmaceutical Companies
• Others

Bispecific Antibody Therapeutics Contract Manufacturing Market, 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

Company Profiles: Detailed analysis of the major companies present in the Global Bispecific Antibody Therapeutics Contract Manufacturing Market.

Available Customizations:

Global Bispecific Antibody Therapeutics Contract Manufacturing 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

2. Research Methodology

3. Executive Summary

4. Voice of Customers

5. Global Bispecific Antibody Therapeutics Contract Manufacturing Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Indication (Cancer, Infectious Diseases, Autoinflammatory and Autoimmune Diseases, CNS Conditions, Others)
  • 5.2.2. By Route of Administration (Intravenous, Subcutaneous, Others)
  • 5.2.3. By End Use (Pharmaceutical Companies, Biopharmaceutical Companies, Others)
  • 5.2.4. By Company (2024)
  • 5.2.5. By Region
• 5.3. Market Map

6. North America Bispecific Antibody Therapeutics Contract Manufacturing Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Indications
  • 6.2.2. By Route of Administration
  • 6.2.3. By End Use
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 6.3.1.2.2. By Route of Administration
      • 6.3.1.2.3. By End Use
  • 6.3.2. Mexico Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 6.3.2.2.2. By Route of Administration
      • 6.3.2.2.3. By End Use
  • 6.3.3. Canada Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 6.3.3.2.2. By Route of Administration
      • 6.3.3.2.3. By End Use

7. Europe Bispecific Antibody Therapeutics Contract Manufacturing Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Indications
  • 7.2.2. By Route of Administration
  • 7.2.3. By End Use
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. France Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 7.3.1.2.2. By Route of Administration
      • 7.3.1.2.3. By End Use
  • 7.3.2. Germany Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 7.3.2.2.2. By Route of Administration
      • 7.3.2.2.3. By End Use
  • 7.3.3. United Kingdom Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 7.3.3.2.2. By Route of Administration
      • 7.3.3.2.3. By End Use
  • 7.3.4. Italy Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 7.3.4.2.2. By Route of Administration
      • 7.3.4.2.3. By End Use
  • 7.3.5. Spain Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 7.3.5.2.2. By Route of Administration
      • 7.3.5.2.3. By End Use

8. Asia-Pacific Bispecific Antibody Therapeutics Contract Manufacturing Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Indications
  • 8.2.2. By Route of Administration
  • 8.2.3. By End Use
  • 8.2.4. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 8.3.1.2.2. By Route of Administration
      • 8.3.1.2.3. By End Use
  • 8.3.2. India Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 8.3.2.2.2. By Route of Administration
      • 8.3.2.2.3. By End Use
  • 8.3.3. South Korea Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 8.3.3.2.2. By Route of Administration
      • 8.3.3.2.3. By End Use
  • 8.3.4. Japan Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 8.3.4.2.2. By Route of Administration
      • 8.3.4.2.3. By End Use
  • 8.3.5. Australia Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 8.3.5.2.2. By Route of Administration
      • 8.3.5.2.3. By End Use

9. South America Bispecific Antibody Therapeutics Contract Manufacturing Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Indications
  • 9.2.2. By Route of Administration
  • 9.2.3. By End Use
  • 9.2.4. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 9.3.1.2.2. By Route of Administration
      • 9.3.1.2.3. By End Use
  • 9.3.2. Argentina Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 9.3.2.2.2. By Route of Administration
      • 9.3.2.2.3. By End Use
  • 9.3.3. Colombia Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 9.3.3.2.2. By Route of Administration
      • 9.3.3.2.3. By End Use

10. Middle East and Africa Bispecific Antibody Therapeutics Contract Manufacturing Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Indications
  • 10.2.2. By Route of Administration
  • 10.2.3. By End Use
  • 10.2.4. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 10.3.1.2.2. By Route of Administration
      • 10.3.1.2.3. By End Use
  • 10.3.2. Saudi Arabia Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 10.3.2.2.2. By Route of Administration
      • 10.3.2.2.3. By End Use
  • 10.3.3. UAE Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
      • 10.3.3.2.2. By Route of Administration
      • 10.3.3.2.3. By End Use

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Recent Developments
• 12.2. Product Launches
• 12.3. Mergers & Acquisitions

13. PESTLE Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Product

15. Competitive Landscape

• 15.1. Lonza Group AG
  • 15.1.1. Business Overview
  • 15.1.2. Company Snapshot
  • 15.1.3. Product & Services
  • 15.1.4. Financials (In case of listed companies)
  • 15.1.5. Recent Developments
  • 15.1.6. SWOT Analysis
• 15.2. Creative Biolabs Inc
• 15.3. Amgen Inc
• 15.4. Johnson & Johnson
• 15.5. Wuxi Biologics Cayman Inc
• 15.6. Roche Holding AG
• 15.7. Sino Biological Inc
• 15.8. IQVIA Inc
• 15.9. Janssen Pharmaceuticals Inc
• 15.10. AbbVie Inc.

16. Strategic Recommendations

17. About Us & Disclaimer