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二重特異性抗体の世界市場:市場機会、医薬品の売上高、治験の考察 (2026年)

Global Bispecific Antibody Market Opportunity, Drug Sales & Clinical Trials Insight 2026

発行 KuicK Research 商品コード 923628
出版日 ページ情報 英文 510 Pages
納期: 即日から翌営業日
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二重特異性抗体の世界市場:市場機会、医薬品の売上高、治験の考察 (2026年) Global Bispecific Antibody Market Opportunity, Drug Sales & Clinical Trials Insight 2026
出版日: 2020年02月03日 ページ情報: 英文 510 Pages
概要

二重特異性抗体は2015年に上市されてから世界各国で順調に売上高を伸ばしており、2019年までに118%のCAGRで成長してきました。短期的な販売目標の達成だけでなく、次世代の抗体療法としての地位も着々と構築しつつあります。

当レポートでは、世界の二重特異性抗体の市場について分析し、二重特異性抗体の概要や診断・治療上の主な効果、現在開発中・治験中のパイプライン製品の概略、主な市場促進・抑制要因、全体的な市場規模の動向見通し、カテゴリー別の市場規模・価格動向の見通し、今後の市場機会などを調査しております。

第1章 二重特異性モノクローナル抗体:概略

  • モノクローナル抗体の概要
  • 二重特異性モノクローナル抗体の概要
  • 単一特異性モノクローナル抗体に対する、二重特異性抗体の利点

第2章 二重特異性抗体のエンジニアリングと開発

  • IgGに類似した二重特異性抗体
    • Quadroma(ハイブリッド水腫)アプローチ
    • KIH (Knobs Into Holes) アプローチ
    • CrossMabアプローチ
    • 二重可変領域免疫グロブリンアプローチ
  • 小型二重特異性抗体
    • 二重特異性ダイアボディ
    • BiTEs (二重特異性T細胞誘導抗体)

第3章 二重特異性抗体の作用メカニズム

  • 三機能性抗体:カツマキソマブ(Removab (R))
  • ブリナツモマブ

第4章 二重特異性抗体 (BsMAb):診断・治療分野での応用

  • 細菌性・ウイルス性感染症の診断のためのBsMAb
  • がん診断用BsMAb
  • シグナル伝達経路ブロック用BsAbs
  • 腫瘍血管新生を標的とするBsAbs
  • エフェクター化合物の標的への特異的送達
  • 二重特異性抗体と遺伝子治療

第5章 世界の二重特異性抗体市場の将来展望

  • 現在の市場シナリオ
  • 二重特異性抗体の入手可能性
    • カツマキソマブ(Removab)
    • ブリナツモマブ
    • エミシズマブ
    • デュリゴツマブ
    • SAR 156597

第6章 承認済み二重特異性抗体:投与量・価格分析

  • Blincyto
  • Hemlibra

第7章 承認済み二重特異性抗体:販売量の分析

  • Blincyto
  • Hemlibra

第8章 二重特異性抗体:臨床パイプラインの概要

  • 相別 (フェーズ別)
  • 国/地域別
  • 企業別
  • 症状別
  • 希少疾患向け二重特異性抗体

第9章 世界の二重特異性抗体の臨床パイプライン:企業別・症状別・相 (フェーズ) 別

  • 研究
  • 前臨床
  • 第I相
  • 第I / II相
  • 第II相
  • 第II / III相
  • 第III相

第10章 上市済み二重特異性抗体:臨床的考察

  • ブリナツモマブ (Amgen)
  • エミシズマブ (中外製薬)

第11章 世界の二重特異性抗体市場:市場のダイナミクス

  • 有利な市場パラメーター
  • 商業化の課題

第12章 世界の二重特異性抗体市場:将来展望

第13章 競争環境

  • Ablynx
  • Adimab
  • Affimed Therapeutics
  • Amgen
  • AstraZeneca (MedImmune)
  • 中外製薬
  • Eli Lilly
  • EMD Serono
  • Emergent BioSolutions
  • Genentech
  • Genmab
  • Immunomedics
  • Jounce Therapeutics
  • MacroGenics
  • Merus
  • Neovii Biotech
  • NovImmune SA
  • OncoMed Pharmaceuticals
  • Pieris
  • Regeneron Pharmaceuticals
  • Roche
  • Sanofi
図表

List of Figures

  • Figure 1-1: Advantages of Bispecific Antibodies
  • Figure 2-1: Types of Approaches to Form IgG like Bispecific Antibodies
  • Figure 2-2: Method of Formation of Hybrid Hybridoma
  • Figure 2-3: Limitations of Hybrid Hybridoma
  • Figure 2-4: Steps involved in “Knobs into Holes” Approach
  • Figure 2-5: Three different CrossMabs are Obtained by Three Different Modifications
  • Figure 2-6: Method for formation of Dual-Variable-Domain Immunoglobulin
  • Figure 2-7: Advantages of Dual Variable Domain Immunoglobulin approach
  • Figure 2-8: Types of Bispecific Antibodies
  • Figure 3-1: Mechanism of Action of Bispecific Monoclonal Antibody
  • Figure 3-2: Mechanism of Action of Catumaxomab
  • Figure 3-3: Mechanism of Action of Blinatumomab
  • Figure 4-1: Applications of Bispecific Antibodies
  • Figure 5-1: Global - Bispecific Antibody Market Size (US$ Million), 2015 - 2019
  • Figure 5-2: US v/s ROW - Bispecific Antibody Market Share (%) , 2018
  • Figure 5-3: US v/s ROW - Bispecific Antibody Market Share (%) , 2019
  • Figure 5-4: Global - Bispecific Antibody Market Size (US$ Million) by Products (Blincyto & Hemlibra) , 2018 & 2019
  • Figure 5-5: Global - Bispecific Antibody Market Share(%) by Products (Blincyto & Hemlibra) , 2018
  • Figure 5-6: Global - Bispecific Antibody Market Share(%) by Products (Blincyto & Hemlibra) , 2019
  • Figure 5-7: Global - Bispecific Antibody Quarterly Sales (US$ Million), by Products (Blincyto & Hemlibra), 2019
  • Figure 6-1: Blincyto - Recommended Number of Induction & Consolidation Cycles for Treatment of MRD+ B-cell precursor ALL, December'2019
  • Figure 6-2: Blincyto - Duration of Treatment Phase & Resting Phase in Induction & Consolidation Cycles for Treatment of MRD+ B-cell Precursor ALL (Days) , December'2019
  • Figure 6-3: Blincyto - Cost of Single Cycle & Full Treatment Cost of MRD+ B-Cell Precursor ALL (US$), December'2019
  • Figure 6-4: Blincyto - Recommended Number of Induction & Consolidation Treatment Cycle for Relapsed B-Cell Precursor ALL, December'2019
  • Figure 6-5: Blincyto - Duration of Single Induction, Consolidation, Continued Cycle & Full Treatment for Relapsed B-Cell Precursor ALL (Weeks), December'2019
  • Figure 6-6: Blincyto - Cost of 1st & 2nd Induction Cycle for Treatment of Relapsed B-Cell Precursor ALL (US$), December'2019
  • Figure 6-7: Blincyto - Cost of Different Treatment Phases & Full Treatment Cost for Relapsed B-Cell Precursor ALL (US$), December'2019
  • Figure 6-8: Hemlibra - Cost for Single Unit of 30mcg & 150mcg Subcutaneous Injection (US$), December'2019
  • Figure 6-9: Hemlibra - Recommended Loading & Maintenance Dose for Treatment of Hemophilia (mg/Kg/Week), December'2019
  • Figure 6-10: Hemlibra - Average Monthly & Annual Cost for Treatment of Hemophilia A (US$), December'2019
  • Figure 7-1: Blincyto - Sales Value (US$ Million), 2015 - 2019
  • Figure 7-2: US - Blincyto Sales Value (US$ Million), 2016 - 2019
  • Figure 7-3: Global ( Ex USA) - Blincyto Sales Value (US$ Million), 2016 - 2019
  • Figure 7-4: Blincyto - Quarterly Sales Value (US$ Million), 2018
  • Figure 7-5: Blincyto - Quarterly Sales Value (US$ Million), 2019
  • Figure 7-6: Blincyto - US v/s Rest of World Share in Sales Value (%), 2018
  • Figure 7-7: Blincyto - US v/s Rest of World Share in Sales Value (%), 2019
  • Figure 7-8: Hemlibra - Sales Value by Countries (US$ Million), 2019
  • Figure 7-9: Hemlibra - Sales Value by Countries (US$ Million), 2018
  • Figure 7-10: Hemlibra - Sales Value Share by Countries (%), 2018
  • Figure 7-11: Global - Hemlibra Quarterly Sales Value (US$ Million), 2018
  • Figure 7-12: Global - Hemlibra Half Yearly Sales Value (US$ Million), 2018 & 2019
  • Figure 7-13: Hemlibra - Half Year Sales Value by Countries (US$ Million), 2018 & 2019
  • Figure 7-14: Hemlibra - Quarterly Sales Value (US$ Million), 2019
  • Figure 7-15: Hemlibra - 9 Months Sales Value by Countries (US$ Million), 2019
  • Figure 7-16: Hemlibra - 9 Month Sales Value Share by countries (%), 2019
  • Figure 8-1: Global - Bispecific Antibodies Clinical Pipeline by Phase (%), 2020 till 2026
  • Figure 8-2: Global - Bispecific Antibodies Clinical Pipeline by Phase (Numbers), 2020 till 2026
  • Figure 8-3: Global - Bispecific Antibodies in Clinical Pipeline by Country (Numbers), 2020 till 2026
  • Figure 8-4: Global - Bispecific Antibodies in Clinical Pipeline by Company (Numbers), 2020 till 2026
  • Figure 8-5: Global - Bispecific Antibodies in Clinical Pipeline by Indication (Numbers), 2020 till 2026
  • Figure 8-6: Global - Bispecific Antibodies in Clinical Pipeline by Orphan Status (Numbers), 2020 till 2026
  • Figure 11-1: Favorable Market Parameters Global Bispecific Antibody Market
  • Figure 11-2: Commercialization Challenges for Bispecific Antibody
  • Figure 12-1: Global - Bispecific Antibody Market Opportunity Assessment (US$ Billion), 2020 - 2026
  • Figure 13-1: Ablynx - Clinical Pipeline
  • Figure 13-2: Affimed Therapeutics - Clinical Pipeline
  • Figure 13-3: Amgen - Clinical Pipeline
  • Figure 13-4: EMD Serono - Clinical Pipeline
  • Figure 13-5: Emergent Bioscience - Clinical Pipeline
  • Figure 13-6: Genmab - Clinical Pipeline
  • Figure 13-7: Jounce Therapeutics - Clinical Pipeline
  • Figure 13-8: MacroGenics - Clinical Pipeline
  • Figure 13-9: Merus - Clinical Pipeline
  • Figure 13-10: Novimmune - Clinical Pipeline
  • Figure 13-11: OncoMed - Clinical Pipeline
  • Figure 13-12: Pieris Pharmaceuticals - Clinical Pipeline
  • Figure 13-13: Roche - Clinical Pipeline

List of Tables

  • Table 2-1: List of Bispecific Antibodies Formed by Hybrid Hybridoma Method
  • Table 2-2: List of Bispecific Antibodies Formed by DART
  • Table 2-3: List of Bispecific Antibodies Formed by BiTE Method
  • Table 2-4: List of Other BiTEs
  • Table 4-1: Bispecific Antibodies Targeting Cancer
目次

"Global Bispecific Antibody Market Opportunity, Drug Sales & Clinical Trials Insight 2026" Report Highlights:

  • Global Bispecific Antibody Market Opportunity: > US$ 10 Billion
  • Global Bispecific Antibody Market Growth: 118% CAGR (2015 -2019)
  • Global Bispecific Antibody Market Growth In 2019: 280% (> US$ 1.5 Billion)
  • Global Bispecific Antibody Pipeline: 333 Drug
  • Commercially Available Bispecific Antibodies: 2 (Blincyto & Hemlibra)
  • Hemlibra Sales & Market Share 2019: > US$ 1.4 Billion & > 80%

“Global Bispecific Antibody Market Opportunity, Drug Sales & Clinical Trials Insight 2026” provides comprehensive insight on clinical and non-clinical factors that are driving the global bispecific antibodies market and its impact on the global pharmaceutical market landscape. The report has been prepared in a view to deeply profile the current market trends along with the sales insight on two (Blincyto & Hemlibra) commercially available bispecific antibodies with their regional level revenue, market share and the clinical profile.

"Since Commercially Launch In 2015, The Global Bispecific Antibody Market Has Witnessed Growth of 118% CAGR Till 2019"

The availability of the bispecific antibodies in the market and the revenue generated by the drugs in short span of four years (since commercialization in 2015) clearly depicts the current dominant trends followed by its characterization as a next generation of antibody therapy. The number of the investigational agents under preclinical and clinical trials all around the globe adds as a major key component for the establishment of the antibody therapy as a one stop treatment for all the disease.

Pharmaceutical companies involved in the development of these promising bispecific antibodies molecules strongly believe that their products are superior to first generation nonspecific antibody products. No doubt they are adamant to their viewpoint that bispecific antibodies will be more potent against disease targets, which includes combating more than one aspect of the disease simultaneously, better and cheaper production with least side effects. The molecules are also said to have the potential of dealing with multiple disease with a single agent making them more important.

“Structural Diversity Among The Antibodies Are Opening A Wide Plethora For The Novel Bispecific Antibody Agents, And Thus Providing A Great Opportunity For Establishing A Superior Market In The Future.”

Bispecific antibodies are not only being developed for the oncological use but also the non oncological which includes rejection of organ transplants, inflammatory and autoimmune disorders, cardiovascular disease, infectious diseases, allergies and ophthalmic problems making their usage area wide enough to make ample of monetary gains in the near future. Their vitality if approved can also make them a great tool in the diagnostics tests detect and monitor infectious agents like HIV, the cause of AIDS, or the influenza virus causing pandemic flu and for identifying diseases released by biological weapons such as smallpox and anthrax. In addition, monoclonal antibodies have also helped in checks for salmonella and bacteria that cause food poisoning. The global opportunity value of the bispecific antibody market is estimated to be approximately US$ 10 billion per year, which is expected to be achieved in next five year timeframe.

Table of Contents

1. Introduction to Bispecific Monoclonal Antibody

  • 1.1. Overview of Monoclonal Antibody
  • 1.2. Overview of Bispecific Monoclonal Antibody
  • 1.3. Advantage of Bispecific Antibodies upon Monospecific Monoclonal Antibodies

2. The Engineering & Development of Bispecific Antibodies

  • 2.1. Bispecific Antibodies Similar to IgG
    • 2.1.1. Quadroma (Hybrid Hydromas) Approach
    • 2.1.2. “Knobs Into Holes” Approach
    • 2.1.3. CrossMab Approach
    • 2.1.4. Dual-Variable-Domain Immunoglobulin Approach
  • 2.2. Small Bispecific Antibodies
    • 2.2.1. Bispecific Diabodies
    • 2.2.2. Bispecific T-Cell Engager Antibodies (BiTEs)

3. Mechanism Of Action Of Bispecific Antibody

  • 3.1. Trifunctional Antibody: Catumaxomab (Removab®)
  • 3.2. Blinatumomab

4. Applications of Bispecific Antibodies in Diagnostic & Treatment

  • 4.1. BsMAb for Diagnosis of Bacterial & Viral Infectious Diseases
  • 4.2. BsMAb for Cancer Diagnostic
  • 4.3. BsAbs Blocking Signaling Pathways
  • 4.4. BsAbs Targeting Tumor Angiogenesis
  • 4.5. Specific Delivery of Effector Compounds to Targets
  • 4.6. Bispecific Antibodies & Gene Therapy

5. Global Bispecific Antibody Market Outlook

  • 5.1. Current Market Scenario
  • 5.2. Availability of Bispecific Antibodies
    • 5.2.1. Catumaxomab (Removab)
    • 5.2.2. Blinatumomab
    • 5.2.3. Emicizumab
    • 5.2.4. Duligotumab
    • 5.2.5. SAR 156597

6. Approved Bispecific Antibody Dosage & Price Analysis

  • 6.1. Blincyto
  • 6.2. Hemlibra

7. Approved Bispecific Antibody Sales Analysis

  • 7.1. Blincyto
  • 7.2. Hemlibra

8. Global Bispecific Antibodies Clinical Pipeline Overview

  • 8.1. By Phase
  • 8.2. By Country/Region
  • 8.3. By Company
  • 8.4. By Indication
  • 8.5. Orphan Designated Bispecific Antibodies

9. Global Bispecific Antibodies Clinical Pipeline By Company, Indication & Phase

  • 9.1. Research
  • 9.2. Preclinical
  • 9.3. Phase-I
  • 9.4. Phase-I/II
  • 9.5. Phase-II
  • 9.6. Phase-II/III
  • 9.7. Phase-III

10. Marketed Bispecific Antibodies Clinical Insight

  • 10.1. Blinatumomab - Amgen
  • 10.2. Emicizumab - Chugai Pharmaceutical

11. Global Bispecific Antibody Market Dynamics

  • 11.1. Favorable Market Parameters
  • 11.2. Commercialization Challenges

12. Global Bispecific Antibody Market Future Prospects

13. Competitive Landscape

  • 13.1. Ablynx
  • 13.2. Adimab
  • 13.3. Affimed Therapeutics
  • 13.4. Amgen
  • 13.5. AstraZeneca (MedImmune)
  • 13.6. Chugai Pharmaceutical
  • 13.7. Eli Lilly
  • 13.8. EMD Serono
  • 13.9. Emergent BioSolutions
  • 13.10. Genentech
  • 13.11. Genmab
  • 13.12. Immunomedics
  • 13.13. Jounce Therapeutics
  • 13.14. MacroGenics
  • 13.15. Merus
  • 13.16. Neovii Biotech
  • 13.17. NovImmune SA
  • 13.18. OncoMed Pharmaceuticals
  • 13.19. Pieris
  • 13.20. Regeneron Pharmaceuticals
  • 13.21. Roche
  • 13.22. Sanofi