抗体ベース治療薬の発売は、がん治療の分野における大きな変革をもたらしました。モノクローナル抗体は数十年前から存在しており、依然としてその役割は非常に重要です。しかし、臨床的に満たされていない医療ニーズが高まっているため、現在の取り組みはこれらの生物製剤の先進的な剤形の開発に焦点を当てています。抗体生物製剤の研究開発の継続的な拡大によって、二重特異性抗体の時代が到来しました。
	これらの二重特異性抗体は、2 つの異なる標的を攻撃または標的にすることができるため、次のような複数の作用を同時に実行できます。免疫細胞を腫瘍細胞に誘導し、2 つの異なる経路を同時に遮断し、細胞傷害性ペイロードを送達します。過去数十年にわたって、二重特異性抗体の作製には多くの困難が生じてきました。それにもかかわらず、それらは有望な癌治療法として大きな可能性を示しています。
								
						目次
						
	1. Introduction to Bispecific Antibody
	
	1.1 Overview
	1.2 Clinical Advancement of Bispecific Antibodies
	2. Commercially Approved Bispecific Antibodies Insight: Company, Indication, Location and MOA
	3. Global and Regional Bispecific Antibody Market Outlook (2018 till Q1’2023)
	
	3.1 Yearly and Quarterly Sales Insight
	3.2 Approved Bispecific Antibodies Reimbursement Policy
	3.3 Global Bispecific Antibody Market Forecast 2028
	4. Global Bispecific Antibody Market Trends
	
	4.1 US
	4.2 Europe
	4.3 China
	4.4 UK
	4.5 Japan
	4.6 South Korea
	4.7 Australia
	4.8 Canada
	4.9 Latin America
	5. Blincyto: 1st Approved Bispecific Antibody
	
	5.1 Overview and Patent Insight
	5.2 Pricing and Dosage Analysis
	5.3 Sales Analysis
	6. Hemlibra: 2nd Approved Bispecific Antibody
	
	6.1 Overview
	6.2 Dosage and Price Analysis
	6.3 Sales Analysis
	7. Rybrevant: 3rd Approved Bispecific Antibody
	
	7.1 Overview
	7.2 Dosage and Price Analysis
	7.3 Sales Analysis
	8. Kimmtrak: 4th Approved Bispecific Antibody
	
	8.1 Overview
	8.2 Pricing and Dosage Insight
	8.3 Sales Analysis
	9. Vabysmo: 5th Approved Bispecific Antibody
	
	9.1 Overview
	9.2 Dosage and Price Analysis
	9.3 Sales Analysis
	10. Lunsumio: 6th Approved Bispecific Antibody
	
	10.1 Overview and Patent Insight
	10.2 Dosage and Price Analysis
	10.3 Sales Analysis
	11. Cadonilimab: 7th Approved Bispecific Antibody
	12. Tecvayli: 8th Approved Bispecific Antibody
	
	12.1 Overview and Patent Insight
	12.2 Pricing and Dosage Insight
	13. Columvi: 9th Approved Bispecific Antibody
	14. Global Bispecific Antibodies Clinical Pipeline Overview
	
	14.1 By Phase
	14.2 By Country/Region
	14.3 By Company
	14.4 By Indication
	14.5 Orphan Designated Bispecific Antibodies
	14.6 Patient Segment
	15. Global Bispecific Antibodies Clinical Trials By Company, Indication and Phase
	
	15.1 Research
	15.2 Preclinical
	15.3 Phase-I
	15.4 Phase-I/II
	15.5 Phase-II
	15.6 Phase-II/III
	15.7 Phase-III
	15.8 Preregistration
	16. Marketed Bispecific Antibodies Clinical Insight
	17. Competitive Landscape
	
	17.1 ABL Bio
	17.2 Abzyme Therapeutics
	17.3 Affimed Therapeutics
	17.4 Akeso Biopharma
	17.5 Alligator Bioscience
	17.6 Amgen
	17.7 Antibody Therapeutics
	17.8 APITBIO
	17.9 Aptevo Therapeutics
	17.10 Astellas Pharma
	17.11 AstraZeneca
	17.12 BioAtla
	17.13 Biosion
	17.14 Biotheus
	17.15 BJ Bioscience
	17.16 EpimAb Biotherapeutics
	17.17 FutureGen Biopharmaceutical
	17.18 Genentech
	17.19 Genmab
	17.20 Gensun Biopharma
	17.21 Harbour BioMed
	17.22 IGM Biosciences
	17.23 I-MAB Biopharma
	17.24 ImmuneOnco Biopharma
	17.25 ImmunoPrecise Antibodies
	17.26 Innovent Biologics
	17.27 Invenra
	17.28 Janssen Biotech
	17.29 Janssen Research and Development
	17.30 Kenjockety Biotechnology
	17.31 L and L Biopharma
	17.32 LaNova Medicines Limited
	17.33 Light Chain Bioscience
	17.34 Linton Pharm
	17.35 Lyvgen Biopharma
	17.36 MacroGenics
	17.37 Merus
	17.38 NovaRock Biotherapeutics
	17.39 OriCell Therapeutics
	17.40 Pfizer
	17.41 Phanes Therapeutics
	17.42 Prestige BioPharma
	17.43 Regeneron Pharmaceuticals
	17.44 Revitope
	17.45 Roche
	17.46 Virtuoso Therapeutics
	17.47 Xencor
	17.48 Y-Biologics
	17.49 Zhejiang Shimai Pharmaceutical
	17.50 Zymeworks
	List of Figures & Tables
	
	Figure 1-1: Bispecific Antibodies - Advantages
	Figure 2-1: Blincyto - Mechanism of Action
	Figure 2-2: Hemlibra - Mechanism of Action
	Figure 2-3: Rybrevant - Mechanism of Action
	Figure 3-1: Global - Bispecific Antibody Market Size (US$ Million), 2018-2023*
	Figure 3-2: Global - Bispecific Antibody Quarterly Market Size (US$ Million), Q1’2023
	Figure 3-3: Global - Bispecific Antibodies Sales by Drugs (US$ Million), Q1’2023
	Figure 3-4: Global - Bispecific Antibodies Sales by Drugs (%), Q1’2023
	Figure 3-5: Global - Bispecific Antibody Market Size by Region (US$ Million), Q1’2023
	Figure 3-6: Global - Bispecific Antibody Market Size by Region (%), Q1’2023
	Figure 3-7: Global - Bispecific Antibody Quarterly Market Size (US$ Million), 2022
	Figure 3-8: Global - Bispecific Antibodies Sales by Drugs (US$ Million), 2022
	Figure 3-9: Global - Bispecific Antibodies Sales by Drugs (%), 2022
	Figure 3-10: Global - Bispecific Antibody Market Size by Region (US$ Million), 2022
	Figure 3-11: Global - Bispecific Antibody Market Size by Region (%), 2022
	Figure 3-12: Global - Bispecific Antibodies Sales by Drugs (US$ Million), 2021
	Figure 3-13: Global - Bispecific Antibodies Sales by Drugs (%), 2021
	Figure 3-14: Global - Bispecific Antibody Market Size by Region (US$ Million), 2021
	Figure 3-15: Global - Bispecific Antibody Market Size by Region (%), 2021
	Figure 3-16: US - Bispecific Antibody Market Size (US$ Million), 2018 - 2023
	Figure 3-17: ROW - Bispecific Antibody Market Size (US$ Million), 2018 - 2023
	Figure 3-18: US - Bispecific Antibodies Quarterly Sales (US$ Million), 2022
	Figure 3-19: ROW - Bispecific Antibodies Quarterly Sales, 2022
	Figure 3-20: Blincyto - Total Treatment Cost and Reimbursement Cost
	Figure 3-21: Blincyto - In Pocket and Out of Pocket Cost of Treatment
	Figure 3-22: Hemlibra - Total Treatment Cost and Reimbursement Cost
	Figure 3-23: Hemlibra - In Pocket and Out of Pocket Cost of Treatment
	Figure 3-24: Rybrevant - Maximum Coverage by Medicaid (US$), 2023
	Figure 3-25: Rybrevant - Maximum Coverage by Private Insurance Coverage (US$), 2021
	Figure 3-26: Vabysmo - Total Treatment Cost and Reimbursement Cost
	Figure 3-27: Vabysmo - In Pocket and Out of Pocket Cost of Treatment
	Figure 3-28: Global - Bispecific Antibody Market Opportunity Assessment (US$ Billion), 2023 - 2028
	Figure 4-1: US - Bispecific Antibodies Approval
	Figure 4-2: Blincyto - US v/s ROW Sales (US$ Million), Q1'2023
	Figure 4-3: Blincyto - US v/s ROW Sales (US$ Million), Q1'2023
	Figure 4-4: Blincyto - US v/s ROW Sales (US$ Million), 2022
	Figure 4-5: Blincyto - US v/s ROW Shares (%), 2022
	Figure 4-6: Hemlibra - US v/s ROW Sales (US$ Million), Q1'2023
	Figure 4-7: Hemlibra - US v/s ROW Shares (%), Q1'2023
	Figure 4-8: Hemlibra - US v/s ROW Sales (US$ Million), 2022
	Figure 4-9: Hemlibra - US v/s ROW Shares (%), 2022
	Figure 4-10: Global - US v/s ROW Shares in Bispecific Antibodies Market (US$ Million), Q1'2023
	Figure 4-11: Global - US v/s ROW Shares in Bispecific Antibodies Market (%), Q1'2023
	Figure 4-12: Global - US v/s ROW Shares in Bispecific Antibodies Market (US$ Million), 2022
	Figure 4-13: Global - US v/s ROW Shares in Bispecific Antibodies Market (%), 2022
	Figure 4-14: Blincyto - Patent Filing and Expiration Years
	Figure 4-15: Blincyto -Patent Expiration In EU
	Figure 4-16: VABYSMO - Canada Patent Numbers Expiration and Approval Year
	Figure 4-17: Hemlibra - Canada Patent Numbers Approval and Expiration Year
	Figure 4-18: RYBREVANT - Canada Patent Numbers Approval and Expiration dates
	Figure 4-19: KIMMTRAK - Canada Patent Number Approval and Expiration Year
	Figure 5-1: Blincyto - Approval Years By Country
	Figure 5-2: Blincyto - Patent Filing and Expiration Years
	Figure 5-3: Blincyto Treatment Regimen Cycles (Weeks)
	Figure 5-4: Blincyto - Duration of Treatment Phase and Resting Phase in Induction and Consolidation Cycles for Treatment of MRD-Positive B-cell precursor (Days)
	Figure 5-5: Blincyto - Cost of Single Cycle and Treatment Course for the Treatment of MRD-positive B-cell Precursor ALL
	Figure 5-6: Blincyto - Recommended Number of Induction and Consolidation Treatment Cycle for Relapsed B-Cell Precursor ALL
	Figure 5-7: Blincyto - Duration of Single Induction, Consolidation, Continued Cycle and Full Treatment for Relapsed B-Cell Precursor ALL (Weeks)
	Figure 5-8: Blincyto - Cost of Single Cycle and Treatment Course for Treatment for Relapsed B-Cell Precursor ALL
	Figure 5-9: Global - Blincyto Sales Value (US$ Million), 2019 - 2023*
	Figure 5-10: Blincyto - US v/s ROW Share in Sales Value (US$ Million), Q1’2023
	Figure 5-11: Global - Blincyto Quarterly Sales (US$ Million), 2022
	Figure 5-12: Global - Blincyto Sales Value by Region (%), 2022
	Figure 5-13: US - Blincyto Sales Value (US$ Million), 2019-2023*
	Figure 5-14: ROW - Blincyto Sales Value (US$ Million), 2019-2023*
	Figure 6-1: Hemlibra - Approval Years
	Figure 6-2: Hemlibra - Cost for Single Unit of 30 mg/mL and 150 mg/mL Subcutaneous Injection (US$), May’2023
	Figure 6-3: Hemlibra - Recommended Loading and Maintenance Dose for Treatment of Hemophilia (mg/kg/Week)
	Figure 6-4: Global - Hemlibra Sales Value (US$ Million), 2019-2023
	Figure 6-5: Global - Hemlibra Sales Value by Region (US$ Million), Q1’2023
	Figure 6-6: Global - Hemlibra Sales Value by Region (%), Q1’2023
	Figure 6-7: Global - Hemlibra Quarterly Sales Value (US$ Million), 2022
	Figure 6-8: Global - Hemlibra Quarterly Sales Value by Region (US$ Million), 2022
	Figure 6-9: Global - Hemlibra Sales Value by Region (%), 2022
	Figure 6-10: US - Hemlibra Sales Value (US$ Million), 2019-2023*
	Figure 6-11: Europe - Hemlibra Sales Value (US$ Million), 2019-2023*
	Figure 6-12: Japan - Hemlibra Sales Value (US$ Million), 2019-2023*
	Figure 6-13: ROW - Hemlibra Sales Value (US$/ US$ Million), 2019-2023*
	Figure 7-1: Rybrevant - Price for 7 ml Supply and Price per Unit of 50 mg/ml Intravenous Solution (US$), May’2023
	Figure 7-2: Rybrevant - Recommended Dose Per Cycle by Body Weight (mg)
	Figure 7-3: Rybrevant - Dose Reduction in Patients with Weight Less Than 80 kg (mg)
	Figure 7-4: Rybrevant - Dose Reduction in Patients with Weight More Than 80 Kg (mg)
	Figure 8-1: Kimmtrak - Approval Years
	Figure 8-2: Kimmtrak - Cost Per Unit and Per Vial (US$), May’2023
	Figure 8-3: Global - Kimmtrak Sales (US$ Million), 2022
	Figure 8-4: Global - Quarterly Kimmtrak Sales (US$ Million), 2022
	Figure 8-5: Kimmtrak - Sales By Region (US$ Million), 2022
	Figure 8-6: US - Quarterly Kimmtrak Sales (US$ Million), 2022
	Figure 8-7: EU - Quarterly Kimmtrak Sales (US$ Million), 2022
	Figure 8-8 ROW - Quarterly Kimmtrak Sales (US$ ‘000), 2022
	Figure 9-1: Vabysmo - Approval Years
	Figure 9-2: Vabysmo - Price for 0.05 ml Supply and Price per Unit of 6mg/0.05ml Intravitreal Solution (US$), May’2023
	Figure 9-3: Global - Vabysmo Sales Value (US$ Million), 2022-2023*
	Figure 9-4: Global - Vabysmo Sales Value by Region (US$ Million), Q1’2023
	Figure 9-5: Global - Vabysmo Sales Value by Region (%), Q1’2023
	Figure 9-6: Global - Vabysmo Quarterly Sales Value (US$ Million), 2022
	Figure 9-7: Global - Vabysmo Quarterly Sales Value by Region (US$ Million), 2022
	Figure 9-8: Global - Vabysmo Sales Value by Region (%), 2022
	Figure 9-9: US - Vabysmo Sales Value (US$ Million), 2022-2023*
	Figure 9-10: Europe - Vabysmo Sales Value (US$ Million), 2022-2023*
	Figure 9-11: Japan - Vabysmo Sales Value (US$ Million), 2022-2023*
	Figure 9-12: ROW - Vabysmo Sales Value (US$ Million), 2022-2023*
	Figure 10-1: Lunsumio - Approval Years
	Figure 10-2: Lunsumio - Price and Price per unit for Supply of 30 mg/30 ml Intravenous Solution (US$), May’2023
	Figure 10-3: Global - Lunsumio Sales Value (US$ Million), 2022-2023*
	Figure 10-4: Global - Lunsumio Sales Value (US$ Million), 2022-2023*
	Figure 10-5: Global - Lunsumio Sales Value by Region (%), Q1’2023
	Figure 10-6: Global - Lunsumio Quarterly Sales Value (US$ Million), 2022
	Figure 11-1: Global - Cadonilimab Sales v/s Akeso Total Product Sales (US$ Million), 2022
	Figure 12-1: Tecvayli - Approval Years
	Figure 12-2: Tecvayli - Patent Acceptance and Expiration Years
	Figure 12-3: US - Cost of 10 mg/ ml Tecvayli Vial (US$), May’2023
	Figure 12-4: US - Cost of 90 mg/mL Tecvayli Vial (US$), May’2023
	Figure 12-5: EU - Cost of 10 mg/ml Tecvayli Vial (EUR v/s US$), May’2023
	Figure 12-6: EU - Cost of 153 mg/1.7 mL Tecvayli Vial (EUR v/s US$), May’2023
	Figure 14-1: Global - Bispecific Antibodies Clinical Pipeline by Phase (Numbers), 2023
	Figure 14-2: Global - Bispecific Antibodies in Clinical Pipeline by Country (Numbers), 2023
	Figure 14-3: Global - Bispecific Antibodies in Clinical Pipeline by Company (Numbers), 2023
	Figure 14-4: Global - Bispecific Antibodies in Clinical Pipeline by Indication (Numbers), 2023
	Figure 14-5: Global - Bispecific Antibodies in Clinical Pipeline by Orphan Status (Numbers), 2023
	Figure 14-6: Global - Bispecific Antibodies in Clinical Pipeline by Patient Segment (Numbers), 2023
	Table 2-1: Approved Bispecific Antibodies
	Table 4-1: US - FDA IND Applications Accepted, May’2023
	Table 4-2: Bispecific Antibodies In Late Stage Clinical Trials In Different Regions Of European Union
	Table 4-3: Bispecific Antibodies Under Clinical Trials In Latin America, May’2023
	Table 5-1: Blincyto - Active Patents
	Table 5-2: Blincyto - Recommended Dosage and Schedule for the Treatment of MRD-positive B-cell Precursor ALL
	Table 5-3: Blincyto - Recommended Dosage and Schedule for Treatment of Relapsed or Refractory B-cell Precursor ALL
	Table 5-4: Blincyto - Recommended Dosage and Schedule for Treatment of Relapsed or Refractory B-cell Precursor ALL
	Table 7-1: Rybrevant - Premedication
	Table 7-2: Rybrevant - Dose Reductions for Adverse Reactions
	Table 7-3: Rybrevant - Recommended Dosage Modifications for Adverse Reactions
	Table 8-1: Kimmtrak - Recommended Dosage for Treatment of Unresectable or Metastatic Uveal Melanoma
	Table 8-2: Kimmtrak - Dose Modifications for Adverse Reactions
	Table 10-1: Lunsumio - Treatment Cycles
	Table 10-2: Lunsumio - Premedications
	Table 10-3: Lunsumio - Recommendations for Management of Cytokine Release Syndrome
	Table 12-1: Tecvayli - Dosing Schedule
	Table 12-2: Tecvayli - Recommended Dosage Modifications for Adverse Reactions