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レポートナンバー 0000034945

世界の二重特異性抗体の市場機会と臨床試験の洞察2023

Kuick Research

Global Bispecific Antibody Market Opportunity and Clinical Trials Insight 2023

発刊日 2023/05

言語英語

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レポート概要

  • 世界市場の年間および四半期売上に関する洞察 (2018 〜 2023 年第 1 四半期))
  • 2028年までの世界市場予測
  • 世界および地域の医薬品別売上に関する洞察 (2018〜2023年第 1 四半期)
  • 承認された二重特異性抗体: 9
  • 臨床試験中の二重特異性抗体に関する洞察: 二重特異性抗体の数> 700
  • 世界の二重特異性抗体臨床試験‐企業別、適応症別、フェーズ別
  • ファストトラック承認、オーファン指定、優先ステータスに関する洞察
  • 承認された二重特異性抗体の価格設定と用量分析
  • 競争環境: 二重特異性抗体を開発している上位 50 社

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。

レポート詳細

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

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