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二重特異性抗体の世界市場：薬剤販売、特許、価格、臨床試験インサイト（2029年）

Global Bispecific Antibody Market, Drugs Sales, Patent, Price & Clinical Trials Insight 2029

出版日: 2024年03月01日 | 発行: KuicK Research

| ページ情報: 英文 1200 Pages | 納期: 即日から翌営業日

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概要

サンプル依頼リストに入れる

二重特異性抗体は、過去10年来勢いを増しているエキサイティングな新しい治療アプローチです。これらの緻密に設計された分子は、免疫系を利用して悪性細胞やその他の疾患細胞・組織を正確に標的とするユニークな作用機序を提供し、副作用のリスクを最小化する標的アプローチを提供します。過去3年間、二重特異性抗体市場は研究開発と商業活動において急速な盛り上がりを見せており、今後数年間で市場は急速に成長することが予想されます。

二重特異性抗体は、2つの異なる抗原に同時に結合するように設計されたタンパク質であり、通常、異なる細胞型に存在します。その二重標的能力は、病気に対する免疫システムを利用する複数の方法を提供します。がんに対する一般的なアプローチとしては、T細胞やナチュラルキラー細胞を悪性細胞への攻撃に向かわせることが挙げられます。また、免疫細胞と腫瘍細胞を架橋して免疫反応を高めることもできます。さらに、2つの異なるシグナル伝達経路をブロックしたり、免疫細胞を腫瘍微小環境に動員することもできます。

がん以外の適応症では、二重特異性抗体は異なる疾患メディエーターや細胞タイプを二重に標的とすることができます。これにより、炎症、自己免疫、その他の疾患に関与する病原性タンパク質、サイトカイン、細胞を中和または除去する機会が得られます。しかし、適応症によって、二重特異性抗体の作用機序は変わる可能性があります。

二特異性抗体の多様性は、その前身である従来のモノクローナル抗体に比べて、特異性、効力、複数の経路を同時に標的とする柔軟性の向上など、いくつかの利点を提供します。これは、モノクローナル抗体がさまざまながん関連経路を阻害するために多用されているがん治療において、特に重要な意味を持っています。免疫細胞を腫瘍に直接誘導することにより、二重特異性抗体は腫瘍の免疫回避機構を克服することができ、従来の化学療法と比較して有効性の向上と低毒性につながる可能性があります。

米国FDAは2014年にBlinatumomab（市販名Blincyto）を承認し、二重特異性抗体の分野における重要なマイルストーンとなり、再発または難治性の前駆B細胞性急性リンパ芽球性白血病の治療法を根本的に変えました。この成功の後、複数の新しい二重特異性抗体が臨床開発段階にあり、がんを中心に幅広い疾患をカバーしています。それにもかかわらず、がんに加えて、ウイルスや細菌感染、自己免疫疾患などの新たな適応症に対処するために設計された二重特異性候補抗体の数が増加しています。このような多様化は、このクラスの医薬品の治療応用範囲が拡大していることを浮き彫りにしています。

二重特異性抗体は、主要な新薬クラスとしての可能性を検証するのに十分な臨床的成功を収めています。複数の疾患経路を利用できるそのユニークな能力は、モノクローナル抗体を超える新たな治療の可能性を引き出しています。がん領域が先導してきた一方で、他の疾患領域への拡大も加速しています。分子設計とエンジニアリングの継続的な革新により、二重特異性抗体は、幅広いアンメットメディカルニーズにおける治療を変革するエキサイティングな汎用性の高いアプローチとなり、調査も徐々に進んでいます。

当レポートでは、世界の二重特異性抗体市場について調査し、市場の概要とともに、薬剤動向、臨床試験動向、地域別動向、および市場に参入する企業の競合情勢などを提供しています。

ABL Bio
Abzyme Therapeutics
Affimed Therapeutics
Akeso Biopharma
Alligator Bioscience
Amgen
Antibody Therapeutics
APITBIO
Aptevo Therapeutics
Astellas Pharma
AstraZeneca
BioAtla
Biosion
Biotheus
BJ Bioscience
EpimAb Biotherapeutics
FutureGen Biopharmaceutical
Genentech
Genmab
Gensun Biopharma
Harbour BioMed
IGM Biosciences
I-MAB Biopharma
ImmuneOnco Biopharma
ImmunoPrecise Antibodies
Innovent Biologics
Invenra
Janssen Research & Development
Kenjockety Biotechnology
LaNova Medicines Limited
Light Chain Bioscience
Linton Pharm
Lyvgen Biopharma
MacroGenics
Merus
NovaRock Biotherapeutics
Pfizer
Phanes Therapeutics
Prestige BioPharma
Regeneron Pharmaceuticals
Revitope
Roche
Virtuoso Therapeutics
Xencor
Y-Biologics
Zhejiang Shimai Pharmaceutical
Zymeworks

図表

List of Figures

Figure 1-1: Bispecific Antibodies - Advantages
Figure 2-1: Antibody-Chemotherapy Combination - Advantages
Figure 2-2: Antibody-Chemotherapy Combination - Impending Challenges
Figure 3-1: Blincyto - Mechanism of Action
Figure 3-2: Hemlibra - Mechanism of Action
Figure 3-3: Rybrevant - Mechanism of Action
Figure 3-4: Regulatory Designations - Benefits
Figure 4-1: Multiclonics - Distinctive Characteristics
Figure 4-2: Biclonics - Format
Figure 4-3: ADAPTIR Bispecific Structure
Figure 4-4: ADAPTIR-FLEX
Figure 4-5: BEAT Platform - Multispecific Antibodies
Figure 4-6: FIT-Ig - Proprietary Bispecific Platform
Figure 4-7: BiClone format
Figure 4-8: BioAtla CABs - Features
Figure 4-9: BioAtla CABs - Benefits
Figure 4-10: IMBiologic Bispecific Antibodies - Strategy
Figure 4-11: IMBiologic Bispecific Antibodies - Mechanism of Action
Figure 4-12: Novel HBICE
Figure 4-13: HBICE - Mechanism of Action 1
Figure 4-14: HBICE - Mechanism of Action 2
Figure 4-15: Phanes Therapeutics - PACbody Platform
Figure 4-16: Phanes Therapeutics - SPECpair Platform
Figure 4-17: Phanes Therapeutics - ATACCbody
Figure 4-18: Numab Therapeutics - Technology
Figure 4-19: Grabody I Platform - Mechanism of Action
Figure 4-20: Grabody I Platform - Mechanism of Action
Figure 4-21: 3-Step DuoBody Production Process
Figure 4-22: DuoHexaBody Molecules - Schematic
Figure 4-23: iTAb - Patented Structure
Figure 4-24: iTAb - Mechanism of Action
Figure 4-25: Synimmune - Proprietary Bispecific Antibody Format
Figure 4-26: BiTE - Structure
Figure 4-27: BiTE Molecule
Figure 4-28: Sanyou Super Trillion Common Light Chain Antibody Discovery Platform
Figure 4-29: ALiCE - Characteristics
Figure 4-30: ALiCE - Schematic Diagram & Mechanism of Action
Figure 4-31: Abz2 Bispecific Platform
Figure 4-32: Abz2 Bispecifics - Benefits
Figure 4-33: Neo-X-Prime Bispecific Mechanism
Figure 4-34: B-Body Bispecific Antibody - Structre
Figure 4-35: xLinkBsAb - Structure
Figure 4-36: PrecisionGATE Bispecific Antibody - Structure
Figure 5-1: Global - Annual Bispecific Antibody Market (US$ Million), 2019-2023
Figure 5-2: Global - Quarterly Bispecific Antibody Market (US$ Million), 2023
Figure 5-3: Global - Annual Bispecific Antibodies Market by Drug (US$ Million), 2023
Figure 5-4: Global - Bispecific Antibodies Market Shares by Drugs (%), 2023
Figure 5-5: Global - Annual Bispecific Antibody Market by Region (US$ Billion), 2023
Figure 5-6: Global - Bispecific Antibody Market Shares by Region (%), 2023
Figure 5-7: Global - Annual Bispecific Antibodies Sales by Drugs (US$ Million), 2022
Figure 5-8: Global - Bispecific Antibodies Market Shares by Drugs (%), 2022
Figure 5-9: Global - Bispecific Antibody Market by Region (US$ Million), 2022
Figure 5-10: Global - Bispecific Antibody Market Shares by Region (%), 2022
Figure 5-11: US - Annual Bispecific Antibody Market Value (US$ Million), 2019-2023
Figure 5-12: ROW - Global Bispecific Antibody Market Value (US$ Million), 2019-2023
Figure 5-13: US - Quarterly Bispecific Antibodies Market (US$ Million), 2023
Figure 5-14: ROW - Quarterly Bispecific Antibodies Market (US$ Million), 2023
Figure 5-15: Blincyto - Total Treatment Cost & Reimbursement Cost
Figure 5-16: Blincyto - In Pocket & Out of Pocket Cost of Treatment
Figure 5-17: Hemlibra - Total Treatment Cost & Reimbursement Cost
Figure 5-18: Hemlibra - In Pocket & Out of Pocket Cost of Treatment
Figure 5-19: Rybrevant - Maximum Coverage by Medicaid (US$), 2023
Figure 5-20: Rybrevant - Maximum Coverage by Private Insurance Coverage (US$), 2021
Figure 5-21: Vabysmo - Total Treatment Cost & Reimbursement Cost
Figure 5-22: Vabysmo - In Pocket & Out of Pocket Cost of Treatment
Figure 5-23: Global - Bispecific Antibody Market Opportunity Assessment (US$ Billion), 2024 - 2029
Figure 6-1: US - Bispecific Antibodies Approval
Figure 6-2: Blincyto - US v/s ROW Sales (US$ Million), 2023
Figure 6-3: Blincyto - US v/s ROW Shares (%), 2023
Figure 6-4: Blincyto - US v/s ROW Sales (US$ Million), 2022
Figure 6-5: Blincyto - US v/s ROW Shares (%), 2022
Figure 6-6: Hemlibra - US v/s ROW Sales (US$ Million), 2023
Figure 6-7: Hemlibra - US v/s ROW Shares (%), 2023
Figure 6-8: Hemlibra - US v/s ROW Sales (US$ Million), 2022
Figure 6-9: Hemlibra - US v/s ROW Shares (%), 2022
Figure 6-10: Global - US v/s ROW in Bispecific Antibodies Market (US$ Million), 2023
Figure 6-11: Global - US v/s ROW Shares in Bispecific Antibodies Market (%), 2023
Figure 6-12: Global - US v/s ROW in Bispecific Antibodies Market (US$ Million), 2022
Figure 6-13: Global - US v/s ROW Shares in Bispecific Antibodies Market (%), 2022
Figure 6-14: Blincyto - US Patent Filing & Expiration Year
Figure 6-15: Blincyto - EU Patent Expiration
Figure 6-16: Vabysmo - Canada Patent Numbers Expiration & Approval Year
Figure 6-17: Hemlibra - Canada Patent Numbers Approval & Expiration Year
Figure 6-18: Rybrevant - Canada Patent Numbers Approval & Expiration Year
Figure 6-19: Kimmtrak - Canada Patent Number Approval & Expiration Year
Figure 7-1: Bispecific Antibodies - Advantages
Figure 7-2: TG-1801 Phase 1 Study - Initiation & Completion Year
Figure 7-3: Bispecific Antibodies - Future Opportunities
Figure 7-4: Mim8 Phase 3 (NCT05053139) Study - Initiation & Completion Year
Figure 7-5: Mim8 Phase 3 (NCT05878938) Study - Initiation & Completion Year
Figure 7-6: NXT007 Phase 1/2 (NCT05987449) Study - Initiation & Completion Year
Figure 7-7: HMB-001 Phase 1/2 (NCT06211634) Study - Initiation & Completion Year
Figure 7-8: REGN4018 Phase 1/2 (NCT03564340) Study - Initiation & Completion Year
Figure 7-9: PRV-3279 Phase 2 (NCT05087628) Study - Initiation & Completion Year
Figure 8-1: Global - Bispecific Antibodies Clinical Pipeline by Phase (Numbers), 2023
Figure 8-2: Global - Bispecific Antibodies in Clinical Pipeline by Country (Numbers), 2024 till 2029
Figure 8-3: Global - Bispecific Antibodies in Clinical Pipeline by Company (Numbers), 2024 till 2029
Figure 8-4: Global - Bispecific Antibodies in Clinical Pipeline by Indication (Numbers), 2023 till 2029
Figure 8-5: Global - Bispecific Antibodies in Clinical Pipeline by Orphan Status (Numbers), 2023 till 2029
Figure 8-6: Global - Bispecific Antibodies in Clinical Pipeline by Patient Segment (Numbers), 2023 till 2029
Figure 9-1: Blincyto - Approval Year by Region
Figure 9-2: Blincyto - Patent Filing & Expiration Year
Figure 9-3: Blincyto - Treatment Regimen Cycles (Weeks)
Figure 9-4: Blincyto - Duration of Treatment Phase & Resting Phase in Induction & Consolidation Cycles for Treatment of MRD-Positive B-cell precursor (Days)
Figure 9-5: Blincyto - Cost of Single Cycle & Treatment Course for the Treatment of MRD-positive B-cell Precursor ALL
Figure 9-6: Blincyto - Recommended Number of Induction & Consolidation Treatment Cycle for Relapsed B-Cell Precursor ALL
Figure 9-7: Blincyto - Duration of Single Induction, Consolidation, Continued Cycle & Full Treatment for Relapsed B-Cell Precursor ALL (Weeks)
Figure 9-8: Blincyto - Cost of Single Cycle & Treatment Course for Treatment for Relapsed B-Cell Precursor ALL
Figure 9-9: Global - Blincyto Sales (US$ Million), 2019-2023
Figure 9-10: Global - Blincyto Sales (US$ Million), Q1 - Q4'2023
Figure 9-11: Blincyto - US v/s ROW Sales (US$ Million), 2023
Figure 9-12: Global - Blincyto Sales by Region (%), 2023
Figure 9-13: US - Blincyto Sales (US$ Million), Q1 - Q4'2023
Figure 9-14: ROW - Blincyto Sales (US$ Million), Q1 - Q4'2023
Figure 9-15: US - Blincyto Sales ((US$ Million), 2019-2023
Figure 9-16: ROW - Blincyto Sales (US$ Million), 2019-2023
Figure 10-1: Hemlibra - Approval Years by Region
Figure 10-2: Hemlibra - Cost per Unit & Supply of 150 mg/mL Subcutaneous Injection (US$), February'2024
Figure 10-3: Hemlibra - Recommended Loading & Maintenance Dose for Treatment of Hemophilia (mg/kg/Week)
Figure 10-4: Global - Hemlibra Sales (US$ Million), 2019-2023
Figure 10-5: US - Hemlibra Sales (US$ Million), 2019-2023
Figure 10-6: Europe - Hemlibra Sales (US$ Million), 2019-2023
Figure 10-7: Japan - Hemlibra Sales (US$ Million), 2019-2023
Figure 10-8: ROW - Hemlibra Sales (US$ Million), 2019-2023
Figure 10-9: Global - US v/s ROW Sales (US$ Million), 2023
Figure 10-10: Global - Hemlibra Annual Sales by Region (US$ Million), 2023
Figure 10-11: Global - Hemlibra Sales by Region (%), 2023
Figure 10-12: Global - Hemlibra Sales (US$ Million), Q1 - Q4'2023
Figure 10-13: US - Hemlibra Sales (US$ Million), Q1 - Q4'2023
Figure 10-14: Europe - Hemlibra Sales (US$ Million), Q1 - Q4'2023
Figure 10-15: Japan - Hemlibra Sales (US$ Million), Q1 - Q4'2023
Figure 10-16: ROW - Hemlibra Sales (US$/ US$ Million), Q1 - Q4'2023
Figure 11-1: Rybrevant - Price per Unit & Supply of Intravenous Solution (US$), February'2024
Figure 11-2: Rybrevant - Recommended Dose Per Cycle by Body Weight (mg)
Figure 11-3: Rybrevant - Dose Reduction in Patients with Weight less than 80 kg (mg)
Figure 11-4: Rybrevant - Dose Reduction in Patients with Weight more than 80 Kg (mg)
Figure 12-1: Kimmtrak - Approval Year by Region
Figure 12-2: Kimmtrak - Cost Per Unit & Per Vial (US$), February'2024
Figure 12-3: Global - Annual Kimmtrak Sales (US$ Million), 2021-2023
Figure 12-4: Global - Quarterly Kimmtrak Sales (US$ Million), 2023
Figure 12-5: Kimmtrak - Sales by Region (US$ Million), 2023
Figure 12-6: Kimmtrak - US v/s ROW Market Shares (US$ Million), 2023
Figure 12-7: Kimmtrak - US v/s ROW Market Shares (%), 2023
Figure 12-8: US - Quarterly Kimmtrak Sales (US$ Million), 2023
Figure 12-9: EU - Quarterly Kimmtrak Sales (US$ Million), 2023
Figure 12-10 ROW - Quarterly Kimmtrak Sales (US$ Million), 2023
Figure 13-1: Vabysmo - Approval Year by Region
Figure 13-2: Vabysmo - Price per Unit & Supply of Intravitreal Solution (US$), February'2024
Figure 13-3: Global - Vabysmo Sales (US$ Million), 2022-2023
Figure 13-4: Global - Vabysmo US v/s ROW Sales (US$ Million), 2023
Figure 13-5: Global - Vabysmo Annual Sales by Region (US$ Million), 2023
Figure 13-6: Global - Vabysmo Annual Sales by Region (%), 2023
Figure 13-7: US - Vabysmo Sales (US$ Million), 2022-2023
Figure 13-8: Europe - Vabysmo Sales (US$ Million), 2022-2023
Figure 13-9: Japan - Vabysmo Sales (US$ Million), 2022-2023
Figure 13-10: ROW - Vabysmo Sales (US$ Million), 2022-2023
Figure 13-11: Global - Vabysmo Sales (US$ Million), Q1 - Q4'2023
Figure 13-12: US - Vabysmo Sales (US$ Million), Q1 - Q4'2023
Figure 13-13: Europe - Vabysmo Sales (US$ Million), Q1 - Q4'2023
Figure 13-14: Japan - Vabysmo Sales (US$ Million), Q1 - Q4'2023
Figure 13-15: ROW - Vabysmo Sales (US$ Million), Q1 - Q4'2023
Figure 14-1: Lunsumio - Approval Years by Region
Figure 14-2: US - Price per Unit & Supply of Lunsumio Intravenous Solution (US$), February'2024
Figure 14-3: EU - Price per Unit & Supply of Lunsumio Intravenous Solution (US$), February'2024
Figure 14-4: Global - Lunsumio Sales (US$ Million), 2022-2023
Figure 14-5: US - Lunsumio Sales (US$ Million), 2022-2023
Figure 14-6: Europe - Lunsumio Sales (US$ Million), 2022-2023
Figure 14-7: Global - Lunsumio Annual Sales by Region (US$ Million), 2023
Figure 14-8: Global - Lunsumio Annual Sales by Region (%), 2023
Figure 14-9:- Global - Lunsumio Sales (US$ Million), Q1 - Q4'2023
Figure 14-10: US - Lunsumio Sales (US$ Million), Q1 - Q4'2023
Figure 14-11: Europe - Lunsumio Sales (US$ Million), Q1 - Q4'2023
Figure 15-1: Annual - Cadonilimab Sales (US$ Million), H2'2022 & H1'2023
Figure 16-1: Tecvayli - Approval Years by Region
Figure 16-2: Tecvayli - Patent Acceptance & Expiration Years
Figure 16-3: US - Cost per Unit & Supply of Tecvayli Subcutaneous Solution (US$), February'2024
Figure 16-4: EU - Cost per Unit & Supply of Tecvayli Subcutaneous Solution (US$), February'2024
Figure 17-1: Columvi - Approval Year by Region
Figure 17-2: US - Price per Unit & Supply of Columvi Intravenous Solution (US$), February'2024
Figure 17-3: EU - Price per Unit & Supply of Columvi Intravenous Solution (US$), February'2024
Figure 17-4: Global - Columvi Sales by Region (US$ Million), 2023
Figure 17-5: Global - Columvi Sales (US$ Million), Q1 - Q4'2023
Figure 17-6: US - Columvi Sales (US$ Million), Q1 - Q4'2023
Figure 17-7: Europe - Columvi Sales (US$ Million), Q1 - Q4'2023
Figure 18-1: Epkinly - Approval Year by Region
Figure 18-2: US - Cost per Unit & Supply of Epkinly Subcutaneous Solution (US$), February'2024
Figure 18-3: EU - Cost per Unit & Supply of Epkinly Subcutaneous Solution (US$), February'2024
Figure 18-4: Global - Epkinly Sales (US$ Million), 2023
Figure 18-5: Global - Epkinly Sales (US$ Million), Q1 - Q4'2023
Figure 19-1: Talvey - Approval Year by Region
Figure 19-2: Talquetamab - FDA & EMA Designation Year
Figure 19-3: Talvey - Patent Acceptance & Expiration Year
Figure 19-4: US - Price per Unit & Supply of Talvey Intravenous Solution (US$), February'2024
Figure 19-5: EU - Price per Unit & Supply of Talvey Intravenous Solution (US$), February'2024
Figure 20-1: Elrexfio - Approval Years by Region
Figure 20-2: Elranatamab - FDA & EMA Designation Years
Figure 20-3: US - Price per Unit & Supply of Elrexfio Subcutaneous Solution (US$), February'2024

List of Tables

Table 2-1: Bispecific Antibody & Chemotherapy Combinations in Clinical Trials
Table 2-2: Bispecific Antibody & Targeted Therapy Combinations in Clinical Trials
Table 2-3: Bispecific Antibody & Immunotherapy Combinations in Clinical Trials
Table 2-4: Bispecific Antibody & Radiotherapy Combinations in Clinical Trials
Table 3-1: Approved Bispecific Antibodies
Table 3-2: US - Bispecific Antibodies with Regulatory Designations
Table 3-3: EU - Bispecific Antibodies with Regulatory Designations
Table 3-4: EU - Bispecific Antibodies with Regulatory Designations
Table 5-1: Epkinly - Billing Unit Application for Doses
Table 5-2: Talvey - Coverage Summary
Table 5-3: Talvey - Coding Summary
Table 5-4: Elrexfio - HCPCS Codes
Table 5-5: Elrexfio - HCPCS modifiers
Table 6-1: US - FDA IND Applications Accepted, February'2024
Table 6-2: EU - Bispecific Antibodies in Late Stage Clinical Trials
Table 6-3: Bispecific Antibodies in Clinical Trials in Latin America
Table 7-1: Lymphoma - Bispecific Antibodies in Clinical Trials
Table 7-2: Multiple Myeloma - Bispecific Antibodies in Clinical Trials
Table 7-3: Leukemia - Bispecific Antibodies in Clinical Trials
Table 7-4: Lung Cancer - Bispecific Antibodies in Clinical Trials
Table 7-5: Melanoma - Bispecific Antibodies in Clinical Trials
Table 7-6: Digestive System Cancers - Bispecific Antibodies in Clinical Trials
Table 7-7: Breast Cancer - Bispecific Antibodies in Clinical Trials
Table 7-8: Gynecological Cancers - Bispecific Antibodies in Clinical Trials
Table 7-9: Gynecological Cancers - Bispecific Antibodies in Clinical Trials
Table 9-1: Blincyto - Active Patents
Table 9-2: Blincyto - Recommended Dosage & Schedule for the Treatment of MRD-positive B-cell Precursor ALL
Table 9-3: Blincyto - Recommended Dosage & Schedule for Treatment of Relapsed or Refractory B-cell Precursor ALL
Table 9-4: Blincyto - Recommended Dosage & Schedule for Treatment of Relapsed or Refractory B-cell Precursor ALL
Table 11-1: Rybrevant - Premedication
Table 11-2: Rybrevant - Dose Reductions for Adverse Reactions
Table 11-3: Rybrevant - Recommended Dosage Modifications for Adverse Reactions
Table 12-1: Kimmtrak - Recommended Dosage for Treatment of Unresectable or Metastatic Uveal Melanoma
Table 12-2: Kimmtrak - Dose Modifications for Adverse Reactions
Table 14-1: Lunsumio - Recommended Treatment Cycles
Table 14-2: Lunsumio - Recommended Premedications
Table 14-3: Lunsumio - Recommendations for Management of Cytokine Release Syndrome
Table 16-1: Tecvayli - Dosing Schedule
Table 16-2: Tecvayli - Recommended Dosage Modifications for Adverse Reactions
Table 17-1: Columvi - Dosing Schedule (21-Day Treatment Cycles)
Table 17-2: Columvi - Premedications to be Administered
Table 17-3: Columvi - Recommendations for Management of Cytokine Release Syndrome
Table 17-4: Columvi - Recommended Dosage Modification for Neurologic Toxicity (Including ICANS)
Table 17-5: Columvi - Recommended Dosage Modifications for Other Adverse Reactions
Table 18-1: Epkinly - Dosage Schedule
Table 18-2: Epkinly - Recommendations for Management of Cytokine Release Syndrome
Table 18-3: Epkinly - Recommendations for Management of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Table 18-4: Epkinly - Recommended Dosage Modifications for Other Adverse Reactions
Table 19-1: Talvey - Weekly Dosing Schedule
Table 19-2: Talvey - Biweekly Dosing Schedule
Table 19-3: Talvey - Recommendations for Management of CRS
Table 19-4: Talvey - Recommendations for Management of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Table 19-5: Talvey - Recommendations for Management of Neurologic Toxicity (excluding ICANS)
Table 19-6: Talvey - Recommended Dosage Modifications for Other Adverse Reactions
Table 20-1: Elrexfio - Dosing Schedule
Table 20-2: Elrexfio - Recommendations for Management of CRS
Table 20-3: Elrexfio - Recommended Dosage Modifications for Other Adverse Reactions

Global Bispecific Antibody Market, Drugs Sales, Patent, Price & Clinical Trials Insight 2029 Report Highlights:

Bispecific Antibodies Development Proprietary Platforms Insight: > 30 Platforms
Global Bispecific Antibodies Market Size Yearly & Quarterly Sales (2018 till 2023)
Global Bispecific Antibodies Market Size 2023: > USD 8 Billion
Global Bispecific Antibodies Market Forecast Till 2029
Approved Bispecific Antibodies Yearly & Quarterly Sales (2018 till 2023)
Approved Bispecific Antibodies Regional Sales (2018 till 2023)
Clinical & Commercial Insight On Approved Bispecific Antibodies: 12 Antibodies
Approved Bispecific Antibodies Pricing & Dosage Analysis
Global Bispecific Antibodies Clinical Trials By Company, Indication & Phase: > 800 Antibodies
FDA & EMA Fast Track Approval, Orphan Designation, Priority Status Insights

Bispecific antibodies represent an exciting new therapeutic approach that has been gaining momentum since the last decade. These meticulously designed molecules offer a unique mechanism of action that harnesses the immune system to target malignant and other diseased cells and tissues with precision, offering a targeted approach that minimizes the risk of adverse effects. In the last three years, the market of bispecific antibodies has experienced a rapid surge in research and development, and commercial activities, setting the market for a speedy growth in the coming years.

Bispecific antibodies are engineered proteins intended to simultaneously bind two different antigens, typically found on distinct cell types. Their dual targeting ability provides multiple ways to exploit the immune systems against diseases. For cancer, common approaches include redirecting T cells or natural killer cells to attack malignant cells. They can also crosslink immune cells with tumor cells to enhance the immune response. Additionally, they can block two different signaling pathways or recruit immune cells to the tumor microenvironment.

For indications apart from cancer, bispecific antibodies enable dual targeting of different disease mediators or cell types. This provides opportunities to neutralize or clear pathogenic proteins, cytokines or cells involved in inflammation, autoimmunity and other diseases. However, depending on the indications, the mechanism by which bispecific antibodies work can change.

The versatility of bispecific antibodies offers several advantages over their predecessors, traditional monoclonal antibodies, including enhanced specificity, potency and flexibility in targeting multiple pathways at the same time. This become especially relevant in cancer treatment, where monoclonal antibodies are utilized heavily to interfere with different cancer-associated pathways. By directly redirecting immune cells to tumors, bispecific antibodies can overcome tumor immune evasion mechanisms, leading to improved efficacy and potentially lower toxicity compared to conventional chemotherapy.

The US FDA approved Blinatumomab (commercially known as Blincyto) in 2014, marking a key milestone in the field of bispecific antibodies and fundamentally changing how relapsed or refractory precursor B-cell acute lymphoblastic leukemia is treated. Following this success, multiple new bispecific antibodies have arisen in clinical development, covering a wide range of medical disorders, with a focus on cancer. Nonetheless, in addition to cancer, there has been an increase in the number of bispecific candidates designed to address emerging indications such as viral and bacterial infections, as well as autoimmune diseases. This diversification highlights the growing range of therapeutic applications for this class of medicines.

Currently, there are over 800 bispecific candidates in active clinical development. Phase 3 trials are underway across a spectrum of solid cancers like triple negative breast cancer, small cell lung cancer, bladder cancer among others, in addition to hematological cancers, including myeloma and leukemia. Further, a few other phase 3 candidates are also being investigated in indications beyond cancer, like hemophilia A and diabetic macular edema, displaying the diversity in indications.

The heightened attention on the development of this novel therapeutic class has been greatly supported by the increasing global value of the bispecific antibodies market. At present, 12 bispecific antibodies have received approvals in different markets around the globe, which together, generated revenue of over US$ 8.5 Billion in the year 2023. This was an increase of over 47% as compared to the total sales of 2022, which was approximately over US$ 5.8 Billion. A bulk of this value comes from the global sales of Hemlibra, a bispecific antibody indicated for the treatment of Hemophilia A, which is the highest selling member of this drug class.

Since bispecific antibodies were introduced in the market, the US has been a major contributor to the overall sales of these drugs. In 2023, the US market alone generated a revenue of US$ 5.6 Billion, with the international market contributing US$ 2.8 Billion to the total sales. This was an increase of 34% compared to the sales recorded in 2022, showing the growing interest of patients and physicians in novel therapeutics, such as bispecific antibodies.

Therefore, bispecific antibodies have demonstrated enough clinical success to validate their potential as a major new drug class. Their unique ability to tap into multiple disease pathways is unlocking new therapeutic possibilities beyond monoclonal antibodies. While oncology has led the way, expansion into other disease areas is accelerating. With continued innovation in molecular designs and engineering, bispecific antibodies represent an exciting versatile approach to transform treatment across a wide range of unmet medical needs, which researchers are slowly progressing to.

1. Introduction to Bispecific Antibody

1.1. Overview
1.2. Clinical Advancement of Bispecific Antibodies

2. Bispecific Antibodies Combination Strategies

2.1. Chemotherapies
2.2. Targeted Therapies
2.3. Immunotherapies
2.4. Radiotherapy

3. Commercially Approved Bispecific Antibodies Insight

3.1. Company, Indication, Location & MOA
3.2. Bispecific Antibodies Granted FDA & EMA Designations

4. Bispecific Antibodies Proprietary Platforms

5. Global & Regional Bispecific Antibody Market Outlook

5.1. Yearly & Quarterly Sales Insight (2019 to 2023)
5.2. Approved Bispecific Antibodies Reimbursement Policy
5.3. Global Bispecific Antibody Market Forecast 2029

6. Global Bispecific Antibody Market Trends By Region

6.1. US
6.2. Europe
6.3. China
6.4. UK
6.5. Japan
6.6. South Korea
6.7. Australia
6.8. Canada
6.9. Latin America

7. Global Bispecific Antibodies Research & Market Trends by Indications

7.1. Lymphoma
7.2. Multiple Myeloma
7.3. Leukemia
7.4. Lung Cancer
7.5. Melanoma
7.6. Blood Disorders
7.7. Gastrointestinal Cancers
7.8. Other Cancers
7.9. Autoimmune & Inflammatory Diseases
7.10. Microbial Diseases
7.11. Ocular Diseases

8. Global Bispecific Antibodies Clinical Trials Overview

8.1. By Phase
8.2. By Country/Region
8.3. By Company
8.4. By Indication
8.5. By Priority Status
8.6. Patient Segment

9. Blincyto - Clinical, Patent, Pricing & Sales Insight

9.1. Overview & Patent Insight
9.2. Pricing & Dosage Analysis
9.3. Sales Analysis

10. Hemlibra - Clinical, Patent, Pricing & Sales Insight

10.1. Overview
10.2. Pricing & Dosage Insight
10.3. Sales Analysis

11. Rybrevant - Clinical, Patent & Pricing Insight

11.1. Overview
11.2. Pricing & Dosage Insight

12. Kimmtrak - Clinical, Patent, Pricing & Sales Insight

12.1. Overview
12.2. Pricing & Dosage Insight
12.3. Sales Analysis

13. Vabysmo - Clinical, Patent, Pricing & Sales Insight

13.1. Overview
13.2. Pricing & Dosage Insight
13.3. Sales Analysis

14. Lunsumio - Clinical, Patent, Pricing & Sales Insight

14.1. Overview & Patent Insight
14.2. Pricing & Dosage Insight
14.3. Sales Analysis

15. Cadonilimab - Clinical & Sales Insight

16. Tecvayli - Clinical, Patent & Pricing Insight

16.1. Overview & Patent Insight
16.2. Pricing & Dosage Insight

17. Columvi - Clinical, Patent, Pricing & Sales Insight

17.1. Overview & Patent Insight
17.2. Pricing & Dosage Insight
17.3. Sales Analysis

18. Epkinly - Clinical, Patent, Pricing & Sales Insight

18.1. Overview
18.2. Pricing & Dosage Insight
18.3. Sales Analysis

19. Talvey - Clinical, Patent & Pricing Insight

19.1. Overview & Patent Insight
19.2. Pricing & Dosage Insight

20. Elrexfio - Clinical, Patent & Pricing Insight

20.1. Overview
20.2. Pricing & Dosage Insight

21. Global Bispecific Antibodies Clinical Trials By Company, Indication & Phase

21.1. Research
21.2. Preclinical
21.3. Phase-I
21.4. Phase-I/II
21.5. Phase-II
21.6. Phase-II/III
21.7. Phase-III
21.8. Preregistration
21.9. Registered

22. Marketed Bispecific Antibodies Clinical Insight By Company, Country & Indication

23. Competitive Landscape

23.1. ABL Bio
23.2. Abzyme Therapeutics
23.3. Affimed Therapeutics
23.4. Akeso Biopharma
23.5. Alligator Bioscience
23.6. Amgen
23.7. Antibody Therapeutics
23.8. APITBIO
23.9. Aptevo Therapeutics
23.10. Astellas Pharma
23.11. AstraZeneca
23.12. BioAtla
23.13. Biosion
23.14. Biotheus
23.15. BJ Bioscience
23.16. EpimAb Biotherapeutics
23.17. FutureGen Biopharmaceutical
23.18. Genentech
23.19. Genmab
23.20. Gensun Biopharma
23.21. Harbour BioMed
23.22. IGM Biosciences
23.23. I-MAB Biopharma
23.24. ImmuneOnco Biopharma
23.25. ImmunoPrecise Antibodies
23.26. Innovent Biologics
23.27. Invenra
23.28. Janssen Research & Development
23.29. Kenjockety Biotechnology
23.30. LaNova Medicines Limited
23.31. Light Chain Bioscience
23.32. Linton Pharm
23.33. Lyvgen Biopharma
23.34. MacroGenics
23.35. Merus
23.36. NovaRock Biotherapeutics
23.37. Pfizer
23.38. Phanes Therapeutics
23.39. Prestige BioPharma
23.40. Regeneron Pharmaceuticals
23.41. Revitope
23.42. Roche
23.43. Virtuoso Therapeutics
23.44. Xencor
23.45. Y-Biologics
23.46. Zhejiang Shimai Pharmaceutical
23.47. Zymeworks

二重特異性抗体の世界市場：薬剤販売、特許、価格、臨床試験インサイト（2029年）

Global Bispecific Antibody Market, Drugs Sales, Patent, Price & Clinical Trials Insight 2029

目次

第1章 二重特異性抗体のイントロダクション

第2章 二重特異性抗体の組み合わせ戦略

第3章 商業的に承認された二重特異性抗体に関する洞察

第4章 二重特異性抗体の独自プラットフォーム

第5章 世界および地域の二重特異性抗体市場の見通し

第6章 世界の二重特異性抗体市場動向、地域別

第7章 世界の二重特異性抗体の調査と市場動向、適応症別

第8章 世界の二重特異性抗体臨床試験の概要

第9章 Blincyto-臨床、特許、価格、販売に関する洞察

第10章 Hemlibra-臨床、特許、価格、販売に関する洞察

第11章 Rybrevant-臨床、特許、価格に関する洞察

第12章 Kimmtrak-臨床、特許、価格、販売に関する洞察

第13章 Vabysmo-臨床、特許、価格設定および販売に関する洞察

第14章 Lunumio-臨床、特許、価格、販売に関する洞察

第15章 カドニリマブ- 臨床および販売に関する洞察

第16章 Tecvayli-臨床、特許、価格に関する洞察

第17章 Columvi-臨床、特許、価格、販売に関する洞察

第18章 Epkinly-臨床、特許、価格設定、販売に関する洞察

第19章 Talvey-臨床、特許、価格設定に関する洞察

第20章 Elrexfio-臨床、特許、価格に関する洞察

第21章 企業、適応症、および相別の二重特異性抗体の世界の臨床試験

第22章 企業、国、および適応症別の市販二重特異性抗体の臨床的洞察

第23章 競合情勢

List of Figures

List of Tables

Table of Contents

1. Introduction to Bispecific Antibody

2. Bispecific Antibodies Combination Strategies

3. Commercially Approved Bispecific Antibodies Insight

4. Bispecific Antibodies Proprietary Platforms

5. Global & Regional Bispecific Antibody Market Outlook

6. Global Bispecific Antibody Market Trends By Region

7. Global Bispecific Antibodies Research & Market Trends by Indications

8. Global Bispecific Antibodies Clinical Trials Overview

9. Blincyto - Clinical, Patent, Pricing & Sales Insight

10. Hemlibra - Clinical, Patent, Pricing & Sales Insight

11. Rybrevant - Clinical, Patent & Pricing Insight

12. Kimmtrak - Clinical, Patent, Pricing & Sales Insight

13. Vabysmo - Clinical, Patent, Pricing & Sales Insight

14. Lunsumio - Clinical, Patent, Pricing & Sales Insight

15. Cadonilimab - Clinical & Sales Insight

16. Tecvayli - Clinical, Patent & Pricing Insight

17. Columvi - Clinical, Patent, Pricing & Sales Insight

18. Epkinly - Clinical, Patent, Pricing & Sales Insight

19. Talvey - Clinical, Patent & Pricing Insight

20. Elrexfio - Clinical, Patent & Pricing Insight

21. Global Bispecific Antibodies Clinical Trials By Company, Indication & Phase

22. Marketed Bispecific Antibodies Clinical Insight By Company, Country & Indication

23. Competitive Landscape

第1章二重特異性抗体のイントロダクション

第2章二重特異性抗体の組み合わせ戦略

第3章商業的に承認された二重特異性抗体に関する洞察

第4章二重特異性抗体の独自プラットフォーム

第5章世界および地域の二重特異性抗体市場の見通し

第6章世界の二重特異性抗体市場動向、地域別

第7章世界の二重特異性抗体の調査と市場動向、適応症別

第8章世界の二重特異性抗体臨床試験の概要

第15章カドニリマブ- 臨床および販売に関する洞察

第21章企業、適応症、および相別の二重特異性抗体の世界の臨床試験

第22章企業、国、および適応症別の市販二重特異性抗体の臨床的洞察

第23章競合情勢