多重特異性抗体の世界市場：薬剤売上、薬価、臨床試験動向（2029年）

次世代の多重特異性抗体市場は、バイオテクノロジーと医薬品開発におけるエキサイティングなフロンティアであり、革新と成長の大きな機会を提供しています。2つ以上の異なるターゲットに同時に結合できるこれらの人工タンパク質は、特にがん領域において治療アプローチに革命をもたらしています。この分野は、従来の二特異性抗体から、より複雑な三特異性抗体や四特異性抗体へと急速に発展しており、それぞれが複数の疾患経路を標的としたり、がん細胞に対する免疫反応を強化したりする上で、独自の利点を提供しています。

現在、二特異性抗体は、承認済み次世代多重特異性抗体の中で圧倒的なシェアを占めており、世界中で13の製品が規制状況の認可を受けています。この最初の成功は、より複雑な多重特異性抗体への道を開き、さらなる市場拡大の可能性を強調しています。これらの革新的治療薬の市場は、2023年に重要な節目を迎え、世界の売上が80億米ドルを突破しました。この素晴らしい数字は、臨床現場、特にがん領域において、多重特異性抗体が素晴らしい有効性と安全性を示し、受け入れられ、需要が高まっていることを裏付けています。

次世代の多重特異性抗体の主な用途はがん治療であり、従来のモノクローナル抗体療法を改善する能力を示してきました。例えば、小細胞肺がんの治療に用いられるタルラタマブのような二重特異性T細胞エンゲイジャー（BiTE）は、T細胞のCD3と腫瘍細胞のDLL3に同時に結合し、がん細胞とエフェクター細胞を効果的に近接させます。このメカニズムは、このまれで急速に増殖する肺がんにおいて素晴らしい結果を示しています。その他の活動としては、びまん性大細胞型B細胞リンパ腫に対するエプコリタマブや多発性骨髄腫に対するタルケタマブがあり、いずれも二重特異性技術を活用して抗がん活性を高めています。

次世代多重特異性抗体の市場機会は大きく、多面的です。現在承認されている13種類の二特異性抗体以外にも拡大の余地があります。より複雑な多重特異性抗体の臨床試験が進むにつれて、新たな承認が急増し、それぞれがアンメット・メディカル・ニーズに対応したり、既存の治療法よりも有効性が向上したりする可能性があります。

当レポートは、世界の多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。

目次

第1章 次世代多重特異性抗体のイントロダクション

第2章 多重特異性抗体の現在の臨床開発と将来の商業化の展望

• 現在の市場概要
• 将来の商業化の機会

第3章 企業による多重特異性抗体の独自技術

第4章 多重特異性抗体の臨床開発と市場動向、地域別

• 米国
• 欧州連合
• 中国
• 英国
• 日本
• オーストラリア
• 韓国
• カナダ

第5章 多重特異性抗体の臨床動向、適応症別

• がん
• 血液疾患
• 微生物感染症
• 自己免疫疾患および炎症性疾患
• 眼疾患

第6章 承認済み多重特異性抗体- 臨床概要、価格設定、投与量に関する考察

• 概要
• 臨床概要、価格設定、投与量に関する洞察

第7章 承認済み多重特異性抗体- 売上の見通し（2020年～2024年上半期）

第8章 世界の多重特異性抗体- 臨床試験の概要（2024年～2029年）

• フェーズ別
• 国/地域別
• 企業別
• 適応症別
• 優先度別
• 患者セグメント

第9章 企業、適応症、フェーズ別の世界の二特異性抗体臨床試験

• 研究
• 前臨床
• 第I相
• 第I/II相
• 第II相
• 第II/III相
• 第III相
• 事前登録

第10章 市販されている二特異性抗体の企業別、国別、適応症別の臨床的洞察

第11章 企業、国、適応症、フェーズ別の世界的な三特異性抗体- 臨床試験の洞察

• 調査
• 前臨床
• 第I相
• 第I/II相

第12章 四特異性抗体の臨床試験に関する企業、国、適応症、フェーズ別の考察

• 前臨床
• 第I相
• 第I/II相
• 第II相

第13章 競合情勢

List of Figures

• Figure 2-1: Global -Multispecific Antibodies Sales (US$ Million), 2020-2024
• Figure 2-2: Global - Market Sales by Multispecific Antibodies (US$ Million), 2024
• Figure 2-3: Global -Market Sales by Multispecific Antibodies (%), 2024
• Figure 2-4: Global - Quarterly Sales By Multispecific Antibodies (US$ Million), 2024
• Figure 2-5: Global - Quarterly Sales By Multispecific Antibodies (%), 2024
• Figure 2-6: US - Quarterly Sales By Multispecific Antibodies (US$ Million), 2024
• Figure 2-7: ROW - Quarterly Sales By Multispecific Antibodies (US$ Million), 2024
• Figure 2 8: Global - Multispecific Antibodies Market Opportunity Assessment (US$ Billion), 2024 - 2029
• Figure 3-1: Grabody I Platform - Mechanism of Action
• Figure 3-2: Grabody I Platform - Mechanism of Action
• Figure 3-3: Abz2 Bispecific Platform
• Figure 3-4: Abz2 Bispecifics - Benefits
• Figure 3-5: Neo-X-Prime Bispecific Mechanism
• Figure 3-6: BiTE - Structure
• Figure 3-7: BiTE Molecule
• Figure 3-8: ADAPTIR Bispecific Structure
• Figure 3-9: ADAPTIR-FLEX
• Figure 3-10: BioAtla CABs - Features
• Figure 3-11: BioAtla CABs - Benefits
• Figure 3-12: FIT-Ig - Proprietary Bispecific Platform
• Figure 3-13: 3-Step DuoBody Production Process
• Figure 3-14: DuoHexaBody Molecules - Schematic
• Figure 3-15: BEAT Platform - Multispecific Antibodies
• Figure 3-16: IMBiologic Bispecific Antibodies - Strategy
• Figure 3-17: IMBiologic Bispecific Antibodies - Mechanism of Action
• Figure 3-18: ANKET-R Platform - Innate Pharma
• Figure 3-19: B-Body Bispecific Antibody - Structre
• Figure 3-20: iTAb - Patented Structure
• Figure 3-21: iTAb - Mechanism of Action
• Figure 3-22: xLinkBsAb - Structure
• Figure 3-23: Multiclonics - Distinctive Characteristics
• Figure 3-24: Biclonics - Format
• Figure 3-25: Merus - Triclonics Platform
• Figure 3-26: STEALTH - ModeX Therapeutics
• Figure 3-27: MSTAR - ModeX Therapeutics
• Figure 3-28: MSTAR - Features
• Figure 3-29: DARPin Platform - Molecular Partners
• Figure 3-30: Novel HBICE
• Figure 3-31: HBICE - Mechanism of Action 1
• Figure 3-32: HBICE - Mechanism of Action 2
• Figure 3-33: Numab Therapeutics - Technology
• Figure 3-34: Phanes Therapeutics - PACbody Platform
• Figure 3-35: Phanes Therapeutics - SPECpair Platform
• Figure 3-36: Phanes Therapeutics - ATACCbody
• Figure 3-37: Purple Biotech - Tribody Antibody Platform
• Figure 3-38: PrecisionGATE Bispecific Antibody - Structure
• Figure 3-39: Sanyou Super Trillion Common Light Chain Antibody Discovery Platform
• Figure 3-40: GNC Antibodies - Sichuan Baili Pharmaceutical/SystImmune
• Figure 3-41: Synimmune - Proprietary Bispecific Antibody Format
• Figure 3-42: ALiCE - Characteristics
• Figure 3-43: ALiCE - Schematic Diagram & Mechanism of Action
• Figure 3-44: BiClone format
• Figure 3-45: Zyngenia Technology Approach
• Figure 4-1: US - Approved Bispecific Antibodies
• Figure 4-2: Chugai Files New Drug Application in Japan for Mosunetuzumab, anti-CD20xCD3 bispecific antibody
• Figure 4-3: Chugai Pharmaceutical - Multispecific Antibody Clinical Pipeline
• Figure 4-4: SAIL66 Phase I Study (NCT05735366) - Initiation & Completion Year
• Figure 4-5: Japan Next Generation Multispecific Antibody Market - Insight
• Figure 4-6: Hoffmann La Roche AG Patent (JP2018502835A) - Grant & Expiration Year
• Figure 4-7: DR-0201 Phase I Study (NCT06392477) - Initiation & Completion Year
• Figure 4-8: Australia - Universities & Research Centers Conducting Next Generation Multispecific Antibody Clinical Trials
• Figure 4-9: ABL Bio - Bispecific Antibody Pipeline
• Figure 4-10: Multispecific Antibody Combinations
• Figure 4-11: CTX-009 (ABL001) Phase I/II Study (NCT04492033) - Initiation & Completion Year
• Figure 4-12: Elranatamab Phase II Study (NCT06421675) - Initiation & Completion Year
• Figure 4-13: Canada Next Generation Multispecific Antibodies - Key Players
• Figure 5-1: Odronextamab (ELM-1) Phase I (NCT02290951) Study - Initiation & Completion Year
• Figure 5-2: Odronextamab (ELM-1) Phase II (NCT03888105) Study - Initiation & Completion Year
• Figure 5-3: Linvoseltamab (LINKER-MM1) Phase I/II (NCT03761108) Study - Initiation & Completion Year
• Figure 5-4: PIT565 Phase I (NCT05397496) Study - Initiation & Completion Year
• Figure 5-5: JNJ-79635322 Phase I (NCT05652335) Study - Initiation & Completion Year
• Figure 5-6: GNC-038 Phase I/II (NCT05192486) Study - Initiation & Completion Year
• Figure 5-7: GNC-038 Phase I/II (NCT05485753) Study - Initiation & Completion Year
• Figure 5-8: IPH6501 Phase I/II (NCT06088654) Study - Initiation & Completion Year
• Figure 5-9: NM32-2668 Phase I (NCT06299163) Study - Initiation & Completion Year
• Figure 5-10: GB263T Phase I/II (NCT05332574) Study - Initiation & Completion Year
• Figure 5-11: GNC-039 Phase I (NCT04794972) Study - Initiation & Completion Year
• Figure 5-12: Emicizumab Phase II (NCT05345197) Study - Initiation & Completion Year
• Figure 5-13: Emicizumab Phase II/III (NCT06155955) Study - Initiation & Completion Year
• Figure 5-14: Emicizumab (BCDI-XII) Phase I (NCT05500807) Study - Initiation & Completion Year
• Figure 5-15: HMB-001 Phase I/II (NCT06211634) Study - Initiation & Completion Year
• Figure 5-16: YBSW015 Early Phase I (NCT05369754) Study - Initiation & Completion Year
• Figure 5-17: GR1801 Phase III (NCT05846568) Study - Initiation & Completion Year
• Figure 5-18: Imvotamab (IGM-2323-101) Phase I (NCT06041568) Study - Initiation & Completion Year
• Figure 5-19: Imvotamab (IGM-2323-102) Phase I (NCT06087406) Study - Initiation & Completion Year
• Figure 5-20: PRV-3279 (PREVAIL-2) Phase II (NCT05087628) Study - Initiation & Completion Year
• Figure 5-21: DONQ52 (DQB101US) Phase I (NCT05425446) Study - Initiation & Completion Year
• Figure 5-22: Mosunetuzumab (GA43191) Phase I (NCT05155345) Study - Initiation & Completion Year
• Figure 5-23: Faricimab (MAGIC) Phase II (NCT05681884) Study - Initiation & Completion Year
• Figure 5-24: Restoret (EYE103) - Tetravalent, Tri-Specific Antibody Binding Sites
• Figure 5-25: EYE103 (AMARONE) Phase I/II Study (NCT05919693) - Initiation & Completion Year
• Figure 6-1: Blincyto - Approval Year by Region
• Figure 6-2: Blincyto - Patent Filing & Expiration Year
• Figure 6-3: Blincyto - Treatment Regimen Cycles (Weeks)
• Figure 6-4: Blincyto - Duration of Treatment Phase & Resting Phase in Induction & Consolidation Cycles for Treatment of MRD-Positive B-cell precursor (Days)
• Figure 6-5: Blincyto - Cost of Single Cycle & Treatment Course for the Treatment of MRD-positive B-cell Precursor ALL
• Figure 6-6: Blincyto - Recommended Number of Induction & Consolidation Treatment Cycle for Relapsed B-Cell Precursor ALL
• Figure 6-7: Blincyto - Duration of Single Induction, Consolidation, Continued Cycle & Full Treatment for Relapsed B-Cell Precursor ALL (Weeks)
• Figure 6-8: Blincyto - Cost of Single Cycle & Treatment Course for Treatment for Relapsed B-Cell Precursor ALL
• Figure 6-9: Hemlibra - Approval Years by Region
• Figure 6-10: Hemlibra - Cost per Unit & Supply of 30 mg/mL Subcutaneous Injection of Different Volumes (US$), July'2024
• Figure 6-11: Hemlibra - Cost per Unit & Supply of 150 mg/mL Subcutaneous Injection of Different Volumes (US$), July'2024
• Figure 6-12: Hemlibra - Recommended Loading & Maintenance Dose for Treatment of Hemophilia (mg/kg/Week)
• Figure 6-13: Rybrevant - Price per Unit & Supply of Intravenous Solution (US$), July'2024
• Figure 6-14: Rybrevant - Recommended Dose per Cycle by Body Weight (mg)
• Figure 6-15: Rybrevant - Dose Reduction in Patients with Weight less than 80 kg (mg)
• Figure 6-16: Rybrevant - Dose Reduction in Patients with Weight more than 80 Kg (mg)
• Figure 6-17: Vabysmo - First Approval Year by Region
• Figure 6-18: Vabysmo - Price per Unit & Supply of Intravitreal Solution (US$), July'2024
• Figure 6-19: Lunsumio - Approval Years by Region
• Figure 6-20: US - Price per Unit & Supply of Lunsumio Intravenous Solution (US$), July'2024
• Figure 6-21: EU - Price per Unit & Supply of Lunsumio Intravenous Solution (US$), July'2024
• Figure 6-22: Tecvayli - Approval Years by Region
• Figure 6-23: Tecvayli - Patent Acceptance & Expiration Years
• Figure 6-24: US - Cost per Unit & Supply of Tecvayli Subcutaneous Solution (US$), July'2024
• Figure 6-25: EU - Cost per Unit & Supply of Tecvayli Subcutaneous Solution (US$), July'2024
• Figure 6-26: Columvi - Approval Year by Region
• Figure 6-27: US - Price per Unit & Supply of Columvi Intravenous Solution (US$), July'2024
• Figure 6-28: EU - Price per Unit & Supply of Columvi Intravenous Solution (US$), July'2024
• Figure 6-29: Epkinly - Approval Year by Region
• Figure 6-30: US - Cost per Unit & Supply of Epkinly Subcutaneous Solution (US$), July'2024
• Figure 6-31: EU - Cost per Unit & Supply of Epkinly Subcutaneous Solution (US$), July'2024
• Figure 6-32: Talvey - Approval Year by Region
• Figure 6-33: Talquetamab - FDA & EMA Designation Year
• Figure 6-34: Talvey - Patent Acceptance & Expiration Year
• Figure 6-35: US - Price per Unit & Supply of Talvey Intravenous Solution (US$), July'2024
• Figure 6-36: EU - Price per Unit & Supply of Talvey Intravenous Solution (US$), February'2024
• Figure 6-37: Elrexfio - Approval Years by Region
• Figure 6-38: Elranatamab - FDA & EMA Designation Year
• Figure 6-39: US - Price per Unit & Supply of Elrexfio Subcutaneous Solution (US$), July'2024
• Figure 7-1: Global - Annual Blincyto Sales (US$ Million), 2020-2024
• Figure 7-2: Global - Quarterly Blincyto Sales (US$ Million), 2024
• Figure 7-3: Blincyto - US v/s ROW Sales (US$ Million), H1'2024
• Figure 7-4: Global - Blincyto Sales by Region (%), Q1'2024
• Figure 7-5: US - Quarterly Blincyto Sales (US$ Million), 2024
• Figure 7-6: ROW - Quarterly Blincyto Sales (US$ Million), H1'2024
• Figure 7-7: Global - Quarterly Blincyto Sales (US$ Million), 2023
• Figure 7-8: US - Quarterly Blincyto Sales (US$ Million), 2023
• Figure 7-9: ROW - Quarterly Blincyto Sales (US$ Million), 2023
• Figure 7-10: US - Annual Blincyto Sales (US$ Million), 2020-2024
• Figure 7-11: ROW - Annual Blincyto Sales (US$ Million), 2019-2023
• Figure 7-12: Global - Annual Hemlibra Sales (US$ Million), 2020-2024
• Figure 7-13: Regional - US v/s ROW Sales (US$ Million), H1'2024
• Figure 7-14: Global - Hemlibra Sales by Region (US$ Million), H1'2024
• Figure 7-15: Global - Hemlibra Sales by Region (%), H1'2024
• Figure 7-16: US - Annual Hemlibra Sales (US$ Million), 2020-2024
• Figure 7-17: Europe - Annual Hemlibra Sales (US$ Million), 2020-2024
• Figure 7-18: Japan - Annual Hemlibra Sales (US$ Million), 2020-2024
• Figure 7-19: ROW - Hemlibra Sales (US$ Million), 2020-2024
• Figure 7-20: Global - Hemlibra Annual Sales by Region (US$ Million), 2023
• Figure 7-21: Global - Hemlibra Sales by Region (%), 2023
• Figure 7-22: Global - Quarterly Hemlibra Sales (US$ Million), 2023
• Figure 7-23: US - Quarterly Hemlibra Sales (US$ Million), 2023
• Figure 7-24: Europe - Quarterly Hemlibra Sales (US$ Million), 2023
• Figure 7-25: Japan - Quarterly Hemlibra Sales (US$ Million), 2023
• Figure 7-26: ROW - Quarterly Hemlibra Sales (US$ Million), 2023
• Figure 7-27: Global - Annual Vabysmo Sales (US$ Million), 2022-2024
• Figure 7-28: Global - Vabysmo US v/s ROW Sales (US$ Million), H1'2024
• Figure 7-29: Global - Vabysmo Sales by Region (US$ Million), H1'2024
• Figure 7-30: Global - Vabysmo Annual Sales by Region (%), H1'2024
• Figure 7-31: Global - Vabysmo US v/s ROW Sales (US$ Million), 2023
• Figure 7-32: Global - Vabysmo Annual Sales by Region (US$ Million), 2023
• Figure 7-33: Global - Vabysmo Annual Sales by Region (%), 2023
• Figure 7-34: US - Vabysmo Sales (US$ Million), 2022-2024
• Figure 7-35: Europe - Vabysmo Sales (US$ Million), 2022-2024
• Figure 7-36: Japan - Vabysmo Sales (US$ Million), 2022-2024
• Figure 7-37: ROW - Vabysmo Sales (US$ Million), 2022-2024
• Figure 7-38: Global - Quarterly Vabysmo Sales (US$ Million), 2023
• Figure 7-39: US - Quarterly Vabysmo Sales (US$ Million), 2023
• Figure 7-40: Europe - Quarterly Vabysmo Sales (US$ Million), 2023
• Figure 7-41: Japan - Quarterly Vabysmo Sales (US$ Million), 2023
• Figure 7-42: ROW - Quarterly Vabysmo Sales (US$ Million), 2023
• Figure 7-43: Global - Annual Lunsumio Sales (US$ Million), 2022-2024
• Figure 7-44: US - Annual Lunsumio Sales (US$ Million), 2022-2024
• Figure 7-45: Europe - Annual Lunsumio Sales (US$ Million), 2022-2024
• Figure 7-46: Global - Lunsumio Sales by Region (US$ Million), H1'2024
• Figure 7-47: Global - Lunsumio Sales by Region (%), H1'2024
• Figure 7-48: Global - Lunsumio Annual Sales by Region (US$ Million), 2023
• Figure 7-49: Global - Lunsumio Annual Sales by Region (%), 2023
• Figure 7-50:- Global -Lunsumio Sales (US$ Million), Q1 - Q4'2023
• Figure 7-51: US - Quarterly Lunsumio Sales (US$ Million), 2023
• Figure 7-52: Europe - Quarterly Lunsumio Sales (US$ Million), 2023
• Figure 7-53: Global - Annual Tecvayli Sales (US$ Million), 2024
• Figure 7-54: Regional - US v/s ROW Sales (US$ Million), H1'2024
• Figure 7-55: Global - Tecvayli Sales by Region (%), H1'2024
• Figure 7-56: Global - Quarterly Tecvayli Sales (US$ Million), 2024
• Figure 7-57: US - Quarterly Tecvayli Sales (US$ Million), 2024
• Figure 7-58: ROW - Quarterly Tecvayli Sales (US$ Million), 2024
• Figure 7-59: Global - Quarterly Tecvayli Sales (US$ Million), 2023
• Figure 7-60: US - Quarterly Tecvayli Sales (US$ Million), 2023
• Figure 7-61: ROW - Quarterly Tecvayli Sales (US$ Million), 2023
• Figure 7-62: Global - Annual Columvi Sales (US$ Million), 2022-2024
• Figure 7-63: Global - Columvi Sales by Region (US$ Million), H1'2024
• Figure 7-64: Global - Columvi Sales by Region (%), H1'2024
• Figure 7-65: Global - Columvi Sales by Region (US$ Million), 2023
• Figure 7-66: Global - Columvi Sales by Region (%), 2023
• Figure 7-67: Global - Quarterly Columvi Sales (US$ Million), 2023
• Figure 7-68: US - Quarterly Columvi Sales (US$ Million), 2023
• Figure 7-69: Europe - Quarterly Columvi Sales (US$ Million), 2023
• Figure 7-70: Global - Annual Epkinly Sales (US$ Million), 2023-2024
• Figure 7-71: Global - Quarterly Epkinly Sales (US$ Million), 2024
• Figure 7-72: Global - Quarterly Epkinly Sales (US$ Million), 2023
• Figure 7-73: Annual - Cadonilimab Sales (US$ Million), H2'2022 & H1'2023
• Figure 8-1: Global - Multispecific Antibodies Clinical Trials by Phase (Numbers), 2024 till 2029
• Figure 8-2: Global - Bispecific Antibodies Clinical Trials by Phase (Numbers), 2024 till 2029
• Figure 8-3: Global - Tetraspecific Antibodies Clinical Trials By Phase (Number Of Antibodies), 2024 till 2029
• Figure 8-4: Global - Trispecific Antibodies Clinical Trials by Phase, 2024 till 2029
• Figure 8-5: Global - Bispecific Antibodies in Clinical Trials by Country (Numbers), 2024 till 2029
• Figure 8-6: Global - Tetraspecific Antibodies Clinical Trials By Company (Number Of Trials), 2024 till 2029
• Figure 8-7: Global - Trispecific Antibodies Clinical Trials by Country, 2024 till 2029
• Figure 8-8: Global - Bispecific Antibodies in Clinical Trials by Company (Numbers), 2024 till 2029
• Figure 8-9: Global - Tetraspecific Antibodies Clinical Trials By Company (Number Of Antibodies), 2024 till 2029
• Figure 8-10: Global - Trispecific Antibodies Clinical Trials by Company, 2024 till 2029
• Figure 8-11: Global - Bispecific Antibodies in Clinical Trials by Indication (Numbers), 2023 till 2029
• Figure 8-12: Global - Tetraspecific Antibodies Clinical Trials By Indication (Number Of Trials), 2024 till 2029
• Figure 8-13: Global - Trispecific Antibodies Clinical Trials by Indication, 2024 till 2029
• Figure 8-14: Global - Bispecific Antibodies in Clinical Trials by Orphan Status (Numbers), 2024 till 2029
• Figure 8-15: Global - Bispecific Antibodies in Clinical Trials by Patient Segment (Numbers), 2024 till 2029
• Figure 8-16: Global - Trispecific Antibodies Clinical Trials by Patient Segment, 2024 till 2029
• List of Tables
• Table 2-1: Estimated Total Cancer Cases, 2022 & 2040
• Table 2-2: Next Generation Multispecific Antibody Market - Recent Collaborations
• Table 2-3: Next Generation Multispecific Antibody Market - Recent Acquisitions
• Table 2-4: Next Generation Multispecific Antibody Market - Recent Regulatory
• Designations
• Table 4-1: US - Multispecific Antibodies in Clinical Trials
• Table 4-2: Europe - Multispecific Antibodies in Clinical Trials
• Table 4-3: China - Multispecific Antibodies in Clinical Trials
• Table 4-4: UK - Multispecific Antibodies in Clinical Trials
• Table 4-5: Japan - Ongoing Clinical Trials for Next Generation Multispecific Antibodies
• Table 4-6: Australia - Ongoing Clinical Trials for Next Generation Multispecific Antibodies
• Table 4-7: South Korea - Ongoing Clinical Trials for Next Generation Multispecific Antibodies
• Table 4-8: Canada - Ongoing Clinical Trials for Next Generation Multispecific Antibodies
• Table 5-1: Hematological Cancers - Approved Multispecific Antibodies
• Table 5-2: Hematological Malignancies - Estimated Total Cancer Cases, 2022 & 2040
• Table 5-3: Solid Cancers - Approved Multispecific Antibodies
• Table 5-4: Solid Cancers - Estimated Total Cancer Cases, 2022 & 2040
• Table 5-5: Vabysmo - Approval Year by Indication
• Table 6-1: Approved Multispecific Antibodies
• Table 6-2: Blincyto - Active Patents
• Table 6-3: Blincyto - Recommended Dosage & Schedule for the Treatment of MRD-positive B-cell Precursor ALL
• Table 6-4: Blincyto - Recommended Dosage & Schedule for Treatment of Relapsed or Refractory B-cell Precursor ALL
• Table 6-5: Blincyto - Recommended Dosage & Schedule for Treatment of Relapsed or Refractory B-cell Precursor ALL
• Table 6-6: Rybrevant - Premedication
• Table 6-7: Rybrevant - Dose Reductions for Adverse Reactions
• Table 6-8: Rybrevant - Recommended Dosage Modifications for Adverse Reactions
• Table 6-9: Lunsumio - Recommended Treatment Cycles
• Table 6-10: Lunsumio - Recommended Premedications
• Table 6-11: Lunsumio - Recommendations for Management of Cytokine Release Syndrome
• Table 6-12: Tecvayli - Dosing Schedule
• Table 6-13: Tecvayli - Recommended Dosage Modifications for Adverse Reactions
• Table 6-14: Columvi - Dosing Schedule (21-Day Treatment Cycles)
• Table 6-15: Columvi - Premedications to be Administered
• Table 6-16: Columvi - Recommendations for Management of Cytokine Release Syndrome
• Table 6-17: Columvi - Recommended Dosage Modification for Neurologic Toxicity (Including ICANS)
• Table 6-18: Columvi - Recommended Dosage Modifications for Other Adverse Reactions
• Table 6-19: Epkinly - Dosage Schedule
• Table 6-20: Epkinly - Recommendations for Management of Cytokine Release Syndrome
• Table 6-21: Epkinly - Recommendations for Management of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
• Table 6-22: Epkinly - Recommended Dosage Modifications for Other Adverse Reactions
• Table 6-23: Talvey - Weekly Dosing Schedule
• Table 6-24: Talvey - Biweekly Dosing Schedule
• Table 6-25: Talvey - Recommendations for Management of CRS
• Table 6-26: Talvey - Recommendations for Management of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
• Table 6-27: Talvey - Recommendations for Management of Neurologic Toxicity (excluding ICANS)
• Table 6-28: Talvey - Recommended Dosage Modifications for Other Adverse Reactions
• Table 6-29: Elrexfio - Dosing Schedule
• Table 6-30: Elrexfio - Recommendations for Management of CRS
• Table 6-31: Elrexfio - Recommended Dosage Modifications for Other Adverse Reactions
• Table 6-32: Imdelltra - Recommended Concomitant Medications for Administration for Cycle 1
• Table 6-33: Imdelltra - Recommended Dosage and Schedule of
• Table 6-34: Imdelltra - Recommendations for Restarting Therapy After Dosage Delay
• Table 6-35: Imdelltra - Guidelines for Grading and Dosage Modification and Management of Cytokine Release Syndrome
• Table 6-36: Imdelltra - Guidelines for Management of Neurologic Toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome

Global Multispecific Antibodies Market, Drug Sales, Price & Clinical Trials Insight 2029 Report Highlights:

• Global & Regional Market Analysis
• Global Multispecific Antibodies Market Opportunity: > USD 40 Billion
• Global Multispecific Antibodies Market Sales In 2023: > USD 8 Billion
• Number Of Approved Multispecific Antibodies: 13
• Approved Antibodies Global, Regional, Annual & Quarterly Sales Insight
• Approved Antibodies Dosage & Pricing Insight
• Number Of Multispecific Antibodies: In Clinical Trials: > 900
• Comprehensive Insight On All Antibodies In Clinical Trials By Company, Country, Indication, & Phase

The market for next generation multispecific antibodies represents an exciting frontier in biotechnology and pharmaceutical development, offering significant opportunities for innovation and growth. These engineered proteins, capable of binding to two or more different targets simultaneously, are revolutionizing therapeutic approaches, especially in oncology. The field has rapidly evolved from the traditional bispecific antibodies to more complex trispecific and tetraspecific constructs, each offering unique advantages in targeting multiple disease pathways or enhancing immune responses against cancer cells.

Currently, bispecific antibodies dominate the approved next generation multispecific antibodies landscape, with 13 products having received regulatory green light around the globe. This initial success has paved the way for more complex multispecific antibodies, highlighting the potential for further market expansion. The market for these innovative therapies crossed a significant milestone in 2023, surpassing US$ 8 billion in global sales. This impressive figure underscores the growing acceptance and demand for multispecific antibodies in clinical practice, particularly in oncology, where they have shown impressive efficacy and safety profiles.

The primary application of next generation multispecific antibodies has been in cancer treatment where they have demonstrated the ability to improve upon traditional monoclonal antibody therapies. For example, bispecific T-cell engagers (BiTE), like Tarlatamab, used in the treatment of small cell lung cancer, simultaneously bind to CD3 on T cells and DLL3 on tumor cells, effectively bringing cancer cells and effector cells in close proximity. This mechanism has shown impressive results in this rare, fast-growing lung cancer. Other examples include Epcoritamab for diffuse large B-cell lymphoma and Talquetamab for multiple myeloma, both leveraging bispecific technology to enhance anti-cancer activity.

The development of trispecific and tetraspecific antibodies represents the next wave of innovation in the field. These more complex molecules offer the potential to engage multiple proteins or immune cell types simultaneously, potentially leading to more precise and potent therapeutic effects. For example, researchers from the Osaka Metropolitan University and Tokyo University of Agriculture and Technology jointly developed a series of trispecific antibodies to engage T cells and NK cells simultaneously against tumors overexpressing the EGFR receptor, potentially offering a more robust anti-tumor response than bispecific antibodies.

The market opportunity for next-generation multispecific antibodies is substantial and multifaceted. There is room for expansion beyond the current 13 approved bispecific antibodies. As more complex multispecific antibodies progress through clinical trials, we can expect a surge in new approvals, each potentially addressing unmet medical needs or offering improved efficacy over existing therapies.

Moreover, the versatility of multispecific antibodies opens doors to applications beyond oncology. While cancer remains the primary focus, research is underway to apply this technology to autoimmune diseases, infectious diseases and neurological disorders. The diversification of therapeutic areas represents a vast untapped market potential. At present, Hemlibra stands at the forefront of multispecific antibodies developed for non-cancer indications, cementing its place as the highest-selling bispecific antibody in the market for several years consecutively.

The financial trajectory of the multispecific antibody market is highly promising. Having crossed the US$ 8 billion market in 2023, our analysis projects continues robust growth and the market is expected to surpass USD 40 Billion by 2029. Factors driving this growth include the increasing incidence of cancer worldwide, growing acceptance of immunotherapy approaches, and the potential for these therapies to commands premium pricing due to their complex engineering and enhanced efficacy.

In conclusion, the next generation multispecific antibody market presents a compelling opportunity for growth and innovation in the biopharmaceutical industry. With its strong foundation in bispecific antidotes and the emerging potential of tri- and tetraspecific antibodies, this field is poised for significant expansion beyond its currently US$ 8 billion market size. As research progresses and more products receive approved, multispecific antibodies are set to play an increasingly important role in the treatment of cancer and potentially other diseases, offering substantial rewards for companies at the forefront of this technological revolution.

Table of Contents

1. Introduction to Next Generation Multispecific Antibodies

2. Multispecific Antibody Current Clinical Development & Future Commercialization Outlook

• 2.1 Current Market Overview
• 2.2 Future Commercialization Opportunity

3. Multispecific Antibody Proprietary Technologies by Company

4. Multispecific Antibody Clinical Development & Market Trends by Region

• 4.1 US
• 4.2 EU
• 4.3 China
• 4.4 UK
• 4.5 Japan
• 4.6 Australia
• 4.7 South Korea
• 4.8 Canada

5. Multispecific Antibody Clinical Trends by Indication

• 5.1 Cancer
• 5.2 Hematological Disorders
• 5.3 Microbial Infections
• 5.4 Autoimmune & Inflammatory Disorders
• 5.5 Ocular Diseases

6. Approved Multispecific Antibodies - Clinical Overview, Pricing & Dosage Insight

• 6.1 Overview
• 6.2 Clinical Overview, Pricing & Dosage Insight

7. Approved Multispecific Antibodies - Sales Insight ( 2020 - H1'2024)

8. Global Multispecific Antibodies Clinical Trials Overview (2024 - 2029)

• 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. Global Bispecific Antibodies Clinical Trials 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
• 9.8 Preregistration

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

11. Global Trispecific Antibodies Clinical Trials Insight By Company, Country, Indication & Phase

• 11.1 Research
• 11.2 Preclinical
• 11.3 Phase I
• 11.4 Phase I/II

12. Tetraspecific Antibodies Clinical Trials Insight By Company, Country, Indication & Phase

• 12.1 Preclinical
• 12.2 Phase I
• 12.3 Phase I/II
• 12.4 Phase II

13. Competitive Landscape

This Chapter Gives Insight On 55 Companies Involved in Clinical Trials Of Multispecific Antibodies