市場調査レポート

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多特異性抗体の世界市場：薬剤売上、用量、価格、臨床試験動向（2030年）

Global Multispecific Antibodies Market, Drug Sales, Dosage, Price & Clinical Trials Insight 2030

出版日: 2025年05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

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多特異性抗体の世界市場、薬剤売上、用量、価格、臨床試験動向（2030年）レポートのハイライト

世界の多特異性抗体市場の2030年までの機会：500億米ドル以上
世界の多特異性抗体市場の2024年の売上：120億米ドル超
承認済みの多特異性抗体の数：18個
世界の動向と地域の動向
承認済み抗体の世界、地域、年間および四半期別売上
承認済み抗体の用法・用量と価格に関する洞察
臨床試験中の全抗体の企業別、国別、適応症別、相別の包括的動向
臨床試験中の多特異性抗体の数：700超

当レポートは、世界の多特異性抗体市場に関する包括的な1次調査と2次調査の結果をまとめたもので、18の承認済み医薬品を網羅し、価格設定、用量設定、販売データを詳細に分析しています。市場規模、販売薬の地域別売上分析、最近の動向も含まれています。多特異性抗体の価格と市場実績に関する分析の正確性と信頼性を確保するため、企業報告書、取引所への提出書類、年次・四半期報告書、公式プレスリリースなど、広範な情報源を活用しました。

700以上の多特異性抗体に関する包括的な臨床試験情報については、1万0以上のウェブリンクを調査しました。
年次、四半期、世界、地域別の売上分析については、SEC文書、企業報告書、宣言書、プレスリリースを分析しました。
FDAが指定した希少疾病用医薬品の適応症と優先順位を検証するため、オープンソースおよび独自の情報源にアクセスしました。
複数の医薬品専用ウェブサイトや各種ニュース、企業のプレスリリースを調査し、詳細な薬価や用量に関する情報を収集しました。

多特異性抗体市場は、治療上のブレークスルーと、複数の経路を同時に標的とすることで複雑な病態を治療する能力が認められつつあることから、バイオ医薬品ビジネスにおいて世界的に最も精力的で急成長している分野の一つです。2025年5月現在、18の多重特異性抗体が世界的に承認されており、そのすべてが二重特異性抗体です。この拡大するポートフォリオには、二重特異性抗体として初めて承認済みのBlincytoや、二重特異性抗体として初めてがん以外の適応症で承認済みのHemlibraのような先駆的な医薬品があります。この治療薬パイプラインへの最新の参入は、2025年4月に多発性骨髄腫の治療薬として製造販売承認を取得したリジェネロンのLynozyficであり、この分野での継続的な勢いを示しています。

承認済みの多特異性抗体の種類は、様々な適応症や患者層に対するこの治療法の柔軟性を反映しています。一方、中国を拠点とするAkesoのCadonilimabは、2つの免疫チェックポイントを同時に標的とする二重特異性抗体として唯一承認され、中国で開発された二重特異性抗体として初めて承認されました。開発におけるこのような地域差は、成熟した製薬市場と新興国バイオテクノロジーセンターの両方からの情報により、この分野における技術革新の世界的性質を強調しています。

規制環境は現在も急ピッチで変化しており、近い将来さらなる承認が見込まれています。FDAはまた、オドロネクスタマブとリンボセルタマブの販売申請を評価しています。オドロネクスタマブは濾胞性リンパ腫、リンボセルタマブはびまん性大細胞型B細胞リンパ腫、多発性骨髄腫を適応症としてEUですでに承認されています。このような大西洋を越えた規制当局の前進は、世界の規制当局が多特異性抗体技術を受け入れ、信頼を深めていることを反映しています。

市場の業績は極めて好調で、2024年の世界の多特異性抗体市場の売上高は126億米ドルを超え、次いで2025年第1四半期の売上高は34億6,000万米ドルを超えます。米国がこの売上高に最も貢献しており、この主要地域における市場の成熟度と受容性を浮き彫りにしています。ロシュの成熟製品であるHemlibraとVabysmoが市場シェアの半分以上を占めており、この競争市場における先行者利益と効果的な市場参入戦略の価値を強調しています。

開発のためのパイプラインはさらに大変なもので、すでに900以上の多特異性抗体がさまざまな開発段階にあります。多特異性抗体開発の伝統的な優先順位と、がん治療における大きなアンメット・メディカル・ニーズの両方により、がん領域がこのパイプラインをリードしています。しかし、パイプラインの多様性はがん領域だけにとどまらず、自己免疫疾患や炎症性疾患、神経疾患でも有望な候補が同定されており、市場機会を劇的に拡大する可能性を秘めた治療領域の広がりを示しています。

この技術革新を支えている主な業界参入企業は、Amgen、AstraZeneca、Genentech、Regeneronといった大手製薬会社や、ABL Bio、Harbour BioMed、Innovent Biologics、Merus、Zymeworksといった新興バイオテクノロジー企業です。このような老舗企業と新興企業の組み合わせは、継続的な技術革新と技術進歩を確実にする活気ある競合情勢を提供しています。

2025年4月のBoehringer IngelheimとCue Biopharmaによる、ウイルス特異的メモリーT細胞を介して病原性B細胞を攻撃する二重特異性候補薬CUE-501の開発提携のように、戦略的提携は市場開拓に影響を与え続けています。この提携は、契約一時金1,200万米ドルと最大3億4,500万米ドルのマイルストーン支払いを伴うもので、特に既存の治療法では不十分な自己免疫疾患において、企業が多特異性抗体技術を推進するために多額の資金を投入していることを示しています。

再発または難治性の多発性骨髄腫に対するイクノス・グレンマーク・イノベーションの三特異性T細胞エンゲージメントの治験薬であるISB 2001が、2025年4月にFDAからファスト・トラックに指定されたことは、重要なアンメット・メディカル・ニーズを治療する多特異性抗体技術の前進に対する規制当局の継続的な熱意を反映しています。このような継続的な技術革新の結果、世界の多特異性抗体市場は急成長が期待され、製薬業界において最も重要な分野のひとつになろうとしています。

当レポートは、世界の多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。

AbbVie
ABL Bio
Abzyme Therapeutics
Affimed Therapeutics
Akeso Biopharma
Alligator Bioscience
Amgen
Antibody Therapeutics
APITBIO
Astellas Pharma
AstraZeneca
Aptevo Therapeutics
BioAtla
Biocytogen Pharmaceuticals
Biosion
EpimAb Biotherapeutics
FutureGen Biopharmaceutical
Genentech
Genmab
Genor Biopharma
Gensun Biopharma
Harbour BioMed
IGM Biosciences
I-MAB Biopharma
ImmuneOnco Biopharma
ImmunoPrecise Antibodies
Innate Pharma
Innovent Biologics
Invenra
Johnson & Johnson
Kenjockety Biotechnology
LaNova Medicines Limited
Light Chain Bioscience
Linton Pharm
Lyvgen Biopharma
MacroGenics
Merck
Merus
ModeX Therapeutics (OPKO Health)
Molecular Partners
NovaRock Biotherapeutics
Numab
OPKO Health
Pfizer
Regeneron Pharmaceuticals
Revitope
Roche
Sanofi
Sichuan Baili Pharmaceutical
SystImmune
Virtuoso Therapeutics
Xencor
Y-Biologics
Zhejiang Shimai Pharmaceutical
Zymeworks

図表

List of Figures

Figure 2-1: Global - Multispecific Antibodies Sales (US$ Million), 2020-2025
Figure 2-2: Global - Market Sales by Multispecific Antibodies (US$ Million), Q1'2025
Figure 2-3: Global -Market Sales by Multispecific Antibodies (%), Q1'2025
Figure 2-4: Global - Market Sales by Multispecific Antibodies (US$ Million), 2024
Figure 2-5: Global -Market Sales by Multispecific Antibodies (%),2024
Figure 2-6: Global - Multispecific Antibodies Quarterly Sales (US$ Million), Q1-Q4'2024
Figure 2-7: US - Multispecific Antibodies Quarterly Sales (US$ Million), Q1-Q4'2024
Figure 2-8: ROW - Multispecific Antibodies Quarterly Sales (US$ Million), Q1-Q4'2024
Figure 2-9: Global - Multispecific Antibody Market Opportunity Assessment (US$ Billion), 2025 - 2030
Figure 2-10: Grabody I Platform - Mechanism of Action 1
Figure 2-11: Grabody I Platform - Mechanism of Action 2
Figure 2-12: Abz2 Bispecific Platform
Figure 2-13: Abz2 Bispecifics - Benefits
Figure 2-14: Neo-X-Prime Bispecific Mechanism
Figure 2-15: BiTE - Structure
Figure 2-16: BiTE Molecule
Figure 2-17: ADAPTIR Bispecific Structure
Figure 2-18: ADAPTIR-FLEX
Figure 2-19: BioAtla CABs - Features
Figure 2-20: BioAtla CABs - Benefits
Figure 2-21: FIT-Ig - Proprietary Bispecific Platform
Figure 2-22: 3-Step DuoBody Production Process
Figure 2-23: DuoHexaBody Molecules - Schematic
Figure 2-24: BEAT Platform - Multispecific Antibodies
Figure 2-25: IMBiologic Bispecific Antibodies - Strategy
Figure 2-26: IMBiologic Bispecific Antibodies - Mechanism of Action
Figure 2-27: ANKET(R) Platform - Innate Pharma
Figure 2-28: B-Body Bispecific Antibody - Structre
Figure 2-29: iTAb - Patented Structure
Figure 2-30: iTAb - Mechanism of Action
Figure 2-31: xLinkBsAb - Structure
Figure 2-32: Multiclonics - Distinctive Characteristics
Figure 2-33: Biclonics - Format
Figure 2-34: Merus - Triclonics Platform
Figure 2-35: STEALTH - ModeX Therapeutics
Figure 2-36: MSTAR - ModeX Therapeutics
Figure 2-37: MSTAR - Features
Figure 2-38: DARPin Platform - Molecular Partners
Figure 2-39: Novel HBICE
Figure 2-40: HBICE - Mechanism of Action 1
Figure 2-41: HBICE - Mechanism of Action 2
Figure 2-42: Numab Therapeutics - Technology
Figure 2-43: Phanes Therapeutics - PACbody Platform
Figure 2-44: Phanes Therapeutics - SPECpair Platform
Figure 2-45: Phanes Therapeutics - ATACCbody
Figure 2-46: Purple Biotech - Tribody Antibody Platform
Figure 2-47: PrecisionGATE Bispecific Antibody - Structure
Figure 2-48: Sanyou Super Trillion Common Light Chain Antibody Discovery Platform
Figure 2-49: GNC Antibodies - Sichuan Baili Pharmaceutical/SystImmune
Figure 2-50: Synimmune - Proprietary Bispecific Antibody Format
Figure 2-51: ALiCE - Characteristics
Figure 2-52: ALiCE - Schematic Diagram & Mechanism of Action
Figure 2-53: BiClone format
Figure 2-54: Zyngenia Technology Approach
Figure 3-1: Odronextamab (ELM-1) Phase I (NCT02290951) Study - Initiation & Completion Year
Figure 3-2: Odronextamab (ELM-1) Phase II (NCT03888105) Study - Initiation & Completion Year
Figure 3-3: Linvoseltamab (LINKER-MM1) Phase I/II (NCT03761108) Study - Initiation & Completion Year
Figure 3-4: PIT565 Phase I (NCT05397496) Study - Initiation & Completion Year
Figure 3-5: JNJ-79635322 Phase I (NCT05652335) Study - Initiation & Completion Year
Figure 3-6: GNC-038 Phase I/II (NCT05192486) Study - Initiation & Completion Year
Figure 3-7: GNC-038 Phase I/II (NCT05485753) Study - Initiation & Completion Year
Figure 3-8: IPH6501 Phase I/II (NCT06088654) Study - Initiation & Completion Year
Figure 3-9: AFM13 Phase I/II (NCT04074746) Study - Initiation & Completion Year
Figure 3-10: NM32-2668 Phase I (NCT06299163) Study - Initiation & Completion Year
Figure 3-11: GB263T Phase I/II (NCT05332574) Study - Initiation & Completion Year
Figure 3-12: GNC-039 Phase I (NCT04794972) Study - Initiation & Completion Year
Figure 3-13: Emicizumab (AHAEmi) Phase II (NCT05345197) Study - Initiation & Completion Year
Figure 3-14: Emicizumab Phase II/III (NCT06155955) Study - Initiation & Completion Year
Figure 3-15: Emicizumab (BCDI-XII) Phase I (NCT05500807) Study - Initiation & Completion Year
Figure 3-16: HMB-001 Phase I/II (NCT06211634) Study - Initiation & Completion Year
Figure 3-17: YBSW015 Early Phase I (NCT05369754) Study - Initiation & Completion Year
Figure 3-18: CLN-978 (CLN-978-SL-101) Phase I (NCT06613360) Study - Initiation & Completion Year
Figure 3-19: Vabysmo - Approval Year by Indication
Figure 3-20: Faricimab (MAGIC) Phase II (NCT05681884) Study - Initiation & Completion Year
Figure 3-21: Restoret (EYE103) - Tetravalent, Trispecific Antibody Binding Sites
Figure 3-22: Restoret (BRUNELLO) Phase II/III (NCT06571045) Study - Initiation & Completion Year
Figure 3-23: Restoret (BAROLO) Phase II/III (NCT06957080) Study - Initiation & Completion Year
Figure 4-1: US - Approved Multispecific Antibodies
Figure 4-2: EU - Approved Multispecific Antibodies
Figure 4-3: Japan - Approved Multispecific Antibodies
Figure 4-4: Chugai Pharmaceutical - Multispecific Antibody Clinical Pipeline
Figure 4-5: SAIL66 Phase I (NCT05735366) Study - Initiation & Completion Year
Figure 4-6: ONO-4685 (ONO-4685-05) Phase I (NCT06547528) Study - Initiation & Completion Year
Figure 4-7: ABL Bio - Bispecific Antibody Pipeline
Figure 4-8: ZW171 (ZWI-ZW171-101) Phase I (NCT06523803) Study - Initiation & Completion Year
Figure 5-1: Blincyto - Approval Year by Region
Figure 5-2: Blincyto - Patent Filing & Expiration Year
Figure 5-3: Blincyto - Treatment Regimen Cycles (Weeks)
Figure 5-4: Blincyto - Duration of Treatment Phase & Resting Phase in Induction & Consolidation Cycles for Treatment of MRD-Positive B-cell precursor (Days)
Figure 5-5: Blincyto - Recommended Number of Induction & Consolidation Treatment Cycle for Relapsed B-Cell Precursor ALL
Figure 5-6: Blincyto - Duration of Single Induction, Consolidation, Continued Cycle & Full Treatment for Relapsed B-Cell Precursor ALL (Weeks)
Figure 5-7: Hemlibra - Approval Years by Region
Figure 5-8: Hemlibra - Cost per Unit & Supply of 30 mg/mL Subcutaneous Injection of Different Volumes (US$), May'2025
Figure 5-9: Hemlibra - Cost per Unit & Supply of 150 mg/mL Subcutaneous Injection of Different Volumes (US$), May'2025
Figure 5-10: Hemlibra - Recommended Loading & Maintenance Dose for Treatment of Hemophilia (mg/kg/Week)
Figure 5-11: Rybrevant - Price per Unit & Supply of Intravenous Solution (US$), May'2025
Figure 5-12: Rybrevant - Recommended Dose per Cycle by Body Weight (mg)
Figure 5-13: Rybrevant - Dose Reduction in Patients with Weight less than 80 kg (mg)
Figure 5-14: Rybrevant - Dose Reduction in Patients with Weight more than 80 Kg (mg)
Figure 5-15: Vabysmo - First Approval Year by Region
Figure 5-16: Vabysmo - Price per Unit & Supply of Intravitreal Solution (US$), May'2025
Figure 5-17: Lunsumio - Approval Years by Region
Figure 5-18: US - Price per Unit & Supply of Lunsumio Intravenous Solution (US$), May'2025
Figure 5-19: EU - Price per Unit & Supply of Lunsumio Intravenous Solution (US$), May'2025
Figure 5-20: Tecvayli - Approval Years by Region
Figure 5-21: Tecvayli - Patent Acceptance & Expiration Years
Figure 5-22: US - Cost per Unit & Supply of Tecvayli Subcutaneous Solution (US$), May'2025
Figure 5-23: EU - Cost per Unit & Supply of Tecvayli Subcutaneous Solution (US$), May'2025
Figure 5-24: Columvi - Approval Year by Region
Figure 5-25: US - Price per Unit & Supply of Columvi Intravenous Solution (US$), May'2025
Figure 5-26: EU - Price per Unit & Supply of Columvi Intravenous Solution (US$), May'2025
Figure 5-27: Epkinly - Approval Year by Region
Figure 5-28: US - Cost per Unit & Supply of Epkinly Subcutaneous Solution (US$), May'2025
Figure 5-29: EU - Cost per Unit & Supply of Epkinly Subcutaneous Solution (US$), May'2025
Figure 5-30: Talvey - Approval Year by Region
Figure 5-31: Talquetamab - FDA & EMA Designation Year
Figure 5-32: Talvey - Patent Acceptance & Expiration Year
Figure 5-33: US - Price per Unit & Supply of Talvey Intravenous Solution (US$), May'2025
Figure 5-34: EU - Price per Unit & Supply of Talvey Intravenous Solution (US$), February'2024
Figure 5-35: Elrexfio - Approval Years by Region
Figure 5-36: Elranatamab - FDA & EMA Designation Year
Figure 5-37: US - Price per Unit & Supply of Elrexfio Subcutaneous Solution (US$), May'2025
Figure 5-38: Imdelltra - Approval Years by Region
Figure 5-39: Imdelltra - Price per Unit & Supply of Intravenous Powder (US$), May'2025
Figure 5-40: US - Price Per Unit & Supply Of Ziihera (US$), May'2025
Figure 5-41: Zenocutuzumab - Active Patents
Figure 6-1: Global - Annual Blincyto Sales (US$ Million), 2020-2025
Figure 6-2: Regional - Blincyto Sales (US$ Million), Q1'2025
Figure 6-3: Regional - Blincyto Sales Quarterly (%), Q1'2025
Figure 6-4: Blincyto - Sales By Region (US$ Million), 2024
Figure 6-5: Blincyto - Sales By Region (%), 2024
Figure 6-6: US - Blincyto Sales ((US$ Million), 2020-2025
Figure 6-7: US - Blincyto Sales Quarterly (US$ Million), 2024
Figure 6-8: ROW - Blincyto Sales (US$ Million), 2020-2025
Figure 6-9: ROW - Blincyto Sales Quarterly (US$ Million), 2024
Figure 6-10: Global - Annual Hemlibra Sales (US$ Million), 2020-2024
Figure 6-11: Regional - US v/s ROW Sales (US$ Million), Q1'2025
Figure 6-12: Global - Hemlibra Sales by Region (US$ Million), Q1'2025
Figure 6-13: Global - Hemlibra Sales by Region (%), Q1'2025
Figure 6-14: Regional - US v/s ROW Sales (US$ Million), 2024
Figure 6-15: Global - Hemlibra Sales by Region (US$ Million), 2024
Figure 6-16: Global - Hemlibra Sales by Region (%),'2024
Figure 6-17: Global - Hemlibra Sales Quarterly (US$ Million), 2024
Figure 6-18: US - Annual Hemlibra Sales (US$ Million), 2020-2025
Figure 6-19: US - Hemlibra Sales Quarterly (US$ Million), 2024
Figure 6-20: Europe - Annual Hemlibra Sales (US$ Million), 2020-2025
Figure 6-21: Europe - Hemlibra Sales Quarterly (US$ Million), 2024
Figure 6-22: Japan - Annual Hemlibra Sales (US$ Million), 2020-2025
Figure 6-23: Japan - Hemlibra Sales Quarterly (US$ Million), 2024
Figure 6-24: ROW - Hemlibra Sales (US$ Million), 2020-2025
Figure 6-25: ROW - Hemlibra Sales Quarterly (US$ Million), 2024
Figure 6-26: Global - Annual Vabysmo Sales (US$ Million), 2022-2025
Figure 6-27: Global - Vabysmo US v/s ROW Sales (US$ Million), Q1'2025
Figure 6-28: Global - Vabysmo Sales by Region (US$ Million), Q1'2025
Figure 6-29: Global - Vabysmo Annual Sales by Region (%), Q1'2025
Figure 6-30: Global - Vabysmo US v/s ROW Sales (US$ Million), 2024
Figure 6-31: Global - Vabysmo Sales by Region (US$ Million), 2024
Figure 6-32: Global - Vabysmo Annual Sales by Region (%), 2024
Figure 6-33: Global - Vabysmo Sales Quarterly (US$ Million), 2024
Figure 6-34: US - Vabysmo Sales (US$ Million), 2022-2025
Figure 6-35: US - Vabysmo Sales Quarterly (US$ Million), 2024
Figure 6-36: Europe - Vabysmo Sales (US$ Million), 2022-2025
Figure 6-37: Europe - Vabysmo Sales Quarterly (US$ Million), 2024
Figure 6-38: Japan - Vabysmo Sales (US$ Million), 2022-2025
Figure 6-39: Japan - Vabysmo Sales Quarterly (US$ Million), 2024
Figure 6-40: ROW - Vabysmo Sales (US$ Million), 2022-2025
Figure 6-41: ROW - Vabysmo Sales Quarterly (US$ Million), 2024
Figure 6-42: Global - Annual Lunsumio Sales (US$ Million), 2022-2025
Figure 6-43: Global - Lunsumio US v/s ROW Sales (US$ Million), Q1'2025
Figure 6-44: Global - Lunsumio Sales by Region (US$ Million), Q1'2025
Figure 6-45: Global - Lunsumio Annual Sales by Region (%), Q1'2025
Figure 6-46: Global - Lunsumio US v/s ROW Sales (US$ Million), 2024
Figure 6-47: Global - Lunsumio Sales by Region (US$ Million), 2024
Figure 6-48: Global - Lunsumio Annual Sales by Region (%), 2024
Figure 6-49: Global - Lunsumio Sales Quarterly (US$ Million), 2024
Figure 6-50: US - Lunsumio Sales (US$ Million), 2022-2025
Figure 6-51: US - Lunsumio Sales Quarterly (US$ Million), 2024
Figure 6-52: Europe - Lunsumio Sales (US$ Million), 2022-2025
Figure 6-53: Europe - Lunsumio Sales Quarterly (US$ Million), 2024
Figure 6-54: ROW - Lunsumio Sales (US$ Million), 2022-2025
Figure 6-55: ROW - Lunsumio Sales Quarterly (US$ Million), 2024
Figure 6-56: Global - Tecvayli Sales (US$ Million), 2022-2025
Figure 6-57: Regional - Tecvayli Sales US$ Million), Q1'2025
Figure 6-58: Regional - Tecvayli Sales (%), Q1'2025
Figure 6-59: Global - Tecvayli Sales Quarterly (US$ Million), 2024
Figure 6-60: Regional - Tecvayli Sales (US$ Million), 2024
Figure 6-61: Regional - Tecvayli Sales (%), 2024
Figure 6-62: US - Tecvayli Sales (US$ Million), 2022-2025
Figure 6-63: US - Tecvayli Sales Quaterly (US$ Million), 2024
Figure 6-64: ROW - Tecvayli Sales (US$ Million), 2022-2025
Figure 6-65: ROW - Tecvayli Sales Quarterly (US$ Million), 2024
Figure 6-66: Global - Annual Columvi Sales (US$ Million), 2023-2025
Figure 6-67: Regional - US v/s ROW Sales (US$ Million), Q1'2025
Figure 6-68: Global - Columvi Sales by Region (US$ Million), Q1'2025
Figure 6-69: Global - Columvi Sales by Region (%), Q1'2025
Figure 6-70: Regional - US v/s ROW Sales (US$ Million), 2024
Figure 6-71: Global - Columvi Sales by Region (US$ Million), 2024
Figure 6-72: Global - Columvi Sales by Region (%),'2024
Figure 6-73: Global - Columvi Sales Quarterly (US$ Million), 2024
Figure 6-74: US - Annual Columvi Sales (US$ Million), 2023-2025
Figure 6-75: US - Columvi Sales Quarterly (US$ Million), 2024
Figure 6-76: Europe - Annual Columvi Sales (US$ Million), 2023-2025
Figure 6-77: Europe - Columvi Sales Quarterly (US$ Million), 2024
Figure 6-78: ROW - Columvi Sales (US$ Million), 2023-2025
Figure 6-79: ROW - Columvi Sales Quarterly (US$ Million), 2024
Figure 6-80: Global - Annual Epkinly Sales (US$ Million), 2023-2025
Figure 6-81: Global - Columvi Sales Quarterly Reported by AbbVie (US$ Million), 2024
Figure 6-82: US - Columvi Sales Quarterly Reported by AbbVie (US$ Million), 2024
Figure 6-83: ROW - Columvi Sales Quarterly Reported by AbbVie (US$ Million), 2024
Figure 6-84: Annual - Cadonilimab Sales (US$ Million), 2022-2024
Figure 6-85: Global - Annual Talvey Sales (US$ Million), 2025
Figure 6-86: Regional - Talvey Sales (US$ Million), Q1'2025
Figure 6-87: Regional - Talvey Sales Quarterly (%), Q1'2025
Figure 6-88: Global - Elrexfio Sales (US$ Million), 2023-2025
Figure 6-89: Global - Annual Elrexfio Sales (US$ Million), 2025
Figure 6-90: Regional - Elrexfio Sales (US$ Million), Q1'2025
Figure 6-91: Regional - Elrexfio Sales Quarterly (%), Q1'2025
Figure 6-92: US - Elrexfio Sales (US$ Million), 2023-2025
Figure 6-93: ROW - Elrexfio Sales (US$ Million), 2023-2025
Figure 6-94: Global - Imdelltra Sales (US$ Million), 2024-2025
Figure 6-95: Regional - Imdelltra Sales (US$ Million), Q1'2025
Figure 6-96: Regional - Imdelltra Sales Quarterly (%), Q1'2025
Figure 6-97: Global - Imdelltra Sales Quarterly (US$ Million), 2024
Figure 6-98: US - Imdelltra Sales (US$ Million), 2024-2025
Figure 6-99: US - Imdelltra Sales (US$ Million), 2024-2025
Figure 6-100: ROW - Imdelltra Sales (US$ Million), 2024-2025
Figure 6-101: Global - Ordspono Sales (US$ Million), 2022-2024
Figure 6-102: Global - Ordspono Sales Quarterly (US$ Million), 2024
Figure 6-103: Global - Ziihera Sales (US$ Million), 2024
Figure 7-1: Global - Multispecific Antibodies Clinical Trials by Phase (Numbers), 2025 till 2030
Figure 7-2: Global - Bispecific Antibodies Clinical Trials by Phase (Numbers), 2025 till 2030
Figure 7-3: Global - Tetraspecific Antibodies Clinical Trials By Phase (Number Of Antibodies), 2025 till 2030
Figure 7-4: Global - Trispecific Antibodies Clinical Trials by Phase, 2025 till 2030

List of Tables

Table 2-1: Estimated Total Cancer Cases, 2022 & 2040
Table 2-2: Multispecific Antibodies Under Regulatory Review
Table 3-1: Hematological Cancers - Approved Multispecific Antibodies
Table 3-2: Hematological Malignancies - Estimated Total Cancer Cases, 2022 & 2040
Table 3-3: Solid Cancers - Approved Multispecific Antibodies
Table 3-4: Solid Cancers - Estimated Total Cancer Cases, 2022 & 2040
Table 4-1: US - Multispecific Antibodies in Clinical Trials
Table 4-2: EU - Multispecific Antibodies in Clinical Trials
Table 4-3: UK - Multispecific Antibodies in Clinical Trials
Table 4-4: Japan - Multispecific Antibodies in Clinical Trials
Table 4-5: Australia - Multispecific Antibodies in Clinical Trials
Table 4-6: South Korea - Multispecific Antibodies in Clinical Trials
Table 4-7: Canada - Multispecific Antibodies in Clinical Trials
Table 5-1: Approved Multispecific Antibodies
Table 5-2: Blincyto - Active Patents
Table 5-3: Blincyto - Recommended Dosage & Schedule for the Treatment of MRD-positive B-cell Precursor ALL
Table 5-4: Blincyto - Recommended Dosage & Schedule for Treatment of Relapsed or Refractory B-cell Precursor ALL
Table 5-5: Blincyto - Recommended Dosage & Schedule for Treatment of Relapsed or Refractory B-cell Precursor ALL
Table 5-6: Rybrevant - Premedication
Table 5-7: Rybrevant - Dose Reductions for Adverse Reactions
Table 5-8: Rybrevant - Recommended Dosage Modifications for Adverse Reactions
Table 5-9: Lunsumio - Recommended Treatment Cycles
Table 5-10: Lunsumio - Recommended Premedications
Table 5-11: Lunsumio - Recommendations for Management of Cytokine Release Syndrome
Table 5-12: Tecvayli - Dosing Schedule
Table 5-13: Tecvayli - Recommended Dosage Modifications for Adverse Reactions
Table 5-14: Columvi - Dosing Schedule (21-Day Treatment Cycles)
Table 5-15: Columvi - Premedications to be Administered
Table 5-16: Columvi - Recommendations for Management of Cytokine Release Syndrome
Table 5-17: Columvi - Recommended Dosage Modification for Neurologic Toxicity (Including ICANS)
Table 5-18: Columvi - Recommended Dosage Modifications for Other Adverse Reactions
Table 5-19: Epkinly - Dosage Schedule
Table 5-20: Epkinly - Recommendations for Management of Cytokine Release Syndrome
Table 5-21: Epkinly - Recommendations for Management of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Table 5-22: Epkinly - Recommended Dosage Modifications for Other Adverse Reactions
Table 5-23: Talvey - Weekly Dosing Schedule
Table 5-24: Talvey - Biweekly Dosing Schedule
Table 5-25: Talvey - Recommendations for Management of CRS
Table 5-26: Talvey - Recommendations for Management of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Table 5-27: Talvey - Recommendations for Management of Neurologic Toxicity (excluding ICANS)
Table 5-28: Talvey - Recommended Dosage Modifications for Other Adverse Reactions
Table 5-29: Elrexfio - Dosing Schedule
Table 5-30: Elrexfio - Recommendations for Management of CRS
Table 5-31: Elrexfio - Recommended Dosage Modifications for Other Adverse Reactions
Table 5-32: Kaitani - Recommended Dose modifications
Table 5-33: Imdelltra - Recommended Concomitant Medications for Administration for Cycle 1
Table 5-34: Imdelltra - Recommended Dosage and Schedule
Table 5-35: Imdelltra - Recommendations for Restarting Therapy After Dosage Delay
Table 5-36: Imdelltra - Guidelines for Grading & Dosage Modification & Management of Cytokine Release Syndrome
Table 5-37: Imdelltra - Guidelines for Management of Neurologic Toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome
Table 5-38: Ordspono - Recommended dose
Table 5-39: Ordspono - Premedications & post-medications for patients with r/r FL or r/r DLBCL
Table 5-40: Ziihera - Dosage Modifications For Adverse Reactions
Table 5-41: Bizengri - Premedications Prior To Infusions
Table 5-42: Bizengri - Recommended Dosage Modifications & Management For Adverse Reactions
Table 5-43: Lynozyfic - Recommended Posology

Global Multispecific Antibodies Market, Drug Sales, Dosage, Price & Clinical Trials Insight 2030 Report Highlights:

Global Multispecific Antibodies Market Opportunity By 2030: > USD 50 Billion
Global Multispecific Antibodies Market Sales In 2024: > USD 12 Billion
Number Of Approved Multispecific Antibodies: 18
Global & Regional Trends Insight
Approved Antibodies Global, Regional, Annual & Quarterly Sales Insight
Approved Antibodies Dosage & Pricing Insight
Comprehensive Insight On All Antibodies In Clinical Trials By Company, Country, Indication & Phase
Number Of Multispecific Antibodies: In Clinical Trials: > 700

Research Methodology

At Kuick Research, we begin by outlining the foundation of our research methodology, which is driven by an integrated approach that combines multiple data dimensions. In our work, we ensure that the report captures market estimation, regional analysis, and a carefully constructed competitive landscape. We take pride in the detailed inclusion of key components such as the assessment of available information, clinical trial data, and the nuances of dosing and pricing. Every piece of data is purposefully gathered and validated to ensure that our findings are as robust as possible, reflecting the multifaceted nature of the market landscape.

This report on the global multispecific antibodies market is the result of comprehensive primary and secondary research, encompassing 18 approved drugs, alongside in-depth analysis of their pricing, dosing, and sales data. Market size, marketed drugs regional sales analysis and recent trends are also included in the report. To ensure the accuracy and reliability of our analysis on multispecific antibodies pricing and market performance, we leveraged an extensive array of sources, including company reports, exchange filings, annual and quarterly reports, and official press releases.

Over 10000 distinct web links were reviewed for comprehensive clinical trial information on more than 700 multispecific antibodies.
For annual, quarterly, global and regional sales analysis, SEC documents, company reports, declarations, press releases were analyzed.
Open source and proprietary sources were accessed to validate FDA designated orphan drug indications & priority status.
Multiple drug specific website and various news, company press releases were examined to gather detailed drug pricing and dosage information

Multispecific antibodies market globally has been one of the most energetic and fast growing sectors in the biopharmaceutical business as a result of therapeutic breakthroughs and growing acceptance of their ability to treat complicated pathologies by targeting multiple pathways simultaneously. As of May 2025, 18 multispecific antibodies have gained regulatory approval globally, all of which are bispecific constructs, a monumental milestone in the history of targeted therapeutics. This expanding portfolio boasts trailblazing drugs like Blincyto, the first bispecific antibody to gain approval, and Hemlibra, which was the first bispecific antibody to be approved for a non-cancer indication. The latest entrant to this therapeutic pipeline is Regeneron's Lynozyfic, which received marketing approval in April 2025 for the treatment of multiple myeloma, with evidence of ongoing momentum in the segment.

The range of approved multispecific antibodies mirrors the flexibility of this therapeutic modality across various disease indications and patient bases. Rybrevant is another key breakthrough as the first bispecific antibody for a solid tumor, whereas China based Akeso's Cadonilimab is especially noteworthy for being solely approved bispecific antibody intended to target two immune checkpoints at once and becoming the first China developed bispecific antibody to gain regulatory approval. This regional variation in development emphasizes the world nature of innovation in this sector, with input from both mature pharmaceutical markets and developing biotechnology centers.

The regulatory environment is still changing at a rapid pace, with further approvals expected in the near future. The FDA is also evaluating marketing applications for Odronextamab and Linvoseltamab, both of which have already received approval in the EU for follicular lymphoma and diffuse large B-cell lymphoma, and multiple myeloma, respectively. Such transatlantic regulatory advancements reflect the growing acceptability and trust in multispecific antibody technologies by global regulatory bodies.

Market performance has been extremely strong, with global multispecific antibodies market sales in 2024 amounting to over US$ 12.6 Billion, followed by first quarter 2025 sales of over US$ 3.46 Billion. The US is the largest contributor to these sales, highlighting the maturity and acceptance of the market in this prime geography. Roche's mature products, Hemlibra and Vabysmo, lead the market share, with over half of total sales, emphasizing the value of first mover benefit and effective market entry strategies in this competitive market.

The pipeline for development is an even more daunting picture, with more than 900 multispecific antibodies already in various stages of development. Oncology is leading this pipeline, both due to the traditional priority of multispecific antibody development and due to the large unmet medical needs in cancer treatment. However, pipeline diversity is not confined to oncology alone with promising candidates being identified in autoimmune and inflammatory diseases and neurological disorders as well, indicating an expanding therapeutic horizon that has the potential to dramatically expand market opportunities.

Major industry players behind this innovation are well established pharma giants like Amgen, AstraZeneca, Genentech, and Regeneron, as well as new biotech firms like ABL Bio, Harbour BioMed, Innovent Biologics, Merus, and Zymeworks. This combination of well established and new players provides a vibrant competitive landscape that ensures ongoing innovation and technological progress.

Strategic alliances continue to influence the development of the market, such as in the April 2025 alliance of Boehringer Ingelheim and Cue Biopharma for the development of CUE-501, a bispecific candidate that attacks pathogenic B cells via virus-specific memory T cells. The alliance, involving a US$ 12 Million upfront payment and possible milestone payments of up to US$ 345 Million, illustrates the high financial investment that companies are undertaking to drive multispecific antibody technologies, specifically in autoimmune indications where existing treatments are still inadequate.

Regulatory encouragement of innovation continues to be robust, with the FDA's April 2025 fast track designation of ISB 2001, an Ichnos Glenmark Innovation investigational trispecific T-cell engager for relapsed or refractory multiple myeloma, reflecting ongoing regulatory enthusiasm for moving multispecific antibody technologies forward that treat important unmet medical needs. As a result of these ongoing innovations, the global multispecific antibody market is expected to grow rapidly and is on track to become one of the most important segments within the pharmaceutical industry.

1. Introduction to Next Generation Multispecific Antibodies

2. Next Generation Multispecific Antibody Current Clinical Development & Future Commercialization Outlook

2.1 Current Market Overview
2.2 Future Commercialization Opportunity
2.3 Collaborations, License Agreements, Investments & Acquisitions
2.4 Next Generation Multispecific Antibody Proprietary Technologies By Company

3. Next Generation Multispecific Antibody Clinical Trends by Indication

3.1 Cancer
3.2 Hematological Disorders
3.3 Microbial Infections
3.4 Autoimmune & Inflammatory Disorders
3.5 Ocular Diseases

4. Next Generation 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. Approved Multispecific Antibodies - Clinical Overview, Pricing & Dosage Insight

5.1 Overview
5.2 Clinical Overview, Pricing & Dosage Insight

6. Approved Multispecific Antibodies - Sales Insight (2020 - Q1'2025)

7. Global Multispecific Antibodies Clinical Trials Overview

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

8.1 Research
8.2 Preclinical
8.3 Phase-I
8.4 Phase-I/II
8.5 Phase-II
8.6 Phase-II/III
8.7 Phase-III
8.8 Preregistration
8.9 Registered

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

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

10.1 Research
10.2 Preclinical
10.3 Phase I
10.4 Phase I/II
10.5 Phase II/III

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

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

12. Competitive Landscape

12.1 AbbVie
12.2 ABL Bio
12.3 Abzyme Therapeutics
12.4 Affimed Therapeutics
12.5 Akeso Biopharma
12.6 Alligator Bioscience
12.7 Amgen
12.8 Antibody Therapeutics
12.9 APITBIO
12.10 Astellas Pharma
12.11 AstraZeneca
12.12 Aptevo Therapeutics
12.13 BioAtla
12.14 Biocytogen Pharmaceuticals
12.15 Biosion
12.16 EpimAb Biotherapeutics
12.17 FutureGen Biopharmaceutical
12.18 Genentech
12.19 Genmab
12.20 Genor Biopharma
12.21 Gensun Biopharma
12.22 Harbour BioMed
12.23 IGM Biosciences
12.24 I-MAB Biopharma
12.25 ImmuneOnco Biopharma
12.26 ImmunoPrecise Antibodies
12.27 Innate Pharma
12.28 Innovent Biologics
12.29 Invenra
12.30 Johnson & Johnson
12.31 Kenjockety Biotechnology
12.32 LaNova Medicines Limited
12.33 Light Chain Bioscience
12.34 Linton Pharm
12.35 Lyvgen Biopharma
12.36 MacroGenics
12.37 Merck
12.38 Merus
12.39 ModeX Therapeutics (OPKO Health)
12.40 Molecular Partners
12.41 NovaRock Biotherapeutics
12.42 Numab
12.43 OPKO Health
12.44 Pfizer
12.45 Regeneron Pharmaceuticals
12.46 Revitope
12.47 Roche
12.48 Sanofi
12.49 Sichuan Baili Pharmaceutical
12.50 SystImmune
12.51 Virtuoso Therapeutics
12.52 Xencor
12.53 Y-Biologics
12.54 Zhejiang Shimai Pharmaceutical
12.55 Zymeworks

多特異性抗体の世界市場：薬剤売上、用量、価格、臨床試験動向（2030年）

Global Multispecific Antibodies Market, Drug Sales, Dosage, Price & Clinical Trials Insight 2030

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章次世代多重特異性抗体の現在の臨床開発と将来の商業化の見通し

第3章次世代多重特異性抗体の臨床動向、適応症別

第4章次世代多重特異性抗体の臨床開発と地域別市場動向

第5章承認済みの多重特異性抗体- 臨床概要、価格設定および用量の考察

第6章承認済みの多重特異性抗体- 販売動向（2020年～2025年第1四半期）

第7章世界の重特異性抗体臨床試験の概要

第8章世界の二重特異性抗体臨床試験：企業別、適応症別、相別

第9章上市済みの二重特異性抗体の臨床的洞察：企業別、適応症別、相別

第10章世界の三重特異性抗体臨床試験：企業別、適応症別、相別

第11章三重特異性抗臨床試験の洞察：企業、国、適応症、相別

第12章競合情勢

List of Figures

List of Tables

Table of Contents

1. Introduction to Next Generation Multispecific Antibodies

2. Next Generation Multispecific Antibody Current Clinical Development & Future Commercialization Outlook

3. Next Generation Multispecific Antibody Clinical Trends by Indication

4. Next Generation Multispecific Antibody Clinical Development & Market Trends by Region

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

6. Approved Multispecific Antibodies - Sales Insight (2020 - Q1'2025)

7. Global Multispecific Antibodies Clinical Trials Overview

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

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

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

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

12. Competitive Landscape

多特異性抗体の世界市場：薬剤売上、用量、価格、臨床試験動向（2030年）

Global Multispecific Antibodies Market, Drug Sales, Dosage, Price & Clinical Trials Insight 2030

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 次世代多重特異性抗体の現在の臨床開発と将来の商業化の見通し

第3章 次世代多重特異性抗体の臨床動向、適応症別

第4章 次世代多重特異性抗体の臨床開発と地域別市場動向

第5章 承認済みの多重特異性抗体- 臨床概要、価格設定および用量の考察

第6章 承認済みの多重特異性抗体- 販売動向（2020年～2025年第1四半期）

第7章 世界の重特異性抗体臨床試験の概要

第8章 世界の二重特異性抗体臨床試験：企業別、適応症別、相別

第9章 上市済みの二重特異性抗体の臨床的洞察：企業別、適応症別、相別

第10章 世界の三重特異性抗体臨床試験：企業別、適応症別、相別

第11章 三重特異性抗臨床試験の洞察：企業、国、適応症、相別

第12章 競合情勢

List of Figures

List of Tables

Table of Contents

1. Introduction to Next Generation Multispecific Antibodies

2. Next Generation Multispecific Antibody Current Clinical Development & Future Commercialization Outlook

3. Next Generation Multispecific Antibody Clinical Trends by Indication

4. Next Generation Multispecific Antibody Clinical Development & Market Trends by Region

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

6. Approved Multispecific Antibodies - Sales Insight (2020 - Q1'2025)

7. Global Multispecific Antibodies Clinical Trials Overview

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

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

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

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

12. Competitive Landscape

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章次世代多重特異性抗体の現在の臨床開発と将来の商業化の見通し

第3章次世代多重特異性抗体の臨床動向、適応症別

第4章次世代多重特異性抗体の臨床開発と地域別市場動向

第5章承認済みの多重特異性抗体- 臨床概要、価格設定および用量の考察

第6章承認済みの多重特異性抗体- 販売動向（2020年～2025年第1四半期）

第7章世界の重特異性抗体臨床試験の概要

第8章世界の二重特異性抗体臨床試験：企業別、適応症別、相別

第9章上市済みの二重特異性抗体の臨床的洞察：企業別、適応症別、相別

第10章世界の三重特異性抗体臨床試験：企業別、適応症別、相別

第11章三重特異性抗臨床試験の洞察：企業、国、適応症、相別

第12章競合情勢