市場調査レポート

商品コード

二重特異性抗体の世界市場：市場の機会、用量、特許、薬価、売上、臨床試験動向（2030年）

Global Bispecific Antibody Market Opportunity, Drug Dosage, Patent, Price, Sales & Clinical Trials Insight 2030

出版日: 2025年03月01日
発行: KuicK Research
ページ情報: 英文 1000 Pages
納期: 即日から翌営業日

価格

PDF (Single User License)

USD 3,900 579,891円

レポートPDFを1名のみがご利用頂けるライセンスです。 PDF内のテキスト等のコピー＆ペーストは出来ません。 PDFの印刷は一度のみ可能です。印刷したもののご利用はPDFのご利用範囲に準拠します。

PDF (Multi-User License)

USD 6,000 892,140円

レポートPDFを貴社内のすべての方にご利用頂けるライセンスです。PDF内のテキスト等のコピー＆ペースト可能です。PDFの印刷は何回でも可能ですが、印刷したもののご利用はPDFのご利用範囲に準拠します。

価格表記: USDを日本円(税抜)に換算

本日の銀行送金レート: 1USD=148.69円

ご注意:　DRM (デジタル著作権管理システム) 付PDFになります。制限内容は、上記ライセンスの[詳細]アイコンをクリックしてご確認ください。

全表示
概要
図表
目次

概要

サンプル依頼リストに入れる

二重特異性抗体は、絶え間ない技術革新と患者受容の高まりにより、医薬品市場において最も有望かつ商業的に成功したターゲティングアプローチの一つとして台頭してきました。この驚異的な成長の主な要因は、二重特異性抗体の臨床試験数が飛躍的に増加していることであり、2015年には100件未満であったものが、2025年には650件を超えています。この進歩は、医薬品開発者、臨床研究機関、医師、患者といった複数の利害関係者に大きな利益をもたらしています。2025年3月現在、主要市場において17の二特異性抗体が承認されており、最初の二特異性抗体が承認された2015年には7,700万米ドルであったのに対し、累積売上高は350億米ドルを超えています。

二重特異性抗体の市場規模は、2024年に約120億米ドルに達し、2030年までに500億米ドルに急増すると予測されています。この成長軌道は、アンメット・メディカル・ニーズに対応できる革新的な生物製剤に対する需要の高まりを示しています。注目すべきは、HemlibraとVabysmoが世界の二重特異性抗体市場の主役として台頭し、合計で総売上高の75％以上を占めていることです。ロシュが開発した二重特異性抗体ヘムリブラは血友病Aの治療に用いられ、同じくロシュが開発したバビスモは黄斑変性と黄斑浮腫の治療薬です。両剤とも2024年には売上高が40億米ドルを突破し、それぞれの治療領域で主要な参入製品として頭角を現し、二重特異性抗体市場におけるRocheのリーダーシップを確固たるものにしています。

また、現在承認審査中の二重特異性抗体もいくつかあります。特に、治験中の二重特異性抗体であるリンボセルタマブは、多発性骨髄腫の治療薬として米国FDAと欧州医薬品庁（EMA）の審査を受けています。もう一つの有望な候補であるオドロネクスタマブは、様々な血液悪性腫瘍の治療薬として現在FDAの審査を受けています。これらの開発は、二重特異性抗体研究の進行と、がん治療に革命をもたらす可能性を強調するものです。

2025年3月現在、600以上の二特異性抗体が臨床試験中であり、この治療薬が複数の治療領域で計り知れない可能性を秘めていることを示しています。米国は、医薬品の技術革新とヘルスケア支出における主導権を反映し、研究開発（R&D）と売上の両面で二特異性抗体の最大市場であり続けています。

当レポートは、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
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), 2020-2024
Figure 5-2: Global - Annual Bispecific Antibodies Market By Drugs (US$ Million), 2024
Figure 5-3: Global - Bispecific Antibodies Market Shares by Drugs (%), 2024
Figure 5-4: Global - Quarterly Bispecific Antibody Market (US$ Million), 2024
Figure 5-5: Global - Annual Bispecific Antibody Market By Region (US$ Million), 2024
Figure 5-6: Global - Bispecific Antibody Market Shares By Region (%), 2024
Figure 5-7: US -Bispecific Antibody Market (US$ Million), 2020-2024
Figure 5-8: US - Quarterly Bispecific Antibodies Market (US$ Million), 2024
Figure 5-9: US - Quarterly Bispecific Antibodies Market (US$ Million),2023
Figure 5-10: ROW -Bispecific Antibody Market Value (US$ Million), 2020-2024
Figure 5-11: ROW - Quarterly Bispecific Antibodies Market (US$ Million), 2024
Figure 5-12: ROW - Quarterly Bispecific Antibodies Market (US$ Million), 2023
Figure 5-13: Global - Bispecific Antibodies Market By Drug (US$ Million), 2023
Figure 5-14: Global - Bispecific Antibodies Market Shares By Drugs (%), 2023
Figure 5-15: Global - Quarterly Bispecific Antibody Market (US$ Million), 2023
Figure 5-16: Global - Bispecific Antibody Market By Region (US$ Million), 2023
Figure 5-17: Global - Bispecific Antibody Market Shares By Region (%), 2023
Figure 5-18: Blincyto - Total Treatment Cost & Reimbursement Cost
Figure 5-19: Blincyto - In Pocket & Out of Pocket Cost of Treatment
Figure 5-20: Hemlibra - Total Treatment Cost & Reimbursement Cost
Figure 5-21: Hemlibra - In Pocket & Out Of Pocket Cost Of Treatment
Figure 5-22: Rybrevant - Maximum Coverage By Medicaid (US$), 2023
Figure 5-23: Rybrevant - Maximum Coverage By Private Insurance Coverage (US$), 2021
Figure 5-24: Vabysmo - Total Treatment Cost & Reimbursement Cost
Figure 5-25: Vabysmo - In Pocket & Out Of Pocket Cost Of Treatment
Figure 5-26: Global - Bispecific Antibody Market Opportunity Assessment (US$ Billion), 2025 - 2030
Figure 6-1: US - Bispecific Antibodies Approval
Figure 7-1: Bispecific Antibodies - Advantages
Figure 7-2: HX009-II-02 Phase 1/2 Study - Initiation & Completion Year
Figure 7-3: Bispecific Antibodies - Future Opportunities in Melanoma
Figure 7-4: Mim8 Phase 3 (NCT05878938) Study - Initiation & Completion Year
Figure 7-5: NXT007 Phase 1/2 (NCT05987449) Study - Initiation & Completion Year
Figure 7-6: HMB-001 Phase 1/2 (NCT06211634) Study - Initiation & Completion Year
Figure 8-1: Blincyto - Approval Year By Region
Figure 8-2: Blincyto - Patent Filing & Expiration Year
Figure 8-3: Blincyto - Treatment Regimen Cycles (Weeks)
Figure 8-4: Blincyto - Duration Of Treatment Phase & Resting Phase In Induction & Consolidation Cycles For Treatment Of MRD-Positive B-Cell Precursor (Days)
Figure 8-5: Blincyto - Recommended Number Of Induction & Consolidation Treatment Cycle For Relapsed B-Cell Precursor ALL
Figure 8-6: Blincyto - Duration Of Single Induction, Consolidation, Continued Cycle & Full Treatment For Relapsed B-Cell Precursor ALL (Weeks)
Figure 8-7: Global - Blincyto Sales (US$ Million), 2020-2024
Figure 8-8: Global - Blincyto Sales Quaterly (US$ Million), 2024
Figure 8-9: Global - Blincyto Sales Quaterly (US$ Million), 2023
Figure 8-10: Blincyto - Sales By Region (US$ Million), 2024
Figure 8-11: Blincyto - Sales By Region (%), 2024
Figure 8-12: Blincyto - Sales By Region (US$ Million), 2023
Figure 8-13: Global - Blincyto Sales By Region (%), 2023
Figure 8-14: US - Blincyto Sales ((US$ Million), 2020-2024
Figure 8-15: US - Blincyto Sales Quaterly (US$ Million), 2024
Figure 8-16: US - Blincyto Sales Quaterly (US$ Million), 2023
Figure 8-17: ROW - Blincyto Sales (US$ Million), 2020-2024
Figure 8-18: ROW - Blincyto Sales Quaterly (US$ Million), 2024
Figure 8-19: ROW - Blincyto Sales Quaterly (US$ Million), 2023
Figure 9-1: Hemlibra - Approval Years By Region
Figure 9-2: Hemlibra - Cost per Unit & Supply of 30 mg/mL Subcutaneous Injection Of Different Volumes (US$), March'2025
Figure 9-3: Hemlibra - Cost per Unit & Supply of 150 mg/mL Subcutaneous Injection Of Different Volumes (US$), March'2025
Figure 9-4: Hemlibra - Recommended Loading & Maintenance Dose For Treatment Of Hemophilia (mg/kg/Week)
Figure 9-5: Global - Hemlibra Sales (US$ Million), 2020-2024
Figure 9-6: Global - Hemlibra Sales Quaterly (US$ Million), 2024
Figure 9-7: Global - Hemlibra Sales Quaterly (US$ Million), 2023
Figure 9-8: US - Hemlibra Sales (US$ Million), 2020-2024
Figure 9-9: US - Hemlibra Sales Quaterly (US$ Million), 2024
Figure 9-10: US - Hemlibra Sales Quaterly (US$ Million), 2023
Figure 9-11: Europe - Hemlibra Sales (US$ Million), 2020-2024
Figure 9-12: Europe - Hemlibra Sales Quaterly (US$ Million), 2024
Figure 9-13: Europe - Hemlibra Sales Quaterly (US$ Million), 2023
Figure 9-14: Japan - Hemlibra Sales (US$ Million), 2020-2024
Figure 9-15: Japan - Hemlibra Sales Quaterly (US$ Million), 2024
Figure 9-16: Japan - Hemlibra Sales Quaterly (US$ Million), 2023
Figure 9-17: ROW - Hemlibra Sales (US$ Million), 2020-2024
Figure 9-18: ROW - Hemlibra Sales Quaterly (US$ Million), 2024
Figure 9-19: ROW - Hemlibra Sales Quaterly (US$ Million), 2023
Figure 9-20: Global - US v/s ex-US Sales (US$ Million), 2024
Figure 9-21: Global - Hemlibra Annual Sales By Region (US$ Million), 2024
Figure 9-22: Global - Hemlibra Sales By Region (%), 2024
Figure 9-23: Global - US v/s Ex-US Sales (US$ Million), 2023
Figure 9-24: Global - Hemlibra Annual Sales By Region (US$ Million), 2023
Figure 9-25: Global - Hemlibra Sales By Region (%), 2023
Figure 10-1: Rybrevant - Patent Filing & Expiration Year
Figure 10-2: Rybrevant - Price Per Unit & Supply Of Intravenous Solution (US$), March'2025
Figure 10-3: Rybrevant - Recommended Dose Per Cycle By Body Weight (mg)
Figure 10-4: Rybrevant - Dose Reduction In Patients With Weight Less Than 80 kg (mg)
Figure 10-5: Rybrevant - Dose Reduction in Patients with Weight more than 80 Kg (mg)
Figure 11-1: Vabysmo - Approval Year By Region
Figure 11-2: Rybrevant - Patent Filing & Expiration Year
Figure 11-3: Vabysmo - Price Per Unit & Supply Of Intravitreal Solution (US$), March'2025
Figure 11-4: Global - Vabysmo Sales (US$ Million), 2022-2024
Figure 11-5: Global - Vabysmo Sales Quaterly (US$ Million), 2024
Figure 11-6: Global - Vabysmo Sales Quaterly (US$ Million), 2023
Figure 11-7: US - Vabysmo Sales (US$ Million), 2022-2024
Figure 11-8: US - Vabysmo Sales Quaterly (US$ Million), 2024
Figure 11-9: US - Vabysmo Sales Quaterly (US$ Million), 2023
Figure 11-10: Europe - Vabysmo Sales (US$ Million), 2022-2024
Figure 11-11: Europe - Vabysmo Sales Quaterly (US$ Million), 2024
Figure 11-12: Europe - Vabysmo Sales Quaterly (US$ Million), 2023
Figure 11-13: Japan - Vabysmo Sales (US$ Million), 2022-2024
Figure 11-14: Japan - Vabysmo Sales Quaterly (US$ Million), 2024
Figure 11-15: Japan - Vabysmo Sales Quaterly (US$ Million), 2023
Figure 11-16: ROW - Vabysmo Sales (US$ Million), 2022-2024
Figure 11-17: ROW - Vabysmo Sales Quaterly (US$ Million), 2024
Figure 11-18: ROW - Vabysmo Sales Quaterly (US$ Million), 2023
Figure 11-19: Global - Vabysmo US v/s Ex-US Sales (US$ Million), 2024
Figure 11-20: Global - Vabysmo Annual Sales by Region (US$ Million), 2024
Figure 11-21: Global - Vabysmo Sales By Region (%), 2024
Figure 11-22: Global - Vabysmo US v/s Ex-US Sales (US$ Million), 2023
Figure 11-23: Global - Vabysmo Annual Sales By Region (US$ Million), 2023
Figure 11-24: Global - Vabysmo Sales By Region (%), 2023
Figure 12-1: Lunsumio - Approval Years By Region
Figure 12-2: US - Price Per Unit & Supply of Lunsumio Intravenous Solution (US$), March'2025
Figure 12-3: EU - Price Per Unit & Supply of Lunsumio Intravenous Solution (US$), March'2025
Figure 12-4: Global - Lunsumio Sales (US$ Million), 2022-2024
Figure 12-5: Global - Lunsumio Sales Quaterly (US$ Million), 2024
Figure 12-6: Global - Lunsumio Sales Quaterly (US$ Million), 2023
Figure 12-7: US - Lunsumio Sales (US$ Million), 2022-2024
Figure 12-8: US - Lunsumio Sales Quaterly (US$ Million), 2024
Figure 12-9: US - Lunsumio Sales Quaterly (US$ Million), 2023
Figure 12-10: Europe - Lunsumio Sales (US$ Million), 2022-2024
Figure 12-11: Europe - Lunsumio Sales Quaterly (US$ Million), 2024
Figure 12-12: Europe - Lunsumio Sales Quaterly (US$ Million), 2023
Figure 12-13: ROW - Lunsumio Sales (US$ Million), 2022-2024
Figure 12-14: ROW - Lunsumio Sales Quaterly (US$ Million), 2024
Figure 12-15: Lunsumio - US v/s Ex-US Sales (US$ Million), 2024
Figure 12-16: Global - Lunsumio Annual Sales By Region (US$ Million), 2024
Figure 12-17: Global - Lunsumio Sales By Region (%), 2024
Figure 12-18: Global - US v/s Ex-US Sales (US$ Million), 2023
Figure 12-19: Global - Lunsumio Annual Sales By Region (US$ Million), 2023
Figure 12 20: Global - Lunsumio Sales By Region (%), 2023
Figure 13-1: China - Kaitani Sales (US$ Million), 2022-2023
Figure 13-2: China - Kaitani Sales (US$ Million), H1-H2'2023
Figure 14-1: Tecvayli - Approval Years by Region
Figure 14-2: Tecvayli - Patent Acceptance & Expiration Year
Figure 14-3: US - Cost Per Unit & Supply Of Tecvayli Subcutaneous Solution (US$), March'2025
Figure 14-4: EU - Cost of Supply Of Tecvayli Subcutaneous Solution (US$), March'2025
Figure 14-5: Global - Tecvayli Sales (US$ Million), 2022-2024
Figure 14-6: Global - Tecvayli Sales Quaterly (US$ Million), 2024
Figure 14-7: Global - Tecvayli Sales Quaterly (US$ Million), 2023
Figure 14-8: US - Tecvayli Sales (US$ Million), 2022-2024
Figure 14-9: US - Tecvayli Sales Quaterly (US$ Million), 2024
Figure 14-10: US - Tecvayli Sales Quaterly (US$ Million), 2023
Figure 14-11: ROW - Tecvayli Sales (US$ Million), 2022-2024
Figure 14-12: ROW - Tecvayli Sales Quaterly (US$ Million), 2024
Figure 14-13: ROW - Tecvayli Sales Quaterly (US$ Million), 2023
Figure 14-14: Tecvayli - US v/s Ex-US Sales (US$ Million), 2024
Figure 14-15: Tecvayli - US v/s Ex-US Sales (%), 2024
Figure 14-16: Tecvayli - US v/s Ex-US Sales (US$ Million), 2023
Figure 14-17: Tecvayli - US v/s Ex-US Sales (%), 2023
Figure 15-1: Columvi - Approval Year By Region
Figure 15-2: US - Price Per Unit & Supply Of Columvi Intravenous Solution (US$), March'2025
Figure 15-3: EU - Price Of Supply Of Columvi Intravenous Solution (US$), March'2025
Figure 15-4: Global - Columvi Sales (US$ Million), 2023-2024
Figure 15-5: Global - Columvi Sales Quaterly (US$ Million), 2024
Figure 15-6: Global - Columvi Sales Quaterly (US$ Million), 2023
Figure 15-7: US - Columvi Sales (US$ Million), 2023-2024
Figure 15-8: US - Columvi Sales Quaterly (US$ Million), 2024
Figure 15-9: US - Columvi Sales Quaterly (US$ Million), 2023
Figure 15-10: Europe - Columvi Sales (US$ Million), 2023 & 2024
Figure 15-11: Europe - Columvi Sales Quaterly (US$ Million), 2024
Figure 15-12: Europe - Columvi Sales Quaterly (US$ Million), 2023
Figure 15-13: ROW - Columvi Sales (US$ Million), 2023 & 2024
Figure 15-14: ROW - Columvi Sales Quaterly (US$ Million), 2024
Figure 15-15: ROW - Columvi Sales Quaterly (US$ Million), 2023
Figure 15-16: Global - Columvi US v/s Ex-US Sales (US$ Million), 2024
Figure 15-17: Global - Columvi Annual Sales By Region (US$ Million), 2024
Figure 15-18: Global - Columvi Sales By Region (%), 2024
Figure 15-19: Global - Columvi US v/s Ex-US Sales (US$ Million), 2023
Figure 15-20: Global - Columvi Annual Sales By Region (US$ Million), 2023
Figure 15-21: Global - Columvi Sales By Region (%), 2023
Figure 16-1: Epkinly - Approval Year By Region
Figure 16-2: US - Cost Per Unit & Supply Of Epkinly Subcutaneous Solution (US$), March'2025
Figure 16-3: EU - Cost Of Supply Of Epkinly Subcutaneous Solution (US$), March'2025
Figure 16-4: Global - Epkinly Sales (US$ Million), 2023 & 2024
Figure 16-5: Global - Epkinly Sales Reported By Genmab (US$ Million), 2023 & 2024
Figure 16-6: Global - Epkinly Sales Reported By AbbVie (US$ Million), 2023 & 2024
Figure 16-7: Global - Epkinly Sales By Company (US$ Million), 2024
Figure 16-8: Global - Epkinly Sales By Company (US$ Million), 2023
Figure 17-1: Talvey - Approval Year By Region
Figure 17-2: Talquetamab - FDA & EMA Designation Year
Figure 17-3: Talvey - Patent Acceptance & Expiration Year
Figure 17-4: US - Price Per Unit & Supply Of Talvey Intravenous Solution (US$), March'2025
Figure 17-5: EU - Price Per Supply Of Talvey Intravenous Solution (US$), March'2025
Figure 18-1: Elrexfio - Approval Year by Region
Figure 18-2: Elranatamab - FDA & EMA Designation Year
Figure 18-3: US - Price Per Unit & Supply Of Elrexfio Subcutaneous Solution (US$), March'2025
Figure 18-4: Global - Elrexfio Sales (US$ Million), 2023 & 2024
Figure 18-5: US - Elrexfio Sales (US$ Million), 2023 & 2024
Figure 18-6: ROW - Elrexfio Sales (US$ Million), 2023 & 2024
Figure 19-1: Imdelltra - Approval Year By Region
Figure 19-2: US - Price Of Supply Of Imdelltra Intravenous Powder (US$), March'2025
Figure 19-3: EU - Price Of Supply Of Imdelltra Intravenous Powder (US$), March'2025
Figure 19-4: Global - Imdelltra Sales (US$ Million), 2024
Figure 19-5: Global - Imdelltra Sales Quaterly (US$ Million), 2024
Figure 21-1: Global - Ordspono Sales (US$ Million), 2022-2024
Figure 21-2: Global - Ordspono Sales Quaterly (US$ Million), 2024
Figure 22-1: US - Price Per Unit & Supply Of Ziihera (US$), March'2025
Figure 22-2: Global - Ziihera Sales (US$ Million), 2024
Figure 23-1: Zenocutuzumab - Active Patents

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: China - 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 5-6: Imdelltra - Payer Coverage & Reimbursement Details
Table 5-7: Ziihera - ICD-10-CM Codes
Table 5-8: Ziihera - ICD-10-PCS Codes
Table 6-1: US - Some FDA Designated Bispecific Antibodies
Table 6-2: US - Bispecific Antibodies With Recent IND Clearances
Table 6-3: EU - Bispecific Antibodies in Late Stage Clinical Trials
Table 6-4: Latin America - Bispecific Antibodies in Clinical Trials
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: Gastrointestinal Cancers - Bispecific Antibodies in Clinical Trials
Table 8-1: Blincyto - Active Patents
Table 8-2: Blincyto - Recommended Dosage & Schedule For The Treatment of MRD-Positive B-Cell Precursor ALL
Table 8-3: Blincyto - Recommended Dosage & Schedule for Treatment Of Relapsed Or Refractory B-Cell Precursor ALL
Table 8-4: Blincyto - Recommended Dosage & Schedule For Treatment Of Relapsed Or Refractory B-Cell Precursor ALL
Table 10-1: Rybrevant - Premedication
Table 10-2: Rybrevant - Dose Reductions For Adverse Reactions
Table 10-3: Rybrevant - Recommended Dosage Modifications For Adverse Reactions
Table 12-1: Lunsumio - Recommended Treatment Cycles
Table 12-2: Lunsumio - Recommended Premedications
Table 12-3: Lunsumio - Recommendations For Management Of Cytokine Release Syndrome
Table 14-1: Tecvayli - Dosing Schedule
Table 14-2: Tecvayli - Recommended Dosage Modifications For Adverse Reactions
Table 15-1: Columvi - Dosing Schedule (21-Day Treatment Cycles)
Table 15-2: Columvi - Premedications To Be Administered
Table 15-3: Columvi - Recommendations For Management Of Cytokine Release Syndrome
Table 15-4: Columvi - Recommended Dosage Modification For Neurologic Toxicity (Including ICANS)
Table 15-5: Columvi - Recommended Dosage Modifications For Other Adverse Reactions
Table 16-1: Epkinly - Dosage Schedule
Table 16-2: Epkinly - Recommendations For Management Of Cytokine Release Syndrome
Table 16-3: Epkinly - Recommendations for Management of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Table 16-4: Epkinly - Recommended Dosage Modifications For Other Adverse Reactions
Table 17-1: Talvey - Weekly Dosing Schedule
Table 17-2: Talvey - Biweekly Dosing Schedule
Table 17-3: Talvey - Recommendations for Management of CRS
Table 17-4: Talvey - Recommendations for Management of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Table 17-5: Talvey - Recommendations For Management Of Neurologic Toxicity (excluding ICANS)
Table 17-6: Talvey - Recommended Dosage Modifications For Other Adverse Reactions
Table 18-1: Elrexfio - Dosing Schedule
Table 18-2: Elrexfio - Recommendations For Management Of CRS
Table 18-3: Elrexfio - Recommended Dosage Modifications For Other Adverse Reactions
Table 22-1: Ziihera - Dosage Modifications For Adverse Reactions
Table 23-1: Bizengri - Premedications Prior To Infusions
Table 23-2: Bizengri - Recommended Dosage Modifications & Management For Adverse Reactions

Global Bispecific Antibody Market Opportunity, Drug Dosage, Patent, Price, Sales & Clinical Trials Insight 2030 Report findings & Highlights:

Global & Regional Market Size, Clinical Trends Insight
Global Bispecific Antibodies Sales Opportunity US$ 50 Billion By 2030
Global Bispecific Antibodies Sales Surpassed US$ 11 Billion In 2024
17 Bispecific Antibodies Approved Across Key Markets
Approved Antibodies Dosage, Patent, Pricing & Sales Insight
Comprehensive Insight On More than 600 Bispecific Antibodies In Clinical Trials
Global Bispecific Antibodies Clinical Trials By Company, Indication & Phase

Bispecific antibodies have emerged as one of the most promising and commercially successful targeting approaches in the pharmaceutical market, driven by continuous innovations and growing patient acceptance. A major factor contributing to this phenomenal growth is the exponential increase in the number of clinical trials for bispecific antibodies, which has surpassed 650 in 2025 from less than 100 in 2015. This progress has significantly benefited multiple stakeholders like drug developers, clinical research organizations, physicians, and patients. As of March 2025, 17 bispecific antibodies have been approved across key markets, with cumulative sales exceeding US$ 35 Billion as compared to US$ 77 Million in 2015 when the first bispecific antibody was approved.

The bispecific antibody market reached approximately US$ 12 billion in 2024, with projections by Kuick Research suggesting that this market will surge to US$ 50 billion by 2030. This growth trajectory highlights the increasing demand for innovative biologics that can address unmet medical needs. Notably, Hemlibra and Vabysmo have emerged as major contributors to the global bispecific antibodies market, collectively accounting for over 75% of the total sales. Hemlibra, a bispecific antibody developed by Roche, is used to treat hemophilia A, while Vabysmo, also developed by Roche, is a treatment for macular degeneration and macular edema. Both drugs saw sales surpassing US$ 4 Billion in 2024, emerging as key players in their respective therapeutic areas and solidifying Roche's leadership in the market for bispecific antibodies.

There are also several bispecific antibodies currently under regulatory review. Notably, Linvoseltamab, an investigational bispecific antibody, is undergoing review by the US FDA and the European Medicines Agency (EMA) for the treatment of multiple myeloma. Another promising candidate, Odronextamab, is currently under FDA review for the treatment of various hematologic malignancies. These developments underscore the ongoing progress in bispecific antibody research and their potential to revolutionize cancer treatment.

As of March 2025, more than 600 bispecific antibodies are currently undergoing clinical trials, demonstrating the immense potential of these therapeutics across multiple therapeutic areas. The US remains the largest market for bispecific antibodies in terms of both research and development (R&D) and sales, reflecting the country's leadership in pharmaceutical innovation and healthcare spending.

Leading players in the bispecific antibody market include Roche, Gilead, Amgen, Pfizer, Johnson & Johnson (Janssen), and others. These companies are at the forefront of developing innovative bispecific therapies, with a focus on oncology and other high-need areas. For example, Roche has leveraged its expertise in biologics to bring to market Hemlibra and Vabysmo, while Amgen is advancing bispecific T-cell engagers for cancer immunotherapy.

In addition to these leading companies, there have been significant regulatory designations granted to bispecific antibodies, enhancing the overall market landscape. Ivonescimab, a PD-1 x VEGF bispecific antibody developed by Akeso, received FDA Fast Track Designation in October 2024 for the treatment of non-small cell lung cancer (NSCLC) with EGFR mutations in the second-line or beyond setting. This designation accelerates the development process and highlights the growing interest in bispecific antibodies for treating cancer. Akeso is collaborating with Summit Therapeutics in the US and other countries to develop Ivonescimab.

Additionally, Invenra's Novel Antibody INV724 has received both Rare Pediatric Disease and Orphan Drug Designations from the US FDA for the treatment of neuroblastoma, a rare and aggressive cancer affecting children. INV724 targets the GD2 and B7-H3 antigens and has shown promise in early-stage clinical trials, offering hope for more effective treatments for pediatric cancers.

In conclusion, the bispecific antibody market is poised for substantial growth, driven by increasing approvals, ongoing clinical trials, and strong regulatory support. With major players like Roche, Gilead, Amgen, and Pfizer leading the charge, and promising candidates undergoing review, bispecific antibodies are set to transform the landscape of modern therapeutics. The market's rapid expansion from US$ 12 Billion in 2024 to an expected US$ 50 Billion by 2030, reflects the increasing recognition of bispecific antibodies as key solutions for treating complex and life-threatening diseases.

Table of Contents

1. Introduction To Bispecific Antibody

1.1 Overview
1.2 Clinical Advancement of Bispecific Antibodies

2. Bispecific Antibodies Combination Strategies

2.1 Chemotherapy
2.2 Targeted Therapy
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 (2020 to 2024)
5.2 Approved Bispecific Antibodies Reimbursement Policy
5.3 Global Bispecific Antibody Market Forecast 2030

6. Global Bispecific Antibody Market Trends By Region

6.1 Japan
6.2 South Korea
6.3 US
6.4 Europe
6.5 China
6.6 UK
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 Gastrointestinal Cancers
7.7 Other Cancers
7.8 Blood Disorders
7.9 Autoimmune & Inflammatory Diseases
7.10 Microbial Diseases
7.11 Ocular Diseases

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

8.1 Overview & Patent Insight
8.2 Pricing & Dosage Analysis
8.3 Sales Analysis

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

9.1 Overview
9.2 Pricing & Dosage Insight
9.3 Sales Analysis

10. Rybrevant - Clinical, Patent & Pricing Insight

10.1 Overview
10.2 Pricing & Dosage Insight

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

11.1 Overview
11.2 Pricing & Dosage Insight
11.3 Sales Analysis

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

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

13. Kaitani - Clinical & Sales Insight

14. Tecvayli - Clinical, Patent & Pricing Insight

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

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

15.1 Overview & Patent Insight
15.2 Pricing & Dosage Insight
15.3 Sales Analysis

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

16.1 Overview
16.2 Pricing & Dosage Insight
16.3 Sales Analysis

17. Talvey - Clinical, Patent & Pricing Insight

17.1 Overview & Patent Insight
17.2 Pricing & Dosage Insight

18. Elrexfio - Clinical, Patent & Pricing Insight

18.1 Overview
18.2 Pricing & Dosage Insight
18.3 Sales Analysis

19. Imdelltra - Clinical, Patent, Pricing & Sales Insight

19.1 Overview & Patent Insight
19.2 Pricing & Dosage Insight
19.3 Sales Analysis

20. Ivonescimab - Clinical Insight

21. Ordspono - Clinical & Sales Insight

21.1 Overview
21.2 Sales Analysis

22. Ziihera - Clinical, Pricing & Sales Insight

22.1 Overview
22.2 Pricing & Dosage
22.3 Sales Insight

23. Bizengri - Clinical, Patent, Pricing & Sales Insight

23.1 Overview
23.2 Dosing & Pricing

24. Korjuny - Clinical Insight

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

25.1 Research
25.2 Preclinical
25.3 Phase-I
25.4 Phase-I/II
25.5 Phase-II
25.6 Phase-II/III
25.7 Phase-III
25.8 Preregistration
25.9 Registered

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

27. Competitive Landscape

27.1 ABL Bio
27.2 Abzyme Therapeutics
27.3 Affimed Therapeutics
27.4 Akeso Biopharma
27.5 Alligator Bioscience
27.6 Amgen
27.7 Antibody Therapeutics
27.8 APITBIO
27.9 Aptevo Therapeutics
27.10 Astellas Pharma
27.11 AstraZeneca
27.12 BioAtla
27.13 Biosion
27.14 Biotheus
27.15 BJ Bioscience
27.16 EpimAb Biotherapeutics
27.17 FutureGen Biopharmaceutical
27.18 Genentech
27.19 Genmab
27.20 Gensun Biopharma
27.21 Harbour BioMed
27.22 IGM Biosciences
27.23 I-MAB Biopharma
27.24 ImmuneOnco Biopharma
27.25 Innovent Biologics
27.26 Invenra
27.27 Janssen Research & Development
27.28 Kenjockety Biotechnology
27.29 LaNova Medicines Limited
27.30 Light Chain Bioscience
27.31 Linton Pharm
27.32 Lyvgen Biopharma
27.33 MacroGenics
27.34 Merus
27.35 NovaRock Biotherapeutics
27.36 Pfizer
27.37 Phanes Therapeutics
27.38 Prestige BioPharma
27.39 Regeneron Pharmaceuticals
27.40 Revitope
27.41 Roche
27.42 Virtuoso Therapeutics
27.43 Xencor
27.44 Y-Biologics
27.45 Zhejiang Shimai Pharmaceutical
27.46 Zymeworks

二重特異性抗体の世界市場：市場の機会、用量、特許、薬価、売上、臨床試験動向（2030年）

Global Bispecific Antibody Market Opportunity, Drug Dosage, Patent, Price, Sales & Clinical Trials Insight 2030

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 上市済み二重特異性抗体の洞察

第4章 二重特異性抗体の独自プラットフォーム

第5章 世界および地域別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の動向、地域別

第7章 世界の二重特異性抗体調査と市場動向、適応症別

第8章 Blincyto-臨床、特許、価格設定、販売に関する洞察

第9章 Hemlibra- 臨床、特許、価格設定、販売に関する洞察

第10章 Rybrevant-臨床、特許、価格設定に関する洞察

第11章 Vabysmo-臨床、特許、価格設定、販売に関する洞察

第12章 Lunsumio-臨床、特許、価格設定、販売に関する洞察

第13章 Kaitani- 臨床と営業の洞察

第14章 Tecvayli-臨床、特許、価格設定に関する洞察

第15章 Columvi-臨床、特許、価格設定、販売に関する洞察

第16章 Epkinly-臨床、特許、価格設定、販売に関する洞察

第17章 Talvey-臨床、特許、価格設定に関する洞察

第18章 Elrexfio-臨床、特許、価格設定に関する洞察

第19章 Imdelltra-臨床、特許、価格設定、販売に関する洞察

第20章 Ivonescimab- 臨床的洞察

第21章 Ordspono-臨床および販売に関する洞察

第22章 Ziihera-臨床、価格設定、販売に関する洞察

第23章 Bizengri-臨床、特許、価格設定、販売に関する洞察

第24章 Korjuny- 臨床的洞察

第25章 企業、適応症、相別の世界の二重特異性抗体臨床試験

第26章 上市済み二重特異性抗体の企業別、国別、適応症別の臨床的洞察

第27章 競合情勢

List of Figures

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. Blincyto - Clinical, Patent, Pricing & Sales Insight

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

10. Rybrevant - Clinical, Patent & Pricing Insight

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

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

13. Kaitani - Clinical & Sales Insight

14. Tecvayli - Clinical, Patent & Pricing Insight

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

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

17. Talvey - Clinical, Patent & Pricing Insight

18. Elrexfio - Clinical, Patent & Pricing Insight

19. Imdelltra - Clinical, Patent, Pricing & Sales Insight

20. Ivonescimab - Clinical Insight

21. Ordspono - Clinical & Sales Insight

22. Ziihera - Clinical, Pricing & Sales Insight

23. Bizengri - Clinical, Patent, Pricing & Sales Insight

24. Korjuny - Clinical Insight

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

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

27. 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章上市済み二重特異性抗体の洞察

第4章二重特異性抗体の独自プラットフォーム

第5章世界および地域別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の動向、地域別

第7章世界の二重特異性抗体調査と市場動向、適応症別

第25章企業、適応症、相別の世界の二重特異性抗体臨床試験

第26章上市済み二重特異性抗体の企業別、国別、適応症別の臨床的洞察

第27章競合情勢