이중 특이성 항체 시장 - 규모, 점유율, 성장률, 산업 분석 : 유형별, 용도별, 지역별 인사이트 및 예측(2026-2034년)

Growth Factors of bispecific antibody Market

The global bispecific antibody market is witnessing robust growth due to its therapeutic potential in oncology, hematology, and other complex diseases. According to Fortune Business Insights, the market was valued at USD 31.17 billion in 2025, projected to grow to USD 34.72 billion in 2026, and reach USD 91.09 billion by 2034, reflecting a CAGR of 12.8%. In 2025, North America dominated the market with a 51.8% share, driven by advanced biotechnology infrastructure, extensive clinical trials, and supportive reimbursement frameworks.

Bispecific antibodies are bioengineered proteins capable of simultaneously targeting multiple antigens. Their unique mechanism allows for more precise targeting of tumor cells or immune modulation compared with conventional monoclonal antibodies. The rising prevalence of cancer, increasing FDA and EMA approvals, and growing investment in clinical trials are significantly fueling the demand for bispecific antibodies. Key industry players, including AbbVie Inc., Pfizer Inc., Bristol-Myers Squibb, and Regeneron Pharmaceuticals, are actively developing pipeline candidates to meet rising therapeutic demand.

Market Dynamics

Drivers

The increasing cancer burden coupled with advancements in antibody engineering is a primary growth driver. Conventional therapies often have limitations in relapsed or refractory patient populations, creating demand for novel modalities such as bispecific antibodies. Collaborative research initiatives are enhancing therapeutic applications globally. For instance, in March 2025, Harbour BioMed partnered with AstraZeneca to develop next-generation multi-specific antibodies, supported by a USD 105 million equity investment.

Restraints

High manufacturing complexity and production costs remain major restraints. Bispecific antibodies require sophisticated engineering to maintain dual target specificity, structural stability, and batch consistency. Regulatory quality standards and advanced purification techniques further increase production costs, limiting broader adoption. In August 2025, the U.S. FDA declined approval of Regeneron's odronextamab for follicular lymphoma due to manufacturing issues.

Opportunities

The expansion into earlier lines of therapy presents a significant opportunity. Currently approved mainly for relapsed or refractory cancers, bispecific antibodies may be used in larger patient populations when combined with standard regimens. In December 2024, Janssen-Cilag (Johnson & Johnson) showcased frontline data for TECVAYLI (teclistamab) in multiple myeloma, highlighting potential for early-line combination therapy.

Challenges

Cytokine Release Syndrome (CRS) and neurotoxicity are critical safety challenges, particularly with T-cell engagers. These adverse effects require careful clinical management and step-up dosing, increasing treatment complexity and cost. In November 2024, the American Society of Hematology reported multi-institution rates of CRS and ICANS associated with lymphoma-targeted bispecific antibodies.

Market Trends

A major trend is the shift from intravenous (IV) infusions to subcutaneous (SC) formulations, enhancing patient convenience, compliance, and reduced hospital dependency. Companies are developing stable, low-viscosity, high-concentration SC formulations to maintain efficacy and safety. In November 2024, Alphamab Oncology reported clinical trial data for JSKN033, a subcutaneous co-formulation combining an anti-HER2 bispecific ADC and a PD-L1 inhibitor.

Segmentation Analysis

By Mechanism of Action

The market is divided into T-cell engaging, dual blockers/inhibitors, co-factor mimetics, and others. The T-cell engaging segment is expected to dominate due to its potent anti-tumor activity and ability to overcome resistance in heavily pretreated cancers. In February 2023, Atreca, Inc. collaborated with Xencor, Inc. to launch a T-cell engager program using XmAb bispecific Fc technology.

By Application

Applications include oncology, hematology, ophthalmology, and others. Oncology held the largest market share in 2025 and is projected to account for 41.99% in 2026. The hematology segment is growing at a CAGR of 6.43%.

By Route of Administration

The market is segmented into intravenous (IV), subcutaneous (SC), and others. IV administration dominated in 2025, with a 58.90% share in 2026. SC administration is anticipated to grow at 14.05% CAGR, driven by convenience and improved patient compliance.

By Distribution Channel

Hospital pharmacies dominate due to controlled settings for IV biologics, cold chain storage, and sterile compounding. The segment is expected to hold 67.19% share in 2026. Retail pharmacies are growing at a CAGR of 11.94%, expanding patient access.

Regional Outlook

• North America: USD 21.49B (2025), USD 23.99B (2026), U.S. USD 22.86B in 2026
• Europe: USD 4.36B (2026); U.K. USD 0.84B, Germany USD 1.03B, France USD 0.64B
• Asia Pacific: USD 5.01B (2026); Japan USD 1.59B, China USD 2.04B, India USD 0.3B
• Latin America: USD 0.86B (2026)
• Middle East & Africa (GCC): USD 0.23B (2025)

North America leads due to advanced biotechnology infrastructure, clinical trials, early regulatory approvals, and strong reimbursement systems.

Competitive Landscape

Key players include Bristol-Myers Squibb, Pfizer, Merck, Genentech, AbbVie, Hoffmann-La Roche, Regeneron, and Harbour BioMed. Strategic collaborations, acquisitions, and R&D investments are driving growth. For example, in June 2025, BioNTech SE collaborated with Bristol-Myers Squibb to co-develop investigational bispecific antibodies for solid tumors.

Conclusion

The global bispecific antibody market is expected to grow from USD 31.17 billion in 2025 to USD 91.09 billion by 2034, driven by rising cancer prevalence, advanced antibody engineering, pipeline expansion, and regulatory approvals. Despite manufacturing complexity, high costs, and safety concerns, innovations in subcutaneous formulations, early-line therapy expansion, and strategic collaborations are set to enhance adoption and market growth globally.

Segmentation By Mechanism of Action, Application, Route of Administration, Distribution Channel, and Region

By Mechanism of Action * T-Cell Engaging

• Dual Blockers/ Inhibitors
• Co-factor Mimetics
• Others

By Application * Oncology

• Hematology
• Ophthalmology
• Others

By Route of Administration * Intravenous

• Subcutaneous
• Others

By Distribution Channel * Hospital Pharmacies

• Retail Pharmacies
• Others

By Region * North America (By Mechanism of Action, Application, Route of Administration, Distribution Channel, and Country)

• U.S.
• Canada
• Europe (By Mechanism of Action, Application, Route of Administration, Distribution Channel, and Country/Sub-region)
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Scandinavia
  • Rest of Europe
• Asia Pacific (By Mechanism of Action, Application, Route of Administration, Distribution Channel, and Country/Sub-region)
  • China
  • Japan
  • India
  • Australia
  • Southeast Asia
  • Rest of Asia Pacific
• Latin America (By Mechanism of Action, Application, Route of Administration, Distribution Channel, and Country/Sub-region)
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa (By Mechanism of Action, Application, Route of Administration, Distribution Channel, and Country/Sub-region)
  • GCC
  • South Africa
  • Rest of the Middle East & Africa

Table of Content

1. Introduction

• 1.1. Research Scope
• 1.2. Market Segmentation
• 1.3. Research Methodology
• 1.4. Definitions and Assumptions

2. Executive Summary

3. Market Dynamics

• 3.1. Market Drivers
• 3.2. Market Restraints
• 3.3. Market Opportunities
• 3.4. Market Trends

4. Key Insights

• 4.1. Regulatory Scenarios, By Key Countries/Regions
• 4.2. Pipeline Analysis, By Key Players
• 4.3. Epidemiology- Key Diseases, By Key Countries/ Regions
• 4.4. Key Industry Developments (Mergers, Acquisitions, Partnerships, Launches, etc.)

5. Global Bispecific Antibody Market Analysis, Insights and Forecast, 2021-2034

• 5.1. Market Analysis, Insights and Forecast - By Mechanism of Action
  • 5.1.1. T-Cell Engaging
  • 5.1.2. Dual Blockers/ Inhibitors
  • 5.1.3. Co- factor Mimetics
  • 5.1.4. Others
• 5.2. Market Analysis, Insights and Forecast - By Application
  • 5.2.1. Oncology
  • 5.2.2. Hematology
  • 5.2.3. Ophthalmology
  • 5.2.4. Others
• 5.3. Market Analysis, Insights and Forecast - By Route of Administration
  • 5.3.1. Intravenous
  • 5.3.2. Subcutaneous
  • 5.3.3. Others
• 5.4. Market Analysis, Insights and Forecast - By Distribution Channel
  • 5.4.1. Hospital Pharmacies
  • 5.4.2. Retail Pharmacies
  • 5.4.3. Others
• 5.5. Market Analysis, Insights and Forecast - Region
  • 5.5.1. North America
  • 5.5.2. Europe
  • 5.5.3. Asia Pacific
  • 5.5.4. Latin America
  • 5.5.5. Middle East & Africa

6. North America Bispecific Antibody Market Analysis, Insights and Forecast, 2021-2034

• 6.1. Market Analysis, Insights and Forecast - By Mechanism of Action
  • 6.1.1. T-Cell Engaging
  • 6.1.2. Dual Blockers/ Inhibitors
  • 6.1.3. Co- factor Mimetics
  • 6.1.4. Others
• 6.2. Market Analysis, Insights and Forecast - By Application
  • 6.2.1. Oncology
  • 6.2.2. Hematology
  • 6.2.3. Ophthalmology
  • 6.2.4. Others
• 6.3. Market Analysis, Insights and Forecast - By Route of Administration
  • 6.3.1. Intravenous
  • 6.3.2. Subcutaneous
  • 6.3.3. Others
• 6.4. Market Analysis, Insights and Forecast - By Distribution Channel
  • 6.4.1. Hospital Pharmacies
  • 6.4.2. Retail Pharmacies
  • 6.4.3. Others
• 6.5. Market Analysis, Insights and Forecast - By Country
  • 6.5.1. U.S.
  • 6.5.2. Canada

7. Europe Bispecific Antibody Market Analysis, Insights and Forecast, 2021-2034

• 7.1. Market Analysis, Insights and Forecast - By Mechanism of Action
  • 7.1.1. T-Cell Engaging
  • 7.1.2. Dual Blockers/ Inhibitors
  • 7.1.3. Co- factor Mimetics
  • 7.1.4. Others
• 7.2. Market Analysis, Insights and Forecast - By Application
  • 7.2.1. Oncology
  • 7.2.2. Hematology
  • 7.2.3. Ophthalmology
  • 7.2.4. Others
• 7.3. Market Analysis, Insights and Forecast - By Route of Administration
  • 7.3.1. Intravenous
  • 7.3.2. Subcutaneous
  • 7.3.3. Others
• 7.4. Market Analysis, Insights and Forecast - By Distribution Channel
  • 7.4.1. Hospital Pharmacies
  • 7.4.2. Retail Pharmacies
  • 7.4.3. Others
• 7.5. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 7.5.1. U.K.
  • 7.5.2. Germany
  • 7.5.3. France
  • 7.5.4. Italy
  • 7.5.5. Spain
  • 7.5.6. Scandinavia
  • 7.5.7. Rest of Europe

8. Asia Pacific Bispecific Antibody Market Analysis, Insights and Forecast, 2021-2034

• 8.1. Market Analysis, Insights and Forecast - By Mechanism of Action
  • 8.1.1. T-Cell Engaging
  • 8.1.2. Dual Blockers/ Inhibitors
  • 8.1.3. Co- factor Mimetics
  • 8.1.4. Others
• 8.2. Market Analysis, Insights and Forecast - By Application
  • 8.2.1. Oncology
  • 8.2.2. Hematology
  • 8.2.3. Ophthalmology
  • 8.2.4. Others
• 8.3. Market Analysis, Insights and Forecast - By Route of Administration
  • 8.3.1. Intravenous
  • 8.3.2. Subcutaneous
  • 8.3.3. Others
• 8.4. Market Analysis, Insights and Forecast - By Distribution Channel
  • 8.4.1. Hospital Pharmacies
  • 8.4.2. Retail Pharmacies
  • 8.4.3. Others
• 8.5. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 8.5.1. China
  • 8.5.2. Japan
  • 8.5.3. India
  • 8.5.4. Southeast Asia
  • 8.5.5. Australia
  • 8.5.6. Rest of Asia Pacific

9. Latin America Bispecific Antibody Market Analysis, Insights and Forecast, 2021-2034

• 9.1. Market Analysis, Insights and Forecast - By Mechanism of Action
  • 9.1.1. T-Cell Engaging
  • 9.1.2. Dual Blockers/ Inhibitors
  • 9.1.3. Co- factor Mimetics
  • 9.1.4. Others
• 9.2. Market Analysis, Insights and Forecast - By Application
  • 9.2.1. Oncology
  • 9.2.2. Hematology
  • 9.2.3. Ophthalmology
  • 9.2.4. Others
• 9.3. Market Analysis, Insights and Forecast - By Route of Administration
  • 9.3.1. Intravenous
  • 9.3.2. Subcutaneous
  • 9.3.3. Others
• 9.4. Market Analysis, Insights and Forecast - By Distribution Channel
  • 9.4.1. Hospital Pharmacies
  • 9.4.2. Retail Pharmacies
  • 9.4.3. Others
• 9.5. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 9.5.1. Brazil
  • 9.5.2. Mexico
  • 9.5.3. Rest of Latin America

10. Middle East & Africa Bispecific Antibody Market Analysis, Insights and Forecast, 2021-2034

• 10.1. Market Analysis, Insights and Forecast - By Mechanism of Action
  • 10.1.1. T-Cell Engaging
  • 10.1.2. Dual Blockers/ Inhibitors
  • 10.1.3. Co- factor Mimetics
  • 10.1.4. Others
• 10.2. Market Analysis, Insights and Forecast - By Application
  • 10.2.1. Oncology
  • 10.2.2. Hematology
  • 10.2.3. Ophthalmology
  • 10.2.4. Others
• 10.3. Market Analysis, Insights and Forecast - By Route of Administration
  • 10.3.1. Intravenous
  • 10.3.2. Subcutaneous
  • 10.3.3. Others
• 10.4. Market Analysis, Insights and Forecast - By Distribution Channel
  • 10.4.1. Hospital Pharmacies
  • 10.4.2. Retail Pharmacies
  • 10.4.3. Others
• 10.5. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 10.5.1. GCC
  • 10.5.2. South Africa
  • 10.5.3. Rest of Middle East & Africa

11. Competitive Analysis

• 11.1. Global Market Share Analysis (2025)
• 11.2. Company Profiles (Overview, Products, SWOT analysis, Recent developments, strategies, financials (based on availability))
  • 11.2.1. Bristol-Myers Squibb Company
  • 11.2.2. Pfizer Inc
  • 11.2.3. Merck & Co., Inc.,
  • 11.2.4. Candid Therapeutics
  • 11.2.5. Dualitas Therapeutics
  • 11.2.6. Genentech, Inc.
  • 11.2.7. AbbVie Inc.
  • 11.2.8. F. Hoffmann-La Roche Ltd
  • 11.2.9. Regeneron Pharmaceuticals Inc.
  • 11.2.10. Harbour BioMed.