United States Bispecific T-cell Engagers (BiTEs) Market Size, Trends & Growth Forecast To 2033 | Top Companies are Regeneron Pharmaceuticals, Inc., Genmab, MacroGenics, Inc., Xencor, Inc., Pfizer Inc

global Bispecific T-cell Engagers (BiTEs) Market size reached US$ 2.10 Billion in 2024 from US$ 1.68 Billion in 2023 and is expected to reach US$ 15.55 Billion by 2033, growing at a CAGR of 25.1% during the forecast period 2025-2033.

United States BiTEs Market size in 2024: USD 3.7Bn and Projected to reach by 2032: USD 14.5 Bn with a CAGR: 19.3% (2025-2032)

United States: Recent Industry Developments
✅ October 2025: Amgen advanced its next-generation BiTE platform with enhanced tumor targeting and reduced cytokine release risk.
✅ September 2025: FDA granted Fast Track designation to emerging BiTE candidates targeting solid tumors and hematologic cancers.
✅ August 2025: Increasing collaborations between biotech firms and cancer centers accelerated clinical evaluation of innovative BiTE therapies.

Japan: Recent Industry Developments
✅ October 2025: Chugai Pharmaceutical expanded R&D into bispecific T-cell engaging antibodies for rare hematologic malignancies.
✅ September 2025: Japanese oncology institutes initiated new clinical trials investigating BiTEs for relapsed or refractory leukemia.
✅ August 2025: Local biopharma companies adopted advanced antibody engineering technologies to strengthen Japan's BiTE development pipeline.

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Key Market Highlights

North America led the Bispecific T-cell Engagers (BiTEs) market in 2024, accounting for 44.64% of total revenue.

Asia-Pacific emerged as the fastest-growing region, projected to expand at a 27.83% CAGR during the forecast period.

By type, the CD19 segment dominated the market with a 41.4% revenue share in 2024.

Key Players:

Amgen Inc., F. Hoffmann‐La Roche Ltd., Regeneron Pharmaceuticals, Inc., Genmab, MacroGenics, Inc., Xencor, Inc., Pfizer Inc., Johnson & Johnson, AbbVie Inc., Takeda Pharmaceutical Company Ltd

Latest M&A Activity

In March 2025, Sanofi announced plans to acquire DR-0201, a bispecific myeloid cell engager from Dren Bio, for $600 million upfront with further milestone payments, expanding its immuno-oncology portfolio.​

Royalty Pharma acquired royalty interests in Amgen's Imdelltra, a DLL3-targeting bispecific T-cell engager, for $885 million upfront, demonstrating strong market confidence in BiTE therapeutics.​

Janssen (Johnson & Johnson) recently invested in next-gen bispecifics such as teclistamab, one of the first IgG-like BiTEs approved for multiple myeloma, and talquetamab targeting novel antigens with high response rates.

Growth Forecast Projected:

The Global Bispecific T-cell Engagers Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2032. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Bispecific T-cell Engagers Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

By Type: (CD19, CD20, CD33, CD123, Others)

By Target Indication: (Hematologic Malignancies, Solid Tumors)

By Mechanism of Action: (Dual Antibody-Based BiTEs, Single-Chain Variable Fragment (scFv)-Based BiTE, Next-Generation BiTEs (Half-life extended, trispecific, or modular BiTEs))

By End User: (Hospitals, Specialty Cancer Clinics, Research and Academic Institutes, Biotechnology & Pharmaceutical Companies)

Regional Analysis for Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Latest FDA Approvals and Product Launches

The FDA granted accelerated approval to linvoseltamab-gcpt (Lynozyfic) in July 2025 for heavily pretreated multiple myeloma patients. This BCMA-targeted bispecific T-cell engager is the third of its kind approved for this indication, following teclistamab and elranatamab.​

Amgen's BiTE technology continues to evolve with newer molecules designed to improve half-life and tolerability by engineering IgG-like structures overcoming traditional BiTE clearance issues.​

Immunocore introduced tebentafusp, a TCR-derived bispecific engager targeting intracellular melanoma antigens, expanding the target landscape beyond classical surface antigens. It recently showed a survival benefit in metastatic uveal melanoma.

Benefits of the Report:

Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.

Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.

Chapter 3: Offers an in-depth look at the competitive landscape among Bispecific T-cell Engagers producers, including revenue shares, strategic moves, and recent mergers and acquisitions.

Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.

Chapters 5 & 6: Analyze Bispecific T-cell Engagers revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.

Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.

Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.

Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.

Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.

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Clinical Trials and T-Cell Therapies

Over 130 oncology patients participated in Phase 1 dose-escalation studies of Candid Therapeutics' bispecifics CND106 and CND261 targeting BCMA and CD20, demonstrating safety and promising efficacy.​

Early-phase trials explore trispecific engagers, CAR-T cells secreting BiTE molecules (CAR.T-BiTEs), and immune-modulatory combinations to enhance specificity, reduce toxicity, and overcome resistance in solid tumors.​

Bispecific T-cell engagers engage T cells via CD3 independent of MHC restriction, facilitating potent immune synapse formation and tumor cell lysis, currently mainly successful in hematological malignancies but progressing in solid tumor research

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