Next-Generation Bispecific Antibody Market Trends and Competitive Landscape Report

The next-generation bispecific antibody market is advancing rapidly, with revenues expected to reach hundreds of millions between 2025 and 2034, reports Towards Healthcare a sister firm of Precedence Research.

Ottawa, Sept. 30, 2025 (GLOBE NEWSWIRE) -- The next-generation bispecific antibody market is rapidly advancing on a global scale, with expectations of accumulating hundreds of millions in revenue between 2025 and 2034. A significant expansion is propelled by a broader range of investments, innovation, and the increasing demand across diverse industries.

These antibodies are playing a key role in improving precision medicine, offering more targeted treatment options for conditions such as cancer, autoimmune disorders, and infectious diseases. At the same time, artificial intelligence is enhancing drug development and analysis, further supporting the progress of these therapies.

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Key Takeaways

North America registered dominance in the market in 2024.
Asia-Pacific is expected to grow at the fastest CAGR during 2025-2034.
By type, the bispecific T-cell engagers (BiTEs) segment led the market in 2024.
By type, the dual-affinity re-targeting (DART) proteins segment is expected to witness the fastest growth in the studied years.
By indication type, the cancer segment was dominant in the next-generation bispecific antibody market in 2024.
By indication type, the autoimmune diseases segment is expected to grow rapidly in the predicted timeframe.
By mechanism of action type, the immune cell engagers segment held a major share of the market in 2024.
By mechanism of action type, the bispecific antibodies for the payload delivery segment are expected to be the fastest-growing in the upcoming years.
By route of administration type, the intravenous segment led the global next-generation bispecific antibody market in 2024.
By route of administration type, the subcutaneous segment is expected to grow at a rapid CAGR during 2025-2034.
By end user, the hospital segment registered dominance in the market in 2024.
By end user, the specialty clinics segment is expected to witness rapid expansion over the projected period.

What is the Next-Generation Bispecific Antibody?

The global next-generation bispecific antibody market is facilitating accelerated precision and efficiency by binding two distinct targets. Currently, the market is imposing bispecific T-cell engagers (BiTEs) and other immune cell engagers for cancer, bispecific checkpoint inhibitors, bsAb-drug conjugates, and molecules that develop target degradation. Alongside novel platforms and plans, like those for mitigating heavy and light chain mispairing during antibody assembly, are enhancing stability and functionality, with ultimate transformations in the market.

What are the Major Drivers Involved in the Market Growth?

The significant drivers of the next-generation bispecific antibody market are the escalating incidences of chronic diseases, crucial advances in antibody engineering, and the boosting demand for highly targeted and tailored medicine. Rapid regulatory approvals & significant investments by pharmaceutical companies, with alliances on bispecific antibody development, are offering comprehensive progression.

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What are Key Drifts in the Respective Market?

The next-generation bispecific antibody market has been increasingly involved in widespread investments in the development of innovative bispecific antibodies.

In June 2025, BioNTech SE and Bristol Myers Squibb signed an agreement for the global co-development and co-commercialization of BioNTech’s investigational bispecific antibody BNT327 across different solid tumor types.
In October 2024, the European Commission's Health Emergency Preparedness and Response Authority (HERA), in alliance with the European Investment Bank (EIB), invested €20 million in the biopharmaceutical company Fabentech to evolve therapeutic antibodies against biological threats, like bispecific antibodies.
In November 2024, Lanchi Ventures invested $42M Series A financing for Allink Biotherapeutics to escalate global development of bispecific antibody and ADC pipeline.

What is the Developing Challenge in the Market?

The next-generation bispecific antibody market is facing significant limitations in greater development expenditures, complex manufacturing approaches, and possible immunogenicity challenges. Also, these kinds of bispecific antibodies are evolving to adverse events like cytokine release syndrome (CRS) and stricter regulatory landscapes for approval.

Regional Analysis

Why did North America Dominate the Market in 2024?

In 2024, North America accounted for the biggest revenue share of the next-generation bispecific antibody market. Involvement of a sophisticated biotechnology hub, robust investment in biopharmaceutical research, and a suitable regulatory framework are fueling this region’s expansion. In the case of oncology, the US has received new approvals for multiple myeloma, such as elranatamab, and innovations in the treatment of solid tumors.

For instance,

In July 2025, IGI Therapeutics SA, a wholly owned subsidiary of New York-based Ichnos Glenmark Innovation, Inc., and AbbVie made an exclusive licensing agreement for IGI’s lead investigational asset, ISB 2001, evolved employing IGI’s proprietary BEAT protein platform, for oncology and autoimmune diseases.

How did the Asia Pacific Grow Notably in the Market in 2024?

During 2025-2034, the Asia Pacific will expand at a rapid CAGR in the next-generation bispecific antibody market. Continuous clinical trials and research activities in China and Japan, strategic collaborations with global firms, and the participation of regional companies, such as AP Biosciences establishing new therapies are mainly fueling the ASAP market growth.

For instance,

In January 2025, China’s collaboration between Innovent Biologics and Roche for the international unveiling of IBI3009, an antibody-drug conjugate (ADC) targeting small cell lung cancer (SCLC).

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Regulatory Landscape: Global Regulations

Country	Regulatory Body	Focused Areas	Notable Initiatives
U.S.	US FDA (United States Food & Drug Administration)	Draft on guidance regarding (AI) and (ML) in drug and biologic manufacturing	In July 2025, the FDA granted expanded approval to linvoseltamab for adult patients with relapsed or refractory multiple myeloma.
India	CDSCO (Central Drugs Standards Control Organization)	Draft Guidelines on Similar Biologics	A 2025 report represented the consistent regulatory cooperation between India and Japan to harmonize regulations for advanced therapies, especially CAR-T and Antibody-Drug Conjugates (ADCs).
South Korea	MFDS (Ministry of Food and Drug Safety)	Long-term Aligning Strategies	South Korea's "Global Innovative Products on Fast Track" (GIFT) program supports expediting the review of novel pharmaceuticals, like cutting-edge bispecific antibodies.

Segmental Insights

By type analysis

What Made the Bispecific T-cell Engagers (BiTEs) Segment Dominant in the Market in 2024?

The bispecific T-cell engagers (BiTEs) segment held a dominant share of the next-generation bispecific antibody market in 2024. This type contributes simultaneous binding to tumor cells and immune T-cells, which leverages a lytic immune synapse. Besides this, BiTEs are being found in combination with other immunotherapies, including PD-1/PD-L1 blockers, which further mitigate tumor escape and accelerate the anti-tumor response. Nowadays, researchers are working on new BiTE formats, consisting of those with prolonged half-lives and expanded affinity, which allow less frequent dosing and optimized drug delivery to tumors.

However, the dual-affinity re-targeting (DART) proteins segment will witness rapid growth in the coming era. DART offers compact, firm structure and improved potency in mediating cell killing through T-cell engagement. Also, they possess the ability to develop stable cell-to-cell contact with greater efficacy. Moreover, they give enhanced flexibility to support numerous T-cell/B-cell associations for cancer immunotherapies and other applications. The latest transformation includes Flotetuzumab (MGD006), a DART that targets CD123 on acute myeloid leukemia (AML) cells and CD3 on T cells.

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By indication type analysis

Which Indication Type Led the Next-Generation Bispecific Antibody Market in 2024?

The cancer segment held a major revenue share of the market in 2024. A rise in breast, colorectal, and lung cancer, and innovations in antibody engineering are driving the segmental growth. A recent study delivers the mechanism of cancer is combined with other mechanisms, specifically VEGF-A neutralization (e.g., BNT327) to restore T-cell activity and cut off tumor blood supply. The emergence of targeting diverse antigens, like EpCAM, CEA, and several ErbB family members, is contributing to the expansion of specificity in solid tumors.

On the other hand, the autoimmune diseases segment is anticipated to expand fastest during 2025-2034. A major involving a catalyst is the emergence of multiple dysregulated signaling pathways, especially in autoimmune and inflammatory disorders, including rheumatoid arthritis and IBD. The incorporation of innovative AI platforms, such as Earendil Labs and DualScreen, is used to boost and enhance the discovery of new bispecific molecules for autoimmune and inflammatory diseases.

By mechanism of action type analysis

How did the Immune Cell Engagers Segment Dominate the Market in 2024?

The immune cell engagers segment accounted for the biggest revenue share of the next-generation bispecific antibody market in 2024. This approach is leveraging a promising combination with other immunotherapies, comprising checkpoint inhibitors, for gaining strong synergistic anti-tumor effects. This further assists in resolving resistance mechanisms that challenge the efficacy of single-agent therapies. The revolutionary solutions are fostering highly advanced antibody engineering, consisting of many formats and effector cell targets.

Moreover, the bispecific antibodies for the payload delivery segment will expand at a rapid CAGR. Inclusion of challenges, mainly low target antigen expression, resistance mechanisms, and toxicity, can be omitted by targeting co-expressed antigens or using dual-target binding for optimized internalization, which is fueling the comprehensive delivery approach. Innovative linkers are facilitating expanded stability in plasma and controlled release of the payload in the tumor microenvironment, applying either cleavable or non-cleavable plans.

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By route of administration type analysis

Why did the Intravenous Segment Lead the Market in 2024?

The intravenous segment captured the largest share of the global next-generation bispecific antibody market in 2024. This type of ROA ensures accurate dosing, faster therapeutic action, and direct drug delivery to the bloodstream. Medical supervision in hospitals or specialty clinics is increasingly using IV infusions in the management of potential adverse events like cytokine release syndrome (CRS) that can be seen with potent biologics. The market is stepping into creating longer-acting BsAbs via the addition of an Fc region or fusion to serum albumin.

The subcutaneous segment is estimated to expand rapidly in the predicted timeframe. SC route is bolstering patient convenience, home-based dosing capabilities offered by high-concentration formulations, and the progress of advanced delivery devices, including wearable on-body injectors. The broader adoption of subcutaneous amivantamab demonstrated enhanced efficacy in the EGFR-targeting bispecific antibody for non-small cell lung cancer (NSCLC).

By end user analysis

What Made the Hospitals Segment Dominant in the Market in 2024?

The hospital segment captured the biggest share of the next-generation bispecific antibody market in 2024. Hospitals encompass specialized professionals, especially hematologist-oncologists, pharmacists, and nurses, who are playing a major role in the management and delivery of these more sophisticated treatments. Alongside, the successful execution of bispecific antibody therapies necessitates a collaborative approach, contributing in different hospital departments and teams, from administration to patient navigators.

Whereas, the specialty clinics segment will expand at a rapid CAGR during 2025-2034. A prominent factor is that their facilities have an emphasized approach to treating specific concerns, which is unique for the targeted nature of bispecific antibodies. Also, these clinics are stepping into the adoption of ambulatory clinics within the specialty center is impacting the comprehensive development of the market. Moreover, they are focusing on targeted therapies with personalized care and enhanced accessibility of pharmacies.

Browse More Insights of Towards Healthcare:

The global bispecific antibody market is experiencing size of USD 11.97 billion in 2024. It is expected to rise to USD 17.24 billion in 2025 and reach USD 460.23 billion by 2034, expanding at an impressive CAGR of 44.04% between 2025 and 2034.

The antibody discovery market was valued at USD 8.31 billion in 2024 and is projected to grow to USD 9.1 billion in 2025. Forecasts indicate steady expansion at a CAGR of 9.54%, reaching USD 20.71 billion by 2034.

The U.S. oncology pharmaceuticals market continues its upward trajectory, with expectations for significant revenue growth over the period from 2025 to 2034, potentially climbing into the hundreds of millions.

The global antibody therapy market is also witnessing strong growth. It reached USD 278.25 billion in 2024, is projected to grow to USD 314.64 billion in 2025, and is expected to hit USD 951.24 billion by 2034, representing a CAGR of 13.08% during 2025–2034.

The epigenetic antibodies market is growing steadily, with a market size of USD 2.29 billion in 2024, projected to increase to USD 2.7 billion in 2025, and expected to reach USD 12.01 billion by 2034, expanding at a CAGR of 18.04%.

The global protein expression technology market is projected to grow from USD 2.85 billion in 2024 to USD 3.05 billion in 2025 and is expected to reach USD 5.58 billion by 2034, with a CAGR of 6.94%.

The human combinatorial antibody libraries market is expanding gradually, with a size of USD 116.2 million in 2024, projected to grow to USD 122 million in 2025, and expected to reach USD 189.57 million by 2034, at a CAGR of 5.04%.

The complement C4 antibody market was valued at USD 19.21 billion in 2023 and is forecasted to reach USD 68.48 billion by 2034, growing at a CAGR of 12.25% from 2024 to 2034.

The antibody drug conjugate (ADC) market is set for strong growth, projected to increase from USD 13.51 billion in 2025 to USD 29.9 billion by 2034, at a CAGR of 9.23% during 2024–2034.

Recent Developments

In May 2025, Avenzo Therapeutics announced FDA clearance of an investigational new drug application for AVZO-1418, a potential best-in-class, new EGFR/HER3 bispecific antibody-drug conjugate.
In July 2025, BioMed X and Servier launched Europe’s first XSeed Labs research project to develop an AI-powered platform for sterically guided bispecific antibody design.
In January 2025, Amgen received approval from the European Commission (EC) for BLINCYTO (blinatumomab) monotherapy used in Philadelphia chromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL).

Next-Generation Bispecific Antibody Market Key Player List

Novartis
Amgen
Sanofi
Roche
Pfizer
Celgene Corporation
AstraZeneca
Johnson & Johnson
Regeneron Pharmaceuticals
GSK plc

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Segments Covered in the Report

By Type

Bispecific T-cell Engagers (BiTEs)
Dual-Affinity Re-Targeting (DART) Proteins
Nanobodies
Others (e.g., CrossMAbs, TandAbs)

By Indication

Cancer (e.g., hematologic malignancies, solid tumors)
Autoimmune Diseases
Infectious Diseases
Others

By Mechanism of Action

Immune Cell Engagers
Receptor/Ligand Blockers
Bispecific Antibodies for Payload Delivery

By Route of Administration

Intravenous
Subcutaneous

By End User

Hospitals
Specialty Clinics
Research Institutes

By Region

North America
- U.S.
- Canada
Asia Pacific
- China
- Japan
- India
- South Korea
- Thailand
Europe
- Germany
- UK
- France
- Italy
- Spain
- Sweden
- Denmark
- Norway
Latin America
- Brazil
- Mexico
- Argentina
Middle East and Africa (MEA)
- South Africa
- UAE
- Saudi Arabia
- Kuwait

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