Bispecific Antibodies Market By Type (IgG-like Bispecific Antibodies; Non-IgG-like Bispecific Antibodies; Bispecific T-cell Engagers (BiTEs); Dual-Variable Domain Antibodies (DVD-Ig)); By Application (Oncology; Autoimmune Diseases; Infectious Diseases; Other Applications); By Mechanism of Action (Immune Modulation; Direct Tumor Targeting; T-cell Engagement); By End-User (Pharmaceutical and Biotechnology Companies; Hospitals and Clinics; Research Institutions); By Geography, Segment Revenue Estimation, Forecast, 2024–2032.

Bispecific Antibodies Market Size & Overview

The bispecific antibodies market was valued at approximately $6.5 billion in 2024 and is projected to reach $15.1 billion by 2030, growing at a CAGR of 14.9%. The market is driven by the increasing prevalence of cancer, autoimmune diseases & other chronic conditions, along with the growing adoption of immuno-oncology therapies.  

 

Bispecific antibodies are a novel class of therapeutics designed to simultaneously bind to two distinct antigens, providing enhanced therapeutic effects for a wide range of diseases.

 

The global prevalence of cancer, as reported by the WHO, continues to rise, with cancer being the 2nd leading cause of death globally, accounting for nearly 10 million deaths in 2020. Bispecific antibodies, particularly bispecific T-cell engagers (BiTEs), have demonstrated promising results in cancer therapies such as acute lymphoblastic leukemia (ALL) & other solid tumors. The CDC states that nearly 1.9 Mn new cancer cases were diagnosed in the US in 2022, contributing to the rising demand for more targeted & effective treatments like bispecific antibodies. They are expected to play a critical role in revolutionizing cancer immunotherapy & other complex diseases, driving market expansion during the forecast period.

 

Bispecific Antibodies Market Dynamics:

Market Drivers

Rising Incidence of Cancer & Hematologic Malignancies

The rise in cancer cases particularly hematologic malignancies like multiple myeloma, non-Hodgkin’s lymphoma & acute lymphoblastic leukemia is driving demand for novel immunotherapies. According to the WHO, cancer was responsible for nearly 10 Mn deaths in 2022, with blood cancers accounting for a significant portion of oncology cases. In the US, someone is diagnosed with leukemia, lymphoma, or myeloma roughly every three minutes. Approximately 456,481 individuals in the US are currently living with leukemia or are in remission from the disease. Bispecific antibodies (BsAbs) such as Blinatumomab (CD19/CD3) have demonstrated high efficacy in targeting cancer cells by redirecting T-cells, thereby offering an alternative to conventional chemotherapy & CAR-T therapies.

Clinical Success and Regulatory Approvals of Next-Gen BsAbs

The US FDA has given accelerated approval to teclistamab (Tecvayli) for treating adults with relapsed or refractory multiple myeloma who have undergone at least 4 previous treatments. This marks the first U.S. approval of a bispecific antibody for this incurable blood cancer. The market is progressing rapidly with the success of FDA approved BsAbs such as Blinatumomab & Teclistamab. These therapies have shown promising results in relapsed/refractory cancers, driving investment in oncology-focused BsAb platforms.

 

Market Restraints

High Manufacturing Complexity & Cost

BsAbs involve intricate engineering to ensure correct folding, dual-binding specificity & biological stability. These complexities lead to higher development & production costs compared to traditional monoclonal antibodies. Bioprocessing of BsAbs often requires customized purification and cell-line optimization, raising the overall cost per treatment—limiting affordability and market access, especially in resource-limited settings.

Safety Concerns and Cytokine Release Syndrome (CRS)

While bispecific antibodies offer targeted cytotoxicity, they can trigger serious immune-related adverse events such as cytokine release syndrome. CRS represents a significant safety concern linked to the on-target effects of T cell BsAbs. CRS has been observed in up to 70% of patients receiving certain BsAbs, requiring careful dosing & intensive monitoring. These safety challenges can hinder adoption & limit use in broader patient populations.

 

Market Opportunities

Expanding Pipeline in Solid Tumors & Autoimmune Diseases

BsAbs are gaining recognition as a breakthrough innovation in the treatment of solid tumors, attributed to their dual-target engagement capability, which opens new possibilities in therapeutic applications. Novel targets such as PD-L1/CTLA-4, HER2/CD3 & IL-6/IL-23 are under investigation in clinical trials. More than 100 bispecific antibodies are currently in clinical development therefore the market is set to benefit from platform diversification & indication expansion.

Strategic Collaborations & Licensing Deals Among Biopharma Companies

Major pharmaceutical companies are increasingly partnering with biotech firms to accelerate BsAb development. On November 17, 2022, Regeneron & CytomX announced a collaboration to develop conditionally-activated bispecific cancer therapies, leveraging CytomX's Probody® platform & Regeneron's Veloci-Bi® technology. On June 8, 2020 Innovent Biologics, Inc. announced a strategic R&D collaboration with Roche covering multiple cell therapies & bispecific antibodies. The partnership will center on the discovery, clinical development & commercialization of bispecific antibodies and various cell therapies, aiming to treat both hematological & solid cancers. These collaborations are enhancing innovation pipelines & accelerating market entry, particularly for Fc-engineered, trispecific & conditionally active BsAb platforms.

 

Bispecific Antibodies Market Segmentation: A Comprehensive Overview

By Type:

• IgG-like Bispecific Antibodies

• Non-IgG-like Bispecific Antibodies

• Bispecific T-cell Engagers (BiTEs)

• Dual-Variable Domain Antibodies (DVD-Ig)

 

By Application:

• Oncology

• Autoimmune Diseases

• Infectious Diseases

• Other Applications

 

By Mechanism of Action:

• Immune Modulation

• Direct Tumor Targeting

• T-cell Engagement

 

By End-User:

• Pharmaceutical and Biotechnology Companies

• Hospitals and Clinics

• Research Institutions

 

By Region:

• North America

• Europe

• Asia Pacific

• Latin America

• Middle East & Africa

 

Bispecific Antibodies Market Segment Analysis: Growth Trends Across Categories

By Type:

Leading Segment: IgG-like Bispecific Antibodies

IgG-like bispecific antibodies hold the largest market share, accounting for 45% of the total bispecific antibodies market. IgG-like bispecific antibodies (bsAbs) preserve Fc-related effector activities, including ntibody-dependent cellular phagocytosis (ADCP), antibody-dependent cell-mediated cytotoxicity (ADCC) & complement-dependent cytotoxicity (CDC). BsAbs designed in IgG-like formats exhibit extended serum half-lives due to their larger molecular size & the recycling mechanism mediated by the neonatal Fc receptor (FcRn). These antibodies are widely used in oncology & autoimmune disease treatments due to their stability, efficacy, and well-understood mechanism of action.

Fastest-Growing Segment: Bispecific T-cell Engagers (BiTEs)

Bispecific T-cell engagers (BiTEs) are the fastest-growing segment, with a projected CAGR of 11.2%. BiTE is engineered to simultaneously bind to CD3 & tumor-specific antigens, thereby enhancing T-cell-mediated cytotoxicity against tumor cells. BiTEs are increasingly used in cancer immunotherapy, particularly for hematologic malignancies like acute lymphoblastic leukemia (ALL). The ability of BiTEs to redirect T-cells to attack tumor cells has led to their growing adoption, driving the segment's rapid growth.

 

By Application:

Leading Segment: Oncology

Oncology is the largest application segment in the bispecific antibodies market, contributing approximately 55% of the market share. The use of bispecific antibodies in treating various cancers, such as leukemia, lymphoma & solid tumors has been a significant driver. These antibodies, especially BiTEs, have revolutionized cancer immunotherapy by enhancing immune responses against tumor cells.

Fastest-Growing Segment: Autoimmune Diseases

Autoimmune diseases are the fastest-growing application for bispecific antibodies, with a CAGR of 9.6%. BsAbs are being explored for conditions such as rheumatoid arthritis, lupus & multiple sclerosis, as they can target specific components of the immune system, improving the regulation of inflammatory responses and offering better treatment outcomes.

 

By Mechanism of Action:

Leading Segment: T-cell Engagement

T-cell engagement is the dominant mechanism of action in the BsAbs market, holding about 50% of the market share. T cell-redirecting bispecific antibodies are uniquely crafted to recognize & bind tumor-associated antigens, while simultaneously interacting with CD3 on the T cell receptor. T-cell engagers such as BiTEs play a crucial role in redirecting T-cells to target cancer cells. This mechanism is important in immuno-oncology, offering potential breakthroughs in cancer treatment.

Fastest-Growing Segment: Immune Modulation

Immune modulation is the fastest-growing mechanism of action, with a CAGR of 10.3%. Bispecific antibodies that modulate the immune system are gaining attention in autoimmune disease therapy & inflammatory conditions. Their ability to enhance or suppress immune responses selectively is making them increasingly important in treating complex diseases.

 

By End-User:

Leading Segment: Pharmaceutical & Biotechnology Companies

Pharmaceutical & biotechnology companies are the largest end-users in the bispecific antibodies market, accounting for approximately 60% of the market share. These companies are the primary developers & manufacturers of bispecific antibody therapies, heavily investing in R&D to expand their applications, particularly in oncology.

Fastest-Growing Segment: Hospitals & Clinics

Hospitals & clinics represent the fastest-growing end-user segment, with a CAGR of 8.8%. The adoption of BsAbs therapies in clinical settings for treating cancers & autoimmune diseases is increasing. The growth is driven by better healthcare access, more clinical trials & the growing use of targeted therapies in hospitals.

 

By Region:

Leading Region: North America

North America holds the largest market share in the bispecific antibodies market, with approximately 40% of the total market. This market dominance is due to the strong presence of pharmaceutical companies, advanced healthcare infrastructure & extensive clinical trials. The US FDA has approved several BsAbs therapies, including Blincyto® (blinatumomab), for the treatment of hematologic cancers. This has significantly influenced the market's growth trajectory. The US is a leader in adopting innovative cancer treatments, particularly those involving bispecific antibodies.

Fastest-Growing Region: Asia Pacific

APAC is the fastest-growing region, with a projected CAGR of 12.1%. Countries such as China, Japan & India are witnessing rapid growth in the adoption of BsAbs therapies due to increased healthcare investments, rising cancer incidences & the expanding healthcare infrastructure. The region's market growth is supported by government initiatives aimed at improving healthcare access.

 

Bispecific Antibodies Market Report Coverage

Report Attribute	Details
Forecast Period	2024 – 2032
Market Size Value in 2024	USD 6.5 Billion
Revenue Forecast in 2030	USD 15.1 Billion
Overall Growth Rate	CAGR of 14.9% (2024 – 2030)
Base Year for Estimation	2023
Historical Data	2017 – 2021
Unit	USD Billion, CAGR (2024 – 2030)
Segmentation	By Type, By Application, By Mechanism of Action, By End-User, By Geography
By Type	IgG-like Bispecific Antibodies, Non-IgG-like Bispecific Antibodies, Bispecific T-cell Engagers (BiTEs), Dual-Variable Domain Antibodies (DVD-Ig)
By Application	Oncology, Autoimmune Diseases, Infectious Diseases, Other Applications
By Mechanism of Action	Immune Modulation, Direct Tumor Targeting, T-cell Engagement
By End-User	Pharmaceutical and Biotechnology Companies, Hospitals and Clinics, Research Institutions
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country Scope	US, Canada, Germany, China, India, etc.
Market Drivers	Rising prevalence of cancer and autoimmune diseases, increasing R&D investments in bispecific antibodies, growing demand for targeted therapies, technological advancements in antibody engineering
Pricing and Purchase Options	Customized options available

 

Key Players in the Bispecific Antibodies Market

1. Genmab A/S

2. Roche Holding AG

3. Amgen Inc.

4. Bristol-Myers Squibb Company

5. Johnson & Johnson (Janssen Biotech)

6. Sanofi S.A.

7. Regeneron Pharmaceuticals, Inc.

8. Novo Nordisk A/S

9. Bayer AG

10. AbbVie Inc.

 

List of FDA Approved Bispecific Antibodies:

• Tarlatamab (Imdelltra®): In May 2024, Amgen got approval for tarlatamab which targets DLL3 & CD3 for the treatment of extensive stage small cell lung cancer .

• Elranatamab (Elrexfio®): In 2023, Pfizer got approval for elranatamab which targets BCMA & CD3 for treatment of multiple myeloma.

• Talquetamab (Talvey®): In 2023, Janssen Biotech got approval for Teclistamab which targets GPRC5D & CD3. It is used for relapsed or refractory multiple myeloma.

• Glofitamab (Columvi®): In 2023, Genentech/Roche got approval for Glofitamab which targets CD20 & CD3.

• Epcoritamab (Epkinly®):In 2023, Genmab & AbbVie got approval for Epcoritamab which targets CD20 & CD3. It is approved for treating diffuse large B-cell lymphoma (DLBCL) & follicular lymphoma.

• Mosunetuzumab (Lunsumio®): In 2022, Genentech/Roche got approval for Mosunetuzumab which targets BCMA & CD3.

• Teclistamab (Tecvayli®): In 2022, Janssen Biotech got approval for Teclistamab which targets BCMA & CD3.

• Faricimab-svoa (Vabysmo®): In 2022 Genentech/Roche got approval for Faricimab-svoa which targets VEGF-A & Angiopoietin-2. It is used for wet age-related macular degeneration & diabetic macular edema.

• Tebentafusp (Kimmtrak®): In 2022 Immunocore got approval for distribution of tebentafusp which targets gp100 & CD3. It is approved for HLA-A*02:01-positive patients.

• Amivantamab (Rybrevant®): In 2021 Janssen Biotech got approval for this antibody which targets EGFR & MET. It is indicated for non-small cell lung cancer (NSCLC).

• Emicizumab (Hemlibra®): In 2017, Genentech/Roche got approval for emicizumab which bridges activated factor IXa & factor X. It is approved for the treatment of hemophilia A.

• Blinatumomab (Blincyto®): In 2014, Amgen got approval for blinatumomab which targets CD19 & CD3.

 

Future Outlook

The future outlook for the bispecific antibodies market is highly promising, with continued strong growth anticipated in the forecast period. The increasing prevalence of cancers & other chronic conditions is driving demand for innovative therapies including bsAbs. BiTEs & immune-modulating antibodies are gaining traction in oncology & autoimmune treatment landscapes due to their ability to target multiple disease pathways simultaneously. Technological advancements such as improved antibody engineering platforms & enhanced targeting capabilities, are expected to broaden the therapeutic applications of bsAbs. Additionally, ongoing clinical trials & regulatory approvals will likely lead to new, more effective treatments, expanding market access. As the healthcare industry shifts towards more personalized & precise treatments, bsAbs are poised to become a cornerstone in modern medicine, particularly in cancer immunotherapy.