이중특이성항체 : 시장 규모, 대상 환자층, 경쟁 구도 및 시장 예측(2036년)

Key Highlights:

• The world's first approved bispecific, REMOVAB, aimed to tackle malignant ascites in solid tumors and gained the nod from the EMA; however, it was later withdrawn in 2017 for commercial reasons.
• Three main bispecific antibody fragment formats: Bispecific T-cell engager (BiTE), Dual-affinity re-targeting proteins (DARTs), and Tandem diabodies (TandAbs).
• Based on pipeline activities most of the bispecific antibodies have being developed in multiple myeloma followed by Non-small-cell Lung Cancer (NSCLC).
• Johnson & Johnson Innovative Medicine is the leading player, with three approved bispecific antibodies: RYBERVANT, TECVAYLI, and TALVEY, followed by other established players such as AbbVie/Genmab, Roche/Biogen, Pfizer, Amgen and, Akeso Biopharma.
• Key Late-Stage (Registered, Phase III and II/III) emerging bispecific players include AstraZeneca (Generalised Myasthenia Gravis), Zenas BioPharma (IgG4-related Disease, Relapsing Multiple Sclerosis [RMS], and Systemic Lupus Erythematosus [SLE]), Merus (Pancreatic Cancer and HNSCC), Regeneron (DLBCL, Follicular lymphoma), Sichuan Baili Pharmaceutical (NSCLC), Alphamab (Pancreatic), AstraZeneca (BTC, NSCLC, HNSCC), and others.
• Odronextamab monotherapy delivered strong efficacy with a manageable safety profile, positioning it as a promising off-the-shelf option for patients who progress after CAR-T therapy.
• IMDELLTRA, is expected to see broader use across the United States due to the high incidence of small cell lung cancer. As its adoption grows, oncologists will need to be equipped with specialized tools and techniques necessary for the safe and effective administration of IMDELLTRA and other bispecific antibodies."

DelveInsight's "Bispecifics Market Size, Target Population, Competitive Landscape & Market Forecast - 2036" report delivers an in-depth understanding of Bispecifics, addressable patient pool, competitive landscape, and future market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the UK, and Japan.

The Bispecifics market report provides insights around existing treatment practices in patients with Bispecifics, approved (if any) and emerging Bispecifics, market share of individual therapies, patient pool eligible for treatment with Bispecifics, along with current and forecasted 7MM Bispecifics market size from 2022-2036 by therapies and by indication. The report also covers current unmet needs and challenges while incorporating new classes in treatment paradigm, variations in accessibility and acceptability of new Bispecifics in different geographies, along with insights on Bispecifics pricing reimbursements to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain), and the UK
• Japan

Study Period: 2022-2036

Bispecifics Overview

Bispecific antibodies, or bispecifics, are a newer class of engineered antibody therapies designed to bind to two different targets simultaneously, unlike conventional monoclonal antibodies that typically recognize a single target. By bringing two molecules or cell types into close proximity, bispecifics can create therapeutic effects that would be difficult to achieve with traditional antibodies-for example, linking immune cells such as T cells to cancer cells to trigger targeted tumor killing. Other bispecifics can block two disease-driving pathways at once or engage one target while directing another biological function. This dual-targeting capability has made bispecifics an important and rapidly expanding modality in oncology, autoimmune diseases, and other therapeutic areas, with developers increasingly exploring them as alternatives or complements to conventional biologics and cell therapies.

Target Patient Pool Analysis

• As per DelveInsight's analysis, the total incident cases of multiple myeloma in the 7MM comprised approximately 70,000 cases in 2025 and are projected to increase during the forecast period.
• In the 7MM, Japan recorded the highest number of Incident cases of BTC accounting for ~22,000 cases in 2025, which are expected to continue increasing through 2034.
• RPE65-linked Inherited Retinal Disease (IRD) account for about 3-16% of Leber congenital amaurosis (LCA2) and approximately 0.6-6% of retinitis pigmentosa.
• In 2025, stage IV specific cases of follicular lymphoma made up around 40% of the total cases of Follicular lymphoma in the US.
• In females, prevalence rates for SLE was observed to be much greater than that of males, constituting for more than 90% of the total prevalent cases.
• In biomarker specific cases, most number of cases is from PD-L1 followed by KRAS, EGFR. On the other hand, NTRK accounted for least number of cases whereas, BRAF and ROS 1 accounted for approximately 5% and 2% cases, respectively.

Bispecifics Drug Chapters

The drug chapter segment of the Bispecifics report encloses a detailed analysis of marketed therapies and late-stage (Phase III and Phase II) therapies. It also helps understand the Bispecifics clinical trial details, pharmacological action, agreements and collaborations related to Bispecifics, their approval timelines, patent details, advantages and disadvantages, latest news and press releases.

Bispecifics Marketed Drugs

ZIIHERA: Zymeworks

ZIIHERA (zanidatamab) by Zymeworks is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. It is being developed by Jazz Pharmaceuticals and BeOne Medicines under license agreements from Zymeworks which first developed the molecule.

In November 2024, the US FDA granted accelerated approval of ZIIHERA for the treatment of adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) BTC.

In December 2025, Jazz Pharmaceuticals announced two abstracts featuring key data for ZIIHERA have been accepted for presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI).

Bispecifics Emerging Drugs

Some of the potential therapies in the pipeline include CA-170, (Aurigene Oncology and Curis), AUR107, and AUR109 (Aurigene Oncology), Givastomig (NovaBridge Biosciences [I-MAB Biopharma], ABL Bio, and Bristol Myers Squibb), Linvoseltamab (Regeneron Pharmaceuticals), Obexelimab (Zenas BioPharma), Volrustomig (AstraZeneca), among others.

Obexelimab: Zenas BioPharma

Obexelimab is a bifunctional monoclonal antibody designed to bind both CD19 and FcYRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. Zenas is conducting a fully enrolled Phase III trial in Immunoglobulin G4-Related Disease and Phase II trials for Relapsing Multiple Sclerosis (RMS) and SLE.

In November 2025, the company anticipated the topline results from their pivotal Phase II trial in SLE expected in mid-2026.

In October 2025, Zenas BioPharma announced positive results from the Phase II (MoonStone) trial of obexelimab in RMS.

Givastomig: NovaBridge Biosciences (I-MAB Biopharma), ABL Bio, and Bristol Myers Squibb

Givastomig, also known as TJ-CD4B/ABL111 or TJ033721, is a bispecific antibody designed to bind to Claudin 18.2 (CLDN18.2) as a tumor engager and 4-1BB as a conditional T-Cell activator. The US FDA granted Orphan Drug Designation for givastomig for the treatment of gastric cancer.

In February 17, 2026, NovaBridge Biosciences announced enrollment of the first patient in a global Phase II study evaluating givastomig plus nivolumab and mFOLFOX6 as first-line treatment for HER2-negative metastatic gastric cancer, with topline results expected in 2027.

In October 2025, NovaBridge Biosciences announced that updated data from the Phase I study (NCT04900818) of givastomig as a monotherapy in heavily pre-treated patients with gastroesophageal carcinoma was presented at AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference 2025.

Volrustomig: AstraZeneca

Volrustomig (MEDI5752) is a monovalent, PD-1/CTLA-4 bispecific, humanized IgG1 monoclonal antibody engineered to inhibit PD-1, with increased CTLA-4 blockade on PD-1+ specifically activated T cells compared to PD-1-resting peripheral T cells. This mode of action may facilitate enhanced CTLA-4 inhibition at tolerable doses beyond those achievable with current PD-1/CTLA-4 combinations. This is one of the first of this kind of molecule.

In its Q3 2025 report, AstraZeneca stated that data from the Phase III eVOLVE-Lung02 trial (NCT05984277) are expected after 2026, while results from the Phase Ib DESTINY-Lung03 study (NCT04686305), in partnership with Daiichi Sankyo, are anticipated in H2 2026.

Recent Developments in the Bispecific Market

• In January 2026, Zenas BioPharma announced the positive results from the Phase III (INDIGO) trial of obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD).
• In October 2025, NovaBridge Biosciences (I-Mab) announced that updated data from the Phase I study (NCT04900818) of givastomig as a monotherapy in heavily pre-treated patients with gastroesophageal carcinoma was presented at AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference 2025.

Drug Class Insights

The Drug Class Insights section will provide comprehensive information on Bispecifics as a class. This will include a broad overview of the class and its role in treating specific conditions. Insights may cover the historical clinical development of Bispecifics, their mechanism of action, their subtypes and future commercial prospects. Additionally, the section will provide detailed information about current trends, challenges, and future prospects for this class of drugs.

Bispecifics Market Outlook

This section will include details on changing Bispecifics market dynamics post initiation of clinical development activities of the inhibitor. It will also provide a detailed summary and comparison of all the therapies being developed by leading players in this space. This section will highlight the advantages of one therapy over the other after assessment based on parameters such as data availability in the form of safety and efficacy, number of patients enrolled in each trial, and trial's inclusion criteria. There will be a Key focus on the importance of development and need for the commercial success of these targeted therapies to achieve treatment goals that physicians and patients are looking for. It will also sum up all the early stage players active in this space.

Bispecifics Drugs Uptake

This section focuses on the uptake rate of potential Bispecifics already launched and expected to be launched in the market during 2022-2036, which depends on the competitive landscape, safety, efficacy data, and order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Bispecifics Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.

Bispecifics Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Bispecifics.

KOL Views

To keep up with current and future market trends, we incorporate Key physicians, Therapy Area Researcher's, and other Industry Experts' opinions working in the domain through primary research to fill in the data gaps and validate our secondary research. 25+ Key Opinion Leaders (KOLs) were contacted for insights on Bispecifics' incorporation in the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along with challenges related to accessibility.

Qualitative Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the analyst's discretion and assessment of the cost analysis and existing and evolving treatment landscape.

Market Access and Reimbursement

This section will include insights around the standard HTA pricing, recent reformations in 2024 and modifications in reimbursement process in the 7MM. For example, In the United States, a multi payer model exists when it comes to drug pricing regime, which is currently undergoing significant changes, with recent federal legislation, such as the Prescription Drug Pricing Reform provisions of the Inflation Reduction Act, significantly altering the pricing regime under certain federal programs. Whereas in Germany, the market access differs from the systems followed in many other countries as no pricing and reimbursement approval is required during launch of a new therapy.

Moreover, this section will also provide details on reimbursement of approved therapy, if any.

Scope of the Report:

• The report covers a segment of key events, an executive summary, target patient pool, epidemiology and market forecasts, information around patient journey and varying biomarker testing rates
• Additionally, an all-inclusive account of the current and emerging therapies drug chapters, insights on Bispecifics addressable patient pool
• A detailed review of the Bispecifics market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, and treatment preferences that help in shaping and driving the 7MM Bispecifics market.
• Market Size of Inhibitors by therapies and indication will be provided

Bispecifics Report Key Strengths

• 11 Years Bispecifics Market Forecast
• The 7MM Coverage
• Bispecifics Competitive Landscape of current and emerging therapies
• Bispecifics Total Addressable patient population
• Drugs Uptake and Key Market Forecast Assumptions
• Approved and Emerging therapy Profiles
• Physician's perspectives/KOL opinions
• Biomarker testing and Patient journey
• Qualitative Analysis (SWOT and Analyst Views)
• Bispecifics Market Size by therapy and indication
• Existing and Future Market Opportunity
• Unmet Needs

FAQs:

• What was the Bispecifics total market size, the market size by therapies, market share (%) distribution in 2022, and what would it look like by 2036? What are the contributing factors for Bispecifics market growth?
• Which Bispecific is going to be the largest contributor by 2036?
• What is the market access and reimbursement scenario of Bispecifics?
• What are the pricing variations among different geographies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?

Reasons to Buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Bispecifics Market.
• Understand the existing Bispecifics market opportunities and future trends in varying geographies
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility and acceptability of emerging treatment options along with unmet need of current therapies
• Details on report methodology, top indications covered, market assumptions, patient journey and KOLs to strengthen the pharmaceutical companies' development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Bispecifics

4. Key Events

5. Bispecifics Market Overview At A Glance

• 5.1. Market Share (%) Distribution of Bispecifics By Therapy in 2025
• 5.2. Market Share (%) Distribution of Bispecifics By Therapy in 2036

6. Background And Overview

7. Target Population

8. Bispecifics Marketed Drugs

• 8.1. Key Competitors
  • 8.1.1. Product Description
  • 8.1.2. Regulatory Milestones
  • 8.1.3. Other Developmental Activities
  • 8.1.4. Ongoing Clinical Development
  • 8.1.5. Safety and Efficacy

9. Bispecifics Emerging Drugs

• 9.1. Key Competitors
  • 9.1.1. Product Description
  • 9.1.2. Other Development Activities
  • 9.1.3. Clinical Development
    • 9.1.3.1. Clinical Trials Information
  • 9.1.4. Safety and Efficacy

10. Bispecifics: The 7MM Analysis

• 10.1. Key Findings
• 10.2. Market Outlook
• 10.3. Key Market Forecast Assumptions
• 10.4. Total Market Size of Bispecifics in the 7MM
  • 10.4.1. Market Size of Bispecifics By Therapies In the 7MM
  • 10.4.2. Market Size of Bispecifics By Indication In the 7MM
• 10.6. United States Market
  • 10.6.1. Total Market Size of Bispecifics in the United States
  • 10.6.2. Market Size of Bispecifics By Therapies in the United States
• 10.7. EU4 and the UK Market
  • 10.7.1. Total Market Size of Bispecifics in EU4 and the UK
  • 10.7.2. Market Size of Bispecifics By Therapies in EU4 and the UK
• 10.8. Japan Market
  • 10.8.1. Total Market Size of Bispecifics in Japan
  • 10.8.2. Market Size of Bispecifics By Therapies in Japan

11. Unmet Needs

12. SWOT Analysis

13. KOL Views

14. Market Access and Reimbursement

• 14.1. United States
  • 14.1.1. Centre for Medicare & Medicaid Services (CMS)
• 14.2. EU4 and the UK
  • 14.2.1. Germany
  • 14.2.2. France
  • 14.2.3. Italy
  • 14.2.4. Spain
  • 14.2.5. United Kingdom
• 14.3. Japan
  • 14.3.1. MHLW

15. Appendix

• 15.1. Bibliography
• 15.2. Report Methodology

16. Delveinsight Capabilities

17. Disclaimer

18. About DelveInsight