종양학 이중특이성항체 시장 규모, 표적 집단, 경쟁 구도, 시장 예측(2040년)

Key Highlights:

• The Bispecifics in Oncology Market Size is naticipated to grow with a significant CAGR during the study period (2020-2040).
• According to DelveInsight's analysis, the total number of new multiple myeloma cases in the 7MM was around 74,900 in 2024 and is expected to rise over the forecast period.
• Within the EU4 and the UK, Germany and France recorded the highest number of new multiple myeloma cases, accounting for roughly 24% of the total in 2024, whereas Spain had the lowest case count.
• In the US, the population eligible for treatment with bispecific antibodies in oncology was estimated to be approximately 895,600 cases.
• Non-small cell lung cancer (NSCLC) represents roughly 85% of all lung cancer diagnoses, indicating it is the most common type of lung cancer.
• In July 2025, I-Mab reported the presentation of encouraging Phase Ib combination results for givastomig, administered alongside nivolumab and mFOLFOX6 for gastric cancer, at the 2025 European Society for Medical Oncology Gastrointestinal Cancers Congress.
• In June 2025, BioNTech and Bristol Myers Squibb revealed a partnership to globally co-develop and co-commercialize BioNTech's investigational bispecific antibody BNT327 for multiple solid tumor types. Through this collaboration, both companies aim to expand and expedite the development of this clinical candidate.

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DelveInsight's "Bispecifics in Oncology Market Size, Target Population, Competitive Landscape and Market Forecast - 2040" report delivers an in-depth understanding of Bispecifics in Oncology, 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 in Oncology market report provides insights around existing treatment practices in patients with Bispecifics in Oncology, approved (if any) and emerging Bispecifics in Oncology market size & market share of individual therapies, patient pool eligible for treatment with Bispecifics in Oncology, along with current and forecasted 7MM Bispecifics in Oncology market size from 2020-2040 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 Oncology in different geographies, along with insights on Bispecifics in Oncology pricing reimbursements to curate the best opportunities and assess the market's potential.

Key Factors Driving the Growth of the Bispecifics in Oncology Market

Rising Cancer Incidence

The increasing global prevalence of cancer is a significant driver for the bispecific antibodies market. As cancer rates climb, there is a heightened demand for innovative therapies that can offer more effective and targeted treatment options. Bispecific antibodies, which can simultaneously target two different antigens, provide a promising solution to this challenge.

BLINCYTO's Evolving Role in Hematologic Oncology

BLINCYTO has been around for almost a decade. This therapy is the current market leader in the ALL sector, and Amgen is expanding its use to earlier stages of illness, as it was first licensed for relapsed/refractory ALL. It is also FDA authorized for Minimal residual disease-positive patients. Amgen is now attempting to enter niche markets with BLINCYTO.

Rising M&A Activity in Dual-Targeted Oncology Therapies

Amid rising industry interest in PD-(L)1 X VEGF bispecifics, Pfizer made a landmark move by acquiring 3SBio's SSGJ-707 for USD 1.25 billion upfront, with potential milestones reaching USD 4.8 billion, marking the largest deal in this emerging field. This follows BioNTech's USD 800 million acquisition of Biotheus, including BNT327, and Merck & Co.'s USD 588 million upfront payment for LaNova Medicines' LM-299, underscoring the growing momentum behind dual-targeted therapies.

Robust Bispecifics in Oncology Clinical Trial Activity

The bispecifics in oncology clinical trials include several promising therapies such as Givastomig (I-MAB Biopharma and BMS), Volrustomig (AstraZeneca), BNT327 (BioNTech and Bristol Myers Squibb), Acasunlimab (Genmab), Rilvegostomig (AstraZeneca), CTX-009 (Compass Therapeutics), IBI363 (Innovent), REGN5459 (Regeneron Pharmaceuticals), CA-170 (Aurigene Oncology and Curis), and others.

Bispecifics in Oncology Drugs Market Overview

This segment will provide detailed information beginning with the inhibitor journey from discovery of the mutation or protein expression to its entry into clinical development followed by its upcoming commercial potential in the Bispecifics in Oncology Drugs Market. This segment will dive into the different indications in Bispecifics in Oncology Market Size for which the inhibitor is being developed for, which would further give insights on the potential addressable patient population. Moreover, this segment will also give a brief overview around the existing treatment paradigm of the target indications.

Bispecifics in Oncology Clinical Trials

This section will give in depth information about the existing local and systemic options in the current treatment paradigm of all the potential indications, in which most of the pharmaceutical companies are actively evaluating their inhibitors. Potential of the emerging Bispecifics in Oncology Market Size in changing the current clinical practice guidelines is crucial to analyze especially when it comes to real world scenario.

It will also include the relevance and importance of incorporation of biomarker testing at varying stages of the disease. It is also important to understand that implementing such tests in routine clinical practice is not uniform in different countries due to issues such as cost, accessibility, reimbursement and non-recommendation in guidelines.

Bispecifics In Oncology Target Patient Pool Analysis:

• According to DelveInsight's analysis, the total number of new multiple myeloma cases in the 7MM was around 74,900 in 2024 and is expected to rise over the forecast period.
• Within the EU4 and the UK, Germany and France recorded the highest number of new multiple myeloma cases, accounting for roughly 24% of the total in 2024, whereas Spain had the lowest case count.
• In the US, the population eligible for treatment with bispecific antibodies in oncology was estimated to be approximately 895,600 cases.
• Non-small cell lung cancer (NSCLC) represents roughly 85% of all lung cancer diagnoses, indicating it is the most common type of lung cancer.
• In 2024, the total incident cases of gastric cancer, including gastroesophageal junction (GEJ) tumors, in the 7MM were estimated at around 211,550, with numbers projected to rise by 2040.
• According to the analysis, Japan recorded approximately 121,910 new cases of NSCLC in 2024.

Bispecifics in Oncology Recent Developments

• In July 2025, I-Mab reported the presentation of encouraging Phase Ib combination results for givastomig, administered alongside nivolumab and mFOLFOX6 for gastric cancer, at the 2025 European Society for Medical Oncology Gastrointestinal Cancers Congress.
• In June 2025, BioNTech and Bristol Myers Squibb revealed a partnership to globally co-develop and co-commercialize BioNTech's investigational bispecific antibody BNT327 for multiple solid tumor types. Through this collaboration, both companies aim to expand and expedite the development of this clinical candidate.

Bispecifics in Oncology Drug Chapters

The Bispecifics in Oncology Drugs Market segment encloses a detailed analysis of marketed therapies and late-stage (Phase III and Phase II) therapies. It also helps understand the Bispecifics in Oncology Clinical Trial details, pharmacological action, agreements and collaborations related to Bispecifics in Oncology, their approval timelines, patent details, advantages and disadvantages, latest news and press releases.

Bispecifics in Oncology Marketed Drugs

The Bispecifics in Oncology marketed drug section will provide detailed drug profiles of already approved therapies. Information around clinical development activities, launch timing, regulatory milestones along with safety and efficacy data of the therapy will be included.

Bispecifics in Oncology Emerging Drugs

Apart from a comprehensive Bispecifics in Oncology Market Forecast competitive landscape in tabular form, the emerging drug chapters provides the product details and other development activities of the emerging Bispecifics in Oncology Market Size under the late and mid-stage of clinical development for various indications.

Some of the potential therapies in the pipeline include -

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. Volrustomig in multiple Phase III trials across various cancer types, including the eVOLVE-cervical study for locally advanced cervical cancer, eVOLVE-HNSCC for unresected locally advanced head and neck squamous cell carcinoma (HNSCC), eVOLVELung02 for first-line metastatic NSCLC, and eVOLVE-Meso for first-line unresectable malignant pleural mesothelioma.

As per the Q1 2025 presentation, anticipated results for the Phase IIb eVOLVE-01 (NCT06448754) trial of volrustomig in NSCLC are expected in H2 2025.

Givastomig: I-MAB Biopharma and BMS

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. Givastomig uniquely binds to tumor cells expressing various levels of CLDN18.2, including gastric cancer and pancreatic cancer cells, and conditionally activates intra-tumoral T-cells at the tumor site through 4-1BB. The US FDA granted Orphan Drug Designation to givastomig for the treatment of gastric cancer, including cancer of the gastroesophageal junction.

• In June 2025, I-Mab announced the publication of the first-in-human monotherapy data for givastomig in Clinical Cancer Research, a journal of the American Association for Cancer Research (CCR).
• In March 2025, I-Mab announced that enrollment had been completed ahead of schedule in the first dose expansion cohort in the Phase Ib givastomig combination study, with continued momentum in the second dose expansion cohort.
• In January 2025, I-Mab highlighted its strategic outlook for 2025 and a re-prioritization of resources, with a focus on advancing its lead program, givastomig, targeting first-line metastatic gastric cancers, with further potential in other solid tumors.

BNT327: BioNTech and Bristol Myers Squibb

BNT327 is a novel investigational bispecific antibody combining two complementary, validated mechanisms in oncology into one single molecule. BNT327 combines PD L1 checkpoint inhibition aimed at restoring T cells' ability to recognize and destroy tumor cells with the neutralization of VEGF-A. Multiple global trials are ongoing or planned to start in 2025, including three global clinical trials with registrational potential in firstline small cell lung cancer (SCLC), first-line NSCLC and first-line triple-negative breast cancer (TNBC).

Bispecifics in Oncology Drug Class Insights

The Bispecifics in Oncology Drugs Market Insights section will provide comprehensive information on Bispecifics in Oncology 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 in Oncology, 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 in Oncology Market Outlook

This section will include details on changing Bispecifics in Oncology 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 in Oncology Drugs Market Uptake

This section focuses on the Bispecifics in Oncology Drugs Market Uptake rate of potential Bispecifics in Oncology already launched and expected to be launched in the market during 2020-2040, 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 in Oncology Pipeline Development Activities

The Bispecifics in Oncology Market report provides insights into different Bispecifics in Oncology clinical trials within Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.

Bispecifics in Oncology Pipeline Development Activities

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

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 in Oncology' incorporation in the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along with challenges related to accessibility.

Bispecifics in Oncology 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.

Bispecifics in Oncology Market Access and Reimbursement

This section will include Bispecifics in Oncology market 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 Bispecifics in Oncology Market Report

• The Bispecifics in Oncology Market report covers a segment of key events, an executive summary, target patient pool, epidemiology and Bispecifics in Oncology market forecast, 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 in Oncology addressable patient pool
• A detailed review of the Bispecifics in Oncology 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 in Oncology market.
• Bispecifics in Oncology Market Size of Inhibitors by therapies and indication will be provided

Bispecifics in Oncology Report Key Strengths

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

FAQs:

• What was the Bispecifics in Oncology total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like by 2040? What are the contributing factors for Bispecifics in Oncology market growth?
• Which drug is going to be the largest contributor by 2040?
• What is the market access and reimbursement scenario of Bispecifics in Oncology?
• 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 Bispecifics in Oncology Market Forecast Report:

• The Bispecifics in Oncology Market report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Bispecifics in Oncology Market.
• Understand the existing Bispecifics in Oncology 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 in Oncology

4. Key Events

5. Bispecifics in Oncology Market Overview At A Glance

• 5.1. Market Share (%) Distribution of Bispecifics in Oncology By Therapy in 2025
• 5.2. Market Share (%) Distribution of Bispecifics in Oncology By Therapy in 2040

6. Background And Overview

7. Bispecifics in Oncology Target Population

8. Bispecifics in Oncology Marketed Drugs

• 8.1. Key Competitors
• 8.2. Company 1: Product 1
  • 8.2.1. Product Description
  • 8.2.2. Regulatory Milestones
  • 8.2.3. Other Developmental Activities
  • 8.2.4. Ongoing Clinical Development
  • 8.2.5. Safety and Efficacy
• 8.3. Company 2: Product 2
  • 8.3.1. Product Description
  • 8.3.2. Regulatory Milestones
  • 8.3.3. Other Developmental Activities
  • 8.3.4. Ongoing Clinical Development
  • 8.3.5. Safety and Efficacy

9. Bispecifics in Oncology Emerging Drugs

• 9.1. Key Competitors
• 9.2. Company 1: Product 1
  • 9.2.1. Product Description
  • 9.2.2. Other Development Activities
  • 9.2.3. Clinical Development
    • 9.2.3.1. Clinical Trials Information
  • 9.2.4. Safety and Efficacy
• 9.3. Company 2: Product 2
  • 9.3.1. Product Description
  • 9.3.2. Other Development Activities
  • 9.3.3. Clinical Development
    • 9.3.3.1. Clinical Trials Information
  • 9.3.4. Safety and Efficacy

10. Bispecifics in Oncology: The 7MM Analysis

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

11. Bispecifics in Oncology Unmet Needs

12. SWOT Analysis

13. KOL Views

14. Bispecifics in Oncology 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