B7-H3 : 시장 규모, 대상 환자층, 경쟁 구도 및 시장 예측(2036년)

Key Highlights:

• Currently, no B7-H3 Inhibitor drug has been approved by any regulatory body in the 7MM. But the pipeline is very robust with potential drugs like ifinatamab deruxtecan (I- DXd) (Daiichi Sankyo/Merck), MGC026 (MacroGenics), Elfetabart Drozuntecan (DB-1311/BNT324; BioNTech/DualityBio), risvutatug rezetecan (GSK5764227; GSK), IBI3001 (Innovent Biologics), and others.
• B7-H3 is expressed in the nucleus of approximately 30% of colorectal cancers, where it is associated with poor overall survival. It is also detected in tumor-associated vasculature, fibroblasts, and the stromal compartment of gastric cancer, with evidence suggesting it promotes exosome secretion and may contribute to tumor progression.
• Currently Ifinatamab deruxtecan (I-DXd), developed by Daiichi sankyo is the most advanced B7-H3 inhibitor in development. It is being tested in a Phase sIII clinical trial for the treatment of SCLC and also being tested as combination therapy and monotherapy for other indications in various phases of clinical trials.

DelveInsight's "B7-H3 Market Size, Target Population, Competitive Landscape & Market Forecast - 2036" report delivers an in-depth understanding of B7-H3, 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 B7-H3 market report provides insights around existing treatment practices in patients with B7-H3, approved (if any) and emerging B7-H3, market share of individual therapies, patient pool eligible for treatment with B7-H3, along with current and forecasted 7MM B7-H3 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 B7-H3 in different geographies, along with insights on B7-H3 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

B7-H3 Overview

B7-H3, a member of the same protein family as PD-L1, has garnered attention as one of a slew of alternative targets riding the wave of success of Immune Checkpoint Inhibitors (ICIs) in cancer immunotherapy. It is found to have overexpression in the body parts.

High B7-H3 expression has been found in breast cancer, and these levels are substantially linked with greater tumor size and lymphatic invasion. Moreover, B7-H3 is highly expressive in NSCLC, SCLC, ovarian cancer, head and neck cancers and prostate cancer. Colorectal cancers and pancreatic ductal adenocarcinoma (PDAC) have lower expression of B7-H3.

Target Patient Pool Analysis

• Among lung cancer cases, NSCLC accounts for approximately 85% of all diagnoses, SCLC represents about 15%. This distribution highlights that NSCLC is the more prevalent form of lung cancer.
• The total incident population of NSCLC in the 7MM in 2025 were 543,500, growing at a positive CAGR due to population growth, an aging demographic, and the increasing prevalence of major risk factors such as smoking and air pollution, which will place a significant burden on both patients and healthcare systems globally.
• More than 90% of malignant ovarian tumors are epithelial. Malignant ovarian cancer, also known as carcinomas, are comprised of five main (HGSCs) are the most common form of epithelial ovarian carcinomas (High-grade Serous Ovarian Cancer [HGSOC]; 70%), endometrioid (10%), clear cell (6-10%), mucinous (3%), and LGSOC constitutes a small proportion of serous ovarian tumors (approximately 3-10%).

B7-H3 Drug Chapters

The drug chapter segment of the B7-H3 report encloses a detailed analysis of marketed therapies and late-stage (Phase III and Phase II) therapies. It also helps understand the B7-H3 clinical trial details, pharmacological action, agreements and collaborations related to B7-H3, their approval timelines, patent details, advantages and disadvantages, latest news and press releases.

B7-H3 Emerging Drugs

Ifinatamab deruxtecan (I-DXd): Daiichi Sankyo/Merck

Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and Merck.

In September 2025, ifinatamab deruxtecan demonstrated clinically meaningful response rates in patients with extensive-stage small cell lung cancer in IDeate-Lung01 Phase II trial.

In August 2025, ifinatamab deruxtecan has been granted breakthrough therapy designation by the FDA for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.

In October 2023, Daiichi Sankyo entered a global collaboration with Merck to develop and commercialize Ifinatamab deruxtecan and two other ADCs worldwide (excluding Japan), supporting its advancement in ESCC, prostate cancer, and other solid tumors.

MGC026: MacroGenics

MGC026 is an investigational B7-H3-targeted antibody-drug conjugate (ADC) that combines a B7-H3-specific monoclonal antibody with the novel SYNtecan E cleavable linker-payload. The payload is based on the potent topoisomerase I inhibitor exatecan and incorporates HydraSpace technology to improve drug delivery, stability, and antitumor activity while enabling selective targeting of B7-H3-expressing tumors. It is currently being evaluated in Phase I/II of clinical trials for solid tumors.

According to MacroGenics 2025 financial results presented in May 2026, the company completed enrollment of a Phase I dose escalation study in 2025 and is currently enrolling patients in a dose expansion study in selected solid tumor indications. The Company anticipates reporting initial MGC026 clinical data in mid-2026.

Elfetabart drozuntecan (DB-1311/BNT324): BioNTech/DualityBio

Elfetabart drozuntecan (DB-1311/BNT324) is an investigational B7-H3-targeted antibody-drug conjugate (ADC) developed by BioNTech and DualityBio. It consists of a humanized anti-B7-H3 monoclonal antibody linked to a proprietary DNA topoisomerase I inhibitor payload via a cleavable linker, enabling selective delivery of the cytotoxic agent to B7-H3-expressing tumor cells. The therapy is being evaluated across multiple advanced solid tumors, including metastatic castration-resistant prostate cancer, non-small cell lung cancer, and other B7-H3-positive malignancies.

Recent Developments in the B7-H3 Market

• In May 2026,Duality Biotherapeutics, announced that the first patient has been dosed in a global pivotal Phase III clinical trial evaluating DB-1311/BNT324 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have not received prior taxane-based chemotherapy.
• In December 2025, preliminary Phase I/II data for DB- 1311/BNT324 demonstrated a manageable safety profile and encouraging early antitumor activity in heavily pretreated cervical and platinum-resistant ovarian cancer patients.

Drug Class Insights

The Drug Class Insights section will provide comprehensive information on B7-H3 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 B7-H3, 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.

B7-H3 Market Outlook

This section will include details on changing B7-H3 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.

B7-H3 Drugs Uptake

This section focuses on the uptake rate of potential B7-H3 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.

B7-H3 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.

B7-H3 Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for B7-H3.

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 B7-H3' 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 B7-H3 addressable patient pool
• A detailed review of the B7-H3 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 B7-H3 market.
• Market Size of Inhibitors by therapies and indication will be provided

B7-H3 Report Key Strengths

• 11 Years B7-H3 Market Forecast
• The 7MM Coverage
• B7-H3 Competitive Landscape of current and emerging therapies
• B7-H3 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)
• B7-H3 Market Size by therapy and indication
• Existing and Future Market Opportunity
• Unmet Needs

FAQs:

• What was the B7-H3 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 B7-H3 market growth?
• Which KRAS Inhibitor is going to be the largest contributor by 2036?
• What is the market access and reimbursement scenario of B7-H3?
• 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 B7-H3 Market.
• Understand the existing B7-H3 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 B7-H3

4. Key Events

5. B7-H3 Market Overview At A Glance

• 5.1. Market Share (%) Distribution of B7-H3 By Therapy in 2025
• 5.2. Market Share (%) Distribution of B7-H3 By Therapy in 2036

6. Background And Overview

7. Target Population

8. B7-H3 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. B7-H3 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. B7-H3: The 7MM Analysis

• 10.1. Key Findings
• 10.2. Market Outlook
• 10.3. Key Market Forecast Assumptions
• 10.4. Total Market Size of B7-H3 in the 7MM
  • 10.4.1. Market Size of B7-H3 By Therapies In the 7MM
  • 10.4.2. Market Size of B7-H3 By Indication In the 7MM
• 10.6. United States Market
  • 10.6.1. Total Market Size of B7-H3 in the United States
  • 10.6.2. Market Size of B7-H3 By Therapies in the United States
• 10.7. EU4 and the UK Market
  • 10.7.1. Total Market Size of B7-H3 in EU4 and the UK
  • 10.7.2. Market Size of B7-H3 By Therapies in EU4 and the UK
• 10.8. Japan Market
  • 10.8.1. Total Market Size of B7-H3 in Japan
  • 10.8.2. Market Size of B7-H3 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