The B7-H3 market is expected to witness strong growth over the coming years, driven by increasing interest in B7-H3 (CD276) as a therapeutic target across multiple solid tumors. B7-H3 is highly expressed in a broad range of cancers, including lung, prostate, breast, head and neck, and other malignancies, while its expression in normal tissues is generally limited, making it an attractive target for precision oncology. Growth is further supported by the expanding pipeline of therapies such as Ifinatamab deruxtecan (I-DXd; Daiichi Sankyo), MGC018 (MacroGenics), IBB0979 (Sunho Biologics), Enoblituzumab (MacroGenics), GSK5764227 (GSK), and others.
LAS VEGAS, Sept. 28, 2026 /PRNewswire/ -- DelveInsight's B7-H3 Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Prostate Cancer, Small Cell Lung Cancer (SCLC), Breast Cancer, Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, Head and Neck Cancers, and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging B7-H3, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets (the US, EU4, UK, and Japan).
Key Takeaways from the B7-H3 Market Report
- The total B7-H3 market size is expected to grow positively by 2036 in the leading markets.
- The United States accounted for the largest B7-H3 market size of the total market size in the 7MM in 2025, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- The report provides the total potential number of patients in the indications, such as Prostate Cancer, Small Cell Lung Cancer (SCLC), Breast Cancer, Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, Head and Neck Cancers, and others.
- The total incident population of NSCLC in the 7MM in 2025 was 543,500.
- Leading B7-H3 companies, such as Daiichi Sankyo, MacroGenics, Sunho Biologics, GSK, BeiGene, DualityBio, BioNTech, Aktis Oncology, ABL Bio, NEOK Bio, and others, are developing novel B7-H3 therapies that can be available in the B7-H3 market in the coming years.
- Some of the key B7-H3 therapies in clinical trials include Ifinatamab deruxtecan (I-DXd), MGC018, IBB0979, Enoblituzumab, GSK5764227, BGB-C354, Elfetabart drozuntecan (DB-1311/BNT324), AKY-2519, ABL206 (NEOK001), and others.
Discover the B7-H3 market size by 2036 @ https://www.delveinsight.com/report-store/b7-h3-market-forecast
Key Factors Driving the B7-H3 Market
- High B7-H3 Expression Across Multiple Cancers: B7-H3 is highly expressed across a broad range of solid tumors while showing relatively limited expression in normal tissues. This tumor-associated profile makes it an attractive target for precision oncology and supports the development of B7-H3-directed therapies.
- Growing Development of B7-H3-Targeted ADCs: Antibody-drug conjugates (ADCs) targeting B7-H3 are advancing across several tumor types, combining selective tumor targeting with potent cytotoxic payloads. Encouraging early clinical findings are strengthening interest in this therapeutic approach.
- Expanding Clinical Pipeline: Multiple B7-H3 therapies, including ADCs, monoclonal antibodies, bispecific antibodies, CAR-T therapies, and radioimmunotherapies, are being evaluated in clinical trials. Continued pipeline expansion of therapies such as Ifinatamab deruxtecan (I-DXd; Daiichi Sankyo), MGC018 (MacroGenics), IBB0979 (Sunho Biologics), Enoblituzumab (MacroGenics), GSK5764227 (GSK), BGB-C354 (BeiGene), and others is expected to increase investment and commercial opportunities in the market.
- Rising Need for Novel Cancer Treatments: Limited treatment options and poor outcomes in several advanced cancers are driving demand for new targeted therapies. B7-H3 programs are particularly being explored in difficult-to-treat malignancies such as small-cell lung cancer and metastatic prostate cancer.
- Increasing Investment in Next-Generation Oncology Therapies: The broader growth of targeted oncology and ADC development is encouraging pharmaceutical and biotechnology companies to invest in B7-H3 programs. The advancement of multiple candidates into clinical development is further supporting the market's growth potential.
Sadaf Javed, Functional Head of Forecasting & Analytics at DelveInsight, said that the attractiveness of B7-H3 as a target for cancer antibody-based therapy has stimulated the development of B7-H3-targeting immunotherapeutic strategies. Preclinical results are encouraging. In addition, data from clinical trials demonstrate a favorable safety profile with limited toxicity. Multiple ongoing clinical trials are evaluating the therapeutic efficacy of B7-H3-targeting strategies, alone or in combination with other checkpoint inhibitors.
B7-H3 Market Analysis
- B7-H3, a member of the same protein family as PD-L1, has emerged as a promising alternative target following the success of immune checkpoint inhibitors (ICIs) in cancer immunotherapy. B7-H3 is aberrantly overexpressed across several tumor types, making it an attractive target for the development of novel cancer therapies.
- High levels of B7-H3 expression have been observed in breast cancer and are significantly associated with larger tumor size and lymphatic invasion. Similarly, B7-H3 is highly expressed in non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), ovarian cancer, head and neck cancers, and prostate cancer.
- In comparison, lower levels of B7-H3 expression have been reported in colorectal cancer and pancreatic ductal adenocarcinoma (PDAC).
- Currently, no B7-H3-targeted inhibitor has received approval from regulatory authorities in the 7MM.
- However, the therapeutic pipeline is highly active, with several promising candidates in development, including ifinatamab deruxtecan (I-DXd; Daiichi Sankyo/Merck), MGC026 (MacroGenics), elfetabart drozuntecan (DB-1311/BNT324; BioNTech/DualityBio), risvutatug rezetecan (GSK5764227; GSK), IBI3001 (Innovent Biologics), and other emerging candidates.
- Overall, B7-H3 represents an exciting and rapidly evolving therapeutic class with considerable potential in oncology.
- As ongoing clinical studies mature over the coming years, emerging efficacy and safety data are expected to provide greater insight into the therapeutic potential of B7-H3-targeted agents and help establish their role in cancer treatment.
Learn more about the B7-H3 therapies @ B7-H3 Targeted Therapies
B7-H3 Competitive Landscape
Some of the emerging B7-H3 therapies under development include Ifinatamab deruxtecan (I-DXd; Daiichi Sankyo), MGC018 (MacroGenics), IBB0979 (Sunho Biologics), Enoblituzumab (MacroGenics), GSK5764227 (GSK), BGB-C354 (BeiGene), Elfetabart drozuntecan (DB-1311/BNT324; DualityBio/BioNTech), AKY-2519 (Aktis Oncology), ABL206 (NEOK001; ABL Bio/NEOK Bio), and others.
Daiichi Sankyo's Ifinatamab deruxtecan is a specifically engineered, potentially first-in-class B7-H3-directed DXd antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and jointly developed by Daiichi Sankyo and Merck. In September 2025, the Phase II IDeate-Lung01 trial demonstrated clinically meaningful response rates in patients with extensive-stage small cell lung cancer (ES-SCLC). In August 2025, the U.S. FDA granted breakthrough therapy designation to ifinatamab deruxtecan for the treatment of adults with ES-SCLC whose disease has progressed during or after platinum-based chemotherapy. In October 2023, Daiichi Sankyo entered into a global collaboration with Merck to develop and commercialize ifinatamab deruxtecan and two additional ADCs worldwide, excluding Japan. The collaboration supports the continued development of these therapies across ESCC, prostate cancer, and other solid tumors.
MacroGenics' MGC026 is an investigational B7-H3-targeted antibody-drug conjugate (ADC) that combines a B7-H3-specific monoclonal antibody with MacroGenics' proprietary SYNtecan E cleavable linker-payload technology. Its payload is derived from the potent topoisomerase I inhibitor exatecan and incorporates HydraSpace technology, which is designed to enhance drug delivery, stability, and antitumor activity while facilitating selective targeting of B7-H3-expressing tumor cells. MGC026 is currently being evaluated in Phase I/II clinical trials for the treatment of advanced solid tumors.
DualityBio/BioNTech's Elfetabart drozuntecan (DB-1311/BNT324) is an investigational B7-H3-targeted antibody-drug conjugate developed by BioNTech and DualityBio. The ADC comprises a humanized anti-B7-H3 monoclonal antibody conjugated to a proprietary DNA topoisomerase I inhibitor payload through a cleavable linker. This design enables targeted delivery of the cytotoxic payload to B7-H3-expressing tumor cells. Elfetabart drozuntecan is being investigated across several advanced solid tumors, including metastatic castration-resistant prostate cancer, non-small cell lung cancer, and other B7-H3-positive malignancies.
The anticipated launch of these emerging therapies are poised to transform the B7-H3 market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the B7-H3 market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about leading biopharmaceutical companies developing B7-H3 therapies, visit @ B7-H3 ADCs
Recent Developments in the B7-H3 Market
- In September 2026, Hansoh Pharmaceutical Group Company Limited announced that the National Medical Products Administration (NMPA) of China accepted the biologics license application (BLA) for the Group's innovative drug HS-20093 (risvutatug rezetecan, or Ris-Rez) for injection on September 2, 2026. The application seeks approval for the treatment of adult patients with small cell lung cancer (SCLC) whose disease has progressed following prior platinum-based chemotherapy.
- In September 2026, T-MAXIMUM PHARMACEUTICAL Inc. announced that its investigational allogeneic CAR-T cell therapy, MT027, has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of recurrent glioblastoma.
- In August 2026, Radiopharm Theranostics announced the dosing of the first patient in the second cohort of its First-In-Human (FIH) Phase 1/2a clinical trial evaluating RV-01 (177Lu-Betabart) in patients with B7-H3-expressing tumors.
- In August 2026, Akeso, Inc. announced that its investigational next-generation B7-H3-targeted antibody-drug conjugate (ADC), AK157D1, has received clinical trial clearance from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA).
- In June 2026, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced that first-in-human data from the study of its novel B7-H3 antibody-drug conjugate (ADC), SKB500, in patients with advanced solid tumors were presented as a rapid oral presentation by Professor Liu Haifeng of Jilin Provincial Cancer Hospital at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, USA.
- 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.
B7-H3 Epidemiology Segmentation
The B7-H3 market report is a comprehensive and specialized analysis, offering in-depth epidemiological insights for the study period 2022-2036 across the leading markets. 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 B7-H3 target patient pool is segmented into:
- Total Cases of Selected Indications for B7-H3
- Total Eligible Patient Pool for B7-H3 in Selected Indications
- Total Treated Cases in Selected Indications for B7-H3
B7-H3 Report Metrics | Details |
Study Period | 2022-2036 |
B7-H3 Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
Key Indications Covered in the Report | Prostate Cancer, Small Cell Lung Cancer (SCLC), Breast Cancer, Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, Head and Neck Cancers, and others |
B7-H3 Target Patient Pool Analysis | Total Cases of Selected Indications for B7-H3, Total Eligible Patient Pool for B7-H3 in Selected Indications, and Total Treated Cases in Selected Indications for B7-H3 |
Key B7-H3 Companies | Daiichi Sankyo, MacroGenics, Sunho Biologics, GSK, BeiGene, DualityBio, BioNTech, Aktis Oncology, ABL Bio, NEOK Bio, and others |
Key B7-H3 Therapies | Ifinatamab deruxtecan (I-DXd), MGC018, IBB0979, Enoblituzumab, GSK5764227, BGB-C354, Elfetabart drozuntecan (DB-1311/BNT324), AKY-2519, ABL206 (NEOK001), and others |
Scope of the B7-H3 Market Report
- B7-H3 Patient Population Forecast
- B7-H3 Therapeutics Market Size
- B7-H3 Pipeline Analysis
- B7-H3 Market Size and Trends
- B7-H3 Market Opportunity
- B7-H3 Market Unmet Needs
- KOL's Views on B7-H3
- B7-H3 Market Access and Reimbursement
Discover B7-H3 latest developments 2026 @ B7-H3 Clinical Trials
Table of Contents
1 | B7-H3 Market Key Insights |
2 | B7-H3 Market Report Introduction |
3 | Executive Summary of B7-H3 |
4 | Key Events |
5 | Epidemiology and Market Forecast Methodology |
6 | B7-H3 Market Overview at a Glance in the 7MM |
6.1 | Market Share (%) Distribution by Therapies in 2026 |
6.2 | Market Share (%) Distribution by Therapies in 2036 |
7 | Background and Overview |
7.1 | Introduction |
7.2 | Treatment |
8 | Target Patient Pool |
8.1 | Key Findings |
8.2 | Assumptions and Rationale: 7MM |
8.3 | Epidemiology Scenario in the 7MM |
8.3.1 | Total Cases in Selected Indications for B7-H3 in the 7MM |
8.3.2 | Total Eligible Patient Pool for B7-H3 in Selected Indications in the 7MM |
8.3.3 | Total Treated Cases in Selected Indications for B7-H3 in the 7MM |
9 | Emerging Drugs |
9.1 | Competitive Landscape of Emerging Drugs |
9.2 | Ifinatamab deruxtecan: Daiichi Sankyo/Merck |
9.2.1 | Product description |
9.2.2 | Other developmental activity |
9.2.3 | Clinical developmental activities |
9.2.3.1 | Clinical trial information |
9.2.4 | Safety and efficacy |
9.2.5 | Analyst Views |
9.3 | MGC026: MacroGenics |
*List to be continued in the full report | |
10 | B7-H3 Market: 7MM analysis |
10.1 | Key Findings |
10.2 | B7-H3 Market Outlook |
10.3 | Conjoint Analysis |
10.4 | Key B7-H3 Market Forecast Assumptions |
10.5 | United States B7-H3 Market Size |
10.5.1 | Market Size by Indications in the US |
10.5.2 | Market Size by Therapies in the US |
10.6 | EU4 and the UK B7-H3 Market Size |
10.7 | Japan B7-H3 Market Size |
11 | Unmet Needs |
12 | SWOT Analysis |
13 | KOL Views |
14 | B7-H3 Market Access and Reimbursement |
15 | Bibliography |
16 | B7-H3 Market Report Methodology |
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