B7-H3 Market Forecast

• The B7-H3 market is expected to grow significantly in the coming years due to the increasing number of patients who are being diagnosed with cancer, the growing awareness of B7-H3, and the increasing number of B7-H3-targeted therapies that are under clinical trials and filed for approval by various companies.
• B7-H3, a member of the same protein family as PD-L1, has gained attention as a promising alternative target in the wake of the success of immune checkpoint inhibitors in cancer immunotherapy. It is expressed in various organs as well as on immune cells such as heart, liver, spleen, T cells, B cells, NKs, DCs, and Tregs. 
• 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 lung cancers, ovarian cancer, Renal Cell Carcinoma (RCC), melanoma, and prostate cancer. Whereas, bladder cancer has a lower expression of B7-H3.
• Currently, no B7-H3 inhibitor has been approved by any regulatory body in the 7MM. However, the development pipeline includes several promising candidates, such as ifinatamab deruxtecan (DS-7300, I-DXd) (Daiichi Sankyo/Merck), BGB-C354 (BeOne Medicines [BeiGene]), DB-1311/BNT324 (BioNTech and DualityBio), GSK5764227 (HS-20093, GSK) and others. In addition, several agents are in preclinical stages including MGC026 (B7-H3-targeting antibody and a novel glycan-linked topoisomerase 1 inhibitor by MacroGenics), ILB-3101 (Innolake Biopharm), and others.
• In March 2025, MacroGenics terminated the evaluation of vobramitamab duocarmazine for the treatment of metastatic Castration-resistant Prostate Cancer (mCRPC). This was due to treatment-related deaths that caused in the Phase II TAMARACK study.
• In January 2025, GSK announced that the US Food and Drug Administration (FDA) ganted Breakthrough Therapy Designation (BTD) to GSK5764227 for the treatment of adult patients with relapsed or refractory osteosarcoma (bone cancer) who have progressed on at least two prior lines of therapy. 
• B7-H3 inhibitors represent an exciting new class of therapeutic agents with significant development potential. As ongoing studies mature over the coming years, they will provide deeper insights into the efficacy and safety of these agents and help clarify their role in cancer treatment.

DelveInsight’s “B7-H3 (CD276) – Target Population, Competitive Landscape, and Market Forecast – 2034” report delivers an in-depth understanding of the B7-H3, historical and Competitive Landscape as well as the B7-H3 inhibitor market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The B7-H3 market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM B7-H3 market size from 2020 to 2034. The B7-H3 antibodies market report also covers current B7-H3 treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the B7-H3 market’s potential.

B7-H3 Antibodies Market: Understanding 

B7-H3 Overview

B7-H3 (also known as CD276) inhibitors are a member of the B7 ligand family. It is a transmembrane receptor, highly prevalent in malignant cells, and plays an important role in adaptive immunity. In nonmalignant tissues, the B7-H3 inhibitors market has a predominantly inhibitory role in adaptive immunity, suppressing T-cell activation and proliferation. In malignant tissues, B7-H3 inhibits tumor antigen-specific immune responses, leading to a protumorigenic effect. B7-H3 also has nonimmunologic protumorigenic functions, such as promoting migration and invasion, angiogenesis, chemoresistance, and endothelial-to-mesenchymal transition, as well as affecting tumor cell metabolism. As a result, B7-H3 expression in tumors is associated with poor prognosis.

Targeted B7-H3 inhibitors, including Antibody-drug Conjugates (ADCs), radioimmunotherapy, and monoclonal antibodies, are a new class of antineoplastic agents showing promising preliminary clinical efficacy, observed with several of these agents against multiple tumor types. B7-H3 has recently received attention because of its significant demodulation and its immunomodulatory effects in many cancers.

Many antibody-based strategies utilizing distinct effector mechanisms to target B7-H3 expressing cancer cells have been developed. These strategies have demonstrated potent antitumor activity and acceptable safety profiles in preclinical models. Ongoing clinical trials are assessing their safety and efficacy in patients. Identification of the B7-H3 receptor will improve our understanding of its role in tumor immunity and will suggest rational strategies to develop blocking antibodies, which may enhance the therapeutic efficacy of tumor immunity.

Further details related to country-based variations are provided in the report…

B7-H3 (CD276) Epidemiology

The B7-H3 epidemiology chapter in the B7-H3 market report provides historical as well as forecasted epidemiology segmented as total cases of selected indications for B7-H3, total eligible patient pool in selected indications for B7-H3, and total treated cases in selected indication for B7-H3 in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034. 

• NSCLC accounts for approximately 85% of all diagnosed cases of lung cancer globally, and Small Cell Lung Cancer (SCLC) represents about 15%. This distribution highlights that NSCLC is the more prevalent form of lung cancer.
• In 2024, there were nearly 200,340 new cases of melanoma diagnosed in the US.
• In 2024, there were nearly 19,700 new cases of ovarian cancer diagnosed in the US.
• B7-H3 has been reported to be expressed in the nucleus of 30% of colon cancer and the expression of nuclear B7-H3 was associated with poor overall survival. 
• In 2024, the total prevalent cases of mCRPC in the US were around 51,700.
• In 2024, the total incident cases of breast cancer were nearly 297,800.

B7-H3 demonstrates high expression on stromal fibroblasts and tumor-associated vasculature.

B7-H3 (CD276) Drug Chapters

The drug chapter segment of the B7-H3 drugs market reports encloses a detailed analysis of late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the B7-H3 clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Emerging B7-H3 Drugs

Ifinatamab deruxtecan (DS-7300, I-DXd): Daiichi Sankyo/Merck

Ifinatamab deruxtecan (I-DXd) is a novel B7-H3–directed ADC. It is currently being evaluated in various clinical trials for the treatment of various indications such as SCLC, solid tumors, and others. It has been designed using Daiichi Sankyo’s proprietary DXd ADC technology to target and deliver a cytotoxic payload inside cancer cells that express a specific cell surface antigen, each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

In October 2023, the company came into a global development and commercialization agreement with Merck for three ADCs including ifinatamab deruxtecan to develop and potentially commercialize these ADC candidates worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. This signals further evaluation and planning for Esophageal Squamous Cell Carcinoma (ESCC), prostate cancer, and other indications.

BNT324/DB-1311: BioNTech/DualityBio

BNT324/DB-1311 is a next-generation topoisomerase-I-inhibitor-based ADC candidate targeting the immune checkpoint protein B7-H3. The transmembrane glycoprotein B7-H3 plays a critical role in the anti-tumor immune response and the shaping of the tumor microenvironment. Preclinical studies have shown that BNT324/DB-1311 exhibits antitumor activity in various solid tumor models. BNT324/DB-1311 is currently being evaluated in a Phase I/II clinical trial in patients with advanced or metastatic solid tumors.

In June 2024, BioNTech SE and and Duality Biologics announced that the US FDA granted Fast Track Designation (FTD) for BNT324/DB-1311 for the treatment of patients with advanced/unresectable, or mCRPC who have progressed on or after standard systemic regimens.

Note: Detailed emerging therapies assessment will be provided in the final report.

B7-H3 (CD276) Market Outlook 

The B7-H3-targeted therapies’ market is expected to grow significantly in the coming years. This is due to the increasing number of patients who are being diagnosed with cancer, the growing awareness of B7-H3, and the increasing number of B7-H3-targeted therapies that are under clinical trials and filed for approval by various companies. The B7-H3 protein is the key immune checkpoint that has gained attention in recent years for its properties differing from other checkpoint proteins, sparking interest among drug developers and researchers.

Currently, B7-H3-targeted therapies are not approved by any regulatory body but many pharma companies are developing B7-H3-targeted therapies and have their products in various stages of clinical studies. Until 2022, omburtamab (131I-8H9) developed by Y-mAbs Therapeutics was the farthest antibody candidate in B7-H3 Inhibitors clinical trials. It was tested in rare cancers like desmoplastic small round cell tumors, diffuse intrinsic pontine glioma, and CNS/leptomeningeal metastases from neuroblastoma in pediatric patients and as intrathecal immunotherapy for leptomeningeal/CNS metastases, but in 2022 FDA and EMA decided not to approve it.

Several key B7-H3 Manufacturers, including Daiichi Sankyo, Merck, GSK, Takeda, and others, are involved in developing drugs for B7-H3 for advanced solid tumors. Overall, this is an exciting new class of agents with great potential for development. The maturation of current studies over the next few years will lead to a better understanding of B7-H3 and define their role in the therapy of cancer.

B7-H3 (CD276) Drugs Uptake

This section focuses on the uptake rate of potential emerging B7-H3 expected to be launched in the B7-H3 market during 2025–2034.

B7-H3 (CD276) Pipeline Development Activities

The B7-H3 market report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key B7-H3 manufacturfers involved in developing targeted therapeutics. 

The presence of numerous drugs under different stages is expected to generate immense opportunity for B7-H3 market growth over the forecast period.

B7-H3 Clinical Trials Activities

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

KOL Views on B7-H3

To keep up with current and future B7-H3 market trends, we take Industry Experts’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on B7-H3' evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight’s analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Johns Hopkins Sidney Kimmel Cancer Center, UCSF Health, Memorial Sloan Kettering Cancer Center, and others.

Their opinion helps understand and validate current and emerging therapy treatment patterns or B7-H3 market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the B7-H3 therapeutics market and the unmet needs.

Qualitative Analysis

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

B7-H3 Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the B7-H3 market. It is provided to reduce the high costs and make the essential drugs affordable. Health Technology Assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. 

In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.

The B7-H3 market report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Key Updates on B7-H3 (CD276) Clinical Trials

• In May 2025, BioNTech and DualityBio presented the Phase I/II data targeting patients with mCRPC at the American Society of Clinical Oncology (ASCO) 2025.
• In May 2025, Daiichi Sankyo and Merck presented the Phase I/II data of ifinatamab deruxtecan for recurrent or metastatic solid tumors at ASCO 2025.
• In September 2024, the interim analysis of Phase II of ifinatamab deruxtecan for the treatment of pretreated extensive-stage SCLC was presented at the World Conference on Lung Cancer (WCLC24) 2024
• In August 2024, the FDA granted BTD to the B7-H3–targeted ADC, GSK5764227, for the treatment of patients with extensive-stage SCLC that has progressed on or following platinum-based chemotherapy. 

The abstract list is not exhaustive, will be provided in the final report

Scope of the B7-H3 Market Report

• The B7-H3 market report covers a segment of key events, an executive summary, and a descriptive overview of the B7-H3, explaining its mechanism, and therapies (emerging).
• Comprehensive insight into the competitive landscape, and forecasts, the future growth potential of treatment rate, drug uptake, and drug information have been provided.
• Additionally, an all-inclusive account of emerging B7-H3 therapies and the elaborative profiles of late-stage and prominent therapies will impact the current landscape.
• 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, covering the 7MM drug outreach.
• The B7-H3 antibodies market report provides an edge while developing business strategies, by understanding trends, through SWOT analysis, expert insights/KOL views, and treatment preferences that help shape and drive the 7MM B7-H3 market.

B7-H3 Market Report Insights

• B7-H3 Targeted Patient Pool
• Therapeutic Approaches
• B7-H3 Pipeline Analysis
• B7-H3 Market Size
• B7-H3 Market Trends
• Existing and Future B7-H3 Market Opportunity

B7-H3 Market Report Key Strengths

• Ten years Forecast
• The 7MM Coverage 
• Key Cross Competition 
• B7-H3 Drugs Uptake
• Key B7-H3 Market Forecast Assumptions

B7-H3 Market Report Assessment

• Current Treatment Practices
• B7-H3 Unmet Needs
• B7-H3 Pipeline Product Profiles
• B7-H3 Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions

• What was the B7-H3 market size, the market size by therapies, market share (%) distribution, and what would it look like in 2034? What are the contributing factors for this growth?
• Which B7-H3 drug is going to be the largest contributor in 2034?
• Which is the most lucrative market for B7-H3?
• What are the risks, burdens, and unmet needs of treatment with B7-H3? What will be the growth opportunities across the 7MM for the patient population of B7-H3?
• What are the key factors hampering the growth of the B7-H3 market?
• What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
• What key designations have been granted to the therapies for B7-H3?
• What is the cost burden of approved B7-H3 therapies on the patient?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved B7-H3 therapies? 

Reasons to buy

• The B7-H3 market report will help develop business strategies by understanding the latest trends and changing dynamics driving the B7-H3 Market.
• Understand the existing B7-H3 market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan.
• Identifying strong upcoming B7-H3 companies in the B7-H3 market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• 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, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing B7-H3 market so that the upcoming B7-H3 companies can strengthen their development and launch strategy.