B7-H4 Targeting Therapies Market Growth Set to Accelerate Across the 7MM During the Study Period (2025-2040) with Advances in Immunotherapy | DelveInsight

The market for B7-H4 targeted therapies is projected to experience substantial growth in the coming years, driven by a rising incidence of cancer diagnoses, growing awareness of the B7-H4 biomarker, and an expanding pipeline of B7-H4-targeted treatments currently in clinical development.

LAS VEGAS, July 24, 2025 /PRNewswire/ -- DelveInsight's B7-H4 Targeting Therapies 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 NSCLC, Ovarian Cancer, Endometrial Cancer, Triple Negative Breast Cancer, Biliary Tract Cancer, and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging B7-H4 targeting therapies, market share of individual therapies, and current and forecasted market size from 2020 to 2040, segmented into 7MM.

Key Takeaways from the B7-H4 Targeting Therapies Market Report

• As per DelveInsight's analysis, the total market size of B7-H4 targeting therapies in the 7MM is expected to surge significantly by 2040.
• The report provides the total potential number of patients in the indications, such as NSCLC, Ovarian Cancer, Endometrial Cancer, Triple Negative Breast Cancer, Biliary Tract Cancer, and others.
• Leading B7-H4 targeting therapies companies, such as AstraZeneca, Pfizer (Seagen), Mersana Therapeutics, GlaxoSmithKline, NextCure, and others, are developing novel B7-H4 targeting therapies that can be available in the B7-H4 targeting therapies market in the coming years. 
• Some of the key B7-H4 targeting therapies in the pipeline include Puxitatug samrotecan (AZD8205), Felmetatug vedotin, Emiltatug ledadotin, GSK5733584, LNCB74, and others.
• In January 2025, the FDA granted an additional Fast Track Designation (FTD) to emiltatug ledadotin for the treatment of advanced or metastatic breast cancer in patients with human epidermal growth factor receptor 2 (HER2) low (IHC 1+ or IHC 2+/ISH–) or HER2-negative (IHC 0) disease, including triple-negative breast cancer (TNBC).

Discover which indication is expected to grab the major B7-H4 targeting therapies market share @ B7-H4 Targeting Therapies Market Report

B7-H4 Targeting Therapies Market Dynamics

The B7-H4 targeting therapies market is rapidly emerging as a promising frontier in immuno-oncology. B7-H4 is a member of the B7 family of immune checkpoint molecules that has been implicated in tumor immune evasion. It is highly expressed in a wide range of solid tumors, including breast, ovarian, endometrial, and non-small cell lung cancers, while its expression in normal tissues is relatively limited. This differential expression has made B7-H4 an attractive therapeutic target, particularly for ADCs, monoclonal antibodies, and T-cell engagers.

A key driver of the market is the growing recognition of B7-H4's immunosuppressive role within the tumor microenvironment, where it inhibits T-cell activation and contributes to immune escape. As immune checkpoint inhibitors targeting PD-1/PD-L1 and CTLA-4 reach saturation in terms of patient eligibility and response, there is a strong push to identify novel checkpoints like B7-H4. Companies are now investing in developing B7-H4-targeted ADCs, which utilize cytotoxic payloads to selectively eliminate B7-H4-expressing tumor cells, showing encouraging preclinical and early clinical results.

The competitive landscape is witnessing increasing activity, with several biotech and pharmaceutical players entering this space through internal R&D or strategic collaborations. Partnerships and licensing agreements are likely to intensify as companies seek to combine B7-H4 therapies with existing immunotherapies or targeted agents to enhance treatment efficacy. Additionally, advancements in biomarker development are enabling better patient stratification, which is critical for B7-H4-targeting strategies, given its heterogeneous expression across tumor types and stages.

Despite the enthusiasm, the market also faces several challenges. These include limited understanding of B7-H4's broader biological functions, potential on-target off-tumor toxicities, and the need for robust companion diagnostics. Moreover, clinical trials are still in early phases, and long-term safety and efficacy data are lacking. Regulatory hurdles and competition from other novel checkpoints, such as TIGIT, LAG-3, and TIM-3, could also influence the pace and direction of market growth.

Overall, the B7-H4 targeting therapies market holds strong potential to reshape cancer immunotherapy, particularly for patients who are refractory to current checkpoint inhibitors. As clinical validation continues and combination strategies evolve, the coming years could witness a transformation in how immune escape mechanisms like B7-H4 are tackled in precision oncology.

B7-H4 Targeting Therapies Treatment Market 

B7-H4 has emerged as a promising biomarker and therapeutic target across several indications, including cancer, inflammatory disorders, autoimmune conditions, and organ transplant settings. It is currently under early-stage development, primarily for advanced solid tumors.

Therapies targeting B7-H4 generally exhibit a manageable safety profile, with no infusion-related reactions reported. Common side effects include fatigue, neutropenia, anemia, neuropathy, and gastrointestinal disturbances. Adverse effects related to antibody-drug conjugates are consistent with those seen in traditional cytotoxic treatments.

B7-H4-directed ADCs have demonstrated encouraging activity in various cancers, including bladder, ovarian, and breast tumors. There remains a significant unmet need for effective and well-tolerated targeted therapies in these cancers, especially among patients who have relapsed or become resistant to standard treatments.

Learn more about the B7-H4 targeting therapies @ B7-H4 Targeting Therapies Analysis

Key Emerging B7-H4 Targeting Therapies and Companies

Several key players, including AstraZeneca (Puxitatug samrotecan), Mersana Therapeutics (Emiltatug ledadotin), Pfizer (Seagen) (Felmetatug vedotin), GSK (GSK5733584), and others, are involved in developing drugs for B7-H4 for various indications such as breast cancer, non-small cell lung cancer, and others.

Felmetatug vedotin is an investigational antibody-drug conjugate (ADC) built on the vedotin platform. It consists of a human monoclonal antibody targeting B7-H4, linked to the cytotoxic agent monomethyl auristatin E (MMAE) through a protease-cleavable maleimidocaproyl valine citrulline (mc-vc) linker. This vedotin linker-payload technology has been clinically validated in several FDA-approved therapies, including brentuximab vedotin, enfortumab vedotin, and tisotumab vedotin. Felmetatug vedotin is currently in Phase I clinical trials for the treatment of advanced solid tumors such as ovarian, peritoneal, and triple-negative breast cancers, among others. Early results from the trial demonstrated objective responses in 7 of 28 breast cancer patients and 4 of 20 ovarian cancer patients. Additionally, 1 out of 16 patients with endometrial cancer achieved a complete response.

In December 2023, Pfizer finalized its acquisition of Seagen, purchasing all outstanding common shares for $229 per share in cash, amounting to a total enterprise value of approximately $43 billion.

Emiltatug ledadotin is another B7-H4-targeting ADC, utilizing Mersana's Dolasynthen platform. It features a precisely engineered drug-to-antibody ratio (DAR) of 6 and a proprietary payload designed to deliver a controlled bystander effect. B7-H4 is highly expressed in several tumor types, including breast, ovarian, and endometrial cancers. In 2022, Mersana launched a multicenter Phase I clinical trial to evaluate the safety, tolerability, and preliminary efficacy of emiltatug ledadotin in patients with solid tumors, including those affecting the breast, ovary, and endometrium. The U.S. FDA has granted Fast Track Designation to the drug for adults with advanced or metastatic triple-negative breast cancer.

Initial results from the Phase I trial indicated that emiltatug ledadotin was generally well tolerated. No Grade 4 or 5 treatment-related adverse events (TRAEs) were observed. The most common TRAEs of any grade included transient increases in AST (38%), asymptomatic and reversible proteinuria (31%), mild nausea (29%), and fatigue (28%). Grade 3 TRAEs occurring in 5% or more of patients were limited to AST elevation (14%) and proteinuria (9%).

The anticipated launch of these emerging therapies are poised to transform the B7-H4 Targeting Therapies 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-H4 Targeting Therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

To know more about B7-H4 targeting therapies clinical trials, visit @ B7-H4 Targeting Therapies Treatment 

B7-H4 Targeting Therapies Overview

B7-H4, a key member of the B7 protein family, is abnormally expressed in various conditions such as cancer, inflammation, and autoimmune disorders. It acts as a negative regulator of the T cell immune response, contributing to immune evasion by suppressing T cell proliferation, cytokine production, and cell cycle progression. B7-H4 is also critically involved in cancer initiation and progression, influencing processes like cell growth, invasion, metastasis, and resistance to cell death. Beyond oncology, B7-H4 plays additional biological roles, including protecting against type 1 diabetes and supporting islet cell transplantation. Given these functions, B7-H4 has gained attention as a potential biomarker and therapeutic target in cancer, immune-related diseases, and transplantation.

As a transmembrane protein, B7-H4 has attracted significant interest in solid tumor therapy, particularly in the development of antibody-drug conjugates (ADCs) targeting this pathway. Notably, its overexpression has been documented in several cancers, including ovarian, lung, renal, breast, and gastric tumors. Elevated B7-H4 levels in these cancers are often linked with larger tumor size, higher tumor grade, and reduced patient survival. Its role in tumor progression is mediated through multiple mechanisms, including enhanced proliferation, invasion, metastasis, and inhibition of apoptosis.

B7-H4 Targeting Therapies Epidemiology Segmentation

The B7-H4 targeting therapies market report proffers epidemiological analysis for the study period 2020–2040 in the 7MM, segmented into:

• Total Cases of Selected Indications for B7-H4
• Total Eligible Patient Pool of Selected Indications for B7-H4
• Total Treated Cases of Selected Indications for B7-H4 

Scope of the B7-H4 Targeting Therapies Market Report

• B7-H4 Targeting Therapies Therapeutic Assessment: B7-H4 Targeting Therapies current marketed and emerging therapies
• B7-H4 Targeting Therapies Market Dynamics: Conjoint Analysis of Emerging B7-H4 Targeting Therapies Drugs
• Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Unmet Needs, KOL's views, Analyst's views, B7-H4 Targeting Therapies Market Access and Reimbursement

Discover more about B7-H4 targeting therapies in development @ B7-H4 Targeting Therapies Clinical Trials

Table of Contents

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