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HER2-low cancers market

The HER2-low cancers market across the seven major markets (7MM), the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, is poised for significant expansion over the coming decade. Valued at USD 3,530 million in 2025, the market is projected to reach approximately USD 8,997 million by 2034, growing at an impressive CAGR of 11% during the forecast period.

The United States is expected to remain the dominant contributor to market revenue, driven by a large patient pool, higher diagnosis rates, and rapid adoption of advanced targeted therapies. The EU4 and the UK collectively account for a considerable share of the global patient population, while Japan continues to play a notable role in the evolving HER2-low treatment landscape.

The HER2-low category represents a newly defined subgroup of cancers, particularly within breast cancer, characterized by low levels of HER2 expression. In 2024, the HER2-low breast cancer target population was estimated at around 64,000 cases, a figure anticipated to rise steadily through the forecast period due to improved diagnostic precision and awareness.

Despite the availability of traditional chemotherapy and endocrine-based therapies, significant unmet needs persist in the management of HER2-low cancers, especially in patients exhibiting resistance to standard treatment options. The emergence of antibody-drug conjugates (ADCs) has transformed the therapeutic paradigm, offering more effective and targeted approaches.

Leading pharmaceutical companies such as AstraZeneca and Daiichi Sankyo (with DATROWAY), Pfizer (disitamab vedotin), Gilead Sciences (TRODELVY), Duality Biologics and BioNTech (DB-1303/BNT323), Bliss Biopharmaceutical (BB-1701), and Daiichi Sankyo and Merck (ifinatamab deruxtecan) are at the forefront of innovation, actively advancing their clinical pipelines to expand treatment options and improve patient outcomes.

The HER2-low cancers market is on track for strong, sustained growth through 2034, propelled by advancements in molecular diagnostics, the expanding use of next-generation ADCs, and increased recognition of HER2-low as a distinct and actionable biomarker subgroup.

DelveInsight’s report, “HER2-low Cancers Market Insights, Epidemiology, and Market Forecast – 2034,” provides a comprehensive analysis of the evolving landscape. The report offers detailed insights into disease epidemiology, treatment dynamics, and competitive developments across major markets, empowering stakeholders with strategic intelligence for informed decision-making, investment, and research planning.

Some of the key facts of the HER2-low Cancers Market Report:

• The leading HER2-low Cancers Companies developing therapies include Daiichi Sankyo, AstraZeneca, RemeGen, Pfizer (Seagen), Gilead Sciences, Duality Biologics, BioNTech, Immutep, Merck, Bliss Biopharmaceutical (Hangzhou), Zymeworks/Jazz Pharmaceuticals/ALX Oncology, Dragonfly Therapeutics, and others.

• Potential future therapies for HER2-low Cancers include ENHERTU, DATROWAY (datopotamab deruxtecan), AIDIXI (disitamab vedotin), TRODELVY (sacituzumab govitecan), DB-1303/BNT323 (trastuzumab pamirtecan), Eftilagimod alpha (IMP321), Ifinatamab deruxtecan, BB-1701, ZIIHERA (zanidatamab), and others.

• The future of HER2-low Cancers treatment holds promise, driven by ongoing research and the development of innovative therapies. Current management strategies, such as symptomatic medications, physical therapy, and supportive care, remain essential.

HER2-low Cancers Overview

HER2, a transmembrane tyrosine kinase receptor encoded by the ERBB2 gene, plays a crucial role in regulating cell growth, differentiation, and survival. Belonging to the epidermal growth factor receptor (EGFR) family, HER2 status is typically assessed through molecular diagnostic methods—immunohistochemistry (IHC) is used to evaluate protein overexpression, while fluorescence in situ hybridization (FISH) detects gene amplification.

HER2-low tumors are defined by an IHC score of 1+ or 2+ without amplification on in situ hybridization (ISH), indicating FISH-negative results. Functionally, HER2/neu mediates downstream signaling primarily via the MAPK and PI3K pathways, promoting malignant transformation when overexpressed or amplified. HER2 expression has been identified in multiple cancer types, including breast, colorectal, ovarian, endometrial, gastric, bladder, and biliary tract cancers, with breast cancer being the most prevalent.

The advent of novel antibody-drug conjugates (ADCs) has revolutionized the therapeutic landscape for HER2-low cancers, offering improved efficacy and extended survival outcomes. Among these, ENHERTU (trastuzumab deruxtecan) represents a breakthrough ADC that combines a HER2-targeting monoclonal antibody with a topoisomerase I inhibitor payload, delivering potent and targeted cytotoxic activity to HER2-expressing tumor cells.

Key Factors Driving Growth in the HER2-low Cancers Market

• Recognition of HER2-low as a Distinct Clinical Subtype: The reclassification of HER2-low tumors as a separate and actionable subgroup has expanded the eligible patient population for targeted therapies, particularly within breast and gastric cancers. This evolving understanding has created new therapeutic opportunities and driven significant market interest.

• Advancements in Antibody-Drug Conjugate (ADC) Technology: The emergence of next-generation ADCs such as ENHERTU (trastuzumab deruxtecan) and TRODELVY (sacituzumab govitecan) has transformed the treatment landscape. These therapies combine precise targeting of HER2-expressing cells with potent cytotoxic payloads, offering improved efficacy and survival outcomes in HER2-low patients.

• Expanding Research and Clinical Development: A robust pipeline of innovative agents—including DATROWAY (AstraZeneca/Daiichi Sankyo), disitamab vedotin (Pfizer), DB-1303/BNT323 (Duality Biologics/BioNTech), and BB-1701 (Bliss Biopharmaceutical)—is expected to further strengthen the treatment armamentarium, supporting long-term market growth.

• Improved Diagnostic Capabilities: Advances in IHC and ISH/FISH testing, along with the integration of digital pathology and AI-based image analysis, have enhanced the precision of HER2 expression detection. These improvements enable better patient stratification and optimal therapy selection, contributing to higher adoption of targeted therapies.

• Rising Disease Awareness and Screening Rates: Increased awareness of HER2-low status among clinicians, combined with growing efforts in molecular profiling and biomarker testing, is driving earlier identification of eligible patients, thereby expanding the treatment-eligible population.

Recent Developments in HER2-low Cancers Clinical Trials:

• In October 2025, AstraZeneca/Daiichi Sankyo reported that DATROWAY demonstrated a statistically significant and clinically meaningful improvement in both overall survival (OS) and progression-free survival (PFS) versus investigator’s choice chemotherapy as first-line therapy for metastatic triple-negative breast cancer (TNBC) patients ineligible for immunotherapy — a high-impact Phase III result that broadens ADC utility beyond HER2-low breast tumors and may drive label expansions and uptake.

• In September 2025, the FDA granted Priority Review to an application evaluating trastuzumab deruxtecan plus pertuzumab as a first-line HER2-positive metastatic breast cancer regimen, an action that underscores continued regulatory activity around T-DXd combinations and could influence labeling/usage considerations for HER2-expressing subgroups.

• Companies (notably Daiichi Sankyo / AstraZeneca) flagged additional DESTINY and other T-DXd program readouts to be presented at conferences and in company releases in Q4 2025, expanding evidence across subtypes and lines of therapy.

Learn more about the recent advancements in HER2-low Cancers treatment landscape @ HER2-low Cancers Recent Developments

HER2-low Cancers Epidemiology

• In 2024, the HER2-low breast cancer target population was estimated at around 64,000 cases, with numbers expected to rise steadily over the forecast period.

• Age-specific analysis revealed that patients aged 60–69 years represented the largest segment, contributing approximately 30% of all HER2-low breast cancer cases.

• Across the EU4 and the United Kingdom, Stage I breast cancer accounted for the highest proportion, with nearly 31,000 cases reported in 2024.

• Meanwhile, in Japan, the HER2-low urothelial carcinoma target population was estimated at approximately 15,000 cases during the same year.

HER2-low Cancers Epidemiology Segmentation

• Total targeted HER2-low cancers patient pool

• Treatment eligible pool of HER2-low cancers

• Total incident cases of breast cancer

• Age-specific cases of HER2-low breast cancers

• Stage-specific cases of HER2-low breast cancers

HER2-low Cancers Marketed Drugs

• ENHERTU (trastuzumab deruxtecan): Daiichi Sankyo and AstraZeneca

HER2-low Cancers Emerging Drugs

• DATROWAY (datopotamab deruxtecan/Dato-DXd): AstraZeneca and Daiichi Sankyo

• DB-1303/BNT323 (trastuzumab pamirtecan): Duality Biologics and BioNTech

HER2-low Cancers Market Barriers

• Diagnostic Challenges and Lack of Standardization: Despite advancements in testing, accurately identifying HER2-low status remains challenging. Variability in IHC scoring, inter-laboratory inconsistencies, and subjective interpretation often lead to misclassification, limiting the identification of eligible patients for targeted therapies.

• Limited Awareness Among Clinicians and Pathologists: Many healthcare professionals are still adapting to the redefined HER2-low classification. Limited awareness and understanding of its clinical relevance can delay appropriate treatment decisions and reduce adoption of advanced HER2-targeted therapies.

• High Cost of ADC Therapies: Next-generation antibody-drug conjugates (ADCs) such as ENHERTU and DATROWAY offer remarkable efficacy but come with substantial treatment costs. The financial burden associated with these premium therapies may restrict access, particularly in regions with constrained healthcare budgets or limited reimbursement.

Scope of the HER2-low Cancers Market Report:

• Study Period: 2020–2034

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

• Key HER2-low Cancers Companies: Daiichi Sankyo, AstraZeneca, RemeGen, Pfizer (Seagen), Gilead Sciences, Duality Biologics, BioNTech, Immutep, Merck, Bliss Biopharmaceutical (Hangzhou), Zymeworks/Jazz Pharmaceuticals/ALX Oncology, Dragonfly Therapeutics, and others

• Key HER2-low Cancers Therapies: ENHERTU, DATROWAY (datopotamab deruxtecan), AIDIXI (disitamab vedotin), TRODELVY (sacituzumab govitecan), DB-1303/BNT323 (trastuzumab pamirtecan), Eftilagimod alpha (IMP321), Ifinatamab deruxtecan, BB-1701, ZIIHERA (zanidatamab), and others

• HER2-low Cancers Therapeutic Assessment: HER2-low Cancers current marketed and HER2-low Cancers emerging therapies

• HER2-low Cancers Market Dynamics: HER2-low Cancers market drivers and HER2-low Cancers market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• HER2-low Cancers Unmet Needs, KOL’s views, Analyst’s views, HER2-low Cancers Market Access and Reimbursement

About DelveInsight

DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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