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"HER2 Low Cancers Market"The HER2-low cancers market is projected to grow at a CAGR of 11%, reaching USD 8,997 million by 2034 in leading countries (US, EU4, UK and Japan).

Innovative therapies such as ENHERTU, DATROWAY (datopotamab deruxtecan), AIDIXI (disitamab vedotin), TRODELVY (sacituzumab govitecan), DB-1303, BNT323 (trastuzumab pamirtecan), Eftilagimod alpha (IMP321), Ifinatamab deruxtecan, BB-1701, and ZIIHERA (zanidatamab) are poised to significantly drive the HER2 Low Cancers market in the coming years.

DelveInsight's newly released report,“HER2 Low Cancers – Market Insights, Epidemiology, and Market Forecast 2034,” provides a comprehensive overview of the disease, analyzing both historical and projected epidemiology along with evolving market trends across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

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Some of the key facts of the HER2 Low Cancers Market Report:

• As of 2024, the HER2-low cancer market in the United States was valued at approximately USD 1.6 billion, making it the largest among the 7 major markets (7MM), with substantial growth projected through 2034.

• In April 2025, Allogene's allogeneic dual-targeted CAR‐T therapy ALLO‐329 (CD19/CD70) received FDA Fast Track Designation for refractory HER2-low cancers, including dermatomyositis, necrotizing myopathy, and anti–synthetase syndrome, as well as lupus and scleroderma. The therapy is expected to enter a Phase I RESOLUTION trial by mid‐2025, with proof-of-concept results anticipated by year-end.

• Earlier, in January 2025, RESTEM's umbilical cord stem cell therapy Restem‐L was granted FDA Fast Track status and Orphan Drug Designation for polymyositis and dermatomyositis. Phase I results showed 78% clinical improvement and a 35% reduction in steroid use, with a Phase II/III IIMPACT trial expected in Q1 2025.

• Among HER2-low cancers in the 7MM, breast cancer accounts for the majority, followed by colorectal cancer, while ovarian cancer represents the fewest cases. The prevalence of breast cancer in older adults is rising, and HER2-low cases now constitute over half of all breast cancer diagnoses.

• Until 2022, HER2-low patients were generally treated like HER2-negative cases, primarily with chemotherapy or endocrine therapy, especially in HR-negative patients. A significant milestone came in August 2022, when the FDA approved ENHERTU (trastuzumab deruxtecan) for HER2-low breast cancer based on the DESTINY-Breast04 trial, establishing HER2-low as a clinically actionable target and paving the way for earlier-line therapies and additional regulatory approvals.

• The HER2-low classification is now being explored in multiple solid tumors, including gastric and urothelial cancers, broadening its therapeutic relevance. Leading companies in this evolving space include AstraZeneca and Daiichi Sankyo (DATROWAY), Pfizer (disitamab vedotin), Gilead Sciences (TRODELVY), Duality Biologics and BioNTech (DB-1303/BNT323), Bliss Biopharmaceutical (BB-1701), and Merck and Daiichi Sankyo (ifinatamab deruxtecan).

• Emerging therapies targeting HER2-low cancers include TROP2-directed ADCs (such as TRODELVY and DATROWAY), bispecific antibodies (e.g., zanidatamab), and immune-based therapies like eftilagimod alpha, notable for its subcutaneous delivery, which allows at-home administration and greater patient convenience.

• Additionally, Dragonfly Therapeutics' DF1001, a dual NK and T cell engager, is under development for heavily pretreated HER2-low cancer patients, offering a novel immunotherapy approach.

• In 2024, Japan reported approximately 15,000 cases of HER2-low urothelial carcinoma eligible for targeted treatment. Looking ahead, the HER2-low cancer market is expected to expand significantly, driven by a robust pipeline, personalized therapies, and increasing global cancer incidence.

• Key companies advancing the HER2-low treatment landscape include Daiichi Sankyo and AstraZeneca, RemeGen and Pfizer (Seagen), Gilead Sciences, Duality Biologics and BioNTech, Immutep, Merck, Bliss Biopharmaceutical (Hangzhou), Zymeworks, Jazz Pharmaceuticals, ALX Oncology, Dragonfly Therapeutics, and others.

• Promising therapies in development 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), among others.

HER2 Low Cancers Overview

HER2 is a transmembrane tyrosine kinase receptor encoded by the ERBB2 gene, playing a key role in regulating cell growth, differentiation, and survival. As a member of the epidermal growth factor receptor (EGFR) family, HER2 status is typically assessed using molecular diagnostics: immunohistochemistry (IHC) to detect protein overexpression and fluorescence in situ hybridization (FISH) to evaluate gene amplification. The HER2-low category refers to tumors with an IHC score of 1+ or 2+ without evidence of gene amplification (FISH-negative or ISH-negative).

HER2/neu primarily signals through the MAPK and PI3K pathways, driving cancer progression when overexpressed or amplified. HER2 expression occurs in multiple cancers, including breast, colorectal, ovarian, endometrial, bladder, gastric, and biliary tract cancers, with breast cancer being the most common.

The emergence of novel antibody-drug conjugates (ADCs) has transformed the treatment of HER2-low tumors, providing meaningful survival advantages. A notable example is ENHERTU, an advanced ADC that links a HER2-targeted monoclonal antibody to a topoisomerase I inhibitor, enabling targeted delivery of cytotoxic therapy to HER2-expressing tumor cells.

HER2 Low Cancers Market Outlook

Treatment approaches for HER2-low cancers, including gastric, endometrial, and other tumor types, are rapidly advancing as emerging research provides deeper insights into HER2's role in these malignancies. Traditional therapies, such as monoclonal antibodies and small-molecule tyrosine kinase inhibitors (TKIs), have demonstrated limited efficacy in breast cancers with low HER2 expression.

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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

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 and AstraZeneca, RemeGen and Pfizer (Seagen), Gilead Sciences, Duality Biologics and 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

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Key benefits of the HER2 Low Cancers Market Report:

HER2 Low Cancers market report covers a descriptive overview and comprehensive insight of the HER2 Low Cancers Epidemiology and HER2 Low Cancers market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).

The HER2 Low Cancers market report provides insights into the current and emerging therapies.

The HER2 Low Cancers market report provides a global historical and forecasted market covering drug outreach in 7MM.

The HER2 Low Cancers market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the HER2 Low Cancers market.

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Table of Contents

1. Report Introduction

2. Executive Summary

3. SWOT analysis

4. HER2 Low Cancers Patient Share (%) Overview at a Glance

5. HER2 Low Cancers Market Overview at a Glance

6. HER2 Low Cancers Disease Background and Overview

7. HER2 Low Cancers Epidemiology and Patient Population

8. Country-Specific Patient Population of HER2 Low Cancers

9. HER2 Low Cancers Current Treatment and Medical Practices

10. Unmet Needs

11. HER2 Low Cancers Emerging Therapies

12. HER2 Low Cancers Market Outlook

13. Country-Wise HER2 Low Cancers Market Analysis (2020–2034)

14. Market Access and Reimbursement of Therapies

15. Market drivers

16. Market barriers

17. Appendix

18. HER2 Low Cancers Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

Click here to read more about HER2 Low Cancers Market Outlook 2034

Related Reports:

HER2 Low Cancers Pipeline Insights, DelveInsight

"HER2 Low Cancers Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the HER2 Low Cancers market. A detailed picture of the HER2 Low Cancers pipeline landscape is provided, which includes the disease overview and HER2 Low Cancers treatment guidelines.

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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