HER2 Low Cancers Market: Epidemiology, Therapies, Companies, DelveInsight | Daiichi Sankyo and AstraZeneca, RemeGen and Pfizer (Seagen), Gilead Sciences, Duality Biologics and BioNTech, Immutep, Merck, Bliss Biopharmaceutical (Hangzhou), Zymeworks, Jazz P

HER2 Low Cancers 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, ZIIHERA (zanidatamab), and others, are expected to boost the HER2 Low Cancers Market in the upcoming years.

DelveInsight has launched a new report on "HER2 Low Cancers - Market Insights, Epidemiology, and Market Forecast-2034" that delivers an in-depth understanding of the HER2 Low Cancers, historical and forecasted epidemiology as well as the HER2 Low Cancers market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

Discover about the HER2 Low Cancers market report @ https://www.delveinsight.com/report-store/her2-low-cancers-market-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=kpr

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

As of 2024, the HER2-low cancer market was valued at approximately USD 1.6 billion in the US, the largest among the 7 major markets (7MM), and is projected to grow substantially by 2034.
In April, 2025, Allogene's allogeneic dual-targeted CAR‐T therapy ALLO‐329 (CD19/CD70) received Fast Track Designation for treatment of refractory HER2 Low Cancers (including dermatomyositis, necrotizing myopathy, anti-synthetase syndrome), alongside lupus and scleroderma indications. It's slated to enter a Phase I RESOLUTION trial by mid‐2025 with proof-of-concept expected by year-end.
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 data showed a 78% clinical improvement and 35% steroid reduction; a Phase II/III trial (IIMPACT) is expected in Q1 2025.
Among HER2-low cancers across the 7MM, breast cancer accounts for the majority of cases, followed by colorectal cancer, with ovarian cancer having the fewest. With an aging population, the prevalence of breast cancer in older adults is increasing, and HER2-low cases now represent over half of all traditional breast cancer diagnoses.

Until 2022, HER2-low patients were managed similarly to HER2-negative ones, primarily through chemotherapy or endocrine therapy, especially in HR-negative cases. A turning point occurred in August 2022, when the FDA approved ENHERTU (trastuzumab deruxtecan) for HER2-low breast cancer based on the DESTINY-Breast04 trial. This approval established HER2-low as a viable therapeutic target, setting the stage for further regulatory advances and a shift toward earlier-line treatments.

The HER2-low classification is now under investigation in various solid tumors, including gastric and urothelial cancers, expanding its therapeutic relevance. Leading companies in this evolving landscape 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 treatments targeting HER2-low cancers include TROP2-directed ADCs (like TRODELVY and DATROWAY), bispecific antibodies (zanidatamab), and immune therapies such as eftilagimod alpha, which stands out for its subcutaneous delivery, allowing for at-home administration and improved patient convenience.

Additionally, Dragonfly Therapeutics' DF1001, a novel dual NK and T cell engager, is being developed for heavily pretreated HER2-low cancer patients, offering a new immunotherapy approach.
In 2024, Japan had an estimated 15,000 cases of HER2-low urothelial carcinoma eligible for targeted therapies.
Looking forward, the HER2-low cancer space is set for significant growth, fueled by a strong pipeline, personalized treatment approaches, and rising global cancer incidence.
Key HER2 Low Cancers companies such as 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 are evaluating new drugs for HER2 Low Cancers to improve the treatment landscape.
Promising HER2 Low Cancers therapies 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.

HER2 Low Cancers Overview

HER2 is a transmembrane tyrosine kinase receptor encoded by the ERBB2 gene, playing a critical role in regulating cell growth, differentiation, and survival. It is part of the epidermal growth factor receptor (EGFR) family and is evaluated using standard molecular diagnostics-immunohistochemistry (IHC) for protein overexpression and fluorescence in situ hybridization (FISH) for gene amplification. The HER2-low category includes tumors with an IHC score of 1+ or 2+ but without gene amplification (FISH-negative or ISH-negative).

HER2/neu transmits signals primarily through the MAPK and PI3K pathways, promoting cancer development when overexpressed or amplified. Its expression is seen across a range of malignancies, including breast, colorectal, ovarian, endometrial, bladder, gastric, and biliary tract cancers, with breast cancer being the most prevalent.

The advent of novel antibody-drug conjugates (ADCs) has revolutionized treatment for HER2-low tumors, offering substantial survival benefits. A prominent example is ENHERTU, an advanced ADC that combines a HER2-targeted monoclonal antibody with a topoisomerase I inhibitor, delivering potent anti-cancer effects directly to HER2-expressing tumor cells.

HER2 Low Cancers Market Outlook

Current treatment strategies for HER2-low cancers-including gastric, endometrial, and other tumor types-are rapidly evolving as research sheds new light on the role of HER2 in these malignancies. Conventional therapies such as monoclonal antibodies and small-molecule tyrosine kinase inhibitors (TKIs) have shown limited effectiveness 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

To know what's more in our HER2 Low Cancers report, visit https://www.delveinsight.com/report-store/her2-low-cancers-market-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=kpr

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

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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.

Contact Info:

Kritika Rehani, Assistant Manager, Marketing & Branding
krehani@delveinsight.com
info@delveinsight.com
www.delveinsight.com
+14699457679

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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