Emerging therapies such as Pyrotinib, DZD9008, Mobocertinib (TAK-788), among others, are anticipated to drive significant growth in the HER2+ Non-Small Cell Lung Cancer market in the coming years.
DelveInsight has introduced a new report, “HER2+ Non-Small Cell Lung Cancer – Market Insights, Epidemiology, and Market Forecast 2034,” offering a comprehensive analysis of the disease, including historical and projected epidemiology, as well as 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+ Non Small Cell Lung Cancer Market Report:
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The HER2+ NSCLC market (mutations, overexpression, and amplification) across the 7MM was estimated at ~USD 850 million in 2023 and is forecasted to grow to ~USD 3,110 million by 2034, reflecting a CAGR of 13.2%. NSCLC accounts for 80–85% of all lung cancers, with HER2+ mutations observed in 1–4% of cases. Additionally, HER2+ amplification occurs in 2–5% and HER2+ overexpression in 2–30% of NSCLC patients in the US.
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In May 2025, Emrelis was approved as the first FDA therapy targeting c-Met overexpression in adults with previously treated advanced non-squamous NSCLC.
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In December 2024, Zenocutuzumab-zbco became the first FDA-approved therapy for NRG1 gene fusion-positive NSCLC, addressing a rare subset of patients with disease progression after systemic therapy.
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In April 2024, Enhertu (trastuzumab deruxtecan) gained approval as the first tumor-agnostic HER2-directed therapy for adults with unresectable or metastatic HER2-positive (IHC 3+) solid tumors, including NSCLC, who had received prior systemic therapy.
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Current treatment options for HER2-mutant NSCLC include chemotherapy, immunotherapy, targeted therapy, surgery, radiation, laser therapy, and photodynamic therapy. At present, ENHERTU remains the only FDA-approved therapy for HER2+ (ERBB2) mutant NSCLC after prior systemic treatment, having received accelerated approval in August 2022. However, it is limited to later-line settings, leaving unmet needs in the first-line treatment space.
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Recently, new selective oral HER2+ tyrosine kinase inhibitors (TKIs) have been developed, aiming to improve patient outcomes and potentially challenge ENHERTU’s market dominance.
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The HER2+ NSCLC pipeline features several promising candidates, including Pyrotinib (Jiangsu HengRui Medicine), Zongertinib (Boehringer Ingelheim), BAY 2927088 (Bayer), FWD1509 (Forward Pharmaceuticals), ORIC-114 (ORIC Pharmaceuticals), IAM1363 (Iambic Therapeutics), Firmonertinib (ArriVent BioPharma), and XMT-2056 (Mersana Therapeutics/GSK), currently in different stages of clinical development. These therapies are expected to significantly impact the market from 2024 to 2034.
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In the US, the total diagnosed NSCLC cases by stage in 2023 were approximately: 59,400 (Stage I), 16,900 (Stage II), 26,700 (Stage IIIA), 11,200 (Stage IIIB), and 88,300 (Stage IV).
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In the same year, incident cases of advanced HER2+ NSCLC included ~6,000 with HER2+ mutations, ~32,400 with HER2+ overexpression, and ~8,100 with HER2+ amplification.
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Key HER2+ NSCLC companies such as Spectrum Pharmaceuticals, AstraZeneca, Daiichi Sankyo, Jiangsu HengRui Medicine, Dizal Pharmaceuticals, Takeda Pharmaceuticals, and others are actively working on innovative therapies to enhance the treatment landscape.
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Promising HER2+ NSCLC therapies include Pyrotinib, DZD9008, Mobocertinib (TAK-788), and others.
Her2+ Non Small Cell Lung Cancer Overview
HER2+ (ERBB2) is a receptor tyrosine kinase encoded by the ERBB2 proto-oncogene, located on chromosome 17’s long arm (17q21). It is a member of the EGFR/ErbB receptor family, which also includes HER1/EGFR, HER3, and HER4. Unlike other family members, HER2+ has no identified ligand. Its activation occurs via homodimerization or heterodimerization with another ligand-bound HER receptor, triggering cross-phosphorylation and subsequent activation of its tyrosine kinase domain.
In non-small cell lung cancer (NSCLC), HER2+ dysregulation occurs mainly through three mechanisms:
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Gene mutation
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Gene amplification
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Protein overexpression
Each alteration arises through distinct processes, leading to unique biological and clinical outcomes. These HER2+ abnormalities affect tumor cell behavior and patient prognosis, making them critical factors in guiding treatment strategies for NSCLC.
Symptoms of HER2+ NSCLC often include:
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Persistent cough
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Chest pain
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Shortness of breath
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Wheezing
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Loss of appetite
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Weight loss
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Fatigue
Her2+ Non Small Cell Lung Cancer Market Outlook
HER2+ alterations are major oncogenic drivers in NSCLC. Recent years have seen significant advances in understanding HER2+-driven disease and assessing the efficacy of therapies targeting HER2+. Currently, platinum-based chemotherapy, with or without immunotherapy, remains the first-line treatment for patients with advanced or metastatic HER2+ NSCLC. Historically, standard therapies—including chemotherapy, immunotherapy, checkpoint inhibitors, and targeted cell therapies—have achieved a median progression-free survival (PFS) of only ~4 months, emphasizing the urgent need for improved treatment options.
ENHERTU (trastuzumab deruxtecan) received FDA approval in August 2022 for HER2+-mutant NSCLC patients previously treated with systemic therapy, representing a major advancement in care. It subsequently gained approval from Japan’s MHLW in August 2023, followed by European regulatory approval in September 2023.
The HER2+ NSCLC treatment landscape is evolving rapidly as research uncovers more about the genetic drivers of these tumors. Emerging therapies such as Pyrotinib (Jiangsu HengRui Medicine), Zongertinib (Boehringer Ingelheim), and BAY2927088 (Bayer) are gaining attention for HER2+-mutant NSCLC. The development of these HER2-targeted tyrosine kinase inhibitors (TKIs) highlights a shift toward more selective and effective treatments. Other candidates, including FWD1509 (Forward Pharmaceuticals), IAM1363 (Iambic Therapeutics), ORIC-114 (ORIC Pharmaceuticals), Firmonertinib (ArriVent BioPharma), and others, are progressing through clinical trials, fostering innovation and competition in the HER2+ NSCLC space. Combination therapies are also being explored to further enhance the efficacy of anti-HER2 treatments.
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Her2+ Non Small Cell Lung Cancer Marketed Drugs
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ENHERTU (trastuzumab deruxtecan): Daiichi Sankyo and AstraZeneca
Her2+ Non Small Lung Cancer Emerging Drugs
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Zongertinib (BI-1810631): Boehringer Ingelheim
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BAY 2927088: Bayer
Scope of the Her2+ Non Small Cell Lung Cancer Market Report
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Study Period: 2020-2034
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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
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Key Her2+ Non Small Cell Lung Cancer Companies: Spectrum Pharmaceuticals, AstraZeneca, Daiichi Sankyo, Jiangsu HengRui Medicine, Dizal Pharmaceuticals, Takeda Pharmaceuticals, and others.
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Key Her2+ non small cell lung cancer therapies: Pyrotinib, DZD9008, Mobocertinib (TAK-788), and others.
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Her2+ Non Small Cell Lung Cancer Therapeutic Assessment: Her2+ Non Small Cell Lung Cancer current marketed and Her2+ Non Small Cell Lung Cancer emerging therapies
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Her2+ Non Small Cell Lung Cancer Market Dynamics: Her2+ Non Small Cell Lung Cancer market drivers and Her2+ Non Small Cell Lung Cancer market barriers
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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
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Her2+ Non Small Cell Lung Cancer Unmet Needs, KOL's views, Analyst's views, Her2+ Non Small Cell Lung Cancer Market Access and Reimbursement
To know what’s more in our Her2+ Non Small Cell Lung Cancer report, visit https://www.delveinsight.com/report-store/her2-non-small-cell-lung-cancer-market?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr
Key benefits of the Her2+ Non Small Cell Lung Cancer Market Report:
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Her2+ Non Small Cell Lung Cancer market report covers a descriptive overview and comprehensive insight of the Her2+ Non Small Cell Lung Cancer Epidemiology and Her2+ Non Small Cell Lung Cancer market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).
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The Her2+ Non Small Cell Lung Cancer market report provides insights into the current and emerging therapies.
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The Her2+ Non Small Cell Lung Cancer market report provides a global historical and forecasted market covering drug outreach in 7MM.
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The Her2+ Non Small Cell Lung Cancer market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Her2+ Non Small Cell Lung Cancer market.
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Table of Contents
1. Report Introduction
2. Executive Summary
3. SWOT analysis
4. Her2+ Non Small Cell Lung Cancer Patient Share (%) Overview at a Glance
5. Her2+ Non Small Cell Lung Cancer Market Overview at a Glance
6. Her2+ Non Small Cell Lung Cancer Disease Background and Overview
7. Her2+ Non Small Cell Lung Cancer Epidemiology and Patient Population
8. Country-Specific Patient Population of Her2+ Non Small Cell Lung Cancer
9. Her2+ Non Small Cell Lung Cancer Current Treatment and Medical Practices
10. Unmet Needs
11. Her2+ Non Small Cell Lung Cancer Emerging Therapies
12. Her2+ Non Small Cell Lung Cancer Market Outlook
13. Country-Wise Her2+ Non Small Cell Lung Cancer Market Analysis (2020–2034)
14. Market Access and Reimbursement of Therapies
15. Market drivers
16. Market barriers
17. Appendix
18. Her2+ Non Small Cell Lung Cancer Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
Click here to read more about Her2+ Non Small Cell Lung Cancer Market Outlook 2034
Related Reports:
Her2+ Non Small Cell Lung Cancer Pipeline Insights, DelveInsight
"Her2+ Non Small Cell Lung Cancer Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Her2+ Non Small Cell Lung Cancer market. A detailed picture of the Her2+ Non Small Cell Lung Cancer pipeline landscape is provided, which includes the disease overview and Her2+ Non Small Cell Lung Cancer treatment guidelines.
About DelveInsight
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