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(Albany, US), October 24, 2026 – DelveInsight’s “HER2 Metastatic Non-Small Cell Lung Cancer – Market Insights, Epidemiology, and Market Forecast – 2032” report delivers an in-depth understanding of HER2 Non-Small Cell Lung Cancer, historical and forecasted epidemiology, as well as the HER2 Non-Small Cell Lung Cancer market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

Explore the intricate details of the HER2 Metastatic Non-Small Cell Lung Cancer Market Report @ HER2 Metastatic Non-Small Cell Lung Cancer Treatment Market Size

Key Takeaways from the HER2 Metastatic Non-Small Cell Lung Cancer Market Report

• In Sepetember 2026, The FDA has granted accelerated approval to Bayer’s Hyrnuo (sevabertinib) as a first-line treatment for adults with locally advanced or metastatic non-squamous NSCLC harboring activating HER2 (ERBB2) tyrosine kinase domain mutations, detected by an approved test. Previously, the drug was approved only for second-line and later treatment.

• As per DelveInsight’s analysis, the total incident cases of HER2 non-small cell lung cancer in the 7MM were ~11,000 in 2022, and these cases are estimated to increase by 2032.

• The total market size of HER2-mutated non-small cell lung cancer in the 7MM was ~USD 120 million in 2022.

• In 2022, the US captured a market size of ~USD 90 million for HER2 NSCLC.

• Among EU4 and the UK, Germany captured the highest market size of HER2 NSCLC, followed by the UK, in 2022.

• Over the past couple of years, progress has been made toward defining HER2-driven disease and determining the benefit of different classes of agents targeting HER2.

• ENHERTU (trastuzumab deruxtecan) was approved in August 2022 in the US for patients after receipt of prior systemic therapy.

• Due to their rarity and the lack of late-stage clinical studies, the treatment paradigm for rare NSCLC mutations is less clear. Rare biomarkers like ROS-1, HER2, RET fusion, and NTRK1/2/3 gene fusion have seen considerable progress in the past few years.

• The leading HER2 Metastatic Non-Small Cell Lung Cancer companies include AstraZeneca, Daiichi Sankyo, Forward Pharmaceuticals, Jiangsu HengRui Medicine, Dizal Pharmaceutical, and others.

• Promising HER2 Metastatic Non-Small Cell Lung Cancer therapies include ENHERTU (trastuzumab deruxtecan), Pyrotinib, FWD1509, Sunvozertinib, and others.

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HER2 Metastatic Non-Small Cell Lung Cancer Overview

HER2 is a common oncogene identified in various cancer types, and dysregulation of HER2 signaling can be caused by mutation, amplification, and overexpression. All three types of HER2 dysregulation could appear in NSCLC with almost no overlap between mutation and amplification. They are considered distinct tumor subtypes with different biological behaviors and infrequent overlap.

In general, there are two ways to detect HER2 mutations. The best way is through comprehensive next-generation sequencing (NGS) or Sanger sequencing, which places tissue from a patient’s tumor (gathered from a biopsy) in a machine that looks for a large number of possible biomarkers at one time. Where a patient cannot undergo the biopsy needed for NGS, liquid biopsy is recommended, which can look for certain biomarkers in a patient’s blood. Sometimes, direct DNA sequencing and FISH techniques are also performed.

HER2 Metastatic Non-Small Cell Lung Cancer Epidemiology Segmentation in the 7MM

• Total Incident Cases of HER2 Non-Small Cell Lung Cancer

• Total Incident Cases of HER2 Non-Small Cell Lung Cancer by Histology

• Total Cases of Non-Small Cell Lung Cancer by Stages

• Total Cases of NSCLC by Genetic Mutations/Biomarkers

• Total Treated Cases of Non-Small Cell Lung Cancer by Line of Therapies

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HER2 Metastatic Non-Small Cell Lung Cancer Epidemiology Key Findings

• In 2022, there were ~4,000 cases of HER2 non-small cell lung cancer in the US.

• NSCLC is more common in males than in females. In the United States, around 56% of males are diagnosed with NSCLC.

• Among EU4 and the UK, Germany had the highest number of HER2 non-small cell lung cancer cases, followed by the UK.

Approved Therapies for HER2 Metastatic Non-Small Cell Lung Cancer

• ENHERTU: Daiichi Sankyo/AstraZeneca

ENHERTU (trastuzumab deruxtecan) is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. Fam-trastuzumab deruxtecan-nxki is a HER2-directed antibody–drug conjugate. The antibody is a humanized anti-HER2 IgG1. The small molecule DXd is a topoisomerase I inhibitor attached to the antibody by a cleavable linker. Following binding to HER2 on tumor cells, fam-trastuzumab deruxtecan-nxki undergoes internalization and intracellular linker cleavage by lysosomal enzymes. Upon release, the membrane-permeable DXd causes DNA damage and apoptotic cell death.

HER2 Metastatic Non-Small Cell Lung Cancer Pipeline Analysis

• Pyrotinib: Jiangsu HengRui Medicine

Pyrotinib is a novel multi-target tyrosine kinase inhibitor with pronounced clinical efficacy in inhibiting tumor growth. Pyrotinib can covalently bind to the ATP binding site of the intracellular kinase domain of HER1, HER2, and HER4, preventing the formation of HER family homo/heterodimers, inhibiting autophosphorylation, and blocking the activation of downstream signaling pathways.

• Sunvozertinib: Dizal Pharmaceutical

Sunvozertinib (DZD9008) is an oral, potent, irreversible, and selective EGFR TKI targeting EGFR exon20-ins as well as EGFR sensitizing, T790M, and uncommon mutations, with weak activity against wild-type EGFR. In addition, sunvozertinib exhibits desirable drug metabolism and pharmacokinetic (DMPK) properties as an oral drug in preclinical and clinical settings. In August 2023, Dizal Pharmaceuticals announced the first global approval registered for NSCLC (late-stage disease, metastatic disease, second-line therapy or greater) in China. Two global pivotal studies are ongoing in the second-line or greater setting (WU-KONG1 Part B) and the first-line setting (WU-KONG28) in NSCLC patients with EGFR exon20-ins mutations.

Comparison of Emerging Drugs Under Development

• Pyrotinib (Jiangsu HengRui Medicine): Irreversible HER1, 2, and 4 inhibitor | Phase III | HER2 NSCLC | Oral

• FWD1509 (Forward Pharmaceuticals): EGFR/HER2 inhibitor | Phase I/II | EGFR exon 20 insertion mutations NSCLC | Oral

• Sunvozertinib (Dizal Pharmaceutical): Irreversible EGFR inhibitor | Phase I/II | EGFR exon 20 insertion mutations NSCLC | Oral

Discover more about therapies set to grab Major HER2 Metastatic Non-Small Cell Lung Cancer Market Share @ HER2 Metastatic Non-Small Cell Lung Cancer Market Drivers and Barriers

HER2 Metastatic Non-Small Cell Lung Cancer Market Outlook

HER2 alterations represent important oncogenic drivers in NSCLC. Currently, platinum-based chemotherapy with or without immunotherapy is the preferred first-line treatment in patients with advanced or metastatic HER2-mutant NSCLC, while ENHERTU (T-DXd) was approved in August 2022 in the US for the same subgroup of patients after receipt of prior systemic therapy. Previous studies have shown that both HER2-targeted monoclonal antibodies (trastuzumab and pertuzumab) and traditional pan-HER tyrosine kinase inhibitors (TKIs) yielded disappointing antitumor activity in NSCLC with HER2 alterations; therefore, platinum-based chemotherapy has remained the standard treatment for this subset of patients for more than a decade.

Novel selective HER2 TKIs (pyrotinib and sunvozertinib) have shown better antitumor effects than previous anti-HER2 agents, while the antibody–drug conjugate trastuzumab deruxtecan has made significant progress, revolutionizing the therapeutic paradigm of pretreated HER2-mutant NSCLC. Although pyrotinib has shown greater activity against HER2-mutant NSCLC compared to other TKIs, ADC-based therapies seem to offer the highest response rates and the best survival outcomes in both HER2-mutant and HER2-positive refractory NSCLC patients. Combination therapies are also being investigated to enhance the efficacy of anti-HER2 agents, and these new data reinforce the need to make HER2 testing a systematic reflex upon diagnosing advanced NSCLC.

In the 7MM, the total market size of HER2 NSCLC was ~USD 120 million in 2022, which is expected to increase by 2032. In 2022, the US captured a market size of ~USD 90 million, while Germany captured the highest market size among EU4 and the UK, followed by the UK.

HER2 Metastatic Non-Small Cell Lung Cancer Treatment Landscape

Treatment options and recommendations depend on several factors, including the type and stage of cancer, possible side effects, and the patient’s preferences and overall health. The most common treatments for HER2 non-small cell lung cancer are surgery, radiotherapy, chemotherapy, chemotherapy with radiotherapy, immunotherapy, HER2-targeted tyrosine kinase inhibitors (TKIs), and ENHERTU.

Among drug classes, novel selective HER2 TKIs have been developed for pretreated HER2-mutant patients. Pyrotinib has shown moderate efficacy and a manageable safety profile and is now being evaluated in Phase III, whereas poziotinib demonstrated promising preliminary results, but its development was later put on hold as additional data from a randomized controlled study are needed for FDA approval in this indication.

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Scope of the HER2 Metastatic Non-Small Cell Lung Cancer Market Report

• Coverage: 7MM

• Study Period: 2019–2032

• HER2 Metastatic Non-Small Cell Lung Cancer Companies: AstraZeneca, Daiichi Sankyo, Forward Pharmaceuticals, Jiangsu HengRui Medicine, Dizal Pharmaceutical, and others.

• HER2 Metastatic Non-Small Cell Lung Cancer Therapies: ENHERTU (trastuzumab deruxtecan), Pyrotinib, FWD1509, Sunvozertinib, and others.

• HER2 Metastatic Non-Small Cell Lung Cancer Market Dynamics: Market drivers and market barriers

• HER2 Metastatic Non-Small Cell Lung Cancer Competitive Intelligence Analysis: SWOT Analysis, Analyst Views

• HER2 Metastatic Non-Small Cell Lung Cancer Unmet Needs, KOL Views, Market Access and Reimbursement

Table of Contents

1. Key Insights

2. Report Introduction

3. Key Highlights

4. Executive Summary

5. HER2 mNSCLC Market Overview at a Glance

6. Key Events

7. Epidemiology and Market Forecast Methodology

8. Disease Background and Overview

9. Diagnosis of NSCLC

10. Current Treatment Practices: NSCLC

11. Treatment Guidelines and Recommendations for Non-small Cell Lung Cancer (NSCLC)

12. Epidemiology and Patient Population

13. Patient Journey

14. Key Endpoints in NSCLC

15. Marketed Drugs

16. Emerging Drugs

17. HER2 mNSCLC: The 7MM Market Analysis

18. Unmet Needs

19. SWOT Analysis

20. KOL Views

21. Market Access and Reimbursement

22. Appendix

23. DelveInsight Capabilities

24. Disclaimer

25. About DelveInsight

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