HER2 양성 비소세포폐암 시장의 주요 촉진요인
HER2 양성 비소세포폐암의 유병률 상승
HER2 양성 돌연변이는 비소세포폐암 환자의 약 1-4%에서 발생하며, 미국에서는 증폭이 2-5%, 과발현이 2-30%에서 각각 나타납니다. 비소세포폐암은 전체 폐암 진단의 약 80-85%를 차지하며, HER2 양성 아형 확인이 증가함에 따라 표적치료제에 대한 니즈가 증가하고 있습니다.
HER2 양성 비소세포폐암의 현재 치료 상황
HER2 양성 비소세포폐암의 치료 옵션에는 화학요법, 표적치료, 면역요법, 수술, 방사선치료, 레이저치료, 광역학치료 등이 있습니다. ENHERTU(trastuzumab deruxtecan)는 현재 절제불능 또는 전이성 HER2 양성 비소세포폐암의 후기 치료단계에서 FDA 승인을 받은 유일한 치료제로, 초기 치료단계로 확대 적용될 여지가 남아 있습니다.
HER2 양성 비소세포폐암 시장 활성화 요인
HER2 양성 비소세포폐암 시장은 진단법 개선, HER2 돌연변이에 대한 인식 증가, 의료 투자 증가로 확대될 것으로 예측됩니다. 새로운 경구용 HER2 티로신 키나아제 억제제(TKI)가 개발 중이며, 이는 환자의 치료 성적을 개선하고 치료 옵션을 확대하는 것을 목표로 하고 있습니다.
이 보고서는 HER2 양성 비소세포폐암의 주요 7개국(미국, 독일, 스페인, 이탈리아, 프랑스, 영국, 일본) 시장을 조사 분석했으며, 각국 시장 규모와 예측, 각 치료법 시장 점유율, 현재 치료법, 미충족 수요 등의 정보를 전해드립니다.
Key Factors Driving HER2+ Non Small Cell Lung Cancer Market
HER2+ Non Small Cell Lung Cancer Rising Prevalence
HER2+ mutations occur in approximately 1-4% of NSCLC cases, with amplification and overexpression seen in 2-5% and 2-30% of cases respectively in the US. NSCLC accounts for roughly 80-85% of all lung cancer diagnoses, and the growing identification of HER2+ subtypes is increasing the need for targeted therapies.
HER2+ Non Small Cell Lung Cancer Current Treatment Landscape
Treatment options for HER2+ NSCLC include chemotherapy, targeted therapy, immunotherapy, surgery, radiation, laser therapy, and photodynamic therapy. ENHERTU (trastuzumab deruxtecan) is currently the only FDA-approved therapy for unresectable or metastatic HER2+ NSCLC in later-line settings, leaving room for expansion in earlier lines of treatment.
HER2+ Non Small Cell Lung Cancer Market Drivers
The HER2+ NSCLC market is expected to expand due to improved diagnostic approaches, increased awareness of HER2 mutations, and rising healthcare investments. Novel oral HER2 tyrosine kinase inhibitors (TKIs) are in development, aiming to improve patient outcomes and broaden treatment options.
HER2+ Non Small Cell Lung Cancer Clinical Trials and Competitive Landscape
The pipeline features multiple candidates in different stages of development, 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). Zongertinib and BAY2927088 are leading in clinical trials as potential first targeted small-molecule therapies for HER2+-mutated NSCLC, reflecting a highly competitive landscape.
DelveInsight's "HER2+ NSCLC Market Insight, Epidemiology, and Market Forecast - 2036" report delivers an in-depth understanding of HER2+ NSCLC, historical and forecasted epidemiology as well as the HER2+ NSCLC market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The HER2+ NSCLC Treatment Market report provides current treatment practices, emerging drugs, HER2+ NSCLC market share of individual therapies, and current and forecasted HER2+ NSCLC market size from 2022 to 2036, segmented by seven major markets. The report also covers current HER2+ NSCLC treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.
HER2+ NSCLC Treatment Market: Understanding and Algorithm
HER2+ (also called ERBB2) is a receptor tyrosine kinase encoded by the ERBB2 proto-oncogene located on chromosome 17's long arm (17q21). It belongs to the EGFR/ErbB receptor family, which includes HER1/EGFR, HER2+, HER3, and HER4. Unlike the other family members, HER2+ has no identified ligand. Instead, it becomes active when it forms homodimers or pairs with another HER receptor that has already bound a ligand, leading to cross-phosphorylation and activation of its tyrosine kinase domain.
In non-small cell lung cancers (NSCLCs), three major forms of HER2+ dysregulation are recognized: gene mutations, gene amplification, and protein overexpression. These alterations arise through distinct biological mechanisms and result in different clinical effects. They influence tumor behavior, patient outcomes, and therapeutic decision-making in NSCLC. Symptoms associated with HER2-positive NSCLC may include chronic coughing, chest discomfort, shortness of breath, wheezing, decreased appetite, weight loss, and fatigue.
HER2+ NSCLC Diagnosis
HER2+ NSCLC Treatment
Outcomes from conventional treatments for HER2-positive NSCLC remain poor, except in cases where the cancer is highly localized. Newly diagnosed individuals with HER2-positive NSCLC are therefore good candidates for clinical trials investigating novel therapeutic strategies. Although several treatment modalities exist, management typically relies on standard options such as surgery, radiation therapy, chemotherapy, targeted therapy, immunotherapy, laser therapy, photodynamic therapy, cryosurgery, electrocautery, and watchful waiting.
ENHERTU is currently the only therapy approved by the U.S. Food and Drug Administration for HER2-positive NSCLC. It was authorized in August 2022 in the United States for patients with HER2-mutant NSCLC who have previously received systemic treatment. This approval has markedly reshaped treatment options for individuals with pretreated HER2-mutant NSCLC.
The HER2+ NSCLC epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the total incident cases of NSCLC, gender-specific cases of NSCLC, age-specific cases of NSCLC, total incident cases of NSCLC by histology, total incident cases of NSCLC by stage, and total incident cases of advanced HER2+ NSCLC (mutation, overexpression and amplification) in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2022 to 2036.
HER2+ NSCLC Marketed Drugs
ENHERTU (trastuzumab deruxtecan) is an antibody-drug conjugate targeting HER2 that delivers a topoisomerase inhibitor. It is approved for adults with unresectable or metastatic NSCLC harboring activating HER2 (ERBB2) mutations, confirmed using a test authorized by the US FDA, and who have previously undergone systemic treatment.
HER2+ NSCLC Emerging Drugs
Zongertinib (BI 1810631) is an experimental, orally administered HER2-selective TKI being developed for the treatment of HER2-mutated non-small cell lung cancer (NSCLC). The therapy received FDA Fast Track status in 2023, followed in 2024 by Breakthrough Therapy Designation from both the U.S. FDA and China's CDE for adults with advanced NSCLC harboring activating HER2 mutations who have previously undergone systemic treatment.
The company is currently testing the drug in the Phase III Beamion LUNG-2 study as a first-line option for patients with unresectable, locally advanced, or metastatic non-squamous NSCLC with HER2 tyrosine kinase domain mutations. Additionally, the Phase I Beamion LUNG-1 trial is assessing zongertinib as a standalone therapy in individuals whose NSCLC carries HER2 mutations. In September 2024, the company announced favorable findings from the Phase Ib primary analysis of Cohort 1 in Beamion LUNG-1.
BAY 2927088 is an orally administered small-molecule tyrosine kinase inhibitor designed to strongly target mutant HER2+, including HER2+ exon 20 insertions and point mutations, as well as EGFR, while showing strong selectivity for mutant over wild-type EGFR. In February 2024, it was granted Breakthrough Therapy designation for use in adults with unresectable or metastatic NSCLC harboring activating HER2+ (ERBB2) mutations who have previously undergone systemic treatment.
The drug is currently being studied in the Phase III SOHO-02 trial as a first-line treatment for patients with locally advanced or metastatic NSCLC with HER2-activating mutations. Based on the company's Q2 2024 update, submission of BAY 2927088 for second-line treatment of HER2-mutated NSCLC is expected in 2025.
HER2+ NSCLC Drugs Market Insights
Tyrosine kinase inhibitors (TKIs) are targeted treatments that work by blocking tyrosine kinases-enzymes essential for signaling pathways that control how cells grow, divide, and survive. Currently, there are few approved TKIs for treating HER2-mutant NSCLC. Although HER2-directed therapies are well established in breast cancer, their application in lung cancer is beginning to attract interest.
Several next-generation TKIs are under investigation for HER2-mutant NSCLC, including Zongertinib from Boehringer Ingelheim, BAY 2927088 from Bayer, IAM1363 from Iambic Therapeutics, Firmonertinib from ArriVent BioPharma, and NVL-330 from Nuvalent. Early evidence suggests that these emerging TKIs may also demonstrate activity in patients with brain metastases.
At present, only one antibody-drug conjugate is authorized for treating HER2-positive NSCLC. The therapy generating the most attention in HER2-mutated NSCLC is ENHERTU, developed by Daiichi Sankyo and AstraZeneca. It's worth remembering that ADCs function as a more targeted form of chemotherapy, so side effects are anticipated. Careful monitoring is especially important in lung cancer patients, as conditions like interstitial lung disease (ILD) or pneumonitis may occur.
HER2+ alterations are recognized as key oncogenic drivers in NSCLC. In recent years, meaningful progress has been made in characterizing HER2-driven disease and understanding how various classes of HER2-targeted therapies perform. At present, platinum-based chemotherapy-with or without immunotherapy-remains the recommended first-line option for patients with advanced or metastatic HER2+ NSCLC. Historically, standard treatments such as chemotherapy, immunotherapy, checkpoint inhibitors, and targeted cellular approaches have achieved a median progression-free survival of only about four months, highlighting the urgent need for more effective therapeutic strategies.
ENHERTU (T-DXd) received approval from the U.S. Food and Drug Administration in August 2022 for patients with HER2-mutant NSCLC previously treated with systemic therapy, marking a major shift in the management of pretreated disease. The therapy was subsequently approved by Japan's MHLW in August 2023 and gained authorization in Europe in the following month.
The treatment landscape for HER2+ NSCLC is rapidly advancing as ongoing research continues to illuminate the genetic drivers of these tumors. Several emerging agents-such as Pyrotinib from Jiangsu Hengrui Medicine, Zongertinib from Boehringer Ingelheim, and BAY2927088 developed by Bayer-are drawing significant interest. These next-generation HER2-targeted TKIs reflect a shift toward more precise and potent treatment approaches.
The development pipeline also includes additional candidates such as FWD1509 from Forward Pharma, IAM1363 from Iambic Therapeutics, ORIC-114 from ORIC Pharmaceuticals, and Firmonertinib from ArriVent BioPharma, all at varying clinical stages. Together, these emerging therapies are driving innovation and increasing competition in the HER2+ NSCLC field. In addition, combination strategies are under investigation to further improve the effectiveness of HER2-directed treatments.
Recent Developments in the HER2+ NSCLC Treatment Market Landscape
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2022-2036. The landscape of HER2+ NSCLC treatment has experienced an uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, oncology professionals, and the entire healthcare community in their tireless pursuit of advancing treatment care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.
Boehringer's zongertinib and Bayer's BAY2927088 (both are oral agents) have had differing development histories, but they are now neck and neck in a race to become the first targeted small molecule approved for HER2+-mutated NSCLC. Experts agrees that zongertinib has better tolerability than BAY 2927088. It is important to highlight that we do not see much of future for pyrotinib since zongertinib and BAY2927088 have shown nearly 70% ORR in the Phase I/II trials.
HER2+ NSCLC Pipeline Development Activities
The HER2+ NSCLC therapeutics market report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key HER2+ NSCLC Companies involved in developing targeted therapeutics.
Pipeline Development Activities
The HER2+ NSCLC therapeutics market report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for HER2+ NSCLC emerging therapies.
KOL- Views
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, Professor and Vice Chair Department of Critical Care Medicine and Director, PhD, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or HER2+ NSCLC Market Trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the HER2+ NSCLC unmet needs.
Delveinsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Versailles Saint Quentin University, France; Fred Hutchinson Cancer Center, US; Lung Clinic Grosshansdorf, Germany; Sylvester Comprehensive Cancer Center, US; University Hospital Munster, Munster, Germany; Johns Hopkins University School of Medicine, US; Massachusetts General Hospital, US; Nagasaki University, Japan; Vall d'Hebron University Hospital, Spain; Georgetown University, US, etc., were contacted. Their opinion helps understand and validate HER2+ NSCLC epidemiology and market trends.
HER2+ NSCLC Therapeutics Market: Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving HER2+ NSCLC Treatment Market Landscape.
The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated. Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.
HER2+ NSCLC Therapeutics Market Access and Reimbursement
ENHERTU: Patient Savings Program
Eligible patients may pay as little as USD 0 per ENHERTU prescription. The annual benefit can be used for the cost of the drug itself and may also cover up to USD 100 in infusion costs per administration. There are no income requirements to participate in the program. Patients who are residents of Massachusetts or Rhode Island are not eligible for infusion assistance.
Key eligibility criteria:
Patients who are enrolled in a state or federally funded prescription insurance program are not eligible for this offer. This includes patients enrolled in Medicare Part B, Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), Department of Defense (DoD) programs or TRICARE, and patients who are Medicare-eligible and enrolled in an employer-sponsored group waiver health plan or government-subsidized prescription drug benefit program for retirees. Suppose the patient is enrolled in a state or federally funded prescription insurance program. In that case, they may not use this program even if they elect to be processed as an uninsured (cash-paying) patient. This offer is not insurance and is restricted to residents of the United States and Puerto Rico.
HER2+ NSCLC Treatment Market Report Scope