HER2 Metastatic Non-small Cell Lung Cancer Market
Key Highlights
- As per DelveInsight’s analysis, the total incident cases of HER2 non-small cell lung cancer in the 7MM were ~11,000 cases in the year 2022; these cases are estimated to increase by the year 2032.
- The total market size of HER2 mutated non-small cell lung cancer in the 7MM was ~USD 120 million in 2022.
- During 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 a lot of progress in past few years.
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 HER2 Non-small Cell Lung Cancer market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The HER2 Non-small Cell Lung Cancer market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted the 7MM HER2 Non-small Cell Lung Cancer market size from 2019 to 2032. The report also covers current HER2 Non-small Cell Lung Cancer treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.
Geography Covered
- The United States
- EU4 (Germany, France, Italy, and Spain) and the United Kingdom
- Japan
Study Period: 2019–2032
Human Epidermal Growth Factor Receptor 2 Metastatic Non-small Cell Lung Cancer Disease Understanding and Treatment Algorithm
HER2 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.
HER2 Non-small Cell Lung Cancer Diagnosis
In general, there are two ways to detect HER2 mutations. The best way is through comprehensive next-generation sequencing (NGS) or Sanger Sequencing. This type of testing 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. There may be some situations where a patient cannot undergo the biopsy needed to perform NGS, and so liquid biopsy is recommended. A liquid biopsy can look for certain biomarkers in a patient’s blood. Sometimes, direct DNA sequencing and FISH techniques are performed.
Further details related to diagnosis are provided in the report…
HER2 Non-small Cell Lung Cancer Treatment
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 inhibitor (TKI), and ENHERTU.
Further details related to treatment are provided in the report…
Human Epidermal Growth Factor Receptor 2 Metastatic Non-small Cell Lung Cancer Epidemiology
The HER2 Non-small Cell Lung Cancer epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by 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 in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2019 to 2032.
- In 2022, there were ~4,000 cases of HER2 non-small cell lung cancer in the US.
- NSCLC is more common in males as compared to 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.
Human Epidermal Growth Factor Receptor 2 Metastatic Non-small Cell Lung Cancer Drug Chapters
The drug chapter segment of the HER2 Non-small Cell Lung Cancer report encloses a detailed analysis of the marketed and the late-stage (Phase III) pipeline drug. The marketed drugs segment encloses the drug ENHERTU (Daiichi Sankyo/AstraZeneca). Furthermore, the current key players for the upcoming emerging drugs and their respective drug candidates include Jiangsu HengRui Medicine (Pyrotinib), Forward Pharmaceuticals (FWD1509), Dizal Pharmaceutical (Sunvozertinib), and others. The drug chapter also helps understand the HER2 Non-small cell lung cancer clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, and the latest news and press releases.
Marketed Drugs
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.
Emerging Drugs
Pyrotinib: Jiangsu HengRui Medicine
Pyrotinib is a novel tyrosine kinase inhibitor with multiple targets with a more 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 homologous/heterodimer, 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 greater than or equal to second-line (WU-KONG1 Part B) and first-line setting (WU-KONG28), respectively, in NSCLC patients with EGFR Exon20-Ins mutations.
Drug Class Insights
HER2 tyrosine kinase inhibitors (TKIs): Novel selective HER2 TKIs have been developed for pretreated HER2-mutant patients. Pyrotinib has shown moderate efficacy as well as a manageable safety profile, and it is now evaluated as in Phase III; by contrast, while poziotinib has demonstrated promising preliminary results but the company latter hold the development due to additional data are needed from a randomized controlled study for poziotinib to be approved for this indication by the FDA.
Note: Detailed insights will be provided in the final report.
Human Epidermal Growth Factor Receptor 2 Metastatic Non-small Cell Lung Cancer Market Outlook
HER2 alterations represent important oncogenic drivers in NSCLC. During 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. Currently, platinum-based chemotherapy with/without immunotherapy is the preferred first-line treatment in patients with advanced or metastatic HER2-mutant NSCLC; 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) have 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. Fortunately, novel selective HER2 TKIs (pyrotinib and sunvozertinib) have shown better antitumor effects than previous anti-HER2 agents. In addition, more recently, the antibody–drug conjugate (ADCs) trastuzumab deruxtecan has made significant progress, revolutionizing the therapeutic paradigms of pretreated HER2-mutant NSCLC. Recently, novel, more selective, and structurally advantageous pan-HER2 TKIs have been developed to improve outcomes in NSCLC with HER2 mutations. Although pyrotinib has shown greater activity against HER2-mutant NSCLC when compared to other TKIs, ADC-based therapies seem to offer the highest response rates and the best survival outcomes both in patients with HER2-mutant and HER2-positive refractory NSCLC patients. Furthermore, combination therapies are being investigated to enhance the efficacy of anti-HER2 agents. These new data reinforce the need to make HER2 testing a systematic reflex upon diagnosing advanced NSCLC.
Key players, such as AstraZeneca, Daiichi Sankyo, Forward Pharmaceuticals, Jiangsu HengRui Medicine, and others are evaluating their lead candidates in different stages of clinical development, respectively.
- 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, US captured the market size of ~USD 90 million of HER2 NSCLC.
- Among EU4 and the UK, Germany captured the highest market size of HER2 NSCLC followed by the UK in 2022.
Human Epidermal Growth Factor Receptor 2 Metastatic Non-small Cell Lung Cancer Drugs Uptake
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019–2032, which depends on the competitive landscape, safety, efficacy data, and order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.
Further detailed analysis of emerging therapies drug uptake in the report…
Human Epidermal Growth Factor Receptor 2 Metastatic Non-small Cell Lung Cancer Activities
The report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for HER2 Non–Small Cell Lung Cancer emerging therapies.
KOL Views
To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient’s therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific writers, Medical Oncologists, Pulmonologists and Professors, Chief of the Thoracic Service at the Memorial Sloan Kettering Cancer Center, and Others.
Delveinsight’s analysts connected with 40+ KOLs to gather insights; however, interviews were conducted with 18+ KOLs in the 7MM. Centers such as MD Anderson Cancer Center, Texas, UT Southwestern Medical Center in Dallas, Cancer Research UK Barts Centre in London, LUNGevity Foundation, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Non-small Cell Lung Cancer market trends.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. 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 treatment landscape.
Market Access and Reimbursement
The ENHERTU Patient Assistance Programs (PAP) are offered by AstraZeneca/Daiichi Sankyo to provide ENHERTU to qualifying patients at no cost. They are neither government programs nor insurance plans. After qualification, the patient may get free ENHERTU for up to 1 year, depending upon the Program in which the patient is enrolled. AstraZeneca/Daiichi Sankyo will send an application for renewal once enrollment ends. ENHERTU will be sent to the patient’s doctor’s office due to specific handling requirements. The Programs can be changed or stopped by AstraZeneca/Daiichi Sankyo at any time or for any reason.
Scope of the Report
- The report covers a segment of key events, an executive summary, and a descriptive overview of HER2 Non-small Cell Lung Cancer, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
- Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and with treatment guidelines.
- Additionally, an all-inclusive account of the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will impact the current treatment landscape.
- A detailed review of the HER2 Non-small Cell Lung Cancer market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
- The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM HER2 Non-small Cell Lung Cancer market.
Human Epidermal Growth Factor Receptor 2 Non-small Cell Lung Cancer Report Insights
- Patient Population
- Therapeutic Approaches
- HER2 Non-small Cell Lung Cancer Pipeline Analysis
- HER2 Non-small Cell Lung Cancer Market Size and Trends
- Existing and future Market Opportunity
Report Key Strengths
- Ten Years Forecast
- The 7MM Coverage
- HER2 Non-small Cell Lung Cancer Epidemiology Segmentation
- Key Cross Competition
- Conjoint analysis
- Drugs Uptake and Key Market Forecast Assumptions
HER2 Non-small Cell Lung Cancer Report Assessment
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- Qualitative Analysis (SWOT and Conjoint Analysis)
FAQs
- What is the historical and forecasted HER2 Non-small Cell Lung Cancer patient pool in the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan?
- What was the HER2 Non-small Cell Lung Cancer total market size, the market size by therapies, market share (%) distribution in 2019, and what would it look like by 2032? What are the contributing factors for this growth?
- What will be the market size of ENHERTU in HER2 NSCLC in 2025?
- What are the pricing variations among different geographies for approved and off-label therapies?
- How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
- Although multiple expert guidelines recommend testing for targetable mutations prior to therapy initiation, why do barriers to testing remain high?
- What are the current and emerging options for treating HER2 Non-small Cell Lung Cancer?
- What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
- Patient acceptability in terms of preferred treatment options as per real-world scenarios?
- What are the country-specific accessibility issues of expensive, recently approved therapies?
Reasons to Buy
- The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the HER2 Non-small Cell Lung Cancer Market.
- Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
- Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
- Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.
- Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
- To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
- Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
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