Epidermal Growth Factor Receptor Metastatic Non-small Cell Lung Cancer Market

Key Highlights

• The total market size of EGFR mNSCLC in the 7MM was ~USD 3,920 million in 2022.
• NSCLC is increasingly becoming a biomarker-driven market. EGFR is one of the profitable biomarker segments, with blockbuster therapies such as TAGRISSO.
• Two therapies, RYBREVANT (Johnson & Johnson) and EXKIVITY (Takeda) were approved for the niche EXON-20 mutant non-small cell lung cancer segment. EXON-20 mutant non-small cell lung cancer is currently an unproven market with a small addressable market (10–12% of EGFR non-small cell lung cancer). Recently in September 2023, Takeda withdrew EXKIVITY from the market.
• HER3-directed therapies, Patritumab Deruxtecan, demonstrated clinically meaningful and durable responses in patients with EGFR mNSCLC in the HERTHENA-Lung01 Phase II Trial (third-line).
• The total incident cases of EGFR NSCLC in the US was ~30,000 in 2022. The majority of the cases fall under EGFR exon 19 deletions followed by Exon 21 L858R substitution.

DelveInsight’s “Epidermal Growth Factor Receptor Metastatic Non-small Cell Lung Cancer – Market Insights, Epidemiology, and Market Forecast – 2032” report delivers an in-depth understanding of EGFR Metastatic Non-small Cell Lung Cancer, historical and forecasted epidemiology as well as EGFR Metastatic Non-small Cell Lung Cancer market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The EGFR Non-small Cell Lung Cancer market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted the 7MM EGFR Metastatic Non-small Cell Lung Cancer market size from 2019 to 2032. The report also covers current EGFR Metastatic 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

Epidermal Growth Factor Receptor Metastatic Non-small Cell Lung Cancer Disease Understanding and Treatment Algorithm

EGFR Metastatic Non-small Cell Lung Cancer Overview

EGFR is a protein in cells that helps them grow. A mutation in the gene for EGFR can make it grow too much, which can cause cancer. There are different types of EGFR mutations, including deletions or insertions and point mutations. In test results, individuals may be identified as having an EGFR 19 deletion or an EGFR L858R point mutation, which are the most common types of EGFR mutations. These mutations are typically treated the same way. Amongst the EGFR mutations that are tested for in lung cancer, there are a few rare types that are treated differently than the more common EGFR mutations. The major example of this in lung cancer is EGFR exon 20 insertions. This is a type of EGFR mutation that does not respond to the typical treatment for EGFR-positive lung cancer, which are called tyrosine kinase inhibitors, or TKIs.

EGFR Non-small Cell Lung Cancer Diagnosis

In general, there are 2 ways to detect EGFR mutations. The best way is through comprehensive next-generation sequencing (NGS). 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, so liquid biopsy is recommended. A liquid biopsy can look for certain biomarkers in a patient’s blood.

Further details related to diagnosis are provided in the report…

EGFR 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. he most common treatments for EGFR non-small cell lung cancer are:

Epidermal Growth Factor Receptor Metastatic Non-small Cell Lung Cancer Epidemiology

The EGFR Non-small Cell Lung Cancer epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Incident Cases of NSCLC, Gender-specific Cases of NSCLC, Age-specific Cases of NSCLC, Total Incident Cases of NSCLC, Total Incident Cases of NSCLC by Stage, and Total Cases of NSCLC by Genetic Mutations/Biomarkers in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2019 to 2032.

• The total number of incident cases of NSCLC in the 7MM was nearly 526,800 cases in 2022 and is projected to increase during the forecasted period.
• The total number of incident cases of NSCLC in the United States was nearly 201,200 in 2022.
• The total number of cases in EU4 and the UK for EGFR NSCLC was estimated to be nearly 30,900 cases in 2022.
• The total number of cases of EGFR Exon 20 insertion mutations in Japan was estimated to be nearly 6,500 in 2022.

Epidermal Growth Factor Receptor Metastatic Non-small Cell Lung Cancer Drug Chapters

The drug chapter segment of the EGFR 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 drugs such as TAGRISSO (AstraZeneca), GILOTRIF/GIOTRIF (Boehringer Ingelheim), VIZIMPRO (Pfizer), and others. Furthermore, the current key players for the upcoming emerging drugs and their respective drug candidates include EQRx International/Hansoh Pharmaceutical (aumolertinib), Taiho Pharmaceutical/Cullinan Oncology (zipalertinib), Arrivent Biopharma (furmonertinib), and others. The drug chapter also helps understand the EGFR 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

TAGRISSO: AstraZeneca

TAGRISSO (osimertinib) is a prescription medicine used to treat adults with non-small cell lung cancer that has certain abnormal EGFR genes to help prevent the lung cancer from coming back after the tumor has been removed by surgery or as a first treatment when the lung cancer has spread to other parts of the body (metastatic), or when the lung cancer has spread to other parts of the body and the patient have had previous treatment with an EGFR tyrosine kinase inhibitor (TKI) medicine that did not work or is no longer working. It is a kinase inhibitor of the EGFR, which binds irreversibly to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletions) at approximately ninefold lower concentrations than wild-type.

Data readout from the COMPEL Phase III trial is anticipated by the second half of 2024, while data readout from the ORCHARD Phase II trial is anticipated in 2024. The company is planning to file TAGRISSO + CTx (chemotherapy) based on the FLAURA2 trial in the second half of 2023. Recently the company presented FLAURA2 trial data in WCLC 2023.

RYBREVANT: Janssen

RYBREVANT (amivantamab) is a prescription medicine used to treat adults with non-small cell lung cancer that has spread to other parts of the body (metastatic) or cannot be removed by surgery and has a certain abnormal epidermal growth factor receptor “EGFR” gene(s) and whose disease has worsened while on or after chemotherapy that contains platinum. Amivantamab is a bispecific antibody that binds to the extracellular domains of EGFR and MET. In in vitro and in vivo studies amivantamab-vmjw was able to disrupt EGFR and MET signaling functions through blocking ligand binding and, in exon 20 insertion mutation models, degradation of EGFR and MET. The presence of EGFR and MET on the surface of tumor cells also allows for targeting of these cells for destruction by immune effector cells, such as natural killer cells and macrophages, through antibody-dependent cellular cytotoxicity (ADCC) and trogocytosis mechanisms, respectively.

In July 2023, Janssen announced positive topline results from the Phase III PAPILLON study evaluating RYBREVANT (amivantamab) in combination with chemotherapy (carboplatin-pemetrexed) in patients with newly diagnosed advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. The Phase III PAPILLON study, the first late-stage clinical program for RYBREVANT, is a confirmatory study supporting the approved use for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy and is the first randomized study evaluating patients with newly diagnosed NSCLC with EGFR exon 20 insertion mutations to demonstrate clinically meaningful result. In 2023, the company is planning to file RYBREVANT in combination with CTX based on the PAPILLON trial in the US and EU.

Emerging Drugs

Aumolertinib: EQRx International/Hansoh Pharmaceutical

Aumolertinib is a third-generation EGFR-tyrosine kinase inhibitor (TKI) in development for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with activating EGFR mutations and for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer.

In December 2022, EQRx announced the acceptance of the Marketing Authorization Application for review by the EMA for Aumolertinib in EGFR-mutated non-small cell lung cancer. A randomized, three-arm Phase IIIb clinical study (the TREBLE trial) evaluating the safety and efficacy of aumolertinib in combination with chemotherapy vs. aumolertinib and osimertinib reference arms for the first-line treatment of EGFR-mutated non-small cell lung cancer, is ongoing. Results from this study could be used to support combination and monotherapy use, with the potential ability to file for US approval by 2027.

Zipalertinib: Taiho Pharmaceutical/Cullinan Oncology

Zipalertinib (CLN-081/TAS6417) is a novel, orally bioavailable, irreversible EGFR inhibitor that, based on preclinical models, selectively and potently targets cells expressing EGFRex20ins mutations while relatively sparing cells expressing wild-type EGFR to avoid the toxicities associated with inhibition of wild-type EGFR. This was rationally designed with a distinct chemical scaffold to be highly selective for mutant vs. wild-type EGFR and to avoid inhibiting the closely related receptor human epidermal growth factor receptor 2 (HER2). Zipalertinib demonstrates the potential to become a new standard of care to treat non-small cell lung cancer harboring EGFRex20ins mutations. Cullinan Oncology is actively enrolling for Phase IIb 2L+ and Phase III 1L pivotal studies of zipalertinib.

Drug Class Insights

The existing EGFR non-small cell lung cancer is mainly dominated by targeted therapies for mutations such as EGFR-sensitizing mutations and EGFR exon 20 insertions. EGFR mutations are frequently observed, EGFR exon 19 deletions and EGFR exon 21 L858R mutations. The FDA has approved various tyrosine kinase inhibitors (TKIs) to treat these mutations.

First and second-generation EGFR TKI: Compared to platinum-based chemotherapy (i.e., cisplatin or carboplatin combined with either gemcitabine, pemetrexed, paclitaxel, or docetaxel), first- and second-generation EGFR TKIs have higher response rates (RRs) and progression-free survival (PFS).

Third-generation EGFR TKI: TAGRISSO is the only targeted therapy that has shown survival benefits in both early- and late-stages of EGFRm NSCLC. Due to resistance development, osimertinib is recommended for patients with EGFR T790M-mutant NSCLC who progress after a first- or second-generation TKI.

HER-3 inhibitor: Patritumab Deruxtecan demonstrated clinically meaningful and durable responses in patients with EGFR-mutated metastatic NSCLC. At present, there are no HER3-directed therapies approved for these patients despite the high prevalence (up to 75%) of HER3 overexpression.

Note: Detailed insights will be provided in the final report.

Epidermal Growth Factor Receptor Metastatic Non-small Cell Lung Cancer Market Outlook

The treatment of EGFR-mutant non-small cell lung cancer has been transformed by the development of targeted therapies in the last two decades; however, choosing the best therapy after EGFR TKIs fail is still a challenge. There are five EGFR tyrosine kinase inhibitors (TKIs) approved for first-line treatment of advanced non-small cell lung cancer with common EGFR-sensitizing mutations (e.g., EGFR exon 19 deletions or exon 21 mutations [L858R]): erlotinib, gefitinib, afatinib, dacomitinib, and osimertinib. These drugs have different efficacy and safety profiles and are classified as first- (e.g., erlotinib, gefitinib), second- (e.g., afatinib, dacomitinib), or third-generation (e.g., osimertinib) TKIs. Afatinib and osimertinib, which are second- and third-generation TKIs, respectively, have shown prolonged activity against some rare EGFR mutations (e.g., T790M [osimertinib], G719X, L861Q, or S768I [afatinib and osimertinib]).

Compared to platinum-based chemotherapy, second-generation EGFR TKIs generally offer superior response rates and progression-free survival. Dacomitinib and osimertinib outperform first-generation EGFR TKIs in overall survival. Afatinib surpasses platinum-based chemotherapy but not first-generation EGFR TKIs in PFS and OS. However, no direct prospective trial compares second- and third-generation EGFR TKIs. Afatinib was FDA-approved as the first second-generation EGFR TKI in 2013.

Second-generation TKIs offer improved safety and efficacy compared to first-generation TKIs. Osimertinib is preferred for EGFR T790M-mutant non-small cell lung cancer after progression on earlier TKI therapy, as shown in the AURA3 trial, with higher response rates and longer progression-free survival. To combat progression, osimertinib, afatinib, and dacomitinib are favored over first-generation TKIs upfront. However, drug resistance remains a challenge despite enhanced efficacy. Patient outcomes may differ among these drugs.

Many companies are developing third-generation EGFR TKIs for exon 20 insertion in non-small cell lung cancer, such as ArriVent Biopharma (furmonertinib), Cullinan Oncology/Taiho Oncology (zipalertinib), and Dizal Pharmaceutical (sunvozertinib). These drugs will compete with each other for this niche market.

• The total market size in the US for EGFR mNSCLC was estimated to be nearly USD 2,100 million in 2022, which is expected to increase due to the launch of emerging therapies and label expansion of current therapies.
• The majority of the emerging key players focus on the Exon 20 insertion segment. Recently withdrawal of EXKIVITY from the market of Exon 20 insertion stands behind RYBREVANT in the current market for this segment. Companies like Cullinan Oncology/Taiho Oncology, ArriVent BioPharma, and Dizal Pharmaceutical, are aiming at EXON-20 mutant EGFR NSCLC segment.
• Chinese players are trying to enter into the 7MM market. Aumolertinib is approved in China. Last year EQRx announced the acceptance of the Marketing Authorization Application for review by the EMA for Aumolertinib in EGFR-mutated NSCLC based on China trial data.
• TAGRISSO is the market leader in the EGFR NSCLC market. TAGRISSO is the market leader in the EGFR NSCLC market. Resistant to EGFR TKI is increasing in patients. The post-TAGRISSO setting is one of the highest areas of unmet need.

Epidermal Growth Factor Receptor 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. By overcoming the resistance from first and second-generation EGFR inhibitors, and better efficacy in terms of overall response and progression-free survival TAGRISSO become the market leader in the EGFR NSCLC market with fast uptake.

Further detailed analysis of emerging therapies drug uptake in the report…

Epidermal Growth Factor Receptor 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 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 cost of treating EGFR Non-small Cell Lung Cancer has shown significant increases over time, irrespective of the stage of the disease. This is particularly true for younger patients treated in the outpatient setting, according to real-world findings. The first-generation epidermal growth factor receptor tyrosine kinase inhibitors were reimbursed and available in all countries.

The TAGRISSO Patient Savings Program aims to assist eligible, commercially insured patients with their out-of-pocket costs for TAGRISSO. Most eligible patients will pay USD 0 per month and may have access to up to USD 26,000 per year to assist with TAGRISSO out-of-pocket costs. There are no income requirements to participate in the program.

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of EGFR 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 treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the EGFR 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 EGFR Non-small Cell Lung Cancer market.

Epidermal Growth Factor Receptor Metastatic Non-small Cell Lung Cancer Report Insights

• Patient Population
• Therapeutic Approaches
• EGFR Non-small Cell Lung Cancer Pipeline Analysis
• EGFR Non-small Cell Lung Cancer Market Size and Trends
• Existing and Future Market Opportunity

Report Key Strengths

• Ten Years Forecast
• The 7MM Coverage
• Non-small Cell Lung Cancer Epidemiology Segmentation
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

Epidermal Growth Factor Receptor Metastatic Non-small Cell Lung Cancer Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT)

FAQs

• What is the historical and forecasted EGFR 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 EGFR 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?
• Which class is going to be the largest contributor by 2032?
• What will be the impact of TAGRISSO’s expected patent expiry?
• How will TAGRISSO compete with RYBREVANT in the first- and second lines?
• 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?
• Which major player is focusing on this patient population and how many patients have HER3 overexpression?
• How many key players are developing therapies for exon 20 insertion EGFR NSCLC?
• Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
• 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 EGFR 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.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• 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.