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Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) - Market Insight, Epidemiology, and Market Forecast - 2036

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    Report

  • 328 Pages
  • April 2026
  • Region: Global
  • DelveInsight
  • ID: 5025138

Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC) Insights and Trends

  • According to DelveInsight’s analysis, EGFR NSCLC market size was found to be ~USD 6.60 billion in the leading markets (the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan) in 2025.
  • EGFR-mutated NSCLC is more prevalent in Asian counties such as Japan, with mutation rates estimated at 45%, compared to 15% in Western countries. Majorly due to genetic predisposition, lower smoking rates among Asian patients, and distinct environmental factors that contribute to a higher likelihood of oncogenic driver mutations.
  • Males face a higher lifetime risk of developing lung cancer and experience greater mortality compared to females. This disparity is partly attributed to lifestyle factors, as men are more likely to engage in cigarette smoking, alcohol consumption, high-calorie diets, and drug use, all of which elevate lung cancer risk.
  • NSCLC is increasingly becoming a biomarker-driven market, and EGFR is one of the most profitable biomarker segments, led by blockbuster therapies such as osimertinib (TAGRISSO), which now generates nearly USD 6 billion annually. The prevalence of patients with this resistance mutation has increased since TAGRISSO was authorized for use in the first line. The post-TAGRISSO setting is one of the highest areas of unmet need.
  • The ADC space in EGFR NSCLC awaits more launches down the road, with several compounds under development in pivotal studies. The ADC space in EGFR NSCLC awaits more launches down the road, with several compounds under development in pivotal studies. After the approval of Dato-Dxd, leading pharma players drive ADC innovation with agents such as izalontamab brengitecan (BMS), telisotuzumab adizutecan (AbbVie), and sacituzumab tirumotecan (Merck).
  • Convergence of TKIs, ADCs, bispecifics, CDAC, and gene-therapy combinations signals a densely crowded and competitive future, where differentiation by efficacy, resistance coverage, administration route, and combination potential will define market winners.
  • From last few years, exon 20 insertions EGFR mutations have received the most attention and this space has become competitive. In EGFR NSCLC, uncommon/atypical EGFR mutations (G719X, S768I, as well as PACC mutations), represent another frontier in this segment.

Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC) Market Size and Forecast

  • 2025 EGFR NSCLC Market Size: ~USD 6.60 billion
  • 2036 Projected EGFR NSCLC Market Size: ~USD 14.20 billion
  • EGFR NSCLC Growth Rate (2026-2036): 7.3% CAGR
The ‘Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC) - Market Insights, Epidemiology and Market Forecast - 2036’ report delivers an in-depth understanding of the EGFR NSCLC, historical and forecasted epidemiology, as well as the EGFR NSCLC market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC) market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, EGFR NSCLC patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in EGFR NSCLC and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC) Understanding and Treatment Algorithm

Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC) Overview and Diagnosis

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, a few rare types 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.

In general, there are two 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.

Current Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC) Treatment Landscape

Treatment of EGFR-mutated NSCLC mainly involves targeted therapies called EGFR tyrosine kinase inhibitors (TKIs), which block the abnormal EGFR signaling that drives tumor growth. Commonly used TKIs include first-, second-, and third-generation agents such as osimertinib, erlotinib, and afatinib. For patients with specific resistant mutations like EGFR exon 20 insertions, alternative targeted therapies or newer agents may be used instead of standard TKIs. In some cases, chemotherapy, immunotherapy, or combination therapies may also be considered depending on the mutation type and disease stage.

Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC) Unmet Needs

The section “unmet needs of Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC)” outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Problem of Resistance Development

2. CNS Metastases and Limited Brain Penetration

3. Limited Access and Affordability

4. Therapy Gaps after Targeted Therapy Progression, and others…..

Note: Comprehensive unmet needs insights in EGFR NSCLC and their strategic implications are provided in the full report.

Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC) Epidemiology

Key Findings from EGFR NSCLC Epidemiological Analysis and Forecast

  • According to the publisher’s estimates, the total number of incident cases of NSCLC in the 7MM was nearly 540,000 cases in 2025 and is projected to increase during the forecasted period.
  • The total number of incident cases of NSCLC in the United States was nearly 202,900 in 2025.
  • In 2025, adenocarcinoma (~116,000 cases) accounted for the largest share of incident NSCLC cases in the United States, followed by squamous cell carcinoma, while large cell carcinoma comprised the smallest proportion.
  • The total number of cases of EGFR NSCLC in the United States was estimated to be nearly 30,400 in 2025.
  • NSCLC shows a slight male predominance and is most common in individuals aged =65 years. However, cases among people younger than 65 are increasing, likely due to changing smoking patterns, environmental and occupational exposures, air pollution, and improved early diagnostic detection.
Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC) Drug Analysis & Competitive Landscape
The EGFR NSCLC drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I/II-II clinical trials. It covers mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, strategic partnerships upcoming Key catalyst for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the EGFR NSCLC treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the EGFR NSCLC therapeutics market.

Approved Therapies for EGFR NSCLC

Osimertinib (TAGRISSO): AstraZeneca

Osimertinib is a prescription medicine for adults with NSCLC with abnormal EGFR genes. It is used to prevent recurrence after surgery, as a first-line treatment for metastatic NSCLC, or when previous EGFR TKI treatments have failed. Osimertinib is a kinase inhibitor that targets mutant EGFR forms (T790M, L858R, exon 19 deletions) at lower concentrations than wild-type EGFR. In November 2015, it was initially approved 80mg once-daily tablets for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC. In February 2024, the FDA approved osimertinib with platinum-based chemotherapy for patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.

Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC) Pipeline Analysis

Zipalertinib: Cullinan Oncology/Taiho Pharmaceutical

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.

Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC) Key Players, Market Leaders and Emerging Companies
  • Cullinan Oncology
  • Taiho Pharmaceuticals
  • ArriVent BioPharma
  • Akeso Biopharma
  • Summit Therapeutics
  • Pfizer
  • Daiichi Sankyo
  • AstraZeneca
  • Merck
  • Kelun-Biotech
  • CSPC Pharmaceutical
  • Shanghai JMT-Bio
  • Bristol-Myers Squibb, and others

Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC) Drug Updates

  • In January 2026, the US FDA accepted for filing Summit’s Biologics License Application (BLA) for the HARMONi Phase III trial and assigned a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.
  • In November 2025, a New Drug Application (NDA) was submitted for zipalertinib for the treatment of EGFR exon 20-mutant NSCLC, with completion and priority review planned for Q1 2026, based on data from the REZILIENT1 Phase I/II study.
  • Silvertinib is being evaluated for 1L NSCLC, with Phase II DOR/PFS data expected in Q2 2026 and subsequent FDA feedback. Final Phase II data in 2L/3L NSCLC are also expected in Q2 2026, and the drug has received FDA Fast Track Designation (FTD) for C797S+ patients while partnering options for pivotal development are being explored.

Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC) Market Outlook

Treatment of EGFR-mutant NSCLC has improved with targeted EGFR TKIs over the past two decades. First-generation TKIs (erlotinib, gefitinib), second-generation TKIs (afatinib, dacomitinib), and the third-generation TKI (osimertinib) have progressively improved response and survival compared with chemotherapy. Osimertinib is also effective against the T790M resistance mutation; however, drug resistance still develops and optimal treatment after TKI failure remains challenging.

Osimertinib remains the global standard of care for EGFR-mutant NSCLC, supported by strong overall survival (OS) and progression-free survival (PFS) data and broad approvals across disease stages. Amivantamab is emerging as a key competitor, expanding beyond EGFR exon 20 mutations through combination regimens with lazertinib and chemotherapy. The landscape is becoming more competitive with new entrants such as Datopotamab deruxtecan, Sunvozertinib, and Aumolertinib. Real-world data from the 7MM show that EGFR TKIs dominate treatment, with osimertinib widely used as first-line therapy, while chemotherapy and immunotherapy remain options in later lines or for rare mutations (e.g., exon 20 insertions).

EGFR exon 20 insertion NSCLC is difficult to treat with standard TKIs. Amivantamab was the main approved therapy after mobocertinib was withdrawn. In 2025, Sunvozertinib was approved, increasing competition, while TKIs like Furmonertinib and Zipalertinib are in development. Emerging ADCs and next-generation therapies are further intensifying competition in the EGFR NSCLC market.

Overall, the launch of first-in-class therapies, improved genetic testing, and rising disease awareness are expected to drive steady growth in the 7MM EGFR NSCLC market from 2022-2036, with strong commercial implications for both marketed products and emerging pipelines.
  • Among the 7MM, the US accounted for the largest market size of EGFR NSCLC. i.e., USD ~3,800 million in 2025.
  • In 2036, among all the therapies for EGFR NSCLC, the highest revenue is estimated to be generated by amivantamab (RYBREVANT) ± lazertinib (LAZCLUZE) followed by osimertinib (TAGRISSO), in the US.
  • The entry of late-stage candidates such as zipalertinib, furmonertinib is expected to intensify competition in the EGFR NSCLC treatment landscape during the latter forecast period.

Drug Class/Insights into Leading Emerging and Marketed Therapies in EGFR NSCLC (2022-2036 Forecast)
The EGFR NSCLC market comprises monoclonal/bispecific antibody, ADC, and small molecules, each targeting different aspects of EGFR NSCLC.
  • Small molecules: Small-molecule therapies in development for EGFR-mutant NSCLC include zipalertinib (CLN-081) by Cullinan Oncology/Taiho Pharma, firmonertinib by ArriVent BioPharma, and LP-300 by Lantern Pharma.
  • ADCs: Key ADCs in the pipeline include PF-08046054 (Pfizer), patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), sacituzumab tirumotecan (MK-2870) (Merck/Kelun-Biotech), SYS6010 (CSPC Pharmaceutical), izalontamab brengitecan (BMS-986507) (Bristol-Myers Squibb), and telisotuzumab adizutecan (ABB-400) (AbbVie).
Small molecules and ADCs defines the core innovation landscape, with monoclonal and bispecific antibodies currently commercially validated and small molecules driving pipeline growth.

Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC) Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the EGFR NSCLC drug’s uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.

The uptake of therapies in EGFR NSCLC is expected to vary based on clinical positioning, mechanism of action, and stage of development. Adoption of amivantamab (RYBREVANT) + chemotherapy and amivantamab (RYBREVANT) + lazertinib (LAZCLUZE) in EGFR NSCLC is expected to occur at a moderate uptake rate, supported by their targeted approach, favorable clinical data, and increasing integration into earlier lines of therapy.

The adoption of emerging therapies in EGFR-mutant NSCLC is expected to vary based on clinical maturity, combination strategies, and differentiation from existing standards of care. Furmonertinib/firmonertinib may achieve relatively faster uptake due to encouraging clinical data and potential positioning in targeted therapy settings. In contrast, pamvatamig (MCLA-129) ± osimertinib and telisotuzumab adizutecan (Temab-A) + TAGRISSO are likely to experience gradual uptake, reflecting their earlier clinical positioning and the need for stronger comparative evidence against established EGFR TKIs.

Detailed insights of emerging therapies' drug uptake is included in the report

Market Access and Reimbursement of Approved therapies in Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC)

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

Reimbursement is a crucial factor that affects the drug’s access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

NOTE: Further Details are provided in the final report….

Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC) Therapies Price Scenario & Trends
Pricing and analogue assessment of EGFR NSCLC therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most approproiate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.
  • Pricing of EGFR NSCLC Approved Drugs
In the first-line setting, treatment costs vary significantly, with platinum-based chemotherapy estimated at USD 8,747, first- and second-generation TKIs at USD 27,943, and osimertinib reaching approximately USD 212,580, reflecting the higher cost associated with targeted therapies.

Industry Experts and Physician Views for Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC)

To keep up with EGFR NSCLC market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the EGFR NSCLC emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in EGFR NSCLC, including MD, Ph.D, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

The analysts connected with 15+ KOLs to gather insights at country level. Centers such as the Ohio State University, Norris Comprehensive Cancer Center, and University of Southern California, etc. were contacted. Their opinion helps understand and validate current and emerging EGFR NSCLC therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in EGFR NSCLC.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of EGFR NSCLC, 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.

Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The team of analysts analyzes promising 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, whereas the therapies’ safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report

  • The report covers a segment of key events, an executive summary, a descriptive overview of Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC), explaining their causes, signs and symptoms, pathogenesis, and currently available treatments.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
  • A detailed review of the Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC) 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 Epidermal Growth Factor Receptor (EGFR) Non-small Cell Lung Cancer (NSCLC) market.

Report Insights

  • EGFR NSCLC Patient Population Forecast
  • EGFR NSCLC Therapeutics Market Size
  • EGFR NSCLC Pipeline Analysis
  • EGFR NSCLC Market Size and Trends
  • EGFR NSCLC Market Opportunity (Current and forecasted)

Report Key Strengths

  • Epidemiology-based (Epi-based) Bottom-up Forecasting
  • Artificial Intelligence (AI)-enabled Market Research Report
  • 11-year forecast
  • EGFR NSCLC Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (by geography)
  • EGFR NSCLC Treatment Addressable Market (TAM)

EGFR NSCLC Competitive Landscape

  • EGFR NSCLC Major Companies Insights
  • EGFR NSCLC Price Trends and Analogue Assessment
  • EGFR NSCLC Therapies Drug Adoption/Uptake
  • EGFR NSCLC Therapies Peak Patient Share Analysis

Report Assessment

  • EGFR NSCLC Current Treatment Practices
  • EGFR NSCLC Unmet Needs
  • EGFR NSCLC Clinical Development Analysis
  • EGFR NSCLC Emerging Drugs Product Profiles
  • EGFR NSCLC Market Attractiveness
  • EGFR NSCLC Qualitative Analysis (SWOT and conjoint analysis)

FAQs

Market Insights

  • What was the EGFR NSCLC market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
  • What can be the future treatment paradigm of EGFR NSCLC?
  • What impact will patent expiry have on the EGFR therapy market?
  • What are the disease risks, burdens, and unmet needs of EGFR NSCLC? What will be the growth opportunities across the 7MM concerning the patient population with EGFR NSCLC?
  • Who is the major future competitor in the market, and how will the competitors affect their market share?
  • What are the current options for the treatment of EGFR NSCLC? What are the current guidelines for treating EGFR NSCLC in the US, Europe, and Japan?

Reasons to Buy

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the EGFR NSCLC market.
  • Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
  • Insights on patient burden/disease incidence, 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.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • To understand KOLs’ perspectives on 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.
  • This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets within the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights2. Report Introduction3. Executive Summary of EGFR-NSCLC
4. Key Events
4.1. Upcoming Key Catalysts
4.2. Key Conferences and Meetings
4.3. Key Transactions and Collaborations
4.4. News Flow
5. Epidemiology and Market Forecast Methodology
6. EGFR-NSCLC Market Overview at a Glance
6.1. Clinical Landscape (Analysis by Molecule Type, Phase, and Route of Administration [RoA])
6.2. Market Share (%) Distribution of EGFR-NSCLC by Line of Therapy (LoT) in 2025 in the 7MM
6.3. Market Share (%) Distribution of EGFR-NSCLC by Line of Therapy (LoT) in 2036 in the 7MM
7. Disease Background and Overview
7.1. Introduction
7.2. Structure and Mechanism of EGFR
7.3. Types of EGFR Mutation in NSCLC
7.4. Risk Factors Associated With EGFR-mutated NSCLC
7.5. Diagnosis
7.5.1. Biomarker Testing for EGFR Mutation
7.5.2. Diagnosis Algorithm of EGFR
7.5.3. Diagnosis Guidelines
7.6. Treatment
7.6.1. Current Treatment
7.6.2. Treatment Algorithm
7.6.3. Treatment Guidelines
8. Epidemiology and Patient Population
8.1. Key Findings
8.2. Assumptions and Rationale
8.3. Total Incident Cases of EGFR-NSCLC in the 7MM
8.4. The United States
8.4.1. Total Incident Cases of NSCLC in the United States
8.4.2. Gender-specific Incident Cases of NSCLC in the United States
8.4.3. Age-specific Incident Cases of NSCLC in the United States
8.4.4. Total Incident Cases of NSCLC by Histology in the United States
8.4.5. Total Incident Cases of NSCLC by Stage in the United States
8.4.6. Total Incident Cases of EGFR-NSCLC in the United States
8.4.7. Line-wise Treated Cases of EGFR-NSCLC in the United States
8.5. EU4 and the UK
8.5.1. Total Incident Cases of NSCLC in EU4 and the UK
8.5.2. Gender-specific Incident Cases of NSCLC in EU4 and the UK
8.5.3. Age-specific Incident Cases of NSCLC in EU4 and the UK
8.5.4. Total Incident Cases of NSCLC by Histology in EU4 and the UK
8.5.5. Total Incident Cases of NSCLC by Stage in EU4 and the UK
8.5.6. Total Incident Cases of EGFR-NSCLC in EU4 and the UK
8.5.7. Line-wise Treated Cases of EGFR-NSCLC in EU4 and the UK
8.6. Japan
8.6.1. Total Incident Cases of NSCLC in Japan
8.6.2. Gender-specific Incident Cases of NSCLC in Japan
8.6.3. Age-specific Incident Cases of NSCLC in Japan
8.6.4. Total Incident Cases of NSCLC by Histology in Japan
8.6.5. Total Incident Cases of NSCLC by Stage in Japan
8.6.6. Total Incident Cases of EGFR-NSCLC in Japan
8.6.7. Line-wise Treated Cases of EGFR-NSCLC in Japan
9. Patient Journey10. Key Endpoints
11. Marketed Therapies
11.1. Key Cross Competition of Marketed Therapies
11.2. AUMSEQA (Aumolertinib): Jiangsu Hansoh Pharmaceutical
11.2.1. Product Description
11.2.2. Regulatory Milestones
11.2.3. Other Developmental Activity
11.2.4. Summary of Pivotal Clinical Trial
11.2.5. Analyst View
11.3. VIZIMPRO (Dacomitinib): Pfizer
11.3.1. Product Description
11.3.2. Regulatory Milestones
11.3.3. Other Developmental Activities
11.3.4. Summary of Pivotal Trials
11.3.5. Clinical Development
11.3.6. Safety and Efficacy
11.3.7. Analyst Views
11.4. GILOTRIF/GIOTRIF (Afatinib maleate): Boehringer Ingelheim
11.4.1. Product Description
11.4.2. Regulatory Milestones
11.4.3. Other Developmental Activities
11.4.4. Summary of Pivotal Trials
11.4.5. Safety and Efficacy
11.4.6. Analyst Views
11.5. TAGRISSO (Osimertinib): AstraZeneca
11.5.1. Product Description
11.5.2. Regulatory Milestones
11.5.3. Other Developmental Activities
11.5.4. Summary of Pivotal Trials
11.5.5. Clinical Development
11.5.6. Safety and Efficacy
11.5.7. Analyst Views
11.6. PORTRAZZA (Necitumumab): Eli Lilly and Company
11.6.1. Product Description
11.6.2. Regulatory Milestones
11.6.3. Other Developmental Activities
11.6.4. Summary of Pivotal Trials
11.6.5. Safety and Efficacy
11.6.6. Analyst Views
11.7. RYBREVANT (Amivantamab) ± LAZCLUZE (Lazertinib): Johnson & Johnson Innovative Medicine/Yuhan Corporation
11.7.1. Product Description
11.7.2. Regulatory Milestones
11.7.3. Other Developmental Activities
11.7.4. Summary of Pivotal Trials
11.7.5. Clinical Development
11.7.6. Safety and Efficacy
11.7.7. Analyst Views
11.8. ZEGFROVY (Sunvozertinib): Dizal Pharmaceutical
11.8.1. Product Description
11.8.2. Regulatory Milestones
11.8.3. Other Developmental Activities
11.8.4. Summary of Pivotal Trials
11.8.5. Clinical Development
11.8.6. Safety and Efficacy
11.8.7. Analyst Views
11.9. DATROWAY (Datopotamab Deruxtecan): Daiichi Sankyo/AstraZeneca
11.9.1. Product Description
11.9.2. Regulatory Milestones
11.9.3. Other Developmental Activities
11.9.4. Summary of Pivotal Trials
11.9.5. Clinical Development
11.9.6. Safety and Efficacy
11.9.7. Analyst Views
12. Emerging drugs
12.1. Key Cross Competition of Emerging Therapies
12.2. Ivonescimab (AK112): Akeso Bio and Summit Therapeutics
12.2.1. Product Description
12.2.2. Other Developmental Activity
12.2.3. Clinical Development
12.2.4. Safety and Efficacy
12.2.5. Analyst Views
12.3. Firmonertinib: ArriVent BioPharma and Shanghai Allist Pharmaceuticals
12.3.1. Product Description
12.3.2. Other Developmental Activities
12.3.3. Clinical Development
12.3.4. Safety and Efficacy
12.3.5. Analyst Views
12.4. Sacituzumab Tirumotecan (MK-2870): Merck and Kelun-Biotech
12.4.1. Product Description
12.4.2. Other Developmental Activities
12.4.3. Clinical Development
12.4.4. Safety and Efficacy
12.4.5. Analyst Views
12.5. Iza-bren (izalontamab brengitecan): SystImmune and Bristol Myers Squibb
12.5.1. Product Description
12.5.2. Other Developmental Activities
12.5.3. Clinical Development
12.5.4. Safety and Efficacy
12.5.5. Analyst Views
12.6. PF-08046054: Pfizer
12.6.1. Product Description
12.6.2. Other Developmental Activities
12.6.3. Clinical Development
12.6.4. Safety and Efficacy
12.6.5. Analyst Views
12.7. Zipalertinib (CLN-081): Cullinan Therapeutics and Taiho Pharma
12.7.1. Product Description
12.7.2. Other Developmental Activities
12.7.3. Clinical Development
12.7.4. Safety and Efficacy
12.7.5. Analyst Views
12.8. SYS6010: CSPC Pharmaceutical
12.8.1. Product Description
12.8.2. Other Developmental Activities
12.8.3. Clinical Development
12.8.4. Safety and Efficacy
12.8.5. Analyst Views
12.9. Telisotuzumab adizutecan, Temab-A (ABBV-400): AbbVie
12.9.1. Product Description
12.9.2. Other Developmental Activities
12.9.3. Clinical Development
12.9.4. Safety and Efficacy
12.9.5. Analyst Views
12.10. Sutetinib: Teligene
12.10.1. Product Description
12.10.2. Clinical Development
12.10.3. Safety and Efficacy
12.10.4. Analyst Views
12.11. LP-300: Lantern Pharma
12.11.1. Product Description
12.11.2. Other Developmental Activities
12.11.3. Clinical Development
12.11.4. Safety and Efficacy
12.11.5. Analyst Views
12.12. DB-1310: DualityBio
12.12.1. Product Description
12.12.2. Other Developmental Activities
12.12.3. Clinical Development
12.12.4. Safety and Efficacy
12.12.5. Analyst Views
12.13. JIN-A02: J INTS BIO
12.13.1. Product Description
12.13.2. Other Developmental Activities
12.13.3. Clinical Development
12.13.4. Safety and Efficacy
12.13.5. Analyst Views
12.14. Pamvatamig (MCLA-129): Merus
12.14.1. Product Description
12.14.2. Other Developmental Activities
12.14.3. Clinical Development
12.14.4. Safety and Efficacy
12.14.5. Analyst Views
12.15. Quaratusugene ozeplasmid (REQORSA): Genprex
12.15.1. Product Description
12.15.2. Other Developmental Activities
12.15.3. Clinical Development
12.15.4. Safety and Efficacy
12.15.5. Analyst Views
12.16. Silevertinib (BDTX-1535): Black Diamond Therapeutics
12.16.1. Product Description
12.16.2. Other Developmental Activity
12.16.3. Clinical Development
12.16.4. Safety and Efficacy
12.16.5. Analyst Views
13. EGFR-NSCLC: 7MM Market Analysis
13.1. Key Findings
13.2. The 7MM
13.2.1. Total Market Size of EGFR-NSCLC by Country in the 7MM
13.2.2. Market Size of EGFR NSCLC by Therapies in the 7MM
13.3. Market Outlook
13.4. Conjoint Analysis
13.5. Key Market Forecast Assumptions
13.5.1. Cost Assumptions and Rebates
13.5.2. Pricing Trends
13.5.3. Analogue Assessment
13.5.4. Launch Year and Therapy Uptakes
13.6. The United States
13.6.1. Total Market Size of EGFR NSCLC in the United States
13.6.2. Market Size of EGFR NSCLC by Therapies in the United States
13.7. EU4 and the UK
13.7.1. Total Market Size of EGFR NSCLC in EU4 and the UK
13.7.2. Market Size of EGFR NSCLC by Therapies in EU4 and the UK
13.8. Japan
13.8.1. Total Market Size of EGFR NSCLC in Japan
13.8.2. Market Size of EGFR NSCLC by Therapies in Japan
14. Unmet Needs15. SWOT Analysis16. KOL Views
17. Market Access and Reimbursement
17.1. The United States
17.2. In EU4 and the UK
17.2.1. Germany
17.2.2. France
17.2.3. Italy
17.2.4. Spain
17.2.5. United Kingdom
17.3. Japan
17.4. Summary and Comparison of Market Access and Pricing Policy Developments in 2025
17.5. Market Access and Reimbursement of EGFR-NSCLC Therapies
18. Appendix
18.1. Bibliography
18.2. Report Methodology
19. Publisher Capabilities20. Disclaimer21. About the Publisher
List of Tables
Table 1: Summary of EGFR-NSCLC Epidemiology and Market (2025-2036)
Table 2: Upcoming Key Catalyst
Table 3: Conference Highlights
Table 4: Key Transactions and Collaborations
Table 5: News Flow
Table 6: Types of EGFR Mutation
Table 7: Molecular and Biomarker-directed Therapy for Advanced or Metastatic Diseasea,b
Table 8: First-line Treatment for EGFR Gene Mutation-positive: Exon 19 Deletion or L858R Mutation-positive
Table 9: First-line Treatment for EGFR Mutation-positive: Exon 18-21 mutations (Excluding Exon 19 Deletion and L858R Mutation and Exon 20 Insertion Mutation)
Table 10: First-line Treatment for EGFR Mutation-positive Patients: Exon 20 Insertion Mutation
Table 11: Second-line Treatment and Beyond for EGFR Mutation-positive Patients
Table 12: EGFR Biomarker Epidemiology
Table 13: Total Incident Cases of EGFR-NSCLC in the 7MM (2022-2036)
Table 14: Total Incident Cases of NSCLC in the United States (2022-2036)
Table 15: Gender-specific Incident Cases of NSCLC in the United States (2022-2036)
Table 16: Age-specific Incident Cases of NSCLC in the United States (2022-2036)
Table 17: Total Incident Cases of NSCLC by Histology in the United States (2022-2036)
Table 18: Total Incident Cases of NSCLC by Stage (at diagnosis) in the United States (2022-2036)
Table 19: Total Incident Cases of Advanced/Metastatic NSCLC in the United States (2022-2036)
Table 20: Total Incident Cases of EGFR-NSCLC in the United States (2022-2036)
Table 21: Line-wise Treated Cases of NSCLC in the United States (2022-2036)
Table 22: Total Incident Cases of NSCLC in EU4 and the UK (2022-2036)
Table 23: Gender-specific Incident Cases of NSCLC in Germany (2022-2036)
Table 24: Gender-specific Incident Cases of NSCLC in France (2022-2036)
Table 25: Gender-specific Incident Cases of NSCLC in Italy (2022-2036)
Table 26: Gender-specific Incident Cases of NSCLC in Spain (2022-2036)
Table 27: Gender-specific Incident Cases of NSCLC in the UK (2022-2036)
Table 28: Gender-specific Incident Cases of NSCLC in EU4 and the UK (2022-2036)
Table 29: Age-specific Incident Cases of NSCLC in Germany (2022-2036)
Table 30: Age-specific Incident Cases of NSCLC in France (2022-2036)
Table 31: Age-specific Incident Cases of NSCLC in Italy (2022-2036)
Table 32: Age-specific Incident Cases of NSCLC in Spain (2022-2036)
Table 33: Age-specific Incident Cases of NSCLC in the UK (2022-2036)
Table 34: Age-specific Incident Cases of NSCLC in EU4 and the UK (2022-2036)
Table 35: Total Incident Cases of NSCLC by Histology in Germany (2022-2036)
Table 36: Total Incident Cases of NSCLC by Histology in France (2022-2036)
Table 37: Total Incident Cases of NSCLC by Histology in Italy (2022-2036)
Table 38: Total Incident Cases of NSCLC by Histology in Spain (2022-2036)
Table 39: Total Incident Cases of NSCLC by Histology in the UK (2022-2036)
Table 40: Total Incident Cases of NSCLC by Histology in EU4 and the UK (2022-2036)
Table 41: Total Incident Cases of NSCLC by Stage (at diagnosis) in Germany (2022-2036)
Table 42: Total Incident Cases of NSCLC by Stage (at diagnosis) in France (2022-2036)
Table 43: Total Incident Cases of NSCLC by Stage (at diagnosis) in Italy (2022-2036)
Table 44: Total Incident Cases of NSCLC by Stage (at diagnosis) in Spain (2022-2036)
Table 45: Total Incident Cases of NSCLC by Stage (at diagnosis) in the UK (2022-2036)
Table 46: Total Incident Cases of NSCLC by Stage (at diagnosis) in EU4 and the UK (2022-2036)
Table 47: Total Incident Cases of Advanced/Metastatic NSCLC in the EU4 and the UK (2022-2036)
Table 48: Total Incident Cases of EGFR-NSCLC in Germany (2022-2036)
Table 49: Total Incident Cases of EGFR-NSCLC in France (2022-2036)
Table 50: Total Incident Cases of EGFR-NSCLC in Italy (2022-2036)
Table 51: Total Incident Cases of EGFR-NSCLC in Spain (2022-2036)
Table 52: Total Incident Cases of EGFR-NSCLC in the UK (2022-2036)
Table 53: Total Incident Cases of EGFR-NSCLC in EU4 and the UK(2022-2036)
Table 54: Line-wise Treated Cases of NSCLC in Germany (2022-2036)
Table 55: Line-wise Treated Cases of NSCLC in France (2022-2036)
Table 56: Line-wise Treated Cases of NSCLC in Italy (2022-2036)
Table 57: Line-wise Treated Cases of NSCLC in Spain (2022-2036)
Table 58: Line-wise Treated Cases of NSCLC in the UK (2022-2036)
Table 59: Line-wise Treated Cases of NSCLC in EU4 and the UK (2022-2036)
Table 60: Total Incident Cases of NSCLC in Japan (2022-2036)
Table 61: Gender-specific Incident Cases of NSCLC in Japan (2022-2036)
Table 62: Age-specific Incident Cases of NSCLC in Japan (2022-2036)
Table 63: Total Incident Cases of NSCLC by Histology in Japan (2022-2036)
Table 64: Total Incident Cases of NSCLC by Stage (at diagnosis) in Japan (2022-2036)
Table 65: Total Incident Cases of Advanced/Metastatic NSCLC in the Japan (2022-2036)
Table 66: Total Incident Cases of EGFR-NSCLC in Japan (2022-2036)
Table 67: Line-wise Treated Cases of NSCLC in Japan (2022-2036)
Table 68: Marketed Drug Key Competitors
Table 69: VIZIMPRO (Dacomitinib), Clinical Trial Description, 2026
Table 70: TAGRISSO (Osimertinib), Clinical Trial Description, 2026
Table 71: RYBREVANT (Amivantamab) ± LAZCLUZE (Lazertinib), Clinical Trial Description, 2026
Table 72: ZEGFROVY (Sunvozertinib), Clinical Trial Description, 2026
Table 73: DATROWAY (Datopotamab deruxtecan), Clinical Trial Description, 2026
Table 74: Comparison of Emerging Drugs Under Development
Table 75: Ivonescimab (AK112), Clinical Trial Description, 2026
Table 76: Firmonertinib, Clinical Trial Description, 2026
Table 77: Sacituzumab tirumotecan (MK-2870/SKB264), Clinical Trial Description, 2026
Table 78: Iza-bren (izalontamab brengitecan), Clinical Trial Description, 2026
Table 79: PF-08046054, Clinical Trial Description, 2026
Table 80: Zipalertinib, Clinical Trial Description, 2026
Table 81: SYS6010, Clinical Trial Description, 2026
Table 82: Telisotuzumab adizutecan, Temab-A (ABBV-400), Clinical Trial Description, 2026
Table 83: Sutetinib, Clinical Trial Description, 2026
Table 84: LP-300, Clinical Trial Description, 2026
Table 85: DB-1310, Clinical Trial Description, 2026
Table 86: JIN-A02, Clinical Trial Description, 2026
Table 87: Pamvatamig (MCLA-129), Clinical Trial Description, 2026
Table 88: Quaratusugene ozeplasmid (REQORSA), Clinical Trial Description, 2026
Table 89: Silevertinib (BDTX-1535), Clinical Trial Description, 2026
Table 90: Market Size of EGFR-NSCLC by Country in the 7MM, in USD million (2022-2036)
Table 91: Market Size of EGFR NSCLC by Therapies in the 7MM, USD million (2022-2036)
Table 92: Key Market Forecast Assumption of EGFR NSCLC in the United States
Table 93: Key Market Forecast Assumption of EGFR NSCLC in EU4 and the UK
Table 94: Key Market Forecast Assumption of EGFR NSCLC in Japan
Table 95: Total Market Size of EGFR NSCLC in the United States, USD million (2022-2036)
Table 96: Market Size of EGFR NSCLC by Therapies in the United States, USD million (2022-2036)
Table 97: Total Market Size of EGFR NSCLC in EU4 and the UK, USD million (2022-2036)
Table 98: Market Size of EGFR NSCLC by Therapies in Germany, USD million (2022-2036)
Table 99: Market Size of EGFR NSCLC by Therapies in France, USD million (2022-2036)
Table 100: Market Size of EGFR NSCLC by Therapies in Italy, USD million (2022-2036)
Table 101: Market Size of EGFR NSCLC by Therapies in Spain, USD million (2022-2036)
Table 102: Market Size of EGFR NSCLC by Therapies in the UK, USD million (2022-2036)
Table 103: Market Size of EGFR NSCLC by Therapies in EU4 and the UK, USD million (2022-2036)
Table 104: Total Market Size of EGFR NSCLC in Japan, USD million (2022-2036)
Table 105: Market Size of EGFR NSCLC by Therapies in the Japan, USD million (2022-2036)
Table 106: US Reimbursement for EGFR-NSCLC therapies
Table 107: Summary of Recommendations in EU4 and The UK
Table 108: IQWiG Assessment for EGFR-NSCLC therapies
Table 109: HAS Decisions for EGFR-NSCLC therapies
Table 110: AIFA Assessment for EGFR-NSCLC therapies
Table 111: NICE Decisions for EGFR-NSCLC therapies
Table 112: AEMPS Assessment for EGFR-NSCLC
Table 113: NHI Pricing for EGFR-NSCLC therapies
List of Figures
Figure 1: Mechanism of Action of EGFR
Figure 2: Types of EGFR Mutation in NSCLC
Figure 3: Risk Factors Associated With EGFR-mutated NSCLC
Figure 4: Diagnosis Algorithm of EGFR
Figure 5: Management of EGFR-mutated NSCLC Stage I
Figure 6: Management of unresectable Stage III NSCLC
Figure 7: Management of EGFR-mutated NSCLC Stage II-III
Figure 8: Tumor Biomarker Testing Rate
Figure 9: Total Incident Cases of EGFR-NSCLC in the 7MM (2022-2036)
Figure 10: Total Incident Cases of NSCLC in the United States (2022-2036)
Figure 11: Gender-specific Incident Cases of NSCLC in the United States (2022-2036)
Figure 12: Age-specific Incident Cases of NSCLC in the United States (2022-2036)
Figure 13: Total Incident Cases of NSCLC by Histology in the United States (2022-2036)
Figure 14: Total Incident Cases of NSCLC by Stage (at diagnosis) in the United States (2022-2036)
Figure 15: Total Incident Cases of EGFR-NSCLC in the United States (2022-2036)
Figure 16: Line-wise Treated Cases of NSCLC in the United States (2022-2036)
Figure 17: Total Incident Cases of NSCLC in EU4 and the UK (2022-2036)
Figure 18: Gender-specific Incident Cases of NSCLC in EU4 and the UK (2022-2036)
Figure 19: Age-specific Incident Cases of NSCLC in EU4 and the UK (2022-2036)
Figure 20: Total Incident Cases of NSCLC by Histology in EU4 and the UK (2022-2036)
Figure 21: Total Incident Cases of NSCLC by Stage (at diagnosis) in EU4 and the UK (2022-2036)
Figure 22: Total Incident Cases of EGFR-NSCLC in EU4 and the UK (2022-2036)
Figure 23: Line-wise Treated Cases of NSCLC in EU4 and the UK (2022-2036)
Figure 24: Total Incident Cases of NSCLC in Japan (2022-2036)
Figure 25: Gender-specific Incident Cases of NSCLC in Japan (2022-2036)
Figure 26: Age-specific Incident Cases of NSCLC in Japan (2022-2036)
Figure 27: Total Incident Cases of NSCLC by Histology in Japan (2022-2036)
Figure 28: Total Incident Cases of NSCLC by Stage (at diagnosis) in Japan (2022-2036)
Figure 29: Total Incident Cases of EGFR-NSCLC in Japan (2022-2036)
Figure 30: Line-wise Treated Cases of NSCLC in Japan (2022-2036)
Figure 31: Total Market Size of EGFR-NSCLC by Country in the 7MM, in USD million (2022-2036)
Figure 32: Market Size of EGFR NSCLC by Therapies in the 7MM (2022-2036)
Figure 33: Total Market Size of EGFR NSCLC in the United States in USD million (2022-2036)
Figure 34: Market Size of EGFR NSCLC by Therapies in the United States in USD million (2022-2036)
Figure 35: Total Market Size of EGFR NSCLC in EU4 and the UK in USD million (2022-2036)
Figure 36: Market Size of EGFR NSCLC by Therapies in EU4 and the UK in USD million (2022-2036)
Figure 37: Total Market Size of EGFR NSCLC in Japan in USD million (2022-2036)
Figure 38: Market Size of EGFR NSCLC by Therapies in Japan in USD million (2022-2036)
Figure 39: Health Technology Assessment
Figure 40: 7MM HTA bodies
Figure 41: US Healthcare Programs
Figure 42: Reimbursement Process of Germany
Figure 43: Reimbursement Process of France
Figure 44: Reimbursement Process of Italy
Figure 45: Reimbursement Process in Spain
Figure 46: Reimbursement Process in the United Kingdom
Figure 47: UK MHRA Approval Through IRF
Figure 48: Reimbursement Process in Japan

Executive Summary

Country Wise- Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Epidemiology

Estimates show the highest Incident population of EGFR-NSCLC is in the United States. Furthermore, among the European 5 countries, the Germany had highest incident population of NSCLC.

Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Drug Chapters

Drug chapter segment of the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer report encloses the detailed analysis of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Marketed Drugs

Iressa (gefitinib): AstraZeneca
In July 2015, the US FDA approved Iressa (gefitinib) for the first-line treatment of patients with NSCLC whose tumor harbor specific types of EGFR gene mutations, as detected by an FDA-approved test. However, before a nod from the US FDA, in July 2009, European Medicines Agency (EMA) granted marketing authorization for gefitinib for the treatment of locally advanced or metastatic NSCLC with sensitizing mutations of the EGFR gene, across all lines of therapy.

Tagrisso (Osimertinib): AstraZeneca
Tagrisso (Osimertinib) has been approved for the first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. For the previously untreated EGFR mutation-positive metastatic NSCLC, it was demonstrated in a randomized, multicenter, double-blind, active-controlled trial (FLAURA [NCT02296125]). The use of osimertinib in the frontline setting had increased quite rapidly in the few months after the FLAURA data were released, and was expected to continue for a while.

Products detail in the report.

Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Emerging Drugs

TAK-788 (AP32788): Takeda
Takeda is investigating their drug candidate, TAK-788 (AP32788), which is a potent and selective next-generation, small-molecule tyrosine kinase inhibitor (TKI) intelligently designed and under clinical investigation to inhibit EGFR and human EGFR 2 (HER2) exon 20 mutations with selectivity over wild type (WT) EGFR. It is currently being explored in EGFR exon 20 insertion mutations in several clinical trials. Previously conducted non-clinical studies demonstrated antitumor activity against de novo mutations in EGFR including EGFR exon 20 insertions and the acquired resistance mutation T790M. Last year, Takeda presented the result of phase I/II trial, and results from this trial showed that TAK-788 effectively treated NSCLC patients whose tumor harbor EGFR exon 20 insertion mutations and who had been previously treated with multiple prior therapies.

Lazertinib: Yuhan Corporation/ Janssen Research & Development
It is a third-generation EGFR- tyrosine kinase (EGFR-TK) inhibitor that could penetrate the brain barrier. Yuhan believes that it has the potential to be first-line therapy for treatment of NSCLC. Lazertinib is currently undergoing Phase III trials in Korea. Interim data has shown that Lazertinib exhibited robust disease activity in patients with NSCLC with acquired resistance to EGFR-TKIs, with or without brain metastasis and was well-tolerated with low rates of Grade 3 or higher adverse events. The South Korean firm entered into licensing deal with Janssen for Lazertinib. Under this agreement, Janssen will be responsible for the development of Lazertinib. In addition to this, Janssen will also be responsible for the manufacturing and commercialization of this drug except for Korea. Both companies under this collaboration initiated Phase I/II clinical trial outside Korea.

JNJ-61186372 (JNJ-6372): Janssen
Janssen, a Johnson and Johnson Company is currently investigating their lead product JNJ-61186372 (JNJ-6372) in Advance NSCLC patients. It is a novel Human Bispecific EGFR and c-Met Antibody that company believes has the potential to benefit patients with Exon 20 mutation insertions who often do not respond to currently available oral EGFR-targeted or immune checkpoint inhibitor therapies. These two receptors (EGFR and c-Met), in their mutant form, play major roles in the proliferation of cancer cells. By targeting EGFR and c-Met, JNJ-61186372 triggers a chain of events leading to the degradation of these receptors and prevents their activation in the future. The mechanism of JNJ-61186372 is believed to prevent the proliferation of tumor cells and thus aids in the treatment of cancer.

Products detail in the report.

Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Market Outlook

Key Findings

According to the publisher, Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market in the 7MM is expected to change in the study period 2017-2030. The therapeutic market of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer in seven major markets was found to be USD 1,893 million in 2017 which is expected to increase during study period (2017-2030).

The United States Market Outlook

In 2017, the total market size of EGFR-NSCLC therapies was found to be USD 1,150 million in the United States which is expected to increase in the study period (2017-2030).

EU-5 Countries: Market Outlook

In 2017, the total market size of EGFR-NSCLC therapies was found to be USD 536 million in the EU-5 countries which is expected to increase in the study period (2017-2030).

Japan Market Outlook

The total market size of EGFR-NSCLC therapies in Japan was found to be USD 208 million in 2017.

Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Pipeline Development Activities

The drugs which are in pipeline includes:
1. JNJ-61186372 (JNJ-6372): Janssen Research & Development
2. Lazertinib: Yuhan Corporation/ Janssen Research & Development
3. TAK-788: Takeda
and others….

Products detail in the report.

Pipeline Development Activities

Key Points

1. In March 2020, the Janssen Pharmaceutical Companies of Johnson & Johnson announced stated that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for JNJ-61186372 for the treatment of patients with metastatic NSCLC with EGFR Exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.

Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Drugs Uptake

The EGFR NSCLC market is expected to be dominated by Tagrisso (osimertinib). The market domination is mainly because of it selectively inhibits EGFR-TKI-sensitizing and EGFR T790M resistance mutations, also its use as first-line therapy in NSCLC does not lead to T790M mutations. Other therapies like JNJ-6372 and TAK-788 which are mainly targeting EGFR exon 20 insertion mutations are expected to generate revenue mainly attributed due to lack of treatment options for EGFR exon 20 insertion mutations.

Access and Reimbursement Scenario in Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Therapies


  • In January 2020, the National Institute for Health and Care Excellence (NICE) has published final guidance. And as per that guidance, NICE does not recommend AstraZeneca’s Tagrisso for untreated locally advanced or metastatic EGFR-positive NSCLC. This decision was entirely based on a clinical trial, which despite showing that the drug stalled cancer-growth for around 18.9 months compared with 10.2 months in patients treated with erlotinib or gefitinib, did not show direct evidence that the drug would be more effective than afatinib, which may be more effective than erlotinib or gefitinib. As it stands, the first line of treatment for locally advanced stages of NSCLC is a daily oral dose of afatinib, erlotinib, gefitinib or dacomitinib, which have all previously been recommended by NICE. Unfortunately, the drug is not considered eligible for inclusion in the Cancer Drugs Fund (CDF) as it does not have the potential to be cost-effective at the price offered

KOL - Views

To keep up with current market trends, we take KOLs and SME’s opinion working in Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform Competitive and Market Intelligence analysis of the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Market by using various Competitive Intelligence tools that includes - SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report


  • The report covers the descriptive overview of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer, explaining its causes, signs and symptoms, pathophysiology and currently available therapies.
  • Comprehensive insight has been provided into the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer epidemiology and treatment in the 7MM.
  • Additionally, an all-inclusive account of both the current and emerging therapies for Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
  • A detailed review of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market; historical and forecasted is included in the report, covering drug outreach in the 7MM.
  • The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market.

Report Highlights


  • In the coming years, Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
  • Major players are involved in developing therapies for Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer. Launch of emerging therapies, will significantly impact the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market.
  • A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer.
  • Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Report Insights


  • Patient Population
  • Therapeutic Approaches
  • Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Pipeline Analysis
  • Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Market Size and Trends
  • Market Opportunities
  • Impact of upcoming Therapies

Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Report Key Strengths


  • 11 Years Forecast
  • 7MM Coverage

Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Epidemiology Segmentation


  • Key Cross Competition
  • Highly Analyzed Market
  • Drugs Uptake

Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Report Assessment


  • SWOT Assessment
  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Conjoint Analysis
  • Market Attractiveness
  • Market Drivers and Barriers

Key Questions Answered

Market Insights:


  • What was the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Market share (%) distribution in 2017 and how it would look like in 2030?
  • What would be the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer total market Size as well as market size by therapies across the 7MM during the study period (2017-2030)?
  • What are the key findings pertaining to the market across the 7MM and which country will have the largest Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market size during the study period (2017-2030)?
  • At what CAGR, the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market is expected to grow in 7MM during the study period (2017-2030)?
  • What would be the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market outlook across the 7MM during the study period (2017-2030)?
  • What would be the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market growth till 2030 and what will be the resultant market size in the year 2030?
  • How would the market drivers, barriers and future opportunities affect the market dynamics and a subsequent analysis of the associated trends?
  • Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer patient types/ pool where unmet need is more and whether emerging therapies will be able to address the residual unmet need?
  • How emerging therapies are performing on the parameters like efficacy, safety, route of administration (RoA), treatment duration and frequencies based on their clinical trial results?
  • Among the emerging therapies, what are the potential therapies which are expected to disrupt the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market?

Epidemiology Insights:


  • What is the disease risk, burden and unmet needs of the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer?
  • What is the historical Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer patient pool in seven major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
  • What would be the forecasted patient pool of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer in 7 major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
  • What will be the growth opportunities in the 7MM with respect to the patient population pertaining to Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer?
  • Out of all the 7MM countries, which country would have the highest Incident population of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer during the study period (2017-2030)?
  • At what CAGR the population is expected to grow in the 7MM during the study period (2017-2030)?
  • What are the various recent and upcoming events which are expected to improve the diagnosis of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:


  • What are the current options for the treatment of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer along with the approved therapy?
  • What are the current treatment guidelines for the treatment of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer in the US, Europe and Japan?
  • What are the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
  • How many companies are developing therapies for the treatment of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer?
  • How many therapies are developed by each company for the treatment of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer?
  • How many emerging therapies are in mid stage, and late stage of development for the treatment of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer?
  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer therapies?
  • What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer and their status?
  • What are the key designations that have been granted for the emerging therapies for Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer?
  • What are the global historical and forecasted market of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer?

Reasons to buy


  • The report will help in developing business strategies by understanding trends shaping and driving the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market.
  • To understand the future market competition in the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market and Insightful review of the key market drivers and barriers.
  • Organize sales and marketing efforts by identifying the best opportunities for Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer in the US, Europe (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
  • Identification of strong upcoming players in market will help in devising strategies that will help in getting ahead of competitors.
  • Organize sales and marketing efforts by identifying the best opportunities for Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market.
  • To understand the future market competition in the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market.

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • AstraZeneca
  • Boehringer Ingelheim
  • Eli Lilly
  • Hansoh Pharmaceutical
  • Johnson & Johnson Innovative Medicine
  • Pfizer
  • Cullinan Oncology
  • Taiho Pharmaceutical
  • ArriVent Biopharma
  • Black Diamond Therapeutics
  • Daiichi Sankyo
  • Akeso Biopharma
  • Summit Therapeutics