EGFR 변이 비소세포폐암의 치료는 지난 20년간 표적 치료제의 개발로 크게 달라졌지만, EGFR TKI 실패 후 최적의 치료법 선택은 여전히 과제로 남아있습니다. 일반적인 EGFR 민감성 돌연변이(예: EGFR 엑손 19 결실 또는 엑손 21 돌연변이[L858R])를 가진 비소세포폐암에는 afatinib과 osimertinib이 있습니다. 이들 약제는 효능과 안전성 프로파일이 다르며, 1세대(예: erlotinib, gefitinib), 2세대(예: afatinib, dacomitinib), 3세대(예: osimertinib) TKI로 분류됩니다. afatinib과 osimertinib은 각각 2세대와 3세대 TKI로, 여러 희귀 EGFR 변이(예: T790M[osimertinib], G719X, L861Q, S768I[afatinib 및 osimertinib])에 대해 장기간의 장기간의 활성을 보이고 있습니다.
gefitinib은 최초의 EGFR TKI로 일본에서는 2002년에 진행성 비소세포폐암 적응증으로 승인되었고, 미국에서는 2004년에 erlotinib, 유럽에서는 2009년에 gefitinib이 승인되었습니다. 이들 1세대 및 2세대 TKI는 백금 기반 화학요법에 비해 우수한 반응률과 무진행 생존율을 보였으나, 내성으로 인해 지속성이 제한적이었습니다. 2013년 FDA의 승인을 받은 최초의 2세대 TKI인 afatinib은 dacomitinib과 함께 점진적인 효과를 보였으며, osimertinib은 AURA3 임상에서 확인된 바와 같이 특히 T790M 돌연변이 환자에서 우수한 PFS와 OS를 보여주었습니다. 결과를 보여주는 새로운 기준을 세웠습니다.
본 보고서에서는 EGFR-NSCLC의 주요 7개국(미국, 독일, 스페인, 이탈리아, 프랑스, 영국, 일본) 시장을 조사 분석하여 각 지역의 시장 규모, 현재 치료법, 미충족 수요, 신약 등의 정보를 제공하고 있습니다.
DelveInsight's "Epidermal Growth Factor Receptor Non-small Cell Lung Cancer (EGFR-NSCLC) - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of EGFR-NSCLC, historical and forecasted epidemiology as well as EGFR-NSCLC market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The EGFR-NSCLC market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted the 7MM EGFR-NSCLC market size from 2020 to 2034. The report also covers current EGFR-NSCLC treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
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, 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.
EGFR Non-small Cell Lung Cancer Diagnosis
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.
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. The most common treatments for EGFR non-small cell lung cancer are:
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 by Histology, Total Incident Cases of NSCLC by Stage, Total Cases of EGFR-positive NSCLC, EGFR-positive NSCLC incident cases by Subtypes, and Line-wise Treated Cases of EGFR-positive NSCLC in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.
The total number of incident cases of NSCLC in the United States was nearly 204,800 in 2024.
The total number of cases in EU4 and the UK for EGFR-NSCLC was estimated to be nearly 211,000 cases in 2024.
Among the total NSCLC cases, EGFR mutations represented the most prevalent biomarker, accounting for 50% of cases, followed by EGFR exon 19 deletions (sensitizing/classical mutations) at 15%, while PACC mutations (G719X, S768I, L792X, T854I, etc.) were the least common, comprising 5%.
The total number of cases of EGFR Exon 20 insertion mutations in Japan was estimated to be nearly 5,000 in 2024.
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 Osimertinib (TAGRISSO), Amivantamab (RYBREVANT), Sunvozertinib (ZEGFROVY), Aumolertinib (AUMSEQA), and others. Furthermore, the current key players for the upcoming emerging drugs and their respective drug candidates include Taiho Pharmaceutical/Cullinan Oncology (zipalertinib), Arrivent Biopharma (furmonertinib), and others. The drug chapter also helps understand the EGFR-NSCLC clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, and the latest news and press releases.
Marketed Drugs
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.
In September 2025, Osimertinib plus chemotherapy demonstrated a median overall survival of nearly 4 years, the longest benefit ever reported in a global Phase III trial in EGFR-mutated advanced lung cancer.
In July 2025, Osimertinib plus chemotherapy demonstrated statistically significant and clinically meaningful improvement in overall survival in EGFR-mutated advanced lung cancer.
Sunvozertinib (ZEGFROVY): Dizal Pharmaceutical
Sunvozertinib is an oral, irreversible kinase inhibitor specifically approved for the treatment of adults with locally advanced or NSCLC harboring EGFR exon 20 insertion mutations, as confirmed by an FDA-approved test, whose disease has progressed after platinum-based chemotherapy. By selectively inhibiting mutant EGFR and showing reduced activity on wild-type EGFR, sunvozertinib effectively disrupts oncogenic signaling pathways that drive tumor growth, while generally limiting toxicity commonly associated with EGFR-targeted therapies.
In July 2025, the US FDA granted an accelerated approval to sunvozertinib as the only targeted oral therapy for NSCLC with EGFR Exon 20 insertion mutations.
Emerging Drugs
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.
In September 2025, according to the company's corporate presentation, Pending FDA discussions, a potential NDA filing by Taiho is targeted for YE 2025 in relapsed EGFR ex20ins NSCLC and randomized REZILIENT3 Phase III frontline trial is ongoing, with completion of enrolment expected in H1 2026.
Firmonertinib: ArriVent BioPharma
Firmonertinib (formerly furmonertinib), is an oral, highly brain-penetrant, and broadly active mutation-selective EGFR inhibitor active against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations.
Firmonertinib is currently being studied in a global Phase III trial for first-line NSCLC patients with EGFR exon 20 insertion mutations (FURVENT; NCT05607550) and in a global Phase Ib study evaluating firmonertinib in patients with EGFR PACC mutations (FURTHER; NCT05364043). In addition, firmonertinib is also being studied in a clinical combination study targeting advanced or metastatic NSCLC patients with EGFR classical mutations in partnership with InnoCare Pharma.
According to ArriVent BioPharma's Second Quarter 2025 Financial Results, Top-line firmonertinib monotherapy data from the global pivotal FURVENT Phase III study for first-line EGFR exon20 insertion mutant NSCLC are projected to be in early 2026.
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: Osimertinib is the only targeted therapy that has shown survival benefits in both early- and late-stages of EGFR-NSCLC. Due to resistance development, osimertinib is recommended for patients with EGFR T790M-mutant NSCLC who progress after a first- or second-generation TKI.
TROP-2 directed ADC
TROP2-directed antibody-drug conjugates (ADCs) are a novel class of targeted cancer therapeutics that harness an anti-TROP2 monoclonal antibody to deliver highly potent cytotoxic payloads selectively to tumor cells expressing the TROP2 surface antigen. It is an emerging therapeutic class in EGFR-mutated NSCLC, particularly following resistance to EGFR tyrosine kinase inhibitors (TKIs). Dato-dxd is the first TROP2-ADC approved for adults with EGFR-mutant, locally advanced or metastatic NSCLC after progression on EGFR-targeted therapy and chemotherapy.
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 non-small cell lung cancers with common EGFR-sensitizing mutations (e.g., EGFR exon 19 deletions or exon 21 mutations [L858R]): afatinib 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]).
Gefitinib was the first EGFR TKI, gaining approval in Japan in 2002 for advanced NSCLC, followed by erlotinib in the US in 2004 and gefitinib in Europe in 2009. These first- and second-generation TKIs showed superior response rates and progression-free survival compared with platinum-based chemotherapy, though resistance limited durability. Afatinib, the first second-generation TKI approved by the FDA in 2013, along with dacomitinib, demonstrated incremental efficacy, while osimertinib set a new standard with superior PFS and OS outcomes, particularly in patients with T790M mutations, as confirmed in the AURA3 trial.
Despite these advances, no prospective head-to-head trials have directly compared second- and third-generation EGFR TKIs. While later-generation agents clearly outperform earlier ones in efficacy and safety, acquired resistance remains a major limitation. This underscores the evolving therapeutic landscape, where successive generations of EGFR TKIs have significantly improved outcomes in advanced NSCLC, but overcoming resistance remains the key challenge in optimizing long-term benefit.
Many companies, such as ArriVent Biopharma (furmonertinib), and Cullinan Oncology/Taiho Pharmaceuticals (zipalertinib) are developing third-generation EGFR TKIs for exon 20 insertion in non-small cell lung cancer. These drugs will compete with each other for this niche market.
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034, 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, osimertinib became the market leader in the EGFR-NSCLC market.
Epidermal Growth Factor Receptor 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 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as University of Southern California, Santa Maria della Misericordia Hospital, 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 Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.
Conjoint Analysis analyzes multiple approved and 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.
In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most crucial primary outcome measures is event-free survival and overall survival.
Further, the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed, and this clearly explains the drug's side effects in the trials. In addition, the scoring is also based on the 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.
Market Access and Reimbursement
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.
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 Osimertinib. Most eligible patients will pay USD 0 per month and may have access to up to USD 26,000 per year to assist with Osimertinib out-of-pocket costs. There are no income requirements to participate in the program.
What are the country-specific accessibility issues of expensive, recently approved therapies?