Emerging EGFR-NSCLC therapies—such as TAGRISSO, GILOTRIF/GIOTRIF, TARCEVA, RYBREVANT, VIZIMPRO, IRESSA, PORTRAZZA, Aumolertinib, Zipalertinib, Furmonertinib, BDTX-1535, Dato-DXd, JIN-A02, NX-019, STX-721, and ORIC-11—are expected to drive market growth in the coming years.
DelveInsight’s report, “Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) – Market Insights, Epidemiology, and Market Forecast-2034,” provides a comprehensive analysis of EGFR-NSCLC, including historical and projected epidemiology, market trends, and developments across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
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Some of the key facts of the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Market Report:
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In 2023, the EGFR-mutant metastatic non-small cell lung cancer (mNSCLC) market across the seven major markets (7MM) was valued at roughly USD 4 billion. Biomarkers are increasingly shaping treatment strategies, with EGFR emerging as one of the most lucrative segments. TAGRISSO continues to dominate this space, though resistance to EGFR tyrosine kinase inhibitors (TKIs) is growing, creating a notable unmet need for patients who relapse after TAGRISSO therapy.
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On December 3, 2024, Merck announced that the FDA granted Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) for advanced or metastatic nonsquamous NSCLC patients with EGFR exon 19 deletions or exon 21 L858R mutations, whose disease progressed following TKIs and platinum-based chemotherapy. In the U.S. in 2023, exon 19 deletions accounted for the largest number of EGFR mNSCLC cases, with nearly 14,300 reported.
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In July 2024, the European Union approved TAGRISSO with pemetrexed and platinum chemotherapy for first-line treatment of adults with advanced EGFR-mutated NSCLC. In June 2024, Janssen received approval for a Type II RYBREVANT regimen combined with carboplatin and pemetrexed for first-line treatment of adult NSCLC patients with EGFR exon 20 insertion mutations. Johnson & Johnson is also developing a subcutaneous formulation of RYBREVANT, increasing competition with AstraZeneca in this segment.
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The exon 20 insertion mutation subsegment is a primary focus for emerging companies. With EXKIVITY withdrawn, RYBREVANT currently leads this space, while Cullinan Oncology/Taiho Oncology, ArriVent BioPharma, and Dizal Pharmaceutical are also targeting this mutation. Next-generation EGFR inhibitors under development include BDTX-1535 (Black Diamond Therapeutics), JIN-A02 (J INTS BIO), NX-019 (NALO Therapeutics), and STX-721 (Scorpion Therapeutics). The EGFR-NSCLC landscape is increasingly competitive; Blueprint Medicines exited this market in January 2024, discontinuing BLU-945 and BLU-451 programs.
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In 2023, approximately 524,000 new NSCLC cases were reported across the 7MM, with 202,500 cases in the U.S. alone. Antibody-drug conjugates (ADCs) like Dato-DXd, as monotherapy or combined with TAGRISSO, are being investigated in the TROPION-Lung14 (NCT06350097) and TROPION-Lung15 (NCT06417814) trials for EGFR-mutant locally advanced or metastatic NSCLC.
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Key companies advancing the EGFR-NSCLC pipeline include AstraZeneca, Boehringer Ingelheim, Genentech/Roche, Eli Lilly, Hansoh Pharmaceutical, J&J Innovative Medicine, Pfizer, Cullinan Oncology, Taiho Pharmaceutical, ArriVent Biopharma, Black Diamond Therapeutics, Daiichi Sankyo, J INTS BIO, NALO Therapeutics, Scorpion Therapeutics, ORIC Pharmaceuticals, and others. Promising therapies include TAGRISSO, GILOTRIF/GIOTRIF, TARCEVA, RYBREVANT, VIZIMPRO, IRESSA, PORTRAZZA, Aumolertinib, Zipalertinib, Furmonertinib, BDTX-1535, Dato-DXd, JIN-A02, NX-019, STX-721, ORIC-11, and more.
Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Overview
EGFR is a cellular protein involved in regulating cell growth. Mutations in the EGFR gene can cause uncontrolled cell proliferation, potentially leading to cancer. These mutations can take the form of deletions, insertions, or point mutations. Common variants detected in diagnostic tests include the exon 19 deletion and the L858R point mutation, which are generally treated with similar approaches. However, certain rare EGFR mutations in lung cancer, such as exon 20 insertions, often require alternative strategies, as they typically do not respond to standard EGFR-targeted tyrosine kinase inhibitors (TKIs).
Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Market Outlook
Targeted therapies have transformed the management of EGFR-mutant non-small cell lung cancer (NSCLC) over the past 20 years, but treatment options remain limited once resistance to EGFR TKIs develops. Common mutations, such as exon 19 deletions and exon 21 L858R, are treated with first-generation (erlotinib, gefitinib), second-generation (afatinib, dacomitinib), and third-generation (osimertinib) TKIs, each with distinct efficacy and safety profiles. Afatinib and osimertinib also show activity against certain rare mutations, including T790M and G719X.
Second-generation TKIs generally improve outcomes compared to chemotherapy, while third-generation osimertinib is preferred after resistance emerges, particularly in T790M-positive cases. Despite these advances, resistance remains a challenge, and no direct comparisons between second- and third-generation TKIs have been conducted.
Next-generation third-generation EGFR TKIs targeting exon 20 insertions—such as furmonertinib (ArriVent), zipalertinib (Cullinan Oncology/Taiho), and sunvozertinib (Dizal)—are under development to address this growing niche.
In 2023, the U.S. EGFR-mutant mNSCLC market was valued at approximately USD 2.19 billion and is expected to expand with new therapies and broader indications. AstraZeneca’s TAGRISSO remains the global leader, generating nearly USD 6 billion annually, with further market consolidation anticipated through the FLAURA2 trial expansion.
Chinese entrants are also emerging, with Aumolertinib approved domestically and under EMA review based on Chinese trial data. Meanwhile, the FDA issued a complete response letter in June 2024 for patritumab deruxtecan’s accelerated approval in EGFR-mutated NSCLC, although global submissions will continue using data from the HERTHENA-Lung02 study.
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Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Marketed Drugs
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TAGRISSO: AstraZeneca
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RYBREVANT: J&J Innovative Medicine
Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Emerging Drugs
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Aumolertinib: Hansoh Pharmaceutical
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Zipalertinib: Cullinan Oncology/Taiho Pharmaceutical
Scope of the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Market Report
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Study Period: 2020-2034
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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
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Key Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Companies: AstraZeneca, Boehringer Ingelheim, Genentech/Roche, Eli Lilly, Hansoh Pharmaceutical, J&J Innovative Medicine, Pfizer, Cullinan Oncology, Taiho Pharmaceutical, ArriVent Biopharma, Black Diamond Therapeutics, Daiichi Sankyo, Black Diamond Therapeutic, J INTS BIO, NALO Therapeutics, Scorpion Therapeutics, ORIC Pharmaceuticals, and others
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Key Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Therapies: TAGRISSO, GILOTRIF/GIOTRIF, TARCEVA, RYBREVANT, VIZIMPRO, IRESSA, PORTRAZZA, Aumolertinib, Zipalertinib, Furmonertinib, BDTX-1535, Dato-DXd, BDTX-1535, JIN-A02, NX-019, STX-721, ORIC-11, and others.
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Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Therapeutic Assessment: Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) current marketed and Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) emerging therapies
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Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Market Dynamics: Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) market drivers and Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) market barriers
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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
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Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Unmet Needs, KOL's views, Analyst's views, Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Market Access and Reimbursement
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Key benefits of the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Market Report:
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Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) market report covers a descriptive overview and comprehensive insight of the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Epidemiology and Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).
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The Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) market report provides insights into the current and emerging therapies.
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The Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) market report provides a global historical and forecasted market covering drug outreach in 7MM.
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The Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) market.
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Table of Contents
1. Report Introduction
2. Executive Summary
3. SWOT analysis
4. Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Patient Share (%) Overview at a Glance
5. Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Market Overview at a Glance
6. Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Disease Background and Overview
7. Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Epidemiology and Patient Population
8. Country-Specific Patient Population of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC)
9. Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Current Treatment and Medical Practices
10. Unmet Needs
11. Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Emerging Therapies
12. Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Market Outlook
13. Country-Wise Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Market Analysis (2020–2034)
14. Market Access and Reimbursement of Therapies
15. Market drivers
16. Market barriers
17. Appendix
18. Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
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Related Reports:
Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Pipeline Insights, DelveInsight
"Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) market. A detailed picture of the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) pipeline landscape is provided, which includes the disease overview and Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) treatment guidelines.
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.
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