EGFR-NSCLC Market to Observe Stunning Growth at a CAGR of 9.6% During the Forecast Period (2025-2034) | DelveInsight

The EGFR-NSCLC market is expected to grow owing to the approval of new agents such as Zipalertinib (Cullinan Oncology/Taiho Pharma), Ivonescimab (Akeso Biopharma/Summit Therapeutics), Sacituzumab Tirumotecan (Merck/Kelun-Biotech), Izalontamab Brengitecan (Bristol-Myers Squibb), Firmonertinib (ArriVent BioPharma), and others in frontline and combination settings, rising therapy costs, and increasing testing rates that enable the identification of more patients with EGFR alterations.

LAS VEGAS, Feb. 11, 2026 /PRNewswire/ -- DelveInsight's EGFR-NSCLC Market Insights report includes a comprehensive understanding of current treatment practices, EGFR-NSCLC emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets [the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. 

EGFR-NSCLC Market Summary

• The market size for EGFR-NSCLC was found to be USD 6 billion in the leading markets in 2024.
• The United States accounted for the largest EGFR-NSCLC treatment market size, approximately 56% of the total market size in the 7MM in 2024, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• The total number of incident cases of EGFR-NSCLC in the leading market was nearly 117,000 in 2024.
• In histology-specific cases, adenocarcinoma accounts for the highest number of cases, i.e., approximately 60% followed by squamous cell carcinoma in the 7MM.
• Leading EGFR-NSCLC companies developing emerging therapies, such as ArriVent BioPharma (NASDAQ: AVBP), Akeso Biopharma (HKG: 9926), Summit Therapeutics (NASDAQ: SMMT), J INTS BIO, Merus (NASDAQ: MRUS), Merck (NYSE: MRK), Kelun-Biotech (HKG: 6990), Genprex (NASDAQ: GNPX), Cullinan Oncology (NASDAQ: CGEM), Taiho Pharma, CSPC Pharmaceutical (HKG: 1093), AbbVie (NYSE: ABBV), Teligene, Bristol–Myers Squibb (NYSE: BMY), SystImmune, Black Diamond Therapeutics (NASDAQ: BDTX), Lantern Pharma (NASDAQ: LTRN), and others, are developing new EGFR-NSCLC treatment drugs that can be available in the EGFR-NSCLC market in the coming years. 
• The promising EGFR-NSCLC therapies in clinical trials include Firmonertinib, Ivonescimab (SMT112), JIN-A02, Pamvatamig (MCLA-129), Sacituzumab Tirumotecan (MK-2870), Quaratusugene ozeplasmid (REQORSA), Zipalertinib (CLN-081), SYS6010, Telisotuzumab adizutecan (Temab-A, ABBV-400), Sutetinib, Izalontamab Brengitecan (BMS-986507), Silevertinib (BDTX-1535), LP-300, and others.
• 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.

Discover the new EGFR-NSCLC treatment @ https://www.delveinsight.com/sample-request/epidermal-growth-factor-receptor-non-small-cell-lung-cancer-market?utm_source=cision&utm_medium=pressrelease&utm_campaign=spr

Key Factors Driving the Growth of the EGFR-NSCLC Market 

• Rising Burden of NSCLC and the EGFR-positive Patient Population: Global lung-cancer incidence remains high, and NSCLC is the dominant histology; a meaningful subset of those patients carries EGFR driver mutations, creating a persistent addressable patient base for EGFR-targeted therapies. As per DelveInsight's analysis, the total number of incident cases of NSCLC in the US was nearly 205,000 in 2024. These cases are further expected to increase by 2034. 
• Rising EGFR-NSCLC Clinical Trial Activity: The EGFR-NSCLC pipeline possesses some drugs in mid- and late-stage developments to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including zipalertinib (Cullinan Oncology/Taiho Pharma), IVONESCIMAB (Akeso Biopharma/Summit Therapeutics), Sacituzumab Tirumotecan (Merck/Kelun-Biotech), Izalontamab Brengitecan (Bristol-Myers Squibb), Firmonertinib (ArriVent BioPharma), and others. The expected launch of these therapies shall further create a positive impact on the market.
• Emerging ADC Landscape in EGFR-NSCLC: 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 Patritumab Deruxtecan (Daiichi Sankyo/AstraZeneca), Izalontamab Brengitecan (BMS), Telisotuzumab Adizutecan (AbbVie), Sacituzumab Tirumotecan (Merck), SYS6010 (CSPC Pharmaceutical), BNT326 (BioNTech), and others.
• CDACs in Spotlight: The emerging pipeline of EGFR-NSCLC includes BG-60366, a first-in-class Chimeric Degradation Activation Compound (CDAC), representing a novel therapeutic class in EGFR-NSCLC beyond current bispecific antibodies and ADCs.
• Zipalertinib's Best-in-Class Potential in EGFR-Resistant NSCLC: Zipalertinib's best-in-class potential provides a unique chance to address substantial unmet needs in patients who have progressed on currently approved EGFR therapies. Its differentiated mechanism and efficacy could position it as a leading option in difficult-to-treat populations.
• Firmonertinib Targets Unmet Needs in EGFR Exon 20 Insertion and PACC: Firmonertinib offers the potential to become the first oral, chemo-free first-line therapy for patients with EGFR Exon 20 insertions and PACC variants. This could address a highly underserved segment and establish a new standard of care for these rare mutations.
• Emerging Competitors in Exon 20 Insertion Segment: The majority of the emerging key players focus on the Exon 20 insertion segment. EXKIVITY's withdrawal from this segment stands behind RYBREVANT in the current market. Companies like EQRx International/Hansoh Pharmaceutical, ArriVent BioPharma, Merus/Betta Pharmaceuticals, Cullinan Oncology, and Taiho Oncology are aiming at the Exon-20 mutant EGFR-NSCLC segment.

EGFR-NSCLC Market Analysis

• Over the past two decades, the management of EGFR-mutant NSCLC has been revolutionized by the advent of targeted therapies. However, determining the optimal treatment approach after resistance to EGFR TKIs emerges remains a major challenge. 
• Common EGFR-sensitizing mutations, such as exon 19 deletions and exon 21 L858R substitutions, are typically treated with drugs like afatinib and osimertinib. 
• These agents differ in efficacy and safety and are categorized into first- (erlotinib, gefitinib), second- (afatinib, dacomitinib), and third-generation (osimertinib) TKIs. 
• Notably, afatinib and osimertinib, representing second- and third-generation inhibitors, respectively, have demonstrated durable activity against select rare EGFR mutations, including T790M (osimertinib), G719X, L861Q, and S768I (both).
• Gefitinib was the pioneering EGFR TKI, approved 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 agents showed superior response rates and progression-free survival compared with platinum-based chemotherapy, although resistance limited their long-term effectiveness. 
• The approval of afatinib in 2013 marked the first second-generation TKI to gain FDA clearance, followed by dacomitinib, both offering incremental improvements in efficacy. 
• Osimertinib, however, established a new benchmark by significantly extending progression-free and overall survival, especially in patients with T790M mutations, as validated in the AURA3 trial.
• Despite these achievements, no prospective head-to-head studies have yet compared second- and third-generation EGFR TKIs directly. 
• While newer agents generally demonstrate superior efficacy and tolerability over earlier ones, acquired resistance remains a persistent obstacle. 
• This reflects an evolving therapeutic landscape where each generation of EGFR TKIs has improved outcomes in advanced NSCLC. Yet, the central challenge remains the development of strategies to overcome resistance and sustain long-term benefit.
• Currently, multiple companies, including ArriVent Biopharma (furmonertinib) and Cullinan Oncology/Taiho Pharmaceuticals (zipalertinib), are advancing third-generation EGFR TKIs targeting exon 20 insertion mutations in NSCLC, setting the stage for increased competition in this emerging therapeutic niche.

EGFR-NSCLC Competitive Landscape

The EGFR-NSCLC clinical trial pipeline includes several drugs in mid- and late-stage development that are expected to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including Zipalertinib (Cullinan Oncology/Taiho Pharma), Ivonescimab (Akeso Biopharma/Summit Therapeutics), Sacituzumab Tirumotecan (Merck/Kelun-Biotech), Izalontamab Brengitecan (Bristol-Myers Squibb), Firmonertinib (ArriVent BioPharma), and others.

Cullinan Oncology/Taiho Pharma's Zipalertinib (CLN-081/TAS6417) is an innovative, orally available, irreversible EGFR inhibitor that, according to preclinical data, selectively and effectively targets cells with EGFR exon 20 insertion (EGFRex20ins) mutations while largely sparing wild-type EGFR-expressing cells, thereby minimizing the toxicities typically linked to wild-type EGFR inhibition. It features a distinct chemical structure designed for strong selectivity toward mutant EGFR and reduced activity against both wild-type EGFR and the closely related HER2 receptor. Zipalertinib holds promise as a potential new standard of care for treating non-small cell lung cancer (NSCLC) with EGFRex20ins mutations.

ArriVent BioPharma's Firmonertinib is an orally administered, brain-penetrant, mutation-selective EGFR inhibitor with broad activity against both common and uncommon EGFR alterations, including PACC and exon 20 insertion mutations. It is currently being investigated in a global Phase III clinical trial for first-line treatment of NSCLC patients harboring EGFR exon 20 insertion mutations (FURVENT; NCT05607550) and in a global Phase Ib trial assessing its efficacy in patients with EGFR PACC mutations (FURTHER; NCT05364043).

The anticipated launch of these emerging therapies are poised to transform the EGFR-NSCLC market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the EGFR-NSCLC market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

Discover more about the EGFR-NSCLC drugs market @ EGFR-NSCLC Clinical Trials

Recent Developments in the EGFR-NSCLC Market

• In October 2025, SystImmune and Bristol Myers Squibb will present the first safety and efficacy data from the global phase I US-Lung-101 study (NCT05983432) of iza-bren (BL-B01D1) at the European Society for Medical Oncology (ESMO) Congress. It demonstrated promising antitumor activity in heavily pre-treated patients across multiple tumor types, including EGFR mutant and wild-type NSCLC.
• In October 2025, ALX Oncology presented preclinical data and the trial design for the ongoing Phase I clinical trial for its ADC candidate, ALX2004. In preclinical findings it has shown potent anti-tumor activity and a favorable toxicity profile. 
• In September 2025, Firmonertinib showed a 68.2% ORR and 16 months mPFS in EGFR PACC-mutant NSCLC (Phase Ib FURTHER trial). It also demonstrated strong CNS activity, including complete responses in brain metastases.
• In September 2025, Sunvozertinib achieved an ORR >80% and 100% disease control in treatment-naïve EGFR exon20ins NSCLC when combined with anlotinib. In previously treated patients, the combination with bevacizumab led to 85.7% tumor shrinkage and a median duration of response of 19.1 months.

What is EGFR-NSCLC?

EGFR is a cellular protein that promotes cell growth. Mutations in the EGFR gene can lead to excessive growth, which may result in cancer. These mutations can take various forms, such as deletions, insertions, or point mutations. In clinical testing, patients may be identified as having an EGFR exon 19 deletion or an EGFR L858R point mutation; these are the most common EGFR mutations and are usually managed in the same way. However, some rarer EGFR mutations in lung cancer are treated differently from the common types. A key example is EGFR exon 20 insertions, which do not respond to standard EGFR-targeted therapies known as tyrosine kinase inhibitors (TKIs).

EGFR-NSCLC Epidemiology Segmentation

The EGFR-NSCLC epidemiology section provides insights into the historical and current EGFR-NSCLC patient pool and forecasted trends for the leading markets. In 2024, EGFR Exon 19 deletions accounted for the highest number of cases, approximately 10,000 in EGFR NSCLC in the US.

The EGFR-NSCLC treatment market report proffers epidemiological analysis for the study period 2020–2034 in the leading markets, segmented into:

• Total Incident Cases of NSCLC
• Gender-specific Incident Cases of NSCLC
• Age-specific Incident Cases of NSCLC
• Total Incident Cases of NSCLC by Histology
• Total Incident Cases of NSCLC by Stage (at diagnosis)
• Total Cases of EGFR-NSCLC
• Treated Patient Pool Across the Lines of Therapies

Scope of the EGFR-NSCLC Market Report

• Therapeutic Assessment: EGFR-NSCLC current marketed and emerging therapies
• EGFR-NSCLC Market Dynamics: Key Market Forecast Assumptions of Emerging EGFR-NSCLC Drugs and Market Outlook
• Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Unmet Needs, KOL's views, Analyst's views, EGFR-NSCLC Market Access and Reimbursement

Download the report to understand the factors driving the EGFR-NSCLC market @ EGFR-NSCLC Market Analysis

Table of Contents

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