시장보고서
상품코드
1855032

상피 성장인자 수용체 비소세포폐암(EGFR-NSCLC) - 시장 인사이트, 역학, 시장 예측(2034년)

Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) - Market Insight, Epidemiology And Market Forecast - 2034

발행일: | 리서치사: DelveInsight | 페이지 정보: 영문 292 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




■ 보고서에 따라 최신 정보로 업데이트하여 보내드립니다. 배송일정은 문의해 주시기 바랍니다.

주요 하이라이트

  • 주요 7개 시장의 EGFR-NSCLC 시장 규모는 2024년 약 6,000달러에 달했으며, 향후 몇 년간 EGFR 유전자 변이가 있는 환자를 식별할 수 있는 검사 비율의 증가, 치료 비용의 상승 및 병용요법의 신약 승인으로 인해 확대될 것으로 예상됩니다.
  • osimertinib이 시장 리더십을 유지하고 있는 EGFR-NSCLC에서 J&J의 amivantamab이 꾸준히 부상하고 있습니다. 경구용 EGFR 티로신 키나아제 억제제인 라제르티닙과 병용하여 보다 광범위한 EGFR 변이 1차 치료제 시장에 진입하고, 유럽에서 amivantamab+lazertinib 피하주사제를 출시했으며, 미국에서도 곧 출시될 예정입니다. amivantamab은 EGFR과 cMET 이중특이성 제제로서의 역할과 이중 기전을 가지고 있어 10억 달러 규모의 제품으로 발전할 수 있는 잠재력을 충분히 가지고 있습니다.
  • 비소세포폐암 시장은 점점 더 바이오마커에 의해 주도되고 있으며, EGFR은 가장 유리한 부문 중 하나입니다. EGFR-NSCLC 시장의 주요 치료제인 osimertinib은 압도적인 지위를 차지하고 있습니다. 그러나 EGFR 티로신 키나아제 억제제에 대한 내성은 환자들 사이에서 증가하는 추세입니다. 오시머티닙 치료 후 내성을 획득한 환자의 치료 니즈에 대한 대응은 미충족 수요의 가장 중요한 부문 중 하나입니다.
  • EGFR-NSCLC의 ADC 영역에서는 여러 화합물이 피벗얼 시험으로 개발 중이며, 향후 추가 출시를 기다리고 있습니다. EGFR-NSCLC ADC 영역에서는 피보탈 시험으로 여러 화합물이 개발 중이며, 향후 추가 출시를 기다리고 있습니다. Dato-Dxd 승인 이후 주요 제약사들은 izalontamab brengitecan(BMS), telisotuzumab adizutecan(AbbVie), sacituzumab tirumotecan(Merck)과 같은 약물로 ADC 혁신을 추진하고 있습니다.
  • EGFR-NSCLC의 새로운 파이프라인에는 최초의 키메라분해 활성화 화합물(CDAC)인 BG-60366이 포함되어 있으며, 현재 이중특이성항체 및 ADC를 뛰어넘는 새로운 EGFR-NSCLC 치료제가 될 것으로 기대됩니다.
  • 대부분의 신흥 주요 기업들은 엑손 20 삽입 부문에 집중하고 있습니다. EXKIVITY의 이 부문에서의 철수는 현재 시장에서 RYBREVANT의 후발주자로서의 입지를 굳히고 있습니다. EQRx International/Hansoh Pharmaceuticals, Merus/Betta Pharmaceuticals, Taiho Oncology 등의 기업이 엑손20 변이 EGFR-NSCLC 부문을 노리고 있습니다.

상피세포성장인자 수용체 비소세포폐암 시장 전망

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.

목차

제1장 중요한 인사이트

제2장 보고서 소개

제3장 EGFR-NSCLC 주요 요약

제4장 주요 사건

  • 향후의 중요한 촉매
  • 주요 회의와 회합
  • 주요 거래와 제휴
  • 뉴스 플로우

제5장 역학과 시장 예측 조사 방법

제6장 EGFR-NSCLC 시장 개요

  • 임상 상황(분자 유형, 단계, 투여 경로(RoA)별 분석)
  • 주요 7개 시장 EGFR-NSCLC 시장 점유율 분포 : 치료 라인(LoT)별(2024년)
  • 주요 7개 시장 EGFR-NSCLC 시장 점유율 분포 : 치료 라인(LoT)별(2034년)

제7장 질환 배경과 개요

  • 소개
  • EGFR 구조와 메커니즘
  • 비소세포폐암의 EGFR 변이 종류
  • EGFR 변이 양성 NSCLC 관련 위험인자
  • 진단
    • EGFR 변이 바이오마커 검사
    • EGFR 진단 알고리즘
    • 진단 가이드라인
  • 치료
    • 현재 치료
    • 치료 알고리즘
    • 치료 가이드라인

제8장 역학과 환자 인구

  • 주요 조사 결과
  • 가정과 근거
  • 주요 7개 시장 NSCLC 발증총 환자 수
  • 미국
  • 유럽 4개국·영국
  • 일본

제9장 환자 여정

제10장 주요 평가 항목

제11장 출시된 치료법

  • 출시된 치료법의 주요 경쟁
  • Sunvozertinib(ZEGFROVY) : Dizal Pharmaceutical
  • Datopotamab Deruxtecan(DATROWAY) : Daiichi Sankyo/AstraZeneca
  • Aumolertinib(AUMSEQA) : Jiangsu Hansoh Pharmaceutical
  • Osimertinib(TAGRISSO) : AstraZeneca
  • Afatinib maleate(GILOTRIF/GIOTRIF) : Boehringer Ingelheim
  • Dacomitinib(VIZIMPRO) : Pfizer
  • Amivantamab(RYBREVANT)+- Lazertinib(LAZCLUZE) : Johnson & Johnson Innovative Medicine/Yuhan Corporation
  • Necitumumab(PORTRAZZA) : Eli Lilly and Company

제12장 신약

  • 주요 경쟁
  • Firmonertinib : ArriVent BioPharma
  • Ivonescimab(SMT112) : Akeso Biopharma/Summit Therapeutics
  • JIN-A02 : J INTS BIO
  • Pamvatamig(MCLA-129) : Merus
  • Sacituzumab Tirumotecan(MK-2870) : Merck and Kelun-Biotech
  • Quaratusugene ozeplasmid(REQORSA) : Genprex
  • Zipalertinib(CLN-081) : Cullinan Oncology/Taiho Pharma
  • SYS6010 : CSPC Pharmaceutical
  • Temab-A(telisotuzumab adizutecan)(ABBV-400) : AbbVie
  • Sutetinib : Teligene
  • Izalontamab Brengitecan(BMS-986507) : Bristol-Myers Squibb/SystImmune
  • Silevertinib(BDTX-1535) : Black Diamond Therapeutics
  • LP-300 : Lantern Pharma

제13장 EGFR-NSCLC : 주요 7개 시장 분석

  • 주요 조사 결과
  • 주요 7개 시장
    • 주요 7개 시장 EGFR-NSCLC 국가별 시장 규모
    • 주요 7개 시장 EGFR-NSCLC 시장 규모 : 치료법별
  • 시장 룩
  • 컨조인트 분석
  • 주요 시장 예측 가정
    • 비용 상정
  • 미국
    • 미국의 EGFR-NSCLC 전체 시장 규모
    • 미국의 EGFR-NSCLC 시장 규모 : 치료법별
  • 유럽 4개국·영국
    • 유럽 4개국·영국의 EGFR-NSCLC 전체 시장 규모
    • 유럽 4개국·영국의 EGFR-NSCLC 시장 규모 : 치료법별
  • 일본
    • 일본의 EGFR-NSCLC 전체 시장 규모
    • 일본의 EGFR-NSCLC 시장 규모 : 치료법별

제14장 미충족 수요

제15장 SWOT 분석

제16장 KOL의 견해

제17장 시장 진입과 상환

  • 미국
  • 유럽 4개국·영국
    • 독일
    • 프랑스
    • 이탈리아
    • 스페인
    • 영국
  • 일본
  • 시장 진입과 가격 책정 정책 발전 요약과 비교(2025년)
  • EGRF-NSCLC 치료 시장 진입과 상환

제18장 부록

제19장 DelveInsight의 서비스 내용

제20장 면책사항

제21장 DelveInsight 소개

KSM 25.11.10

Key Highlights:

  • The total market size of EGFR-NSCLC in the 7MM was ~USD 6,000 in 2024 and expected to increase in coming years owing to the approval of new agents in frontline and combination settings, rising therapy costs, and increasing testing rates that enable the identification of more patients with EGFR alterations
  • Within EGFR-NSCLC, where osimertinib maintains market leadership, J&J's amivantamab is steadily gaining ground. It has entered the broader first-line EGFR-mutated market through combination with the oral EGFR-Tyrosine Kinase Inhibitor lazertinib, and the company has launched a subcutaneous version of amivantamab + lazertinib in Europe, with a US launch expected soon. Given its expanding role and dual mechanism as an EGFR x cMET bispecific, amivantamab is well-positioned to evolve into a potential billion-dollar product.
  • The market for NSCLC is increasingly driven by biomarkers, with EGFR being one of the most lucrative segments. Osimertinib, a leading therapy in the EGFR-NSCLC market, holds a dominant position. However, resistance to EGFR tyrosine kinase inhibitors is on the rise among patients. Addressing the needs of patients who develop resistance after Osimertinib treatment represents one of the most significant 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).
  • 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.
  • 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, Merus/Betta Pharmaceuticals, and Taiho Oncology are aiming at the Exon-20 mutant EGFR-NSCLC segment.

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.

Geography Covered:

  • The United States
  • EU4 (Germany, France, Italy, and Spain) and the United Kingdom
  • Japan

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

EGFR Metastatic Non-small Cell Lung Cancer Overview

EGFR is a protein in cells that helps them grow. A mutation in the gene for EGFR can make it grow too much, which can cause cancer. There are different types of EGFR mutations, including deletions or insertions and point mutations. In test results, individuals may be identified as having an EGFR 19 deletion or an EGFR L858R point mutation, which are the most common types of EGFR mutations. These mutations are typically treated the same way. Amongst the EGFR mutations that are tested for in lung cancer, 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:

Epidermal Growth Factor Receptor Non-small Cell Lung Cancer Epidemiology

The EGFR Non-small Cell Lung Cancer epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Incident Cases of NSCLC, Gender-specific Cases of NSCLC, Age-specific Cases of NSCLC, Total Incident Cases of NSCLC 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.

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

The drug chapter segment of the EGFR Non-small Cell Lung Cancer report encloses a detailed analysis of the marketed and the late-stage (Phase III) pipeline drug. The marketed drugs segment encloses drugs such as 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.

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

The treatment of EGFR-mutant non-small cell lung cancer has been transformed by the development of targeted therapies in the last two decades; however, choosing the best therapy after EGFR TKIs fail is still a challenge. There are 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.

  • The total market size in the US for EGFR-NSCLC was estimated to be nearly USD 3,300 million in 2024, which is expected to increase due to the launch of emerging therapies and label expansion of current therapies.
  • The EGFRm NSCLC space in 2025 is more competitive than ever, with the arrival of three new therapies Dato-DXd, sunvozertinib, and aumolertinib that expand treatment options and challenge established players like osimertinib and amivantamab.

Epidermal Growth Factor Receptor Metastatic Non-small Cell Lung Cancer Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 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.

Scope of the Report:

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

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

  • Patient Population
  • Therapeutic Approaches
  • EGFR-NSCLC Pipeline Analysis
  • EGFR-NSCLC Market Size and Trends
  • Existing and Future Market Opportunity

Report Key Strengths

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

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

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

FAQs:

  • What is the historical and forecasted EGFR-NSCLC patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
  • What was the EGFR-NSCLC total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
  • Which class is going to be the largest contributor by 2034?
  • What will be the impact of Osimertinib's expected patent expiry?
  • How will Osimertinib compete with Amivantamab in the first- and second lines?
  • What are the pricing variations among different geographies for approved and off-label therapies?
  • How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
  • How many key players are developing therapies for exon 20 insertion EGFR-NSCLC?
  • Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
  • Patient acceptability in terms of preferred treatment options as per real-world scenarios?

What are the country-specific accessibility issues of expensive, recently approved therapies?

  • Reasons to Buy
  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the EGFR-NSCLC Market.
  • Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
  • To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. 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 2024 in the 7MM
  • 6.3. Market Share (%) Distribution of EGFR-NSCLC by Line of Therapy (LoT) in 2034 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 NSCLC in the 7MM
  • 8.4. United States
    • 8.4.1. Total Incident Cases of NSCLC in the United States
    • 8.4.2. Gender-specific Cases of NSCLC in the United States
    • 8.4.3. Age-specific 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 Cases of EGFR-NSCLC in the United States
    • 8.4.7. Treated Patient Pool across the Lines of Therapies 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 Cases of NSCLC in EU4 and the UK
    • 8.5.3. Age-specific 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 Cases of EGFR-NSCLC in EU4 and the UK
    • 8.5.7. Total Treated Patient Pool across the Lines of Therapies in EU4 and the UK
  • 8.6. Japan
    • 8.6.1. Total Incident Cases of NSCLC in Japan
    • 8.6.2. Gender-specific Cases of NSCLC in Japan
    • 8.6.3. Age-specific 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 Cases of EGFR-NSCLC in Japan
    • 8.6.7. Treated Patient Pool across the Lines of Therapies in Japan

9. Patient Journey

10. Key Endpoints

11. Marketed Therapies

  • 11.1. Key Cross of Marketed Therapies
  • 11.2. Sunvozertinib (ZEGFROVY): Dizal Pharmaceutical
    • 11.2.1. Product Description
    • 11.2.2. Regulatory Milestones
    • 11.2.3. Other Developmental Activities
    • 11.2.4. Summary of Pivotal Trials
    • 11.2.5. Clinical Development
    • 11.2.6. Safety and Efficacy
    • 11.2.7. Analyst Views
  • 11.3. Datopotamab Deruxtecan (DATROWAY): Daiichi Sankyo/AstraZeneca
    • 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. Aumolertinib (AUMSEQA): Jiangsu Hansoh Pharmaceutical
    • 11.4.1. Product Description
    • 11.4.2. Regulatory Milestones
    • 11.4.3. Other Developmental Activity
    • 11.4.4. Summary of Pivotal Clinical Trial
    • 11.4.5. Analyst View
  • 11.5. Osimertinib (TAGRISSO): 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. Afatinib maleate (GILOTRIF/GIOTRIF): Boehringer Ingelheim
    • 11.6.1. Product Description
    • 11.6.2. Regulatory Milestones
    • 1.1.1. Other Developmental Activities
    • 11.6.3. Summary of Pivotal Trials
    • 11.6.4. Safety and Efficacy
    • 11.6.5. Analyst Views
  • 11.7. Dacomitinib (VIZIMPRO): Pfizer
    • 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. Amivantamab (RYBREVANT) +- Lazertinib (LAZCLUZE): Johnson & Johnson Innovative Medicine/Yuhan Corporation
    • 11.8.1. Product Description
    • 11.8.2. Regulatory Milestones
    • 11.8.3. Other Developmental Activities
    • 11.8.4. Pivotal Clinical Trial
    • 11.8.5. Clinical Development
    • 11.8.6. Safety and Efficacy
    • 11.8.7. Analyst Views
  • 11.9. Necitumumab (PORTRAZZA): Eli Lilly and Company
    • 11.9.1. Product Description
    • 11.9.2. Regulatory Milestones
    • 11.9.3. Other Developmental Activities
    • 11.9.4. Safety and Efficacy
    • 11.9.5. Analyst Views

12. Emerging drugs

  • 12.1. Key Cross Competition
  • 12.2. Firmonertinib: ArriVent BioPharma
    • 12.2.1. Product Description
    • 12.2.2. Other Developmental Activities
    • 12.2.3. Clinical Development
    • 12.2.4. Safety and Efficacy
    • 12.2.5. Analyst View
  • 12.3. Ivonescimab (SMT112): Akeso Biopharma/Summit Therapeutics
    • 12.3.1. Product Description
    • 12.3.2. Other Developmental Activity
    • 12.3.3. Clinical Development
    • 12.3.4. Safety and Efficacy
    • 12.3.5. Analyst View
  • 12.4. JIN-A02: J INTS BIO
    • 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 View
  • 12.5. Pamvatamig (MCLA-129): Merus
    • 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 View
  • 12.6. Sacituzumab Tirumotecan (MK-2870): Merck and Kelun-Biotech
    • 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 View
  • 12.7. Quaratusugene ozeplasmid (REQORSA): Genprex
    • 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. Zipalertinib (CLN-081): Cullinan Oncology/Taiho Pharma
    • 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. SYS6010: CSPC Pharmaceutical
    • 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
  • 12.1. Temab-A (telisotuzumab adizutecan) (ABBV-400): AbbVie
    • 12.10.1. Product Description
    • 12.10.2. Other Developmental Activities
    • 12.10.3. Clinical Development
    • 12.10.4. Safety and Efficacy
    • 12.10.5. Analyst Views
  • 12.11. Sutetinib: Teligene
    • 12.11.1. Product Description
    • 12.11.2. Clinical Development
    • 12.11.3. Safety and Efficacy
    • 12.11.4. Analyst Views
  • 12.12. Izalontamab Brengitecan (BMS-986507): Bristol-Myers Squibb/SystImmune
    • 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 View
  • 12.13. Silevertinib (BDTX-1535): Black Diamond Therapeutics
    • 12.13.1. Product Description
    • 12.13.2. Other Developmental Activity
    • 12.13.3. Clinical Development
    • 12.13.4. Safety and Efficacy
    • 12.13.5. Analyst View
  • 12.14. LP-300: Lantern Pharma
    • 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 View

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 Oulook
  • 13.4. Conjoint Analysis
  • 13.5. Key Market Forecast Assumptions
    • 13.5.1. Cost Assumptions
  • 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 Needs

15. SWOT Analysis

16. 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 EGRF-NSCLC Therapies

18. Appendix

  • 18.1. Bibliography
  • 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

샘플 요청 목록
0 건의 상품을 선택 중
목록 보기
전체삭제