DelveInsight’s “Metastatic Non-Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the Metastatic Non-Small Cell Lung Cancer, historical and forecasted epidemiology as well as the Metastatic Non-Small Cell Lung Cancer market trends in the United States, EU4 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
To Know in detail about the Metastatic Non-Small Cell Lung Cancer market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Metastatic Non-Small Cell Lung Cancer Market Forecast
Some of the key facts of the Metastatic Non-Small Cell Lung Cancer Market Report:
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The Metastatic Non-Small Cell Lung Cancer market size was valued ~21 billion in 2023 and is anticipated to grow with a significant CAGR during the study period (2020-2034).
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In September 2025, Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib, in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab). The designation applies to the first-line treatment of patients with unresectable advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation and PD-L1 expression ≥ 50%, confirmed through FDA-approved testing. Olomorasib, a potent and selective second-generation KRAS G12C inhibitor, has also shown early evidence of central nervous system (CNS) activity.
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In September 2025, Adagrasib (Krazati; Bristol Myers Squibb) showed a statistically significant improvement in progression-free survival (PFS) compared with docetaxel (Taxotere; Sanofi-Aventis) in patients with previously treated KRAS G12C-mutated non–small cell lung cancer (NSCLC), based on findings from the phase 3 KRYSTAL-12 trial (NCT04685135) published in The Lancet. Importantly, adagrasib presented no new safety concerns in this patient group, with adverse events (AEs) reported as generally mild in severity.
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In September 2025, The FDA has granted breakthrough therapy designation to olomorasib in combination with pembrolizumab (Keytruda) for first-line treatment of patients with unresectable advanced or metastatic non–small cell lung cancer (NSCLC) carrying a KRAS G12C mutation and exhibiting PD-L1 expression of ≥50%, as confirmed by FDA-approved testing.
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In August 2025, The FDA has granted accelerated approval to Boehringer Ingelheim’s HERNEXEOS® (zongertinib tablets) for the treatment of adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) carrying HER2 (ERBB2) activating mutations who have previously undergone systemic therapy.
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In August 2025, SystImmune and Bristol Myers Squibb announced that the FDA has granted Breakthrough Therapy Designation to izalontamab brengitecan (iza-bren) for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations in patients whose disease has progressed following EGFR TKI and platinum-based chemotherapy.
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In July 2025, DualityBio reported that the FDA has granted Fast Track Designation to DB-1310, its next-generation HER3-targeting antibody-drug conjugate, for the treatment of advanced or metastatic nonsquamous non-small cell lung cancer (nsqNSCLC) in patients with certain EGFR mutations who have experienced disease progression following prior targeted therapy and chemotherapy.
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In July 2025, Dizal announced that the FDA has approved ZEGFROVY® (sunvozertinib) for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations whose disease has advanced following platinum-based chemotherapy.
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In June 2025, The FDA has approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a kinase inhibitor, for use in adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
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In March 2025, Johnson & Johnson reported that updated findings from its oncology pipeline, including overall survival data from the Phase 3 MARIPOSA trial, will be shared at the 2025 European Lung Cancer Congress. The study compares RYBREVANT® (amivantamab-vmjw) combined with LAZCLUZE™ (lazertinib) against osimertinib as a first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or L858R mutations.
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In February 2025, The FDA has granted Fast Track designation to IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, for the treatment of patients with unresectable, locally advanced, or metastatic squamous NSCLC that has progressed following anti–PD-(L)1 therapy and platinum-based chemotherapy.
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In December 2024, Xcovery Holdings, Inc., an oncology-focused pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has approved ensartinib (Ensacove) for treating patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). This approval represents a significant step forward in offering a new first-line treatment option for individuals with ALK-positive NSCLC.
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In 2023, the United States reported around 202,600 new lung cancer cases, including approximately 114,300 in men and 88,400 in women. Of these, about 10–15% were classified as small cell lung cancer (SCLC), while 80–85% were identified as non-small cell lung cancer (NSCLC).
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By age distribution, individuals aged 65 years and older are more frequently affected by NSCLC compared to those under 65. In 2023, the United States recorded approximately 138,700 NSCLC cases in the 65+ age group.
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In 2023, the United States reported approximately 445 incident cases of NTRK-positive metastatic NSCLC.
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The two primary subtypes of KRAS NSCLC are KRAS G12C and KRAS non-G12C (including G12V, G12D, G13D, G12R, and others). In 2023, the United States recorded approximately 22,300 cases of KRAS G12C and around 38,400 cases of KRAS non-G12C.
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Key Metastatic Non-Small Cell Lung Cancer Companies: Merck, Regeneron Pharmaceuticals, Daiichi Sankyo/AstraZeneca, Gilead Sciences, BieGene, GlaxoSmithKline, DualityBio, Latin American Cooperative Oncology Group, Mirati Therapeutics Inc., Eli Lilly and Company, Fox Chase Cancer Center, Merck Sharp & Dohme LLC, BeiGene, NeoImmuneTech, Iovance Biotherapeutics, Inc, Sanofi, Hutchison Medipharma Limited, OncoC4, Inc., Sichuan Kelun Pharmaceutical, Arcus Biosciences, Inc., and others
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Key Metastatic Non-Small Cell Lung Cancer Therapies: KEYTRUDA (pembrolizumab), LIBTAYO (cemiplimab-rwlc), DatopotamabDeruxtecan(Dato-DXd), TRODELVY, Ociperlimab, JEMPERLI, ZEJULA, DB-1305, Amivantamab, AZD2936, Adagrasib, LY3537982, Nivolumab, Pembrolizumab/Vibostolimab, Tislelizumab, efineptakin alfa, LN-145, SAR408701, Dostarlimab, Savolitinib, Gotistobart, Trastuzumab deruxtecan, SKB264, Domvanalimab, and others
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The Non-Small Cell Lung Cancer epidemiology based on gender analyzed that males are affected more in case of PD-L1 NSCLC as compared to females.
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The Metastatic Non-Small Cell Lung Cancer market is expected to surge due to the disease’s increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Metastatic Non-Small Cell Lung Cancer pipeline products will significantly revolutionize the Metastatic Non-Small Cell Lung Cancer market dynamics.
Metastatic Non-Small Cell Lung Cancer Overview
Metastatic non-small cell lung cancer (NSCLC) is a type of lung cancer that has spread from the primary tumor in the lungs to other parts of the body. NSCLC is the most common type of lung cancer, accounting for about 85% of all lung cancer cases. The term “metastatic” indicates that the cancer cells have traveled through the bloodstream or lymphatic system to distant organs or tissues, such as the brain, bones, liver, or adrenal glands.
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Metastatic Non-Small Cell Lung Cancer Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.
Metastatic Non-Small Cell Lung Cancer Epidemiology Segmentation:
The Metastatic Non-Small Cell Lung Cancer market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
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Total Prevalence of Metastatic Non-Small Cell Lung Cancer
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Prevalent Cases of Metastatic Non-Small Cell Lung Cancer by severity
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Gender-specific Prevalence of Metastatic Non-Small Cell Lung Cancer
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Diagnosed Cases of Episodic and Chronic Metastatic Non-Small Cell Lung Cancer
Download the report to understand which factors are driving Metastatic Non-Small Cell Lung Cancer epidemiology trends @ Metastatic Non-Small Cell Lung Cancer Epidemiology Forecast
Metastatic Non-Small Cell Lung Cancer Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Metastatic Non-Small Cell Lung Cancer market or expected to get launched during the study period. The analysis covers Metastatic Non-Small Cell Lung Cancer market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Metastatic Non-Small Cell Lung Cancer Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.
Metastatic Non-Small Cell Lung Cancer Therapies and Key Companies
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KEYTRUDA (pembrolizumab): Merck
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LIBTAYO (cemiplimab-rwlc): Regeneron Pharmaceuticals
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DatopotamabDeruxtecan(Dato-DXd): Daiichi Sankyo/AstraZeneca
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TRODELVY: Gilead Sciences
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Ociperlimab: BieGene
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JEMPERLI: GlaxoSmithKline
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ZEJULA: GlaxoSmithKline
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DB-1305: DualityBio
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Amivantamab: Latin American Cooperative Oncology Group
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AZD2936: AstraZeneca
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Adagrasib: Mirati Therapeutics Inc.
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LY3537982: Eli Lilly and Company
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Nivolumab: Fox Chase Cancer Center
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Pembrolizumab/Vibostolimab: Merck Sharp & Dohme LLC
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Tislelizumab: BeiGene
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efineptakin alfa: NeoImmuneTech
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LN-145: Iovance Biotherapeutics, Inc
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SAR408701: Sanofi
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Dostarlimab: GlaxoSmithKline
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Savolitinib: Hutchison Medipharma Limited
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Gotistobart: OncoC4, Inc.
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Trastuzumab deruxtecan: Daiichi Sankyo
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SKB264: Sichuan Kelun Pharmaceutical
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Domvanalimab: Arcus Biosciences, Inc.
To know more about Metastatic Non-Small Cell Lung Cancer companies working in the treatment market, visit @ Metastatic Non-Small Cell Lung Cancer Clinical Trials and Therapeutic Assessment
Metastatic Non-Small Cell Lung Cancer Market Strengths
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NSCLC has emerged as a target indication of interest in oncology in the last decade. The focus of most trials in NSCLC in recent years has been in the metastatic setting as monotherapy or in combination with chemotherapy and other targeted agents.
Metastatic Non-Small Cell Lung Cancer Market Opportunities
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Front-line NSCLC represents a large market,currently only being dominated by anti-PD 1 drugs and anti-PD-1 + CTx combination, leaving a significant opportunity for therapy beyond antiPD1 to deliver higher clinical benefit.
Scope of the Metastatic Non-Small Cell Lung Cancer 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 Metastatic Non-Small Cell Lung Cancer Companies: Merck, Regeneron Pharmaceuticals, Daiichi Sankyo/AstraZeneca, Gilead Sciences, BieGene, GlaxoSmithKline, DualityBio, Latin American Cooperative Oncology Group, Mirati Therapeutics Inc., Eli Lilly and Company, Fox Chase Cancer Center, Merck Sharp & Dohme LLC, BeiGene, NeoImmuneTech, Iovance Biotherapeutics, Inc, Sanofi, Hutchison Medipharma Limited, OncoC4, Inc., Sichuan Kelun Pharmaceutical, Arcus Biosciences, Inc., and others
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Key Metastatic Non-Small Cell Lung Cancer Therapies: KEYTRUDA (pembrolizumab), LIBTAYO (cemiplimab-rwlc), DatopotamabDeruxtecan(Dato-DXd), TRODELVY, Ociperlimab, JEMPERLI, ZEJULA, DB-1305, Amivantamab, AZD2936, Adagrasib, LY3537982, Nivolumab, Pembrolizumab/Vibostolimab, Tislelizumab, efineptakin alfa, LN-145, SAR408701, Dostarlimab, Savolitinib, Gotistobart, Trastuzumab deruxtecan, SKB264, Domvanalimab, and others
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Metastatic Non-Small Cell Lung Cancer Therapeutic Assessment: Metastatic Non-Small Cell Lung Cancer current marketed and Metastatic Non-Small Cell Lung Cancer emerging therapies
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Metastatic Non-Small Cell Lung Cancer Market Dynamics: Metastatic Non-Small Cell Lung Cancer market drivers and Metastatic Non-Small Cell Lung Cancer 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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Metastatic Non-Small Cell Lung Cancer Unmet Needs, KOL’s views, Analyst’s views, Metastatic Non-Small Cell Lung Cancer Market Access and Reimbursement
Discover more about therapies set to grab major Metastatic Non-Small Cell Lung Cancer market share @ Metastatic Non-Small Cell Lung Cancer Treatment Market
Table of Contents
1. Metastatic Non-Small Cell Lung Cancer Market Report Introduction
2. Executive Summary for Metastatic Non-Small Cell Lung Cancer
3. SWOT analysis of Metastatic Non-Small Cell Lung Cancer
4. Metastatic Non-Small Cell Lung Cancer Patient Share (%) Overview at a Glance
5. Metastatic Non-Small Cell Lung Cancer Market Overview at a Glance
6. Metastatic Non-Small Cell Lung Cancer Disease Background and Overview
7. Metastatic Non-Small Cell Lung Cancer Epidemiology and Patient Population
8. Country-Specific Patient Population of Metastatic Non-Small Cell Lung Cancer
9. Metastatic Non-Small Cell Lung Cancer Current Treatment and Medical Practices
10. Metastatic Non-Small Cell Lung Cancer Unmet Needs
11. Metastatic Non-Small Cell Lung Cancer Emerging Therapies
12. Metastatic Non-Small Cell Lung Cancer Market Outlook
13. Country-Wise Metastatic Non-Small Cell Lung Cancer Market Analysis (2020–2034)
14. Metastatic Non-Small Cell Lung Cancer Market Access and Reimbursement of Therapies
15. Metastatic Non-Small Cell Lung Cancer Market Drivers
16. Metastatic Non-Small Cell Lung Cancer Market Barriers
17. Metastatic Non-Small Cell Lung Cancer Appendix
18. Metastatic Non-Small Cell Lung Cancer Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
About DelveInsight
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It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.
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