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Non-Small Cell Lung Cancer Market Poised for Robust Expansion at a 6.6% CAGR Through 2036, Driven by Emerging Targeted and Immunotherapy Innovations | DelveInsight

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PFE Pfizer is highlighted for its involvement in emerging therapies like PF-08046054 (SGN-PDL1V) and marketed drugs like VIZIMPRO, suggesting a positive outlook in the NSCLC market. ABBV AbbVie is noted for its emerging therapy Temab-A (ABBV-400) and marketed drug EMRELIS, suggesting positive contributions to the NSCLC market. RMD Revolution Medicines is mentioned for its emerging therapy Daraxonrasib (RMC-6236), a RAS inhibitor, indicating potential growth and innovation in the NSCLC market. GSK GlaxoSmithKline is mentioned for its marketed drug ZEJULA (niraparib) and its involvement in emerging therapies, indicating continued relevance in the NSCLC market. AZN AstraZeneca is mentioned for multiple marketed drugs (TAGRISSO, IMFINZI) and emerging therapies (Rilvegostomig, Ceralasertib, Volrustomig), indicating a strong and diverse presence in the NSCLC market. BNTX BioNTech is mentioned for its involvement in emerging therapies Pumitamig (BNT327/PM8002) and Gotistobart (BNT316), indicating potential contributions to the NSCLC market. INCY Incyte is mentioned for its emerging therapy ZYNYZ (retifanlimab-dlwr), indicating potential growth and innovation in the NSCLC market. IOVA Iovance Biotherapeutics is highlighted for its emerging therapy LN-145, a TIL therapy, indicating positive development and potential in the NSCLC market. RGEN Regeneron Pharmaceuticals is mentioned for its emerging therapy Fianlimab (REGN3767) and marketed drug LIBTAYO, indicating a positive outlook in the NSCLC market. MRK Merck is mentioned for its involvement in emerging therapies like Sacituzumab Tirumotecan (MK-2870) and Intismeran autogene (mRNA-4157/V940), as well as marketed KEYTRUDA, indicating a strong presence in the NSCLC market. LLY Eli Lilly and Company is mentioned for its emerging therapy Olomorasib and marketed drugs PORTRAZZA and RETEVMO, indicating a significant presence and positive outlook in the NSCLC market. IBIO ImmunityBio is mentioned for its emerging therapy ANKTIVA, indicating potential development and contribution to the NSCLC market. GILD Gilead Sciences is mentioned for its marketed drug TRODELVY and involvement in emerging therapies like Domvanalimab + Combination Therapies, indicating a positive outlook in the NSCLC market. AMGN Amgen is mentioned for its marketed drug LUMAKRAS, indicating continued relevance and success in the KRAS-mutated NSCLC market. JNJ Johnson & Johnson is mentioned for its marketed drug RYBREVANT (Amivantamab) ± LAZCLUZE (Lazertinib), indicating a strong presence in the NSCLC market. NVS Novartis is mentioned for marketed drugs TABRECTA and TAFINLAR + MEKINIST, indicating a significant presence in the NSCLC market. RIGL Rigel Pharmaceuticals is mentioned as a partner for GAVRETO (Pralsetinib), indicating potential growth in the NSCLC market. BIIB Biogen is not explicitly mentioned in the article. While Bristol Myers Squibb (BMS) is mentioned, Biogen is a separate entity.

Non-Small Cell Lung Cancer Market Poised for Robust Expansion at a 6.6% CAGR Through 2036, Driven by Emerging Targeted and Immunotherapy Innovations | DelveInsight The non-small cell lung cancer market is experiencing robust growth, driven by the increasing incidence of lung cancer and continuous advancements in precision medicine. The introduction of targeted therapies, immune checkpoint inhibitors, and biomarker-driven treatment approaches has significantly improved patient outcomes and expanded treatment options. Additionally, the expected launch of emerging therapies such as BMS-986504 + Pembrolizumab (BMS), Iza-bren (izalontamab brengitecan) (SystImmune and Bristol Myers Squibb), Neladalkib (NVL-655) (Nuvalent), PF-08046054 (SGN-PDL1V) (Pfizer), and others will further propel the market growth.

LAS VEGAS, July 2, 2026 /PRNewswire/ -- Recently published Non-small Cell Lung Cancer Market Insights report includes a comprehensive understanding of current treatment practices, non-small cell lung cancer emerging drugs, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Non-small Cell Lung Cancer Market Summary

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Key Factors Driving the Growth of the Non-small Cell Lung Cancer Market

Sadaf Javed, Functional Head, Forecasting at DelveInsight, said that the total market size of KRAS-mutated NSCLC in the US was nearly USD 2.23 billion in 2025. The most frequent KRAS variant in NSCLC is G12C. KRAS-mutated NSCLC represents a rapidly evolving and highly competitive market across 1L and 2L+ settings, driven by the shift from first-generation monotherapies to next-generation, combination-based strategies. In the 2L+ settings, approved agents such as LUMAKRAS (2021) and KRAZATI (2023) established the KRAS G12C class, with KRAZATI demonstrating slightly stronger competitive positioning.

Non-small Cell Lung Cancer Market Analysis

Non-small Cell Lung Cancer Competitive Landscape

Some of the NSCLC drugs under late stage of development include BMS-986504 + Pembrolizumab (BMS), Iza-bren (izalontamab brengitecan) (SystImmune and Bristol Myers Squibb), Neladalkib (NVL-655) (Nuvalent), PF-08046054 (SGN-PDL1V) (Pfizer), Telisotuzumab adizutecan, Temab-A (ABBV-400) (AbbVie), Daraxonrasib (RMC-6236) (Revolution Medicines), ZEJULA (niraparib) (GSK), Rilvegostomig (AZD2936) (AstraZeneca/Compugen), Pumitamig (BNT327/PM8002) (BioNTech/BMS), CAN-2409 (aglatimagene besadenovec) (Candel Therapeutics), Gotistobart (BNT316, ONC-392) (OncoC4/BioNTech), ZYNYZ (retifanlimab-dlwr, INCMGA00012) (Incyte/Macrogenics), LN-145 (Iovance Biotherapeutics), Divarasib (GDC-6036) (Hoffmann-La Roche/Genentech), Fianlimab (REGN3767) (Regeneron Pharmaceuticals), Sacituzumab tirumotecan (MK-2870/SKB264) (Merck and Kelun-Biotech), Eftilagimod alpha (Immutep), Intismeran autogene (mRNA-4157/ V940) (Moderna Therapeutics and Merck), Plinabulin (BeyondSpring), Zipalertinib (Cullinan Oncology/Taiho Pharma), Olomorasib (Eli Lilly and Company), Ceralasertib (AstraZeneca), TEDOPI OSE (Immuno-therapeutics), Sigvotatug vedotin (Pfizer), ANKTIVA (ImmunityBio), Pyrotinib (Jiangsu HengRui Medicine), Volrustomig (AstraZeneca), TRODELVY (sacituzumab govitecan) (Gilead Sciences), Domvanalimab + Combination Therapies (Arcus Biosciences/Gilead Sciences), OPDUALAG (nivolumab and relatlimab) (Bristol Myers Squibb), Calderasib (MK-1084) [Merck, Otsuka Pharmaceutical (Taiho, and Astex Pharmaceuticals)], Firmonertinib (ArriVent BioPharma/Shanghai Allist Pharmaceuticals), IBI363 (Innovent Biologics and Takeda Pharmaceutical), Vebreltinib (APL-101) (Apollomics and Avistone Biotechnology), and others.

Immutep's Eftilagimod alpha is a recombinant soluble protein composed of a dimeric form of LAG-3 that has been engineered to circulate freely rather than remain attached to the cell surface. As a first-in-class activator of antigen-presenting cells (APCs), it enhances immune system activity and has demonstrated the ability to generate durable immune responses in cancer patients. The therapy can be administered at lower doses as an adjuvant to cancer vaccines or at higher doses to achieve broader systemic activation of APCs.

Nuvalent's Neladalkib is an advanced, brain-penetrant ALK inhibitor with high selectivity, developed to effectively target ALK resistance mutations while minimizing central nervous system toxicities associated with TRK inhibition. Created by Nuvalent for the treatment of ALK-driven malignancies, the therapy is designed to address resistance mechanisms and offer improved tolerability. It is currently undergoing clinical investigation.

Revolution Medicines' Daraxonrasib (RMC-6236) is an orally administered, multi-selective inhibitor that directly targets the active RAS(ON) state, enabling broad applicability across cancers driven by RAS mutations. By preventing activated RAS proteins from interacting with downstream signaling effectors, it disrupts key pathways responsible for tumor growth and survival. The drug is active against several oncogenic RAS variants, including G12X, G13X, and Q61X mutations, which are frequently observed in cancers such as non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC).

Iovance Biotherapeutics' LN-145 is an autologous tumor-infiltrating lymphocyte (TIL) therapy that harnesses a patient's own immune cells to combat cancer. The treatment is produced by isolating T cells from a patient's tumor tissue and expanding them outside the body before reinfusion. A related product, LN-145-S1, is manufactured through an enhanced process that selectively enriches a specific subset of T cells, potentially improving therapeutic activity.

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

Discover more about non-small cell lung cancer PD-L1 inhibitors competitors 2026 @ Non-small Cell Lung Cancer Therapeutics Market

Recent Developments in the Non-small Cell Lung Cancer Market

What is Non-small Cell Lung Cancer?

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 85% of all lung cancer cases. It is a heterogeneous group of malignancies that originate from the epithelial cells of the lung and includes several histological subtypes, primarily adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. NSCLC typically grows and spreads more slowly than small cell lung cancer (SCLC), although disease progression can vary depending on the tumor subtype and molecular characteristics. Major risk factors include tobacco smoking, exposure to environmental carcinogens such as radon and asbestos, air pollution, and certain genetic predispositions. Advances in molecular diagnostics have identified key genetic alterations, including mutations in EGFR, ALK, ROS1, KRAS, and other oncogenic drivers, enabling the development of targeted therapies and immunotherapies that have significantly improved treatment outcomes for patients with advanced disease.

Non-small Cell Lung Cancer Epidemiology Segmentation

The non-small cell lung cancer epidemiology section provides insights into the historical and current non-small cell lung cancer patient pool and forecasted trends for the leading markets. Among the 7MM, the US accounted for the highest incident cases of NSCLC in 2025. This was followed by Japan, whereas the least number of cases were accounted by Spain.

The non-small cell lung cancer treatment market report proffers epidemiological analysis for the study period 2022–2036 in the leading markets, segmented into:

Non-small Cell Lung Cancer Market Report Metrics

Details

Study Period

2022–2036

Coverage

7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Non-small Cell Lung Cancer Market CAGR

6.6 %

Non-small Cell Lung Cancer Market Size in 2025

USD 33 Billion

Key Non-small Cell Lung Cancer Companies

SystImmune, Bristol Myers Squibb, Nuvalent, AbbVie, Revolution Medicines, GSK, Compugen, BioNTech, Candel Therapeutics, OncoC4, BioNTech, Incyte, Macrogenics, Iovance Biotherapeutics, Hoffmann-La Roche, Genentech, Regeneron Pharmaceuticals, Kelun-Biotech, Immutep, Moderna Therapeutics, BeyondSpring, Cullinan Oncology, Eli Lilly and Company, OSE Immuno-therapeutics, Pfizer, ImmunityBio, Jiangsu HengRui Medicine, AstraZeneca, Arcus Biosciences, Gilead Sciences, Merck, Otsuka Pharmaceutical (Taiho, and Astex Pharmaceuticals), ArriVent BioPharma, Shanghai Allist Pharmaceuticals, Innovent Biologics, Takeda Pharmaceutical, Apollomics, Avistone Biotechnology, Boehringer Ingelheim, Hansoh Pharma, Dizal (Jiangsu) Pharmaceutical, Johnson & Johnson Innovative Medicine (Janssen), and others

Key Non-small Cell Lung Cancer Therapies

Iza-bren (izalontamab brengitecan), BMS-986504 + Pembrolizumab, Neladalkib (NVL-655), PF-08046054 (SGN-PDL1V), Telisotuzumab adizutecan, Temab-A (ABBV-400), Daraxonrasib (RMC-6236), ZEJULA (niraparib), Rilvegostomig (AZD2936), Pumitamig (BNT327/PM8002), CAN-2409 (aglatimagene besadenovec), Gotistobart (BNT316, ONC-392), ZYNYZ (retifanlimab-dlwr, INCMGA00012), LN-145, Divarasib (GDC-6036), Fianlimab (REGN3767), Sacituzumab tirumotecan (MK-2870/SKB264), Eftilagimod alpha, Intismeran autogene (mRNA-4157/V940), Plinabulin, Zipalertinib, Olomorasib, Ceralasertib, TEDOPI, Sigvotatug vedotin, ANKTIVA, Pyrotinib, Volrustomig, TRODELVY (sacituzumab govitecan), Domvanalimab + Combination Therapies, OPDUALAG (nivolumab and relatlimab), Calderasib (MK-1084), Firmonertinib, IBI363, Vebreltinib (APL-101), TAGRISSO, GILOTRIF/GIOTRIF, VIZIMPRO, EXKIVITY, AUMSEQA, ZEGFROVY, RYBREVANT, DATROWAY, PORTRAZZA, KEYTRUDA, OPDIVO and others

Scope of the Non-small Cell Lung Cancer Market Report

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Table of Contents

1

Non-small Cell Lung Cancer Market Key Insights

2

Non-small Cell Lung Cancer Market Report Introduction

3

Key Highlights

4

Executive Summary

5

Key Events

6

Epidemiology and Market Forecast Methodology of NSCLC

7

NSCLC Market Overview at a Glance

7.1

Emerging Landscape Analysis in the 7MM (by Phase)

7.2

Market Share of NSCLC by Biomarker (%) in the 7MM in 2025

7.3

Market Share of NSCLC by Biomarker (%) in the 7MM in 2036

8

Disease Background and Overview of NSCLC

8.1

Introduction

8.2

Disease Biology: NSCLC

8.3

Diagnosis

9

Current Treatment Practices: NSCLC

9.1

Treatment Algorithm

9.2

Treatment Guidelines and Recommendations for NSCLC

10

Epidemiology and Patient Population

10.1

Key Findings

10.2

Assumptions and Rationale

10.3

Total Incident Cases of NSCLC in the 7MM

10.4

United States

10.4.1

Total Incident Cases of NSCLC in the United States

10.4.2

Gender-specific Cases of NSCLC in the United States

10.4.3

Age-specific Cases of NSCLC in the United States

10.4.4

Total Incident Cases of NSCLC by Histology in the United States

10.4.5

Total Incident Cases of NSCLC by Stage in the United States

10.4.6

Total Cases of NSCLC by Genetic Mutations/Biomarkers in the United States

10.4.7

Patient Seeking Treatment for NSCLC in the United States

10.4.8

Line-wise Treated Cases of NSCLC in the United States

10.5

EU4 and the UK

10.6

Japan

11

Patient Journey

12

Key Endpoints in NSCLC

13

Marketed NSCLC Therapies

13.1

Competitive Landscape

13.1.1

Regulatory Approval History Across the 7MM

13.2

EGFR Mutations

13.2.1

AUMSEQA (Aumolertinib): Jiangsu Hansoh Pharmaceutical

13.2.1.1

Product Description

13.2.1.2

Regulatory Milestones

13.2.1.3

Other Developmental Activity

13.2.1.4

Summary of Pivotal Clinical Trial

13.2.2

VIZIMPRO (Dacomitinib): Pfizer

13.2.3

GILOTRIF/GIOTRIF (Afatinib maleate): Boehringer Ingelheim

13.2.4

TAGRISSO (Osimertinib): AstraZeneca

13.2.5

PORTRAZZA (Necitumumab): Eli Lilly and Company

13.2.6

RYBREVANT (Amivantamab) ± LAZCLUZE (Lazertinib): Johnson & Johnson Innovative Medicine/Yuhan Corporation

13.2.7

ZEGFROVY (Sunvozertinib): Dizal Pharmaceutical

13.2.8

DATROWAY (Datopotamab Deruxtecan): Daiichi Sankyo/AstraZeneca

13.3

PD-1 Inhibitors

13.3.1

OPDIVO (Nivolumab): Bristol Myers Squibb/Ono Pharmaceutical

13.3.2

KEYTRUDA (Pembrolizumab): Merck

13.3.3

LIBTAYO (Cemiplimab): Regeneron/Sanofi

13.3.4

TEVIMBRA (Tislelizumab): BeiGene

13.3.5

IMFINZI (Durvalumab) + IMJUDO (Tremelimumab): AstraZeneca

13.3.6

CEJEMLY (Sugemalimab): CStone Pharmaceuticals

13.3.7

IMFINZI (Durvalumab): AstraZeneca

13.3.8

TECENTRIQ (Atezolizumab): Genentech/Roche

13.4

Other Mutations

13.4.1

LORBRENA/LORVIQUA (Lorlatinib): Pfizer

13.4.2

ENSACOVE (Ensartinib): Betta Pharmaceuticals/Xcovery

13.4.3

ALUNBRIG (Brigatinib): Takeda Pharmaceuticals

13.4.4

AUGTYRO (Repotrectinib): BMS

13.4.5

ALECENSA (Alectinib): Roche/Chugai Pharmaceutical

13.4.6

ROZLYTREK (Entrectinib): Roche (Genentech)

13.4.7

IBTROZI (Taletrectinib): Nuvation Bio

13.4.8

GAVRETO (Pralsetinib): Blueprint Medicines/Rigel Pharmaceuticals

13.4.9

RETEVMO/RETSEVMO (Selpercatinib): Eli Lilly and Company

13.4.10

TEPMETKO (Tepotinib): EMD Serono (Merck KGaA)

13.4.11

HAIYITAN (Gumarontinib): Haihe Biopharma and Taiho Pharmaceutical

13.4.12

TABRECTA (Capmatinib): Novartis

13.4.13

LUMAKRAS/LUMYKRAS (Sotorasib): Amgen

13.4.14

KRAZATI (Adagrasib): BMS

13.4.15

ENHERTU (Trastuzumab deruxtecan): Daiichi Sankyo /AstraZeneca

13.4.16

TAFINLAR (Dabrafenib) + MEKINIST (Trametinib): Novartis

13.4.17

BRAFTOVI (Encorafenib) + MEKTOVI (Binimetinib): Pfizer/Pierre Fabre

13.4.18

VITRAKVI (Larotrectinib): Bayer

13.4.19

EMRELIS (Telisotuzumab vedotin-tllv): AbbVie

13.4.20

BIZENGRI (Zenocutuzumab): Merus and Partner Therapeutics

13.4.21

HYRNUO (Sevabertinib): Bayer

13.4.22

HERNEXEOS (Zongertinib): Boehringer Ingelheim

14

Emerging NSCLC Therapies

14.1

Competitive Landscape

14.2

Ateganosine: MAIA Biotechnology

14.2.1

Product Description

14.2.2

Other Developmental Activities

14.2.3

Clinical Development

14.2.3.1

Clinical Trials Information

14.2.4

Safety and Efficacy

14.3

BMS-986504 + Pembrolizumab: Bristol-Myers Squibb

14.4

Iza-bren (izalontamab brengitecan): SystImmune and Bristol Myers Squibb

14.5

Neladalkib (NVL-655): Nuvalent

14.6

PF-08046054 (SGN-PDL1V): Pfizer

14.7

Telisotuzumab adizutecan, Temab-A (ABBV-400): AbbVie

14.8

Daraxonrasib (RMC-6236): Revolution Medicines

14.9

ZEJULA (niraparib): GlaxoSmithKline

14.10

Rilvegostomig (AZD2936): AstraZeneca/Compugen

14.11

Pumitamig (BNT327/PM8002): BioNTech/Bristol Myers Squibb

14.12

CAN-2409 (aglatimagene besadenovec): Candel Therapeutics

14.13

Gotistobart (BNT316): OncoC4/BioNTech

14.14

ZYNYZ (retifanlimab-dlwr): Incyte/Macrogenics

14.15

LN-145: Iovance Biotherapeutics

14.16

Divarasib (GDC-6036): Hoffmann-La Roche/Genentech

14.17

Fianlimab (REGN3767): Regeneron Pharmaceuticals

14.18

Sacituzumab Tirumotecan (MK-2870): Merck and Kelun-Biotech

14.19

Eftilagimod alpha (Efti, IMP321): Immutep

14.20

Intismeran autogene (mRNA-4157/V940): Moderna Therapeutics and Merck Sharp & Dohme

14.21

Plinabulin: BeyondSpring

14.22

Zipalertinib (CLN-081): Cullinan Therapeutics and Taiho Pharma

14.24

Olomorasib (LY3537982): Eli Lilly and Company

14.25

Ceralasertib (AZD6738): AstraZeneca

14.26

TEDOPI (OSE2101): OSE Immunotherapeutics

14.27

Sigvotatug Vedotin (PF08046047, SGN-B6A): Pfizer

14.28

ANKTIVA (N-803, nogapendekin alfa inbakicept-pmln): ImmunityBio

14.29

Pyrotinib: Jiangsu HengRui Medicine

14.30

Volrustomig (MEDI5752): AstraZeneca

14.31

TRODELVY (sacituzumab govitecan): Gilead Sciences

14.32

Domvanalimab + Combination Therapies: Arcus Biosciences and Gilead Sciences

14.33

OPDUALAG (nivolumab and relatlimab): Bristol-Myers Squibb

14.34

Calderasib (MK-1084): Merck, Otsuka Pharmaceutical (Taiho, and Astex Pharmaceuticals)

14.35

Firmonertinib: ArriVent BioPharma and Shanghai Allist Pharmaceuticals

14.36

Livmoniplimab (ARGX-115): AbbVie

14.37

IBI363: Innovent Biologics and Takeda Pharmaceutical

14.38

Ivonescimab (AK112): Akeso Bio and Summit Therapeutics

14.39

Vebreltinib (APL-101): Apollomics and Avistone Biotechnology

14.4

Zidesamtinib (NVL-520): Nuvalent

15

Phase II Emerging Drugs Under Development

16

NSCLC: 7MM Market Analysis

16.1

Key Findings

16.2

Total Market Size of NSCLC by Country in the 7MM

16.3

Total Market Size of NSCLC by Biomarker in the 7MM

16.4

Market Outlook of NSCLC

16.4.1

7MM Market Dynamics Overview of NSCLC

16.4.1.1

PD-L1 Expression

16.4.1.2

EGFR Mutation

16.4.1.3

ALK Mutation

16.4.1.4

KRAS Mutation

16.4.1.5

BRAF Mutation

16.4.1.6

MET

16.4.1.7

Others Emerging Biomarkers

16.5

Key Market Forecast Assumptions

16.5.1

PD-L1 Expression

16.5.2

EGFR NSCLC

16.5.3

ALK NSCLC

16.5.4

KRAS NSCLC

16.5.5

ROS-1 NSCLC

16.5.6

HER2 NSCLC

16.5.7

BRAF NSCLC

16.5.8

C-Met NSCLC

16.5.9

RET NSCLC

16.5.10

NTRK NSCLC

16.5.11

NRG1 Fusion NSCLC

16.6

The United States NSCLC Market

16.7

EU4 and the UK NSCLC Market

16.8

Japan NSCLC Market

17

Unmet Needs of NSCLC

18

SWOT Analysis of NSCLC

19

KOL Views of NSCLC

20

Market Access and Reimbursement of NSCLC

21

Bibliography

22

NSCLC Market Report Methodology

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