The multi-billion-dollar non-small-cell lung cancer (NSCLC) market is highly dynamic, with a plethora of approved therapies but still a high unmet need. Immune checkpoint inhibitors such as Keytruda (Merck & Co), which gained label expansion in January 2023 in the adjuvant setting, have broad applicability in many stages and settings of NSCLC and dominate the market, while biomarker-targeted therapeutics increasingly drive segmentation of the space. The range of drug-addressable disease drivers continues to expand, with the entry of KRAS inhibitors and the 2022 approval of Enhertu, the first targeted therapy for previously treated metastatic HER2-mutant NSCLC. Continued drug development in the biomarker and immune checkpoint inhibitor classes, plus further new market entrants, will further drive competition in this commercially lucrative market.
Questions answered
How will the recent and expected new market entrants shape the treatment landscapes across the various settings and stages (I-IV) of NSCLC?
Which therapy options will dominate the commercially lucrative first-line metastatic NSCLC setting?
What are the most promising pipeline products, and what is their forecast uptake and patient share in NSCLC?
What are NSCLC’s key market drivers and constraints, and how will the market evolve over the forecast period?
Product description
Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.
Solution enhancements
Disease Landscape & Forecast will be updated throughout the year to provide timely insights and analyses as material indication-specific news and events unfold.
Disease Landscape & Forecast features a Drug Pipeline chapter with real-time, global pipeline intelligence content directly from Cortellis. This chapter is updated daily and features interactive figures that can be easily downloaded for detailed analysis or presentations.
Key current therapies in NSCLC: population positioning
Emerging therapies in NSCLC: population positioning
NSCLC SWOT analysis
Market drivers and constraints
What factors are driving the market for NSCLC?
What factors are constraining the market for NSCLC?
Drug-treatable population share and major-market sales share in NSCLC: 2022
Drug-treatable population share and major-market sales share in NSCLC: 2032
Major-market sales of drug classes in NSCLC: 2022-2032
Major-market sales of select drugs in NSCLC: 2022-2032
Major-market sales share of select drugs in NSCLC by patient population (all histologies): 2022 and 2032
Segment-specific trends
Stage IA NSCLC
Stage IB-II NSCLC
Stage III NSCLC
Patient-share dynamics of select therapies in stage III NSCLC (adenocarcinoma), United States: 2022-2032
Patient-share dynamics of key regimens in first-line metastatic NSCLC (adenocarcinoma), United States: 2022-2032
Patient-share dynamics of immune checkpoint inhibitor-containing regimens in first-line metastatic NSCLC (adenocarcinoma), United States: 2022-2032
Patient-share dynamics of key therapies in first-line EGFR-positive metastatic NSCLC (adenocarcinoma), United States: 2022-2032
Patient-share dynamics of key therapies in first-line ALK-positive metastatic NSCLC (adenocarcinoma), United States: 2022-2032
Patient-share dynamics of key regimens in second-line metastatic NSCLC (adenocarcinoma), United States: 2022-2032
Patient-share dynamics of key regimens in third-line metastatic NSCLC (adenocarcinoma), United States: 2022-2032
Forecast
Market Forecast Assumptions
Market Forecast Dashboard
Etiology and Pathophysiology
Disease overview
Disease pathophysiology
Progression of NSCLC
Anatomy and histology of NSCLC
Natural history of NSCLC
Timing of genetic changes in NSCLC
Staging and classification
Classification of NSCLC
Staging of NSCLC
Key pathways and drug targets
Key pathways and drug targets for NSCLC
Epidemiology
Key findings
Epidemiology populations
Disease definition, methods, and sources used
Diagnosed incident cases of NSCLC by histology: 2022-2032
Disease definition, methods, and sources used
Diagnosed incident cases of adenocarcinoma by stage at diagnosis: 2022-2032
Diagnosed incident cases of squamous cell carcinoma by stage at diagnosis: 2022-2032
Diagnosed incident cases of large-cell and other types of NSCLC by stage at diagnosis: 2022-2032
Diagnosed incident cases of NOS NSCLC by stage at diagnosis: 2022-2032
Disease definition, methods, and sources used
Recurrent incident cases of NSCLC by histology: 2022-2032
Non-small-cell lung cancer patient flow
Drug-treatable cases of adenocarcinoma NSCLC: 2022-2032
Drug-treatable cases of large-cell, other, and NOS NSCLC: 2022-2032
Drug-treatable cases of squamous cell NSCLC: 2022-2032
Drug-treated cases of adenocarcinoma NSCLC: 2022-2032
Drug-treated cases of large-cell, other, and NOS NSCLC: 2022-2032
Drug-treated cases of squamous cell NSCLC: 2022-2032
Current Treatment
Key findings
Treatment goals
Key endpoints used in clinical trials for non-small-cell lung cancer
Key current therapies
Overview
Mechanism of action of key current drug classes used for non-small-cell lung cancer
Current treatments used for non-small-cell lung cancer
Market events impacting the use of key current therapies in non-small-cell lung cancer
Key results from select clinical trials investigating Keytruda for the treatment of non-small-cell lung cancer
Ongoing clinical development of Keytruda
Key ongoing clinical trials of Keytruda in the treatment of non-small-cell lung cancer
Expert insight: Keytruda
Key results from select clinical trials investigating Opdivo for the treatment of non-small-cell lung cancer
Ongoing clinical development of Opdivo
Key ongoing clinical trials of Opdivo in the treatment of non-small-cell lung cancer
Key results from select clinical trials investigating Opdivo combination therapies for the treatment of non-small-cell lung cancer
Ongoing clinical development of Opdivo combination therapies
Key ongoing clinical trials of Opdivo combination therapies in the treatment of non-small-cell lung cancer
Expert insight: Opdivo combination therapies
Tecentriq
Key results from select clinical trials investigating Tecentriq for the treatment of non-small-cell lung cancer
Ongoing clinical development of Tecentriq
Key ongoing clinical trials of Tecentriq in the treatment of non-small-cell lung cancer
Expert insight: Tecentriq
Key results from select clinical trials investigating Imfinzi for the treatment of non-small-cell lung cancer
Ongoing clinical development of Imfinzi
Key ongoing clinical trials of Imfinzi in the treatment of non-small-cell lung cancer
Expert insight: Imfinzi
Key results from select clinical trials investigating Imfinzi plus Imjudo for the treatment of non-small-cell lung cancer
Expert insight: Imfinzi plus Imjudo
Key results from select clinical trials investigating Libtayo for the treatment of non-small-cell lung cancer
Expert insight: Libtayo
Key results from select clinical trials investigating Tagrisso for the treatment of non-small-cell lung cancer
Ongoing clinical development of Tagrisso
Key ongoing clinical trials of Tagrisso in the treatment of non-small-cell lung cancer
Expert insight: Tagrisso
Ongoing clinical development of erlotinib
Key ongoing clinical trials of erlotinib in the treatment of non-small-cell lung cancer
Key results from select clinical trials investigating Exkivity for the treatment of non-small-cell lung cancer
Ongoing clinical development of Exkivity
Expert insight: Exkivity
Rybrevant
Key results from select clinical trials investigating Rybrevant for the treatment of non-small-cell lung cancer
Ongoing clinical development of Rybrevant
Expert insight: Rybrevant
Key results from select clinical trials investigating Alecensa for the treatment of non-small-cell lung cancer
Ongoing clinical development of Alecensa
Key ongoing clinical trials of Alecensa in the treatment of non-small-cell lung cancer
Expert insight: Alecensa
Key results from select clinical trials investigating Alunbrig for the treatment of non-small-cell lung cancer
Ongoing clinical development of Alunbrig
Expert insight: Alunbrig
Key results from select clinical trials investigating Lorbrena / Lorviqua for the treatment of non-small-cell lung cancer
Ongoing clinical development of Lorbrena / Lorviqua
Expert insight: Lorbrena / Lorviqua
Key results from select clinical trials investigating Xalkori for the treatment of non-small-cell lung cancer
Ongoing clinical development of Xalkori
Key ongoing clinical trials of Xalkori in the treatment of non-small-cell lung cancer
Ongoing clinical development of Zykadia
Expert insight: Zykadia
Key results from select clinical trials investigating Rozlytrek for the treatment of non-small-cell lung cancer
Ongoing clinical development of Rozlytrek
Key ongoing clinical trials of Rozlytrek in the treatment of non-small-cell lung cancer
Expert insight: Rozlytrek
Key results from select clinical trials investigating Retevmo / Retsevmo for the treatment of non-small-cell lung cancer
Ongoing clinical development of Retevmo / Retsevmo
Key ongoing clinical trials of Retevmo / Retsevmo in the treatment of non-small-cell lung cancer
Expert insight: Retevmo
Key results from select clinical trials investigating Gavreto for the treatment of non-small-cell lung cancer
Ongoing clinical development of Gavreto
Key ongoing clinical trials of Gavreto in the treatment of non-small-cell lung cancer
Expert insights: RET inhibitors
Key results from select clinical trials investigating Tabrecta for the treatment of non-small-cell lung cancer
Ongoing clinical development of Tabrecta
Key ongoing clinical trials of Tabrecta in the treatment of non-small-cell lung cancer
Expert insight: Tabrecta
Key results from select clinical trials investigating Tepmetko for the treatment of non-small-cell lung cancer
Ongoing clinical development of Tepmetko
Expert insight: MET inhibitors for non-small-cell lung cancer
Key results from select clinical trials investigating Lumakras / Lumykras for the treatment of non-small-cell lung cancer
Ongoing clinical development of Lumakras / Lumykras
Key ongoing clinical trials of Lumakras / Lumykras in the treatment of non-small-cell lung cancer
Expert insight: Lumakras / Lumykras
Key results from select clinical trials investigating Krazati for the treatment of non-small-cell lung cancer
Ongoing clinical development of Krazati
Key ongoing clinical trials of Krazati in the treatment of non-small-cell lung cancer
Expert insight: Krazati
Key results from select clinical trials investigating Enhertu for the treatment of non-small-cell lung cancer
Ongoing clinical development of Enhertu
Key ongoing clinical trials of Enhertu in the treatment of non-small-cell lung cancer
Expert insight: Avastin
Key results from select clinical trials investigating Cyramza for the treatment of non-small-cell lung cancer
Ongoing clinical development of Cyramza
Key ongoing clinical trials of Cyramza in the treatment of non-small-cell lung cancer
Medical practice
Localized stage I/II and resectable and unresectable stage III non-small-cell lung cancer
First-line metastatic nonsquamous non-small-cell lung cancer
First-line metastatic squamous non-small-cell lung cancer
Second- and third-line metastatic nonsquamous non-small-cell lung cancer
Second- and third-line metastatic squamous non-small-cell lung cancer
Treatment guidelines
Patient characteristics influencing drug selection
Treatment decision tree for early-stage (stage I - III) non-small-cell lung cancer
Treatment decision tree for metastatic (stage IV) nonsquamous non-small-cell lung cancer with EGFR, ALK, BRAF V600E, ROS1, RET, or MET exon 14 skipping mutations
Treatment decision tree metastatic (stage IV) nonsquamous non-small-cell lung cancer with KRAS G12C, HER2, or EGFR exon 20 insertion mutations, or without actionable mutations
Treatment decision tree for metastatic (stage IV) squamous non-small-cell lung cancer
Unmet Need Overview
Current and future attainment of unmet needs in non-small-cell lung cancer
Top unmet needs in non-small-cell lung cancer: current and future attainment
Drug Pipeline
Pipeline
Regulatory milestones
Indication Comparison
Emerging Therapies
Key findings
Key emerging therapies
Key therapies in development for non-small-cell lung cancer
Estimated market authorization dates of key emerging therapies for the treatment of non-small-cell lung cancer
Key results from select clinical trials investigating Tevimbra for the treatment of non-small-cell lung cancer
Analysis of the clinical development program for Tevimbra
Expectations for market authorization and sales opportunity of Tevimbra in non-small-cell lung cancer
Key ongoing clinical trials of retifanlimab for the treatment of non-small-cell lung cancer
Analysis of clinical development program for retifanlimab
Expectations for market authorization and sales opportunity of retifanlimab in non-small-cell lung cancer
Key results from select clinical trials investigating Jemperli for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of Jemperli in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for Jemperli
Expectations for market authorization and sales opportunity of Jemperli in non-small-cell lung cancer
Key results from select clinical trials investigating ivonescimab for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of ivonescimab in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for ivonescimab
Expectations for market authorization and sales opportunity of ivonescimab in non-small-cell lung cancer
Key results from select clinical trials investigating fianlimab for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of fianlimab in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for fianlimab
Expectations for market authorization and sales opportunity of fianlimab in non-small-cell lung cancer
Key results from select clinical trials investigating tiragolumab for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of tiragolumab for the treatment of non-small-cell lung cancer
Analysis of clinical development program for tiragolumab
Expert insight: tiragolumab
Expectations for market authorization and sales opportunity of tiragolumab in non-small-cell lung cancer
Key results from select clinical trials investigating vibostolimab for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of vibostolimab in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for vibostolimab
Expert insight: vibostolimab
Expectations for market authorization and sales opportunity of vibostolimab in non-small-cell lung cancer
Key ongoing clinical trials of ociperlimab in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for ociperlimab
Expectations for market authorization and sales opportunity of ociperlimab in non-small-cell lung cancer
Key results from select clinical trials investigating domvanalimab for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of domvanalimab for the treatment of non-small-cell lung cancer
Analysis of clinical development program for domvanalimab
Expectations for market authorization and sales opportunity of domvanalimab in non-small-cell lung cancer
Key results from select clinical trials investigating oleclumab for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of oleclumab in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for oleclumab
Expert insight: oleclumab
Expectations for market authorization and sales opportunity of oleclumab in non-small-cell lung cancer
Analysis of the clinical development program for monalizumab
Expert insight: oleclumab and monalizumab in non-small-cell lung cancer
Expectations for market authorization and sales opportunity of monalizumab in non-small-cell lung cancer
Gotistobart
Key results from select clinical trials for gotistobart
Key ongoing trials of gotistobart
Analysis of the clinical development program for gotistobart
Expectations for market authorization and sales for gotistobart
Key results from select clinical trials investigating lazertinib for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of lazertinib in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for lazertinib
Expert insight: lazertinib
Expectations for market authorization and sales opportunity of lazertinib in non-small-cell lung cancer
Key results from select clinical trials investigating aumolertinib for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of aumolertinib in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for aumolertinib
Expectations for market authorization and sales opportunity of aumolertinib in non-small-cell lung cancer
Key results from select clinical trials investigating furmonertinib for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of furmonertinib in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for furmonertinib
Expectations for market authorization and sales opportunity of furmonertinib in non-small-cell lung cancer
Key results from select clinical trials investigating sunvozertinib for the treatment of non-small-cell lung cancer
Analysis of the clinical development program for sunvozertinib
Expectations for market authorization and sales opportunity of sunvozertinib in non-small-cell lung cancer
Key results from select clinical trials investigating zipalertinib for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of zipalertinib in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for zipalertinib
Expectations for market authorization and sales opportunity of zipalertinib in non-small-cell lung cancer
Key results from select clinical trials investigating ensartinib for the treatment of non-small-cell lung cancer
Analysis of the clinical development program for ensartinib
Expectations for market authorization and sales opportunity of ensartinib in non-small-cell lung cancer
Key results from select clinical trials investigating Bravtovi and Mektovi combination therapy for the treatment of non-small-cell lung cancer
Expert insight: Braftovi and Mektovi
Expectations for market authorization and sales opportunity of Bravtovi and Mektovi combination therapy in non-small-cell lung cancer
Key results from select clinical trials investigating avutometinib for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of avutometinib in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for avutometinib
Expectations for market authorization and sales opportunity of avutometinib in non-small-cell lung cancer
Key results from select clinical trials investigating repotrectinib for the treatment of non-small-cell lung cancer
Analysis of the clinical development program for repotrectinib
Expert insight: repotrectinib
Expectations for market authorization and sales opportunity of repotrectinib in non-small-cell lung cancer
Key results from select clinical trials investigating taletrectinib for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of taletrectinib in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for taletrectinib
Expectations for market authorization and sales opportunity of taletrectinib in non-small-cell lung cancer
Key results from select clinical trials investigating NVL-520 for the treatment of non-small-cell lung cancer
Analysis of the clinical development program for NVL-520
Expectations for market authorization and sales opportunity of NVL-520 in non-small-cell lung cancer
Key results from select clinical trials investigating savolitinib for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of savolitinib in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for savolitinib
Expert insight: savolitinib
Expectations for market authorization and sales opportunity of savolitinib in non-small-cell lung cancer
Key results from select clinical trials investigating telisotuzumab vedotin for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of telisotuzumab vedotin in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for telisotuzumab vedotin
Expert insight: telisotuzumab vedotin
Expectations for market authorization and sales opportunity of telisotuzumab vedotin in non-small-cell lung cancer
Key results from select clinical trials investigating opnurasib for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of opnurasib in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for opnurasib
Expert insight: emerging KRAS inhibitors
Expectations for market authorization and sales opportunity of opnurasib in non-small-cell lung cancer
Key results from select clinical trials investigating divarasib for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of divarasib in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for divarasib
Expectations for market authorization and sales opportunity of divarasib in non-small-cell lung cancer
Key results from select clinical trials investigating pyrotinib for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of pyrotinib in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for pyrotinib
Expectations for market authorization and sales opportunity of pyrotinib in non-small-cell lung cancer
Key results of select clinical trials investigating ceralasertib for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of ceralasertib in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for ceralasertib
Expert insight: ceralasertib
Expectations for market authorization and sales opportunity of ceralasertib in non-small-cell lung cancer
Key results from select clinical trials investigating tusamitamab ravtansine for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of tusamitamab ravtansine in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for tusamitamab ravtansine
Expert insight: use of tusamitamab ravtansine in non-small-cell lung cancer
Expectations for market authorization and sales opportunity of tusamitamab ravtansine in non-small-cell lung cancer
Key results from select clinical trials investigating patritumab deruxtecan for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of patritumab deruxtecan in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for patritumab deruxtecan
Expert insight: use of patritumab deruxtecan in non-small-cell lung cancer
Expectations for market authorization and sales opportunity of patritumab deruxtecan in non-small-cell lung cancer
Key results from select clinical trials investigating datopotamab deruxtecan for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of datopotamab deruxtecan in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for datopotamab deruxtecan
Expert insight: use of anti-TROP2 ADCs in non-small-cell lung cancer
Expectations for market authorization and sales opportunity of datopotamab deruxtecan in non-small-cell lung cancer
Key results from select clinical trials investigating Trodelvy for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of Trodelvy in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for Trodelvy
Expectations for market authorization and sales opportunity of Trodelvy in non-small-cell lung cancer
Key results from select clinical trials investigating lifileucel for the treatment of non-small-cell lung cancer
Analysis of the clinical development program for lifileucel
Expert insights: the use of lifileucel in non-small-cell lung cancer
Expectations for market authorization and sales opportunity of lifileucel in non-small-cell lung cancer
Key results from select clinical trials investigating OSE-2101 for the treatment of non-small-cell lung cancer
Analysis of the clinical development program for OSE-2101
Expert insight: use of OSE-2101 in the treatment of non-small-cell lung cancer
Expectations for market authorization and sales opportunity of OSE-2101 in non-small-cell lung cancer
Key results from select clinical trials investigating Lenvima for the treatment of non-small-cell lung cancer
Analysis of the clinical development program for Lenvima
Expert insight: Lenvima
Expectations for market authorization and sales opportunity of Lenvima in non-small-cell lung cancer
Key results from select clinical trials investigating plinabulin for the treatment of non-small-cell lung cancer
Analysis of the clinical development program for plinabulin
Expert insight: use of plinabulin in the treatment of non-small-cell lung cancer
Expectations for market authorization and sales opportunity of plinabulin in non-small-cell lung cancer
Key ongoing clinical trials of Lynparza in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for Lynparza
Expert insight: Lynparza
Expectations for market authorization and sales opportunity of Lynparza in non-small-cell lung cancer
Key results from select clinical trials investigating Zejula for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of Zejula in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for Zejula
Expectations for market authorization and sales opportunity of Zejula in non-small-cell lung cancer
Key results from select clinical trials investigating nogapendekin alfa (N-803) for the treatment of non-small-cell lung cancer
Key ongoing clinical trials of nogapendekin alfa (N-803) in the treatment of non-small-cell lung cancer
Analysis of the clinical development program for nogapendekin alfa (N-803)
Expectations for market authorization and sales opportunity of nogapendekin alfa (N-803) in non-small-cell lung cancer
Early-phase pipeline analysis
Select compounds in Phase 2 development for non-small-cell lung cancer
Access and Reimbursement Overview
Region-specific reimbursement practices
Key market access considerations in NSCLC: United States
General reimbursement environment: United States
Key market access considerations in NSCLC: EU5
General reimbursement environment: EU5
Key market access considerations in NSCLC: Japan
General reimbursement environment: Japan
Appendix
Abbreviations
Bibliography
Charlotte Jago
Charlotte Jago, Ph.D., Senior Healthcare Research & Data Analyst, Oncology. Dr. Jago is a pharmaceutical industry analyst with more than 18 years’ experience, preceded by 5 years of laboratory research in academia (Imperial College London) and industry (Celltech, now UCB). She wrote the flagship Cortellis Drugs to Watch reports in 2013, 2014, 2015, and 2019 and led the improvement in immuno-oncology coverage on the Cortellis Competitive Intelligence platform. She holds a Ph.D. in immunology, a first-class degree in pharmacology, and a postgraduate certificate in journalism.