Biomarker- and histology-driven prescribing has become standard practice in the treatment of non-small-cell lung cancer (NSCLC). The treatment algorithms for NSCLC—including those for biomarker-defined patient subpopulations—continue to evolve, driven by the approval of novel agents, often with associated biomarkers. Several underserved areas of high unmet need offer significant commercial opportunity for innovative agents. This report provides insight on how treatment options for NSCLC are likely to change over the 2015-2025 forecast period. It also analyzes the current and future earnings potential of drugs already in the market and those expected to be approved for NSCLC.

Questions Answered:

  • The first immune checkpoint inhibitor for NSCLC was approved in early 2015. How will the treatment algorithm of NSCLC change as a result of this approval? Which other immune checkpoint inhibitors are most promising in NSCLC? Which patient populations are immune checkpoint inhibitors most likely to be used for? What will be the impact to the NSCLC market?
  • Next-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) have entered the NSCLC market and next-generation epidermal growth fact receptor (EGFR) TKIs are in late-phase development. How will such agents change the treatment pathways for ALK-translocation-positive and EGFR-mutation-positive patients, respectively? How do the various agents differ? How will they compete with current and emerging agents?
  • Numerous drug classes are represented in the NSCLC late-phase pipeline. How will established drug classes compete with emerging therapies in an increasingly fragmented landscape? How will the safety and tolerability of emerging agents impact their uptake?
  • Accumulating evidence supporting the administration of maintenance therapy has resulted in relatively high use of such protocols following first-line treatment for advanced/metastatic patients. How large is the maintenance therapy market? How will it be affected by increasingly biomarker-driven prescribing in the first-line treatment setting? Will novel therapies entering the NSCLC market have a positive impact on maintenance therapy sales?


Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 32 country-specific interviews with key opinion leaders and 212 country-specific surveys with community oncologists treating NSCLC.

Epidemiology: Incidence by disease stage (stage IA, stage IB, stage IIIA, stage IIIB, stage IV) for adenocarcinoma, large-cell NSCLC, squamous-cell carcinoma, and other NSCLC histologies; progressed incidence of stage IV adenocarcinoma, large-cell/other NSCLC histologies, and squamous-cell NSCLC. (Note: We have applied a smoking model based on historical smoking rates when projecting the size of the future NSCLC population.)

Population segments in market forecast: For adenocarcinoma, large-cell/other NSCLC histologies, and squamous-cell/unverified histology lung cancer NSCLC: stage IB/II, stage III, metastatic first line, second line, and third line.

Emerging therapies: Phase II: 27 drugs; Phase III: 25.


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