Last Updated 20 October 2014
Biomarker- and histology-driven prescribing is standard practice in the treatment of non-small-cell lung cancer (NSCLC) across the major pharmaceutical markets. The treatment of NSCLC patients including that of molecularly defined subpopulations continues to evolve, driven by the development of novel agents and increasingly, associated biomarkers and companion diagnostics. Codeveloping a drug and a companion diagnostic is one of the most promising avenues for commercial success. Several underserved areas of high unmet need offer significant commercial opportunity for innovative agents.

Questions Answered in This Report:

  • Despite hurdles in development, numerous immunotherapies are, or are entering, late-stage clinical trials in NSCLC. Which immunotherapies are most promising in NSCLC? Which patient populations are immunotherapies most likely to enter? What would be the impact on the total NSCLC market, should immunotherapies be approved for the treatment of NSCLC?

  • Next-generation EGFR and ALK inhibitors are in late-stage development. How will these therapies be used, if approved? What are the clinical advantages of next- generation EGFR and ALK inhibitors? How will they compete with currently available agents, such as Genentech/Roche/Chugai’s erlotinib (Tarceva) and Pfizer’s crizotinib (Xalkori)?

  • The sizable NSCLC pipeline includes drugs in numerous novel drug classes, including immunotherapies, poly ADP-ribose polymerase inhibitors, BRAF/MEK inhibitors, and CDK 4/6 inhibitors. How will established drug classes compete with emerging therapies in an increasingly fragmented market landscape? How will safety and tolerability of emerging agents impact uptake?

  • Accumulating evidence supports the administration of maintenance therapy that 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 have a positive impact on maintenance therapy sales?


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

Primary research: 39 country-specific interviews with NSCLC thought-leaders.

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 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, and squamous-cell NSCLC: stage IB/II, stage III, advanced/metastatic first line, second line, third line.

Emerging therapies: Phase I/II: 32 drugs; Phase III: 24 drugs; preregistration: 2 drugs; registered: 2 drugs.

Author(s): Orestis Mavroudis-Chocholis, Ph.D.
Lade Ayodele, M.B.B.S., M.P.H.

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