Introduction:
Non-small-cell lung cancer (NSCLC) makes up approximately
85% of all diagnosed incident cases of lung cancer. Most patients are diagnosed
with advanced NSCLC—i.e., stage IIIB with pleural effusion (PE) or stage IV
disease. The five-year survival rate for such advanced disease is less than 3%.
The large NSCLC market is dominated by increasingly generic chemotherapy
agents, although it includes three biological agents that have shown modest
efficacy in select groups of patients. The launch of six premium-priced
biologic agents, including two monoclonal antibodies (MAbs) and one vaccine,
will nearly triple sales over the 2008-2018 forecast period.
Questions Answered in This Report:
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Following its 2007 approval for NSCLC in the United States and
Europe, the VEGF MAb bevacizumab (Roche/Chugai’s Avastin) has been experiencing
increased uptake in the first-line setting. Two other MAbs are expected to
launch between 2008 and 2018.
What patient populations will these agents be
used in? Will they compete with bevacizumab and/or each other? Will
they fulfill any major unmet needs in NSCLC? Will the improvements in efficacy
be sufficient to justify their high price, or will cost be a barrier to their
uptake?
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The first vaccine for NSCLC is set to launch toward the end of
our forecast period.
Which of the five vaccines in Phase III development
will enter the NSCLC market? In which setting will this vaccine be used? How
much patient share can it expect to capture?
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Erlotinib is available in every major market and is used
increasingly in the second-line setting in specific subgroups of NSCLC
patients. Two new EGFR TKIs will enter the market by 2018, while gefitinib
(AstraZeneca’s Iressa), an EGFR TKI commonly used in Japan, is set to make a
comeback in the West.
What patient subgroups will benefit from these drugs?
Will they steal patient share from erlotinib? Will they be used alone or in
combination with chemotherapy?
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Several current and emerging therapies have been trialed as
maintenance treatments for NSCLC.
How frequently will maintenance therapy be
used for NSCLC in 2018? Which agents will be successful in the maintenance
setting? Which populations are likely to benefit from maintenance
treatment?Scope:
Markets covered: United States, France, Germany, Italy,
Spain, United Kingdom, Japan.
Primary research: 34 country-specific interviews with
key opinion leaders.
Epidemiology: Incidence of stage IA, IB, II, IIIA, IIIB
without malignant PE, stage IIIB plus malignant PE, and stage IV NSCLC;
prevalence of non-drug-treatable and drug-treatable (resectable and
nonresectable) NSCLC.
Population segments in market forecast: Stage IB/II
NSCLC; stage IIIA NSCLC; stage IIIB NSCLC without PE; stage IIIB NSCLC plus
PE/stage IV NSCLC; second-line NSCLC; third- and subsequent-line NSCLC.
Emerging therapies: Phase
II: 10 drugs; Phase III: 17 drugs; preregistration: 1 drug; registered: 0
drugs.
Market forecast features: Using a proprietary
patient-flow model incorporating mortality, we forecast population sizes and
drug sales for all patient segments through 2018.
Alternative market scenarios: (1) adjuvant bevacizumab
(Roche/Chugai’s Avastin) does not receive regulatory approval; (2) sorafenib
(Bayer/Onyx’s Nexavar) does not receive regulatory approval for refractory
(third- and fourth-line) NSCLC; (3) vandetanib (AstraZeneca’s Zactima) does not
receive regulatory approval for second-line treatment of NSCLC; (4) BLP-25
(Merck Serono’s Stimuvax) receives regulatory approval in the United States and
Europe in 2013 and in Japan in 2016; (5) albumin-bound paclitaxel (Abraxis
BioScience’s Abraxane) receives regulatory approval in the United States and
Europe in 2012 and in Japan in 2015.