Introduction:
Last Updated 20 April 2010Despite earlier diagnosis and improved treatment, the high incidence
of breast cancer (CaB) makes it the second-leading cause of cancer-related
deaths in women. In 2008, more than 450,000 incident cases were diagnosed in
the major pharmaceutical markets under study (United States, France, Germany,
Italy, Spain, United Kingdom, and Japan)—incident cases that may be divided
among numerous subpopulations, each with distinctly different disease
characteristics. Hormonal, chemotherapeutic, and targeted therapies aim to
address the needs of these specific patient segments, but current drugs have
very little impact on improving the prognosis of patients with metastatic or
triple-negative CaB. The unmet need in these patient segments reflects a
considerable opportunity for drug developers, particularly for those seeking to
advance targeted therapies. Targeted therapies have the greatest commercial
potential in the CaB market as a result of their premium pricing and limited
generic erosion during our forecast period. The CaB therapy market will
continue to grow owing to the uptake of premium-priced treatments, launches of
emerging therapies, and a growing incident population.
Questions Answered in This Report:
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PARP inhibitors are among the numerous emerging therapies being
explored for BRCA1/BRCA2-mutated, basal-like, or triple-negative CaB—patient
populations who have traditionally been underserved because of the lack of
effective therapies.
What do PARP inhibitors offer in terms of efficacy and
safety? How do key opinion leaders perceive these drugs? What is the commercial
potential of the PARP inhibitors in the CaB market?
*
Bevacizumab entered the CaB market as the first anti-vascular
endothelial growth factor (VEGF) therapy for the treatment of metastatic CaB.
Numerous other angiogenesis inhibitors are in development for CaB, of which
ramucirumab is among the most promising.
What do experts think about the
potential of this drug class? How will a new VEGF inhibitor be used? Will any
VEGF inhibitors be approved for the treatment of CaB patients in the adjuvant
setting? How will bevacizumab’s sales be affected by the launch of new VEGF
inhibitors?
*
Pan-kinase inhibitors will likely play a role in the treatment
of CaB by 2018. As developers seek CaB drugs with improved efficacy, they are
also interested in drugs capable of evading cancer cells’ drug resistance
mechanisms.
How will a pan-kinase inhibitor be prescribed? What are the
potential advantages and disadvantages of such a drug? What do experts think
about the pan-kinase inhibitors in clinical development?
*
Trastuzumab (Roche/Chugai’s Herceptin) offers CaB patients who
are positive for the human epidermal growth factor receptor (HER2) an
effective and well-tolerated treatment in both the adjuvant and metastatic
settings.
How will physicians treat patients who experience progressed
disease but were already treated with trastuzumab? What will the role of
combination targeted therapies be during the 2008-2018 study period? How will
trastuzumab fare against current and emerging treatments for HER2-positive
patients? How will the possible launch of a trastuzumab biosimilar affect the
HER2-positive market?
*
In May 2008, the FDA approved the TCH regimen—docetaxel
(Sanofi-Aventis’s Taxotere), carboplatin (Bristol-Myers Squibb’s Paraplatin,
generics), and trastuzumab—for the adjuvant treatment of HER2-positive CaB; in
July 2008, however, Europe’s Committee for Medicinal Products for Human Use
(CHMP) rejected the TCH regimen.
How has the regimen been received in the
United States? What do European oncologists think about such a combination for
CaB?
*
To date, no therapeutic
vaccines have been launched in any of the major oncology markets, but several
drug developers are seeking to harness the commercial potential of an effective
CaB vaccine. Two therapies in Phase III development—Apthera’s NeuVax and Merck
KGaA/Oncothyreon’s Stimuvax—hold the potential for becoming among the first
vaccines to enter this market.
What do thought-leading oncologists think of
vaccines’ potential in the CaB market? Will any vaccines launch for CaB during
the 2008-2018 study period?Scope:
Markets covered: United
States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 33 country-specific interviews with
CaB thought leaders.
Epidemiology: Incidence and prevalence of stages I, IIa,
IIb, III, and IV CaB; incidence of hormonal CaB by stage at diagnosis;
prevalence of hormonal CaB at diagnosis; incidence of nonhormonal CaB by stage
at diagnosis; prevalence of nonhormonal CaB at diagnosis; incidence of HER2-positive
CaB by stage at diagnosis; prevalence of HER2-positive CaB at diagnosis;
incidence of basal-like CaB by stage at diagnosis; prevalence of basal-like CaB
at diagnosis; incidence of premenopausal CaB by stage at diagnosis; incidence
of postmenopausal CaB by stage at diagnosis.
Population segments in market forecast: Adjuvant and
neoadjuvant HR+/HER2- premenopausal, adjuvant and neoadjuvant HR+/HER2+
postmenopausal, adjuvant and neoadjuvant HR+/HER2+ premenopausal, adjuvant and
neoadjuvant HR-/HER2+, adjuvant and neoadjuvant HR-/HER2- (triple-negative),
first-line metastatic HR+/HER2-, second-line metastatic HR+/HER2-,
third/fourth-line metastatic HR+/HER2-, first-line metastatic HER2+ (HR+ and
HR-), second-line metastatic HER2+ (HR+ and HR-), third/fourth-line metastatic
HER2+ (HR+ and HR-), first-line metastatic HR-/HER2- (triple-negative),
second-line metastatic HR-/HER2- (triple-negative), third/fourth metastatic
line HR-/HER2 (triple-negative).
Emerging therapies: Phase II: 24 drugs; Phase III: 15
drugs. Coverage of 8 select preclinical and Phase I products.
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) bevacizumab is
approved in the adjuvant setting, (2) neratinib fails to launch in the adjuvant
setting, and (3) pertuzumab fails to launch for first-line metastatic CaB.