Introduction:Last Updated 15 August 2013
The potential reward for novel therapies to treat breast
cancer (CaB) is high owing to its large population; however, a competitive
market means that barriers to entry are high as well. Indeed, despite the
active CaB pipeline, relatively few drugs will enter the market over our
forecast period. Increasingly, a personalized treatment approach using targeted
therapies is evolving in CaB, and those therapies paired with a biomarker
predictive of benefit, such as HER2-targeted therapies, have fared well in this
indication. Unmet need remains for triple-negative CaB, for which no therapy is
Questions Answered in This Report:
The HER2-positive market
segment is becoming increasingly dynamic. August 2013 saw European approval of
Tyverb (GlaxoSmithKline’s lapatinib) in combination with Herceptin
(Roche/Genentech/Chugai’s trastuzumab) for a subset of HER2-positive metastatic
patients. In 2012, pertuzumab (Roche/Genentech/Chugai’s Perjeta) was approved
by the FDA for first-line metastatic HER2-positive CaB. European and Japanese
approvals have followed in March and June 2013, respectively. Ado-trastuzumab
emtansine (Roche/Genentech/Chugai’s Kadcyla [T-DM1]) was approved in the United
States in February 2013. Both agents are being investigated in Phase III
clinical trials as adjuvant therapies. How rapidly will T-DM1 and pertuzumab
be taken up in the CaB market? How will these agents fare in the adjuvant
setting? What dynamics will emerge as these agents move into different
The FDA and European Medicines Agency approved everolimus
(Novartis’s Afinitor) to treat hormone-receptor (HR-) positive, HER2-negative
advanced CaB in combination with exemestane (Pfizer’s Aromasin, generics) in
July 2012. The CaB pipeline contains numerous early-stage agents aimed at the
PI3K/AKT/mTOR pathway. How will everolimus fit into the current treatment
algorithm for HR-positive CaB? How well has it been received by oncologists?
What do interviewed experts think of other agents targeting this pathway?
Pfizer’s novel CDK 4/6 inhibitor, palbociclib, won FDA
Breakthrough Therapy Designation in 2013 based on impressive Phase II data in
HR-positive, HER2-negative CaB. How has palbociclib’s data been received by
oncologists? Where in the treatment algorithm will palbociclib be used? What
uptake will palbociclib receive?
New entrants into the HER2-positive and HR-positive CaB market
segments will pave the way for changing treatment dynamics over our forecast
period. How will currently available HER2-targeted agents (trastuzumab
[Roche/Genentech/Chugai’s Herceptin], lapatinib [GlaxoSmithKline’s
Tykerb/Tyverb]) fare against competition from pertuzumab and T-DM1? How will
the treatment of HR-positive disease change with the uptake of palbociclib and
Markets covered: United States, France, Germany, Italy,
Spain, United Kingdom, Japan.
Primary research: 31 country-specific interviews with
Epidemiology: Incidence of stages I, IIa, IIb, IIIa,
IIIb, IIIc, and IV CaB; incidence of hormonal CaB by stage at diagnosis;
incidence of nonhormonal CaB by stage at diagnosis; incidence of HER2-positive
CaB by stage at diagnosis; incidence of triple-negative CaB by stage 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- and
subsequent-line metastatic HR+/HER2-, first-line metastatic HER2+ (HR+ and
HR-), second-line metastatic HER2+ (HR+ and HR-), third- and subsequent-line
metastatic HER2+ (HR+ and HR-), first-line metastatic HR-/HER2-
(triple-negative), second-line metastatic HR-/HER2- (triple-negative), third-
and subsequent-line metastatic HR-/HER2- (triple-negative).
Emerging therapies: Phase II: 31 drugs; Phase III: 11
drugs; registered: 26 drugs.
Market forecast features: Using a proprietary
patient-flow model incorporating mortality, we forecast drug-treatable population sizes and drug sales for all patient
segments annually through 2022.
scenarios: Novartis’s buparlisib
is approved for HR+/HER2- advanced/metastatic CaB; palbociclib is not approved
for HR+/HER2- first-line advanced CaB; lapatinib is approved for
adjuvant HER2-positive CaB.