REFERENCE CODE GDHC86PIDR | PUBLICATION DATE SEPTEMBER 2014
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS
TO 2023
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
Executive Summary
HER2-Positive Breast Cancer: Key Metrics in the Eight Major Pharmaceutical Markets, 2013–2023 2013 Epidemiology
Breast cancer incident cases 853,902
HER2-positive breast cancer incident cases 182,487
2013 Market Sales
US $2.41bn
5EU $1.99bn
Japan $126m
China $425m
Total $4.95bn
Late-Stage Pipeline Assessment
Number of drugs in Phase III profiled 2
Most Promising Late-Stage Pipeline Drugs Peak-Year Sales
Neratinib (Puma Biotechnology) $90m
Key Events (2013–2023) Level of Impact
Herceptin (trastuzumab) patent expiry in the 5EU in 2014
Launch of biosimilar trastuzumab in the 5EU in 2015
Approval of Perjeta (pertuzumab) in the adjuvant setting in 2017
Launch of neratinib in the metastatic setting in 2018
Launch of Kadcyla (ado-trastuzumab emtansine, T-DM1) in the adjuvant setting in 2019
2023 Market Sales
US $7.95bn
5EU $3.90bn
Japan $239m
China $613m
Total $12.70bn Source: GlobalData 5EU = France, Germany, Italy, Spain, and UK
The table above presents the key metrics for
human epidermal growth factor receptor type 2
(HER2)-positive breast cancer in the eight major
pharmaceutical markets (US, France, Germany,
Italy, Spain, UK, Japan, and China) during the
forecast period from 2013–2023.
HER2-Positive Breast Cancer Market to Increase by 2.5-Fold by 2023
In the 8MM in this report, GlobalData valued the
HER2-positive breast cancer market at $4.95
billion in 2013, and expects the market to increase
to $12.70 billion in 2023, at a Compound Annual
Growth Rate (CAGR) of 9.88%. The US
contributes almost half of the total market sales in
both 2013 and 2023.
The top drivers of growth in the HER2-positive
breast cancer market during the forecast period
include:
The rapid uptake of the premium-priced
biologics, Perjeta and Kadcyla, in all settings of
the disease, where their sales will increase at a
CAGR of 30.2% and 35.1%, respectively,
during the forecast period. By 2023, together,
they will capture 75% of the total HER2-
positive breast cancer market.
The launch of Perjeta and Kadcyla in early
disease in the neoadjuvant and adjuvant
settings will have the greatest impact on the
HER2-positive breast cancer therapeutics
market, with both agents capturing 77% of the
non-metastatic market by 2023.
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 3 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
Executive Summary
Combinations of branded therapies in both the
early-stage and metastatic settings will inflate
the annual cost of therapy (ACOT). For
instance, the ACOT for the combination of
Perjeta with Herceptin is three times that for
Herceptin alone in both adjuvant and
metastatic settings in the US.
A growing aging population and an increasing
incidence of HER2-positive breast cancer
cases across the 8MM. This is especially the
case in urban China, where over the forecast
period, the female population will increase
faster than in any other market covered in this
report, at a CAGR of 2.9%.
Major barriers to growth in the HER2-positive breast cancer market include:
The patent expiry of Herceptin in the 5EU in
2014, and in the US in 2019, will negatively
impact the market, as Herceptin sales will
decrease at a CAGR of 4.7% by 2023.
Tighter control of healthcare total expenditures
in the 5EU will be a significant hurdle for the
uptake of new premium-priced drugs,
especially when they are used in combination.
In the US, the Affordable Care Act (ACA) is
creating a new cost-conscious environment
that could impact the free-pricing system.
Inconsistent healthcare coverage across China
continues to be a barrier to growth in the
HER2-positive breast cancer market. In
addition, there is low participation in breast
screening programs in China, and there are
drug reimbursement issues as well.
The figure shown below provides the global sales
for HER2-positive breast cancer during the
forecast period.
Global Sales for HER2-Positive Breast Cancer by Region, 2013–2023
Source: GlobalData
$2,412
$425
$686
$450
$157
$270$126
$425
United States
France
Germany
Italy
Spain
United Kingdom
Japan
China
2013$4,950m
2023$12.697m
$7,944
$806
$1,262
$1,046
$307$475
$239 $613
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 4 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
Executive Summary
Roche Retains Its Monopoly in the HER2-Positive Breast Cancer Market
In 2013, Roche was the undeniable global leader
in the HER2-positive breast cancer market,
capturing 95% of the total HER2-targeted drug
sales. This leadership was built on the success of
Herceptin, which has been the standard of care in
all settings of HER2-positive breast cancer since
its launch in 1998. Herceptin alone accounted for
84% of the HER2-positive market in 2013. With a
looming patent expiry for Herceptin, Roche
recently launched two new anti-HER2 monoclonal
antibodies (mAbs): Perjeta in 2012, and Kadcyla in
2013. Roche’s mAbs have no real competition in
the market, and as such, these new agents are
forecast to see rapid uptake, thereby maintaining
Roche’s dominance of the market. By 2023,
GlobalData expects that Roche’s share of the
HER2-positive breast cancer market will exceed
$12 billion.
To enter this challenging market, competitors have
been focusing on the development of tyrosine
kinase inhibitors (TKIs). In 2007, GlaxoSmithKline
(GSK) launched Tykerb (lapatinib), the first HER2-
targeted TKI. Puma and Boehringer Ingelheim are
currently investigating TKIs for breast cancer;
however, the role for TKIs remains small, as
Tykerb accounted for less than 5% of the HER2-
positive market in 2013. Indeed, the role of TKIs in
early disease appears very uncertain. GlobalData
foresees that TKIs will only be used in later lines of
therapy, after the use of Roche’s mAbs. By the end
of the forecast period in 2023, GlobalData
anticipates that the HER2-positive TKI market will
have decreased to $198m, from $212m in 2013.
Ultimately, GlobalData believes that Roche’s
monopoly of this market will only be challenged by
companies with innovative product portfolios, such
as Novartis, and Pfizer.
The figure shown below provides an analysis of the
company portfolio gap in HER2-positive breast
cancer during the forecast period.
Company Portfolio Gap Analysis in HER2-Positive Breast Cancer, 2013–2023
Source: GlobalData
Strength of PipelineLow
Hig
hLo
wS
treng
th o
f Mar
kete
d P
rodu
cts
High
Current and Future Players
Future Players
Current Players
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 5 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
Executive Summary
Kadcyla Will Experience Strong Uptake Across the 8MM
Since launching for use in the second-line
metastatic breast cancer setting in February 2013,
Roche’s Kadcyla has been rapidly adopted in the
US. In 2013, Kadcyla captured 10% of the US
market and 5% of the US, 5EU, and Japan. In
comparison, only 7% of patients in these markets
in which Perjeta was launched received Perjeta in
combination with Herceptin in the first-line setting,
despite Perjeta having been launched six months
before Kadcyla. In fact, key opinion leaders (KOLs)
and global prescribers interviewed by GlobalData
praised the high efficacy and low side effect profile
of Kadcyla, which is expected to result in its
continued strong uptake across the 8MM. With
expected approval in the first-line setting in 2017,
and as an adjuvant therapy in 2019, GlobalData
forecasts Kadcyla to become the leader in the
HER2-positive market, capturing 38% of the total
market by 2023.
Non-Metastatic Breast Cancer Represents the Largest Market for HER2-Targeting Agents
In 2013, the combined sales of anti-HER2 agents
used in the neoadjuvant and adjuvant treatment of
early-stage (non-metastatic) breast cancer
represented 55% of the total market. The use of
Herceptin is particularly strong in the adjuvant
setting, where its sales contributed to 99% of the
total adjuvant market, and 49% of total Herceptin
sales, in 2013. During the forecast period,
GlobalData expects the adjuvant and neoadjuvant
settings to remain the largest markets, and
forecasts their sales to reach $8.60 billion in 2023,
representing 67% of the total HER2-positive
market. This increase in market size will be driven
primarily by the uptake of premium-priced
therapies, such as Perjeta, which was the first drug
to receive approval in the neoadjuvant setting in
the US in 2013.
The dynamism of the adjuvant and neoadjuvant
markets has prompted many companies to try to
position their products in these settings, especially
since the early lines of therapy for metastatic
disease are considered to be inaccessible due to
Roche’s monopoly in this area. TKIs were of
particular interest, since they offer greater
convenience than mAbs, but the negative results
for Tykerb in the adjuvant setting, which were
released in early 2014, showed that TKIs may not
be a good fit for this setting. Generally, TKIs have
more side effects, with little efficacy benefit,
compared with antibodies. Therefore, GlobalData
believes that the adjuvant and neoadjuvant
settings will remain an exclusive market for anti-
HER2 mAbs, hence constituting the most lucrative
opportunity for biosimilar developments. In 2023,
GlobalData expects the biosimilar market for
trastuzumab to be worth $962m in 8MM, with 65%
of sales being in the neoadjuvant and adjuvant
settings.
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 6 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
Executive Summary
Better Treatment for Brain Metastases Remains the Most Pressing Unmet Need
Although the efficacy of HER2-targeted therapies
substantially improves the life expectancy of
patients with HER2-positive disease, by nature,
HER2-positive breast cancer is still a more
aggressive form of the disease, with a poorer
prognosis and worse outcomes than for patients
with HER2-negative (and hormone receptor [HR]-
positive) disease. Two unmet needs are of high
importance to increase survival in HER2-positive
disease:
The effective treatment of central nervous
system (CNS) metastases
The treatment of disease that has become
resistant to HER2-targeting therapies
HER2-targeting mAbs have failed to deliver
benefits to patients with brain metastases, because
they cannot pass the blood-brain barrier. TKIs,
such as Tykerb or neratinib, may be effective here;
however, resistance to kinase inhibitors is
common, so innovative therapies to treat TKI-
resistant HER2-positive disease will also be
required. The agents in early-stage development
that target phosphoinositide 3-kinase (PI3K), such
as NVP-BYL719 and the cyclin-dependent kinase
4/6 (CDK 4/6) inhibitor, palbociclib, have both been
suggested for use in the treatment of anti-HER2-
resistant breast cancer. With impressive results in
the HER2-negative setting, as well as some
evidence of blood-brain barrier penetration, these
agents also have the possibility of addressing the
unmet needs that plague the HER2-positive
market.
Future Breast Cancer Therapies Will Unite the HER2-Positive and HER2- Negative Markets
The agents in the most advanced stages of
development for HER2-positive breast cancer are
the TKIs — namely, Boehringer Ingelheim’s (BIs)
Gilotrif (afatinib) and Puma’s neratinib. However,
recent study results show that TKIs may not
demonstrate a great benefit over the existing
therapies. GlobalData foresees that TKIs will be
used in these scenarios: almost exclusively in later
lines of therapy; after the failure of anti-HER2
therapies in the earlier stages of metastatic
disease; or for patients with known brain
metastases. Puma is positioning neratinib for use
as a later line of therapy, and in this setting
(second-line metastatic and beyond), GlobalData
forecasts neratinib to generate $128m in sales by
2023.
A very limited number of agents are being
developed specifically for HER2-positive breast
cancer. For example, Array’s ARRY-380 (ONT-
380) is another TKI that is currently in Phase I/II for
HER2-positive disease, while Galena is developing
NeuVax (nelipepimut-S), a vaccine that is also
being investigated in HER2-negative disease. In
fact, GlobalData believes that the most promising
agents for HER2-positive disease are being
developed primarily for HER2-negative disease. In
particular, KOLs have expressed interest in PI3K
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 7 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
Executive Summary
inhibitors, such as Novartis’s BYL-719, as well as
in CDK 4/6 inhibitors, such as Pfizer’s palbociclib
and Novartis’s LEE011, in the treatment of HER2-
positive disease. Other drugs in the early phases
of development include Daiichi Sankyo’s
patritumab (U3-1287), which is an anti-HER3 mAb,
and Syntha’s ganetespib (STA-9090), which is a
heat shock protein 90 (HSP90) inhibitor. However,
the clinical relevance of these agents still remains
to be established.
The HER2-positive market has become very
mature since the launch of anti-HER2 antibodies.
For agents to be successful, the strategy may not
be to target HER2 specifically, but rather, to target
a separate pathway that is applicable to both
HER2-positive and -negative disease, thus unifying
the breast cancer market.
“For HER2-negative disease, [there] is much
easier uptake [of drugs], so that is why they went
there [first]. But obviously, those kinds of drugs
could be of high interest in HER2-positive disease,
too.”
OUS Key Opinion Leader, April 2014
“…drugs like palbociclib will be very interesting in
HER2-positive disease, and some of them do
cross the blood-brain barrier, so…those might be
interesting approaches.”
US Key Opinion Leader, January 2014
The figure shown below provides a competitive
assessment of the most promising agents for
HER2-positive breast cancer during the forecast
period.
Competitive Assessment of Most Promising Agents for HER2-Positive Breast Cancer, 2013–2023
Source: GlobalData
Clinical AttributesLow
Hig
hLo
wC
omm
erci
al A
ttrib
utes
High
Puma’sneratinib
HER2-targeting agent
Other mechanisms of action
Galena’sNeuVax
Array’sARRY-380
Syntha’sganetespib
Daiichi Sankyo’spatritumab
Novartis’NVP-BYL719
Novartis’LEE011
Pfizer’spalbociclib
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 8 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
Executive Summary
What Do Physicians Think?
KOLs praised the efficacy of Kadcyla for metastatic
disease, and are already anticipating its use in
earlier settings.
“The effectiveness with the lack of toxicity is one of
the big attractions of T-DM1 [Kadcyla].”
OUS Key Opinion Leader, April 2014
“I am a big believer in TDM-1. I did lots of those
first trials with TDM-1, and I think it’s a great drug.
And so, we are very hopeful that it’s going to have
positive results in the different adjuvant trials that
are underway.”
US Key Opinion Leader, January 2014
“We are hopeful that HER2-positive disease will be
essentially cured in the next decade, or shorter, by
the new agents that we have, that all clearly
showed a dramatic benefit in patients who had
received prior trastuzumab in the case of Kadcyla,
and in those who hadn’t [been treated with prior
trastuzumab] in the case of Perjeta. I mean, there
was clearly an improved survival. So, that suggests
that by adding those agents in some form in the
early-stage setting, that we will cure more patients
with HER2-positive disease.”
US Key Opinion Leader, January 2014
“If [Kadcyla] turned out to be an active agent in the
early-stage setting, that’s where it will get used. I
mean, ultimately, there is not going to be a desire
to hold back on drugs — [that is,] to use better
drugs later. We are going to want to use our best
drugs up front. If T-DM1 is better, and we can use
T-DM1 up front and have a better result in terms of
efficacy, and have a lower toxicity, then that’s what
will be used.”
US Key Opinion Leader, December 2013
KOLs still believe there is room for TKIs, especially
after disease progression following the use of anti-
HER2 mAbs. Neratinib, in particular, is a TKI under
development that they are looking forward to using
in the metastatic setting.
“What I tell people is, at some point, you should be
using a lapatinib combination, either with Herceptin
or with Xeloda [(capecitabine)], and then you
should be using whatever other chemotherapies
with Herceptin that you have still left — eribulin,
navelbine, gemcitabine — and I don’t think the
order matters.”
US Key Opinion Leader, January 2014
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 9 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
Executive Summary
“In my opinion, it [Tykerb] has always been a very
promising drug, but the promise…has never been
held in the clinic, probably because of scheduling,
which doesn’t allow the full potential of anti-tumor
activity because you have to stop at a certain point
because of unacceptable toxicity. The same is for
neratinib or afatinib; probably playing with the
schedule and ensuring optimal exposure of the
tumor to optimal saturation of receptors may really
reveal additional properties of these drugs in the
treatment of trastuzumab-, or antibody-, in general,
refractory HER2-positive tumors.”
OUS Key Opinion Leader, April 2014
“[Neratinib is] such a potent oral tyrosine kinase
inhibitor [that], maybe instead of pitching
themselves against Herceptin, they could look at
how they are going to work in patients who don’t
respond, or who have higher-risk disease, or
afterwards, etcetera.”
US Key Opinion Leader, January 2014
“[Neratinib is a] drug that has a very impressive
anti-tumor activity, very impressive. I remember the
Phase II study in patients [who were] never treated
before with anti-tumor agents, that, as a single
agent it, gave a 50% response rate, which is quite
remarkable.”
OUS Key Opinion Leader, April 2014
“The real difficulty is that the market has moved on
so much from when the trials [for neratinib and
Gilotrif] have been done, and one assumes these
drugs are going to be expensive, with a lot of
toxicity, and without a clear data set to support
them, because everyone has moved on to giving
totally different treatment. I think it’s going to be
much harder to get those in.”
OUS Key Opinion Leader, April 2014
Effective therapies for the treatment of brain
metastases remain the biggest unmet need, and
KOLs are interested to see how cyclin-dependant
kinase inhibitors, which are currently in
development for HER2-negative disease, can
deliver in this setting.
“…HER2-positive patients very frequently get brain
metastases….Radiation is a good treatment, but it
doesn’t last forever, so progression in the brain
after radiation is a real problem. We do not have
any good treatments for that; that’s an unmet
medical need.”
US Key Opinion Leader, January 2014
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 10 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
Executive Summary
“Another class of drugs which has activity in HER2-
positive disease, but is being pursued in ER
[estrogen-receptor]-positive disease, of course, are
CDK 4/6 inhibitors, and those are quite
interesting….They have the potential of crossing
the blood-brain barrier, and are highly effective in
ER-positive disease, and I’m hopeful [that we] are
going to really change the course of patients who
have ER-positive breast cancer.”
US Key Opinion Leader, January 2014
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 11 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
1 Table of Contents
1 Table of Contents ..................................................................................................................... 11
1.1 List of Tables .................................................................................................................... 18
1.2 List of Figures ................................................................................................................... 23
2 Introduction ............................................................................................................................... 26
2.1 Catalyst ............................................................................................................................. 26
2.2 Related Reports ................................................................................................................ 26
2.3 Upcoming Related Reports ............................................................................................... 27
3 Disease Overview ..................................................................................................................... 28
3.1 Etiology and Pathophysiology ........................................................................................... 28
3.1.1 Etiology ......................................................................................................................... 28
3.1.2 Pathophysiology ............................................................................................................ 28
3.2 Basic Breast Anatomy ....................................................................................................... 30
3.3 Breast Cancer Staging ...................................................................................................... 31
3.4 Prognosis .......................................................................................................................... 32
3.5 Quality of Life .................................................................................................................... 33
3.6 Symptoms ......................................................................................................................... 35
4 Epidemiology ............................................................................................................................ 36
4.1 Disease Background ......................................................................................................... 36
4.2 Risk Factors and Comorbidities ........................................................................................ 37
4.2.1 A family history of breast cancer and BRCA1/2 gene mutations significantly increase the breast cancer risk ......................................................................................................... 38
4.2.2 Reproductive hormonal factors influence the risk of breast cancer ................................ 39
4.2.3 Modifiable lifestyle-related factors increase the risk of mortality in breast cancer patients ..................................................................................................................................... 41
4.2.4 Screening programs have been shown to reduce breast cancer mortality, although the benefits need to be carefully weighed against the risks ................................................ 43
4.3 Global Trends ................................................................................................................... 45
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 12 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
4.3.1 Incidence ....................................................................................................................... 45
4.3.2 Prevalence and Survival ................................................................................................ 51
4.4 Forecast Methodology ....................................................................................................... 55
4.4.1 Sources Used................................................................................................................ 56
4.4.2 Sources Not Used ......................................................................................................... 61
4.4.3 Forecast Assumptions and Methods ............................................................................. 61
4.5 Epidemiological Forecast for Breast Cancer (2013–2023) – Diagnosed Incident Cases ... 65
4.5.1 Diagnosed Incident Cases of Breast Cancer ................................................................. 65
4.5.2 Diagnosed Incident Cases of Breast Cancer by Age ..................................................... 67
4.5.3 Diagnosed Incident Cases of Breast Cancer by Menopausal Status ............................. 69
4.5.4 Diagnosed Incident Cases of Breast Cancer Segmented by Stage at Diagnosis ........... 71
4.5.5 Age-Standardized Diagnosed Incidence Rate of Breast Cancer .................................... 72
4.6 Epidemiological Forecast for Breast Cancer (2013–2023) — Diagnosed Prevalent Cases73
4.6.1 Five-Year Diagnosed Prevalent Cases of Breast Cancer .............................................. 73
4.6.2 Five-Year Diagnosed Prevalent Cases by Menopausal Status ...................................... 75
4.6.3 Five-Year Diagnosed Prevalent Cases by Hormone Receptor Subtypes ....................... 76
4.7 Discussion ........................................................................................................................ 78
4.7.1 Epidemiological Forecast Insight ................................................................................... 78
4.7.2 Limitations of the Analysis ............................................................................................. 80
4.7.3 Strengths of the Analysis ............................................................................................... 81
5 Disease Management ............................................................................................................... 83
5.1 Treatment Overview .......................................................................................................... 83
5.1.1 Treatment of Early-Stage Breast Cancer (Stage 0 to Stage IB) ..................................... 83
5.1.2 Treatment of Locally-Advanced and Regional Breast Cancer (Stage IB to IIIA) ............. 84
5.1.3 Treatment of Metastatic HER2-Positive Breast Cancer (Stage IV) ................................ 87
5.2 US..................................................................................................................................... 90
5.2.1 Diagnosis ...................................................................................................................... 90
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 13 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
5.2.2 Clinical Practice ............................................................................................................. 90
5.3 France .............................................................................................................................. 93
5.3.1 Diagnosis ...................................................................................................................... 93
5.3.2 Clinical Practice ............................................................................................................. 94
5.4 Germany ........................................................................................................................... 96
5.4.1 Diagnosis ...................................................................................................................... 96
5.4.2 Clinical Practice ............................................................................................................. 97
5.5 Italy ................................................................................................................................... 99
5.5.1 Diagnosis ...................................................................................................................... 99
5.5.2 Clinical Practice ............................................................................................................. 99
5.6 Spain .............................................................................................................................. 102
5.6.1 Diagnosis .................................................................................................................... 102
5.6.2 Clinical Practice ........................................................................................................... 103
5.7 UK................................................................................................................................... 104
5.7.1 Diagnosis .................................................................................................................... 104
5.7.2 Clinical Practice ........................................................................................................... 105
5.8 Japan .............................................................................................................................. 108
5.8.1 Diagnosis .................................................................................................................... 108
5.8.2 Clinical Practice ........................................................................................................... 108
5.9 China .............................................................................................................................. 109
5.9.1 Diagnosis .................................................................................................................... 109
5.9.2 Clinical Practice ........................................................................................................... 110
6 Competitive Assessment ........................................................................................................ 112
6.1 Overview ......................................................................................................................... 112
6.2 Product Profiles – HER2-Targeted Therapies ................................................................. 113
6.2.1 Herceptin (trastuzumab) .............................................................................................. 113
6.2.2 Tykerb (lapatinib) ........................................................................................................ 120
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 14 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
6.2.3 Perjeta (pertuzumab) ................................................................................................... 125
6.2.4 Kadcyla (ado-trastuzumab emtansine, T-DM1) ........................................................... 130
6.3 Product Profiles – General Targeted Therapies .............................................................. 134
6.3.1 Afinitor (everolimus) .................................................................................................... 134
6.3.2 Xeloda (capecitabine) .................................................................................................. 138
6.3.3 Avastin (bevacizumab) ................................................................................................ 141
6.3.4 Halaven (eribulin mesylate) ......................................................................................... 144
6.3.5 Abraxane (nab-paclitaxel)............................................................................................ 148
6.3.6 Ixempra (ixabepilone) .................................................................................................. 151
6.4 Hormonal Agents ............................................................................................................ 155
6.4.1 Tamoxifen ................................................................................................................... 155
6.4.2 Faslodex (fulvestrant) .................................................................................................. 155
6.4.3 Aromatase Inhibitors ................................................................................................... 156
7 Unmet Need and Opportunity ................................................................................................. 158
7.1 Overview ......................................................................................................................... 158
7.2 Brain Metastases ............................................................................................................ 159
7.2.1 Unmet Need ................................................................................................................ 159
7.2.2 Gap Analysis ............................................................................................................... 159
7.2.3 Opportunity ................................................................................................................. 161
7.3 Resistance to HER2-Targeting Therapies ....................................................................... 161
7.3.1 Unmet Need ................................................................................................................ 161
7.3.2 Gap Analysis ............................................................................................................... 162
7.3.3 Opportunity ................................................................................................................. 163
8 Pipeline Assessment............................................................................................................... 165
8.1 Overview ......................................................................................................................... 165
8.2 Promising Drugs in Clinical Development ........................................................................ 166
8.2.1 Gilotrif (afatinib) ........................................................................................................... 166
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 15 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
8.2.2 Neratinib ...................................................................................................................... 171
8.3 Promising Drugs in Early-Stage Development................................................................. 175
8.3.1 Palbociclib ................................................................................................................... 177
8.3.2 NeuVax (nelipepimut-S) .............................................................................................. 181
8.3.3 Patritumab ................................................................................................................... 185
8.3.4 Ganetespib .................................................................................................................. 188
8.3.5 ARRY-380 (ONT-380) ................................................................................................. 191
8.3.6 NVP-BYL719 ............................................................................................................... 194
8.4 Biosimilars ...................................................................................................................... 196
9 Current and Future Players ..................................................................................................... 198
9.1 Overview ......................................................................................................................... 198
9.2 Trends in Corporate Strategy .......................................................................................... 201
9.3 Company Profiles ............................................................................................................ 203
9.3.1 Roche/Genentech ....................................................................................................... 203
9.3.2 GlaxoSmithKline .......................................................................................................... 205
9.3.3 Boehringer Ingelheim .................................................................................................. 207
9.3.4 Novartis ....................................................................................................................... 208
9.3.5 Pfizer ........................................................................................................................... 211
10 Market Outlook ....................................................................................................................... 214
10.1 Global Markets ................................................................................................................ 214
10.1.1 Forecast ...................................................................................................................... 214
10.1.2 Drivers and Barriers – Global Issues ........................................................................... 219
10.2 United States .................................................................................................................. 222
10.2.1 Forecast ...................................................................................................................... 222
10.2.2 Key Events .................................................................................................................. 225
10.2.3 Drivers and Barriers .................................................................................................... 225
10.3 France ............................................................................................................................ 228
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 16 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
10.3.1 Forecast ...................................................................................................................... 228
10.3.2 Key Events .................................................................................................................. 231
10.3.3 Drivers and Barriers .................................................................................................... 231
10.4 Germany ......................................................................................................................... 233
10.4.1 Forecast ...................................................................................................................... 233
10.4.2 Key Events .................................................................................................................. 236
10.4.3 Drivers and Barriers .................................................................................................... 236
10.5 Italy ................................................................................................................................. 238
10.5.1 Forecast ...................................................................................................................... 238
10.5.2 Key Events .................................................................................................................. 241
10.5.3 Drivers and Barriers .................................................................................................... 241
10.6 Spain .............................................................................................................................. 243
10.6.1 Forecast ...................................................................................................................... 243
10.6.2 Key Events .................................................................................................................. 246
10.6.3 Drivers and Barriers .................................................................................................... 246
10.7 United Kingdom .............................................................................................................. 248
10.7.1 Forecast ...................................................................................................................... 248
10.7.2 Key Events .................................................................................................................. 251
10.7.3 Drivers and Barriers .................................................................................................... 251
10.8 Japan .............................................................................................................................. 254
10.8.1 Forecast ...................................................................................................................... 254
10.8.2 Key Events .................................................................................................................. 257
10.8.3 Drivers and Barriers .................................................................................................... 257
10.9 China .............................................................................................................................. 259
10.9.1 Forecast ...................................................................................................................... 259
10.9.2 Key Events .................................................................................................................. 262
10.9.3 Drivers and Barriers .................................................................................................... 262
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 17 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
11 Appendix................................................................................................................................. 265
11.1 Bibliography .................................................................................................................... 265
11.2 Abbreviations .................................................................................................................. 295
11.3 Methodology ................................................................................................................... 303
11.4 Forecasting Methodology ................................................................................................ 303
11.4.1 Diagnosed HER2-Positive Breast Cancer Patients ...................................................... 303
11.4.2 Percent Drug-Treated Patients .................................................................................... 304
11.4.3 Drugs Included in Each Therapeutic Class .................................................................. 304
11.4.4 Launch and Patent Expiry Dates ................................................................................. 305
11.4.5 General Pricing Assumptions ...................................................................................... 306
11.4.6 Individual Drug Assumptions ....................................................................................... 307
11.4.7 Generic Erosion .......................................................................................................... 316
11.4.8 Pricing of Pipeline Agents............................................................................................ 316
11.5 Primary Research – KOLs Interviewed for this Report .................................................... 318
11.6 Primary Research – Prescriber Survey ........................................................................... 320
11.7 About the Authors ........................................................................................................... 321
11.7.1 Analyst ........................................................................................................................ 321
11.7.2 Therapy Area Director ................................................................................................. 321
11.7.3 Epidemiologist ............................................................................................................. 322
11.7.4 Acting Director of Epidemiology................................................................................... 322
11.7.5 Global Head of Healthcare .......................................................................................... 323
11.8 About GlobalData ............................................................................................................ 324
11.9 Disclaimer ....................................................................................................................... 324
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 18 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
1.1 List of Tables
Table 1: AJCC Stage Definitions for Breast Cancer ................................................................................... 32
Table 2: Prognosis for Breast Cancer in the US ........................................................................................ 33
Table 3: Selected Major Risk Factors and Comorbidities for Breast Cancer ............................................... 38
Table 4: Breast Cancer Mortality Attributable to Lifestyle-Related Risk Factors.......................................... 42
Table 5: 8MM, Current Status and Plans of Large-Scale Breast Cancer Screening Programs.................... 44
Table 6: 8MM, Relative Survival Rate for Breast Cancer, All Ages*, Women, %, 1991–2004** .................. 51
Table 7: Conversion of Common Staging Systems for Breast Cancer Used in the Forecast ....................... 55
Table 8: 8MM, Sources of the Breast Cancer Diagnosed Incidence Data Used in the Epidemiological
Forecast ...................................................................................................................................... 56
Table 9: 8MM, Diagnosed Incident Cases of Breast Cancer, Ages ≥20 Years, Women, N, 2013–2023 ...... 66
Table 10: 8MM, Diagnosed Incident Cases of Breast Cancer by Age, Women, N (Row %), 2013 ................ 68
Table 11: 8MM, Diagnosed Incident Cases of Breast Cancer by Menopausal Status, Ages ≥20 Years,
Women, N (Row %), 2013 ........................................................................................................... 70
Table 12: 8MM, Diagnosed Incident Cases of Breast Cancer by Stage at Diagnosis, Ages ≥20 Years,
Women, N, 2013 ......................................................................................................................... 71
Table 13: 8MM, Five-Year Diagnosed Prevalent Cases of Breast Cancer, Ages ≥20 Years, Women, N,
2013–2023 .................................................................................................................................. 74
Table 14: 8MM, Five-Year Diagnosed Prevalent Cases of Breast Cancer by Hormone Receptor Subtypes,
Ages ≥20 Years, Women, N, 2013 ............................................................................................... 77
Table 15: Treatment Guidelines for HER2-Positive Breast Cancer .............................................................. 89
Table 16: Product Profile – Herceptin ........................................................................................................ 115
Table 17: Clinical Studies for Herceptin in the Adjuvant Setting ................................................................. 117
Table 18: Herceptin SWOT Analysis, 2013................................................................................................ 119
Table 19: Global Sales Forecast ($m) for Herceptin, 2013–2023 ............................................................... 120
Table 20: Product Profile – Tykerb ............................................................................................................ 122
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 19 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
Table 21: Tykerb SWOT Analysis, 2013 .................................................................................................... 124
Table 22: Global Sales Forecast ($m) for Tykerb, 2013–2023 ................................................................... 125
Table 23: Product Profile – Perjeta ............................................................................................................ 127
Table 24: Perjeta SWOT Analysis, 2013 ................................................................................................... 129
Table 25: Global Sales Forecast ($m) for Perjeta, 2013–2023 ................................................................... 129
Table 26: Product Profile – Kadcyla .......................................................................................................... 131
Table 27: Kadcyla SWOT Analysis, 2013 .................................................................................................. 133
Table 28: Global Sales Forecast ($m) for Kadcyla, 2013–2023 ................................................................. 134
Table 29: Product Profile – Afinitor ............................................................................................................ 136
Table 30: Afinitor SWOT Analysis, 2013.................................................................................................... 137
Table 31: Product Profile – Xeloda ............................................................................................................ 139
Table 32: Xeloda SWOT Analysis, 2013.................................................................................................... 141
Table 33: Product Profile – Avastin ........................................................................................................... 142
Table 34: Summary of Avastin Phase III Clinical Trials in Metastatic Breast Cancer .................................. 143
Table 35: Avastin SWOT Analysis, 2013 ................................................................................................... 144
Table 36: Product Profile – Halaven .......................................................................................................... 145
Table 37: Halaven SWOT Analysis, 2013 .................................................................................................. 147
Table 38: Global Sales Forecast ($m) for Halaven, 2013–2023 ................................................................. 148
Table 39: Product Profile – Abraxane ........................................................................................................ 149
Table 40: Abraxane SWOT Analysis, 2013................................................................................................ 150
Table 41: Global Sales Forecast ($m) for Abraxane, 2013–2023 ............................................................... 151
Table 42: Product Profile – Ixempra .......................................................................................................... 152
Table 43: Ixempra SWOT Analysis, 2013 .................................................................................................. 154
Table 44: Global Sales Forecast ($m) for Ixempra, 2013–2023 ................................................................. 154
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 20 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
Table 45: Summary of Minor Therapeutic Classes Used to Treat HER-2 positive breast cancer, 2013....... 157
Table 46: Unmet Need and Opportunity in HER2-Positive Breast Cancer .................................................. 158
Table 47: Product Profile – Gilotrif ............................................................................................................. 168
Table 48: Gilotrif SWOT Analysis, 2014 .................................................................................................... 170
Table 49: Product Profile – Neratinib ......................................................................................................... 172
Table 50: Neratinib SWOT Analysis, 2013 ................................................................................................ 175
Table 51: Global Sales Forecast ($m) for Neratinib, 2013–2023 ................................................................ 175
Table 52: Comparison of Therapeutic Classes in Development for HER2-Positive/HER2-Negative Breast
Cancer, 2014 ............................................................................................................................ 176
Table 53: HER2-Positive Breast Cancer – Early-Phase Pipeline, 2014 ...................................................... 177
Table 54: Product Profile – Palbociclib ...................................................................................................... 179
Table 55: Palbociclib SWOT Analysis, 2014 .............................................................................................. 181
Table 56: Product Profile – NeuVax .......................................................................................................... 183
Table 57: NeuVax SWOT Analysis, 2014 .................................................................................................. 185
Table 58: Product Profile – Patritumab ...................................................................................................... 186
Table 59: Patritumab SWOT Analysis, 2014.............................................................................................. 188
Table 60: Product Profile – Ganetespib ..................................................................................................... 189
Table 61: Ganetespib SWOT Analysis, 2014 ............................................................................................. 191
Table 62: Product Profile – ARRY-380 ...................................................................................................... 192
Table 63: ARRY-380 SWOT Analysis, 2014 .............................................................................................. 193
Table 64: Product Profile – NVP-BYL719 .................................................................................................. 194
Table 65: NVP-BYL719 SWOT Analysis, 2014 .......................................................................................... 195
Table 66: Trastuzumab Biosimilars, 2014 .................................................................................................. 197
Table 67: Key Companies in the HER2-Positive Breast Cancer Market in the 8MM, 2013–2023 ................ 199
Table 68: Roche’s HER2-Positive Breast Cancer Portfolio Assessment, 2014 ........................................... 204
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 21 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
Table 69: Roche SWOT Analysis, 2014 .................................................................................................... 205
Table 70: GSK’s HER2-Positive Breast Cancer Portfolio Assessment, 2014.............................................. 206
Table 71: GSK SWOT Analysis, 2014 ....................................................................................................... 207
Table 72: BI’s HER2-Positive Breast Cancer Portfolio Assessment, 2014 .................................................. 208
Table 73: BI SWOT Analysis, 2014 ........................................................................................................... 208
Table 74: Novartis’ HER2-Positive Breast Cancer Portfolio Assessment, 2014 .......................................... 210
Table 75: Novartis SWOT Analysis, 2014 .................................................................................................. 210
Table 76: Pfizer’s HER2-Positive Breast Cancer Portfolio Assessment, 2014 ............................................ 212
Table 77: Pfizer SWOT Analysis, 2014 ..................................................................................................... 213
Table 78: Global Sales Forecast ($m) for HER2-Positive Breast Cancer, 2013–2023 ................................ 216
Table 79: Global HER2-Positive Breast Cancer Market – Drivers and Barriers, 2013–2023 ....................... 219
Table 80: Sales Forecast ($m) for HER2-Positive Breast Cancer in the US, 2013–2023 ............................ 223
Table 81: Key Events Impacting Sales for HER2-Positive Breast Cancer in the US, 2013–2023 ................ 225
Table 82: US HER2-Positive Breast Cancer Market – Drivers and Barriers, 2013–2023 ............................ 225
Table 83: Sales Forecast ($m) for HER2-Positive Breast Cancer in France, 2013–2023 ............................ 229
Table 84: Key Events Impacting Sales for HER2-Positive Breast Cancer in France, 2013–2023 ................ 231
Table 85: French HER2-Positive Breast Cancer Market – Drivers and Barriers, 2013–2023 ...................... 231
Table 86: Sales Forecast ($m) for HER2-Positive Breast Cancer in Germany, 2013–2023 ........................ 234
Table 87: Key Events Impacting Sales for HER2-Positive Breast Cancer in Germany, 2013–2023 ............ 236
Table 88: German HER2-Positive Breast Cancer Market – Drivers and Barriers, 2013–2023 .................... 236
Table 89: Sales Forecast ($m) for HER2-Positive Breast Cancer in Italy, 2013–2023 ................................ 239
Table 90: Key Events Impacting Sales for HER2-Positive Breast Cancer in Italy, 2013–2023 .................... 241
Table 91: Italian HER2-Positive Breast Cancer Market – Drivers and Barriers, 2013–2023 ........................ 241
Table 92: Sales Forecast ($m) for HER2-Positive Breast Cancer in Spain, 2013–2023.............................. 244
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 22 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
Table 93: Key Events Impacting Sales for HER2-Positive Breast Cancer in Spain, 2013–2023.................. 246
Table 94: Spanish HER2-Positive Breast Cancer Market – Drivers and Barriers, 2013–2023 .................... 246
Table 95: Sales Forecast ($m) for HER2-Positive Breast Cancer in the UK, 2013–2023 ............................ 249
Table 96: Key Events Impacting Sales for HER2-Positive Breast Cancer in the UK, 2013–2023 ................ 251
Table 97: UK HER2-Positive Breast Cancer Market – Drivers and Barriers, 2013–2023 ............................ 251
Table 98: Sales Forecast ($m) for HER2-Positive Breast Cancer in Japan, 2013–2023 ............................. 255
Table 99: Key Events Impacting Sales for HER2-Positive Breast Cancer in Japan, 2013–2023 ................. 257
Table 100: Japanese HER2-Positive Breast Cancer Market – Drivers and Barriers, 2013–2023 .................. 257
Table 101: Sales Forecast ($m) for HER2-Positive Breast Cancer in China, 2013–2023 ............................. 260
Table 102: Key Events Impacting Sales for HER2-Positive Breast Cancer in China, 2013–2023 ................. 262
Table 103: Chinese HER2-Positive Breast Cancer Market – Drivers and Barriers, 2013–2023 .................... 262
Table 104: HER2-Positive Breast Cancer Incidence, 2013–2023 ................................................................ 304
Table 105: HER2-Positive Breast Cancer Drugs, Key Launch Dates ........................................................... 305
Table 106: HER2-Positive Breast Cancer Drugs, Key Patent Expiries ......................................................... 306
Table 107: Average Body Weight and Surface Area Across the 8MM .......................................................... 307
Table 108: Average Annual Cost of Therapy ($) – Herceptin, Adjuvant........................................................ 309
Table 109: Average Annual Cost of Therapy ($) – Subcutaneous Herceptin, Adjuvant ................................ 310
Table 110: Average Annual Cost of Therapy ($) – Perjeta, First Line ........................................................... 311
Table 111: Average Annual Cost of Therapy ($) – Tykerb, First Line ........................................................... 312
Table 112: Average Annual Cost of Therapy ($) – Kadcyla, Second Line .................................................... 313
Table 113: Average Annual Cost of Therapy ($)– Halaven, Fourth Line....................................................... 313
Table 114: Average Annual Cost of Therapy ($) – Abraxane, Fourth Line ................................................... 314
Table 115: Average Annual Cost of therapy ($) – Ixempra, Fourth Line ....................................................... 315
Table 116: Average Annual Cost of Therapy ($) – Neratinib, Third Line....................................................... 317
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 23 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
Table 117: Physicians Surveyed by Country ............................................................................................... 320
1.2 List of Figures
Figure 1: Basic Breast Anatomy, Including Key Lymph Nodes .................................................................... 30
Figure 2: 8MM, Age-Standardized Incidence Rate of Breast Cancer, Ages ≥15 Years, Women, Cases per
100,000 Population, 2008 ............................................................................................................ 45
Figure 3: 8MM, Incidence Rate of Breast Cancer, Ages ≥15 Years, Women, Rate per 100,000 Population,
2008............................................................................................................................................ 46
Figure 4: US, Incidence Rate of Breast Cancer, All Ages, Women, Cases per 100,000 Population, 1975–
2009............................................................................................................................................ 47
Figure 5: 5EU, Incidence Rate of Breast Cancer, Ages ≥15 Years, Women, Cases per 100,000 Population,
1975–2010 .................................................................................................................................. 49
Figure 6: Japan, Incidence Rate of Breast Cancer, All Ages, Women, Cases per 100,000 Population, 2003–
2008............................................................................................................................................ 50
Figure 7: 8MM, Relative Survival Rate for Breast Cancer, All Ages*, Women, %, 1991–2004** .................. 52
Figure 8: 8MM, Diagnosed Incident Cases of Breast Cancer, Ages ≥20 Years, Women, N, 2013–2023 ...... 66
Figure 9: 8MM, Diagnosed Incident Cases of Breast Cancer, by Age, Women, N, 2013 ............................. 69
Figure 10: 8MM, Diagnosed Incident Cases of Breast Cancer by Menopausal Status, Ages ≥20 Years,
Women, N, 2013 ......................................................................................................................... 70
Figure 11: 8MM, Diagnosed Incident Cases of Breast Cancer by Stage at Diagnosis, Ages ≥20 Years,
Women, N, 2013 ......................................................................................................................... 72
Figure 12: 8MM, Age-Standardized Diagnosed Incidence Rate of Breast Cancer, Ages ≥20 Years, Women,
Cases per 100,000 Population, 2013 ........................................................................................... 73
Figure 13: 8MM, Five-Year Diagnosed Prevalent Cases of Breast Cancer, Ages ≥20 Years, Women, N,
2013–2023 .................................................................................................................................. 75
Figure 14: 8MM, Five-Year Diagnosed Prevalent Cases of Breast Cancer by Menopausal Status, Ages ≥20
Years, Women, N, 2013 .............................................................................................................. 76
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 24 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
Figure 15: 8MM, Five-Year Diagnosed Prevalent Cases of Breast Cancer by Hormone Receptor Subtypes,
Ages ≥20 Years, Women, N, 2013 ............................................................................................... 78
Figure 16: Primary Completion Dates of Active Phase III Clinical Trials for Tykerb ...................................... 121
Figure 17: Active Late-Stage Clinical Trials for Perjeta ............................................................................... 126
Figure 18: Active Phase III Clinical Trials for Kadcyla ................................................................................. 131
Figure 19: Active Phase III Clinical Trials for Afinitor ................................................................................... 135
Figure 20: Clinical Trials for Halaven .......................................................................................................... 145
Figure 21: HER2-Positive Breast Cancer – Phase II–III Pipeline, 2013 ....................................................... 166
Figure 22: Gilotrif’s Clinical Development in Breast Cancer ........................................................................ 167
Figure 23: Clinical and Commercial Positioning of Gilotrif ........................................................................... 170
Figure 24: Neratinib’s Clinical Development ............................................................................................... 172
Figure 25: Clinical and Commercial Positioning of neratinib. ....................................................................... 174
Figure 26: Global Sales ($m) of Branded Products for HER2-Positive Breast Cancer by Company, 2013–2023
................................................................................................................................................. 200
Figure 27: Company Portfolio Gap Analysis in HER2-Positive Breast Cancer, 2013–2023 .......................... 201
Figure 28: Global Sales for HER2-Positive Breast Cancer by Region, 2013–2023 ...................................... 217
Figure 29: Global Sales for HER2-Positive Breast Cancer by Drug Class, 2013–2023 ................................ 218
Figure 30: Sales for HER2-Positive Breast Cancer in the US by Drug Class, 2013–2023............................ 224
Figure 31: Sales for HER2-Positive Breast Cancer in France by Drug Class, 2013–2023 ........................... 230
Figure 32: Sales for HER2-Positive Breast Cancer in Germany by Drug Class, 2013–2023 ........................ 235
Figure 33: Sales for HER2-Positive Breast Cancer in Italy by Drug Class, 2013–2023 ................................ 240
Figure 34: Sales for HER2-Positive Breast Cancer in Spain by Drug Class, 2013–2023 ............................. 245
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 25 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Table of Contents
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
Figure 35: Sales for HER2-Positive Breast Cancer in the UK by Drug Class, 2013–2023............................ 250
Figure 36: Sales for HER2-Positive Breast Cancer in Japan by Drug Class, 2013–2023 ............................. 256
Figure 37: Sales for HER2-Positive Breast Cancer in China by Drug Class, 2013–2023 ............................. 261
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 26 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
Introduction
2 Introduction
2.1 Catalyst
HER2-positive breast cancer is the second most common cancer in the world and the most
common cancer in women worldwide. When diagnosed at a very early stage, the prognosis is
positive, with a five-year survival rate of nearly 100%. However, in the later stages of the disease,
survival rapidly decreases. HER2-positive breast cancer is aggressive, and historically, has had a
worse overall survival (OS) compared with HER2-negative disease, which is considered to be less
aggressive. In 1998, the launch of the first HER2-targeted therapy, Herceptin (trastuzumab),
revolutionized the treatment of the disease, bringing the OS close to that of HER2-negative breast
cancer. The realization that introducing HER2-targeted therapies earlier into the disease
management strategy could improve disease-free survival (DFS) has created a large market for
HER2-directed therapies. Today, HER2-positive breast cancer patients are living longer with their
disease, thanks to established disease management strategies using numerous combinations of
chemotherapy with Herceptin and the tyrosine kinase inhibitor (TKI), Tykerb (lapatinib). During the
forecast period from 2013–2023, GlobalData expects that the HER2-positive market will grow due
to the aging populations in the US, 5EU, Japan, and China.
Furthermore, with the new premium-priced agents, such as Perjeta (pertuzumab) and Kadcyla
(ado-trastuzumab emtansine) becoming established in the early lines of metastatic disease,
physicians will have additional treatment options for patients. More therapies will be used in the
neoadjuvant and adjuvant settings, and several pipeline agents are also being investigated in the
non-metastatic market in this disease. A number of these agents are looking to address the
greatest unmet need for HER2-positive breast cancer patients — brain metastases — which
typically occur in the later lines of metastatic therapy and are caused by increasingly resistant
disease.
2.2 Related Reports
GlobalData (2014). Non-Small Cell Lung Cancer (NSCLC) – Global Drug Forecast and Market
Analysis to 2022 – Event-Driven Update, April 2014, GDHC002EPIDR
GlobalData (2014). Pancreatic Cancer – Opportunity Analysis and Forecasts to 2017, March
2014, GDHC016POA
The realization that introducing HER2-targeted therapies earlier into the disease management strategy could improve disease-free survival (DFS) has created a large market for HER2-directed therapies.
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 27 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
Introduction
GlobalData (2013). Bladder Cancer – Opportunity Analysis and Forecasts to 2017, December
2013, GDHC014POA
2.3 Upcoming Related Reports
GlobalData (Q3 2014). HER2-Negative Breast Cancer – Global Drug Forecast and Market
Analysis to 2023
GlobalData (Q3 2014). Renal Cell Carcinoma – Global Drug Forecast and Market Analysis to
2023
HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2023 324 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
Appendix
HER2-POSITIVE BREAST CANCER – GLOBAL DRUG FORECAST AND MARKET ANALYSIS TO 2023
11.8 About GlobalData
GlobalData is a leading global provider of business intelligence in the healthcare industry.
GlobalData provides its clients with up-to-date information and analysis on the latest developments
in drug research, disease analysis, and clinical research and development. Our integrated business
intelligence solutions include a range of interactive online databases, analytical tools, reports, and
forecasts. Our analysis is supported by a 24/7 client support and analyst team.
GlobalData has offices in New York, San Francisco, Boston, London, India, Korea, Japan,
Singapore, and Australia.
11.9 Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any
form by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior
permission of the publisher, GlobalData.