A Datamonitor Report

Commercial Insight: Cancer Market

Top 20 Drugs
Supportive Care Grows the Cancer Market
Published: Jan-05 Product Code: DMHC2050

Providing you with:

Overview of current cancer market,
including profiles of the leading 20 brands
by sales in 2004 and key events impacting
each brand during 2004-2014

Use this Report to...

Understand market-specific drivers
and predict the future performance
of key compounds

Assessment of current and future

opportunities and threats in the cancer
sector across the seven major
pharmaceutical markets
Individual country sales for leading
products, with projections for future
performance up to 2014
Detailed discussion of assumptions
and events used in forecast analysis

www.datamonitor.com/healthcare

Commercial Insight: Cancer Market Top 20 Drugs Supportive Care Grows the Cancer Market
DMHC2050

Introduction

The global cancer market is predicted to grow at a CAGR

exceeding 10%. However, a number of global and
country-specific factors will support or threaten this trend
including epidemiological, regulatory, legislative and
pharmacoeconomic influences. Companies can mitigate
the ensuing commercial risk through innovative strategies
in lifecycle management and sustained R&D productivity.
Strategies to allay the challenge of patent expiry, generic incursion and therapeutic
competition will rely on innovative approaches to lifecycle management and
sustained R&D productivity to maintain a commercially attractive product pipeline.
This is well evidenced in the cytotoxic market where more reformulated
second-generation 'supergeneric' drugs are expected to be launched from 2005.
The higher returns achievable from the sales of improved generics should allow
companies to make a higher up-front investment in product development,
commercialization and marketing.

Key findings and highlights

The oncology market is the third largest pharmaceutical market, behind the
cardiovascular and CNS therapy areas, and is currently experiencing strong
growth. Worth an estimated $40 billion in 2004, Datamonitor projects the sector
to grow to $53 billion by 2008, yielding a compound annual growth rate (CAGR)
greater than 10% over this period.
In 2004, the top 20 cancer drugs in each of the seven major pharmaceutical
markets generated combined sales exceeding $27 billion, with the US
accounting for 66% of this total, Japan 13% and the five EU countries 21%
(Midas, IMS Health, April 2004). Collective sales in these markets represent
approximately 77% of global oncology revenues.
Over the next ten years, Datamonitor predicts that of the cancer drugs that
currently hold a top 20 position in one or more of the seven markets, only those
in the innovative and supportive care classes will maintain a positive CAGR.
Conversely, cytotoxics and antihormonals will experience declining sales.

Reasons to buy
Understand market-specific drivers and predict the future performance of key
compounds
Quantify the impact of key patent expiries
Adopt knowledge to drive strategic planning for the lifecycle management
of mature products and to optimize the market penetration of new entrants

For more information...

Contact Richard Faint, Oncology Business Unit Director
tel:

+44 20 7675 7295

fax:

+44 20 7675 7016

email:

hcinfo@datamonitor.com

www.datamonitor.com/healthcare

Sample pages from the analysis

Commercial Impact and Lifecycle

Management: Case Studies

CHAPTER 5 COMMERCIAL IMPACT

MANAGEMENT: CASE STUDIES

AND

LIFECYCLE

Case studies

Forecast Analysis
AstraZeneca - Market retention through patent expiry management, maturing
brand loyalty and recognized disease expertise
Early market entry

Erbitux (cetuximab)

Developed
by ImClone
andhormone-dependent
marketed by BMS in the US and Merck KGaA in Europe,
AstraZeneca (AZ) has a strong foothold
in the field
of treating
Erbitux (cetuximab)
a chimerized
monoclonal
malignancies and has maintained a particularly
prominentisrole
in the breast
cancer antibody that targets the epidermal
growth factor
receptor
(EGFR).
currently FDA and EU approved for use in
market dating back to its launch of Nolvadex
(tamoxifen)
in 1973.
TheErbitux
drugs is
first-tocombination
with enabled
irinotecan
in irinotecan-refractory
colorectal cancer patients or as
market status and robust, evidenced-based
efficacy
Nolvadex
to rapidly
monotherapy
in recurrent
metastatic
colorectal cancer for patients intolerant of
establish itself as a blockbuster therapy,
becoming
the mainstay
anti-estrogen
irinotecan-based
treatment for early- and late-stage breast
cancer. Inchemotherapy.
addition, inCountry
1998 Nolvadex
Market Assessments
became the first and only antihormonal to garner FDA approval for the prevention of
indications such as NSCLC, head and neck, and pancreatic
breast cancer in women at high risk of Although
developingadditional
the disease.
cancer could significantly add to the total sales of Erbitux from 2006 onwards, there
are a number of threats that could dampen the sales growth of the drug. Healthcare
Attempting to mitigate the impact of Nolvadex patent expiry
Figuremeans
3:
Global
oncology
sales
growth,
cost pressure in the seven major markets
that
Erbituxs
benefits
may
not 200309
justifyin its
at least
in the
European patents for Tamoxifen expired
thehigh
midcost,
1980s,
though
the US
USwhere
patentthe drug costs approximately $10,000
peratmonth,
thereby
limiting its
sales growth.
remained in place until 2002. Further,
this time
AZ obtained
a six-month
US Furthermore, there are competitive
from Abgenixs
a fully humanized EGFR monoclonal antibody, and
pediatric exclusivity extension for thethreats
treatment
of femalesABX-EGF,
with McCune-Albright
other signalhormonal
transduction
that could depress
70,000 the growth of Erbitux.
syndrome, a rare hereditary disease influencing
andinhibitors
sexual development.

Sales ($ millions)

By the time of full patent expiration in February 2003, generic erosion of Nolvadex
60,000
Erbitux is in a Phase I trial in Japan; as a result,
Datamonitor does not expect the
revenues had already commenced. However, AZ had been able to proactively and
drug to be launched in the market before 2010.
pragmatically manage the US patent expiry through the establishment of 50,000
a
confidential settlement with Barr in 1993, following the latters challenge of AZs
40,000
patent protection. Under the terms of Glivec
this agreement
AZ, or Zeneca as it was then
(imatinib)
trading, supplied Barr with tamoxifen for re-sale as a generic at a discount of 15%
30,000
Developed and marketed by Novartis Pharmaceuticals, Datamonitor considers the
less than the price of Nolvadex.
commercialization of Glivec as archetypal among
20,000MTTs. Initially approved for the
In 2002, the US market for Nolvadex and
generic
tamoxifen
was
worth
approximately
treatment of chronic myeloid leukemia (CML), Glivec targets the hyper-functioning
10,000
$500m and by the first quarter of 2003Bcr-Abl
generictyrosine
tamoxifen
salesthat
had characterizes
overtaken those
kinase
this
malignancy. Further, the drug has
of Nolvadex. In 2003, AZ reported Nolvadex
sales of
$178m,
down 63% from
2002 disease (GIST), a consequence of its
demonstrable
activity
in gastrointestinal
stromal
0
(IMS Health, April 2004). However, as activity
alreadyagainst
described,
the relationshipC-kit
between
AZ kinase.
the over-amplified
tyrosine
2002 2003 2004 2005 2006 2007 2008 2009
and Barr somewhat mitigated the formers loss in Nolvadex revenues. However,
The drug garnered global sales of $757m in the first half of 2004 (Novartis
Commercial Insight: Cancer Market Top 20 Drugs Pharmaceuticals) and while Datamonitor
DMHC2050
Source:
nitor PharmaVitae,
2004in the relatively
DATAMONITOR
feelsDatamo
that market
penetration
Datamonitor (Published 12/2004)
rare malignancies of CML and GIST isPage
close63to saturation, recent data on alternate
This report is a licensed product and is not to be photocopied
dosing schedules and potential future indications has the capacity to drive further
revenue generation. Specifically, data
High presented
unmet needat the American Society of
Hematology (ASH) conference in December 2004 (Abstract #999: Cortes J et al.,
High-dose imatinib mesylate treatment
in patients
untreated
early research for many years, successful
Although
cancerwith
haspreviously
been the focus
of intensive
chronic phase chronic myeloid leukemia)
intimated of
thatthe
patients
withespecially
CML receiving
management
disease,
for advanced tumors, is limited. Surgery
800mg of Glivec were more likely to attain
complete
cytogenetic
responses
remains
the single
treatment
optioncompared
most likely to lead to long-term survival for
to the standard dose of 400mg. The patients
drug hasdiagnosed
also recently
activity inwith pharmacotherapy often providing
withdemonstrated
early-stage disease,
Kaposis sarcoma (Koon et al., 2004)
illness responses
believed to
be
only an
briefAIDS-defining
and unpredictable
in those
patients whose disease is more
advanced at diagnosis. Because the majority of patients presenting to physicians fall
Commercial Insight: Cancer Market Top 20 Drugs into this latter category, there is a tremendous
DMHC2050 unmet need for treatments that can
Datamonitor (Published 12/2004)
52 quality of life. Datamonitor believes
provide durable clinical responses and Page
improve
This report is a licensed product and is not to be photocopied
that this high unmet need is likely to result in the continued favorable pricing of

oncology therapies.
The era of molecular-targeted treatment (MTT)
Historically, the approaches to identifying new cancer treatments have been relatively
unsophisticated, relying on crude measures of cancer cell growth or inhibition in
animals and test tubes. With the emergence of new technologies and an increased
understanding of the molecular basis for cancer evolution, the molecular changes that
Commercial Insight: Cancer Market Top 20 Drugs
Datamonitor (Published 12/2004)

DMHC2050
Page 18

This report is a licensed product and is not to be photocopied

...Lifecycle management strategies and approaches to realizing

vertical and horizontal product expansion will play a prominent role
in maximizing revenues and ensuring an adequate return
for the financial risks incurred in developing new drugs...
Datamonitor Senior Oncology Analyst

Commercial Insight: Cancer Market Top 20 Drugs Supportive Care Grows the Cancer Market
DMHC2050

Table of contents
EXECUTIVE SUMMARY

- Threats

Biennial price cuts

Regulatory processes stifling growth
EU5: opportunities and threats
Opportunities
Parallel importation
Threats
France: opportunities and threats
Opportunities
'Accord Cadre' raises novel drug prices
and accelerates time to market
Threats
Germany: opportunities and threats
Opportunities
Threats
Italy: opportunities and threats
Opportunities
Threats
Spain: opportunities and threats
Threats
UK: opportunities and threats
Opportunities
Threats
-

MARKET DEFINITION AND OVERVIEW

Scope
Market definition for this report
- Cytotoxics
L1A Alkylating agents
L1B Antimetabolites
L1C Vinca alkaloids and other plant products
L1D Antineoplastic antibiotics
L1X Other cytotoxics
- Antihormonals
L2A3 Luteinizing hormone-releasing hormones
(LHRH) agonists
L2B2 Anti-androgens
L2B1 Anti-estrogens
L2B3 Aromatase inhibitors
- Immunostimulating agents
L3A1 Colony-stimulating factors
- Anti-emetics
A4A1 Serotonin antagonists anti-emetics
- Anti-anemic preparations
B3C0 Erythropoietin products
COUNTRY MARKET ASSESSMENTS
Current and future opportunities and threats
in the cancer market
- Global opportunities and threats
Opportunities
Threats
- US: opportunities and threats
Opportunities
Threats
- Japan: opportunities and threats
Opportunities
Aging patient population
Slow introduction of generic products
Lack of approved agents in Japan represents
an opportunity

FORECAST ANALYSIS
Cytotoxics
- Taxotere (docetaxel)
- Paraplatin (carboplatin)
- Eloxatin (oxaliplatin)
- Gemzar (gemcitabine)
- Taxol (paclitaxel)
- Campto/Camptosar (irinotecan)
- Temodar/Temodal (temozolomide)
- Farmorubicin/Ellence (epirubicin)
- Xeloda (capecitabine)
- UFT (tegafur-uracil)
Antihormonals
- Lupron (leuprorelin)
- Zoladex (goserelin)

For more information...

Contact Richard Faint, Oncology Business Unit Director
tel:

+44 20 7675 7295

fax:

+44 20 7675 7016

email:

hcinfo@datamonitor.com

www.datamonitor.com/healthcare

- Arimidex (anastrozole)
- Casodex (bicalutamide)
- Femara (letrozole)
- Molecular-targeted agents
- Iressa (gefitinib)
- Avastin (bevacizumab)
- Erbitux (cetuximab)
- Glivec (imatinib)

Monoclonal antibodies
- MabThera/Rituxan (rituximab)
- Herceptin (trastuzumab)
Anti-emetics
- Kytril (granisetron) and Zofran (ondansetron)
Growth factors
- Neupogen (filgrastim)
- Neulasta (pegylated filgrastim)
- Epogen (epoetin alfa)
- Erypo/Procrit (epoetin alfa)
- Recormon/Epogin (epoetin beta)
- Aranesp (darbopoetin)
Forecasts

COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT

Case studies
- AstraZeneca Market retention through patent expiry
management, maturing brand loyalty and recognized
disease expertise
- Amgen Protection of Epogen from biogeneric
and therapeutic competition through rigorous patent
protection and the development of enhanced
next-generation formulations

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Gemzar: key facts

Taxol: key facts
Camptosar: key facts
Temodar: key facts
Farmorubicin: key facts
Xeloda: key facts
UFT: Key facts
Lupron: key facts
Zoladex: key facts
Arimidex: key facts
Casodex: key facts
Femara: key facts
Iressa: key facts
Avastin: key facts
Erbitux: key facts
Glivec: key facts
Rituxan: key facts
Herceptin: key facts
Kytril: key facts
Zofran: key facts
Neupogen: key facts
Neulasta: key facts
Epogen: key facts
Procrit: key facts
Recormon: key facts
Aranesp: key facts

FIGURES
Figure 1: World population aged 60 and over, 1950-2050
Figure 2: Increasing combined incidence for breast, lung,
prostate and colorectal cancer with increasing
age
Figure 3: Global oncology sales growth, 2003-2009

APPENDIX
TABLES
Table 1:
Table
Table
Table
Table

2:
3:
4:
5:

Summary of current generic substitution policies

in the EU5
Patent expiration of selected top 20 cancer drugs
Taxotere: key facts
Paraplatin: key facts
Eloxatin: key facts

...Players in the biotechnology industry can succeed in effectively managing

product lifecycles and maintain market domination by rigorously defending patents
and exploiting the absence of a biogeneric approval pathway in the US...
Datamonitor Senior Oncology Analyst

Commercial Insight: Cancer Market Top 20 Drugs Supportive Care Grows the Cancer Market
DMHC2050

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