A Datamonitor Report
Commercial Perspectives:
Multiple Sclerosis
How to Find Opportunities in an Unremitting Market
Published: Jun-04
Product Code: DMHC2015
Providing you with:
• In-depth profiles of current market-leading
brands, including major events impacting
each brand during 2003
• Analysis of potential strategies to help
maximize and protect revenues
• Global sales (US, Japan, France,
Germany, Italy, Spain, UK) for leading
Use this Report to...
multiple sclerosis drugs from 1999 to 2003,
Benchmark pipeline multiple sclerosis
drugs against currently marketed
products and assess their future
market potential
2012
www.datamonitor.com/healthcare
with projections for future performance to
• Analysis of various lifecycle management
strategies, using case studies, and
an evaluation of their future applicability
Commercial Perspectives: Multiple Sclerosis – How to Find Opportunities in an Unremitting Market
DMHC2015
Introduction
The multiple sclerosis market is highly lucrative and
competitive, with only five marketed drugs, worth $2.8
billion in 2003. However, the dynamics of the market will
shift from 2005 onwards with the launch of Antegren
(natalizumab), a novel monthly drug. Beta-interferons will
also face generic threat in Europe, and the launch of oral
multiple sclerosis therapeutics will negatively impact
current injectable drug sales.
Datamonitor forecasts that revenues of currently marketed drugs will peak
at $3.6 billion in 2006 and decline thereafter. Nevertheless, the uptake of newly
launched novel drugs, driven primarily by Antegren, will ensure continued revenue
growth to 2012, even exceeding $6 billion. Therefore, branded manufacturers who
have traditionally maximized their revenues through product differentiation and
innovative lifecycle strategies, including product reformulation and improved
delivery mechanisms, will need to consider more innovative strategies to maintain
and maximize future revenues.
Key findings and highlights
• The multiple sclerosis market has continued to grow, with revenues increasing
by 23.4% in 2003, in a market valued at $2.8 billion. Biogen-IDEC's Avonex
remains market leader, although with the continued, rapid up-take of Rebif in the
US, Avonex’s days at the top are numbered.
• Manufacturers are seeking co-development and marketing agreements to
increase their market share. Consequently, Serono’s multiple sclerosis franchise
is forecast to become a blockbuster in 2006, and remain so over the forecast
period, while the launch of Antegren in 2005 will ensure growth of Biogen-IDEC's
blockbuster franchise to 2012.
• Efficacy remains the primary unmet need of multiple sclerosis treatment. Despite
numerous clinical trials, no drug has been approved for the treatment of primary
progressive MS, the most aggressive form of MS. Moreover, Datamonitor does
not believe any of the currently marketed drugs will gain an indication in this
niche market.
Reasons to buy
• Assess leading multiple sclerosis drugs and identify key success factors within
this sector
• Understand key market drivers and predict the future performance of key
compounds
• Benchmark pipeline multiple sclerosis drugs against currently marketed
products and assess their future market potential
For more information...
Contact Lynda Lynch PhD, CNS Business Unit Director
tel:
+44 20 7675 7159
fax:
+44 20 7576 7016
email:
hcinfo@datamonitor.com
www.datamonitor.com/healthcare
Sample pages from the analysis
MARKET SEGMENTATION &
DEFINITION
Table 5 summarizes the profiles of the current marketed, disease modifying therapies
for MS.
Table 5:
Comparison of marketed MS brands
Brand
Rebif
Avonex
Generic
Interferon
beta 1a
Interferon
beta 1a
Indications
RRMS
RRMS & first
RRMS SPMS
RRMS
attack of MS
(EU), relapsing
(FAMS) (US),
forms of RRMS
RRMS and
and SPMS (US)
CDMS (EU) Continued development
Formulation
22/44mcg s/c
30mcg im There
250mcg
s/c
20mg
12.5, 15ml
are currently
twos/cpipeline10,drugs
in Phase III, which are potential follow-up
injectable
drugs to Copaxone, both of whichinfusion
are administered orally.
Pre-filled
syringe
Yes
Dose
frequency
3 tw
Storage
Room
temperature
Side effects
Betaseron
Copaxone
Novantrone
GLOBALInterferon
MARKET
OVERVIEW
beta Glatiramer
Mitoxantrone
Yes
1b
Yes
acetate
RRMS SPMS
PRMS
of pipeline drugs
Yes
No
Teva is currently developing an oral version of Copaxone, under license from
Autoimmune.
However,
the company
announced disappointing results from
every 2 days
daily in 2001, every
3
months
an interim analysis of its multicenter
CORAL trial,
involving the
oral form of Copaxone
GLOBAL
MARKET
OVERVIEW
Refrigerate in over
Room
Room with RRMS.
RoomTeva is currently conducting additional clinical
1,600 patients
temperature
temperature
temperature
studies with higher doses of oral glatiramer acetate.
1 tw
Flu like symptoms and injection site reactions
Nausea,
alopecia,
Similarly, Aventis is developing an
oral version of teriflunomide, which is currently in
menstrual
Figure
illustrates
the annual
revenues of MS drugs from 1999–2003.
disorders,
UTI 5 entered
discovery for MS. In February 2004,
teriflunomide
Phase
III in Germany.
US launch
2002
1996
EU launch
1998
1997
Japanese
launch
N/A
N/A
Market share 17
2003 (%)
38
1993
1997
2000
5: perform
Annual
class contribution to the MS market growth,
Datamonitor
predicts
products
well comparative
in their respective
1995
2000that if both
N/Athese Figure
Phase
are expected during 1999–2003
2007–08. As such, these
2000III trials, their
N/A launchesN/A
formulations have the propensity to be the first non-injectable MS therapeutics to
Beta-interferons
21 the market, 22
2 huge advantage over current
reach
which will be a
MS drugs and even
other pipeline drugs such as Antegren and Campath,Rebif
which are
expected Betaseron
to receive
Avonex
Copaxone Novantrone
good uptake on launch.
3,000
Source: MIDAS Prescribing Insights, IMS Health, April 2004,
Copyright©, reprinted with permission.
DATAMONITOR
Promotion of Copaxone as both a first- and2,500
second-line treatment
Revenue ($m)
In June 2003, a prospective study demonstrated
that patients who failed with Avonex
2,000
Currently there are five marketed disease
modifying
MS drugs,
the three abetaand switched
to Copaxone
experienced
significant reduction in relapses. In the trial,
interferons Avonex, Rebif and Betaseron,
in addition
Copaxone
85 patients
who hadtofailed
Avonex(glatiramer
treatment after
18–24 months of treatment were
1,500
acetate) and Novantrone (mitoxantrone).switched to Copaxone and followed for 36–42 months. Results demonstrated that
patients experienced a 58% reduction in relapse
after
1,000 the switch, with mean annual
Datamonitor has assessed the five drugs based upon the following criteria: efficacy in
reduction of relapses from 1.13 annually to 0.47 (p = 0.0001)
reducing relapses; side-effect profile; dosing and storage convenience; cost; patient
(www.tevaneuroscience.com).
500
coverage; marketing strength; and overall performance. Drugs were rated upon their
Datamonitor believes that this study is very encouraging
for Teva, because now, in
0
addition to Copaxone’s status as a first-line
therapeutic, Teva
has proven clinical
DMHC2015
1999
2000 data 2001
to which could be used to encourage Page
physicians
to use Copaxone as a second-line
29
N/A
Annual revenue
34.6 not to
43.6
treatment after failure with beta-interferons. However, Teva has to be careful
This report is a licensed product and is not to be photocopied
growth (%)
infer that its product should not be reserved only for second-line treatment.
Nevertheless, Datamonitor believes that with the correct marketing campaign, this
data could be used to help quell the futureSource:
competition
Antegren.
MIDAS from
Prescribing
Insights, IMS Health, April 2004, Copyright©,
Commercial Perspectives: Multiple Sclerosis
2002
2003
25.1
22.6
© Datamonitor (Published 06/2003)
reprinted with permission.
Commercial Perspectives: Multiple Sclerosis
© Datamonitor (Published 06/2003)
DATAMONITOR
As can be observed in Figure 5, the MS market is continually growing, with a mean
annual growth rate of approximately 30% from 1999–2003. Beta-interferon drugs form
the bulk of the market revenues, DMHC2015
attributed to 77% of the market share in 1999 and
Page 93
74% in 2003.
This report is a licensed product and is not to be photocopied
Commercial Perspectives: Multiple Sclerosis
© Datamonitor (Published 06/2003)
DMHC2015
Page 36
This report is a licensed product and is not to be photocopied
“...We cannot assume that the biological mode of action of any of the products would be
inappropriate or a benefit for primary progressive multiple sclerosis...the problem could be
because the drugs don’t work, or that the trials that have been done were incorrectly designed
to show that benefit, or both...”
Datamonitor Key Opinion Leader
Commercial Perspectives: Multiple Sclerosis – How to Find Opportunities in an Unremitting Market
DMHC2015
Table of contents
EXECUTIVE SUMMARY
PORTFOLIO AND LIFECYCLE MANAGEMENT
•
• Portfolio management
Scope of the analysis
• Datamonitor insight into the multiple sclerosis market
-
Market attractiveness
• Positioning of the major MS market players
MARKET SEGMENTATION AND DEFINITION
-
• Strategic scoping and focus
Portfolio analysis
• Lifecycle management
• Market definition
-
MS product lifecycle
• Diagnostic definitions
-
Optimizing peak sales and revenue protection strategies
• Marketed drugs
-
Threatening generic penetration
• The gold standard in MS
-
Comparison of key brands
STRATEGIC PRODUCT POSITIONING
• Physician-focused product positioning
GLOBAL MARKET OVERVIEW
-
• Multiple sclerosis market analysis
Physician definition
• Brand imaging
-
Seven major market forecast
-
Product-specific websites and promotional literature
-
R&D MS drugs
-
Company health information websites
• Rebif
-
Independent MS websites
-
Drug overview
-
Treatment guidelines
-
Rebif strategic analysis
-
The cannabis debate
-
Rebif revenues to date
-
Forecast to 2012
• Pricing and reimbursement
• Avonex
-
Reimbursement
-
Pricing data for key products across the seven major
-
Drug overview
-
Avonex strategic analysis
-
Avonex revenues to date
APPENDIX
-
Forecast to 2012
• Key Opinion Leaders
markets
• Betaseron/Betaferon
• Bibliography
-
Drug overview
-
Betaseron strategic analysis
-
Betaseron revenues to date
• Websites
-
Forecast to 2012
• Report methodology
• Copaxone
-
Conference abstracts
-
Journal articles
-
Date of research completion
-
Drug overview
-
Copaxone strategic analysis
-
About Datamonitor Healthcare
-
Copaxone revenues to date
-
Datamonitor Healthcare's research and analysis
-
Forecast to 2012
• About Datamonitor
methodologies
• Novantrone
• Datamonitor Healthcare's therapy area capabilities
-
Drug overview
-
About the CNS analysis team
-
Novantrone strategic analysis
-
Key therapy team members
-
Novantrone revenues to date
-
Disclaimer
-
Forecast to 2012
• Alfaferone
For more information...
Contact Lynda Lynch PhD, CNS Business Unit Director
tel:
+44 20 7675 7159
fax:
+44 20 7576 7016
email:
hcinfo@datamonitor.com
www.datamonitor.com/healthcare
TABLES
Figure 4:
Comparison of MS brands
Figure 5:
Annual comparative class contribution to the MS
Table 1:
Drug revenues, 2003
Table 2:
Key parameters of the MS market to 2012
Table 3:
Market forecast for currently marketed MS products
Figure 6:
Revenue growth of MS drugs, 1999-2003
to 2012
Figure 7:
MS market forecast, 2003-2012
Table 4:
Classification of MS
Figure 8:
SWOT analysis of Rebif, 2004
Table 5:
Comparison of marketed MS brands
Figure 9:
Rebif revenues and growth, 1999-2003
Table 6:
MS market forecast, 2003-2012
Figure 10:
Rebif forecast, 2004-2012
Table 7:
R&D drugs, 2004
Figure 11:
SWOT analysis of Avonex, 2004
Table 8:
Rebif: key facts
Figure 12:
Avonex revenues and growth, 1999-2003
Table 9:
Key Rebif events, 2003-2004
Figure 13:
Avonex forecast, 2004-2012
Table 10:
Avonex: key facts
Figure 14:
SWOT analysis of Betaseron, 2004
Table 11:
Key Avonex events, 2003-2004
Figure 15:
Betaseron revenues and growth, 1999-2003
Table 12:
Betaseron: key facts
Figure 16:
Betaseron forecast, 2004-2012
Table 13:
Key Betaseron events, 2003-2004
Figure 17:
SWOT analysis of Copaxone, 2003
Table 14:
Copaxone: key facts
Figure 18:
Copaxone revenues and growth, 1999-2003
Table 15:
Key Copaxone events, 2003-2004
Figure 19:
Copaxone forecast, 2004-2012
Table 16:
Novantrone: key facts
Figure 20:
SWOT analysis of Novantrone, 2003
Table 17:
Key Novantrone events, 2003-2004
Figure 21:
US Novantrone revenues and growth, 1999-2003
Table 18:
Total CNS and MS drug performance of the MS
Figure 22:
US Novantrone forecast, 2004-2012
manufacturers, 2003
Figure 23:
Competitive attractiveness of the MS market,
Figure 24:
Comparative attractiveness of beta-interferons
Figure 25:
Positioning of MS drug manufacturer portfolios,
Table 19:
Growth in ethical, CNS and MS drug revenues
for the MS manufacturers, 2002-2003
Table 20:
market growth, 1999-2003
2003-2012
Overview of multiple sclerosis pipeline and key
players' marketed drugs
versus other drug classes, 2003-2012
Table 21:
Biogen-IDEC's MS portfolio to 2012
Table 22:
Serono's MS portfolio to 2012
Figure 26:
Global sales of Betaseron, 1993-2003
Table 23:
Oral formulations in the late-stage MS pipeline,
Figure 27:
Medical professionals diagnosing MS
2004
Figure 28:
Medical professionals treating MS
Table 24:
Future biogeneric threats
Figure 29:
Avonex: strong all week long
Table 25:
Health information websites
Figure 30:
Rebif: promotion of efficacy
Table 26:
Key themes pursued by major MS manufacturers
Figure 31:
Betaseron: BETA nurses
at the AAN, 2004
Figure 32:
Copaxone's leading message
Selected market pricing data for MS drugs
Figure 33:
Novantrone: patient resources
Figure 34:
MultipleSclerosis.com homepage
Figure 35:
MSIF website sponsors
Figure 36:
Pricing strategies in the MS market
Table 27:
FIGURES
Figure 1:
Key drivers in the MS market to 2012
Figure 2:
Types of MS
Figure 3:
Timeline: the launch dates of MS therapies,
2002-2003
1993-2002
“...I think patients will not give up injectable drugs for an oral product that turns out to be less
effective. That will be the first question they ask. But if you can find an equally effective
or more effective oral product, it's going to wipe the other ones off the face of the map...”
Datamonitor Key Opinion Leader
Commercial Perspectives: Multiple Sclerosis – How to Find Opportunities in an Unremitting Market
DMHC2015
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