gdhc1073cfr multiple sclerosis country cut france sample(dmt) for multiple sclerosis (ms) in france...
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Multiple Sclerosis France Drug Forecast and Market Analysis to 2022
GDHC1073CFR / Published March 2013
Executive Summary
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Sales for Multiple Sclerosis in France
GlobalData estimates that disease-modifying therapies
(DMT) for multiple sclerosis (MS) in France generated
$305.3 million in 2012, and that the market will increase
to $357.5 million in 2022 at a CAGR of 1.6%.
Major drivers to the growth of the MS market over the
forecast period will include:
The anticipated launch of efficacious pipeline
products that target the progressive MS subtypes,
which will increase the treatment rates in patients
with primary-progressive MS (PPMS) and secondary-
progressive MS (SPMS).
Launch of oral therapies such as Aubagio and BG-
12, will drive up overall treatment rates, due to their
improved convenience of administration over the
current injectables.
Major barriers to the growth of the MS market will
include:
Government initiatives to increase generic uptake will
accelerate brand erosion of off-patent drugs.
Healthcare cuts will limit pricing and reimbursement
Patent expiries of market-leading branded products
throughout the forecast period, which will significantly
expose sales to generic erosion and will result in
market contraction.
The figure below illustrates the MS DMT sales by drug
class in France during the forecast period.
Sales for Multiple Sclerosis in France by Drug Class, 2012–2022
Source: GlobalData
56.6%
17.3%
5.8%
20.2%
0.1%
IFNβ agentsImmunomodulatory agentsS1P receptor modulatorsS.E.M inhibitorsAnti-CD52 agentsIL-2 receptor modulatorsAnti-CD20 agentsKinase inhibitorsMS vaccinesOther
2012Total: $305.3m
17.2%
19.5%
13.6%10.7%
9.7%
10.9%
12.3%
2.2%
3.9%0.0%
IFNβ agentsImmunomodulatory agentsS1P receptor modulatorsS.E.M inhibitorsAnti-CD52 agentsIL-2 receptor modulatorsAnti-CD20 agentsKinase inhibitorsMS vaccinesOther
2022Total: $357.5m
Executive Summary
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What Do the Physicians Think?
Our experts believe that the most promising DMTs in
the Phase III pipeline are Biogen’s BG-12 and
Roche’s/Genentech’s/Biogen’s ocrelizumab.
“Higher efficacy generally comes with higher risks. The
only drug which has not followed this pattern is BG-12 –
that has a high efficacy, but there haven’t been very
many associated infections. So far, the BG-12 profile has
been quite safe, so I would expect it will come out as a
first-line drug.”
[EU] Key Opinion Leader, November 2012
“I think ocrelizumab will have a big impact. It is
essentially the same drug as rituximab, which we have a
lot of experience with, but is more humanized. Like
rituximab, it looks to be well-tolerated and doesn’t need
to be taken very often because of its long-lasting effect.”
[US] Key Opinion Leader, November 2012
The launch of oral MS DMTs is expected to
progressively diminish the role of the injectable first-
line therapies through the forecast period.
“If we just focus on the interferons and glatiramer acetate
[Copaxone], I would say the main downfall of them is that
they are injectable agents, as a lot of patients don’t like
injecting themselves. Plus, they also have to be
administered quite frequently, so people might find them
quite disruptive. Oral DMTs are highly desired by
patients, as they are much more convenient, and
fortunately, there are several in the pipeline. I expect the
role of the first-line injectable drugs will diminish over
time, as more patients will prefer the oral drugs.”
[US] Key Opinion Leader, November 2012
Physicians interviewed in this report have highlighted
the current challenges in diagnosing MS, which can
negatively impact the treatment of patients.
“I would say the biggest challenge in diagnosing MS is
differential diagnosis. Without a definitive test, ruling out
that your patient may have something else is difficult, and
there are a lot of conditions that share the same features
as MS, like neuromyelitis optica. So, do you wait and
delay starting your patient on treatment while you monitor
progress? Or, do you risk giving the wrong treatment to
your patient? That is the problem we currently face.”
[EU] Key Opinion Leader, November 2012
Key Opinion Leaders (KOLs) interviewed for this
report are in agreement that the proportion of
patients with SPMS will progressively decrease over
time as more efficacious DMTs become available for
patients with RRMS, as well as the earlier initiation of
treatment in patients.
“In the next few years, there will be many strong disease-
modifying drugs that will become available for patients. I
really do expect, and I think we are already starting to
see this trend, is that the overall population of secondary-
progressive patients will drop over time as therapies
become more effective in stopping patients from
progressing to this subtype,”
[US] Key Opinion Leader, November 2012
“As more patients are started on treatment early in MS,
we will see fewer patients with secondary-progressive
MS in the future,”
[EU] Key Opinion Leader, October 2012
Table of Contents
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1 Table of Contents
1 Table of Contents ............................................................................................................... 4
1.1 List of Tables ............................................................................................................... 8
1.2 List of Figures ........................................................................................................... 10
2 Introduction ....................................................................................................................... 11
2.1 Catalyst ..................................................................................................................... 11
2.2 Related Reports ........................................................................................................ 12
2.3 Upcoming Related Reports ........................................................................................ 13
3 Disease Overview ............................................................................................................. 14
3.1 Etiology and Pathophysiology .................................................................................... 14
3.1.1 Etiology ............................................................................................................... 14
3.1.2 Pathophysiology.................................................................................................. 15
3.1.3 Classification of Multiple Sclerosis ....................................................................... 16
3.2 Symptoms ................................................................................................................. 18
3.2.1 Prognosis ............................................................................................................ 19
3.2.2 Quality of Life ...................................................................................................... 20
4 Disease Management ....................................................................................................... 21
4.1 Diagnosis .................................................................................................................. 21
4.2 Treatment Overview .................................................................................................. 24
4.2.1 Management of Acute Relapse ........................................................................... 25
4.2.2 Treatment with Disease-Modifying Therapies ...................................................... 25
4.2.3 Symptomatic Therapies....................................................................................... 28
4.3 France ...................................................................................................................... 29
4.3.1 Diagnosis ............................................................................................................ 29
4.3.2 Clinical Practice .................................................................................................. 29
5 Competitive Assessment ................................................................................................... 31
5.1 Overview ................................................................................................................... 31
5.2 Strategic Competitor Assessment .............................................................................. 32
Table of Contents
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5.3 Product Profiles – Major Brands ................................................................................ 34
5.3.1 Betaseron/Betaferon (interferon beta-1b)............................................................. 34
5.3.2 Avonex (interferon beta-1a) ................................................................................. 39
5.3.3 Rebif (interferon beta-1a) .................................................................................... 44
5.3.4 Copaxone (glatiramer acetate; copolymer-1) ....................................................... 48
5.3.5 Tysabri (natalizumab) .......................................................................................... 52
5.3.6 Gilenya/Imusera (fingolimod; FTY720) ................................................................ 57
5.3.7 Aubagio (teriflunomide) ....................................................................................... 62
5.3.8 Other Disease–Modifying Therapies .................................................................... 67
6 Opportunity and Unmet Need ............................................................................................ 68
6.1 Overview ................................................................................................................... 68
6.2 Unmet Needs ............................................................................................................ 69
6.2.1 Currently Available MS Drugs Only Provide Partial Benefits ................................ 69
6.2.2 The High Cost of MS Drugs Could Continue to Price out Patients ........................ 70
6.2.3 Safety and Tolerability of Therapy is Undermined by Side Effects ........................ 71
6.2.4 Effective Treatments for Progressive MS Are Still Elusive .................................... 72
6.2.5 Inconvenient Route of Administration and Frequent Dosing Limits Compliance .... 73
6.2.6 The Lack of Predictive Biomarkers Delays MS Diagnosis .................................... 74
6.3 Unmet Needs Gap Analysis ....................................................................................... 75
6.4 Opportunities ............................................................................................................. 76
6.4.1 Treatments for Progressive MS ........................................................................... 76
6.4.2 Targeting Patients with Clinically Isolated Syndrome ........................................... 76
7 Pipeline Assessment......................................................................................................... 77
7.1 Overview ................................................................................................................... 77
7.2 Promising Drugs in Clinical Development .................................................................. 79
7.2.1 BG-12 (dimethyl fumarate; BG00012).................................................................. 81
7.2.2 Lemtrada (alemtuzumab) .................................................................................... 86
7.2.3 Laquinimod (ABR-215062) .................................................................................. 92
Table of Contents
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7.2.4 Daclizumab High-Yield Process (HYP) ................................................................ 97
7.2.5 Ocrelizumab (RG1594) ..................................................................................... 102
7.2.6 Siponimod (BAF-312) ........................................................................................ 107
7.2.7 NU-100 (interferon beta-1b) .............................................................................. 111
7.2.8 Masitinib (AB-1010)........................................................................................... 115
7.2.9 Tcelna (imilecleucel-T) ...................................................................................... 119
8 Market Outlook ............................................................................................................... 123
8.1 France .................................................................................................................... 123
8.1.1 Forecast............................................................................................................ 123
8.1.2 Key Events ....................................................................................................... 127
8.1.3 Drivers and Barriers .......................................................................................... 127
9 Appendix ........................................................................................................................ 130
9.1 Bibliography ............................................................................................................ 130
9.2 Abbreviations .......................................................................................................... 141
9.3 Methodology ........................................................................................................... 145
9.4 Forecasting Methodology ........................................................................................ 145
9.4.1 Diagnosed MS patients ..................................................................................... 145
9.4.2 Percent Drug-Treated Patients .......................................................................... 146
9.4.3 Drugs Included in Each Therapeutic Class ........................................................ 146
9.4.4 Launch and Patent Expiry Dates ....................................................................... 147
9.4.5 General Pricing Assumptions ............................................................................ 148
9.4.6 Individual Drug Assumptions ............................................................................. 149
9.4.7 Generic Erosion ................................................................................................ 153
9.4.8 Pricing of Pipeline agents .................................................................................. 153
9.5 Physicians and Specialists Included in This Report .................................................. 154
9.6 Primary Research – Prescriber Survey .................................................................... 155
9.7 About the Authors ................................................................................................... 156
9.7.1 Analysts ............................................................................................................ 156
Table of Contents
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9.7.2 Global Head of Healthcare ................................................................................ 157
9.8 About GlobalData .................................................................................................... 158
9.9 Contact Us .............................................................................................................. 158
9.10 Disclaimer ............................................................................................................... 158
Table of Contents
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1.1 List of Tables
Table 1: Common Presenting Symptoms of Multiple Sclerosis ............................................ 18
Table 2: Factors That Can Affect Prognosis in Multiple Sclerosis ........................................ 19
Table 3: Revised 2010 McDonald Criteria for the Diagnosis of Multiple Sclerosis ................ 22
Table 4: Treatment Guidelines for Multiple Sclerosis .......................................................... 24
Table 5: Top Three Disease-Modifying Therapies Prescribed for Multiple Sclerosis by Market
............................................................................................................................. 26
Table 6: Pharmacotherapy for Common Multiple Sclerosis Symptoms ................................ 28
Table 7: Disease-Modifying Drugs for the Treatment of Multiple Sclerosis, 2012 ................. 33
Table 8: Product Profile – Betaseron .................................................................................. 35
Table 9: Betaseron/Betaferon SWOT Analysis, 2012 .......................................................... 38
Table 10: Product Profile – Avonex ...................................................................................... 40
Table 11: Avonex SWOT Analysis, 2012 .............................................................................. 43
Table 12: Product Profile – Rebif .......................................................................................... 45
Table 13: Rebif SWOT Analysis, 2012 .................................................................................. 47
Table 14: Product Profile – Copaxone .................................................................................. 49
Table 15: Copaxone SWOT Analysis, 2012 .......................................................................... 51
Table 16: Product Profile – Tysabri ....................................................................................... 53
Table 17: Tysabri SWOT Analysis, 2012 .............................................................................. 56
Table 18: Product Profile – Gilenya ...................................................................................... 58
Table 19: Gilenya SWOT Analysis, 2012 .............................................................................. 61
Table 20: Product Profile – Aubagio ..................................................................................... 63
Table 21: Aubagio SWOT Analysis, 2012 ............................................................................. 66
Table 22: Summary of Alternative MS DMTs, 2012............................................................... 67
Table 23: Overall Unmet Needs – Current Level of Attainment ............................................. 68
Table 24: Clinical Unmet Needs – Gap Analysis, 2012 ......................................................... 75
Table 25: Multiple Sclerosis – Phase Pipeline, 2012 ............................................................. 79
Table 26: Comparison of Therapeutic Classes in Development for Multiple Sclerosis, 2012 .. 80
Table 27: Product Profile – BG-12 ........................................................................................ 82
Table of Contents
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Table 28: BG-12 SWOT Analysis, 2012 ................................................................................ 85
Table 29: Product Profile – Lemtrada ................................................................................... 87
Table 30: Lemtrada SWOT Analysis, 2012 ........................................................................... 91
Table 31: Product Profile – Laquinimod ................................................................................ 93
Table 32: Laquinimod SWOT Analysis, 2012 ........................................................................ 96
Table 33: Product Profile – Daclizumab High-Yield Process ................................................. 98
Table 34: Daclizumab SWOT Analysis, 2012...................................................................... 101
Table 35: Product Profile – Ocrelizumab............................................................................. 103
Table 36: Ocrelizumab SWOT Analysis, 2012 .................................................................... 106
Table 37: Product Profile – Siponimod ................................................................................ 107
Table 38: Siponimod SWOT Analysis, 2012 ....................................................................... 110
Table 39: Product Profile – NU-100 .................................................................................... 112
Table 40: NU-100 SWOT Analysis, 2012 ............................................................................ 114
Table 41: Product Profile – Masitinib .................................................................................. 115
Table 42: Masitinib SWOT Analysis, 2012 .......................................................................... 118
Table 43: Product Profile – Tcelna...................................................................................... 120
Table 44: Tcelna SWOT Analysis, 2012 ............................................................................. 122
Table 45: Sales Forecasts ($m) for Multiple Sclerosis in France, 2012–2022 ...................... 125
Table 46: Key Events Impacting Sales for Multiple Sclerosis in France, 2012 ..................... 127
Table 47: Multiple Sclerosis Market in France – Drivers and Barriers, 2012 ....................... 127
Table 48: Key Launch Dates .............................................................................................. 147
Table 49: Key Patent Expiries ............................................................................................ 147
Table 50: Physicians Surveyed, By Country ....................................................................... 155
Table of Contents
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1.2 List of Figures
Figure 1: Accrual of Disability in the Four Subtypes of Multiple Sclerosis.............................. 17
Figure 2: Expanded Disability Status Scale (EDSS) ............................................................. 23
Figure 3: Current Algorithm for the Treatment of MS with Disease-Modifying Therapies ....... 27
Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in Multiple Sclerosis,
2012–2022 ........................................................................................................... 79
Figure 5: Sales for Multiple Sclerosis in France by Drug Class, 2012–2022 ....................... 126
Introduction
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2 Introduction
2.1 Catalyst
The Multiple Sclerosis (MS) therapeutics market is set to enter an exciting phase, with an upsurge
of available treatment options and several promising late-stage pipeline products offering diverse
mechanisms of action. The arrival of novel oral disease-modifying therapies (DMTs) fulfills a
significant unmet need in the treatment of MS by providing patients with a more convenient route of
administration. Novartis’s Gilenya (fingolimod), the first available oral MS drug, and the recently
approved Aubagio (teriflunomide; Sanofi/Genzyme) are threatening the stronghold of the currently
established injectable therapies, including Teva’s Copaxone (glatiramer acetate) and the interferon
beta (IFNβ) agents. However, the safety concerns of Gilenya and the modest efficacy of Aubagio
are key stumbling blocks in their attempts to make a significant impact in the rapidly growing MS
market.
The current MS pipeline is very robust, with numerous promising DMTs set to enter the market
within the forecast period. Biogen Idec’s BG-12 (dimethyl fumarate) demonstrated an impressive
efficacy and safety profile in clinical trials prior to its expected launch in 2013, and anticipation is
high that it could become the next mega-blockbuster oral treatment for MS. In addition, agents
such as Sanofi/Genzyme’s Lemtrada (alemtuzumab) will provide stiff competition for Biogen’s
Tysabri (natalizumab) and challenge its position as the escalating therapy of choice when first-line
treatment options have failed. With the market becoming increasingly competitive, the established
players are investing heavily to bolster their MS portfolios and are entering into key collaborations
with innovative biotech companies. The most recent is Merck (EMD) Serono’s agreement with
Opexa Therapeutics for the development and commercialization of Tcelna (imilecleucel-T), a novel
first-in-class MS vaccine that is making important strides through the phases of clinical
development.
There are several drivers for growth in the MS market. Initiating early DMT treatment in patients
with clinically isolated syndrome (CIS) will delay the onset of clinically-definite MS and increase the
overall treated patient population. However, the challenges of the MS industry include an
increasingly crowded marketplace, making it more difficult for drugs to distinguish themselves,
whereas a natural conservatism among neurologists will also delay the uptake of new drugs trying
to gain market entry. Furthermore, the impending patent expiry of current leading DMTs, such as
Copaxone, will pave the way for the entry of generics and biosimilars, forcing pharmaceutical
companies to derive alternative strategies to offset potential losses in sales.
Introduction
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2.2 Related Reports
GlobalData (2013). Multiple Sclerosis – US Drug Forecast and Market Analysis to 2022.
GDHC1072CFR
GlobalData (2013). Multiple Sclerosis – Germany Drug Forecast and Market Analysis to 2022.
GDHC1074CFR
GlobalData (2013). Multiple Sclerosis – Italy Drug Forecast and Market Analysis to 2022.
GDHC1075CFR
GlobalData (2013). Multiple Sclerosis – Spain Drug Forecast and Market Analysis to 2022.
GDHC1076CFR
GlobalData (2013). Multiple Sclerosis – UK Drug Forecast and Market Analysis to 2022.
GDHC1077CFR
GlobalData (2013). Multiple Sclerosis – Japan Drug Forecast and Market Analysis to 2022.
GDHC1078CFR
GlobalData (2013). Multiple Sclerosis – India Drug Forecast and Market Analysis to 2022.
GDHC1079CFR
GlobalData (2013). Multiple Sclerosis – China Drug Forecast and Market Analysis to 2022.
GDHC1080CFR
GlobalData (2013). Multiple Sclerosis – Canada Drug Forecast and Market Analysis to 2022.
GDHC1081CFR
GlobalData (2013). Betaseron/Betaferon (Multiple Sclerosis) –Forecast and Market Analysis to
2022. GDHC1112DFR
GlobalData (2013). Avonex (Multiple Sclerosis) –Forecast and Market Analysis to 2022.
GDHC1113DFR
GlobalData (2013). Copaxone (Multiple Sclerosis) –Forecast and Market Analysis to 2022.
GDHC1114DFR
GlobalData (2013). Rebif (Multiple Sclerosis) –Forecast and Market Analysis to 2022.
GDHC1115DFR
GlobalData (2013). Tysabri (Multiple Sclerosis) –Forecast and Market Analysis to 2022.
GDHC1116DFR
Introduction
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GlobalData (2013). Gilenya/Imusera (Multiple Sclerosis) –Forecast and Market Analysis to
2022. GDHC1117DFR
GlobalData (2013). Aubagio (Multiple Sclerosis) –Forecast and Market Analysis to 2022.
GDHC1118DFR
GlobalData (2013). BG-12 (Multiple Sclerosis) –Forecast and Market Analysis to 2022.
GDHC1119DFR
GlobalData (2013). Lemtrada (Multiple Sclerosis) –Forecast and Market Analysis to 2022.
GDHC1120DFR
GlobalData (2013). Laquinimod (Multiple Sclerosis) –Forecast and Market Analysis to 2022.
GDHC1121DFR
GlobalData (2013). Ocrelizumab (Multiple Sclerosis) –Forecast and Market Analysis to 2022.
GDHC1122DFR
GlobalData (2013). Daclizumab (Multiple Sclerosis) –Forecast and Market Analysis to 2022.
GDHC1123DFR
GlobalData (2013). Masitinib (Multiple Sclerosis) –Forecast and Market Analysis to 2022.
GDHC1124DFR
GlobalData (2013). Siponimod (Multiple Sclerosis) –Forecast and Market Analysis to 2022.
GDHC1125DFR
GlobalData (2013). NU-100 (Multiple Sclerosis) –Forecast and Market Analysis to 2022.
GDHC1126DFR
GlobalData (2013). Tcelna (Multiple Sclerosis) –Forecast and Market Analysis to 2022.
GDHC1127DFR
GlobalData (2013). Multiple Sclerosis – Current and Future Players. GDHC1009FPR
Appendix
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9.8 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, Boston, London, India, and Singapore.
9.10 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.