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Transcript of Global Drug Forecast and Market Analysis to 2022 Event ... · Global Drug Forecast and Market...
Multiple Sclerosis Global Drug Forecast and Market Analysis to 2022 Event-Driven Update
GDHC34PIDR / Published April 2013
Executive Summary
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 2 GDHC34PIDR / Published APR 2013
The table below presents the key metrics for multiple
sclerosis (MS) in the seven major pharmaceutical
markets.
Multiple Sclerosis: Key Metrics in the Seven Major Pharmaceutical Markets
2012 Epidemiology
Diagnosed Prevalence Population – 7MM 0.68 million
Diagnosed Prevalence Population – Global 0.84 million
2012 Market Sales
US $8.10bn
5EU $2.49bn
Japan $0.13bn
Total 7MM $10.72bn
Total Global* $12.60bn
Pipeline Assessment
Number of drugs in Phase II–III 45
Number of first-in-class drugs in late-stage pipeline 6
Most Promising Pipeline Drugs 2022 Sales
Tecfidera (dimethyl fumarate [Biogen Idec.]) $3.87bn
Ocrelizumab (RG1594 [Roche/Genentech/Biogen]) $1.31bn
Daclizumab (Abbott/Biogen) $1.11bn
Lemtrada (alemtuzumab [Sanofi/Genzyme/Bayer]) $0.81bn
Siponimod (BAF-312 [Novartis]) $0.83bn
Key events (2012–2022) Level of Impact
Avonex patent expiry in Europe in 2012 ↓↓↓
Global launch of Tecfidera in 2013
Copaxone patent expiry in the US in 2014 ↓↓↓
Launch of ocrelizumab in the US in 2016
Gilenya patent expiry/loss of data exclusivity in the US in 2017 ↓↓↓
2022 Market Sales
US $9.69bn
5EU $3.41bn
Japan $0.12bn
Total 7MM $13.22bn
Total Global* $15.73bn
7 MM = US, France, Germany, Italy, Spain, UK, Japan; 5EU = France, Germany, Italy, Spain, UK *For the purposes of this report, Global = US, France, Germany, Italy, Spain, UK, Japan, Canada, China, India Source: GlobalData
Continuous Growth in the Multiple Sclerosis Market is Expected from 2012–2022
GlobalData estimates the 2012 disease-modifying
therapy (DMT) sales for multiple sclerosis to be
approximately $12.6 billion across the 10 markets
covered in this forecast: US, France, Germany, Italy,
Spain, UK, Japan, Canada, China, and India. By the end
of the forecast period, sales will grow to $15.73 billion,
with a Compound Annual Growth Rate (CAGR) of 2.25%.
The majority of sales will come from the US, which
represents more than 60% of the market, especially as
financial austerity measures remain a primary barrier to
growth in other countries.
Major drivers to the growth of the MS market over the
forecast period will include:
The launch of efficacious pipeline products with
convenient oral formulations or less frequent dosing,
in addition to DMTs that target the progressive MS
subtypes, which are expected to demand higher
prices than conventional therapies
The push by the physician base for the swift
diagnosis of the disease, and the earlier initiation of
therapy in patients with clinically isolated syndrome
(CIS) and early MS will drive up overall treatment
rates
Increasing access to MS pharmacotherapies in the
key emerging markets of India and China
Executive Summary
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Major barriers to the growth of the MS market will
include:
Patent expiries of market-leading branded products
throughout the forecast period will significantly
expose sales to generic erosion and will result in
market contraction.
Increased pressure for cost-effectiveness will result
in reimbursement challenges and price cuts, while
governments undergoing financial austerity
measures are likely to promote the use of generic
drugs over branded products.
The increasingly crowded MS marketplace will make
it more difficult for newer DMTs to differentiate
themselves from the established agents and achieve
significant individual patient share.
The figure below illustrates the global MS sales for the
seven major markets (US, 5EU, Japan), Canada, China,
and India during the forecast period.
Global Sales for Multiple Sclerosis by Region, 2012–2022
64.3%
19.8%
1.1%
14.8%0.1%
US5EUJapanCanadaChina and India
2012Total: $12.6 bn
61.6%
21.7%
0.8%
15.8%0.1%
US5EUJapanCanadaChina and India
2022Total: $15.7 bn
Source: GlobalData
Executive Summary
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 4 GDHC34PIDR / Published APR 2013
Established Players are Investing Heavily to Maintain Their Presence in the Increasingly Competitive MS Market
The MS market has historically been dominated by four
players: Biogen Idec, Merck Serono (EMD Serono in the
US), Teva, and Bayer HealthCare. These companies
have been the leading competitors globally since 1993,
beginning with the successful launch of Bayer’s
Betaseron/Betaferon (interferon beta-1b), followed soon
after by Biogen’s Avonex (interferon beta-1a), Teva’s
Copaxone (glatiramer acetate), and Merck’s Rebif
(interferon beta-1a). These established first-line therapies
have shaped the treatment paradigm and now generate
the majority of global sales. However, the MS market has
become increasingly competitive with the emergence of
oral therapies, several pipeline products with notable
efficacies, and looming biosimilars following the patent
expiries of key branded products. Therefore, the
established players are due to face major challenges in
maintaining their position in the MS marketplace,
especially as new challengers enter the competitive
landscape.
In an attempt to gain market share, companies are
generally looking to expand the coverage of their current
products to increase the treated-patient population, and
are targeting alternative disease subtypes where the
competition is less fierce. For example, Biogen is
investigating Tysabri (natalizumab) for the treatment of
secondary-progressive multiple sclerosis (SPMS), while
Novartis’ Gilenya (fingolimod) is being evaluated for
primary-progressive multiple sclerosis (PPMS). Another
common strategy is to seek approval or brand extensions
based on combination therapies. Sanofi’s/Genzyme’s
Aubagio (teriflunomide) and Teva’s/Active Biotech’s
laquinimod are already being evaluated as possible
adjuvant therapies, which if successful, would allow these
drugs to generate uptake, even if more efficacious
treatment options are available.
Other corporate trends include entering partnerships in a
bid for companies to broaden their pipeline portfolio or to
build important experience in target markets. Of particular
strategic importance is the recent collaborative
agreement between Merck and Opexa Therapeutics for
the development and commercialization of Tcelna
(imilecleucel-T), a novel first-in-class MS vaccine. In
addition, Teva’s acquisition of Taiyo Pharmaceutical
Industry in 2011 will boost the company’s presence in
Japan, with significant opportunity for Teva to extend its
MS franchise in the region. Companies that have had no
historical involvement in the MS market have also formed
collaborations with established players to gain a vital
foothold: for example, Sanofi’s previous partnership with
Teva for the distribution of Copaxone, and
Roche/Genentech’s collaboration with Biogen in the
development of its late-stage product, ocrelizumab.
The figure below provides an analysis of the company
portfolio gap in MS for the forecast period.
Company Portfolio Gap Analysis in Multiple Sclerosis, 2012–2022
Source: GlobalData Current Players: Currently marketed products and no products in Phase III Current and Future Players: Marketed products and products in Phase III Future Players: No marketed products but products in Phase III
Executive Summary
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 5 GDHC34PIDR / Published APR 2013
The MS Market is Still Littered with Unmet Needs
While the last two decades have brought many important
advances in the management of MS with the FDA
approval of nine DMTs, there still remain significant
unmet needs in the market. There are no curative
therapies for MS, and most existing DMTs are only
partially effective in preventing relapses, with limited
impact on the accrual of disability. There are also
insufficient options for patients with progressive forms of
MS. The current use of escalation therapy with drugs like
Tysabri can provide an improved efficacy over the
standard first-line treatments, but they are associated
with a higher risk of serious side effects. While Gilenya
and the recently approved Aubagio and Tecfidera
(dimethyl fumarate; Biogen Idec) offer added
convenience with their oral formulations, the established
first-line treatments are injectables, which can hinder
patient adherence.
The unmet needs that remain drive the research for
better MS DMTs. Several oral pipeline products that
target the need for more convenient routes of
administration will emerge onto the market by mid-
forecast or even earlier, including Tecfidera, which was
recently launched in the US, and laquinimod. These
agents will compete with Gilenya and Aubagio for patient
share. Other agents, such as ocrelizumab, aim to provide
high efficacy for patients who require escalation therapy,
but do not carry the risk of progressive multifocal
leukoencephalopathy (PML) that is associated with
Tysabri use.
A Crowded Relapsing-Remitting MS Market Leaves Opportunities to Target Progressive MS Patient Populations
Most of the late-stage pipeline products due to emerge
during the forecast period are geared towards treating
patients with relapsing-remitting multiple sclerosis
(RRMS), which leaves the population of patients with
SPMS or PPMS largely devoid of treatment options in
comparison. Therefore, while the RRMS market is
becoming overcrowded, competition for market share in
the progressive MS segment is considerably less fierce,
even with the anticipated arrival of agents such as
Novartis’ siponimod (BAF-312) for these subtypes by
late-forecast.
In addition, the conventional MS DMTs, including those in
the pipeline, are mainly directed at the inflammatory and
systemic origins of the disease, but have largely
insufficient impact on the underlying neuro - deterioration
process. DMTs that have strong neuroprotective
properties and can halt the progression of the disease
are still very much elusive. This is a prime need, which if
addressed, will greatly impact the market both from a
clinical and commercial prospective.
Such a drug will achieve unparalleled success not only in
the treatment of progressive MS, but also in the early
stages of the disease.
Executive Summary
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Newer Drugs Dominate the Pipeline with Improved Efficacy and More Convenient Administration
The anticipated emergence of several promising pipeline
DMTs will threaten the stronghold of the established MS
therapies. Current research and development (R&D)
efforts will deliver newer pharmaceuticals touting
improved efficacy in reducing the risk of relapses or
delaying the accumulation of permanent disability, novel
mechanisms of action, and more convenient
administration through oral formulations or infrequent
dosing.
Tecfidera, which received Food and Drug
Administration (FDA) approval on March 27, 2013, is
hotly anticipated to be the next mega-blockbuster
treatment for MS, owing to its first-in-class
mechanism of action, attractive oral route of
administration, and strong efficacy and safety data in
clinical trials, which will position the drug as a first-
line therapy. Tecfidera will provide the stiffest
competition to the conventional first-line injectable
DMTs and is expected to overtake Copaxone’s
position as the best-selling MS drug, with predicted
global sales reaching $3.2 billion by 2019.
The launch of ocrelizumab in mid-forecast will
threaten the sales of Tysabri as the current treatment
of choice for escalation therapy. Ocrelizumab will
achieve strong market penetration due to its low-
frequency dosing, lack of established risk of
developing PML, and similarities to Rituxan
(rituximab), a drug commonly prescribed off label for
MS. Given its strong product characteristics,
GlobalData projects global ocrelizumab end-of-
forecast sales of $1.3 billion in 2022, narrowly edging
out Lemtrada (alemtuzumab; Sanofi/Genzyme/Bayer)
and daclizumab (Abbott/Biogen), which are also
strong candidates for escalation therapy.
In the progressive MS market, siponimod is projected
to generate the highest sales within the forecast
period, given its likely premium pricing, oral
formulation, and promising results from previous
clinical trials, thus outcompeting masitinib (AB1010;
AB Science), while Tcelna arrives late onto the
market. As a “me-too” product, siponimod has a
higher specificity with regard to mechanism of action
than Gilenya, with the potential for improved safety
without sacrificing efficacy. GlobalData predicts
global end-of-forecast sales of $830m for siponimod
in 2022.
The figure below provides a competitive assessment of
the late-stage pipeline agents in development for MS for
the forecast period.
Competitive Assessment of Late-Stage Pipeline Agents in Multiple Sclerosis, 2012–2022
Source: GlobalData
Executive Summary
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What Do the Physicians Think?
Our experts believe that the most promising DMTs
are Biogen’s Tecfidera, which was recently launched
in the US, 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
[Tecfidera] – that has a high efficacy, but there haven’t
been very many associated infections. So far, the BG-12
[Tecfidera] 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
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 8 GDHC34PIDR / Published APR 2013
1 Table of Contents
1 Table of Contents ............................................................................................................... 8
1.1 List of Tables ............................................................................................................. 16
1.2 List of Figures ........................................................................................................... 21
2 Introduction ....................................................................................................................... 23
2.1 Catalyst ..................................................................................................................... 23
2.2 Upcoming Related Reports ........................................................................................ 24
3 Disease Overview ............................................................................................................. 25
3.1 Etiology and Pathophysiology .................................................................................... 25
3.1.1 Etiology ............................................................................................................... 25
3.1.2 Pathophysiology.................................................................................................. 26
3.1.3 Classification of Multiple Sclerosis ....................................................................... 27
3.2 Symptoms ................................................................................................................. 29
3.2.1 Prognosis ............................................................................................................ 30
3.2.2 Quality of Life ...................................................................................................... 31
4 Epidemiology .................................................................................................................... 32
4.1 Risk Factors .............................................................................................................. 32
4.1.1 Family members of MS patients have a 1–5% risk of developing MS ................... 32
4.1.2 Women are twice as likely to develop MS, but men have a worse prognosis ........ 32
4.1.3 Caucasians have a higher risk of MS than any other race/ethnicity ...................... 33
4.1.4 Protective effect of vitamin D on MS may relate to latitude and month of birth ...... 33
4.1.5 Timing of environmental exposures affects MS risk ............................................. 34
4.1.6 Exposure to smoking may increase MS risk and worsen prognosis...................... 34
4.2 Comorbidities ............................................................................................................ 35
4.2.1 Autoimmune diseases may be comorbidities of MS ............................................. 35
4.2.2 Mental comorbidities are found in up to 60% of MS patients and may affect
relapse rates ...................................................................................................... 36
4.3 Global Trends ........................................................................................................... 37
4.3.1 North America ..................................................................................................... 37
Table of Contents
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4.3.2 Europe ................................................................................................................ 38
4.3.3 Asia .................................................................................................................... 38
4.4 Forecast Methodology ............................................................................................... 39
4.4.1 Sources Used ..................................................................................................... 41
4.4.2 Forecast Assumptions and Methods .................................................................... 47
4.4.3 Sources Not Used ............................................................................................... 56
4.5 Epidemiology Forecast for Multiple Sclerosis ............................................................. 57
4.5.1 Total Prevalent Cases of Multiple Sclerosis ......................................................... 57
4.5.2 Age-Specific Prevalent Cases of Multiple Sclerosis ............................................. 59
4.5.3 Gender-Specific Prevalent Cases of Multiple Sclerosis ........................................ 61
4.5.4 Total Incident Cases of Multiple Sclerosis............................................................ 63
4.5.5 Age-Specific Incident Cases of Multiple Sclerosis ................................................ 65
4.5.6 Gender-Specific Incident Cases of Multiple Sclerosis .......................................... 67
4.5.7 Multiple Sclerosis Subtypes ................................................................................. 69
4.6 Discussion................................................................................................................. 70
4.6.1 Conclusions on Epidemiological Trends .............................................................. 70
4.6.2 Limitations of the Analysis ................................................................................... 71
4.6.3 Strengths of the Analysis ..................................................................................... 71
5 Disease Management ....................................................................................................... 72
5.1 Diagnosis .................................................................................................................. 72
5.2 Treatment Overview .................................................................................................. 75
5.2.1 Management of Acute Relapse ........................................................................... 76
5.2.2 Treatment with Disease-Modifying Therapies ...................................................... 76
5.2.3 Symptomatic Therapies....................................................................................... 79
5.3 US ........................................................................................................................... 80
5.3.1 Diagnosis ............................................................................................................ 80
5.3.2 Clinical Practice .................................................................................................. 80
5.4 France ...................................................................................................................... 82
Table of Contents
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5.4.1 Diagnosis ............................................................................................................ 82
5.4.2 Clinical Practice .................................................................................................. 82
5.5 Germany ................................................................................................................... 84
5.5.1 Diagnosis ............................................................................................................ 84
5.5.2 Clinical Practice .................................................................................................. 84
5.6 Italy ........................................................................................................................... 86
5.6.1 Diagnosis ............................................................................................................ 86
5.6.2 Clinical Practice .................................................................................................. 86
5.7 Spain ........................................................................................................................ 88
5.7.1 Diagnosis ............................................................................................................ 88
5.7.2 Clinical Practice .................................................................................................. 88
5.8 UK ........................................................................................................................... 90
5.8.1 Diagnosis ............................................................................................................ 90
5.8.2 Clinical Practice .................................................................................................. 90
5.9 Japan ........................................................................................................................ 92
5.9.1 Diagnosis ............................................................................................................ 92
5.9.2 Clinical Practice .................................................................................................. 92
5.10 Canada ..................................................................................................................... 93
5.10.1 Diagnosis ............................................................................................................ 93
5.10.2 Clinical Practice .................................................................................................. 93
5.11 China ........................................................................................................................ 94
5.11.1 Diagnosis ............................................................................................................ 94
5.11.2 Clinical Practice .................................................................................................. 94
5.12 India .......................................................................................................................... 96
5.12.1 Diagnosis ............................................................................................................ 96
5.12.2 Clinical Practice .................................................................................................. 96
6 Competitive Assessment ................................................................................................... 98
6.1 Overview ................................................................................................................... 98
Table of Contents
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6.2 Strategic Competitor Assessment .............................................................................. 99
6.3 Product Profiles – Major Brands .............................................................................. 101
6.3.1 Betaseron/Betaferon (interferon beta-1b)........................................................... 101
6.3.2 Avonex (interferon beta-1a) ............................................................................... 107
6.3.3 Rebif (interferon beta-1a) .................................................................................. 113
6.3.4 Copaxone (glatiramer acetate; copolymer-1) ..................................................... 118
6.3.5 Tysabri (natalizumab) ........................................................................................ 124
6.3.6 Gilenya/Imusera (fingolimod; FTY720) .............................................................. 130
6.3.7 Aubagio (teriflunomide) ..................................................................................... 136
6.3.8 Other Disease–Modifying Therapies .................................................................. 142
7 Opportunity and Unmet Need .......................................................................................... 143
7.1 Overview ................................................................................................................. 143
7.2 Unmet Needs .......................................................................................................... 144
7.2.1 Currently Available MS Drugs Only Provide Partial Benefits .............................. 144
7.2.2 The High Cost of MS Drugs Could Continue to Price out Patients ...................... 145
7.2.3 Safety and Tolerability of Therapy is Undermined by Side Effects ...................... 146
7.2.4 Effective Treatments for Progressive MS Are Still Elusive .................................. 147
7.2.5 Inconvenient Route of Administration and Frequent Dosing Limits Compliance .. 148
7.2.6 The Lack of Predictive Biomarkers Delays MS Diagnosis .................................. 149
7.3 Unmet Needs Gap Analysis ..................................................................................... 150
7.4 Opportunities ........................................................................................................... 152
7.4.1 Treatments for Progressive MS ......................................................................... 152
7.4.2 Targeting Patients with Clinically Isolated Syndrome ......................................... 152
8 Pipeline Assessment....................................................................................................... 153
8.1 Overview ................................................................................................................. 153
8.2 Clinical Trial Mapping .............................................................................................. 155
8.2.1 Clinical Trials by Country ................................................................................... 155
8.3 Clinical Trials by Phase and Trial Status .................................................................. 156
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8.4 Promising Drugs in Clinical Development ................................................................ 157
8.4.1 Tecfidera (dimethyl fumarate) ............................................................................ 159
8.4.2 Lemtrada (alemtuzumab) .................................................................................. 165
8.4.3 Laquinimod (ABR-215062) ................................................................................ 172
8.4.4 Daclizumab High-Yield Process (HYP) .............................................................. 179
8.4.5 Ocrelizumab (RG1594) ..................................................................................... 185
8.4.6 Siponimod (BAF-312) ........................................................................................ 191
8.4.7 NU-100 (interferon beta-1b) .............................................................................. 197
8.4.8 Masitinib (AB-1010)........................................................................................... 202
8.4.9 Tcelna (imilecleucel-T) ...................................................................................... 207
9 Current and Future Players ............................................................................................. 212
9.1 Overview ................................................................................................................. 212
9.2 Trends in Corporate Strategy................................................................................... 214
9.3 Company Profiles .................................................................................................... 216
9.3.1 Biogen Idec ....................................................................................................... 216
9.3.2 Teva Pharmaceutical Industries ........................................................................ 219
9.3.3 Merck Serono (EMD Serono) ............................................................................ 222
9.3.4 Sanofi ............................................................................................................... 225
9.3.5 Bayer HealthCare Pharmaceuticals ................................................................... 228
9.3.6 Novartis International ........................................................................................ 230
9.3.7 Hoffmann-La Roche .......................................................................................... 233
9.3.8 GlaxoSmithKline ............................................................................................... 235
10 Market Outlook ............................................................................................................... 237
10.1 Global Markets ........................................................................................................ 237
10.1.1 Forecast............................................................................................................ 237
10.1.2 Drivers and Barriers – Global Issues ................................................................. 240
10.2 United States .......................................................................................................... 244
10.2.1 Forecast............................................................................................................ 244
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10.2.2 Key Events ....................................................................................................... 248
10.2.3 Drivers and Barriers .......................................................................................... 248
10.3 France .................................................................................................................... 251
10.3.1 Forecast............................................................................................................ 251
10.3.2 Key Events ....................................................................................................... 255
10.3.3 Drivers and Barriers .......................................................................................... 255
10.4 Germany ................................................................................................................. 258
10.4.1 Forecast............................................................................................................ 258
10.4.2 Key Events ....................................................................................................... 262
10.4.3 Drivers and Barriers .......................................................................................... 262
10.5 Italy ......................................................................................................................... 265
10.5.1 Forecast............................................................................................................ 265
10.5.2 Key Events ....................................................................................................... 268
10.5.3 Drivers and Barriers .......................................................................................... 268
10.6 Spain ...................................................................................................................... 271
10.6.1 Forecast............................................................................................................ 271
10.6.2 Key Events ....................................................................................................... 275
10.6.3 Drivers and Barriers .......................................................................................... 275
10.7 United Kingdom ....................................................................................................... 277
10.7.1 Forecast............................................................................................................ 277
10.7.2 Key Events ....................................................................................................... 281
10.7.3 Drivers and Barriers .......................................................................................... 281
10.8 Japan ...................................................................................................................... 284
10.8.1 Forecast............................................................................................................ 284
10.8.2 Key Events ....................................................................................................... 287
10.8.3 Drivers and Barriers .......................................................................................... 287
10.9 Canada ................................................................................................................... 289
10.9.1 Forecast............................................................................................................ 289
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10.9.2 Key Events ....................................................................................................... 293
10.9.3 Drivers and Barriers .......................................................................................... 293
10.10 China ................................................................................................................ 295
10.10.1 Forecast .......................................................................................................... 295
10.10.2 Key Events ...................................................................................................... 298
10.10.3 Drivers and Barriers ......................................................................................... 299
10.11 India.................................................................................................................. 301
10.11.1 Forecast .......................................................................................................... 301
10.11.2 Key Events ...................................................................................................... 303
10.11.3 Drivers and Barriers ......................................................................................... 304
11 Appendix ........................................................................................................................ 306
11.1 Bibliography ............................................................................................................ 306
11.2 Abbreviations .......................................................................................................... 324
11.3 Methodology ........................................................................................................... 328
11.4 Forecasting Methodology ........................................................................................ 328
11.4.1 Diagnosed MS patients ..................................................................................... 328
11.4.2 Percent Drug-Treated Patients .......................................................................... 329
11.4.3 Drugs Included in Each Therapeutic Class ........................................................ 329
11.4.4 Launch and Patent Expiry Dates ....................................................................... 330
11.4.5 General Pricing Assumptions ............................................................................ 331
11.4.6 Individual Drug Assumptions ............................................................................. 332
11.4.7 Generic Erosion ................................................................................................ 336
11.4.8 Pricing of Pipeline agents .................................................................................. 336
11.5 Physicians and Specialists Included in This Report .................................................. 338
11.6 Primary Research – Prescriber Survey .................................................................... 339
11.7 About the Authors ................................................................................................... 340
11.7.1 Analysts ............................................................................................................ 340
11.7.2 Epidemiologists ................................................................................................. 341
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11.7.3 Global Head of Healthcare ................................................................................ 341
11.8 About GlobalData .................................................................................................... 342
11.9 Contact Us .............................................................................................................. 342
11.10 Disclaimer ......................................................................................................... 342
Table of Contents
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1.1 List of Tables
Table 1: Common Presenting Symptoms of Multiple Sclerosis .......................................... 29
Table 2: Factors That Can Affect Prognosis in Multiple Sclerosis ...................................... 30
Table 3: Sources of Prevalence and Incidence Data Used in the Epidemiology Forecast ......
........................................................................................................................... 40
Table 4: 10 Markets, Prevalent Cases of Multiple Sclerosis, Ages ≥20, Male and Female, N,
Select ................................................................................................................. 58
Table 5: 10 Markets, Prevalent Cases of Multiple Sclerosis, By Age*, Male and Female, N
(Row %), 2012 .................................................................................................... 59
Table 6: 10 Major Markets, Prevalent Cases of Multiple Sclerosis, Ages ≥20, By Gender, N
(Row %), 2012 .................................................................................................... 61
Table 7: 10 Markets, Incident Cases of Multiple Sclerosis, Ages ≥20, Male and Female, N,
Select Years, 2012–2022 .................................................................................... 64
Table 8: 10 Markets, Incident Cases of Multiple Sclerosis, By Age*, Male and Female, N
(Row %), 2012 .................................................................................................... 65
Table 9: 10 Major Markets, Incident Cases of Multiple Sclerosis, By Gender, N (Row %),
2012 ................................................................................................................... 67
Table 10: Revised 2010 McDonald Criteria for the Diagnosis of Multiple Sclerosis .............. 73
Table 11: Treatment Guidelines for Multiple Sclerosis ......................................................... 75
Table 12: Top Three Disease-Modifying Therapies Prescribed for Multiple Sclerosis by
Market ................................................................................................................ 77
Table 13: Pharmacotherapy for Common Multiple Sclerosis Symptoms .............................. 79
Table 14: Disease-Modifying Drugs for the Treatment of Multiple Sclerosis, 2012 ............. 100
Table 15: Product Profile – Betaseron ............................................................................... 102
Table 16: Betaseron/Betaferon SWOT Analysis, 2012 ...................................................... 105
Table 17: Global Sales Forecasts ($m) for Betaseron/Betaferon, 2012–2022 .................... 106
Table 18: Product Profile – Avonex ................................................................................... 108
Table 19: Avonex SWOT Analysis, 2012........................................................................... 111
Table 20: Global Sales Forecasts ($m) for Avonex, 2012–2022 ........................................ 112
Table 21: Product Profile – Rebif ...................................................................................... 114
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Table 22: Rebif SWOT Analysis, 2012 .............................................................................. 116
Table 23: Global Sales Forecasts ($m) for Rebif, 2012–2022 ............................................ 117
Table 24: Product Profile – Copaxone ............................................................................... 119
Table 25: Copaxone SWOT Analysis, 2012 ...................................................................... 122
Table 26: Global Sales Forecasts ($m) for Copaxone, 2012–2022 .................................... 123
Table 27: Product Profile – Tysabri ................................................................................... 125
Table 28: Tysabri SWOT Analysis, 2012 ........................................................................... 128
Table 29: Global Sales Forecasts ($m) for Tysabri, 2012–2022 ........................................ 129
Table 30: Product Profile – Gilenya ................................................................................... 131
Table 31: Gilenya SWOT Analysis, 2012 .......................................................................... 134
Table 32: Global Sales Forecasts ($m) for Gilenya/Imusera, 2012–2022 .......................... 135
Table 33: Product Profile – Aubagio .................................................................................. 137
Table 34: Aubagio SWOT Analysis, 2012 ......................................................................... 140
Table 35: Global Sales Forecasts ($m) for Aubagio, 2012–2022 ....................................... 141
Table 36: Summary of Alternative MS DMTs, 2012 ........................................................... 142
Table 37: Overall Unmet Needs – Current Level of Attainment .......................................... 143
Table 38: Clinical Unmet Needs – Gap Analysis, 2012 ...................................................... 151
Table 39: Multiple Sclerosis – Clinical Trials by Phase and Status, 2012 ........................... 156
Table 40: Multiple Sclerosis – Phase IIb/III Pipeline, 2012 ................................................. 157
Table 41: Comparison of Therapeutic Classes in Development for Multiple Sclerosis, 2012
......................................................................................................................... 158
Table 42: Product Profile – Tecfidera ................................................................................ 160
Table 43: Tecfidera SWOT Analysis, 2012 ........................................................................ 163
Table 44: Global Sales Forecasts ($m) for Tecfidera, 2012–2022 ..................................... 164
Table 45: Product Profile – Lemtrada ................................................................................ 166
Table 46: Lemtrada SWOT Analysis, 2012 ....................................................................... 170
Table 47: Global Sales Forecasts ($m) for Lemtrada, 2012–2022 ..................................... 171
Table 48: Product Profile – Laquinimod ............................................................................ 173
Table 49: Laquinimod SWOT Analysis, 2012 .................................................................... 177
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Table 50: Global Sales Forecasts ($m) for Laquinimod, 2012–2022 .................................. 178
Table 51: Product Profile – Daclizumab High-Yield Process .............................................. 180
Table 52: Daclizumab SWOT Analysis, 2012 .................................................................... 183
Table 53: Global Sales Forecasts ($m) for Daclizumab, 2012–2022 .................................. 184
Table 54: Product Profile – Ocrelizumab ........................................................................... 186
Table 55: Ocrelizumab SWOT Analysis, 2012 ................................................................... 189
Table 56: Global Sales Forecasts ($m) for Ocrelizumab, 2012–2022 ................................ 190
Table 57: Product Profile – Siponimod .............................................................................. 192
Table 58: Siponimod SWOT Analysis, 2012 ...................................................................... 195
Table 59: Global Sales Forecasts ($m) for Siponimod, 2012–2022 ................................... 196
Table 60: Product Profile – NU-100 .................................................................................. 198
Table 61: NU-100 SWOT Analysis, 2012 .......................................................................... 200
Table 62: Global Sales Forecasts ($m) for NU-100, 2012–2022 ........................................ 201
Table 63: Product Profile – Masitinib ................................................................................. 202
Table 64: Masitinib SWOT Analysis, 2012 ........................................................................ 205
Table 65: Global Sales Forecasts ($m) for Masitinib, 2012–2022 ...................................... 206
Table 66: Product Profile – Tcelna .................................................................................... 208
Table 67: Tcelna SWOT Analysis, 2012 ............................................................................ 210
Table 68: Global Sales Forecasts ($m) for Tcelna, 2012–2022 ......................................... 211
Table 69: Key Companies in the Multiple Sclerosis Market, 2012 ...................................... 213
Table 70: Biogen’s Multiple Sclerosis Portfolio Assessment, 2012..................................... 217
Table 71: Biogen SWOT Analysis, 2012 ........................................................................... 218
Table 72: Teva’s Multiple Sclerosis Portfolio Assessment, 2012 ........................................ 220
Table 73: Teva SWOT Analysis, 2012 .............................................................................. 221
Table 74: Merck’s Multiple Sclerosis Portfolio Assessment, 2012 ...................................... 223
Table 75: Merck SWOT Analysis, 2012 ............................................................................. 224
Table 76: Sanofi’s Multiple Sclerosis Portfolio Assessment, 2012 ..................................... 226
Table 77: Sanofi SWOT Analysis, 2012 ............................................................................ 227
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Table 78: Bayer’s Multiple Sclerosis Portfolio Assessment, 2012 ...................................... 229
Table 79: Bayer SWOT Analysis, 2012 ............................................................................. 229
Table 80: Novartis’ Multiple Sclerosis Portfolio Assessment, 2012 .................................... 231
Table 81: Novartis SWOT Analysis, 2012 ......................................................................... 232
Table 82: Roche’s Multiple Sclerosis Portfolio Assessment, 2012 ..................................... 234
Table 83: Roche SWOT Analysis, 2012 ............................................................................ 234
Table 84: GlaxoSmithKiline’s Multiple Sclerosis Portfolio Assessment, 2012 ..................... 236
Table 85: GlaxoSmithKline SWOT Analysis, 2012 ............................................................ 236
Table 86: Global Sales Forecasts ($m) for Multiple Sclerosis, 2012–2022 ......................... 238
Table 87: Global Multiple Sclerosis Market – Drivers and Barriers, 2012 ........................... 240
Table 88: Sales Forecasts ($m) for Multiple Sclerosis in the United States, 2012–2022 .... 246
Table 89: Key Events Impacting Sales for Multiple Sclerosis the United States, 2012........ 248
Table 90: Multiple Sclerosis Market in the United States – Drivers and Barriers, 2012 ....... 248
Table 91: Sales Forecasts ($m) for Multiple Sclerosis in France, 2012–2022 .................... 253
Table 92: Key Events Impacting Sales for Multiple Sclerosis in France, 2012 .................... 255
Table 93: Multiple Sclerosis Market in France – Drivers and Barriers, 2012 ....................... 255
Table 94: Sales Forecasts ($m) for Multiple Sclerosis in Germany, 2012–2022 ................. 260
Table 95: Key Events Impacting Sales for Multiple Sclerosis in Germany, 2012 ................ 262
Table 96: Multiple Sclerosis Market in Germany – Drivers and Barriers, 2012 ................... 262
Table 97: Sales Forecasts ($m) for Multiple Sclerosis in Italy, 2012–2022 ......................... 266
Table 98: Key Events Impacting Sales for Multiple Sclerosis in Italy, 2012 ........................ 268
Table 99: Multiple Sclerosis Market in Italy – Drivers and Barriers, 2012 ........................... 268
Table 100: Sales Forecasts ($m) for Multiple Sclerosis in Spain, 2012–2022 ...................... 273
Table 101: Key Events Impacting Sales for Multiple Sclerosis in Spain, 2012 ...................... 275
Table 102: Multiple Sclerosis Market in Spain – Drivers and Barriers, 2012......................... 275
Table 103: Sales Forecasts ($m) for Multiple Sclerosis in the United Kingdom, 2012–2022 .......
......................................................................................................................... 279
Table 104: Key Events Impacting Sales for Multiple Sclerosis in the United Kingdom, 2012 ......
......................................................................................................................... 281
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Table 105: Multiple Sclerosis Market in the United Kingdom – Drivers and Barriers, 2012 .........
......................................................................................................................... 281
Table 106: Sales Forecasts ($m) for Multiple Sclerosis in Japan, 2012–2022 ...................... 285
Table 107: Key Events Impacting Sales for Multiple Sclerosis in Japan, 2012 ..................... 287
Table 108: Multiple Sclerosis Market in Japan – Drivers and Barriers, 2012 ........................ 287
Table 109: Sales Forecasts ($m) for Multiple Sclerosis in Canada, 2012–2022 ................... 291
Table 110: Key Events Impacting Sales for Multiple Sclerosis in Canada, 2012 .................. 293
Table 111: Multiple Sclerosis Market in Canada – Drivers and Barriers, 2012 ..................... 293
Table 112: Sales Forecasts ($m) for Multiple Sclerosis in China, 2012–2022 ...................... 296
Table 113: Key Events Impacting Sales for Multiple Sclerosis in China, 2012...................... 298
Table 114: Multiple Sclerosis Market in China – Drivers and Barriers, 2012 ........................ 299
Table 115: Sales Forecasts ($m) for Multiple Sclerosis in India, 2012–2022 ........................ 302
Table 116: Key Events Impacting Sales for Multiple Sclerosis in India, 2012 ....................... 303
Table 117: Multiple Sclerosis Market in India – Drivers and Barriers, 2012 .......................... 304
Table 118: Key Launch Dates ............................................................................................. 330
Table 119: Key Patent Expiries ........................................................................................... 330
Table 120: Physicians Surveyed, By Country ...................................................................... 339
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1.2 List of Figures
Figure 1: Accrual of Disability in the Four Subtypes of Multiple Sclerosis ............................ 28
Figure 2: 10 Markets, Prevalent Cases of Multiple Sclerosis, Ages ≥20, Male and Female, N,
Select ................................................................................................................. 58
Figure 3: 10 Markets, Prevalent Cases of Multiple Sclerosis, By Age*, Male and Female, N,
2012 ................................................................................................................... 60
Figure 4: 10 Markets, Prevalent Cases of Multiple Sclerosis, Ages ≥20, By Gender, N, 2012 .
........................................................................................................................... 62
Figure 5: 10 Markets, Incident Cases of Multiple Sclerosis, Ages ≥20, Male and Female, N,
Select Years, 2012–2022 .................................................................................... 64
Figure 6: 10 Markets, Incident Cases of Multiple Sclerosis, By Age*, Male and Female, N,
2012 ................................................................................................................... 66
Figure 7: 10 Markets, Incident Cases of Multiple Sclerosis, By Gender, N, 2012 ................ 68
Figure 8: 10 Markets, Multiple Sclerosis Subtypes in Prevalent Cases, %*, 2012–2022 ...... 69
Figure 9: Expanded Disability Status Scale (EDSS) ........................................................... 74
Figure 10: Current Algorithm for the Treatment of MS with Disease-Modifying Therapies ..... 78
Figure 11: Multiple Sclerosis Therapeutics – Clinical Trials by Country, 2012 ..................... 155
Figure 12: Competitive Assessment of Late-Stage Pipeline Agents in Multiple Sclerosis,
2012–2022 ........................................................................................................ 157
Figure 13: Company Portfolio Gap Analysis in Multiple Sclerosis, 2012–2022 .................... 215
Figure 14: Global Market Sales for Multiple Sclerosis by Region, 2012–2022 ..................... 239
Figure 15: Sales for Multiple Sclerosis in the United States by Drug Class, 2012–2012 ...... 247
Figure 16: Sales for Multiple Sclerosis in France by Drug Class, 2012–2012 ...................... 254
Figure 17: Sales for Multiple Sclerosis in Germany by Drug Class, 2012–2012 .................. 261
Figure 18: Sales for Multiple Sclerosis in Italy by Drug Class, 2012–2012 .......................... 267
Figure 19: Sales for Multiple Sclerosis in Spain by Drug Class, 2012–2012 ........................ 274
Figure 20: Sales for Multiple Sclerosis in the United Kingdom by Drug Class, 2012-2012 .........
......................................................................................................................... 280
Figure 21: Sales for Multiple Sclerosis in Japan by Drug Class, 2012-2012 ........................ 286
Figure 22: Sales for Multiple Sclerosis in Canada by Drug Class, 2012-2012 ..................... 292
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Figure 23: Sales for Multiple Sclerosis in China by Drug Class, 2012-2012 ........................ 297
Figure 24: Sales for Multiple Sclerosis in India by Drug Class, 2012-2012 .......................... 303
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 Tecfidera (dimethyl fumarate; formerly BG-12)
demonstrated an impressive efficacy and safety profile in clinical trials prior to its recent approval
by the Food and Drug Administration (FDA) on March 27, 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 Upcoming Related Reports
GlobalData (2013). PharmaPoint: Migraine – Global Drug Forecast and Market Analysis to
2022, May, 2013.
GlobalData (2013). PharmaPoint: Fibromyalgia – Global Drug Forecast and Market Analysis to
2022, July, 2013.
GlobalData (2013). PharmaPoint: Neuropathic Pain – Global Drug Forecast and Market
Analysis to 2022, July, 2013.
Appendix
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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, Boston, London, India, and Singapore.
11.10 Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system or transmitted in any
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permission of the publisher, GlobalData.