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Multiple Sclerosis Global Drug Forecast and Market Analysis to 2022 Event-Driven Update

GDHC34PIDR / Published April 2013

Executive Summary

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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


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


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


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


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


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.”


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,”


“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


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


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


5.4.1 Diagnosis ............................................................................................................ 82


5.5 Germany ................................................................................................................... 84

5.5.1 Diagnosis ............................................................................................................ 84


5.6 Italy ........................................................................................................................... 86

5.6.1 Diagnosis ............................................................................................................ 86


5.7 Spain ........................................................................................................................ 88

5.7.1 Diagnosis ............................................................................................................ 88


5.8 UK ........................................................................................................................... 90

5.8.1 Diagnosis ............................................................................................................ 90


5.9 Japan ........................................................................................................................ 92

5.9.1 Diagnosis ............................................................................................................ 92


5.10 Canada ..................................................................................................................... 93

5.10.1 Diagnosis ............................................................................................................ 93


5.11 China ........................................................................................................................ 94

5.11.1 Diagnosis ............................................................................................................ 94


5.12 India .......................................................................................................................... 96

5.12.1 Diagnosis ............................................................................................................ 96


6 Competitive Assessment ................................................................................................... 98

6.1 Overview ................................................................................................................... 98

Table of Contents


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

Table of Contents


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

Table of Contents


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


10.4 Germany ................................................................................................................. 258

10.4.1 Forecast............................................................................................................ 258

10.4.2 Key Events ....................................................................................................... 262


10.5 Italy ......................................................................................................................... 265

10.5.1 Forecast............................................................................................................ 265

10.5.2 Key Events ....................................................................................................... 268


10.6 Spain ...................................................................................................................... 271

10.6.1 Forecast............................................................................................................ 271

10.6.2 Key Events ....................................................................................................... 275


10.7 United Kingdom ....................................................................................................... 277

10.7.1 Forecast............................................................................................................ 277

10.7.2 Key Events ....................................................................................................... 281


10.8 Japan ...................................................................................................................... 284

10.8.1 Forecast............................................................................................................ 284

10.8.2 Key Events ....................................................................................................... 287


10.9 Canada ................................................................................................................... 289

10.9.1 Forecast............................................................................................................ 289

Table of Contents


10.9.2 Key Events ....................................................................................................... 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

Table of Contents


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


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

Table of Contents


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

Table of Contents


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

Table of Contents


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

Table of Contents


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

Table of Contents


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

Table of Contents


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


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


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


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

form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior

permission of the publisher, GlobalData.

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