Multiple Sclerosis
Global Drug Forecast and Market Analysis to 2022
Event-Driven Update
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
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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% US 5EU Japan Canada China and India
2012 Total: $12.6 bn 61.6% 21.7% 0.8% 15.8% 0.1% US 5EU Japan Canada China and India
2022 Total: $15.7 bn
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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
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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.
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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
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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,”
Table of Contents
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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 ... 232.2 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
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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
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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 5.10Canada ... 93 5.10.1 Diagnosis ... 93 5.10.2 Clinical Practice ... 93 5.11China ... 94 5.11.1 Diagnosis ... 94 5.11.2 Clinical Practice ... 94 5.12India ... 96 5.12.1 Diagnosis ... 96 5.12.2 Clinical Practice ... 96 6 Competitive Assessment ... 98 6.1 Overview ... 98
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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
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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 10Market Outlook ... 237 10.1Global Markets ... 237 10.1.1 Forecast... 237
10.1.2 Drivers and Barriers – Global Issues ... 240
10.2United States ... 244
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10.2.2 Key Events ... 248
10.2.3 Drivers and Barriers ... 248
10.3France ... 251
10.3.1 Forecast... 251
10.3.2 Key Events ... 255
10.3.3 Drivers and Barriers ... 255
10.4Germany ... 258
10.4.1 Forecast... 258
10.4.2 Key Events ... 262
10.4.3 Drivers and Barriers ... 262
10.5Italy ... 265
10.5.1 Forecast... 265
10.5.2 Key Events ... 268
10.5.3 Drivers and Barriers ... 268
10.6Spain ... 271
10.6.1 Forecast... 271
10.6.2 Key Events ... 275
10.6.3 Drivers and Barriers ... 275
10.7United Kingdom ... 277
10.7.1 Forecast... 277
10.7.2 Key Events ... 281
10.7.3 Drivers and Barriers ... 281
10.8Japan ... 284
10.8.1 Forecast... 284
10.8.2 Key Events ... 287
10.8.3 Drivers and Barriers ... 287
10.9Canada ... 289
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10.9.2 Key Events ... 293
10.9.3 Drivers and Barriers ... 293
10.10 China ... 295
10.10.1Forecast ... 295
10.10.2Key Events ... 298
10.10.3Drivers and Barriers ... 299
10.11 India... 301
10.11.1Forecast ... 301
10.11.2Key Events ... 303
10.11.3Drivers and Barriers ... 304
11Appendix ... 306 11.1Bibliography ... 306 11.2Abbreviations ... 324 11.3Methodology ... 328 11.4Forecasting 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
11.5Physicians and Specialists Included in This Report ... 338
11.6Primary Research – Prescriber Survey ... 339
11.7About the Authors ... 340
11.7.1 Analysts ... 340
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11.7.3 Global Head of Healthcare ... 341
11.8About GlobalData ... 342
11.9Contact Us ... 342
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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 ($m) for Avonex, 2012–2022 ... 112
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Table 22: Rebif SWOT Analysis, 2012 ... 116
Table 23: Global Sales Forecasts ($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
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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 ($m) for Tcelna, 2012–2022 ... 211
Table 69: Key Companies in the Multiple Sclerosis Market, 2012 ... 213
Table 70: Biogen’s Multiple Sclerosis Portfolio Assessment, 2012... 217
Table 71: Biogen SWOT Analysis, 2012 ... 218
Table 72: Teva’s Multiple Sclerosis Portfolio Assessment, 2012 ... 220
Table 73: Teva SWOT Analysis, 2012 ... 221
Table 74: Merck’s Multiple Sclerosis Portfolio Assessment, 2012 ... 223
Table 75: Merck SWOT Analysis, 2012 ... 224
Table 76: Sanofi’s Multiple Sclerosis Portfolio Assessment, 2012 ... 226
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Table 78: Bayer’s Multiple Sclerosis Portfolio Assessment, 2012 ... 229
Table 79: Bayer SWOT Analysis, 2012 ... 229
Table 80: Novartis’ Multiple Sclerosis Portfolio Assessment, 2012 ... 231
Table 81: Novartis SWOT Analysis, 2012 ... 232
Table 82: Roche’s Multiple Sclerosis Portfolio Assessment, 2012 ... 234
Table 83: Roche SWOT Analysis, 2012 ... 234
Table 84: GlaxoSmithKiline’s Multiple Sclerosis Portfolio Assessment, 2012 ... 236
Table 85: GlaxoSmithKline SWOT Analysis, 2012 ... 236
Table 86: Global Sales Forecasts ($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
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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
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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 form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData.
