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(Medical-NewsWire.com, December 19, 2015 ) Multiple Sclerosis (MS) is an inflammatory autoimmune disease of the central nervous system which leads to neurological disability. The exact underlying cause of the disease is poorly understood; however, it appears to involve a complex combination of genetic susceptibility and a non-genetic trigger. The MS therapeutics market has entered an exciting phase, with an upsurge of available treatment options. Over the forecast period, patients are expected to continue to switch to the oral disease-modifying therapies (DMTs), lessening the stronghold of the established injectable treatments. There are also several promising products in the late-stage pipeline, with a diverse range of mechanisms offering clinical advantages intended to address unmet needs. Both pipeline and marketed DMTs are seeking approval for the treatment of progressive MS, which currently represents a significant unmet need. These factors are expected to increase treatment rates throughout the 10MM resulting, driving market growth. However, this will be largely offset by brand erosion due to the emergence of biosimilars and generic small molecules.
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Highlights
Key Questions Answered
- The MS market has experienced a paradigm shift with the launch of first-line oral DMTs and efficacious escalation therapies. In light of this, what are the current clinical and environmental unmet needs? Will there be opportunities in this market for drug developers throughout the forecast period?
- The current late-stage MS pipeline is robust and diverse, with 13 products in Phase III. GlobalData has profiled nine DMT drug therapies, of which eight are anticipated to launch during the forecast period. What impact will these drugs have on the market? How will they affect the treatment algorithm for MS? Will these drugs fulfil any of the unmet needs for MS?
- The diagnosis and management of MS is challenging, even for the most experienced neurologists. How does the diagnosis and management of MS differ amongst the 10MM? Which DMT treatments are most commonly prescribed in each market, and how will prescribing patterns change over the forecast period?
Key Findings
- The main driver of growth in the MS market will be the introduction of novel DMT products over the forecast period. Drugs targeting clinical unmet needs; such as improved efficacy, more convenient administration, or progressive MS approval; will increase treatment rates and drive market growth.
- There is a high disparity between treatments for RRMS and progressive MS amongst the currently available drugs and, despite its diversity, the late late-stage pipeline remains skewed towards RRMS. As such, the RRMS market will become increasingly competitive making it more difficult for new entrants to gain patient share.
- The biggest barrier for growth in the MS market will be competition from generic/biosimilar products for key branded therapies. In particular, the launch of generic small-molecules will hamper future growth of the MS market.
- Considerable opportunity remains for products that meet the unmet needs in the MS market. A drug that prevents disease progression and the accumulation of disability would be viewed favourably. Additionally, targeting progressive MS will be an ongoing opportunity.
Scope
- Overview of MS, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized MS market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.
- Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late stage clinical trial analysis and implications for the MS therapeutics market.
- Pipeline analysis: focus on nine late-stage pipeline MS drugs, discussing emerging trends as well as an overview of earlier phase drugs and a top-line analysis of therapeutic vaccines.
- Analysis of the current and future market competition in the global MS therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
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Reasons to buy
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global MS therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global MS therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global MS therapeutics market from 2014-2024.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
Table of Contents
1 Table of Contents 10
1.1 List of Tables 17
1.2 List of Figures 23
2 Introduction 25
2.1 Catalyst 25
2.2 Related Reports 26
3 Disease Overview 27
3.1 Etiology and Pathophysiology 27
3.1.1 Etiology 27
3.1.2 Pathophysiology 28
3.2 Classification 29
3.2.1 Relapse-Remitting Multiple Sclerosis 29
3.2.2 Secondary Progressive Multiple Sclerosis 30
3.2.3 Primary Progressive Multiple Sclerosis 30
3.2.4 Progressive Relapsing Multiple Sclerosis 30
3.3 Symptoms 31
3.4 Prognosis 32
3.5 Quality of Life 33
4 Epidemiology 34
4.1 Disease Background 34
4.2 Risk Factors and Comorbidities 35
4.2.1 Family members of MS patients have a 1-5% risk of developing MS 36
4.2.2 Women are twice as likely to develop MS, but men have a worse prognosis 37
4.2.3 Caucasians have a higher risk of MS than any other race/ethnicity 37
4.2.4 Protective effect of vitamin D on MS may relate to latitude and month of birth 37
4.2.5 Timing of environmental exposures affects MS risk 38
4.2.6 Exposure to smoking may increase MS risk and worsen prognosis 38
4.2.7 Autoimmune Disease Comorbidities of MS 39
4.2.8 Mental comorbidities are found in up to 60% of MS patients and may affect relapse rates 39
4.3 Global Trends 40
4.3.1 North America 40
4.3.2 Europe 41
4.3.3 Asia 41
4.4 Forecast Methodology 42
4.4.1 Sources Used 45
4.4.2 Sources Not Used 51
4.4.3 Forecast Assumptions and Methods 51
4.5 Epidemiological Forecast of Multiple Sclerosis (2014-2024) 58
4.5.1 Diagnosed Prevalent Cases of MS 58
4.5.2 Age-Specific Diagnosed Prevalent Cases of MS 60
4.5.3 Sex-Specific Diagnosed Prevalent Cases of MS 62
4.5.4 Diagnosed Incident Cases of MS 64
4.5.5 Age-Specific Diagnosed Incident Cases of MS 66
4.5.6 Sex-Specific Diagnosed Incident Cases of MS 68
4.5.7 MS Subtypes 69
4.6 Discussion 70
4.6.1 Epidemiological Forecast Insight 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 76
5.2.1 Management of Acute Relapse 78
5.2.2 Treatment with Disease-Modifying Therapies 78
5.2.3 Symptomatic Therapies 83
5.3 US 84
5.3.1 Diagnosis 84
5.3.2 Drug Treatment 85
5.4 France 89
5.4.1 Diagnosis 89
5.4.2 Drug Treatment 90
5.5 Germany 92
5.5.1 Diagnosis 92
5.5.2 Drug Treatment 93
5.6 Italy 95
5.6.1 Diagnosis 95
5.6.2 Drug Treatment 96
5.7 Spain 98
5.7.1 Diagnosis 98
5.7.2 Drug Treatment 99
5.8 UK 101
5.8.1 Diagnosis 101
5.8.2 Drug Treatment 102
5.9 Japan 104
5.9.1 Diagnosis 104
5.9.2 Drug Treatment 105
5.10 Canada 107
5.10.1 Diagnosis 107
5.10.2 Drug Treatment 108
5.11 China 110
5.11.1 Diagnosis 110
5.11.2 Drug Treatment 111
5.12 India 113
5.12.1 Diagnosis 113
5.12.2 Drug Treatment 114
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