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.
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?
– 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.
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– 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.
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
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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
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