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Multiple Sclerosis - Global Drug Forecast and Market Analysis to 2028

December 2019 | 356 pages | ID: MCC2504BC63EN
GlobalData

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Multiple Sclerosis - Global Drug Forecast and Market Analysis to 2028

SUMMARY

MS is a primary autoimmune disease with a mechanism involving recurrent inflammatory attacks on the central nervous system (CNS) due to a dysfunctional immune system, leading to neurological disability . The exact underlying cause of the inflammatory autoimmune process remains unknown; however, it is widely believed that MS results from a complex interaction of genetic susceptibility and environmental factors.

MS is primarily considered an inflammatory demyelinating disorder of the CNS, and is characterized by lymphocyte and macrophage infiltrates, as well as glial cell activation. The key pathological finding in MS neural tissue is the presence of diffuse inflammatory lesions, also known as plaques, which are primarily found in the spinal cord, optic nerves, brainstem, periventricular white matter, and also extend into the grey matter. Neurologists are in general agreement that MS patients can be grouped into four major categories on the basis of the disease course.

These categories are relapse-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS), primary progressive multiple sclerosis (PPMS), and progressive relapsing multiple sclerosis (PRMS).

The current MS market is highly competitive, with 14 available treatment options, most of which are considered to be immunomodulatory agents. The majority of approved treatments address the inflammatory and systemic origins of the disease, but few possess neuroprotective effects and, as such, have an insufficient impact on the underlying neurologic deterioration caused by MS. The primary goal of treatment with DMTs is to effectively manage disease activity by reducing the frequency of relapses and delaying the accrual of permanent disability.

GlobalData estimates that drug sales for MS in 2018 were approximately $19.8B across the seven major markets covered in this report. Over the 10-year forecast period, the market is expected to grow to $32.9B at a CAGR of 5.2%. This growth will be driven by the launch of eleven late-stage pipeline products.

KEY HIGHLIGHTS
  • Significant growth is expected in the MS market from 2018 to 2028
  • GlobalData’s anticipate that eleven late stage pipeline drugs will launch over the forecast period. These are expected to be the main driver of growth in the MS market across the 7MM.
  • GlobalData projects that Ocrevus will be one of the highest-selling DMT for MS, generating $7.6B in the 7MM in 2028.
  • There are no curative therapies for MS, and most existing DMTs only have limited efficacy on slowing neurodegeneration and disease progression. This will remain an unmet need in the 7MM.
  • Opportunities are expected for pharmaceutical companies to develop drugs which have novel MOAs; which have potential disease modifying properties.
Key Questions Answered
  • What are the key MS treatments in 2018?
  • When will the late stage pipeline products launch, and how will it affect drug sales and the overall MS market in the 7MM?
  • Which unmet needs will remain unaddressed in the forecast period and what opportunities remain for pharmaceutical companies?
SCOPE
  • Overview of Multiple Sclerosis, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
  • Annualized Multiple Sclerosis therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (RRMS, SPMS and PPMS) forecast from 2018 to 2028.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the Multiple Sclerosis therapeutics market
  • Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for Multiple Sclerosis therapy. The most promising candidates in Phase III development are profiled.
  • Analysis of the current and future market competition in the global Multiple Sclerosis therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
REASONS TO BUY

The report will enable you to -
  • 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.
  • Develop business strategies by understanding the trends shaping and driving the global Multiple Sclerosis therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global Multiple Sclerosis therapeutics market in the 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.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
1.1 List of Tables
1.2 List of Figures

2 EXECUTIVE SUMMARY

2.1 Moderate Growth Expected in the MS Market from 2018 to 2028
2.2 R&D and Corporate Strategies Within the MS Market
2.3 Current Treatments Leave a High Level of Unmet Need in the MS Market
2.4 Opportunities Remain for Products that Fulfill Significant Unmet Needs in the MS Market
2.5 Late-Stage Pipeline Drugs Entering the MS Market Will Be a Key Driver of Growth
2.6 What Do the Physicians Think?

3 INTRODUCTION

3.1 Catalyst
3.2 Related Reports

4 DISEASE OVERVIEW

4.1 Etiology and Pathophysiology
  4.1.1 Etiology
  4.1.2 Pathophysiology
4.2 Classification
  4.2.1 Relapsing-Remitting MS
  4.2.2 Secondary Progressive MS
  4.2.3 Primary Progressive MS
  4.2.4 Progressive Relapsing MS
4.3 Symptoms
4.4 Prognosis
4.5 Quality of Life

5 EPIDEMIOLOGY

5.1 Disease Background
5.2 Risk Factors and Comorbidities
5.3 Global and Historical Trends
5.4 Forecast Methodology
  5.4.1 Sources
  5.4.2 Forecast Assumptions and Methods
5.5 Epidemiological Forecast for MS (2018-2028)
  5.5.1 Diagnosed Incident Cases of MS
  5.5.2 Age-Specific Diagnosed Incident Cases of MS
  5.5.3 Sex-Specific Diagnosed Incident Cases of MS
  5.5.4 Diagnosed Prevalent Cases of MS
  5.5.5 Age-Specific Diagnosed Prevalent Cases of MS
  5.5.6 Sex-Specific Diagnosed Prevalent Cases of MS
  5.5.7 Diagnosed Prevalent Cases of MS by Type
5.6 Discussion
  5.6.1 Epidemiological Forecast Insight
  5.6.2 Limitations of Analysis
  5.6.3 Strengths of Analysis

6 DISEASE MANAGEMENT

7 COMPETITIVE ASSESSMENT

8 UNMET NEEDS AND OPPORTUNITY ASSESSMENT

9 PIPELINE ASSESSMENT

10 CURRENT AND FUTURE PLAYERS

11 MARKET OUTLOOK

12 APPENDIX

LIST OF TABLES

Table 1: Multiple Sclerosis: Key Metrics in the Seven Major Pharmaceutical Markets
Table 2: Common Presenting Symptoms of MS
Table 3: Factors That Can Affect Prognosis in MS
Table 4: Risk Factors and Comorbid Conditions Associated with MS
Table 5: Revised 2017 McDonald Criteria for the Diagnosis of MS
Table 6: Treatment Guidelines for MS
Table 7: Top Three Disease-Modifying Therapies Prescribed for MS, by Market, 2018
Table 8: Pharmacotherapy for Common MS Symptoms
Table 9: US - MS Diagnosis Metrics
Table 10: US - MS Treatment Metrics
Table 11: France - MS Diagnosis Metrics
Table 12: France - MS Treatment Metrics
Table 13: Germany - MS Diagnosis Metrics
Table 14: Germany - MS Treatment Metrics
Table 15: Italy - MS Diagnosis Metrics
Table 16: Italy - MS Treatment Metrics
Table 17: Spain - MS Diagnosis Metrics
Table 18: Spain - MS Treatment Metrics
Table 19: UK - MS Diagnosis Metrics
Table 20: UK - MS Treatment Metrics
Table 21: Japan - MS Diagnosis Metrics
Table 22: Japan - MS Treatment Metrics
Table 23: Leading Disease-Modifying Drugs for the Treatment of MS, 2019
Table 24: Product Profile - Betaseron
Table 25: Efficacy Results for Betaseron in a Phase III (IFNBMS) Trial
Table 26: Betaseron SWOT Analysis, 2019
Table 27: Product Profile - Avonex
Table 28: Efficacy Results for Avonex in a Phase III Trial
Table 29: Avonex SWOT Analysis, 2019
Table 30: Product Profile - Rebif
Table 31: Rebif SWOT Analysis, 2019
Table 32: Product Profile - Plegridy
Table 33: Clinical and MRI Endpoints at Year 1 from a Phase III Trial of Plegridy in MS
Table 34: Clinical and MRI Endpoints at Year 2 from a Phase III Trial of Plegridy in MS
Table 35: AEs During Year 1 of a Phase III Trial of Plegridy in MS
Table 36: Plegridy SWOT Analysis, 2019
Table 37: Product Profile - Copaxone
Table 38: Copaxone SWOT Analysis, 2019
Table 39: Product Profile - Tysabri
Table 40: Efficacy Results for Tysabri in a Phase III (DECIDE) Trial
Table 41: Tysabri SWOT Analysis, 2019
Table 42: Product Profile - Lemtrada
Table 43: Efficacy Results for Lemtrada in a CARE II Extension Trial
Table 44: Lemtrada SWOT Analysis, 2019
Table 45: Product Profile - Ocrevus
Table 46: Efficacy Results for Ocrevus in a Phase III (OPERA I and OPERA II) MS Trial
Table 47: Efficacy Results for Ocrevus in Phase III (OPERA I and OPERA II) MS Trials
Table 48: Efficacy Results for Ocrevus in Phase III (OPERA OLE) MS Trials
Table 49: Efficacy Results for Ocrevus in Phase III (ORATORIO OLE) MS Trials
Table 50: Safety Results for Ocrevus in Phase III (OPERA I and OPERA II) MS Trials
Table 51: Safety Results for Ocrevus in Phase III (ORATARIO) MS Trials
Table 52: Ocrevus SWOT Analysis, 2019
Table 53: Product Profile - Gilenya
Table 54: Gilenya SWOT Analysis, 2019
Table 55: Product Profile - Aubagio
Table 56: Aubagio SWOT Analysis, 2019
Table 57: Product Profile - Tecfidera
Table 58: Tecfidera SWOT Analysis, 2019
Table 59: Product Profile - Mavenclad
Table 60: Efficacy Results for Mavenclad in a Phase III (CLARITY and CLARITY EXTENSION) MS Trial

The Multiple Myeloma (MM) market is expected to grow from $14.5bn in 2017 to $27.8bn by 2027 across the eight major markets (8MM*) at a compound annual growth rate (CAGR) of 6.7%. The main driver of growth in the global market for the next ten years will be the approval and launch of pipeline therapies in multiple treatment lines.

Volkan Gunduz, PhD, Senior Oncology Analyst at GlobalData, says: “The modest growth of the MM market will be driven by increasing prevalence, primarily by aging populations, as well as the approval and launch of new branded therapies: isatuximab, bb2121, JNJ-4528, GSK2857916, AMG 420, Venclexta, selinexor, Ygalo, BL-8040, galinpepimut-S, and Opdivo. In addition, label expansion of currently marketed therapies: Darzalex, Kyprolis, Pomalyst, Ninlaro, and Empliciti will promote market growth during the forecast period.”

BCMA-targeting class of therapies is highly anticipated in MM and they are expected to improve treatment outcome in heavily-treated patients, an area of major unmet need in MM. Generic and biosimilar erosion of some of the mainstays of MM treatment is also expected between 2017 and 2027.

A major barrier for market growth in MM will be the increased use of generics, in particular generic lenalidomide. The branded Revlimid alone brought in around $6.1bn in the US in 2018. Patent expiry is also expected for other major current standards of treatment, Velcade, Kyprolis, Pomalyst, Ninlaro, and Darzalex, during the forecast period. Generic and biosimilar erosion is expected to temper market growth significantly.”



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