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Opportunity Analyzer: Myasthenia Gravis - Opportunity Analysis and Forecasts to 2024

Summary

Myasthenia gravis is an autoimmune disease affecting the nervous system . While myasthenia gravis is a rare disease, it is considered to be the most common neuromuscular disorder and presents itself as a weakness of the muscles. In the majority of patients the disease is initially localized and limited to the eye muscles causing a drooping of the eyelid and double vision. The majority of patients progress to a more severe and generalized form, where the disease spreads to other muscles such as bulbar, limb, and respiratory muscles. Weakness of the respiratory muscles can lead to shortness of breath or in more severe cases it can lead to the patients requiring assisted ventilation. A worsening of myasthenia gravis of this sort is referred to as myasthenia crisis and is a life threatening condition, which typically occurs within the first two years after myasthenia gravis onset.

Highlights

Key Questions Answered

- The myasthenia gravis market has been dominated by short and long-term-immunosuporessants and acetylcholinesterase inhibitors in the last decades. New classes of drugs are anticipated the reach the market within the forecast period. How will these drugs change the myasthenia gravis market? What impact will they have on the market size?
- The current late stage myasthenia gravis pipeline is dominated by monoclonal antibodies. Which monoclonal antibody will have the biggest impact on the market? What strategies are developers undertaking to penetrate this highly generic market? Will the new drugs fulfil any unmet needs?
- Population aging is occurring in almost all countries worldwide, particularly in the 7MM. This is expected to have a significant impact on the prevalence of myasthenia gravis. How will epidemiological changes impact the growth of the future market?

Key Findings

- The main driver of growth in the myasthenia gravis market will be the introduction of monoclonal antibodies over the forecast period. The increase in prevalence will support the market growth and a high level of unmet needs will insure that the market remains interesting in the future.
- The biggest barrier for growth in the myasthenia gravis market are anticipated difficulties for the reimbursement of monoclonal antibodies. Furthermore, the myasthenia gravis market is dominated by generics and off-label drugs, limiting treatment cost for patients who have an acceptable level of disease control.
- The largest unmet needs in myasthenia gravis is a targeted, steroid sparing therapy. Approximately 10% of patients are currently treatment refractory and urgently need new treatment options. Patients currently treated with steroids also would benefit from treatment regimen additions.

Scope

- Overview of myasthenia gravis, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized myasthenia gravis a 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 myastenia gravis therapeutics market.
- Pipeline analysis: focus on the late-stage pipeline myasthenia gravis drugs discussing emerging trends as well as overview of earlier phase drugs.
- Analysis of the current and future market competition in the global myasthenia gravisa 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

- 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 myasthenia gravis therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global myasthenia gravis 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 myasthenia gravis 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

Opportunity Analyzer: Myasthenia Gravis - Opportunity Analysis and Forecasts to 2024
1 Table of Contents
1 Table of Contents 9
1.1 List of Tables 13
1.2 List of Figures 14
2 Introduction 15
2.1 Catalyst 15
2.2 Related Reports 15
2.3 Upcoming Reports 16
3 Disease Overview 17
3.1 Etiology and Pathophysiology 17
3.1.1 The Complement System and Myasthenia Gravis 18
3.1.2 B-Cells and Myasthenia Gravis 19
3.1.3 Thymoma and Thymectomy 19
3.1.4 Mechanisms of Action of Current and Future Myasthenia Gravis Treatments 20
3.2 Myasthenic Crisis and Other Symptoms 20
3.3 Diagnostic Criteria 21
3.3.1 MGFA and Osserman Classification Systems 21
3.3.2 Diagnostic Tools 23
3.3.3 Treatment Guidelines 24
4 Epidemiology 26
4.1 Disease Background 26
4.2 Risk Factors and Comorbidities 26
4.3 Global Trends 28
4.4 Forecast Methodology 29
4.4.1 Sources Used 31
4.4.2 Sources Not Used 34
4.4.3 Forecast Assumptions and Methods 35
4.5 Epidemiological Forecast of Myasthenia Gravis (2014-2024) 38
4.5.1 Diagnosed Prevalent Cases of Myasthenia Gravis 38
4.5.2 Age-Specific Diagnosed PrevaIent Cases of Myasthenia Gravis 40
4.5.3 Sex-Specific Diagnosed Prevalent Cases of Myasthenia Gravis 41
4.5.4 Age-Standardized Diagnosed Prevalence of Myasthenia Gravis 43
4.5.5 Diagnosed Prevalent Cases of Myasthenia Gravis by MGFA Class 44
4.6 Discussion 45
4.6.1 Epidemiological Forecast Insight 45
4.6.2 Limitations of the Analysis 46
4.6.3 Strengths of the Analysis 46
5 Current Treatment Options 47
5.1 Overview 47
5.1.1 Acetylcholine Inhibitors 54
5.1.2 Short-Term Immunosuppressants 55
5.1.3 Long-Term Immunosuppressants 57
5.1.4 Rapid, Short-Term Immunomodulation 62
5.1.5 Biologics 65
5.2 Product Profiles — Major Brands 67
5.2.1 Rituxan/MabThera (Rituximab) 67
5.2.2 Prograf (Tacrolimus) 70
6 Unmet Needs Assessment and Oppportunity Analysis 73
6.1 Overview 73
6.2 Unmet Needs Analysis 74
6.2.1 Fast, Targeted Therapy Restoring Muscle Strength 74
6.2.2 Reduction of steroid side effects 78
6.2.3 Reimbursement of Biologics 80
6.2.4 Difficult-to-Treat Myasthenia Gravis Patient: Refractory, Cancer, Diabetic, and Pregnant patients 82
6.2.5 Biomarkers 84
6.2.6 Undiagnosed Myasthenia Gravis 86
6.3 RandD Strategies 88
6.3.1 Overview 88
6.3.2 Monoclonal Antibodies 88
6.3.3 Targeting of Complement System 89
6.3.4 Targeting of B-cells 90
6.3.5 Myasthenia Gravis as an Add-on Indication 90
6.4 Clinical Trial Design 91
6.4.1 Recommendation for Clinical Research Standards 91
6.4.2 Trial Design Tailored to Fit Individual Pipeline Drug 93
6.4.3 Pitfalls of Clinical Trials in Myasthenia Gravis 94
7 Pipeline Assessment 96
7.1 Overview 96
7.2 Promising Drugs in Clinical Development 97
7.2.1 Soliris (Eculizumab) 97
7.3 Innovative Early-Stage Approaches 104
7.3.1 Benlysta (Belimumab) 104
7.3.2 Tirasemtiv (CK-2017357) 106
7.3.3 Alternative Approaches for Targeting the Complement System 107
7.4 Very Early-Stage Approaches 109
8 Pipeline Valuation Analysis 111
8.1 Overview 111
8.2 Clinical Benchmark of Key Pipeline Drugs 111
8.3 Commercial Benchmark of Key Pipeline Drugs 113
8.4 Competitive Assessment 114
8.5 Top Line Ten-Year Forecast 116
8.5.1 US 119
8.5.2 5EU 120
8.5.3 Japan 120
9 Appendix 122
9.1 Bibliography 122
9.2 Abbreviations 135
9.3 Methodology 138
9.4 Forecasting Methodology 138
9.4.1 Diagnosed Myasthenia Gravis patients 138
9.4.2 Percent Drug-Treated Patients 139
9.4.3 Drugs Included in Each Therapeutic Class 139
9.4.4 Launch and Patent Expiry Dates 140
9.4.5 General Pricing Assumptions 140
9.4.6 Individual Drug Assumptions 141
9.4.7 Generic Erosion 147
9.4.8 Pricing of Pipeline Agents 147
9.5 Physicians and Specialists Included in this Study 148
9.5.1 Primary Research — Prescriber Survey 149
9.6 About the Authors 150
9.6.1 Author 150
9.6.2 Reviewer 150
9.6.3 Epidemiologists 150
9.6.4 Global Head of Healthcare 151
9.7 About GlobalData 152
9.8 Disclaimer 152

1.1 List of Tables
Table 1: Current and Future Myasthenia Gravis Treatments and Their MOAs 20
Table 2: Osserman Classifications 22
Table 3: MGFA Clinical Classifications 22
Table 4: Myasthenia Gravis Diagnostics 24
Table 5: Myasthenia Gravis Guidelines 25
Table 6: Risk Factors and Comorbidities for Myasthenia Gravis 27
Table 7: Global Estimates for the Diagnosed Prevalence of Myasthenia Gravis 29
Table 8: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of Myasthenia Gravis 30
Table 9: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of Myasthenia Gravis Segmented by MGFA Classifications 31
Table 10: 8MM, Sources Not Used in Epidemiological Analysis of Myasthenia Gravis 34
Table 11: 7MM, Diagnosed Prevalent Cases of Myasthenia Gravis, Both Sexes, All Ages, N, Select Years 2014-2024 39
Table 12: 7MM, Age-Specific Diagnosed Prevalent Cases of Myasthenia Gravis, Both Sexes, N (Row %), 2014 40
Table 13: 7MM: Sex-Specific Diagnosed Prevalent Cases of Myasthenia Gravis, All Ages, N (Row %), 2014 42
Table 14: Treatment Recommendations and Clinical Evidence 51
Table 15: Leading Treatments and Formulations for Myasthenia Gravis 53
Table 16: Product Profile — Rituxan/MabThera 68
Table 17: Rituxan SWOT analysis, 2015 70
Table 18: Product Profile — Prograf 71
Table 19: Prograf SWOT analysis, 2015 72
Table 20: Overall Unmet Needs — Current Level of Attainment 74
Table 21: Myasthenia Gravis — Late Stage Pipeline, 2015 97
Table 22: Product Profile - Eculizumab 100
Table 23: Soliris SWOT Analysis, 2015 103
Table 24: Early-Stage Pipeline Products for Myasthenia Gravis, April 2015 104
Table 25: Clinical Benchmark of Key Pipeline Drugs 112
Table 26: Commercial Benchmark of Key Pipeline Drugs 114
Table 27: Top Line Sales Forecast ($m) for Myasthenia Gravis, 2014-2024 116
Table 28: Key Events Impacting Sales for Myasthenia Gravis, 2014-2024 118
Table 29: Myasthenia Gravis Market — Drivers and Barriers, 2014-2024 118
Table 30: Key Launch Dates 140
Table 31: Key Patent Expiries 140
Table 32: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 149

1.2 List of Figures
Figure 1: Neuromuscular Terminals and their Role in Myasthenia Gravis 18
Figure 2: 7MM, Diagnosed Prevalent Cases of Myasthenia Gravis, Both Sexes, All Ages, N, 2014-2024 39
Figure 3: 7MM, Age-Specific Diagnosed Prevalent Cases of Myasthenia Gravis, Both Sexes, N, 2014 41
Figure 4: 7MM, Sex-Specific Diagnosed Prevalent Cases of Myasthenia Gravis, All Ages, 2014 43
Figure 5: 7MM, Age-Standardized Diagnosed Prevalence of Myasthenia Gravis (Cases per 100,000 Population), Both Sexes, All Ages, 2014 44
Figure 6: 7MM, Diagnosed Prevalent Cases of Myasthenia Gravis by MGFA Class, Both Sexes, All Ages, N, 2014 45
Figure 7: Current Myasthenia Gravis Treatments 48
Figure 8: Competitive Assessment of Late-Stage Pipeline Agents in Myasthenia Gravis , 2014-2024 115
Figure 9: Global Sales for Myasthenia Gravis by Region, 2014and 2024 117

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