Myasthenia Gravis - Competitive Analysis 2019
- UNI4065856
- 140 Pages
- June 2019
- Healthcare
Myasthenia Gravis (MG) is the prototype neuromuscular disease with the immunological pathogenesis. It is an acquired autoimmune disease affecting synaptic transmission via the neuromuscular junction mainly due to the presence of autoantibodies against the acetylcholine receptors (AChR) between the synaptic space of the skeletal muscles. It leads to an impairment of the neuromuscular transmission and corresponding clinical symptoms such as fluctuating muscle weakness and fatigability.
Myasthenia gravis affects both men and women and most commonly impacts young adult women (under 40) and older men (over 60), but it can occur at any age, including childhood. The indication is diagnosed based upon a thorough clinical evaluation, detection of characteristic symptoms and physical findings, a detailed patient history and a variety of specialized tests. The diagnosis is suspected based on a characteristic distribution of muscle weakness and fatigue, without impairment of other neurologic function. The several tests to confirm the diagnosis include a physical and neurological examination, an edrophonium test, a blood test, electrodiagnostics, diagnostic imaging and pulmonary function testing.
The recommended treatment for MG may include various measures that may alleviate symptoms, including anticholinesterase drugs (cholinesterase inhibitors) or alter the disease course, such as immunosuppressive drugs or surgery (thymectomy). The initial treatment commonly includes the use of cholinesterase inhibitors, which increase muscle strength by preventing the normal breakdown of the neurotransmitter acetylcholine. Pyridostigmine by mouth (orally) is primarily used.
The therapeutic pipeline of Myasthenia Gravis consists of approximately 15+ products in different stages of development. Currently, 3+ drugs are in Phase III development and major drugs are in mid stage and pre-clinical stage.
Top Company Analysed
Some of the key players include Akari Therapeutics, Alexion Pharmaceuticals, Alpha Cancer Technologies, Amarin Corporation, AnTolRx, Argenx, Astellas, Catalyst Pharmaceuticals, CSL Behring, CuraVac, Cytokinetics, GlaxoSmithKline, Grifols Therapeutics, GT Biopharma, Hibernaid, Immunovant (Roivant Sciences), Mitsubishi Tanabe Pharma Corporation, Momenta Pharmaceuticals, Novartis, Protalex, Ra Pharmaceuticals, Toleranzia, Tolerion and UCB Pharma.
Scope of the report:
• The report provides the marketed drugs information including its approval details, development activities and details of patent expiry
• Provides an overview of therapeutic pipeline activity for Myasthenia Gravis across the complete product development cycle including all clinical and non-clinical stages
• The report comprises of detailed profiles of Myasthenia Gravis therapeutic products with key coverage of developmental activities including licensing & collaboration deals, patents issued, designations, technologies and chemical information
• Therapeutic assessment of the active pipeline products by stage, product type, molecule type, and route of administration
• Detailed profiles of the dormant and discontinued products have been included in the report
Reasons to buy:
• The Myasthenia Gravis competitive report presents the detailed profile of drugs. The analysis offered in the report is a combination of deep dive secondary research and input from Key Opinion Leader of the industry
• The report presents a quick review of the current scenario regarding the drug development of the indication at one glance
• The report covers in-depth analysis of prominent industry peers with a primary focus on company consolidation, designation, technology, agreements and patents regarding the therapy
• Detailed examination on diagnosis, treatment and guidelines prevailing in the industry
• Examination of industry attractiveness with the help of approval timelines
• The study comprehensively covers the market across drugs in different phases of development
• Extensive domain knowledge on therapy areas support the client in decision-making process regarding their therapeutic portfolio by identifying the reason behind the dormancy and discontinuation of the products
Customization Options:
The Myasthenia Gravis competitive analysis report can be customized to the country level or any other competitive segment. Besides this, UMI understands that you may have your own business need, hence we also provide fully customized solutions to clients.
1.1 Objective of the Study 13
1.2 Secondary Research 13
1.3 Scope of the report: 13
2. DISEASE OVERVIEW 14
2.1 Introduction 14
2.2 Classification of MG 15
2.2.1 Congenital MG 15
2.2.2 Ocular MG 15
2.2.3 Generalized MG 15
2.2.4 Transient Neonatal MG 15
2.2.5 Juvenile MG 16
2.3 Clinical Classification 18
2.4 Signs and Symptoms 20
2.5 Causes 22
2.6 Pathogenesis 23
2.7 Pathophysiology 25
2.7.1 Presynaptic Surface 25
2.7.2 Synaptic Cleft 26
2.7.3 Postsynaptic Surface 27
2.7.4 The Acetylcholine Receptor 28
2.7.5 Neuromuscular Junction Formation and Muscle-Specific Kinase 29
2.7.6 Safety Factor for Neuromuscular Transmission 29
2.7.7 Immunopathology 30
2.7.8 Autoantibodies in MG 30
2.7.9 Cellular Autoimmunity 31
2.7.10 Cytokine Influences 32
2.7.11 The Thymus in MG Pathogenesis 33
2.7.12 The Differential Involvement of Muscle Groups by MG 34
2.8 Diagnosis 35
2.8.1 Differential Diagnosis 37
2.9 Treatment 39
2.9.1 International Consensus guidance for management of Myasthenia Gravis 40
2.9.1.1 Development of guidance treatment statements 40
2.9.2 Myasthenia gravis: Association of British Neurologists’ Management Guidelines 46
2.9.2.1 International Consensus Guidance for Management of Myasthenia Gravis 46
2.9.2.2 Treatment of Generalized Myasthenia Gravis 48
2.9.2.3 Management of side effects: Propantheline or mebeverine can help cholinergic side effects 48
2.9.2.4 Assessment and Management of the relapsing patient with Myasthenia 51
2.9.3 Japanese Clinical Guidelines for Myasthenia Gravis 54
2.9.3.1 Recommendations 55
2.9.3.2 Thymectomy for non-thymomatous patients 56
2.9.3.2.1 Recommendations 56
2.9.3.3 Oral immunosuppressive therapy 56
2.9.3.3.1 Recommendations 56
2.9.3.4 High-dose Intravenous Methylprednisolone treatment 58
2.9.3.4.1 Recommendations 58
2.9.3.5 IVIg treatment 58
2.9.3.5.1 Recommendations 58
2.9.3.6 PE/PP 59
2.9.3.6.1 Recommendations 59
2.9.3.7 Treatment for anti-AChR antibody-negative patients (including MuSK-MG) 59
2.9.3.7.1 Recommendations 59
2.9.3.8 Treatment strategies for ocular MG 59
2.9.3.8.1 Recommendations 59
2.9.3.9 Treatment Strategies for LOMG and elderly MG patients 60
2.9.3.9.1 Recommendations 60
2.10 Treatment Algorithm 61
3. PRODUCTS ANALYSIS BY TECHNOLOGY 62
3.1 Product Analysis of the Technology 62
4. PRODUCTS ANALYSIS BY DESIGNATION 63
4.1 Comparative Analysis 63
5. TOTAL NUMBER OF MARKETED AND EMERGING PRODUCTS 64
5.1 Comparative Analysis 64
6. LIST OF MARKETED PRODUCTS 65
6.1 List of Marketed Products 65
6.2 Eculizumab: Alexion Pharmaceuticals 65
6.2.1 Product Description 65
6.2.2 Regulatory Milestones 66
6.2.2.1 Approval 66
6.2.3 Research and Development 67
6.2.3.1 Clinical Studies 67
6.2.3.1.1 Phase III 67
6.2.3.1.2 Results of Analysis 67
6.2.3.2 Current Pipeline Activity 69
6.2.3.2.1 Phase III 69
6.2.4 Product Development Activities 69
6.2.4.1 Patent Dispute 69
6.2.4.2 Acquisition 69
6.2.4.3 Designation 70
6.2.4.4 Patent 70
6.3 Tacrolimus: Astellas 71
6.3.1 Product Description 71
6.3.2 Regulatory Milestones 72
6.3.2.1 Approval 72
6.3.3 Research and Development 72
6.3.3.1 Clinical Studies 72
6.3.4 Product Development Activities 73
6.3.4.1 Designation 73
6.4 Venoglobulin IH: Mitsubishi Tanabe Pharma Corporation 74
6.4.1 Product Description 74
6.4.2 Regulatory Milestones 74
6.4.2.1 Approval 74
6.4.2.2 Clinical Studies 74
6.4.2.2.1 Results of Analysis 75
6.4.3 Product Development Activities 75
6.4.3.1 Merger 75
6.4.3.2 Designation 75
7. PIPELINE THERAPEUTICS AT A GLANCE 77
7.1 Pipeline Therapeutics at a Glance 77
8. COMPARATIVE ANALYSIS 78
8.1 Total Number of Emerging Products in Myasthenia Gravis 78
9. LATE PHASE PRODUCTS (PHASE III) 79
9.1 Comparative Analysis 79
9.2 Amifampridine Phosphate: Catalyst Pharmaceuticals 79
9.2.1 Product Description 79
9.2.2 Research and Development 80
9.2.2.1 Clinical Studies 80
9.2.2.1.1 Phase III 80
9.2.2.1.2 Phase II 80
9.2.2.1.3 Results of Analysis 81
9.2.3 Product Development Activities 82
9.2.3.1 Agreement 82
9.2.3.2 Designation 83
9.3 Efgartigimod: Argenx 84
9.3.1 Product Description 84
9.3.2 Research and Development 84
9.3.2.1 Clinical Studies 84
9.3.2.1.1 Phase III 84
9.3.2.1.2 Results of Analysis 85
9.3.3 Product Development Activities 86
9.3.3.1 Designation 86
9.3.3.2 Grant 86
9.3.3.3 Technology 86
9.4 Human normal immunoglobulin G (IgG): CSL Behring 87
9.4.1 Product Description 87
9.4.2 Research and Development 88
9.4.2.1 Clinical Studies 88
9.4.2.1.1 Phase III 88
9.4.2.1.2 Phase II 88
9.5 IGIV-C: Grifols Therapeutics 89
9.5.1 Product Description 89
9.5.2 Research and Development 90
9.5.2.1 Clinical Studies 90
9.5.2.1.1 Phase III 90
9.5.2.1.2 Phase II 90
10. MID PHASE PRODUCTS (PHASE II) 92
10.1 Comparative Analysis 92
10.2 Iscalimab: Novartis 92
10.2.1 Product Description 92
10.2.2 Research and Development 93
10.2.2.1 Pre-clinical Studies 93
10.2.2.2 Clinical Studies 94
10.2.2.2.1 Phase II 94
10.2.2.2.2 Results of Analysis 94
10.3 M281: Momenta Pharmaceuticals 95
10.3.1 Product Description 95
10.3.2 Research and Development 96
10.3.2.1 Clinical Studies 96
10.3.2.1.1 Phase II 96
10.3.2.1.2 Phase I 96
10.3.2.1.3 Results of Analysis 96
10.4 Rozanolixizumab: UCB Pharma 98
10.4.1 Product Description 98
10.4.2 Research and Development 98
10.4.2.1 Clinical Studies 98
10.4.2.1.1 Phase II 98
10.4.2.1.2 Results of Analysis 98
10.5 RVT-1401: Immunovant (Roivant Sciences) 100
10.5.1 Product Description 100
10.5.2 Research and Development 100
10.5.2.1 Clinical Studies 100
10.5.2.1.1 Phase II 100
10.5.3 Product Development Activities 101
10.5.3.1 Licensing Agreement 101
10.6 Zilucoplan: Ra Pharmaceuticals 102
10.6.1 Product Description 102
10.6.2 Research and Development 102
10.6.2.1 Clinical Studies 102
10.6.2.1.1 Phase II 102
10.6.2.1.2 Results of Analysis 102
10.6.3 Product Development Activities 104
10.6.3.1 Technology 104
10.6.3.2 Patent 104
10.7 Myasterix: CuraVac 105
10.7.1 Product Description 105
10.7.2 Research and Development 105
10.7.2.1 Clinical Studies 105
10.7.2.1.1 Phase I/II 105
10.7.2.1.2 Results of Analysis 106
10.7.3 Product Development Activities 106
10.7.3.1 Designation 106
10.7.3.2 Grant 106
11. EARLY STAGE PRODUCTS (PHASE I) 108
11.1 Comparative Analysis 108
11.2 GTP-004: GT Biopharma 108
11.2.1 Product Description 108
11.2.2 Research and Development 108
11.2.2.1 Clinical Studies 108
11.2.2.1.1 Phase I 108
11.2.2.1.2 Results of Analysis 109
11.2.3 Product Development Activities 109
11.2.3.1 Patents 109
12. PRE-CLINICAL AND DISCOVERY STAGE PRODUCTS 111
12.1 Comparative Analysis 111
12.2 ACT-101: Alpha Cancer Technologies 111
12.2.1 Product Description 111
12.2.2 Research and Development 112
12.2.2.1 Pre-clinical Studies 112
12.2.3 Product Development Activities 112
12.2.3.1 Designation 112
12.3 HBN-1 (IV): Hibernaid 113
12.3.1 Product Description 113
12.4 Myasthenia Gravis-Tolerogen: Toleranzia 114
12.4.1 Product Description 114
12.5 Pre-clinical Program: AnTolRx 115
12.5.1 Product Description 115
12.5.2 Product Development Activities 115
12.5.2.1 Financing 115
12.5.2.2 Technology 115
12.6 PRTX-100: Protalex 116
12.6.1 Product Description 116
12.6.2 Research and Development 116
12.6.2.1 Pre-clinical Studies 116
12.6.3 Product Development Activities 116
12.6.3.1 Patent 116
12.7 TOL 3034: Tolerion 117
12.7.1 Product Description 117
12.7.2 Product Development Activities 117
12.7.2.1 Technology 117
12.8 Coversin: Akari Therapeutics 118
12.8.1 Product Description 118
12.8.2 Product Development Activities 119
12.8.2.1 Patent 119
12.8.2.2 Financing 119
12.8.2.3 Merger Agreement 119
12.9 HBN-100: Hibernaid 120
12.9.1 Product Description 120
13. THERAPEUTIC ASSESSMENT 122
13.1 Assessment by Product Type 122
13.2 Assessment by Stage and Product Type 122
13.3 Assessment by Route of Administration 123
13.4 Assessment by Stage and Route of Administration 124
13.5 Assessment by Molecule Type 125
13.6 Assessment by Stage and Molecule Type 126
14. APPROVAL TIMELINES 127
14.1 Approval Timelines for Clinical Products 127
15. ANALYST INSIGHTS 129
16. INACTIVE PRODUCTS 130
16.1 Comparative Analysis 130
16.2 Belimumab: GlaxoSmithKline 130
16.2.1 Product Description 130
16.2.2 Research and Development 131
16.2.2.1 Clinical Studies 131
16.2.2.1.1 Results of Analysis 131
16.3 EN101: Amarin Corporation 133
16.3.1 Product Description 133
16.3.2 Research and Development 133
16.3.2.1 Clinical Studies 133
16.3.2.1.1 Phase IIa 133
16.3.2.1.2 Results of Analysis 133
16.3.3 Product Development Activities 134
16.3.3.1 Designation 134
16.3.3.2 Agreement 134
16.4 Tirasemtiv: Cytokinetics 135
16.4.1 Product Description 135
16.4.2 Research and Development 135
16.4.2.1 Clinical Studies 135
16.4.2.1.1 Phase II 135
16.4.2.1.2 Results of Analysis 135
16.4.3 Product Development Activities 136
16.4.3.1 Collaboration Agreement 136
Table 2: Features of different subtypes of MG 17
Table 3: Osserman und Genkins classification of myasthenia gravis, modified by the MGFA/Task Force 37
Table 4: Definition of QMG score 38
Table 5: MG-MMT scores 39
Table 6: Proposed Diagnostic Criteria for Myasthenia Gravis 54
Table 7: Products Analysis by Technology 62
Table 8: Products Analysis by Designation 63
Table 9: Total Number of Marketed and Emerging Products 64
Table 10: List of Marketed Products 65
Table 11: Clinical Trial Description: Eculizumab 69
Table 12: General Description: Eculizumab 70
Table 13: Clinical Trial Description: Tacrolimus 73
Table 14: General Description: Tacrolimus 73
Table 15: Clinical Trial Description: Venoglobulin IH 5% 75
Table 16: General Description: Venoglobulin IH 5% 75
Table 17: Total Number of Emerging Products in Myasthenia Gravis 78
Table 18: Late Stage Products (Phase III) 79
Table 19: Clinical Trial Description: Amifampridine Phosphate 82
Table 20: General Description: Amifampridine Phosphate 83
Table 21: Clinical Trial Description: Efgartigimod 86
Table 22: General Description: Efgartigimod 87
Table 23: Clinical Trial Description: Hizentra 88
Table 24: General Description: Human normal immunoglobulin G (IgG) 89
Table 25: Clinical Trial Description: IGIV-C 90
Table 26: General Description: IGIV-C 90
Table 27: Mid Stage Products (Phase II) 92
Table 28: Clinical Trial Description: Iscalimab 95
Table 29: General Description: Iscalimab 95
Table 30: Clinical Trial Description: M281 97
Table 31: General Description: M281 97
Table 32: Clinical Trial Description: Rozanolixizumab 99
Table 33: General Description: Rozanolixizumab 99
Table 34: Clinical Trial Description: RVT-1401 100
Table 35: General Description: RVT-1401 101
Table 36: Clinical Trial Description: Zilucoplan 103
Table 37: General Description: Zilucoplan 104
Table 38: Clinical Trial Description: Myasterix 106
Table 39: General Description: Myasterix 106
Table 40: Early Stage Products (Phase I) 108
Table 41: Clinical Trial Description: GTP-004 109
Table 42: Patents: GTP-004 109
Table 43: General Description: GTP-004 110
Table 44: Pre-clinical and Discovery Stage Products 111
Table 45: General Description: ACT-101 112
Table 46: General Description: HBN-1 (IV) 113
Table 47: General Description: Myasthenia Gravis-Tolerogen 114
Table 48: General Description: Pre-clinical Program 115
Table 49: General Description: PRTX-100 117
Table 50: General Description: TOL 3034 118
Table 51: General Description: Coversin 119
Table 52: General Description: HBN-100 120
Table 53: Assessment by Product Type 122
Table 54: Assessment by Stage and Product Type 123
Table 55: Assessment by Route of Administration 123
Table 56: Assessment by Stage and Route of Administration 124
Table 57: Assessment by Molecule Type 125
Table 58: Assessment by Stage and Molecule Type 126
Table 59: Approval Timelines for Clinical Products 127
Table 60: Inactive Products 130
Table 61: Clinical Trial Description: Belimumab 132
Table 62: General Description: Belimumab 132
Table 63: Clinical Trial Description: EN101 133
Table 64: General Description: EN101 134
Table 65: Clinical Trial Description: Tirasemtiv 136
Table 66: General Description: Tirasemtiv 137
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