関節リウマチ（RA）治療薬の世界市場...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 7
2 Introduction 9
2.1 Disease Introduction 9
2.2 Symptoms 10
2.3 Etiology 10
2.4 Pathophysiology 10
2.5 Diagnosis 11
2.5.1 Physical Examination 11
2.5.2 Blood Tests 11
2.5.3 1987 Rheumatoid Arthritis Classification 12
2.5.4 The 2010 ACR-EULAR Classification Criteria for Rheumatoid Arthritis 12
2.6 Epidemiology 13
2.7 Co-morbidities and Complications 13
2.8 Disease Progression 14
2.9 Pharmacotherapy Algorithm 14
2.10 Treatment Options 16
2.10.1 Pharmacological 16
2.10.2 Methotrexate 16
2.10.3 Plaquenil (hydroxychloroquine) 16
2.10.4 Arava (leflunomide) 16
2.10.5 Azulfidine, Salazopyrin (sulfasalazine) 17
2.10.6 Neoral (cyclosporine) 17
2.10.7 Prograf (tacrolimus) 17
2.10.8 Xeljanz (tofacitinib) 17
2.11 Other Non-biologics 17
2.11.1 Non-steroidal Anti-inflammatory Drugs 17
2.11.2 Painkillers 18
2.11.3 Glucocorticoids 18
2.12 Biologic Disease-Modifying Anti-rheumatic Drugs 18
2.12.1 Tumor Necrosis Factor Alpha Inhibitors 18
2.12.2 Interleukin Inhibitors 18
2.12.3 Other Biologics that Target B- and T-Cell Antigens 19
2.13 Disease Scoring Methods for Measuring Treatment Efficacy 19
2.13.1 Radiographic Progression 19
2.13.2 Clinical Disease Activity Index and Simplified Disease Activity Index 19
2.13.3 Disease Activity Score-28 19
2.13.4 American College of Rheumatology 20
2.13.5 Health Assessment Questionnaire 20
3 Marketed Products 21
3.1 Overview 21
3.2 Small-Molecule Disease-Modifying Anti-rheumatic Drugs 21
3.2.1 Methotrexate-Based Products 21
3.2.2 Xeljanz (tofacitinib) – Pfizer 22
3.3 Biologic Disease-Modifying Anti-rheumatic Drugs 23
3.3.1 Remicade (infliximab) – Johnson and Johnson, Merck 23
3.3.2 Remsima – infliximab biosimilar 24
3.3.3 Humira (adalimumab) – Abbvie 24
3.3.4 Enbrel (etanercept) – Amgen, Pfizer and Takeda Pharmaceutical 26
3.3.5 Rituxan (rituximab) – Genentech (Roche), Biogen IDEC 27
3.3.6 Reditux (Non-comparable Biologic of Rituxan) 28
3.3.7 AcellBia (rituximab biosimilar) 28
3.3.8 Orencia (abatacept) – Bristol-Myers Squibb 29
3.3.9 Simponi (golimumab) – Johnson and Johnson, Merck 30
3.3.10 Cimzia (certolizumab pegol) – UCB 31
3.3.11 Kineret (anakinra) – Swedish Orphan Biovitrum 32
3.3.12 Actemra (tocilizumab) – Roche 33
3.3.13 Comparative Safety and Efficacy 34
3.4 Unmet Need 37
4 Pipeline Landscape 38
4.1 Overview 38
4.2 Pipeline Distribution by Phase of Development, Molecule Type, Route of Administration and Novelty 38
4.3 Pipeline Distribution by Mechanism of Action 40
4.3.1 Cytokine Inhibitors 41
4.3.2 B- and T-cells 43
4.3.3 Intracellular kinases 44
5 Clinical Trial Analysis 45
5.1 Overall Attrition Rate 45
5.2 Attrition Rate by Phase, Molecule Type and Method of Administration 45
5.3 Average Clinical Trial Size by Molecule Type 48
5.4 Average Clinical Trial Size by Mechanism of Action 51
5.5 Average Clinical Trial Duration per Molecule Type by Product 53
5.6 Average Clinical Trial Duration per Mechanism of Action by Product 55
5.7 Primary and Secondary End Points 56
5.8 Summary 57
5.9 Promising Pipeline Drugs 57
5.9.1 Phase III Programs 57
5.9.2 Phase II Programs 64
5.10 Comparative Heat Map 66
6 Market Forecasts to 2020 69
6.1 Geographical Markets 69
6.2 Global Market 69
6.2.1 Treatment Usage Patterns 70
6.2.2 Market Size 71
6.3 North America 72
6.3.1 Treatment Usage Patterns 72
6.3.2 Annual Cost of Therapy 72
6.3.3 Market Size 74
6.4 Top-Five EU Markets 75
6.4.1 Treatment Usage Patterns 75
6.4.2 Annual Cost of Therapy 76
6.4.3 Market Size 77
6.5 Japan 78
6.5.1 Treatment Usage Patterns 78
6.5.2 Annual Cost of Therapy 78
6.5.3 Market Size 79
6.6 Drivers and Barriers of Rheumatoid Arthritis Therapeutic Market 79
6.6.1 Drivers 79
6.6.2 Barriers 80
7 Deals and Strategic Consolidations 81
7.1 Licensing agreements 81
7.1.1 Deal Values by Therapeutic Molecule Types 83
7.1.2 Deal Values by Therapeutic mechanism of administration 85
7.1.3 AstraZeneca Enters into Licensing Agreement with Rigel Pharma for fostamatinib disodium 87
7.1.4 Alder Biopharmaceuticals Enters into Licensing Deal with Bristol-Myers Squibb Company Alder Biopharmaceuticals for Clazakizumab 87
7.1.5 Janssen Biotech enters into a licensing deal with Astellas Pharma for Peficitinib 87
7.1.6 Ablynx enters into a licensing deal with Abbvie for the Nanobody ALX-006 87
7.2 Co-development 88
7.2.1 Deal Values by Therapeutic Molecule Types and Phase 89
7.2.2 Deal Values by Therapeutic mechanism of administration and Phase 91
7.2.3 GlaxoSmithKline enters into Global Agreement with Archemix 93
7.2.4 Abbott Laboratories Enters into Global Collaboration with Galapagos for filgotinib 93
7.2.5 Chroma Therapeutics Enters into a Co-development Agreement with GlaxoSmithKline 93
8 Appendix 94
8.1 All Pipeline Drugs by Phase of Development 94
8.1.1 Discovery 94
8.1.2 Preclinical 98
8.1.3 IND-CTA Filed 108
8.1.4 Phase I 109
8.1.5 Phase II 111
8.1.6 Phase III 113
8.2 Market Forecasts to 2020 115
8.3 Abbreviations 119
8.4 References 120
8.4.1 References for Error! Reference source not found. 132
8.4.2 References for Figure 32 134
8.5 Research Methodology 135
8.5.1 Secondary Research 136
8.5.2 Marketed Product Profiles 136
8.5.3 Late-Stage Pipeline Candidates 136
8.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 137
8.5.5 Pipeline Analysis 137
8.5.6 Forecasting Model 138
8.5.7 Deals Data Analysis 139
8.6 Contact Us 139
8.7 Disclaimer 139