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 Epidemiology 10
2.3 Symptoms 10
2.4 Etiology and Pathophysiology 11
2.5 Diagnosis 12
2.5.1 Physical Examination 12
2.5.2 Blood Tests 12
2.5.3 1987 Rheumatoid Arthritis Classification 13
2.5.4 2010 ACR-EULAR Classification Criteria for Rheumatoid Arthritis 13
2.6 Prognosis 14
2.7 Treatment Guidelines and Options 14
2.7.1 Pharmacological 16
2.7.2 Methotrexate 16
2.7.3 Hydroxychloroquine 17
2.7.4 Leflunomide 17
2.7.5 Sulfasalazine 17
2.7.6 Cyclosporine 17
2.7.7 Xeljanz (tofacitinib) 17
2.7.8 Other Non-biologics 18
2.7.9 Biologic Disease-Modifying Anti-rheumatic Drugs 18
2.7.10 Disease Scoring Methods for Measuring Treatment Efficacy 20
2.8 Co-morbidities and Complications 21
3 Marketed Products 22
3.1 Overview 22
3.2 Small-Molecule Disease-Modifying Anti-rheumatic Drugs 22
3.2.1 Methotrexate-Based Products 22
3.2.2 Xeljanz (tofacitinib) – Pfizer 23
3.3 Biologic Disease-Modifying Anti-rheumatic Drugs 25
3.3.1 Remicade (infliximab) - Johnson & Johnson 25
3.3.2 Humira (adalimumab) – AbbVie 25
3.3.3 Enbrel (etanercept) - Amgen 26
3.3.4 Rituxan/MabThera (rituximab) - Biogen Idec and Genentech 27
3.3.5 Orencia (abatacept) – Bristol-Myers Squibb 28
3.3.6 Simponi (golimumab) – Johnson & Johnson, Merck 28
3.3.7 Cimzia (certolizumab pegol) – UCB 29
3.3.8 Actemra (tocilizumab) – Roche 30
3.3.9 Olumiant (baricitinib) – Eli Lilly 31
3.3.10 Kevzara (Sarilumab) – Regeneron/Sanofi 33
3.3.11 Prolia (denosumab) – Amgen/Daiichi Sankyo 35
3.4 Comparative Efficacy and Safety of Marketed Products 36
3.4.1 Conventional Synthetic Disease Modifying Anti-rheumatic Drugs (csDMARDs) 36
3.4.2 Anti-TNF-a Biologic Disease Modifying Anti-rheumatic Drugs (bDMARDs) 37
3.4.3 Non-anti-TNF-a Biologic Disease Modifying Anti-rheumatic Drugs 39
3.4.4 Targeted Synthetic Disease Modifying Anti-rheumatic Drugs 40
4 Product Pipeline 42
4.1 Overview 42
4.2 Pipeline Distribution by Phase of Development, Molecule Type, Route of Administration and Novelty 43
4.3 Pipeline Distribution by Molecular Target 45
4.4 Promising Pipeline Candidates 48
4.4.1 Sirukumab – Johnson & Johnson 48
4.4.2 Peficitinib – Astellas 50
4.4.3 Upadacitinib – AbbVie 52
4.4.4 Filgotinib – Galapagos 55
4.4.5 Olokizumab – R-Pharm 58
4.4.6 RCT-18 – Yantai RC-Pharma 59
4.5 Comparative Efficacy and Safety of Pipeline Products 59
4.6 Product Competitiveness Framework 61
5 Clinical Trial Analysis 63
5.1 Failure Rate 63
5.1.1 Overall Failure Rate 63
5.1.2 Failure Rate by Phase and Molecule Type 65
5.1.3 Failure Rate by Phase and Molecular Target 66
5.2 Clinical Trial Duration 67
5.2.1 Clinical Trial Duration by Molecule Type 67
5.2.2 Clinical Trial Duration by Molecular Target 68
5.3 Clinical Trial Size 69
5.3.1 Patient Enrollment per Product by Molecule Type, Molecular Target and Stage of Development 69
5.3.2 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development 70
5.4 Summary of Clinical Trial Metrics 72
6 Multi-Scenario Forecast 74
6.1 Geographical Markets 74
6.2 APAC Markets 74
6.3 India 77
6.3.1 Treatment Usage Patterns 77
6.3.2 Annual Cost of Therapy 77
6.3.3 Market Size 78
6.4 China 79
6.4.1 Treatment Usage Patterns 79
6.4.2 Annual Cost of Therapy 80
6.4.3 Market Size 81
6.5 Australia 82
6.5.1 Treatment Usage Patterns 82
6.5.2 Annual Cost of Therapy 83
6.5.3 Market Size 84
6.6 South Korea 85
6.6.1 Treatment Usage Patterns 85
6.6.2 Annual Cost of Therapy 86
6.6.3 Market Size 87
6.7 Japan 88
6.7.1 Treatment Usage Patterns 88
6.7.2 Annual Cost of Therapy 89
6.7.3 Market Size 90
7 Market Dynamics (Drivers and Barriers) of RA Therapeutics Market 92
7.1 Drivers 92
7.1.1 Rising Prevalence in an Aging Population 92
7.1.2 Launch of Novel Drugs: Oral JAK Inhibitors and Novel Biologics 92
7.1.3 Increasing Awareness of RA 92
7.2 Barriers 93
7.2.1 Increasing Use of Complementary and Alternative Medicine 93
7.2.2 Launch of Cheaper Biosimilars 93
7.2.3 Unmet Needs for Efficacious Therapies Diminishing 93
8 Deals and Strategic Consolidations 94
8.1 Licensing Deals 94
8.1.1 Deals by Region and Value 94
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 96
8.1.3 Deal Value by Stage of Development, Molecule Type and Molecular Target 97
8.1.4 Maruho Enters into Licensing Agreement with 4SC for a Preclinical Compound 99
8.1.5 CSL Enters into Licensing Agreement with Momenta Pharmaceuticals for M230 Preclinical Product Candidate 100
8.1.6 Mylan Enters into Licensing Agreement with Momenta Pharmaceuticals for Biosimilar Candidates 100
8.1.7 Ablynx Enters into a Licensing Deal with AbbVie for the Nanobody ALX-0061 100
8.2 Co-development 103
8.2.1 Deals by Region and Value 103
8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 105
8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 106
8.2.4 Sanofi Enters into an Agreement with JHL Biotech 109
8.2.5 Gilead Sciences Enters into Co-development Agreement with Galapagos 109
8.2.6 Epirus Enters into an Agreement with Orygen Biotecnologia 109
8.2.7 Dynavax Enters into Co-development Agreement with GlaxoSmithKline 110
9 Appendix 112
9.1 All Pipeline Drugs by Stage of Development 112
9.1.1 Discovery 112
9.1.2 Preclinical 115
9.1.3 Investigational New Drug/Clinical Trial Authorization-Filed 125
9.1.4 Phase I 125
9.1.5 Phase II 128
9.1.6 Phase III 130
9.1.7 Pre-registration 131
9.2 Summary of Multi-scenario Market Forecasts to 2023 131
9.2.1 Asia-Pacific 131
9.2.2 India 132
9.2.3 China 132
9.2.4 Australia 132
9.2.5 South Korea 133
9.2.6 Japan 133
9.3 Bibliography 133
9.4 Abbreviations 141
9.5 Research Methodology 144
9.5.1 Secondary Research 144
9.5.2 Marketed Product Profiles 145
9.5.3 Late-Stage Pipeline Candidates 145
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 145
9.5.5 Product Competitiveness Framework 145
9.5.6 Pipeline Analysis 146
9.5.7 Clinical Trials 146
9.5.8 Clinical trial Endpoint Analysis 146
9.5.9 Forecasting Model 147
9.5.10 Deals Data Analysis 148
9.6 Contact Us 148
9.7 Disclaimer 148