Published : Sep-2017
No. of Pages : 227
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 9
2 Osteoarthritis: Executive Summary 10
2.1 OA Market Expected to Experience Strong Growth from 2016-2026 11
2.2 Drug Development Focused on Analgesics with Novel MOAs and DMOADs 13
2.3 Clinical Unmet Need Will Remain Largely Unfulfilled 13
2.4 The OA Market Provides an Abundance of Opportunities for the Development of Novel Analgesics and DMOADs 14
2.5 Anti-NGFs Are Likely to Become the Most Attractive New Treatment Option 14
2.6 What Do Physicians Think? 16
3 Introduction 18
3.1 Catalyst 18
3.2 Related Reports 18
4 Disease Overview 19
4.1 Etiology and Pathophysiology 19
4.1.1 Etiology 19
4.1.2 Pathophysiology 22
4.2 Symptoms 24
4.3 Prognosis and Quality of Life 25
5 Epidemiology 26
5.1 Disease Background 26
5.2 Risk Factors and Comorbidities 27
5.3 Global and Historical Trends 28
5.4 Forecast Methodology 31
5.4.1 Sources 32
5.4.2 Forecast Assumptions and Methods 35
5.5 Epidemiological Forecast for OA (2016-2026) 41
5.5.1 Total Prevalent Cases (Radiographic) of Hand OA 41
5.5.2 Total Prevalent Cases (Symptomatic) of Hand OA 42
5.5.3 Diagnosed Prevalent Cases (Symptomatic) of Hand OA 43
5.5.4 Age-Specific Diagnosed Prevalent Cases (Symptomatic) of Hand OA 45
5.5.5 Sex-Specific Diagnosed Prevalent Cases (Symptomatic) of Hand OA 46
5.5.6 Diagnosed Prevalent Cases (Symptomatic) of Hand OA, by Severity 47
5.5.7 Total Prevalent Cases (Radiographic) of Knee OA 48
5.5.8 Total Prevalent Cases (Symptomatic) of Knee OA 49
5.5.9 Diagnosed Prevalent Cases (Symptomatic) of Knee OA 50
5.5.10 Age-Specific Diagnosed Prevalent Cases (Symptomatic) of Knee OA 51
5.5.11 Sex-Specific Diagnosed Prevalent Cases (Symptomatic) of Knee OA 52
5.5.12 Diagnosed Prevalent Cases (Symptomatic) of Knee OA, by Severity 53
5.5.13 Total Prevalent Cases (Radiographic) of Hip OA 54
5.5.14 Total Prevalent Cases (Symptomatic) of Hip OA 55
5.5.15 Diagnosed Prevalent Cases (Symptomatic) of Hip OA 56
5.5.16 Age-Specific Diagnosed Prevalent Cases (Symptomatic) of Hip OA 57
5.5.17 Sex-Specific Diagnosed Prevalent Cases (Symptomatic) of Hip OA 58
5.5.18 Diagnosed Prevalent Cases (Symptomatic) of Hip OA, by Severity 59
5.6 Discussion 60
5.6.1 Epidemiological Forecast Insight 60
5.6.2 Limitations of Analysis 61
5.6.3 Strengths of Analysis 61
6 Current Treatment Options 62
6.1 Overview 62
6.2 Diagnosis and Treatment 63
6.2.1 Diagnosis 63
6.2.2 Treatment Guidelines and Leading Prescribed Drugs 64
6.3 Product Profiles - Major Therapies 65
6.3.1 Oral NSAIDs (numerous branded and generic products) 65
6.3.2 Topical Therapies (numerous branded and generic products) 70
6.3.3 Opioids (numerous branded and generic products) 75
6.3.4 Antidepressants (numerous branded and generic products) 79
6.3.5 Intra-articular Corticosteroid Injections (numerous branded and generic products) 82
7 Unmet Needs and Opportunity Assessment 87
7.1 Overview 87
7.2 Development of Disease-Modifying OA Drugs to Halt the Progress of OA 89
7.2.1 Unmet Need 89
7.2.2 Gap Analysis 89
7.2.3 Opportunity 91
7.3 Analgesics with Improved Efficacy and Safety Profiles 92
7.3.1 Unmet Need 92
7.3.2 Gap Analysis 93
7.3.3 Opportunity 94
7.4 Therapies to Treat OA in Patients with Comorbid Conditions 95
7.4.1 Unmet Need 95
7.4.2 Gap Analysis 96
7.4.3 Opportunity 96
7.5 Improved Patient Adherence to Non-pharmacological Treatments 97
7.5.1 Unmet Need 97
7.5.2 Gap Analysis 98
7.5.3 Opportunity 99
7.6 Increased Awareness of OA as a Serious Disease that Requires Medical Intervention 99
7.6.1 Unmet Need 99
7.6.2 Gap Analysis 100
7.6.3 Opportunity 100
7.7 Earlier Detection of OA to Facilitate Treatment 101
7.7.1 Unmet Need 101
7.7.2 Gap Analysis 101
7.7.3 Opportunity 102
8 Research & Development Strategies 103
8.1 Overview 103
8.1.1 Development of Analgesics with Novel MOA to Improve Tolerability and Efficacy 103
8.1.2 Development of DMOADs to Differentiate from Competition 105
8.1.3 Strategic Partnerships 106
8.2 Current Clinical Trial Design 107
8.2.1 Limitations of Patient-Reported Outcomes 108
8.2.2 Lack of Appropriate Subpopulations for Targeted Therapies 109
8.2.3 Lack of Consensus on DMOAD Trial Design 109
8.3 Future Clinical Trial Design 110
8.3.1 Sensitive Measurement Tools for Evaluating Joint Morphology 110
8.3.2 Biomarkers to Facilitate Development of DMOADs 111
8.3.3 Need for Consideration of Joint Tissues Other than Articular Cartilage 112
8.3.4 Trials on the Management of Multiple Joint Pain 112
9 Pipeline Assessment 113
9.1 Overview 113
9.2 Promising Analgesics in Clinical Development 116
9.2.1 Tanezumab 116
9.2.2 Fasinumab 121
9.2.3 Zilretta (FX006) 127
9.2.4 Ampion 131
9.2.5 CR845 (difelikefalin) 136
9.2.6 CNTX-4975 140
9.2.7 SI-613 142
9.2.8 X-0002 (ibuprofenamine) 145
9.3 Promising DMOADs in Clinical Development 148
9.3.1 SM04690 148
9.3.2 Invossa (tonogenchoncel-L) 153
9.3.3 ReJoin 157
9.4 Other Drugs in Development 160
9.4.1 Additional Therapies in Late-Stage Clinical Development 161
9.4.2 Drugs in Early-Stage Clinical Development 161
10 Pipeline Valuation Analysis 165
10.1 Clinical Benchmark of Key Pipeline Drugs 165
10.1.1 Clinical Benchmark of Key Pipeline Novel Analgesics 165
10.1.2 Clinical Benchmark of Key Pipeline DMOADs 168
10.2 Commercial Benchmark of Key Pipeline Drugs 168
10.2.1 Commercial Benchmark of Key Pipeline Novel Analgesics 169
10.2.2 Commercial Benchmark of Key Pipeline DMOADs 171
10.3 Competitive Assessment 172
10.4 Top-Line 10-Year Forecast 174
10.4.1 US 177
10.4.2 5EU 179
10.4.3 Japan 181
11 Appendix 183
11.1 Bibliography 183
11.2 Abbreviations 201
11.3 Methodology 207
11.3.1 Forecasting Methodology 207
11.3.2 Diagnosed Patients 207
11.3.3 Percent Drug-Treated Patients 208
11.3.4 Drugs Included in Each Therapeutic Class 208
11.3.5 Launch and Patent Expiry Dates 209
11.3.6 General Pricing Assumptions 209
11.3.7 Individual Drug Assumptions 210
11.3.8 Generic Erosion 214
11.3.9 Assumptions and Pricing of Pipeline Agents 214
11.4 Primary Research - KOLs Interviewed for This Report 220
11.5 Primary Research - Payers Interviewed for This Report 222
11.6 Primary Research - Prescriber Survey 222
11.7 About the Authors 223
11.7.1 Analysts 223
11.7.2 Therapy Area Directors 223
11.7.3 Epidemiologist 224
11.7.4 Managing Epidemiologists 224
11.7.5 Global Director of Therapy Analysis and Epidemiology 225
11.7.6 Global Head and EVP of Healthcare Operations and Strategy 225
11.8 About GlobalData 226
11.9 Contact Us 226
11.10 Disclaimer 227
1.1 List of Tables
Table 1: Osteoarthritis: Key Metrics in Seven Major Pharmaceutical Markets 10
Table 2: Genes Associated with Joint Development and OA 21
Table 3: Etiology of OA 24
Table 4: Risk Factors and Comorbidities for OA 28
Table 5: Severity Scoring System for Classifying the Hand, Knee, and Hip OA Using the KL Grading Scale 32
Table 6: 7MM, Total Prevalent Cases (Radiographic) of Hand OA, Both Sexes, Ages ?18 Years, N, Selected Years 2016-2026 42
Table 7: 7MM, Total Prevalent Cases (Symptomatic) of Hand OA, Both Sexes, Ages ?18 Years, N, Selected Years 2016-2026 43
Table 8: 7MM, Diagnosed Prevalent Cases (Symptomatic) of Hand OA, Both Sexes, Ages ?18 Years, N, Selected Years 2016-2026 44
Table 9: 7MM, Total Prevalent Cases (Radiographic) of Knee OA, Both Sexes, Ages ?18 Years, N, Selected Years 2016-2026 48
Table 10: 7MM, Total Prevalent Cases (Symptomatic) of Knee OA, Both Sexes, Ages ?18 Years, N, Selected Years 2016-2026 49
Table 11: 7MM, Diagnosed Prevalent Cases (Symptomatic) of Knee OA, Both Sexes, Ages ?18 Years, N, Selected Years 2016-2026 50
Table 12: 7MM, Total Prevalent Cases (Radiographic) of Hip OA, Both Sexes, Ages ?18 Years, N, Selected Years 2016-2026 54
Table 13: 7MM, Total Prevalent Cases (Symptomatic) of Hip OA, Both Sexes, Ages ?18 Years, N, Selected Years 2016-2026 55
Table 14: 7MM, Diagnosed Prevalent Cases (Symptomatic) of Hip OA, Both Sexes, Ages ?18 Years, N, Selected Years 2016-2026 56
Table 15: Kellgren-Lawrence (KL) Grading Scale 64
Table 16: Treatment Recommendations for OA 64
Table 17: Overview of Leading NSAIDs Prescribed for OA Treatment 67
Table 18: Studies Evaluating the Efficacy of NSAIDs in OA 68
Table 19: NSAIDs SWOT Analysis, 2017 69
Table 20: Overview of Leading Topical Treatments for OA 71
Table 21: Studies Evaluating the Efficacy of Topical Treatments in OA 73
Table 22: Topical Treatments SWOT Analysis, 2017 75
Table 23: Overview of Leading Opioids for OA Treatment 76
Table 24: Studies Evaluating the Efficacy of Opioids in OA 77
Table 25: Opioids SWOT Analysis, 2017 78
Table 26: Overview of Leading Antidepressants for OA Treatment 80
Table 27: Studies Evaluating the Efficacy of Antidepressants in OA 81
Table 28: Antidepressants SWOT Analysis, 2017 82
Table 29: Overview of Leading IA Corticosteroid Injections for OA Treatment, 2017 84
Table 30: Studies Evaluating the Efficacy of IA Injections in OA 85
Table 31: IA Corticosteroid Injections SWOT Analysis, 2017 86
Table 32: Clinical Trial Design of Key Pipeline Drugs for OA, 2017 107
Table 33: Product Profile - Tanezumab 117
Table 34: Phase III Trials Evaluating the Efficacy of Tanezumab in Treatment of Knee or Hip OA 118
Table 35: Tanezumab SWOT Analysis, 2017 120
Table 36: Product Profile - Fasinumab 122
Table 37: Results from Phase I/II Trial Evaluating the Efficacy of Fasinumab in Treatment of Knee or Hip OA 123
Table 38: Results from Phase II/III Trial Evaluating the Efficacy of Fasinumab in Treatment of Knee or Hip OA 124
Table 39: Results from Phase I/II Trial Evaluating the Safety of Fasinumab in Treatment of Knee or Hip OA 125
Table 40: Fasinumab SWOT Analysis, 2017 126
Table 41: Product Profile - Zilretta 128
Table 42: Open-Label Study Evaluating the Safety of Repeat Administration of Zilretta in Treatment of Knee OA 130
Table 43: Zilretta SWOT Analysis, 2017 130
Table 44: Product Profile - Ampion 132
Table 45: Clinical Trials Evaluating the Efficacy of Ampion for Treatment of Knee OA 134
Table 46: Ampion SWOT Analysis, 2017 135
Table 47: Product Profile - CR845 137
Table 48: Phase IIb Trial Evaluating the Efficacy of CR845 for Treatment of Hip or Knee OA 138
Table 49: CR845 SWOT Analysis, 2017 139
Table 50: Product Profile - CNTX-4975 140
Table 51: CNTX-4975 SWOT Analysis, 2017 142
Table 52: Product Profile - SI-613 143
Table 53: SI-613 SWOT Analysis, 2017 145
Table 54: Product Profile - X-0002 146
Table 55: Phase III Trial Evaluating the Efficacy of X-0002 in Treatment of Knee OA 147
Table 56: X-0002 SWOT Analysis, 2017 148
Table 57: Product Profile - SM04690 150
Table 58: Phase II and Phase III Trials Evaluating the Efficacy of SM04690 in Treatment of Knee OA 152
Table 59: SM04690 SWOT Analysis, 2017 153
Table 60: Product Profile - Invossa 155
Table 61: Invossa SWOT Analysis, 2017 157
Table 62: Product Profile - ReJoin 159
Table 63: ReJoin SWOT Analysis, 2017 160
Table 64: Drugs in Phase III Development for OA, 2017 161
Table 65: Drugs in Phase I and Phase II Development for OA, 2017 163
Table 66: Clinical Benchmark of Key Pipeline Analgesics for OA 167
Table 67: Clinical Benchmark of Key Pipeline Analgesics for OA (continued) 167
Table 68: Clinical Benchmark of Key Pipeline DMOADs for OA 168
Table 69: Commercial Benchmark of Key Pipeline Analgesics for OA 170
Table 70: Commercial Benchmark of Key Pipeline Analgesics for OA (continued) 171
Table 71: Commercial Benchmark of Key Pipeline DMOADs for OA 172
Table 72: Top-Line Sales Forecasts ($m) for OA, 2016-2026 175
Table 73: Key Events Impacting Sales for OA, 2016-2026 175
Table 74: OA Market: 7MM - Drivers and Barriers, 2016-2026 175
Table 75: Key Historical and Projected Launch Dates for OA 209
Table 76: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 222
1.2 List of Figures
Figure 1: Sales for OA by Region, 2016-2026 12
Figure 2: Competitive Assessment of Late-Stage Pipeline Analgesics in OA 15
Figure 3: Competitive Assessment of Late-Stage Pipeline DMOADs in OA 16
Figure 4: Schematic View of the Main Structures of a Healthy Joint and a Joint Affected by OA 23
Figure 5: 7MM, Age-Standardized Diagnosed Prevalence (Symptomatic) (%), Hand OA, Men and Women, Ages ?18 Years, 2016 29
Figure 6: 7MM, Age-Standardized Diagnosed Prevalence (Symptomatic) (%), Knee OA, Men and Women, Ages ?18 Years, 2016 30
Figure 7: 7MM, Age-Standardized Diagnosed Prevalence (Symptomatic) (%), Hip OA, Men and Women, Ages ?18 Years, 2016 31
Figure 8: 7MM, Sources Used to Forecast Total Prevalent Cases (Radiographic), Hand OA 32
Figure 9: 7MM, Sources Used to Forecast Total Prevalent Cases (Symptomatic), Hand OA 33
Figure 10: 7MM, Sources Used to Forecast Total Prevalent Cases (Radiographic), Knee OA 33
Figure 11: 7MM, Sources Used to Forecast Total Prevalent Cases (Symptomatic), Knee OA 34
Figure 12: 7MM, Sources Used to Forecast Total Prevalent Cases (Radiographic), Hip OA 34
Figure 13: 7MM, Sources Used to Forecast Total Prevalent Cases (Symptomatic), Hip OA 35
Figure 14: 7MM, Age-Specific Diagnosed Prevalent Cases (Symptomatic) of Hand OA, Both Sexes, Ages ?18 Years, N, 2016 45
Figure 15: 7MM, Sex-Specific Diagnosed Prevalent Cases (Symptomatic) of Hand OA, Both Sexes, Ages ?18 Years, N, 2016 46
Figure 16: 7MM, Diagnosed Prevalent Cases (Symptomatic) of Hand OA by Severity, Both Sexes, Ages ?18 Years, N, 2016 47
Figure 17: 7MM, Age-Specific Diagnosed Prevalent Cases (Symptomatic) of Knee OA, Both Sexes, Ages ?18 Years, N, 2016 51
Figure 18: 7MM, Sex-Specific Diagnosed Prevalent Cases (Symptomatic) of Knee OA, Both Sexes, Ages ?18 Years, N, 2016 52
Figure 19: 7MM, Diagnosed Prevalent Cases (Symptomatic) of Knee OA by Severity, Both Sexes, Ages ?18 Years, N, 2016 53
Figure 20: 7MM, Age-Specific Diagnosed Prevalent Cases (Symptomatic) of Hip OA, Both Sexes, Ages ?18 Years, N, 2016 57
Figure 21: 7MM, Sex-Specific Diagnosed Prevalent Cases (Symptomatic) of Hip OA, Both Sexes, Ages ?18 Years, N, 2016 58
Figure 22: 7MM, Diagnosed Prevalent Cases (Symptomatic) of Hip OA by Severity, Both Sexes, Ages ?18 Years, N, 2016 59
Figure 23: Stepped-Care Approach for the Treatment of OA 63
Figure 24: Unmet needs and Opportunities in OA 2016 88
Figure 25: Key Phase IIb and Phase III Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for OA in the 7MM During the Forecast Period 114
Figure 26: A Bulls Eye Figure of Key Phase IIb and Phase III Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for OA in the 7MM During the Forecast Period 115
Figure 27: Competitive Assessment of Late-Stage Pipeline Analgesics in OA 173
Figure 28: Competitive Assessment of Late-Stage Pipeline DMOADs in OA 174
Figure 29: Sales for OA by Region, 2016-2026 176
Figure 30: US Sales for OA, 2016-2026 178
Figure 31: 5EU Sales for OA, 2016-2026 180
Figure 32: Japan Sales for OA, 2016-2026 182
