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PharmaPoint: Rheumatoid Arthritis - US Drug Forecast and Market Analysis to 2023

Summary

Rheumatoid arthritis (RA) is a chronic autoimmune disease which causes inflammation and deformity of the joints. It affects over seven million individuals in the 10MM covered in this report (US, France, Germany, Italy, Spain, UK, Japan, Australia, China, and India) and the prevalence is expected to grow to just over 8.5 million individuals by 2023. The anti-TNFs have been effective in treating the signs and symptoms of RA and inhibiting progression to erosive bone disease. However, the landscape is quickly changing with the introduction of biosimilars, novel biologics, and a class of oral therapies known as JAK inhibitors, all of which will change the market dynamics between 2013 and 2023. With the anti-TNFs as extremely effective therapies for RA, the market is extremely competitive for new entrants and will undergo further pressure as biosimilars are approved and launch.

This market will be driven heavily by the increased population of RA patients, due, in part, to the growing overall population, an increased life expectancy, and increased awareness of RA, which requires early diagnosis and treatment. In addition, changes in healthcare resulting from implementation of the Affordable Care Act (ACA) will mean that access to physicians and pharmaceuticals will increase over the forecast period.

Scope

- Overview of Rheumatoid arthritis including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on the key drugs in the US including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the US from 2013-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting the US Rheumatoid arthritis market.

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for Rheumatoid arthritis
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of drug performance
- Obtain sales forecast for drugs from 2013-2023 in the US

Table Of Contents

PharmaPoint: Rheumatoid Arthritis - US Drug Forecast and Market Analysis to 2023
1 Table of Contents
2 Introduction 14
2.1 Catalyst 14
2.2 Related Reports 15
2.3 Upcoming Related Reports 18
3 Disease Overview 19
3.1 Etiology and Pathophysiology 19
3.1.1 Etiology 19
3.1.2 Pathophysiology 19
3.2 Symptoms 24
3.3 Prognosis 25
3.4 Quality of Life 25
4 Disease Management 26
4.1 Diagnosis and Treatment Overview 26
4.1.1 Diagnosis 26
4.1.2 Treatment Guidelines 28
4.1.3 Leading Prescribed Drugs for the Treatment of RA 36
4.1.4 Clinical Practice 37
4.2 US 41
5 Competitive Assessment 46
5.1 Overview 46
5.2 Product Profiles - Major Brands 47
5.2.1 Enbrel (etanercept) 47
5.2.2 Humira (adalimumab) 53
5.2.3 Remicade (infliximab) 56
5.2.4 Simponi (golimumab) 61
5.2.5 Cimzia (certolizumab pegol) 66
5.2.6 Orencia (abatacept) 70
5.2.7 Actemra/RoActemra (tocilizumab) 75
5.2.8 Rituxan/MabThera (rituximab) 81
5.2.9 Inflectra/Remsima (infliximab biosimilar) 85
5.2.10 Xeljanz (tofacitinib) 88
5.2.11 Methotrexate (Numerous Brands) 94
5.3 Biosimilars 97
5.3.1 Introduction 97
5.3.2 Hospira's Inflectra Versus JandJ's Remicade in Key Autoimmune Diseases 99
5.3.3 Biosimilars in the Immunology Community 100
5.3.4 By the Numbers: Biosimilars in Development 100
5.3.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry 104
5.3.6 Uptake of Biosimilars for RA is Expected to Vary by Market 105
5.4 Other Therapies 108
6 Unmet Need and Opportunity 109
6.1 Overview 109
6.2 Development of Cost-Effective Therapies 110
6.2.1 Unmet Need 110
6.2.2 Gap Analysis 111
6.2.3 Opportunity 111
6.3 Biomarkers to Predict Responsiveness to Therapy 111
6.3.1 Unmet Need 111
6.3.2 Gap Analysis 113
6.3.3 Opportunity 114
6.4 Early Diagnosis of RA 114
6.4.1 Unmet Need 114
6.4.2 Gap Analysis 115
6.4.3 Opportunity 116
6.5 Personalized Treatment Approach 117
6.5.1 Unmet Need 117
6.5.2 Gap Analysis 117
6.5.3 Opportunity 119
7 Pipeline Assessment 121
7.1 Overview 121
7.2 Promising Drugs in Clinical Development 121
7.2.1 Sarilumab 128
7.2.2 Sirukumab 135
7.2.3 Clazakizumab 141
7.2.4 Cosentyx (secukinumab) 147
7.2.5 Tregalizumab 152
7.2.6 Mavrilimumab 157
7.2.7 Baricitinib 162
7.2.8 Peficitinib 170
7.2.9 Decernotinib 175
7.2.10 Filgotinib 179
7.2.11 Masitinib 184
7.2.12 RAVAX 190
7.3 Other Drugs in Development 195
8 Market Outlook 198
8.1 Drivers and Barriers - Global Issues 198
8.1.1 Driver: Launch of novel drugs, including oral JAK inhibitors and novel biologics for RA 198
8.1.2 Driver: Earlier diagnosis and treatment 198
8.1.3 Driver: Market entry of biosimilars will bring a therapy option for those who cannot afford branded biologics 199
8.1.4 Driver: Aging population and increasing prevalent cases of RA 199
8.1.5 Barrier: Efforts to reduce costs in the treatment of RA 200
8.1.6 Barrier: Lack of regulatory guidelines for biosimilars will delay their availability in some regions 200
8.1.7 Barrier: Entry of biosimilars will create a less expensive treatment alternative 200
8.2 United States 201
8.2.1 Forecast 201
8.2.2 Key Events 206
8.2.3 Drivers and Barriers - US 207
9 Appendix 210
9.1 Bibliography 210
9.2 Abbreviations 224
9.3 Methodology 229
9.4 Forecasting Methodology 229
9.4.1 Diagnosed RA Patients 229
9.4.2 Percentage of Drug-Treated Patients 230
9.4.3 Drugs Included in Each Therapeutic Class 230
9.4.4 Launch and Patent Expiry Dates 231
9.4.5 General Pricing Assumptions 232
9.4.6 Individual Drug Assumptions 233
9.4.7 Generic and Biosimilar Erosion 242
9.4.8 Pricing of Pipeline Agents 242
9.5 Primary Research - KOLs Interviewed for This Report 244
9.6 Primary Research - Prescriber Survey 246
9.7 About the Authors 247
9.7.1 Analyst 247
9.7.2 Reviewer 247
9.7.3 Therapy Area Director 248
9.7.4 Global Head of Healthcare 248
9.8 About GlobalData 249
9.9 Disclaimer 249

1.1 List of Tables

Table 1: Symptoms of RA 24
Table 2: 1987 ACR Diagnostic Criteria for RA 27
Table 3: 2010 ACR/EULAR Diagnostic Criteria for RA 28
Table 4: Treatment Guidelines for RA Used in the US 30
Table 5: ACR 2012 Criteria for RA Remission and Low/Moderate/High Disease Activity 32
Table 6: EULAR 2013 Criteria for RA Remission 33
Table 7: Most Prescribed Biologics for RA (After csDMARDs) in the US Markets, 2014 37
Table 8: RA Treatment Country Profile - US 45
Table 9: Leading Branded Treatments for RA 2014 47
Table 10: Product Profile - Enbrel 49
Table 11: 10-Year, Open-Label Safety and Efficacy Trial of Enbrel: Efficacy Results at 11 Years for Completers 50
Table 12: 10-year, Open-Label Safety and Efficacy Trial of Enbrel: Overall Safety Results 51
Table 13: Enbrel SWOT Analysis, 2014 52
Table 14: Product Profile - Humira 54
Table 15: Humira SWOT Analysis, 2014 56
Table 16: Product Profile - Remicade 58
Table 17: Remicade SWOT Analysis, 2014 61
Table 18: Product Profile - Simponi 63
Table 19: Simponi SWOT Analysis, 2014 65
Table 20: Product Profile - Cimzia 67
Table 21: Cimzia SWOT Analysis, 2014 69
Table 22: Product Profile - Orencia 71
Table 23: Orencia SWOT Analysis, 2014 74
Table 24: Product Profile - Actemra 78
Table 25: Actemra SWOT Analysis, 2014 80
Table 26: Product Profile - Rituxan 83
Table 27: Rituxan SWOT Analysis, 2014 84
Table 28: Product Profile - Inflectra/Remsima 86
Table 29: Inflectra/Remsima SWOT Analysis, 2014 87
Table 30: Product Profile - Xeljanz 91
Table 31: ORAL Standard ACR20 Responses for Tofacitinib vs. Humira and Placebo at Month 6 92
Table 32: ORAL Step ACR20, 50, and 70 Responses for Xeljanz vs. Placebo at Month 6 92
Table 33: Xeljanz SWOT Analysis, 2014 94
Table 34: Product Profile - MTX 96
Table 35: MTX SWOT Analysis, 2014 97
Table 36: Biosimilars Pipeline for RA, 2013 101
Table 37: Physician Uptake of Biosimilar Products for RA in the US, 2014 107
Table 38: Summary of Minor Therapeutic Drug Classes Used to Treat RA, 2014 108
Table 39: Unmet Need and Opportunity in RA, 2014 110
Table 40: Comparison of Therapeutic Drug Classes in Development for RA, 2014 128
Table 41: Product Profile - Sarilumab 130
Table 42: MOBILITY Study Part, A, Results for Sarilumab at Week 12 131
Table 43: MOBILITY Study, Part B, Results for Sarilumab at Week 52 131
Table 44: Sarilumab SWOT Analysis, 2014 135
Table 45: Product Profile - Sirukumab 136
Table 46: Sirukumab SWOT Analysis, 2014 140
Table 47: Product Profile - Clazakizumab 142
Table 48: Phase IIb Study of Clazakizumab: ACR Responses After 12 Weeks 143
Table 49: Phase IIb Study of Clazakizumab: ACR Responses After 24 Weeks 143
Table 50: Clazakizumab SWOT Analysis, 2014 146
Table 51: Product Profile - Cosentyx 149
Table 52: Cosentyx SWOT Analysis, 2014 152
Table 53: Product Profile - Tregalizumab 154
Table 54: Tregalizumab SWOT Analysis, 2014 157
Table 55: Product Profile - Mavrilimumab 158
Table 56: Mavrilimumab SWOT Analysis, 2014 162
Table 57: Product Profile - Baricitinib 164
Table 58: Baricitinib Phase IIb Trial, Part A: ACR Responses at Week 12 165
Table 59: Baricitinib Phase IIb Trial, Part B: ACR Responses at Weeks 24 and 52 165
Table 60: Baricitinib Phase IIb Trial, Part A: Safety at Week 12 166
Table 61: Baricitinib Phase IIb Trial, Part A, Laboratory Values at Week 12 167
Table 62: Baricitinib SWOT Analysis, 2014 170
Table 63: Product Profile - Peficitinib 171
Table 64: Peficitinib SWOT Analysis, 2014 174
Table 65: Product Profile - Decernotinib 175
Table 66: Phase IIb tudy of Decernotinib: ACR Responses at Week 24 176
Table 67: Decernotinib SWOT Analysis, 2014 179
Table 68: Product Profile - Filgotinib 180
Table 69: Filgotinib SWOT Analysis, 2014 184
Table 70: Product Profile - Masitinib 185
Table 71: ACR Response to Masitinib in RA (12 Weeks) 186
Table 72: ACR Responses for Masitinib in the Phase IIa ITT Population (12-82 Weeks) 187
Table 73: Masitinib SWOT Analysis, 2014 190
Table 74: Product Profile - RAVAX 191
Table 75: RAVAX SWOT Analysis, 2014 194
Table 76: Drugs in Phase II of Development for RA, 2014 196
Table 77: Global RA Market - Drivers and Barriers, 2013-2023 198
Table 78: Sales Forecasts ($m) for RA in the United States, 2013-2023 203
Table 79: Key Events Impacting Sales for RA in the US, 2013-2023 206
Table 80: RA Market in the US - Drivers and Barriers, 2013-2023 207
Table 81: Key Launch Dates of RA Products in the US 231
Table 82: Key Patent Expiries 232
Table 83: High-Prescribing Physicians (non-KOLs) Surveyed in the US 246

1.2 List of Figures

Figure 1: Normal Synovial Joint and Synovial Joint with RA 20
Figure 2: Cellular and Cytokine Targets for the Current RA Drugs 23
Figure 3: Disease Management Flowchart for Early RA - ACR 2012 33
Figure 4: Disease Management Flowchart for Established RA - ACR 2012 34
Figure 5: Flowchart for the Management of RA - EULAR 2013 35
Figure 6: Biosimilar Prescribing Habits in RA Across the 10MM, 2014 107
Figure 7: RA - Phase II-III Pipeline, 2014 123
Figure 8: Competitive Assessment of Late-Stage Pipeline Agents in RA, 2013-2023 127
Figure 9: Clinical and Commercial Positioning of Sarilumab 134
Figure 10: Clinical and Commercial Positioning of Sirukumab 140
Figure 11: Clinical and Commercial Positioning of Clazakizumab 146
Figure 12: Clinical and Commercial Positioning of Cosentyx 151
Figure 13: Clinical and Commercial Positioning of Tregalizumab 156
Figure 14: Clinical and Commercial Positioning of Mavrilimumab 161
Figure 15: Clinical and Commercial Positioning of Baricitinib 169
Figure 16: Clinical and Commercial Positioning of Peficitinib 174
Figure 17: Clinical and Commercial Positioning of Decernotinib 178
Figure 18: Clinical and Commercial Positioning of Filgotinib 183
Figure 19: Clinical and Commercial Positioning of Masitinib 189
Figure 20: Clinical and Commercial Positioning of RAVAX 194
Figure 21: Sales for RA in the United States by Drug Class, 2013-2023 205

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