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PharmaPoint: Rheumatoid Arthritis - 5EU 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.

The key drivers of this growth include an increase in the RA patient population, higher drug prices in Germany as compared with the other four major EU countries, and ample opportunities within the biosimilars market. However, the Italian government is implementing austerity measures to keep healthcare costs low, and is expected to promote the use of less expensive treatment alternatives. However, the growth of the RA market in Spain will be hindered by the implementation of austerity measures, which aim to cut healthcare costs and will thus limit the prescribing of biologic agents. The key drivers of this growth include the increasing RA patient population and the universal healthcare system, which allows all RA patients access to healthcare, while austerity measures aimed at cutting healthcare costs will serve as a barrier to market growth.

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 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the 5EU from 2013-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting the 5EU 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 5EU.

Table Of Contents

PharmaPoint: Rheumatoid Arthritis - 5EU Drug Forecast and Market Analysis to 2023
1 Table of Contents
2 Introduction 16
2.1 Catalyst 16
2.2 Related Reports 17
2.3 Upcoming Related Reports 20
3 Disease Overview 21
3.1 Etiology and Pathophysiology 21
3.1.1 Etiology 21
3.1.2 Pathophysiology 21
3.2 Symptoms 26
3.3 Prognosis 27
3.4 Quality of Life 27
4 Disease Management 28
4.1 Diagnosis and Treatment Overview 28
4.1.1 Diagnosis 28
4.1.2 Treatment Guidelines 30
4.1.3 Leading Prescribed Drugs for the Treatment of RA 39
4.1.4 Clinical Practice 40
4.2 France 44
4.3 Germany 46
4.4 Italy 49
4.5 Spain 51
4.6 UK 52
5 Competitive Assessment 56
5.1 Overview 56
5.2 Product Profiles - Major Brands 57
5.2.1 Enbrel (etanercept) 57
5.2.2 Humira (adalimumab) 63
5.2.3 Remicade (infliximab) 66
5.2.4 Simponi (golimumab) 71
5.2.5 Cimzia (certolizumab pegol) 76
5.2.6 Orencia (abatacept) 80
5.2.7 Actemra/RoActemra (tocilizumab) 85
5.2.8 Rituxan/MabThera (rituximab) 91
5.2.9 Inflectra/Remsima (infliximab biosimilar) 95
5.2.10 Methotrexate (Numerous Brands) 98
5.3 Biosimilars 100
5.3.1 Introduction 100
5.3.2 Hospira's Inflectra Versus JandJ's Remicade in Key Autoimmune Diseases 102
5.3.3 Biosimilars in the Immunology Community 103
5.3.4 By the Numbers: Biosimilars in Development 103
5.3.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry 107
5.3.6 Uptake of Biosimilars for RA is Expected to Vary by Market 108
5.4 Other Therapies 111
6 Unmet Need and Opportunity 113
6.1 Overview 113
6.2 Development of Cost-Effective Therapies 114
6.2.1 Unmet Need 114
6.2.2 Gap Analysis 115
6.2.3 Opportunity 115
6.3 Biomarkers to Predict Responsiveness to Therapy 115
6.3.1 Unmet Need 115
6.3.2 Gap Analysis 117
6.3.3 Opportunity 118
6.4 Early Diagnosis of RA 118
6.4.1 Unmet Need 118
6.4.2 Gap Analysis 119
6.4.3 Opportunity 120
6.5 Personalized Treatment Approach 121
6.5.1 Unmet Need 121
6.5.2 Gap Analysis 121
6.5.3 Opportunity 123
7 Pipeline Assessment 125
7.1 Overview 125
7.2 Promising Drugs in Clinical Development 125
7.2.1 Sarilumab 132
7.2.2 Sirukumab 139
7.2.3 Clazakizumab 145
7.2.4 Cosentyx (secukinumab) 151
7.2.5 Tregalizumab 156
7.2.6 Mavrilimumab 161
7.2.7 Baricitinib 166
7.2.8 Peficitinib 174
7.2.9 Decernotinib 179
7.2.10 Filgotinib 183
7.2.11 Masitinib 188
7.2.12 RAVAX 194
7.3 Other Drugs in Development 199
8 Market Outlook 202
8.1 Drivers and Barriers - Global Issues 202
8.1.1 Driver: Launch of novel drugs, including oral JAK inhibitors and novel biologics for RA 202
8.1.2 Driver: Earlier diagnosis and treatment 202
8.1.3 Driver: Market entry of biosimilars will bring a therapy option for those who cannot afford branded biologics 203
8.1.4 Driver: Aging population and increasing prevalent cases of RA 203
8.1.5 Barrier: Efforts to reduce costs in the treatment of RA 204
8.1.6 Barrier: Lack of regulatory guidelines for biosimilars will delay their availability in some regions 204
8.1.7 Barrier: Entry of biosimilars will create a less expensive treatment alternative 204
8.2 France 205
8.2.1 Forecast 205
8.2.2 Key Events 210
8.2.3 Drivers and Barriers 210
8.3 Germany 213
8.3.1 Forecast 213
8.3.2 Key Events 218
8.3.3 Drivers and Barriers 219
8.4 Italy 222
8.4.1 Forecast 222
8.4.2 Key Events 227
8.4.3 Drivers and Barriers 227
8.5 Spain 229
8.5.1 Forecast 229
8.5.2 Key Events 235
8.5.3 Drivers and Barriers 236
8.6 United Kingdom 238
8.6.1 Forecast 238
8.6.2 Key Events 244
8.6.3 Drivers and Barriers 244
9 Appendix 247
9.1 Bibliography 247
9.2 Abbreviations 263
9.3 Methodology 269
9.4 Forecasting Methodology 269
9.4.1 Diagnosed RA Patients 269
9.4.2 Percentage of Drug-Treated Patients 270
9.4.3 Drugs Included in Each Therapeutic Class 270
9.4.4 Launch and Patent Expiry Dates 271
9.4.5 General Pricing Assumptions 272
9.4.6 Individual Drug Assumptions 273
9.4.7 Generic and Biosimilar Erosion 283
9.4.8 Pricing of Pipeline Agents 283
9.5 Primary Research - KOLs Interviewed for This Report 285
9.6 Primary Research - Prescriber Survey 287
9.7 About the Authors 288
9.7.1 Analyst 288
9.7.2 Reviewer 288
9.7.3 Therapy Area Director 289
9.7.4 Global Head of Healthcare 289
9.8 About GlobalData 290
9.9 Disclaimer 290

1.1 List of Tables

Table 1: Symptoms of RA 26
Table 2: 1987 ACR Diagnostic Criteria for RA 29
Table 3: 2010 ACR/EULAR Diagnostic Criteria for RA 30
Table 4: Treatment Guidelines for RA Used by Each Country across the 5EU 32
Table 5: ACR 2012 Criteria for RA Remission and Low/Moderate/High Disease Activity 35
Table 6: EULAR 2013 Criteria for RA Remission 36
Table 7: Most Prescribed Biologics for RA (After csDMARDs) across the 5EU, 2014 40
Table 8: RA Treatment Country Profile - France 46
Table 9: RA Treatment Country Profile - Germany 48
Table 10: RA Treatment Country Profile - Italy 50
Table 11: RA Treatment Country Profile - Spain 52
Table 12: RA Treatment Country Profile - UK 55
Table 13: Leading Branded Treatments for RA 2014 57
Table 14: Product Profile - Enbrel 59
Table 15: 10-Year, Open-Label Safety and Efficacy Trial of Enbrel: Efficacy Results at 11 Years for Completers 60
Table 16: 10-year, Open-Label Safety and Efficacy Trial of Enbrel: Overall Safety Results 61
Table 17: Enbrel SWOT Analysis, 2014 62
Table 18: Product Profile - Humira 64
Table 19: Humira SWOT Analysis, 2014 66
Table 20: Product Profile - Remicade 68
Table 21: Remicade SWOT Analysis, 2014 71
Table 22: Product Profile - Simponi 73
Table 23: Simponi SWOT Analysis, 2014 75
Table 24: Product Profile - Cimzia 77
Table 25: Cimzia SWOT Analysis, 2014 79
Table 26: Product Profile - Orencia 81
Table 27: Orencia SWOT Analysis, 2014 84
Table 28: Product Profile - Actemra 88
Table 29: Actemra SWOT Analysis, 2014 90
Table 30: Product Profile - Rituxan 93
Table 31: Rituxan SWOT Analysis, 2014 94
Table 32: Product Profile - Inflectra/Remsima 96
Table 33: Inflectra/Remsima SWOT Analysis, 2014 97
Table 34: Product Profile - MTX 99
Table 35: MTX SWOT Analysis, 2014 100
Table 36: Biosimilars Pipeline for RA, 2013 104
Table 37: Physician Uptake of Biosimilar Products for RA Across the 5EU, 2014 111
Table 38: Summary of Minor Therapeutic Drug Classes Used to Treat RA, 2014 112
Table 39: Unmet Need and Opportunity in RA, 2014 114
Table 40: Comparison of Therapeutic Drug Classes in Development for RA, 2014 132
Table 41: Product Profile - Sarilumab 134
Table 42: MOBILITY Study Part, A, Results for Sarilumab at Week 12 135
Table 43: MOBILITY Study, Part B, Results for Sarilumab at Week 52 135
Table 44: Sarilumab SWOT Analysis, 2014 139
Table 45: Product Profile - Sirukumab 140
Table 46: Sirukumab SWOT Analysis, 2014 144
Table 47: Product Profile - Clazakizumab 146
Table 48: Phase IIb Study of Clazakizumab: ACR Responses After 12 Weeks 147
Table 49: Phase IIb Study of Clazakizumab: ACR Responses After 24 Weeks 147
Table 50: Clazakizumab SWOT Analysis, 2014 150
Table 51: Product Profile - Cosentyx 153
Table 52: Cosentyx SWOT Analysis, 2014 156
Table 53: Product Profile - Tregalizumab 158
Table 54: Tregalizumab SWOT Analysis, 2014 161
Table 55: Product Profile - Mavrilimumab 162
Table 56: Mavrilimumab SWOT Analysis, 2014 166
Table 57: Product Profile - Baricitinib 168
Table 58: Baricitinib Phase IIb Trial, Part A: ACR Responses at Week 12 169
Table 59: Baricitinib Phase IIb Trial, Part B: ACR Responses at Weeks 24 and 52 169
Table 60: Baricitinib Phase IIb Trial, Part A: Safety at Week 12 170
Table 61: Baricitinib Phase IIb Trial, Part A, Laboratory Values at Week 12 171
Table 62: Baricitinib SWOT Analysis, 2014 174
Table 63: Product Profile - Peficitinib 175
Table 64: Peficitinib SWOT Analysis, 2014 178
Table 65: Product Profile - Decernotinib 179
Table 66: Phase IIb tudy of Decernotinib: ACR Responses at Week 24 180
Table 67: Decernotinib SWOT Analysis, 2014 183
Table 68: Product Profile - Filgotinib 184
Table 69: Filgotinib SWOT Analysis, 2014 188
Table 70: Product Profile - Masitinib 189
Table 71: ACR Response to Masitinib in RA (12 Weeks) 190
Table 72: ACR Responses for Masitinib in the Phase IIa ITT Population (12-82 Weeks) 191
Table 73: Masitinib SWOT Analysis, 2014 194
Table 74: Product Profile - RAVAX 195
Table 75: RAVAX SWOT Analysis, 2014 198
Table 76: Drugs in Phase II of Development for RA, 2014 200
Table 77: Global RA Market - Drivers and Barriers, 2013-2023 202
Table 78: Sales Forecasts ($m) for RA in France, 2013-2023 207
Table 79: Key Events Impacting Sales for RA in France, 2013-2023 210
Table 80: RA Market in France - Drivers and Barriers, 2013-2023 210
Table 81: Sales Forecasts ($m) for RA in Germany, 2013-2023 215
Table 82: Key Events Impacting Sales for RA in Germany, 2013-2023 218
Table 83: RA Market in Germany - Drivers and Barriers, 2013-2023 219
Table 84: Sales Forecasts ($m) for RA in Italy, 2013-2023 224
Table 85: Key Events Impacting Sales for RA in Italy, 2013-2023 227
Table 86: RA Market in Italy - Drivers and Barriers, 2013-2023 227
Table 87: Sales Forecasts ($m) for RA in Spain, 2013-2023 232
Table 88: Key Events Impacting Sales for RA in Spain, 2013-2023 235
Table 89: RA Market in Spain - Drivers and Barriers, 2013-2023 236
Table 90: Sales Forecasts ($m) for RA in the UK, 2013-2023 241
Table 91: Key Events Impacting Sales for RA in the UK, 2013-2023 244
Table 92: RA Market in the UK - Drivers and Barriers, 2013-2023 244
Table 93: Key Launch Dates of RA Products in the 5EU 271
Table 94: Key Patent Expiries 272
Table 95: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 287

1.2 List of Figures

Figure 1: Normal Synovial Joint and Synovial Joint with RA 22
Figure 2: Cellular and Cytokine Targets for the Current RA Drugs 25
Figure 3: Disease Management Flowchart for Early RA - ACR 2012 36
Figure 4: Disease Management Flowchart for Established RA - ACR 2012 37
Figure 5: Flowchart for the Management of RA - EULAR 2013 38
Figure 6: Biosimilar Prescribing Habits in RA Across the 10MM, 2014 110
Figure 7: RA - Phase II-III Pipeline, 2014 127
Figure 8: Competitive Assessment of Late-Stage Pipeline Agents in RA, 2013-2023 131
Figure 9: Clinical and Commercial Positioning of Sarilumab 138
Figure 10: Clinical and Commercial Positioning of Sirukumab 144
Figure 11: Clinical and Commercial Positioning of Clazakizumab 150
Figure 12: Clinical and Commercial Positioning of Cosentyx 155
Figure 13: Clinical and Commercial Positioning of Tregalizumab 160
Figure 14: Clinical and Commercial Positioning of Mavrilimumab 165
Figure 15: Clinical and Commercial Positioning of Baricitinib 173
Figure 16: Clinical and Commercial Positioning of Peficitinib 178
Figure 17: Clinical and Commercial Positioning of Decernotinib 182
Figure 18: Clinical and Commercial Positioning of Filgotinib 187
Figure 19: Clinical and Commercial Positioning of Masitinib 193
Figure 20: Clinical and Commercial Positioning of RAVAX 198
Figure 21: Sales for RA in France by Drug Class, 2013-2023 209
Figure 22: Sales for RA in Germany by Drug Class, 2013-2023 217
Figure 23: Sales for RA in Italy by Drug Class, 2013-2023 226
Figure 24: Sales for RA in Spain by Drug Class, 2013-2023 234
Figure 25: Sales for RA in the UK by Drug Class, 2013-2023 243

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