Commercial Insight: Rheumatoid arthritis - Anti-TNFs defend first-line biologic position despite competition

Datamonitor forecasts that total sales for the seven major rheumatoid arthritis markets will grow from $7 billion in 2007 to over $12 billion in 2017. The sustained uptake of anti-TNFs combined with the launch of several new biologic products will drive growth in the short-and mid-term. However, biosimilar entry will cause a small contraction in market value at the end of the forecast period.

Report Highlights
Simponi (golimumab) exemplifies a brand adopting both follow-on and dual formulation strategies, but positioning with Remicade will be challenging. Careful brand management, sales and marketing efforts and a well executed switching strategy will see Simponi achieve blockbuster status in the seven major markets.

The TNF-failure pool will increase considerably as patients cycle through a maximum of 2-3 TNF therapies. Currently, Orencia and Rituxan/MabThera compete in this sub-population, which will become increasingly crowded. With its well-perceived safety profile and Actemra's US approval delay, Orencia will cement its first-line position in TNF-failures.

Although some novel biologic products, have amassed convincing efficacy data against anti-TNFs, their use will be limited to the anti-TNF failure patient population, at least in the mid-term. To progress up the treatment algorithm, new agents need to demonstrate superiority to anti-TNFs and show cost-effectiveness.
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ABOUT DATAMONITOR HEALTHCARE 2
About the Immunology & Inflammation pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Related reports 5
CHAPTER 2 MARKET DEFINITION 7
Market definition for this report 7
Biologic DMARDs 7
TNF inhibitors 7
Interleukins 8
Selective T cell co-stimulation modulator 8
B cell targets 9
Traditional DMARDs (non-biologic DMARDs) 9
ICD-10 codes used to define the rheumatoid arthritis market 11
Assumptions and caveats for diagnosis value estimates 12
Diagnosis value based on retail data only 12
CHAPTER 3 MARKET OVERVIEW 14
Seven major markets 14
Current and future market assessment 14
TNF inhibitors drove growth in the seven major rheumatoid arthritis markets between 2004 and 2007 14
Launch of two new biologic classes contributed to growth in the rheumatoid arthritis market between 2004 and 2007 16
US is the largest rheumatoid arthritis market, but 5EU and Japan experienced higher sales growth between 2004 and 2007 17
Rheumatoid arthritis market volume is increasing, but due to the uptake of biologics, sales growth is outstripping it 18
The seven rheumatoid arthritis markets will grow from $7,245m in 2007 to $12,568m in 2017 19
Opportunities and threats 24
Opportunities 24
Threats 30
US 38
Current and future market assessment 38
US experienced the lowest sales growth between 2004 and 2007 38
US will continue to be the largest of the seven rheumatoid arthritis markets 40
Opportunities and threats 44
Opportunities 44
Threats 45
Japan 46
Current and future market assessment 46
Japan was the fastest growing market from 2004 to 2007 46
2017 rheumatoid arthritis sales in Japan will be almost double sales in 2007 49
Opportunities and threats 53
Opportunities 53
Threats 53
Five major European markets (5EU) 55
Current and future market assessment 55
Opportunities and threats 62
Opportunities 62
Threats 64
France 66
Current and future market assessment 66
Germany 70
Current and future market assessment 70
Italy 74
Current and future market assessment 74
Spain 78
Current and future market assessment 78
UK 82
Current and future market assessment 82
Rest of World snapshot 86
Current market assessment 86
Rest of World forms only 15% of global rheumatoid arthritis market sales 86
Humira's sales drove growth in US, 5EU and the rest of world from 2004 to 2007 87
Asia-Pacific experienced the fastest growth in the Rest of World between 2004 and 2007 88
Canada is the largest of the Rest of World markets 89
CHAPTER 4 BRAND DYNAMICS 91
Overview of competitive landscape 91
Patient acquisition process 93
Introduction 93
Patient care path 93
Points of influence in the patient care path 95
Trigger Point 1: Disease duration and activity influence use of biologics 95
Trigger Point 2: Movement from anti-TNFs to biologics with alternative mechanisms of action 96
Drivers of brand choice 97
Disease modification and side-effects are the most important factors to prescribing physicians 97
Factors driving brand choice in the anti-TNF class 100
Patient preference can influence anti-TNF choice 100
Patients wish to participate in treatment decisions regarding anti-TNFs 102
Factors driving brand choice in the cytokine drug class 104
Similar choice between anti-TNFs and cytokines 104
US formulary status for leading brands 104
Enbrel has the most favorable formulary status of the biologic DMARDs 105
Trends in marketing strategies 106
Datamonitor's dosing assumptions for brand forecasts 107
TNF inhibitors 108
Efficacy of TNF inhibitors 108
Safety of TNF inhibitors 111
TNF inhibitors - sales forecast to 2017 112
Enbrel (etanercept; Amgen, Wyeth, Takeda) 114
Product profile 114
Product positioning 115
Marketing mix 119
SWOT analysis 122
Brand forecast to 2017 123
Remicade (infliximab; Centocor/Johnson & Johnson, Schering-Plough and Mitsubishi Tanabe) 125
Product profile 125
Product positioning 126
Marketing mix 129
SWOT analysis 130
Brand forecast to 2017 131
Humira (adalimumab; Abbott, Eisai) 133
Product profile 133
Product positioning 134
Marketing mix 135
Brand forecast to 2017 138
Simponi (golimumab; Centocor/Johnson & Johnson, Schering-Plough, Mitsubishi Tanabe, Janssen Pharmaceutical) 140
Target product profile 141
Development overview 141
Product positioning 143
SWOT analysis 147
Drug forecast to 2017 148
Cimzia (certolizumab; UCB, Otsuka) 150
Target product profile 151
Development overview 152
Product positioning 156
Marketing mix 159
SWOT analysis 160
Drug forecast to 2017 161
Other cytokine targets (non-TNF biologics) 164
Other cytokine targets - sales forecast to 2017 164
Actemra (tocilizumab; Chugai, Roche) 166
Product profile 167
Development overview 168
Product positioning 172
SWOT analysis 175
Brand forecast to 2017 176
Orencia (abatacept; Bristol-Myers Squibb) 179
Product profile 180
Product positioning 181
Marketing mix 189
SWOT analysis 190
Brand forecast to 2017 191
Rituxan/MabThera (rituximab; Genentech, Biogen Idec, Roche and Chugai) 196
Product profile 197
Product positioning 198
SWOT analysis 200
Brand forecast to 2017 201
Ocrelizumab (Genentech, Biogen Idec, Roche and Chugai) 203
Target product profile 203
Development overview 204
Product positioning 205
SWOT analysis 206
Brand forecast to 2017 206
Ofatumumab (Genmab, GlaxoSmithKline) 209
Target product profile 210
Product positioning 210
SWOT analysis 215
Brand forecast to 2017 215
Other promising late-stage pipeline agents 218
JAK inhibitors 218
CHAPTER 5 KEY DEVELOPERS 220
Strategic overview 220
Trends in corporate strategy 222
Several companies will enter the market with follow-on products 222
Companies are going for dual subcutaneous and intravenous delivery formulations 223
Amgen 223
Corporate strategy 223
Rheumatoid arthritis portfolio assessment 225
Roche 227
Corporate strategy 227
Rheumatoid arthritis portfolio assessment 228
Bristol-Myers Squibb 230
Corporate strategy 230
Rheumatoid arthritis portfolio assessment 231
CHAPTER 6 CASE STUDIES 233
Case study 1 - Patient-based rheumatoid arthritis market forecasts 233
Comparison between patient-based forecast and IMS forecast 233
Methodology 235
Sensitivity analysis 238
Case study 2 - Portfolio management: Simponi's (golimumab) positioning strategy 239
Scenario A - Immediate switch to subcutaneous formulation 239
Scenario B - Delayed switch to intravenous formulation 241
Conclusion - Scenario B benefits Simponi and anti-TNF franchise 243
Simponi (golimumab, CNTO-148) pricing scenarios 244
BIBLIOGRAPHY 247
Journal papers 247
Websites 252
Datamonitor reports 256
Publications 256
APPENDIX A - MARKET ASSUMPTIONS 258
New product launches 258
Patent expiries 258
US 258
Arava (leflunomide) used as a case study for brand erosion after small molecule patent expiry in the US 258
Data definitions, limitations and assumptions 259
Standard units 259
Japanese market data 259
Rest of World 259
Derivation of sales forecasts and pricing trends 260
Forecast methodology 260
APPENDIX B 261
Contributing experts 261
Report methodology 261
About Datamonitor 262
About Datamonitor Healthcare 262
About the Immunology & Inflammation analysis team 263
Disclaimer 264
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Table 1: Datamonitor's definition of rheumatoid arthritis 11
Table 2: Rheumatologist breakdown by region for IMS Prescribing Insight data, 2007 13
Table 3: Rheumatoid-arthritis specific sales ($m) split by drug class in the seven major markets, 2004-07 16
Table 4: Rheumatoid arthritis-specific volume sales (million standard units) split by drug class in the seven major markets, 2004-07 19
Table 5: Sales forecasts in rheumatoid arthritis in the seven major markets ($m), 2007-2017 22
Table 6: Patent expiry dates and level of biosimilar risk for the biologic brands for rheumatoid arthritis 33
Table 7: Cost ($) per year per patient for common biologic agents prescribed for rheumatoid arthritis in the US, 2007 36
Table 8: Summary of opportunities and threats in the seven major rheumatoid arthritis markets, 2008 38
Table 9: Sales and growth of rheumatoid arthritis drug classes in the US, 2007 39
Table 10: Sales forecasts in rheumatoid arthritis in US ($m), 2007-2017 42
Table 11: Summary of opportunities and threats in the rheumatoid arthritis market in the US, 2007 46
Table 12: Japan sales and growth of anti-TNF and traditional DMARD drug classes, 2007 47
Table 13: Sales forecasts in rheumatoid arthritis in Japan ($m), 2007-2017 51
Table 14: Summary of opportunities and threats in the rheumatoid arthritis market in Japan, 2007 55
Table 15: Sales of the Top-10 rheumatoid arthritis drugs in the five major EU markets ($m), 2007 57
Table 16: Sales forecasts for rheumatoid arthritis in the five major European markets ($m), 2007-2017 60
Table 17: Summary of opportunities and threats for rheumatoid arthritis in the five major European markets, 2008 66
Table 18: Sales forecasts in rheumatoid arthritis in France ($m), 2007-2017 68
Table 19: Sales forecasts in rheumatoid arthritis in Germany ($m), 2007-2017 72
Table 20: Sales forecasts in rheumatoid arthritis in Italy ($m), 2007-2017 76
Table 21: Sales forecasts in rheumatoid arthritis in Spain ($m), 2007-2017 80
Table 22: Sales forecasts in rheumatoid arthritis in the UK ($m), 2007-2017 84
Table 23: Comparison of leading branded drug sales ($m) for rheumatoid arthritis in the seven major markets and the Rest of World (ROW), 2007 88
Table 24: Leading branded drug sales ($m) for rheumatoid arthritis, 2007-2017 92
Table 25: Key products in late-stage R&D pipeline for rheumatoid arthritis, 2008 93
Table 26: Mean scores for considerations in choosing biologic response modifier therapy for rheumatoid arthritis, 2008 99
Table 27: Summary of patient preferences regarding anti-TNF therapy, showing first choices only 101
Table 28: Factors influencing prescribing decision for anti-TNFs and cytokine biologics in rheumatoid arthritis in the seven major markets, 2008 104
Table 29: Formulary status in the US for leading brands in rheumatoid arthritis, 2008 105
Table 30: Datamonitor's standard unit definition and dosing assumptions for marketed and pipeline products in rheumatoid arthritis market, 2008 107
Table 31: Efficacy of the anti-TNFs: American College of Rheumatology 20, 50 and 70 110
Table 32: Safety of TNF inhibitors, 2008 112
Table 33: Enbrel - Drug profile, 2008 114
Table 34: Ongoing and recently completed clinical trials of Enbrel (etanercept) in juvenile idiopathic rheumatoid arthritis, 2008 118
Table 35: Impacting factors on the revenues of Enbrel, 2007-2017 124
Table 36: Remicade - Drug profile, 2008 125
Table 37: Ongoing post-marketing studies for Remicade in rheumatoid arthritis, 2008 127
Table 38: Impacting factors on the revenues of Remicade, 2007-2017 133
Table 39: Humira - Drug profile, 2008 134
Table 40: Impacting factors on the revenues of Humira, 2007-2017 140
Table 41: Simponi - Target product profile, 2008 141
Table 42: Clinical trial summary for subcutaneous formulation of Simponi (golimumab) 142
Table 43: Clinical trial summary for intravenous formulation of Simponi (golimumab), 2008 143
Table 44: Simponi (golimumab) efficacy summary: Clinical trial data from GO-FORWARD, GO-AFTER and GO-BEFORE, 2008 144
Table 45: Comparison of the route of administration and dosing frequency of the anti-TNFs in rheumatoid arthritis 146
Table 46: Impacting factors on the revenues of Simponi (golimumab), 2007-2017 150
Table 47: Cimzia- Target product profile, 2008 152
Table 48: Cimzia (certolizumab): Pivotal Phase III clinical trials 153
Table 49: Cimzia (certolizumab): Ongoing clinical trials, 2008 154
Table 50: Results of Cimzia's RAPID-1 and RAPID-2 clinical trials 156
Table 51: Impacting factors on the revenues of Cimzia, 2007-2017 163
Table 52: Actemra - Drug profile, 2008 168
Table 53: Actemra (tocilizumab): Pivotal Phase III trials 169
Table 54: Actemra (tocilizumab): summary of results from pivotal Phase III trials OPTION, TOWARD, RADIATE and AMBITION 170
Table 55: LITHE study results: Inhibition of radiographic progression at Week 52 171
Table 56: Actemra (tocilizumab): summary of results from SAMURAI and SATORI trials 171
Table 57: Impacting factors on the revenues of Actemra, 2007-2017 179
Table 58: Orencia - Drug profile, 2008 180
Table 59: Completed Phase III clinical trials for Orencia (abatacept) 182
Table 60: Ongoing clinical trials for Orencia (abatacept) in rheumatoid arthritis, 2008 183
Table 61: The efficacy of abatacept in methotrexate-naïve patients with early erosive rheumatoid arthritis and poor prognostic factors, 2008 185
Table 62: Phase IIIb studies for subcutaneous formulation of Orencia (abatacept), 2008 188
Table 63: Impacting factors on the revenues of Orencia, 2007-2017 196
Table 64: Rituxan/MabThera - Drug profile, 2008 197
Table 65: Comparison of ACR efficacy scores in the TNF-failure patient population: Rituxan/MabThera versus Orencia 198
Table 66: Impacting factors on the revenues of Rituxan/MabThera, 2007-2017 203
Table 67: Ocrelizumab - Drug profile, 2008 204
Table 68: Ocrelizumab ACR efficacy data from Phase II ACTION trial, 2007 204
Table 69: Ocrelizumab Phase III clinical trial details, 2008 205
Table 70: Impacting factors on the revenues of ocrelizumab, 2007-2017 208
Table 71: Ofatumumab - Drug profile, 2008 210
Table 72: Comparison of ofatumumab versus rituximab, 2008 211
Table 73: Ofatumumab's ACR and EULAR efficacy scores in DMARD-failure patients, 2007 211
Table 74: Efficacy of ofatumumab in DMARD-failure patients: 48 Week follow-up, 2008 212
Table 75: Ofatumumab: Ongoing Phase III and Phase II clinical trials, 2008 214
Table 76: Impacting factors on the revenues of ofatumumab, 2007-2017 217
Table 77: JAK inhibitors in development for rheumatoid arthritis, 2008 218
Table 78: CP-690,550: Phase IIb efficacy data, 2008 219
Table 79: Leading companies in the seven major rheumatoid arthritis markets, 2007-17 221
Table 80: Assessment of Amgen's rheumatoid arthritis portfolio, 2008 226
Table 81: Assessment of Roche's rheumatoid arthritis portfolio, 2008 229
Table 82: Assessment of Bristol-Myers Squibb's rheumatoid arthritis portfolio, 2008 232
Table 83: Scenario A: Simponi's US events and market share assumptions from launch in 2009 240
Table 84: Scenario B: Simponi's events and market share assumptions from launch 242
Table 85: Centocor/Johnson & Johnson's anti-TNF franchise sales in rheumatoid arthritis in the US, 2007-17 244
Table 86: Datamonitor's pricing scenarios for Simponi in the US, 2008 245
Table 87: Datamonitor's launch dates for rheumatoid arthritis products in the 5EU and US, 2007-2017 258
Table 88: Arava's brand erosion from time of first generic entrant, Q2 2005 to Q2 2007 259
Figure 1: Rheumatoid arthritis sales ($m) by drug class in the seven major markets, 2004-07 15
Figure 2: Key events impacting the rheumatoid arthritis market, 2005-08 17
Figure 3: Sales performance of the US, five major EU and Japan rheumatoid arthritis markets, 2006-07 18
Figure 4: Rheumatoid arthritis-specific sales ($m) by country, 2004-2017 21
Figure 5: Rheumatoid arthritis sales in the seven major markets, split by country, 2007-17 24
Figure 6: Number of rheumatoid arthritis patients receiving anti-TNF and non-TNF biologics in the seven major markets, 2007-17 29
Figure 7: Rheumatoid arthritis sales ($m) by drug class in US, 2004-07 39
Figure 8: US rheumatoid arthritis-specific sales by class, 2004-17 41
Figure 9: Rheumatoid arthritis-specific sales split by class in Japan ($m), 2004-07 47
Figure 10: Rheumatoid arthritis-specific of Remicade (infliximab) and Enbrel (etanercept), 2004-07 48
Figure 11: Performance of the key rheumatoid arthritis therapies in Japan ($m), 2005-2006 49
Figure 12: Japan rheumatoid arthritis-specific sales by class, 2004-17 50
Figure 13: Price per standard unit ($/SU) for Remicade (infliximab) in Japan, Q1 2007-Q2 2008 54
Figure 14: Rheumatoid arthritis-specific sales split by class in the 5EU ($m), 2004-07 56
Figure 15: Five major EU rheumatoid arthritis-specific sales by class, 2004-17 58
Figure 16: Five major EU rheumatoid arthritis-specific sales by class, 2004-17 59
Figure 17: France rheumatoid arthritis-specific sales by class, 2004-17 67
Figure 18: Germany rheumatoid arthritis-specific sales by class, 2004-17 71
Figure 19: Italy rheumatoid arthritis-specific sales by class, 2004-17 75
Figure 20: Spain rheumatoid arthritis-specific sales by class, 2004-17 79
Figure 21: Rheumatoid arthritis-specific sales split by class in UK ($m), 2004-07 83
Figure 22: Rest of World versus seven major market sales split in the rheumatoid arthritis market ($m), 2007 87
Figure 23: Annual sales ($m) in the Rest of World rheumatoid arthritis markets, split by region, 2004-07 89
Figure 24: Sales value of the largest 10 individual rheumatoid arthritis markets in the Rest of World, 2004-07 90
Figure 25: Rheumatoid arthritis patient care path, 2008 94
Figure 26: Drivers of brand choice for rheumatoid arthritis, 2008 98
Figure 27: Percentage of responses to question about who should choose treatment for patients with rheumatoid arthritis 103
Figure 28: Assessment of formulary status of leading biologic DMARDS in the US, 2008 106
Figure 29: Rheumatoid arthritis sales ($m) for TNF inhibitors in the seven major markets, 2004-17 113
Figure 30: Type of promotional activity for Enbrel as a percentage of total promotional spend in the US and five major EU markets, Q3 2005-Q2 2008 120
Figure 31: Wyeth/Amgen's advertisement for Enbrel in juvenile idiopathic arthritis from the ACR Scientific Meeting, 2008 121
Figure 32: Enbrel (etanercept): SWOT analysis, 2008 122
Figure 33: Enbrel sales ($m) in rheumatoid arthritis by country in the seven major markets, 2007-2017 124
Figure 34: Type of promotional activity for Remicade as a percentage of promotional spend in the US and five major EU markets, Q3 2005-Q2 2008 130
Figure 35: Remicade (infliximab): SWOT analysis, 2008 131
Figure 36: Remicade sales ($m) in rheumatoid arthritis by country in the seven major markets, 2007-2017 132
Figure 37: Type of promotional activity for Humira as a percentage of total promotional spend in the US and five major EU markets, Q3 2005-Q2 2008 137
Figure 38: Humira (adalimumab): SWOT analysis, 2008 138
Figure 39: Humira (adalimumab) sales ($m) by country in the seven major markets, 2007-17 139
Figure 40: Simponi (golimumab): SWOT analysis, 2008 148
Figure 41: Simponi (golimumab) sales ($m) by country in the seven major markets, 2007-17 149
Figure 42: Type of promotional activity for Cimzia as a percentage of total promotional spend in the US, Q2 2008 160
Figure 43: Cimzia (certolizumab): SWOT analysis, 2008 161
Figure 44: Cimzia sales ($m) in rheumatoid arthritis by country in the seven major markets, 2007-2017 162
Figure 45: Rheumatoid arthritis sales ($m) for other cytokine targets in the seven major markets, 2074-17 165
Figure 46: Actemra (tocilizumab): SWOT analysis, 2008 176
Figure 47: Actemra sales ($m) in rheumatoid arthritis by country in the seven major markets, 2007-2017 178
Figure 48: Promotional activity for Orencia by type as a percentage of promotional spend the US and EU (France, Germany, UK), Q3 2005-Q2 2008 190
Figure 49: Orencia (abatacept): SWOT analysis, 2008 191
Figure 50: Orencia sales ($m), split by formulation, in rheumatoid arthritis in the seven major markets, 2007-2017 192
Figure 51: Orencia sales ($m) in rheumatoid arthritis by country in the seven major markets, 2007-2017 194
Figure 52: Orencia, Rituxan/MabThera and Actemra sales ($m) in rheumatoid arthritis in the seven major markets, 2007-2017 195
Figure 53: Rituxan/MabThera (rituximab): SWOT analysis, 2008 200
Figure 54: Rituxan/MabThera sales ($m) in rheumatoid arthritis by country in the seven major markets, 2007-2017 202
Figure 55: Ocrelizumab: SWOT analysis, 2008 206
Figure 56: Ocrelizumab sales ($m) in rheumatoid arthritis by country in the seven major markets, 2007-2017 208
Figure 57: Rituxan/MabThera (rituximab) and ocrelizumab sales ($m) in rheumatoid arthritis in the seven major markets, 2007-2017 209
Figure 58: Ofatumumab: SWOT analysis, 2008 215
Figure 59: Ofatumumab sales ($m) in rheumatoid arthritis by country in the seven major markets, 2007-2017 216
Figure 60: Ofatumumab sales ($m), split by formulation, in rheumatoid arthritis in the seven major markets, 2007-2017 217
Figure 61: Overview of key players with marketed and pipeline drugs in rheumatoid arthritis market, 2008 222
Figure 62: Estimated number of patients treated with biologics split by line and type of therapy, 2006-17 234
Figure 63: Estimated rheumatoid arthritis sales ($m) forecast for biologic brands in the seven major markets, 2006-17 235
Figure 64: Estimated uptake of biologics in moderate and severe rheumatoid arthritis patients in the seven major markets, 2006-17 236
Figure 65: Datamonitor's estimated percentage of patients receiving biologics, by type of therapy, at each line of therapy in 2007 and 2017 238
Figure 66: Datamonitor's sensitivity analysis for biologic sales ($m) in rheumatoid arthritis in the seven major markets, 2017 239
Figure 67: Simponi's rheumatoid arthritis sales in the US assuming an immediate switch from Remicade to subcutaneous Simponi formulation, 2007-17 241
Figure 68: Simponi's rheumatoid arthritis sales in the US assuming a delayed switch from Remicade to intravenous Simponi formulation, 2007-17 243
Figure 69: Simponi's rheumatoid arthritis sales under each pricing scenario in the US, 2007-17 246
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