Commercial Insight Autoimmune Overview Market continues to prosper

CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Datamonitor insight into the autoimmune market 3
Contributing experts 5
Related reports 5
CHAPTER 2 BACKGROUND AND EPIDEMIOLOGY 8
Overview of autoimmune diseases 8
The commonality of autoimmune diseases 8
Rheumatoid arthritis market potential 12
Definition of rheumatoid arthritis 12
Epidemiology of rheumatoid arthritis 12
Segmentation of rheumatoid arthritis 13
Ankylosing spondylitis market potential 17
Definition of ankylosing spondylitis 17
Epidemiology of ankylosing spondylitis 18
Segmentation of ankylosing spondylitis 19
Psoriasis market potential 19
Definition of psoriasis 19
Epidemiology of psoriasis 19
Segmentation of psoriasis 20
Psoriatic arthritis market potential 21
Definition of psoriatic arthritis 21
Epidemiology of psoriatic arthritis 22
Multiple sclerosis market potential 23
Definition of multiple sclerosis 23
Epidemiology of multiple sclerosis 23
Segmentation of multiple sclerosis 25
Crohn's disease and ulcerative colitis market potential 27
Definition of Crohn's disease and ulcerative colitis 27
Epidemiology of Crohn's disease and ulcerative colitis 29
Systemic lupus erythematosus (SLE) market potential 32
Definition of systemic lupus erythematosus 32
Epidemiology of systemic lupus erythematosus 33
Segmentation of systemic lupus erythematosus 34
CHAPTER 3 MARKET OVERVIEW 37
Market definition for this report 37
TNF-inhibitors 38
B and T cell inhibitors 41
Interleukins 42
Immunosuppressants 42
Beta-interferons 43
Other 46
The autoimmune market by mechanism of action 47
TNF-inhibitors 50
Beta-interferons 51
Other 52
T-cell inhibitors 53
Interleukin inhibitors 54
B-cell inhibitors 55
The autoimmune market by indication 56
Rheumatoid arthritis 59
Psoriasis/psoriatic arthritis 63
Multiple sclerosis 66
Crohn's disease 70
The autoimmune market by country 73
Seven major markets 73
Five major European markets 74
US 75
Japan 76
CHAPTER 4 PRODUCT PROFILES AND FORECAST ANALYSIS 78
TNF-inhibitors 78
Enbrel (etanercept) 78
Strategic analysis 78
Indications 79
Forecast 87
Remicade (infliximab) 88
Strategic analysis 88
Indications 89
Forecast 100
Humira (adalimumab) 102
Strategic analysis 102
Indications 103
Forecast 113
Cimzia (certolizumab) 114
Strategic analysis 115
Indications 115
Forecast 117
Golimumab (CNTO-148) 119
Indications 120
Forecast 122
B-cell inhibitors 123
Rituxan/MabThera (rituximab) 123
Strategic analysis 124
Indications 124
Forecast 131
Ocrelizumab 133
Indications 134
Forecast 135
Ofatumumab 136
Indications 137
Forecast 137
Beta interferons 138
Avonex (interferon beta-1a) 138
Strategic analysis 138
Indications 139
Forecast 141
Rebif (interferon beta-1a) 142
Strategic analysis 142
Indications 143
Forecast 146
Betaseron/Betaferon (interferon beta-1b) 147
Strategic analysis 148
Indications 148
Forecast 151
T-cell inhibitors 152
Orencia (abatacept) 152
Strategic analysis 152
Indications 153
Forecast 158
Other T-cell inhibitors 159
Raptiva (efalizumab) 159
Amevive (alefacept) 162
Interleukin inhibitors 164
Actemra (tocilizumab) 164
Indications 165
Forecast 167
Ustekinumab (CNTO-1275) 168
Indications 169
Forecast 171
Other interleukin inhibitors 172
Kineret (anakinra) 172
ABT-874 173
Zenapax (daclizumab) 174
Other mechanisms of action 175
Copaxone (glatiramer acetate) 175
Strategic analysis 175
Indications 176
Forecast 179
Tysabri (natalizumab) 180
Strategic analysis 180
Indications 181
Forecast 186
BG-12 187
Fingolimod 190
Other 192
Arava (leflunomide) 192
Teriflunomide (HMR-1726) 194
CellCept (mycophenolate mofetil) 194
Data definitions, limitations and assumptions 195
Standard units 195
Japanese market data 195
Derivation of sales forecasts and pricing trends 195
Indication calculations 196
Assumptions and caveats for diagnosis value estimates 196
Forecasts 197
Forecast methodology 197
CHAPTER 5 CASE STUDIES 198
Biosimilars 198
Europe has some guidelines, but the US stays behind 198
Opposition from the innovators 199
Multiple stakeholders need to be targeted 200
Physician and patient view on biosimilars will be important 201
Patent expiries in autoimmune diseases 203
Biosimilars in multiple sclerosis 204
Biomarkers 204
B cell biomarkers 205
T cell biomarkers 206
Cytokine and antibody biomarkers 207
The future of biomarkers 207
Indication specific clinical trial issues 209
Established products have strong position 209
Quality of life questionnaires 210
PASI may not be best endpoint for psoriasis 211
The issue of remission in rheumatoid arthritis 211
The revised McDonald criteria allows trials to include early MS patients 212
Standardized ulcerative colitis and SLE endpoints are lacking 212
Placebo-controlled MS trials may be considered unethical 213
Clinical trial design in SLE is a notoriously difficult task 214
Non-responder trials 214
BIBLIOGRAPHY 216
Conferences 236
Datamonitor reports 239
Prescribing information 240
Press releases 241
Websites 246
APPENDIX A - MARKET FORECAST DATA 248
Seven major markets 248
US 249
Five major European markets 250
Japan 251
APPENDIX B BRAND OVERVIEWS 252
Amevive 252
Arava 254
Avonex 255
Betaseron/Betaferon 257
Copaxone 258
Enbrel 259
Humira 260
Kineret 261
Orencia 262
Raptiva 263
Rebif 264
Remicade 265
Rituxan/MabThera 267
Tysabri 269
APPENDIX C 270
Contributing experts 270
Report methodology 270
About Datamonitor 270
About Datamonitor Healthcare 271
Disclaimer 273
List of Tables
Table 1: Overview of studies investigating relationships between autoimmune diseases 10
Table 2: Prevalence of several autoimmune diseases in the seven major markets, 2007 11
Table 3: Prevalence of rheumatoid arthritis in the seven major markets, 2007 13
Table 4: Rheumatoid arthritis disease severity as a percentage of total diagnosed RA population in the seven major markets, 2006 14
Table 5: Physician-estimated proportion of patients defined as having early active rheumatoid arthritis in the seven major markets, 2006 16
Table 6: Prevalence of ankylosing spondylitis in the seven major markets, 2007 18
Table 7: Prevalence of psoriasis in the seven major markets, 2007 20
Table 8: Overview of different forms of psoriasis 21
Table 9: Prevalence of psoriatic arthritis in the seven major markets, 2007 22
Table 10: Prevalence of multiple sclerosis in the seven major markets, 2007 24
Table 11: Multiple sclerosis disease types as a percentage of total diagnosed MS population in the seven major markets, 2006 27
Table 12: Prevalence of Crohn's disease in the seven major markets, 2007 30
Table 13: Prevalence of ulcerative colitis in the seven major markets, 2007 31
Table 14: Prevalence of systemic lupus erythematosus (SLE) in the seven major markets, 2007 33
Table 15: Overview of leading molecules used in the treatment of autoimmune diseases 37
Table 16: Sales per mechanism of action in different geographical areas, 2006 ($millions) 50
Table 17: Sales per indication in different geographical areas, 2006-2016 ($millions) 58
Table 18: Overview of the indications of approved rheumatoid arthritis products 63
Table 19: Overview of the indications of approved psoriasis products 66
Table 20: Overview of the indications of approved psoriatic arthritis products 66
Table 21: Overview of the indications of approved multiple sclerosis products 70
Table 22: Overview of the indications of approved multiple sclerosis products 73
Table 23: Sales of autoimmune disease market per geographical area ($millions) 73
Table 24: Enbrel's approved indications and date of first approval in the US, Europe and Japan for each major indication 79
Table 25: Overview of clinical trials of Enbrel in rheumatoid arthritis and juvenile rheumatoid arthritis 81
Table 26: Overview of clinical trials of Enbrel in rheumatoid arthritis in Japan 82
Table 27: Overview of clinical trials of Enbrel in psoriasis and psoriatric arthritis 85
Table 28: Overview of clinical trials of Enbrel in ankylosing spondylitis (AS) 86
Table 29: Remicade's approved indications and date of first approval in the US, Europe and Japan for each major indication 90
Table 30: Overview of clinical trials of Remicade in Crohn's disease 92
Table 31: Overview of clinical trials of Remicade in rheumatoid arthritis 94
Table 32: Overview of clinical trials of Remicade in psoriasis 97
Table 33: Overview of clinical trials of Remicade in ulcerative colitis 100
Table 34: Humira's approved indications and date of first approval in the US, Europe and Japan for each major indication 104
Table 35: Overview of clinical trials of Humira in rheumatoid arthritis 107
Table 36: Overview of clinical trials of Humira in psoriasis 110
Table 37: Overview of clinical trials of Humira in Crohn's disease 111
Table 38: Overview of clinical trials of Humira in ulcerative colitis 112
Table 39: Overview of Cimzia's development 115
Table 40: Overview of golimumab's development 119
Table 41: Rituxan/MabThera's approved Autoimmune indications and date of first approval in the US, Europe and Japan for each major indication 125
Table 42: Overview of clinical trials of Rituxan/MabThera in rheumatoid arthritis 127
Table 43: Overview of clinical trials of Rituxan/MabThera in multiple sclerosis 129
Table 44: Overview of clinical trials of Rituxan/MabThera in psoriasis, psoriatic arthritis, ulcerative colitis and ankylosing spondylitis 131
Table 45: Overview of ocrelizumab's development 134
Table 46: Overview of ofatumumab's development 136
Table 47: Overview of clinical trials of Avonex in multiple sclerosis 140
Table 48: Overview of clinical trials of Rebif in multiple sclerosis 145
Table 49: Overview of clinical trials of Betaseron/Betaferon in multiple sc