Table of Contents

The Autoimmune Market Outlook to 2013
Executive Summary 12
Epidemiology of autoimmune diseases 12
Global market analysis 13
Pipeline analysis 14
Competitive landscape 15

Chapter 1 Scope and methodology 18
Scope 18
Key autoimmune indications covered in this report: 18
Methodology 19

Chapter 2 Epidemiology of autoimmune
diseases 22
Summary 22
Introduction 23
Osteoarthritis 24
Overview 24
Diagnosis, treatment and management 24
Epidemiology 26
Forecast epidemiology 27
Rheumatoid arthritis 28
Overview 28
Diagnosis, treatment and management 28
Epidemiology 29
Forecast epidemiology 30
Crohn’s disease 31
Overview 31
Diagnosis, treatment and management 31
Epidemiology 33
Forecast epidemiology 34
Systemic lupus erythematosus 35
Overview 35
Diagnosis, treatment and management 36
Epidemiology 38
Forecast epidemiology 39
Ulcerative colitis 40
Overview 40
Diagnosis, treatment and management 41
Epidemiology 42
Forecast epidemiology 43
Multiple sclerosis 44
Overview 44
Diagnosis, treatment and management 45
Epidemiology 46
Forecast epidemiology 47

Chapter 3 Global market analysis 50
Summary 50
Introduction 51
Market analysis by country 51
Trends in generics usage and licensing 53
Market analysis by drug class 54
Leading brands dynamics 56
Key events in the autoimmune market 57
Enbrel growth slowing as it faces stiff competition from Humira 57
RoActemra receives positive opinion in Europe for the treatment of
RA 58
NICE admits previous guidance around sequential use of anti-TNF
therapies in RA is unfair 58
Study shows prohibitive cost of MS treatment 59
Mayo Clinic collaborates to advance Crohn's treatment 59
Arthritis research shows better disease management is more
important than the use of drugs 60
CellCept’s off-label use in lupus continues to increase 60
Immunosuppressants 60
Competitive dynamics of immunosuppressants 60
Leading brands of immunosuppressants 61
Key brands analysis 62
Clinical developments 63
Immunosuppressants sales forecasts to 2013 69
Specific anti-rheumatic agents 70
Competitive dynamics of specific anti-rheumatic agents 70
Leading brands of specific anti-rheumatic agents 71
Key brands analysis 72
Specific anti-rheumatic agents sales forecasts to 2013 81
Non-steroidal plain anti-rheumatics 82
Competitive dynamics of non-steroidal plain anti-rheumatics 82
Leading brands of non-steroidal plain anti-rheumatics 83
Key brands analysis 84
Non-steroidal plain anti-rheumatics sales forecasts to 2013 88
Topical anti-rheumatics 89
Competitive dynamics of topical anti-rheumatics 89
Leading brands of topical anti-rheumatics 90
Topical anti-rheumatic sales forecasts to 2013 92
Coxibs 93
Competitive dynamics of coxibs 93
Leading brands of coxibs 94
Key brands analysis 95
Coxibs sales forecasts to 2013 100
Non-steroidal (combinational) anti-rheumatics 101
Competitive dynamics of non-steroidal (combinational) anti-rheumatics 101
Leading brands of non-steroidal (combinational) anti-rheumatics 102
Non-steroidal (combinational) anti-rheumatics sales forecasts to 2013 103
Anti-rheumatic corticosteroids 104
Competitive dynamics of anti-rheumatic corticosteroids 104
Leading brands of anti-rheumatic corticosteroids 105
Anti-rheumatic corticosteroids sales forecasts to 2013 107
Total autoimmune sales forecasts to 2013 108

Chapter 4 Pipeline analysis 112
Summary 112
Introduction 113
Key trends in R&D 113
Biologics 114
Combination drugs 114
Aggressive medical therapy becoming the standard of care 115
TNF inhibitors has a strong presence in autoimmune market 115
Efforts to develop fully human monoclonal antibodies 115
The autoimmune pipeline 116
Leading drugs in development 119
Profiles of key pipeline products 120
Phase III compounds 120
Licofelone (ML3000) – Merckle GmbH 120
Ocrelizumab (R-1594) – Genentech, Biogen IDEC, Chugai and
Roche 123
LymphoStat-B (belimumab) – Human Genome Sciences (HGS) and
GSK 125
Ofatumumab (HuMax-CD20) – Genmab and GSK 127
Fingolimod (FTY-720) – Novartis/Mitsubishi Tanabe Pharma 130
Fampridine-SR – Acorda 133
Campath (alemtuzumab) – Genzyme and Bayer Schering Pharma 136
Recently approved/marketed drugs 139
Cimzia (certolizumab pegol) – UCB 139
Golimumab (CNTO-148) – Centocor/Schering-Plough 143
Actemra (tocilizumab) – Roche/Chugai 146
Tysabri (natalizumab) – Elan/Biogen Idec 149
Mesavance (mesalamine) – Shire 152
Pipeline forecasts 155
Factors affecting forecasts 155
Autoimmune pipeline forecast 155

Chapter 5 Competitive landscape 158
Summary 158
Introduction 159
Sales performance of leading players 159
Detailed analysis of leading autoimmune players 162
Amgen 162
Overview 162
Sales focus by drug class 162
Marketed product portfolio 163
R&D pipeline analysis 164
Strategic and growth analysis 165
Drivers of growth 165
Resistors of growth 166
Abbott 166
Overview 166
Sales focus by drug class 167
Marketed product portfolio 168
R&D pipeline analysis 169
Strategic and growth analysis 170
Drivers of growth 170
Resistors of growth 170
Johnson and Johnson 171
Overview 171
Sales focus by drug class 171
Marketed product portfolio 172
R&D pipeline analysis 173
Strategic and growth analysis 174
Drivers of growth 174
Resistors of growth 174
Pfizer 175
Overview 175
Sales focus by drug class 175
Marketed product portfolio 176
R&D pipeline analysis 177
Strategic and growth analysis 178
Drivers of growth 178
Resistors of growth 178
Novartis 179
Overview 179
Sales focus by drug class 179
Marketed product portfolio 180
R&D pipeline analysis 181
Strategic and growth analysis 182
Drivers of growth 182
Resistors of growth 183
Wyeth 183
Overview 183
Wyeth and Pfizer 184
Sales focus by drug class 184
Marketed product portfolio 185
R&D pipeline analysis 187
Strategic and growth analysis 188
Drivers of growth 188
Resistors of growth 188
Roche 190
Overview 190
Sales focus by drug class 190
Marketed product portfolio 191
R&D pipeline analysis 192
Strategic and growth analysis 193
Drivers of growth 193
Resistors of growth 193
Astellas 195
Overview 195
Sales focus by drug class 195
Marketed product portfolio 196
R&D pipeline analysis 197
Strategic and growth analysis 198
Drivers of growth 198
Resistors of growth 198

Chapter 6 Appendix 202
IMS Data 202
Immunosuppressive agents 202
L4A: Immunosuppressive agents 202
Musculo-skeletal system 202
M1: Anti-inflammatory and anti-rheumatic products 202
M2: Topical anti-rheumatics 202
Licensing status as per IMS Health 202
Original brand 202
Other brand 203
Licensed brand 203
Not-coded product 203
Unbranded/ generic product 203
Glossary 204
Index 206

List of Figures
Figure 3.1: Worldwide autoimmune market share by geography, 2007 52
Figure 3.2: Sales of types of autoimmune brands, 2007 54
Figure 4.3: Prevailing treatment approach for arthritis (OA and RA) 113
Figure 4.4: The autoimmune pipeline by indication and stage of development, 2007 116
Figure 4.5: Leading recently launched products and late-stage R&D in the autoimmune disorders market, 2008 119
Figure 5.6: Competitive dynamics of the leading players in the global autoimmune market, 2007 161
Figure 5.7: Amgen’s autoimmune sales by drug class, 2007 162
Figure 5.8: Abbott’s autoimmune sales by drug class, 2007 167
Figure 5.9: J&J’s autoimmune sales by drug class, 2007 171
Figure 5.10: Pfizer’s autoimmune sales by drug class, 2007 175
Figure 5.11: Novartis’ autoimmune sales by drug class, 2007 179
Figure 5.12: Wyeth’s autoimmune sales by drug class, 2007 184
Figure 5.13: Roche’s autoimmune sales by drug class, 2007 190
Figure 5.14: Astellas autoimmune sales by drug class, 2007 195

List of Tables
Table 2.1: Estimated prevalence of autoimmune diseases across seven major markets, 2007 23
Table 2.2: Estimated prevalence of OA across seven major markets, 2007 26
Table 2.3: Forecast epidemiology of OA across seven major markets, 2007–13 27
Table 2.4: Estimated prevalence of RA across seven major markets, 2007 29
Table 2.5: Forecast epidemiology of RA across seven major markets, 2007–13 30
Table 2.6: Estimated prevalence of CD across seven major markets, 2007 33
Table 2.7: Forecast epidemiology of CD across seven major markets, 2007–13 34
Table 2.8: Estimated prevalence of lupus across seven major markets, 2007 38
Table 2.9: Forecast epidemiology of lupus across seven major markets, 2007–13 39
Table 2.10: Estimated prevalence of UC across seven major markets, 2007 42
Table 2.11: Forecast epidemiology of UC across seven major markets, 2007–13 43
Table 2.12: Estimated prevalence of MS across seven major markets, 2007 46
Table 2.13: Forecast epidemiology of MS across seven major markets, 2007–13 47
Table 3.14: Worldwide autoimmune sales by countries, 2007 53
Table 3.15: Breakdown of the global autoimmune market by drug class, 2007 54
Table 3.16: Leading brands in the global autoimmune market, 2007 56
Table 3.17: Leading immunosuppressant brands in the global autoimmune market, 2006–07 61
Table 3.18: Remicade launch status in major markets 63
Table 3.19: Immunosuppressants sales forecast, 2007–13 69
Table 3.20: Leading specific anti-rheumatic brands in the global autoimmune market, 2006–07 71
Table 3.21: Enbrel launch status in major markets 73
Table 3.22: Specific anti-rheumatic agents sales forecast, 2007–13 81
Table 3.23: Leading non-steroidal plain anti-rheumatic brands in the global autoimmune market,
2006–07 83