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  4. > PharmaPoint: Systemic Lupus Erythematosus and Lupus Nephritis - Global Drug Forecast and Market Analysis to 2022 - Event-Driven Update

PharmaPoint: Systemic Lupus Erythematosus and Lupus Nephritis - Global Drug Forecast and Market Analysis to 2022 - Event-Driven Update

Summary

The lupus therapeutics market is dominated by generics and GlaxoSmithKline’s Benlysta is the only drug that has gained marketing approval for SLE in more than 50 years. Following Benlysta’s launch, patients’ uptake has remained low, but due to its associated high price-tag Benlysta has managed to grow the lupus market in terms of value and is currently the top-selling drug in this market, having generated approximately $265.6m in 2014 in the seven major markets. There is high R&D activity for the development of new therapies for lupus and seven promising biological therapies have the potential to enter the SLE and LN market during the 2012-2022 forecast period. The introduction of new biologic drugs will shape the future competitive landscape and drive growth in the SLE and LN markets.

Highlights

Key Questions Answered

- What was the impact of Benlysta on the lupus therapeutics market following its approval in 2011 and what is its future outlook in this market?
- What do physicians think about Rituxan following its unsuccessful Phase III trials in LN, and how will it be used off-label in lupus during the forecast period?
- What is the significance of late-phase pipeline products and how will their launch shape the future treatment landscape in SLE and LN?
- What are the significant unmet needs in the SLE and LN markets?
- What are the remaining opportunities in the SLE and LN markets?

Key Findings

- The key drivers of growth for the SLE and LN markets are the increasing uptake of GlaxoSmithKline’s Benlysta, the potential launch of new biologic drugs and the increasing number of prevalent cases of SLE and LN during the 2012-2022 forecast period.
- R&D strategies include the development of me-too and first-in-class therapies, partnerships and acquisitions, and the development of products for LN.
- The lupus therapeutics market is characterized by significant unmet needs. The most pressing unmet need is the development of new therapies that will offer potent clinical benefits, have a positive safety profile and increase the available treatment options for patients.

Scope

- Overview of SLE and LN, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
- Annualized SLE and LN therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2012 and forecast for ten years to 2022.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, and implications for the SLE and LN therapeutics markets.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of mid-stage pipeline drugs.
- Analysis of the current and future market competition in the global SLE and LN therapeutics markets. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

- Develop and design in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global SLE and LN therapeutics markets.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global SLE and LN therapeutics markets in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global SLE and LN therapeutics markets from 2012-2022.
- Organize sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table Of Contents

PharmaPoint: Systemic Lupus Erythematosus and Lupus Nephritis - Global Drug Forecast and Market Analysis to 2022 - Event-Driven Update
1 Table of Contents
1 Table of Contents 9
1.1 List of Tables 16
1.2 List of Figures 22
2 Introduction 24
2.1 Catalyst 24
2.2 Related Reports 25
2.3 Upcoming Related Reports 25
3 Disease Overview 26
3.1 Etiology and Pathophysiology 26
3.1.1 Etiology 26
3.1.2 Pathophysiology 28
3.2 Prognosis 29
3.3 Quality of Life 29
3.4 Symptoms 30
4 Epidemiology 31
4.1 Risk Factors and Comorbidities 31
4.1.1 Women are at a higher risk of developing SLE than men 31
4.1.2 Caucasians are at lower risk of developing SLE than other ethnicities 32
4.1.3 Familial history has been associated with an increased risk of developing SLE 33
4.1.4 Certain occupational and environmental exposures trigger SLE 34
4.2 Global Trends 35
4.2.1 US 36
4.2.2 5EU 37
4.2.3 Japan 40
4.3 Forecast Methodology 40
4.4 Sources Used 42
4.4.1 US 42
4.4.2 France 44
4.4.3 Germany 44
4.4.4 Italy 44
4.4.5 Spain 45
4.4.6 UK 45
4.4.7 Japan 46
4.5 Sources Not Used 47
4.5.1 US 47
4.5.2 5EU 47
4.5.3 Japan 48
4.6 Forecast Assumptions and Methods 48
4.6.1 US 49
4.6.2 5EU 49
4.6.3 Japan 52
4.7 Epidemiological Forecast of SLE (2012-2022) 53
4.7.1 Diagnosed Prevalent Cases of SLE 53
4.7.2 Age-Specific Prevalent Cases of SLE 55
4.7.3 Sex-Specific Prevalent Cases of Diagnosed SLE 57
4.7.4 Age-Standardized Prevalence of SLE 58
4.7.5 Diagnosed Prevalent Cases of LN 59
4.7.6 Prevalent Cases of LN, Segmented by Class 61
4.8 Discussion 63
4.8.1 Conclusions on Epidemiology Trends 63
4.8.2 Limitations of the Analysis 64
4.8.3 Strengths of the Analysis 65
5 Disease Management 67
5.1 Diagnosis Overview 67
5.1.1 SLE Diagnosis 67
5.1.2 LN Diagnosis 70
5.2 Treatment Overview 72
5.3 US 76
5.3.1 Diagnosis 76
5.3.2 Clinical Practice 77
5.4 France 79
5.4.1 Diagnosis 79
5.4.2 Clinical Practice 79
5.5 Germany 80
5.5.1 Diagnosis 80
5.5.2 Clinical Practice 81
5.6 Italy 83
5.6.1 Diagnosis 83
5.6.2 Clinical Practice 83
5.7 Spain 84
5.7.1 Diagnosis 84
5.7.2 Clinical Practice 85
5.8 UK 86
5.8.1 Diagnosis 86
5.8.2 Clinical Practice 87
5.9 Japan 88
5.9.1 Diagnosis 88
5.9.2 Clinical Practice 89
6 Competitive Assessment 91
6.1 Overview 91
6.2 Strategic Competitor Assessment 91
6.3 Product Profiles - Major Brands 92
6.3.1 Antimalarial Therapy (numerous brand names) 92
6.3.2 Steroids (numerous brand names) 98
6.3.3 Methotrexate (numerous brand names) 103
6.3.4 Mycophenolate Mofetil (numerous brand names) 107
6.3.5 Cyclophosphamide (numerous brand names) 112
6.3.6 Azathioprine (numerous brand names) 117
6.3.7 Calcineurin Inhibitors (numerous brand names) 121
6.3.8 Benlysta (belimumab) 126
6.3.9 Rituxan (rituximab) 135
6.3.10 Minor Therapeutic Classes 140
7 Opportunity and Unmet Need 142
7.1 Overview 142
7.2 Unmet Needs 143
7.2.1 Efficacious Treatments with Reduced Side Effects 143
7.2.2 Management of LN 144
7.2.3 Improvement in Patients' Mortality 145
7.2.4 Management of Lupus Comorbidities 146
7.2.5 Sensitive and Reliable Biomarkers 147
7.2.6 Physicians' Education and Public Awareness of SLE 147
7.2.7 Unmet Needs Gap Analysis 148
7.3 Opportunities 149
7.3.1 Efficacious and Safe Therapies 149
7.3.2 Therapies Targeting LN Patients 150
7.3.3 Treatments for Common Lupus Comorbidities 151
7.3.4 Discovery of Biomarkers 151
8 Pipeline Assessment 152
8.1 Overview 152
8.2 Clinical Trial Mapping 152
8.2.1 Clinical Trials by Therapy Type 152
8.3 Promising Drugs in Clinical Development 153
8.3.1 Blisibimod (A-623) 154
8.3.2 Atacicept 162
8.3.3 Epratuzumab 169
8.3.4 Lupuzor (rigerimod) 177
8.3.5 Orencia (abatacept) 183
8.3.6 Sifalimumab (MEDI-545) 190
8.3.7 PF-04236921 196
8.3.8 Anifrolumab (MEDI-546) 202
8.3.9 Lulizumab Pegol (BMS-931699) 204
8.3.10 BIIB023 206
8.3.11 Voclosporin 208
8.4 Other Drugs in Development 211
9 Current and Future Players 212
9.1 Overview 212
9.2 Trends in Corporate Strategy 214
9.3 Company Profiles 215
9.3.1 GlaxoSmithKline 215
9.3.2 Roche 217
9.3.3 UCB 220
9.3.4 Bristol-Myers Squibb 222
9.3.5 Anthera 223
9.3.6 ImmuPharma 225
9.3.7 Merck Serono 227
9.3.8 AstraZeneca 228
9.3.9 Pfizer 230
10 Market Outlook 232
10.1 Global Markets 232
10.1.1 Forecast 232
10.1.2 Drivers and Barriers - Global Issues 240
10.2 US 242
10.2.1 Forecast 242
10.2.2 Key Events 247
10.2.3 Drivers and Barriers 247
10.3 France 249
10.3.1 Forecast 249
10.3.2 Key Events 254
10.3.3 Drivers and Barriers 254
10.4 Germany 256
10.4.1 Forecast 256
10.4.2 Key Events 260
10.4.3 Drivers and Barriers 260
10.5 Italy 261
10.5.1 Forecast 261
10.5.2 Key Events 266
10.5.3 Drivers and Barriers 266
10.6 Spain 267
10.6.1 Forecast 267
10.6.2 Key Events 272
10.6.3 Drivers and Barriers 272
10.7 UK 273
10.7.1 Forecast 273
10.7.2 Key Events 278
10.7.3 Drivers and Barriers 278
10.8 Japan 279
10.8.1 Forecast 279
10.8.2 Key Events 284
10.8.3 Drivers and Barriers 284
11 Appendix 286
11.1 Bibliography 286
11.2 Abbreviations 304
11.3 Methodology 309
11.4 Forecasting Methodology 309
11.4.1 Diagnosed SLE and LN Patients 309
11.4.2 Percent Drug-Treated Patients 310
11.4.3 Drugs Included in Each Therapeutic Class 310
11.4.4 Launch and Patent Expiry Dates 310
11.4.5 General Pricing Assumptions 311
11.4.6 Individual Drug Assumptions 312
11.4.7 Generic Erosion 315
11.4.8 Pricing of Pipeline Agents 316
11.5 Physicians and Specialists Included in this Study 317
11.6 Primary Research - Prescriber Survey 319
11.7 About the Authors 320
11.7.1 Analysts 320
11.7.2 Epidemiologist 321
11.7.3 Global Head of Healthcare 321
11.8 About GlobalData 322
11.9 Disclaimer 322

1.1 List of Tables
Table 1: Symptoms of SLE 30
Table 2: Risk Factors Associated with SLE 31
Table 3: World Health Organization Morphologic Classification of Lupus Nephritis (Modified in 1982) 41
Table 4: Sources of Prevalence Data Used in this Analysis 42
Table 5: 7MM, Prevalent Cases of Diagnosed SLE, All Ages, Both Sexes, N, Select Years 2012-2022 54
Table 6: 7MM, Prevalent Cases of Diagnosed SLE, by Age, Both Sexes, N, Row (%), 2012 56
Table 7: 7MM, Prevalent Cases of Diagnosed SLE, All Ages, by Sex, N, Row (%), 2012 57
Table 8: 7MM, Prevalent Cases of Diagnosed LN, All Ages, Both Sexes, N, Select Years 2012-2022 60
Table 9: 6MM, Prevalent Cases in the Different Classes of LN, All Age, Both Sexes, N, Row (%), 2012 62
Table 10: 1997 Updated ACR Criteria for Classification of SLE 68
Table 11: The SLICC Clinical and Immunologic Criteria for Classification of SLE 69
Table 12: WHO and ISN/RPS classifications of LN 71
Table 13: Treatment Guidelines for SLE and LN 74
Table 14: Most Prescribed Drugs for SLE and LN by Class in the Global Markets 75
Table 15: Leading Treatments for SLE and LN, 2015 92
Table 16: Product Profile - Hydroxychloroquine 94
Table 17: Antimalarial Therapy SWOT Analysis, 2015 96
Table 18: Global SLE Sales Forecasts ($m) for Antimalarial Therapy, 2012-2022 97
Table 19: Global LN Sales Forecasts ($m) for Antimalarial Therapy, 2012-2022 97
Table 20: Product Profile - Steroids 100
Table 21: Steroids SWOT Analysis, 2015 101
Table 22: Global SLE Sales Forecasts ($m) for Steroid Therapy, 2012-2022 102
Table 23: Global LN Sales Forecasts ($m) for Steroid Therapy, 2012-2022 102
Table 24: Product Profile - Methotrexate 104
Table 25: Methotrexate SWOT Analysis, 2015 105
Table 26: Global SLE Sales Forecasts ($m) for MTX, 2012-2022 106
Table 27: Global LN Sales Forecasts ($m) for MTX, 2012-2022 106
Table 28: Product Profile - Mycophenolate Mofetil 108
Table 29: Mycophenolate Mofetil SWOT Analysis, 2015 110
Table 30: Global SLE Sales Forecasts ($m) for MMF, 2012-2022 111
Table 31: Global LN Sales Forecasts ($m) for MMF, 2012-2022 111
Table 32: Product Profile - Cyclophosphamide 113
Table 33: Cyclophosphamide SWOT Analysis, 2015 115
Table 34: Global SLE Sales Forecasts ($m) for CYC, 2012-2022 116
Table 35: Global LN Sales Forecasts ($m) for CYC, 2012-2022 116
Table 36: Product Profile - Azathioprine 118
Table 37: Azathioprine SWOT Analysis, 2015 119
Table 38: Global SLE Sales Forecasts ($m) for AZA, 2012-2022 120
Table 39: Global LN Sales Forecasts ($m) for AZA, 2012-2022 120
Table 40: Product Profile - Calcineurin Inhibitors 122
Table 41: Calcineurin Inhibitors SWOT Analysis, 2015 124
Table 42: Global SLE Sales Forecasts ($m) for Calcineurin Inhibitors, 2012-2022 125
Table 43: Global LN Sales Forecasts ($m) for Calcineurin Inhibitors, 2012-2022 125
Table 44: Product Profile - Benlysta 128
Table 45: Benlysta SWOT Analysis, 2015 132
Table 46: Global SLE Sales Forecasts ($m) for Benlysta, 2012-2022 134
Table 47: Global LN Sales Forecasts ($m) for Benlysta, 2012-2022 134
Table 48: Product Profile - Rituxan 136
Table 49: Rituxan SWOT Analysis, 2015 138
Table 50: Global SLE Sales Forecasts ($m) for Rituxan, 2012-2022 139
Table 51: Global LN Sales Forecasts ($m) for Rituxan, 2012-2022 140
Table 52: Summary of Minor Therapeutic Classes in SLE and LN, 2015 141
Table 53: Overall Unmet Needs in SLE and LN - Current Level of Attainment 143
Table 54: Clinical Unmet Needs in SLE and LN - Gap Analysis, 2015 149
Table 55: Drugs in Late-Stage Clinical Development for SLE and LN, 2015 154
Table 56: Product Profile - Blisibimod 155
Table 57: Blisibimod SWOT Analysis, 2015 160
Table 58: Global SLE Sales Forecasts ($m) for Blisibimod, 2012-2022 161
Table 59: Global LN Sales Forecasts ($m) for Blisibimod, 2012-2022 162
Table 60: Product Profile - Atacicept 164
Table 61: Atacicept SWOT Analysis, 2015 167
Table 62: Global SLE Sales Forecasts ($m) for Atacicept, 2012-2022 168
Table 63: Global LN Sales Forecasts ($m) for Atacicept, 2012-2022 169
Table 64: Product Profile - Epratuzumab 171
Table 65: Epratuzumab SWOT Analysis, 2015 175
Table 66: Global SLE Sales Forecasts ($m) for Epratuzumab, 2012-2022 176
Table 67: Global LN Sales Forecasts ($m) for Epratuzumab, 2012-2022 177
Table 68: Product Profile - Lupuzor 178
Table 69: Lupuzor SWOT Analysis, 2015 181
Table 70: Global SLE Sales Forecasts ($m) for Lupuzor, 2012-2022 182
Table 71: Global LN Sales Forecasts ($m) for Lupuzor, 2012-2022 183
Table 72: Product Profile - Orencia 184
Table 73: Orencia SWOT Analysis, 2015 188
Table 74: Global SLE Sales Forecasts ($m) for Orencia, 2012-2022 189
Table 75: Global LN Sales Forecasts ($m) for Orencia, 2012-2022 189
Table 76: Product Profile - Sifalimumab 191
Table 77: Sifalimumab SWOT Analysis, 2015 194
Table 78: Global SLE Sales Forecasts ($m) for Sifalimumab, 2012-2022 195
Table 79: Global LN Sales Forecasts ($m) for Sifalimumab, 2012-2022 196
Table 80: Product Profile - PF-04236921 197
Table 81: PF-04236921 SWOT Analysis, 2015 200
Table 82: Global SLE Sales Forecasts ($m) for PF-04236921, 2012-2022 201
Table 83: Global LN Sales Forecasts ($m) for PF-04236921, 2012-2022 201
Table 84: Product Profile - Anifrolumab 203
Table 85: Anifrolumab SWOT Analysis, 2015 204
Table 86: Product Profile - Lulizumab Pegol 205
Table 87: Lulizumab Pegol SWOT Analysis, 2015 206
Table 88: Product Profile - BIIB023 207
Table 89: BIIB023 SWOT Analysis, 2015 208
Table 90: Product Profile - Voclosporin 209
Table 91: Voclosporin SWOT Analysis, 2015 210
Table 92: Drugs in Early-stage Clinical Development for SLE and LN, 2015 211
Table 93: Key Companies in the SLE and LN Market, 2015 213
Table 94: GSK's SLE and LN Portfolio Assessment, 2015 217
Table 95: GlaxoSmithKline SWOT Analysis, 2015 217
Table 96: Roche's SLE and LN Portfolio Assessment, 2015 219
Table 97: Roche SWOT Analysis, 2015 219
Table 98: UCB's SLE and LN Portfolio Assessment, 2015 221
Table 99: UCB SWOT Analysis, 2015 221
Table 100: BMS's SLE and LN Portfolio Assessment, 2015 222
Table 101: BMS SWOT Analysis, 2015 223
Table 102: Anthera's SLE and LN Portfolio Assessment, 2015 224
Table 103: Anthera SWOT Analysis, 2015 224
Table 104: ImmuPharma's SLE and LN Portfolio Assessment, 2015 226
Table 105: ImmuPharma SWOT Analysis, 2015 226
Table 106: Merck Serono's SLE and LN Portfolio Assessment, 2015 227
Table 107: Merck Serono SWOT Analysis, 2015 228
Table 108: AstraZeneca's SLE and LN Portfolio Assessment, 2015 229
Table 109: AstraZeneca SWOT Analysis, 2015 229
Table 110: Pfizer's SLE and LN Portfolio Assessment, 2015 230
Table 111: Pfizer SWOT Analysis, 2015 231
Table 112: Global Sales Forecasts ($m) for SLE, 2012-2022 234
Table 113: Global Sales Forecasts ($m) for LN, 2012-2022 235
Table 114: SLE and LN Market - Global Drivers and Barriers, 2012-2022 240
Table 115: Sales Forecasts ($m) for SLE in the US, 2012-2022 244
Table 116: Sales Forecasts ($m) for LN in the US, 2012-2022 245
Table 117: Key Events Impacting Sales for SLE and LN in the US, 2012-2022 247
Table 118: SLE and LN Market in the US - Drivers and Barriers, 2012-2022 247
Table 119: Sales Forecasts ($m) for SLE in France, 2012-2022 251
Table 120: Sales Forecasts ($m) for LN in France, 2012-2022 252
Table 121: Key Events Impacting Sales for SLE and LN in France, 2012-2022 254
Table 122: SLE and LN Market in France - Drivers and Barriers, 2012-2022 254
Table 123: Sales Forecasts ($m) for SLE in Germany, 2012-2022 257
Table 124: Sales Forecasts ($m) for LN in Germany, 2012-2022 258
Table 125: Key Events Impacting Sales for SLE and LN in Germany, 2012-2022 260
Table 126: SLE and LN Market in Germany - Drivers and Barriers, 2012-2022 260
Table 127: Sales Forecasts ($m) for SLE in Italy, 2012-2022 263
Table 128: Sales Forecasts ($m) for LN in Italy, 2012-2022 264
Table 129: Key Events Impacting Sales for SLE and LN in Italy, 2012-2022 266
Table 130: SLE and LN Market in Italy - Drivers and Barriers, 2012-2022 266
Table 131: Sales Forecasts ($m) for SLE in Spain, 2012-2022 269
Table 132: Sales Forecasts ($m) for LN in Spain, 2012-2022 270
Table 133: Key Events Impacting Sales for SLE and LN in Spain, 2012-2022 272
Table 134: SLE and LN Market in Spain - Drivers and Barriers, 2012-2022 272
Table 135: Sales Forecasts ($m) for SLE in the UK, 2012-2022 275
Table 136: Sales Forecasts ($m) for LN in the UK, 2012-2022 276
Table 137: Key Events Impacting Sales for SLE and LN in the UK, 2012-2022 278
Table 138: SLE and LN Market in the UK - Drivers and Barriers, 2012-2022 278
Table 139: Sales Forecasts ($m) for SLE in Japan, 2012-2022 281
Table 140: Sales Forecasts ($m) for LN in Japan, 2012-2022 282
Table 141: Key Events Impacting Sales for SLE and LN in Japan, 2012-2022 284
Table 142: SLE and LN Market in Japan - Drivers and Barriers, 2012-2022 284
Table 143: Key Launch Dates 310
Table 144: Key Patent Expiries 310
Table 145: Number of Physicians Surveyed by Country 319

1.2 List of Figures
Figure 1: Overview of the Etiology and Pathogenesis of SLE 27
Figure 2: Overview of the BAFF/APRIL Ligand and Receptor System 29
Figure 3: 7MM, Prevalent Cases of Diagnosed SLE, All Ages, Both Sexes, N, 2012-2022 54
Figure 4: 7MM, Prevalent Cases of Diagnosed SLE, by Age, Both Sexes, N, Row (%), 2012 56
Figure 5: 7MM, Prevalent Cases of Diagnosed SLE, All Ages, Both Sexes, 2012 58
Figure 6: 7MM, Age-Standardized Prevalence (%) of Diagnosed SLE, All Ages, by Sex, 2012 59
Figure 7: 7MM, Prevalent Cases of Diagnosed LN, All Ages, Both Sexes, N, 2012-2022 61
Figure 8: 6MM, Prevalent Cases of LN, by Class, All Ages, Both Sexes, 2012 62
Figure 9: Overview of the Treatment Management of SLE 72
Figure 10: SLE and LN Therapeutics - Clinical Trials by Type of Therapy and Development Stage, January 2015 152
Figure 11: Competitive Assessment of Late-Stage Pipeline Agents in SLE and LN, 2012-2022 153
Figure 12: Company Portfolio Gap Analysis in SLE and LN, 2012-2022 214
Figure 13: Global Sales for SLE and LN by Region, 2012-2022 236
Figure 14: Sales for SLE in the Seven Major Markets by Drug Class According to Market Value and Volume, 2012-2022 238
Figure 15: Sales for LN in the Seven Major Markets by Drug Class According to Market Value and Volume, 2012-2022 239
Figure 16: Sales for SLE and LN in the US by Drug Class, 2012-2022 246
Figure 17: Sales for SLE and LN in France by Drug Class, 2012-2022 253
Figure 18: Sales for SLE and LN in Germany by Drug Class, 2012-2022 259
Figure 19: Sales for SLE and LN in Italy by Drug Class, 2012-2022 265
Figure 20: Sales for SLE and LN in Spain by Drug Class, 2012-2022 271
Figure 21: Sales for SLE and LN in the UK by Drug Class, 2012-2022 277
Figure 22: Sales for SLE and LN in Japan by Drug Class, 2012-2022 283

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