Summary
Systemic lupus erythematosus (SLE) is a systemic inflammatory autoimmune disease that can affect any organ or tissue and is the prototypic autoimmune disease. As a multisystem disorder, SLE is heterogeneous in nature-no two cases of lupus are alike-and can affect multiple major organ systems in the body, one of its most severe manifestations includes renal (kidney) involvement, known as lupus nephritis (LN). The etiology of SLE and LN remains incompletely understood, but genetic and environmental factors have been shown to play pivotal roles in the development of the disease.
To date, the cornerstone of lupus therapy still relies on generic steroids and unspecific immunosuppressive agents; both of which are associated with severe adverse events (SAEs) and contribute significantly to the morbidity and mortality in lupus. The much anticipated approval of Benlysta (belimumab) in 2011 had only a small impact on the treatment paradigm, and off-label Rituxan/MabThera (rituximab) remains the market leader in terms of sales. R&D efforts in lupus are high, however late-stage clinical failure remains a major barrier to market entry. The anticipated release of six new pipeline agents for SLE and LN will have the potential to revolutionize the lupus treatment. GlobalData expects the global SLE and LN market-which, for the purposes of this report, comprises the seven major pharmaceutical markets (7MM; US, France, Germany, Italy, Spain, UK, Japan)-to expand during the next decade at an astonishing CAGR of 10.6%, reaching total sales of $3.2 billion by 2025.
Highlights
Key Questions Answered
- Based on interviews with key opinion leaders (KOLs), GlobalData has identified key unmet needs in the SLE and LN marketplace.
- What will be the effect of recent and upcoming biologics on the SLE and LN treatment landscape?
- How will the upcoming first-in-class and me-too pipeline agents be received in the different markets?
- What research and development (R&D) strategies will companies leverage to compete in the future SLE and LN marketplace?
- Which patient population(s) are most likely to be targeted by newly introduced pipeline agents?
Key Findings
- GlobalData has calculated that the global SLE and LN market generated about $1.2 billion in sales in 2015. This global market is expected to grow by an astonishingly strong compound annual growth rate (CAGR) of 10.6% from 2015-2025, reaching annual sales of $3.2 billion by the end of the forecast period. The majority of this growth will occur in the US, driven by an increased diagnosed disease prevalence of SLE and LN and the launch of three new first-in-class pipeline drugs (anifrolumab, Orencia [abatacept], and Lupuzor) and three improved therapeutic options (atacicept, blisibimod, and voclosporin). The SLE and LN market in the US is expected to grow at a CAGR of 10.4%, reaching sales of $2.8 billion by 2025. GlobalData estimates that sales in the 5EU to grow at a CAGR of 14.1% during the next 10 years, reaching $312.4m by 2025, while Japan will experience the lowest growth with a CAGR of 9.8%.
- KOLs interviewed by GlobalData repeatedly identified the need for efficacious drugs as the most important clinical unmet need, with reducing lupus morbidity and mortality and the development of sensitive and reliable biomarkers for diagnosis and disease management as key areas of need as well.
- GlobalData anticipates that opportunities will center on the development of safer and more efficacious drugs to treat the various disease manifestations in lupus.
Scope
- Overview of SLE and LN, including epidemiology, etiology, pathophysiology, as well current routine SLE and LN recommendations of all 7MM covered.
- Top-line SLE and LN market revenue from 2015-2025. Recent acquisitions, approvals and governmental recommendations are included in the forecast model.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the SLE and LN market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and analysis of late-stage pipeline products. An interactive clinical and commercial analyzer tool is available.
- Analysis of the current and future market competition in the global SLE and LN marketplace. 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
The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global SLE and LN market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the SLE and LN market 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.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
Companies Mentioned
GlaxoSmithKline
Roche
Bristol-Myers Squibb
AstraZeneca
Merck KGaA
Anthera Pharmaceuticals
Aurinia Pharmaceuticals
ImmuPharma
Pfizer
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1 Table of Contents
1 Table of Contents 10
1.1 List of Tables 17
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 27
3.2 Symptoms 29
3.3 Prognosis 31
3.4 Quality of Life 32
4 Epidemiology 33
4.1 Disease Background 33
4.2 Risk Factors and Comorbidities 35
4.3 Global Trends 37
4.3.1 SLE and LN Prevalence 37
4.3.2 LN Classification 41
4.4 Forecast Methodology 41
4.4.1 Sources Used 42
4.4.2 Forecast Assumptions and Methods 47
4.4.3 Sources Not Used 59
4.5 Epidemiological Forecast for SLE and LN (2015-2025) 61
4.5.1 Diagnosed Prevalent Cases of SLE 61
4.5.2 Age-Specific Diagnosed Prevalent Cases of SLE 63
4.5.3 Sex-Specific Diagnosed Prevalent Cases of SLE 65
4.5.4 Age-Standardized Diagnosed Prevalence of SLE 67
4.5.5 Diagnosed Prevalent Cases of SLE Segmented by Severity 68
4.5.6 Diagnosed Prevalent Cases of LN 70
4.5.7 Diagnosed Prevalent Cases of LN Segmented by Class 72
4.6 Discussion 76
4.6.1 Epidemiological Forecast Insight 76
4.6.2 Limitations of the Analysis 77
4.6.3 Strengths of the Analysis 79
5 Disease Management 80
5.1 Diagnosis Overview 80
5.1.1 SLE Diagnosis 80
5.1.2 LN Diagnosis 83
5.2 Treatment Overview 85
5.2.1 Treatment Guidelines and Leading Prescribed Drugs 87
5.3 US 90
5.3.1 Diagnosis 91
5.3.2 Clinical Practice 92
5.4 France 94
5.4.1 Diagnosis 95
5.4.2 Clinical Practice 95
5.5 Germany 97
5.5.1 Diagnosis 98
5.5.2 Clinical Practice 98
5.6 Italy 100
5.6.1 Diagnosis 101
5.6.2 Clinical Practice 101
5.7 Spain 103
5.7.1 Diagnosis 104
5.7.2 Clinical Practice 104
5.8 UK 106
5.8.1 Diagnosis 107
5.8.2 Clinical Practice 107
5.9 Japan 109
5.9.1 Diagnosis 110
5.9.2 Clinical Practice 110
6 Competitive Assessment 112
6.1 Overview 112
6.2 Strategic Competitor Assessment 113
6.3 Product Profiles - Major Brands, Small Molecules 114
6.3.1 Antimalarials (numerous brand names) 114
6.3.2 Steroids (numerous brand names) 122
6.3.3 Methotrexate (numerous brand names) 129
6.3.4 Mycophenolate Mofetil (numerous brand names) 136
6.3.5 Cyclophosphamide (numerous brand names) 145
6.3.6 Azathioprine (numerous brand names) 151
6.3.7 Calcineurin Inhibitors (numerous brand names) 158
6.4 Product Profiles - Major Brands, Biologics 167
6.4.1 Benlysta (belimumab) 167
6.4.2 Rituxan (rituximab) 177
6.5 Minor Therapeutic Classes 185
7 Unmet Needs Assessment and Opportunity Analysis 186
7.1 Overview 186
7.2 Drugs with Superior Efficacy and Safety Profiles, Particularly for LN 188
7.2.1 Unmet Need 188
7.2.2 Gap Analysis 192
7.2.3 Opportunity 195
7.3 Refined Clinical Trial Design Tailored to Heterogeneous Lupus Patient Populations 197
7.3.1 Unmet Need 197
7.3.2 Gap Analysis 198
7.3.3 Opportunity 200
7.4 Reduced Morbidity and Mortality in Lupus Patients 203
7.4.1 Unmet Need 203
7.4.2 Gap Analysis 204
7.4.3 Opportunity 205
7.5 Improved Physician Education 207
7.5.1 Unmet Need 207
7.5.2 Gap Analysis 208
7.5.3 Opportunity 210
7.6 Sensitive and Reliable Biomarkers for Diagnosis and Disease Management 211
7.6.1 Unmet Need 211
7.6.2 Gap Analysis 212
7.6.3 Opportunity 213
7.7 Increased Compliance Rates for SOC SLE and LN Therapies 213
7.7.1 Unmet Need 213
7.7.2 Gap Analysis 214
7.7.3 Opportunity 215
8 Pipeline Assessment 216
8.1 Overview 216
8.2 Clinical Trial Mapping 216
8.2.1 Clinical Trials by Therapy Type 216
8.3 Promising Drugs in Late-Stage Clinical Development 217
8.3.1 Blisibimod 221
8.3.2 Atacicept 231
8.3.3 Orencia (abatacept) 239
8.3.4 Anifrolumab 247
8.3.5 Lupuzor (IPP-201101, P-140) 255
8.3.6 Voclosporin 261
8.4 Promising Drugs in Early-Stage Clinical Development 270
8.4.1 Overview 270
8.5 Other Drugs in Clinical Development 278
8.6 Biosimilars 280
8.6.1 Overview 280
8.6.2 Hospira’s Inflectra Versus J&J’s Remicade in Key Autoimmune Diseases 281
8.6.3 Biosimilars in the Immunology Community 281
8.6.4 By the Numbers: Biosimilars in Development for Potential Off-Label Use in SLE and LN 281
8.6.5 The Impact of Biosimilars Will Be Felt Throughout the Pharmaceutical Industry 284
8.6.6 Uptake of Biosimilars for SLE and LN Is Expected to Vary by Country/Region 285
8.6.7 Biosimilars Forecast for SLE and LN 285
9 Current and Future Players 287
9.1 Overview 287
9.2 Trends in Corporate Strategy 291
9.3 Company Profiles 292
9.3.1 GlaxoSmithKline 292
9.3.2 Roche 294
9.3.3 Bristol-Myers Squibb 296
9.3.4 AstraZeneca 298
9.3.5 Merck KGaA 300
9.3.6 Anthera Pharmaceuticals 302
9.3.7 Aurinia Pharmaceuticals 303
9.3.8 ImmuPharma 305
9.3.9 Pfizer 306
10 Market Outlook 307
10.1 Global Markets 307
10.1.1 Forecast 307
10.1.2 Drivers and Barriers - Global Issues 316
10.2 US 317
10.2.1 Forecast 317
10.2.2 Key Events 321
10.2.3 Drivers and Barriers 322
10.3 5EU 322
10.3.1 Forecast 322
10.3.2 Key Events 329
10.3.3 Drivers and Barriers 330
10.4 Japan 330
10.4.1 Forecast 330
10.4.2 Key Events 335
10.4.3 Drivers and Barriers 336
11 Appendix 337
11.1 Bibliography 337
11.2 Abbreviations 371
11.3 Methodology 376
11.4 Forecasting Methodology 376
11.4.1 Diagnosed SLE and LN Patients 376
11.4.2 Drugs Included in Each Therapeutic Class 377
11.4.3 Percent Drug-Treated Patients 378
11.4.4 Launch and Patent Expiry Dates 379
11.4.5 General Pricing Assumptions 381
11.4.6 Individual Drug Assumptions 382
11.4.7 Generic Erosion 394
11.4.8 Pricing of Pipeline Agents 395
11.5 Primary Research - KOLs Interviewed for this Report 397
11.6 Primary Research - Prescriber Survey 401
11.7 About the Authors 402
11.7.1 Analyst 402
11.7.2 Therapy Area Directors 402
11.7.3 Epidemiologists 403
11.7.4 Global Director of Therapy Analysis and Epidemiology 405
11.8 About GlobalData 406
11.9 Disclaimer 406
1.1 List of Tables
Table 1: Symptoms of SLE 30
Table 2: The 1982 Revised ACR Criteria For Classification of Systemic Lupus Erythematosus 34
Table 3: WHO and ISN/RPS Classification Systems for LN 35
Table 4: Risk Factors for SLE 36
Table 5: 7MM, Sources Used for Diagnosed Prevalence of SLE 43
Table 6: 7MM, Sources Used for Diagnosed Prevalence of Mild and Moderate/Severe SLE 44
Table 7: 7MM, Sources Used for Diagnosed Prevalence of LN 45
Table 8: 7MM, Sources Used for Diagnosed Prevalent Cases of LN Classified by the WHO Classification 46
Table 9: 7MM, Sources Used for Classifying LN by the ISN/RPS Classification 47
Table 10: 7MM, Sources Not Used in Epidemiological Analysis of SLE 60
Table 11: 7MM, Diagnosed Prevalent Cases of SLE, All Ages, Both Sexes, N, Select Years 2015-2025 62
Table 12: 7MM, Age-Specific Diagnosed Prevalent Cases of SLE, Both Sexes, N, Row (%), 2015 64
Table 13: 7MM, Diagnosed Prevalent Cases of SLE, All Ages, By Sex, N, Row (%), 2015 66
Table 14: 7MM, Diagnosed Prevalent Cases of SLE, All Ages, Men and Women, By Severity, N, Row (%), 2015 69
Table 15: 7MM, Diagnosed Prevalent Cases of LN, All Ages, Both Sexes, N, Select Years 2015-2025 71
Table 16: 7MM, Diagnosed Prevalent Cases of LN, Both Sexes, All Ages, by WHO Classification, Row (%), 2015 72
Table 17: 7MM, Diagnosed Prevalent Cases of LN, Both Sexes, All Ages, by ISN/RPS Classification, Row (%), 2015 74
Table 18: Updated (1997) ACR Criteria for Classification of SLE 81
Table 19: The SLICC Clinical and Immunologic Criteria for Classification of SLE 82
Table 20: WHO and ISN/RPS Classifications of LN 84
Table 21: Treatment Guidelines for SLE and LN 88
Table 22: Most Prescribed Drugs for SLE and LN by Class in the Global Markets, 2015 89
Table 23: Country Profile - US 90
Table 24: Country Profile - France 94
Table 25: Country Profile - Germany 97
Table 26: Country Profile - Italy 100
Table 27: Country Profile - Spain 103
Table 28: Country Profile - UK 106
Table 29: Country Profile - Japan 109
Table 30: Leading Treatments for SLE and LN, 2016 114
Table 31: Product Profile - Hydroxychloroquine 116
Table 32: Efficacy of Antimalarial Therapy in Lupus 117
Table 33: Safety of Antimalarial Therapy in Lupus 119
Table 34: Antimalarial Therapy SWOT Analysis, 2016 120
Table 35: Global Sales Forecasts ($m) of Antimalarials* for SLE and LN Therapy, 2015-2025 122
Table 36: Product Profile - Steroids 125
Table 37: Efficacy of Steroids in SLE Patients 126
Table 38: Safety of Long-Term Prednisone Use* 127
Table 39: Steroids SWOT Analysis, 2016 128
Table 40: Global Sales Forecasts ($m) of Steroids* for SLE and LN Therapy, 2015-2025 129
Table 41: Product Profile - Methotrexate 131
Table 42: Steroid-Sparing Effect of Methotrexate 133
Table 43: Safety of Methotrexate 134
Table 44: Methotrexate SWOT Analysis, 2016 135
Table 45: Global Sales Forecasts ($m) of Methotrexate* for SLE and LN Therapy, 2015-2025 136
Table 46: Product Profile - Mycophenolate Mofetil 138
Table 47: Efficacy of Mycophenolate Mofetil 140
Table 48: Safety of Mycophenolate Mofetil 142
Table 49: Mycophenolate Mofetil SWOT Analysis, 2016 143
Table 50: Global Sales Forecasts ($m) of Mycophenolate Mofetil for SLE and LN Therapy, 2015-2025 144
Table 51: Product Profile - Cyclophosphamide 146
Table 52: Efficacy of Cyclophosphamide 147
Table 53: Safety of Cyclophosphamide 149
Table 54: Cyclophosphamide SWOT Analysis, 2016 150
Table 55: Global Sales Forecasts ($m) of Cyclophosphamide* for SLE and LN Therapy, 2015-2025 151
Table 56: Product Profile - Azathioprine 153
Table 57: Efficacy of Azathioprine 155
Table 58: Safety of Azathioprine 156
Table 59: Azathioprine SWOT Analysis, 2016 157
Table 60: Global Sales Forecasts ($m) of Azathioprine* for SLE and LN Therapy, 2015-2025 158
Table 61: Product Profile - Calcineurin Inhibitors 160
Table 62: Efficacy of Calcineurin Inhibitors 162
Table 63: Safety of Calcineurin Inhibitors 164
Table 64: Calcineurin Inhibitors SWOT Analysis, 2016 165
Table 65: Global Sales Forecasts ($m) of Calcineurin Inhibitors* for SLE and LN Therapy, 2015-2025 166
Table 66: Product Profile - Benlysta 169
Table 67: Efficacy of Benlysta 171
Table 68: Safety of Benlysta 174
Table 69: Benlysta SWOT Analysis, 2016 175
Table 70: Global Sales Forecasts ($m) of Benlysta for SLE and LN Therapy, 2015-2025 177
Table 71: Product Profile - Rituxan 179
Table 72: Efficacy of Rituxan 181
Table 73: Safety of Rituxan 182
Table 74: Rituxan SWOT Analysis, 2016 183
Table 75: Global Sales Forecasts ($m) of Rituxan for SLE and LN Therapy, 2015-2025 184
Table 76: Summary of Minor Therapeutic Classes for the Treatment of SLE and LN, 2016 185
Table 77: Unmet Need and Opportunity in SLE and LN, 2016 187
Table 78: Key Late-Stage Pipeline Agents for SLE and LN, 2016 218
Table 79: Product Profile - Blisibimod 223
Table 80: Blisibimod SWOT Analysis, 2016 229
Table 81: Global Sales Forecasts (7MM) for Blisibimod in SLE and LN, 2015-2025 230
Table 82: Product Profile - Atacicept 233
Table 83: Atacicept SWOT Analysis, 2016 237
Table 84: Global Sales Forecasts ($m) for Atacicept in SLE and LN, 2015-2025 239
Table 85: Product Profile - Orencia 241
Table 86: Orencia SWOT Analysis, 2016 245
Table 87: Global Sales Forecasts ($m) for Orencia in SLE and LN, 2015-2025 246
Table 88: AstraZeneca’s Anifrolumab - Key Phase II and Phase III Clinical Trials 248
Table 89: Product Profile - Anifrolumab 249
Table 90: Anifrolumab SWOT Analysis, 2016 253
Table 91: Global Sales Forecasts ($m) for Anifrolumab in SLE and LN, 2015-2025 254
Table 92: Product Profile - Lupuzor 256
Table 93: Lupuzor SWOT Analysis, 2016 260
Table 94: Global Sales Forecasts ($m) for Lupuzor in SLE and LN, 2015-2025 261
Table 95: Product Profile - Voclosporin 263
Table 96: Voclosporin SWOT Analysis, 2016 268
Table 97: Global Sales Forecasts ($m) for Voclosporin in SLE and LN, 2015-2025 269
Table 98: Other Promising Clinical-Stage Drugs in Development for SLE/LN, 2016 270
Table 99: Drugs in Development for SLE and LN, 2016 279
Table 100: Biosimilars Pipeline for RA, 2016 283
Table 101: Global Sales Forecasts ($m) for Biosimilars (Rituximab and Abatacept) in SLE and LN, 2015-2025 286
Table 102: Key Companies in the SLE and LN Market in the 7MM, 2016 289
Table 103: GSK’s SLE and LN Portfolio Assessment, 2016 294
Table 104: Roche’s SLE and LN Portfolio Assessment, 2016 296
Table 105: BMS’ SLE and LN Portfolio Assessment, 2016 298
Table 106: AstraZeneca’s SLE and LN Portfolio Assessment, 2016 300
Table 107: Merck KGaA’s SLE and LN Portfolio Assessment, 2016 301
Table 108: Anthera’s SLE and LN Portfolio Assessment, 2016 303
Table 109: Aurinia’s SLE and LN Portfolio Assessment, 2016 304
Table 110: ImmuPharma’s SLE and LN Portfolio Assessment, 2016 306
Table 111: Pfizer’s SLE and LN Portfolio Assessment, 2016 306
Table 112: Global (7MM) Sales Forecasts ($m) for SLE and LN, 2015-2025 312
Table 113: SLE and LN Market - Global Drivers and Barriers, 2015‒2025 316
Table 114: Sales Forecasts ($m) for SLE and LN in the US, 2015-2025 319
Table 115: Key Events Impacting Sales for SLE and LN in the US, 2015-2025 321
Table 116: SLE and LN Market - Drivers and Barriers in the US, 2015‒2025 322
Table 117: Sales Forecasts ($m) for SLE and LN in the 5EU, 2015-2025 325
Table 118: Key Events Impacting Sales for SLE and LN in the 5EU, 2015-2025 329
Table 119: SLE and LN Market - Drivers and Barriers in the 5EU, 2015‒2025 330
Table 120: Sales Forecasts ($m) for SLE and LN in Japan, 2015-2025 333
Table 121: Key Events Impacting Sales for SLE and LN in Japan, 2015-2025 335
Table 122: SLE and LN Market - Drivers and Barriers in Japan, 2015‒2025 336
Table 123: Key Historical and Projected Launch Dates for SLE and LN 379
Table 124: Key Historical and Projected Patent Expiry Dates for SLE and LN 380
Table 125: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 401
1.2 List of Figures
Figure 1: Overview of the Etiology and Pathogenesis of SLE 27
Figure 2: Integrated Hypothesis for the Pathogenesis of SLE 29
Figure 3: SLE Forecast Case Flow Map 42
Figure 4: 7MM, Diagnosed Prevalent Cases of SLE, All Ages, Both Sexes, N, 2015-2025 62
Figure 5: 7MM, Diagnosed Prevalent Cases of SLE, by Age, Both Sexes, N, 2015 65
Figure 6: 7MM, Diagnosed Prevalent Cases of SLE, All Ages, By Sex, N, 2015 67
Figure 7: 7MM, Age-Standardized Diagnosed Prevalence (Cases per 100,000 Population) of SLE, All Ages, by Sex, 2015 68
Figure 8: 7MM, Diagnosed Prevalent Cases of SLE, All Ages, Men and Women, By Severity, N, 2015 70
Figure 9: 7MM, Diagnosed Prevalent Cases of LN, All Ages, Both Sexes, N, 2015‒2025 71
Figure 10: 7MM, Diagnosed Prevalent Cases of LN, Both Sexes, All Ages, by WHO Classification, 2015 73
Figure 11: 7MM, Diagnosed Prevalent Cases of LN, Both Sexes, All Ages, by ISN/RPS Classification, 2015 75
Figure 12: Overview of the Treatment Management of SLE and LN 85
Figure 13: SLE and LN Therapeutics - Clinical Trials by Type of Therapy and Development Stage, December 2016 217
Figure 14: SLE and LN - Key Phase II‒III Clinical Trials, 2016 219
Figure 15: Competitive Assessment of Late-Stage Pipeline Agents in SLE and LN, 2015-2025 221
Figure 16: Company Portfolio Gap Analysis in SLE and LN, 2015-2025 290
Figure 17: Average Annual Cost of Therapy (ACOT) for SLE and LN, 2016 311
Figure 18: Global (7MM) Sales for SLE and LN by Country/Region, 2015 and 2025 313
Figure 19: Global (7MM) Sales for SLE and LN by Region, 2015‒2025 314
Figure 20: Global (7MM) Sales for SLE and LN by Drug, 2015 and 2025 315
Figure 21: Sales for SLE and LN by Drug Class in the US, 2015 320
Figure 22: Sales for SLE and LN by Drug Class in the 5EU, 2015 and 2025 326
Figure 23: Global Sales for SLE and LN by Country in the 5EU, 2015 and 2025 327
Figure 24: Global Sales for SLE and LN by Country in the 5EU, 2015‒2025 328
Figure 25: Sales for SLE and LN by Drug Class in Japan, 2015 and 2025 334
