1 Systemic Lupus Erythematosus and Lupus Nephritis: Executive Summary
1.1 SLE market to significantly increase during the forecast period 2024-34
1.2 R&D strategies for the lupus market
1.3 High unmet need for steroid-sparing treatments that can reduce infection risk
1.4 Future SLE and LN players competition
1.5 Pipeline assessment
1.6 What do physicians think?
2 Introduction
2.1 Catalyst
2.2 Related reports
2.3 Upcoming reports
3 Disease Overview
3.1 Etiology and pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Prognosis
3.3 Classification or staging systems
3.3.1 SLE classification
3.3.2 LN classification
4 Epidemiology
4.1 Disease background
4.2 Risk factors and comorbidities
4.3 Global and historical trends
4.4 7MM forecast methodology
4.4.1 Sources
4.4.2 Forecast assumptions and methods
4.4.3 Forecast assumptions and methods: diagnosed prevalent cases of SLE
4.4.4 Forecast assumptions and methods: diagnosed prevalent cases of SLE by severity
4.4.5 Forecast assumptions and methods: diagnosed prevalent cases of LN
4.4.6 Diagnosed prevalent cases of LN by class
4.5 Epidemiological forecast for diagnosed prevalent cases of SLE (2024-34)
4.5.1 Diagnosed prevalent cases of SLE
4.5.2 Age-specific diagnosed prevalent cases of SLE
4.5.3 Sex-specific diagnosed prevalent cases of SLE
4.5.4 Diagnosed prevalent cases of SLE by severity
4.5.5 Diagnosed prevalent cases of LN
4.5.6 Age-specific diagnosed prevalent cases of LN
4.5.7 Sex-specific diagnosed prevalent cases of LN
4.5.8 Diagnosed prevalent cases of LN by class
4.6 Discussion
4.6.1 Epidemiological forecast insight
4.6.2 Limitations of the analysis
4.6.3 Strengths of the analysis
5 Disease Management
5.1 Diagnosis and treatment overview
5.2 Treatment overview
5.3 KOL insights on disease management
6 Current Treatment Options
6.1 Overview
6.2 SOC therapies in lupus
6.2.1 Antimalarials
6.2.2 Steroids
6.2.3 Immunosuppressive agents
6.3 Biologic therapies in lupus
6.3.1 Benlysta (belimumab)
6.3.2 Saphnelo (anifrolumab)
6.3.3 Gazyva/Gazyvaro (obinutuzumab)
6.3.4 Rituximab
7 Unmet Needs and Opportunity Assessment
7.1 Overview
7.2 More efficacious therapies and steroid-free treatment
7.3 Infection prevention
7.4 Improving patient compliance
7.5 Development of biomarkers for lupus disease activity
8 R&D Strategies
8.1 Overview
8.1.1 Novel MoAs
8.1.2 Label Expansion and Reformulation
8.2 Clinical trial design
8.2.1 Design overview
8.2.2 Patient populations
8.2.3 CAR-T clinical trials
9 Pipeline Assessment
9.1 Overview
9.2 Promising drugs in clinical development
10 Pipeline Valuation Analysis
10.1 Overview
10.2 Competitive assessment
11 Current and Future Players
11.1 Overview
11.2 Deal-making trends
12 Market Outlook
12.1 Global markets
12.1.1 Forecast
12.1.2 Drivers and barriers - global issues
12.2 US
12.2.1 Forecast
12.2.2 Key events
12.2.3 Drivers and barriers
12.3 5EU
12.3.1 Forecast
12.3.2 Key events
12.3.3 Drivers and barriers
12.4 Japan
12.4.1 Forecast
12.4.2 Key events
12.4.3 Drivers and barriers
13 Appendix
13.1 Bibliography
13.2 Abbreviations
13.3 Methodology
13.3.1 Forecasting methodology
13.4 Primary research - KOLs interviewed for this report
13.4.1 KOLs
13.5 Primary research - prescriber survey
13.6 About the Authors
13.6.1 Analyst
13.6.2 Managing Analyst
13.6.3 Therapy Area Director
13.6.4 Epidemiologist/Managing Epidemiologist
13.6.5 Vice President of Disease Intelligence and Epidemiology
13.6.6 Global Head of Pharma Research, Analysis, and Competitive Intelligence
- About the Analyst
- Contact the Publisher
List of Tables
Table 1: SLE and LN: key metrics in the 7MM
Table 2 EULAR/ACR 2019 criteria for SLE classification
Table 3: Disease classification definitions in SLE
Table 4: BILAG=2004 index
Table 5 ISN/RPS 2018 classification of LN
Table 6: Risk factors and comorbidities for SLE
Table 7: 7MM, diagnosed prevalent cases of LN by class on the ISN/RPS classification, N, both sexes, all ages, 2024
Table 8 Treatment guidelines for SLE and LN
Table 9 Leading treatments for SLE and LN, 2025
Table 10 Clinical endpoints for recent and current Phase III SLE and LN pipeline assets
Table 11: Top 10 deals by value, 2020-25
Table 12 SLE and LN market - drivers and barriers in the US, 2024-34
Table 13: Key events impacting sales for SLE and LN in the US, 2024-34
Table 14: SLE and LN Market - drivers and barriers in the US, 2024-34
Table 15: Key events impacting sales for SLE and LN in the 5EU, 2024-34
Table 16: SLE and LN market - drivers and barriers in the 5EU, 2024-34
Table 17: Key events impacting sales for SLE and LN in Japan, 2024-34
Table 18: SLE and LN market - drivers and barriers in Japan, 2024-34
Table 20: High-prescribing physicians (non-KOLs) surveyed, by country
List of Figures
Figure 1: Global sales forecast by country for SLE and LN in 2024 and 2034
Figure 2: Analysis of the company portfolio gap in SLE/LN during the forecast period
Figure 3 Competitive assessment of the marketed and pipeline complex molecules benchmarked against the SOC, Benlysta
Figure 4 Competitive assessment of the marketed and pipeline small molecules benchmarked against the SOC, mycophenolate mofetil
Figure 5 Overview of the etiology and pathogenesis of SLE
Figure 6 Integrated hypothesis for the pathogenesis of SLE
Figure 7: 7MM, diagnosed prevalence of SLE, men, women, %, all ages, 2024
Figure 8: 7MM, diagnosed prevalence of LN, men, women, %, all ages, 2024
Figure 9: 7MM, sources used to forecast the diagnosed prevalent cases of SLE
Figure 10: 7MM, sources used to forecast the diagnosed prevalent cases of SLE by severity
Figure 11: 7MM, sources used to forecast the diagnosed prevalent cases of LN
Figure 12: 7MM, sources used to forecast the diagnosed prevalent cases of LN by class
Figure 13: 7MM, diagnosed prevalent cases of SLE, N, both sexes, all ages, 2024
Figure 14: 7MM, diagnosed prevalent cases of SLE by age, N, both sexes, 2024
Figure 15: 7MM, diagnosed prevalent cases of SLE by sex, N, all ages, 2024
Figure 16: 7MM, diagnosed prevalent cases of SLE by severity, N, both sexes, all ages, 2024
Figure 17: 7MM, diagnosed prevalent cases of LN, N, both sexes, all ages, 2024
Figure 18: 7MM, diagnosed prevalent cases of LN by age, N, both sexes, all ages, 2024
Figure 19: 7MM, diagnosed prevalent cases of LN by sex, N, men, women, all ages, 2024
Figure 20 Overview of the treatment management of SLE and LN
Figure 21: Unmet needs and opportunities in SLE and LN
Figure 22: Overview of the development pipeline in SLE in the 7MM
Figure 23: Overview of the development pipeline in LN in the 7MM
Figure 24 Key late-stage trials for the promising pipeline agents that the analyst expects be licensed for SLE and LN in the 7MM during the forecast period
Figure 25 Competitive assessment of the marketed and pipeline small molecules benchmarked against the SOC, mycophenolate mofetil
Figure 26 Competitive assessment of the marketed and pipeline complex molecules benchmarked against the SOC, Benlysta
Figure 27: Analysis of the company portfolio gap in SLE/LN during the forecast period
Figure 28: Global (7MM) sales forecast by country for SLE and LN in 2024 and 2034
Figure 29 Global (7MM) sales forecast by drug class for SLE and LN in 2024 and 2034
Figure 30 Sales forecast by drug class for SLE and LN in the US in 2024 and 2034
Figure 31 Sales forecast by drug class for SLE and LN in the 5EU in 2024 and 2034
Figure 32 Sales forecast by drug class for SLE and LN in Japan in 2024 and 2034