Systemic Lupus Erythematosus (SLE) Market and Forecast Analysis

  • ID: 4238681
  • Report
  • Region: Global
  • 188 pages
  • Datamonitor Healthcare
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Benlysta Became the First New Therapy for Lupus in Over 50 Years when it Gained Approval in 2011

Lupus is a chronic inflammatory autoimmune disorder that can affect many different body systems, including the joints, skin, kidneys, blood cells, brain, heart, and lungs. Systemic lupus erythematosus refers to the systemic form of the disease, which includes organ-specific variants, such as lupus nephritis.

This disorder can be very difficult to diagnose as its signs and symptoms often mimic those of other conditions, and a physician is unlikely to ever see two cases that are alike. The most concerning symptoms are the ones that do not currently respond well to treatment, including renal and neurologic symptoms, as these can cause severe morbidity, disability, and ultimately fatal outcomes. Benlysta (belimumab; GlaxoSmithKline) became the first new therapy for lupus in over 50 years when it gained approval in 2011. However, despite significant hype surrounding its launch, uptake has been low, and the market remains open and eager for effective targeted therapies.

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1. Forecast: Systemic Lupus Erythematosus

  • Executive Summary
  • Market Overview and Trends
  • Market Definition and Methodology
  • anifrolumab
  • Benlysta SLE (belimumab)
  • blisibimod
  • Primary Research Methodology

2. Epidemiology: Systemic Lupus Erythematosus

  • Executive Summary
  • Disease Background
  • Sources and Methodology
  • Forecast
  • Epidemiologist Insight
  • Strengths and Limitations
  • Appendix: Additional Sources

3. Marketed Drugs: Systemic Lupus Erythematosus

  • Executive Summary
  • Product Overview
  • Primary Research Methodology
  • Product profile: Benlysta
  • Product profile: Off-label: CellCept
  • Product profile: Off-label: Rituxan

4. Pipeline: Systemic Lupus Erythematosus

  • Executive Summary
  • Clinical Pipeline Overview
  • Comparator Therapy
  • Clinical Trial Design
  • Recently Discontinued Drugs
  • Product profile (late stage): Lupuzor
  • Product profile (late stage): Orencia
  • Product profile (late stage): anifrolumab
  • Product profile (late stage): atacicept
  • Product profile (late stage): blisibimod

List of Figures:
Figure 1: Timeline: approval/launch dates of key systemic lupus erythematosus therapies
Figure 2: Systemic lupus erythematosus sales in the US, by brand ($m), 2015-24
Figure 3: Systemic lupus erythematosus sales in the five major EU markets, by brand ($m), 2015-24
Figure 4: Patient-based forecast methodology for systemic lupus erythematosus
Figure 5: Price sources and calculations, by country
Figure 6: Anifrolumab forecast sales for systemic lupus erythematosus in the US and five major EU markets ($m), 2015-24
Figure 7: Benlysta forecast sales for systemic lupus erythematosus in the US and five major EU markets ($m), 2015-24
Figure 8: Blisibimod forecast sales for systemic lupus erythematosus in the US and five major EU markets ($m), 2015-24
Figure 9: Trends in age-specific diagnosed prevalent cases of SLE in the US, Japan, and five major EU markets, 2015-35
Figure 10: Absolute change in diagnosed prevalent cases of SLE in the US, Japan, and five major EU markets, by country, 2015-35
Figure 11: Benlysta for systemic lupus erythematosus - SWOT analysis
Figure 12: Drug assessment summary of Benlysta for systemic lupus erythematosus
Figure 13: Drug assessment summary of Benlysta for systemic lupus erythematosus
Figure 14: CellCept for systemic lupus erythematosus - SWOT analysis
Figure 15: Drug assessment summary of CellCept for systemic lupus erythematosus
Figure 16: Drug assessment summary of CellCept for systemic lupus erythematosus
Figure 17: Rituxan for systemic lupus erythematosus - SWOT analysis
Figure 18: Drug assessment summary of Rituxan for systemic lupus erythematosus
Figure 19: Drug assessment summary of Rituxan for systemic lupus erythematosus
Figure 20: Lupuzor for systemic lupus erythematosus - SWOT analysis
Figure 21: Drug assessment summary of Lupuzor for systemic lupus erythematosus
Figure 22: Drug assessment summary of Lupuzor for systemic lupus erythematosus
Figure 23: Orencia for systemic lupus erythematosus - SWOT analysis
Figure 24: Drug assessment summary of Orencia for systemic lupus erythematosus
Figure 25: Drug assessment summary of Orencia for systemic lupus erythematosus
Figure 26: Anifrolumab for systemic lupus erythematosus - SWOT analysis
Figure 27: Drug assessment summary of anifrolumab for systemic lupus erythematosus
Figure 28: Drug assessment summary of anifrolumab for systemic lupus erythematosus
Figure 29: Atacicept for systemic lupus erythematosus - SWOT analysis
Figure 30: Drug assessment summary of atacicept for systemic lupus erythematosus
Figure 31: Drug assessment summary of atacicept for systemic lupus erythematosus
Figure 32: Blisibimod for systemic lupus erythematosus - SWOT analysis
Figure 33: Drug assessment summary of blisibimod for systemic lupus erythematosus
Figure 34: Drug assessment summary of blisibimod for systemic lupus erythematosus

List of Tables:
Table 1: Systemic lupus erythematosus sales in the US, by brand ($m), 2015-24
Table 2: Systemic lupus erythematosus sales in the five major EU markets, by brand ($m), 2015-24
Table 3: Estimated launch dates for key late-stage pipeline products and marketed brands in systemic lupus erythematosus,2015-24
Table 4: Exchange rates used for calculating prices
Table 5: Anifrolumab forecast sales for systemic lupus erythematosus in the US and five major EU markets ($m), 2015-24
Table 6: Benlysta forecast sales for systemic lupus erythematosus in the US and five major EU markets ($m), 2015-24
Table 7: Blisibimod forecast sales for systemic lupus erythematosus in the US and five major EU markets ($m), 2015-24
Table 8: Rheumatologists surveyed for the systemic lupus erythematosus primary research study, 2011
Table 9: Sources used for the epidemiological analysis of SLE in the US, Japan, and five major EU markets, by country
Table 10: Sources not used for the epidemiological analysis of SLE in the US, Japan, and five major EU markets, by country
Table 11: Diagnosed prevalent cases of SLE in the US, Japan, and five major EU markets, by country, 2015-35
Table 12: Age-specific diagnosed prevalent cases of SLE in the US, Japan, and five major EU markets, by country, 2015
Table 13: Gender-specific diagnosed prevalent cases of SLE in the US, Japan, and five major EU markets, by country, 2015
Table 14: Key marketed and off-label products for systemic lupus erythematosus
Table 15: Rheumatologists surveyed for the systemic lupus erythematosus primary research study, 2016
Table 16: Benlysta drug profile
Table 17: Benlysta IV pivotal trial data in systemic lupus erythematosus
Table 18: Benlysta SC late-phase trial data in systemic lupus erythematosus
Table 19: Benlysta IV ongoing late-phase trials in systemic lupus erythematosus
Table 20: Average future usage of biosimilar rituximab when it becomes available, according to rheumatologists surveyed from the US and five major EU markets (France, Germany, Italy, Spain, and the UK), by severity
Table 21: CellCept drug profile
Table 22: CellCept Phase III data in systemic lupus erythematosus - lupus nephritis
Table 23: Rituxan drug profile
Table 24: Rituxan pivotal trial data in systemic lupus erythematosus
Table 25: Average future usage of biosimilar rituximab when it becomes available, according to rheumatologists surveyed from the US and five major EU markets (France, Germany, Italy, Spain, and the UK), by severity
Table 26: Phase III pipeline products in development for systemic lupus erythematosus
Table 27: Benlysta drug profile
Table 28: Benlysta IV pivotal trial data in systemic lupus erythematosus
Table 29: Summary of formal FDA guidance for industry in systemic lupus erythematosus
Table 30: Summary of formal FDA guidance for industry in lupus nephritis
Table 31: Summary of formal EMA guidance for industry in lupus nephritis
Table 32: Commonly used clinical trial endpoints for systemic lupus erythematosus
Table 33: Commonly used clinical trial endpoints for systemic lupus erythematosus - lupus nephritis
Table 34: Late-stage compounds that were recently discontinued for systemic lupus erythematosus
Table 35: Epratuzumab drug profile
Table 36: Epratuzumab trial data in systemic lupus erythematosus
Table 37: Lupuzor drug profile
Table 38: Lupuzor Phase III trials in systemic lupus erythematosus
Table 39: Lupuzor Phase IIb trial data in systemic lupus erythematosus
Table 40: Orencia drug profile
Table 41: Orencia ongoing late-phase trials in systemic lupus erythematosus
Table 42: Orencia Phase III data in systemic lupus erythematosus
Table 43: Anifrolumab drug profile
Table 44: Anifrolumab Phase III trials in systemic lupus erythematosus
Table 45: Anifrolumab Phase IIb data in systemic lupus erythematosus
Table 46: Atacicept drug profile
Table 47: Atacicept Phase III data in systemic lupus erythematosus
Table 48: Blisibimod drug profile
Table 49: Blisibimod Phase III data in systemic lupus erythematosus
Table 50: Blisibimod Phase III trials in systemic lupus erythematosus

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GlaxoSmithKline

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