Systemic lupus erythematosus (SLE) is a complex autoimmune disease that can affect nearly any organ or system in the body. As a result, its course, manifestations, and treatment approach can be highly variable between patients. This lack of consistency has made clinical trial design, as well as understanding the potential market for therapies in SLE, a unique challenge. To date, GlaxoSmithKline’s Benlysta (2011) is the only drug to have launched for SLE in over 50 years; however, its modest efficacy is a deterrent to uptake. GlaxoSmithKline’s Benlysta and Aurinia’s Lupkynis (voclosporin) have recently been granted FDA approval for the treatment of adult patients with active LN. Several therapies (i.e., anifrolumab, baricitinib, dapirolizumab pegol, voclosporin, obinutuzumab) in development for moderate to severe SLE without active renal disease and/or lupus nephritis are expected to fulfill the high unmet need for this condition. The Disease Landscape and Forecast provides detailed analyses of current medical practice, key unmet needs, and new developments in the SLE space, along with an analysis of opportunities and obstacles facing emerging agents.

Questions answered:

  • How large is the treatable SLE population, and how will diagnosis / drug-treatment rates change over time?
  • What is the current state of SLE treatment? What are the most important drugs for the treatment of patients without active renal disease and lupus nephritis, and why? What are interviewed experts’ insights into current treatment options? What are the key unmet needs in SLE?
  • What are KOLs’ perception of key emerging therapies, and where do they see these agents fitting into the treatment algorithm? What sales / uptake could these agents secure in SLE? What therapies of note are progressing in earlier phases?
  • What are the drivers and constraints in the SLE market, and how will the market evolve over the forecast period?

Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, and Japan.

Primary research: Approximately 32 country-specific interviews with rheumatologists and nephrologists.

Epidemiology: Diagnosed prevalence of SLE by country and subpopulations (nonrenal SLE and LN).

Population segments in market forecast: Total population, nonrenal SLE population, renal SLE (LN) population.

Emerging therapies: Phase II: 19 drugs; Phase III: 6 drugs.

Table of contents

  • Systemic Lupus Erythematosus - Landscape & Forecast - Disease Landscape & Forecast
    • Key Updates
      • Q1 2021
        • March 2021
        • February 2021
        • January 2021
      • Q4 2020
        • December 2020
    • Key Findings
      • Systemic Lupus Erythematosus - Key Findings - August 2020
        • December 2020
    • Market Outlook
      • Key Findings
        • Market Share of Drug Classes for Systemic Lupus Erythematosus: 2019
        • Market Share of Drug Classes for Systemic Lupus Erythematosus: 2029
        • Major-Market Sales Share in Systemic Lupus Erythematosus: 2019
        • Major-Market Sales Share in Systemic Lupus Erythematosus: 2029
        • Systemic Lupus Erythematosus SWOT Analysis
      • COVID-19: Areas of Potential Forecast Impact
        • Market Drivers and Constraints
          • What Factors Are Driving the Market for Systemic Lupus Erythematosus?
          • What Factors Are Constraining the Market for Systemic Lupus Erythematosus?
          • Major-Market Sales of Biologics in Systemic Lupus Erythematosus: 2019-2029
          • Major-Market Patient Share of Biologics in Systemic Lupus Erythematosus: 2019-2029
        • Drug-Class-Specific Trends
          • Sales of Antimalarials in Systemic Lupus Erythematosus by Country: 2019-2029
          • Patient Share of Antimalarials in Systemic Lupus Erythematosus by Country: 2019-2029
          • Major-Market Sales of Corticosteroids in Systemic Lupus Erythematosus: 2019-2029
          • Major-Market Patient Share of Corticosteroids in Systemic Lupus Erythematosus: 2019-2029
          • Major-Market Sales of Immunosuppressants / Cytotoxic Drugs in Systemic Lupus Erythematosus: 2019-2029
          • Major-Market Patient Share of Immunosuppressants / Cytotoxic Drugs in Systemic Lupus Erythematosus: 2019-2029
          • Major-Market Sales of B-Cell Modulators in Systemic Lupus Erythematosus: 2019-2029
          • Major-Market Patient Share of B-Cell Modulators in Systemic Lupus Erythematosus: 2019-2029
          • Sales of Interferon-Alpha Inhibitors in Systemic Lupus Erythematosus by Country: 2019-2029
          • Patient Share of Interferon-Alpha Inhibitors in Systemic Lupus Erythematosus by Country: 2019-2029
          • Annual Sales of Jak Inhibitors in Systemic Lupus Erythematosus by Country: 2019-2029
          • Patient Share of Jak Inhibitors in Systemic Lupus Erythematosus by Country: 2019-2029
          • Annual Sales of CD40 Ligand Inhibitors in Systemic Lupus Erythematosus by Country: 2019-2029
          • Patient Share of CD40 Ligand Inhibitors in Systemic Lupus Erythematosus by Country: 2019-2029
        • Alternative Market Scenarios
          • Alternative Scenarios for the Systemic Lupus Erythematosus Market Through 2029
      • Forecast
        • Market Forecast Assumptions
        • Market Forecast Dashboard
      • Etiology and Pathophysiology
        • Disease Overview
          • Etiology
            • Environmental Agents Implicated in Systemic Lupus Erythematosus
          • Pathophysiology
            • Clinical Manifestations
            • Disease Severity
            • Pathogenesis
            • Clinical Manifestations of Systemic Lupus Erythematosus
            • Pathogenesis of Systemic Lupus Erythematosus
          • Key Pathways and Drug Targets
            • B Cells
            • T Cells
            • Tissue Damage
            • Abnormal Cytokine and Chemokine Expression
            • Key Pathways and Drug Targets in Systemic Lupus Erythematosus
        • Epidemiology
          • Key Findings
            • Key Updates
          • Epidemiology Populations
            • Disease Definition
            • Methods
            • Sources Used for Diagnosed Prevalence of SLE
            • Number of Diagnosed Prevalent Cases of Clinically Defined SLE in the Major Pharmaceutical Markets: 2019-2029
            • Number of Diagnosed Prevalent Cases of SLE Defined According to 4+ ACR Criteria in the Major Pharmaceutical Markets: 2019-2029
            • Number of Diagnosed Prevalent Cases of SLE Defined According to 2+ ACR Criteria in the Major Pharmaceutical Markets: 2019-2029
            • Disease Definition: Lupus Nephritis and Nonrenal SLE
            • Methods: Lupus Nephritis and Nonrenal SLE
            • Sources Used for Diagnosed Prevalent Cases by Lupus Nephritis Status
            • Number of Diagnosed Prevalent Cases of Lupus Nephritis in the Major Pharmaceutical Markets: 2019-2029
            • Number of Diagnosed Prevalent Cases of Nonrenal SLE in the Major Pharmaceutical Markets: 2019-2029
            • Disease Definition: Flares and Persistently Active Disease
            • Methods: Flares and Persistently Active Disease
            • Sources Used for Diagnosed Prevalent Cases by Flares and Persistently Active Disease for SLE
            • Number of Diagnosed Prevalent Cases of Flares, Persistently Active Disease, and Both Flares and Persistently Active Disease in the Major Pharmaceutical Markets: 2019-2029
            • Number of Drug-Treated Prevalent Cases of Clinically Defined SLE in the Major Pharmaceutical Markets: 2019-2029 (Thousands)
        • Current Treatment
          • Key Findings
            • Treatment Goals
              • Key Endpoints Used in Clinical Trials for Systemic Lupus Erythematosus
            • Key Current Therapies
              • Overview
              • Mechanism of Action of Key Current Drug Classes Used for Systemic Lupus Erythematosus
              • Current Treatments Used for Systemic Lupus Erythematosus
              • Market Events Impacting the Use of Key Current Therapies in Systemic Lupus Erythematosus
              • Advantages and Disadvantages of Antimalarials
              • Expert Insight: Antimalarials
              • Advantages and Disadvantages of Corticosteroids
              • Expert Insight: Corticosteroids
              • Advantages and Disadvantages of Immunosuppressants and Cytotoxics
              • Expert Insight: Immunosuppressants and Cytotoxic Drugs
              • Advantages and Disadvantages of Benlysta
              • Select Phase III Trials Investigating Benlysta in the Treatment of Systemic Lupus Erythematosus
              • Expert Insight: Benlysta
              • Advantages and Disadvantages of Rituxan / MabThera
              • Expert Insight: Rituxan / MabThera
            • Medical Practice
              • Overview
              • Country-Specific Systemic Lupus Erythematosus Treatment Guidelines
              • Factors Influencing Drug Selection in Systemic Lupus Erythematosus
              • Treatment Decision Tree for Systemic Lupus Erythematosus: United States
              • Treatment Decision Tree for Systemic Lupus Erythematosus: Europe
              • Treatment Decision Tree for Systemic Lupus Erythematosus: Japan
          • Unmet Need Overview
            • Current and Future Attainment of Unmet Needs in Systemic Lupus Erythematosus
            • Top Unmet Needs in Systemic Lupus Erythematosus: Current and Future Attainment
            • Expert Insight: Unmet Need in Systemic Lupus Erythematosus
          • Emerging Therapies
            • Key Findings
              • Pipeline Trends for Systemic Lupus Erythematosus
            • Key Emerging Therapies
              • Key Emerging Therapies in Development for Systemic Lupus Erythematosus
              • Estimated Launch Dates of Key Emerging Therapies for the Treatment of Systemic Lupus Erythematosus
              • Ustekinumab Profile
              • Analysis of the Clinical Development Program for Ustekinumab
              • Expert Insight: Ustekinumab
              • Expectations for Launch and Sales Opportunity of Ustekinumab in Systemic Lupus Erythematosus
              • Baricitinib Profile
              • Analysis of the Clinical Development Program for Baricitinib
              • Expert Insight: Baricitinib
              • Expectations for Launch and Sales Opportunity of Baricitinib in Systemic Lupus Erythematosus
              • Anifrolumab Profile
              • Analysis of the Clinical Development Program for Anifrolumab
              • Expert Insight: Anifrolumab
              • Expectations for Launch and Sales Opportunity of Anifrolumab in Systemic Lupus Erythematosus
              • Voclosporin Profile
              • Analysis of the Clinical Development Program for Voclosporin
              • Expert Insight: Voclosporin
              • Expectations for Launch and Sales Opportunity of Voclosporin in Systemic Lupus Erythematosus
              • Obinutuzumab Profile
              • Analysis of the Clinical Development Program for Obinutuzumab
              • Expert Insight: Obinutuzumab
              • Expectations for Launch and Sales Opportunity of Obinutuzumab in Systemic Lupus Erythematosus
              • Atacicept Profile
              • Analysis of the Clinical Development Program for Atacicept
              • Expert Insight: Atacicept
              • Expectations for Launch and Sales Opportunity of Atacicept in Systemic Lupus Erythematosus
              • Dapirolizumab Pegol Profile
              • Analysis of the Clinical Development Program for Dapirolizumab Pegol
              • Expert Insight: Dapirolizumab Pegol
              • Expectations for Launch and Sales Opportunity of Dapirolizumab Pegol in Systemic Lupus Erythematosus
              • Rigerimod Profile
              • Analysis of the Clinical Development Program for Rigerimod
              • Expert Insight: Rigerimod
              • Expectations for Launch and Sales Opportunity of Rigerimod in Systemic Lupus Erythematosus
            • Early-Phase Pipeline Analysis
              • Select Compounds in Early-Phase Development for Systemic Lupus Erythematosus
          • Access and Reimbursement Overview
            • Region-Specific Reimbursement Practices
              • Key Market Access Considerations in Systemic Lupus Erythematosus: United States
              • General Reimbursement Environment: United States
              • Key Market Access Considerations in Systemic Lupus Erythematosus: France
              • Key Market Access Considerations in Systemic Lupus Erythematosus: Germany
              • Key Market Access Considerations in Systemic Lupus Erythematosus: Italy
              • Key Market Access Considerations in Systemic Lupus Erythematosus: Spain
              • Key Market Access Considerations in Systemic Lupus Erythematosus: United Kingdom
              • General Reimbursement Environment: EU5
              • Key Market Access Considerations in Systemic Lupus Erythematosus: Japan
              • General Reimbursement Environment: Japan
          • Appendix
            • Key Abbreviations Related to Systemic Lupus Erythematosus
            • Brands, Marketers, and Generic Availability of Key Therapies for SLE by Market
            • Systemic Lupus Erythematosus Bibliography

        Author(s): Ajay Puri, M.B.A.; Sunali D. Goonesekera, S.M.

        Ajay Puri, M.B.A., is an Analyst on the Immune and Inflammatory Disorders team at DRG, part of Clarivate. He has developed expertise in ulcerative colitis, Crohn’s disease, and systemic lupus erythematosus. Prior to joining DRG, he worked as a knowledge management associate at ZS Associates, where he conducted competitive assessment, company and product profiling, and other projects. He holds a bachelor’s degree in pharmacy and an M.B.A. in marketing from the National Institute of Pharmaceutical Education and Research in Mohali, India..

        Sunali Goonesekera, S.M., is a senior epidemiologist at DRG, part of Clarivate. Prior to joining DRG, Ms. Goonesekera conducted epidemiological research on racial/ethnic disparities in metabolic diseases at the New England Research Institute and lead-authored two manuscripts. She has contributed to multiple publications in peer-reviewed journals in epidemiology and the biological sciences. She holds a master’s degree in epidemiology from the Harvard School of Public Health and a B.A. in biology (Honors) from Dartmouth College.


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