Systemic Lupus Erythematosus – Landscape & Forecast – Disease Landscape & Forecast
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) was the first drug to launch for SLE in the G7 in more than 50 years; however, its modest efficacy is a deterrent to uptake. Of note, AstraZeneca’s Saphnelo (anifrolumab) was approved in 2021-2022 throughout the G7 for nonrenal SLE. Additionally, GlaxoSmithKline’s Benlysta and Aurinia’s Lupkynis (voclosporin) have been approved for adult patients with active lupus nephritis (LN). Several therapies in development for moderate to severe SLE without active renal disease and/or LN (i.e., anifrolumab, dapirolizumab pegol, voclosporin, obinutuzumab, secukinumab, BIIB059, ianalumab, and telitacicept) are expected to fulfill the high unmet need associated with this condition. The Disease Landscape & Forecast provides detailed analyses of current medical practice, key unmet needs, and new developments in the SLE space, along with an analysis of the 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 LN 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 29 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: 27 drugs; Phase III: 6 drugs.
Product description:
Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.
Solution enhancement:
Disease Landscape & Forecast will feature continual updates in 2022 to provide timely insights and analyses as meaningful indication-specific news and events unfold. Additionally, Disease Landscape & Forecast introduces a new Drug Pipeline chapter with real-time, global pipeline intelligence content directly from Cortellis. This chapter is updated daily and features interactive figures that can be easily downloaded for detailed analysis or presentations.
Table of contents
- Systemic Lupus Erythematosus - Landscape & Forecast - Disease Landscape & Forecast
- Key findings
- Systemic Lupus Erythematosus - Key Findings
- Key updates
- March 2023
- Q4 2022
- November 2022
- Q3 2022
- August 2022
- July 2022
- Q2 2022
- June 2022
- April 2022
- April 2022
- Q1 2022
- March 2022
- February 2022
- January 2022
- Market outlook
- Key findings
- Market share of drug classes for systemic lupus erythematosus: 2021
- Market share of drug classes for systemic lupus erythematosus: 2031
- Patient share in lupus nephritis, by drug class: 2021-2031
- Patient share in nonrenal SLE, by drug class: 2021-2031
- Systemic lupus erythematosus SWOT analysis
- 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: 2021-2031
- Major-market patient share of biologics in systemic lupus erythematosus: 2021-2031
- Drug-class-specific trends
- Total sales and patient share of antimalarials in systemic lupus erythematosus: 2021-2031
- Total sales and patient share of corticosteroids in systemic lupus erythematosus: 2021-2031
- Total sales and patient share of immunosuppressants / cytotoxic drugs in systemic lupus erythematosus: 2021-2031
- Total sales and patient share of B-cell modulators in systemic lupus erythematosus: 2021-2031
- Total sales and patient share of interferon-alpha inhibitors in systemic lupus erythematosus: 2021-2031
- Total sales and patient share of CD40 ligand inhibitors in systemic lupus erythematosus: 2021-2031
- Total sales and patient share of BDCA2 inhibitors in systemic lupus erythematosus: 2021-2031
- Total sales and patient share of IL-17 inhibitors in systemic lupus erythematosus: 2021-2031
- Alternative market scenarios
- Alternative scenarios for the systemic lupus erythematosus market through 2031
- Key findings
- 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 in systemic lupus erythematosus
- B cells
- T cells
- Tissue damage
- Abnormal cytokine and chemokine expression
- Disease overview
- 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: 2021-2031
- Number of diagnosed prevalent cases of SLE defined according to four or more ACR criteria in the major pharmaceutical markets: 2021-2031
- Number of diagnosed prevalent cases of SLE defined according to two or more ACR criteria in the major pharmaceutical markets: 2021-2031
- Disease definition
- Methods
- Sources used for diagnosed prevalent cases of SLE by lupus nephritis status
- Number of diagnosed prevalent cases of lupus nephritis in the major pharmaceutical markets: 2021-2031
- Number of diagnosed prevalent cases of SLE without lupus nephritis in the major pharmaceutical markets: 2021-2031
- Disease definition
- Methods
- Sources used for diagnosed prevalent cases of SLE by flares and of persistently active SLE
- Number of diagnosed prevalent cases of flares, flares or persistently active SLE, no flares or persistently active SLE, and persistently active SLE only in the major pharmaceutical markets: 2021-2031
- Number of drug-treated prevalent cases of clinically defined SLE in the major pharmaceutical markets: 2021-2031 (thousands)
- Key findings
- 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 Lupkynis
- Key results from select clinical trials investigating Lupkynis for the treatment of SLE
- Expert insight: Lupkynis
- 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
- Advantages and disadvantages of Saphnelo
- Key results from select clinical trials investigating Saphnelo for the treatment of systemic lupus erythematosus
- Ongoing clinical development of Saphnelo
- Key ongoing clinical trials of Saphnelo in the treatment of systemic lupus erythematosus
- Expert insight: Saphnelo
- Medical practice
- Overview
- 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
- Key findings
- 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
- Drug pipeline
- Pipeline
- Regulatory Milestones
- Indication Comparison
- Emerging therapies
- Key findings
- Key emerging therapies
- Key therapies in development for systemic lupus erythematosus
- Estimated launch dates of key emerging therapies for the treatment of systemic lupus erythematosus
- Obinutuzumab profile
- Key ongoing clinical trials of obinutuzumab in the treatment of SLE
- 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
- Key results from select clinical trials investigating atacicept for the treatment of systemic lupus erythematosus
- Analysis of the clinical development program for atacicept
- Expert insight: atacicept
- Expectations for launch and sales opportunity of atacicept in systemic lupus erythematosus
- Telitacicept profile
- Key ongoing clinical trials of telitacicept in the treatment of SLE
- Analysis of the clinical development program for telitacicept
- Expert insight: telitacicept
- Expectations for launch and sales opportunity of telitacicept in systemic lupus erythematosus
- Ianalumab profile
- Key ongoing clinical trials of ianalumab in lupus nephritis
- Analysis of the clinical development program for ianalumab
- Expectations for launch and sales opportunity of ianalumab 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
- BIIB059 profile
- Analysis of the clinical development program for BIIB059
- Expert insight: BIIB059
- Expectations for launch and sales opportunity of BIIB059 in systemic lupus erythematosus
- Secukinumab profile
- Analysis of the clinical development program for secukinumab
- Expert insight: secukinumab
- Expectations for launch and sales opportunity of secukinumab 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 Phase II development for systemic lupus erythematosus
- Key discontinuations and failures in systemic lupus erythematosus
- Expert insight: key discontinuations and failures
- Key findings
- 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
- Region-specific reimbursement practices
- Appendix
- Key abbreviations related to systemic lupus erythematosus
- Systemic lupus erythematosus bibliography
- Key findings
Girdhari Roy, Ph.D., Associate Healthcare Research & Data Analyst, Immune and Inflammation. Prior to joining Clarivate, Dr. Roy was a product selection and ideation scientist at Dr. Reddy’s Laboratory. He also worked as a drug metabolism and pharmacokinetics scientist at ADTL Hyderabad. He holds bachelor’s and master’s degrees in pharmacy and a doctorate in pharmaceutical sciences from BITS Pilani, Hyderabad Campus, India.