Systemic Lupus Erythematosus Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• Systemic lupus erythematosus is an autoimmune disorder characterized by antibodies to nuclear and cytoplasmic antigens, multisystem inflammation, protean clinical manifestations, and a relapsing and remitting course.
• Systemic lupus erythematosus mostly affects women. Approximately, 90% of women seem to be affected by the prevalence of systemic lupus erythematosus.
• Among 7MM, the US accounted for the highest number of cases approximately 50% and approximately 51% of the cases accounted for moderate severity.
• Treatments of systemic lupus erythematosus include NSAIDs and antimalarial agents, which are the first-line therapies for mild systemic lupus erythematosus. In addition, glucocorticoids and cytotoxic or immunosuppressive agents. BENLYSTA and SAPHNELO are approved by the FDA for the treatment of systemic lupus erythematosus.
• In May 2024, the US FDA approved a 200 mg subcutaneous route of administration of BENLYSTA for patients five years of age and older with active SLE who are receiving standard therapy. This option provides pediatric patients the possibility to receive the treatment at home.
• The US accounts for approximately 82% of systemic lupus erythematosus market share, with BENLYSTA occupying the largest market among therapies.
• Leading pharmaceutical companies such as Novartis/MorphoSys, Idorsia Pharmaceuticals/Viatris, RemeGen, and Biogen are actively working to improve the treatment landscape for systemic lupus erythematosus. In August 2023, AbbVie initiated its Phase III Select-SLE study to evaluate RINVOQ for moderate to severe SLE.
• The collaboration between Idorsia Pharmaceuticals and Viatris for the global development and commercialization of two Phase III assets, selatogrel and cenerimod, signifies significant progress in research and development.
• The future is certainly hopeful for an improved treatment a better disease understanding and a growing market.

This report delivers an in-depth understanding of Systemic Lupus Erythematosus, historical and forecasted epidemiology as well as the Systemic Lupus Erythematosus market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Systemic Lupus Erythematosus market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM Systemic Lupus Erythematosus market size from 2020 to 2034. The report also covers current Systemic Lupus Erythematosus treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Systemic Lupus Erythematosus Understanding and Treatment Algorithm

Systemic Lupus Erythematosus Overview, Country-Specific Treatment Guidelines and Diagnosis

Systemic lupus erythematosus is a chronic autoimmune disease that can affect many parts of the body. Lupus occurs when the immune system, which normally helps protect the body from infection and disease, attacks its own tissues. This attack causes inflammation, and in some cases permanent tissue damage, which can be widespread - affecting the skin, joints, heart, lung, kidneys, circulating blood cells, and brain.

The diagnosis of systemic lupus erythematosus is based on a combination of clinical findings and laboratory evidence. Familiarity with the diagnostic criteria helps clinicians to recognize systemic lupus erythematosus and to subclassify this complex disease based on the pattern of target-organ manifestations. The ACR/EULAR classification requires an antinuclear antibody (ANA) titer of at least 1:80 on HEp-2 cells or an equivalent positive test at least once. If that is present, 22 "additive weighted" classification criteria are considered, comprising seven clinical domains (constitutional, hematologic, neuropsychiatric, mucocutaneous, serosal, musculoskeletal, renal) and three immunologic domains (antiphospholipid antibodies, complement proteins, SLE-specific antibodies). Each criterion is assigned points, ranging from 2 to 10. Patients with at least one clinical criterion and 10 or more points are classified as having systemic lupus erythematosus.

The systemic lupus erythematosus report provides an overview of systemic lupus erythematosus pathophysiology, diagnostic approaches, and detailed treatment algorithm along with a real-world scenario of a patient’s journey beginning from the first symptom, the time taken for diagnosis to the entire treatment process.

Systemic Lupus Erythematosus Treatment

Treatment in systemic lupus erythematosus aims to prevent organ damage and achieve remission. The choice of treatment is dictated by the organ system/systems involved and the severity of involvement and ranges from minimal treatment (NSAIDs, antimalarials) to intensive treatment (cytotoxic drugs, corticosteroids). Patient education, physical and lifestyle measures, and emotional support play a central role in managing systemic lupus erythematosus.

Systemic Lupus Erythematosus Epidemiology

The Systemic Lupus Erythematosus epidemiology chapter in the report provides historical as well as forecasted in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The Systemic Lupus Erythematosus epidemiology is segmented with detailed insights into Total Diagnosed Prevalent Cases of Systemic Lupus Erythematosus, Total Diagnosed Prevalent Cases of Systemic Lupus Erythematosus by Gender, and Total Diagnosed Prevalent Cases of Systemic Lupus Erythematosus by Age, Severity-Based Diagnosed Prevalent Cases of Systemic Lupus Erythematosus, and Total Treated Cases of Systemic Lupus Erythematosus.

• Between EU4 and the UK, Spain accounted for the highest number of diagnosed prevalent cases followed by the UK and Germany.
• The age group most affected by the prevalence of systemic lupus erythematosus is 40-59 years. In 2023, among 7MM, approximately 40% of cases belonged to the 40-59 years age group.
• In 2023, approximately 50% of cases were found to be moderate cases in Spain.

Systemic Lupus Erythematosus Drug Chapters

The drug chapter segment of the systemic lupus erythematosus report encloses a detailed analysis of systemic lupus erythematosus marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the systemic lupus erythematosus pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Drugs

BENLYSTA (belimumab): GlaxoSmithKline

BENLYSTA (belimumab), a B-lymphocyte stimulator (BLyS) specific inhibitor, is a fully human monoclonal antibody that binds to soluble BLyS, which is found to be increased in patients with systemic autoimmune diseases like SLE and lupus nephritis (LN). ABy bding BLyS, BENLYSTA inhibits the prolonged survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. BENLYSTA does not bind B cells directly. The US FDA first approved BENLYSTA for the treatment of active systemic lupus erythematosus; it is the first and only approved biologic for both SLE and LN in more than 50 years, including for the pediatric population. It was first approved by the US FDA in 2011.

SAPHNELO (anifrolumab): AstraZeneca

SAPHNELO (anifrolumab) is a first in class, fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the activity of type I IFN. Type I IFNs, such as IFN-alpha, IFN-beta and IFN-kappa, are cytokines involved in regulating the inflammatory pathways implicated in SLE. The majority of adults with SLE have increased type I IFN signaling, which is associated with increased disease activity and severity. SAPHNELO is approved to treat systemic lupus erythematosus in more than 60 countries worldwide including the US, EU and Japan, with reviews ongoing in other countries.

Emerging Drugs

Cenerimod: Idorsia Pharmaceuticals/Viatris

Cenerimod is a highly selective sphingosine-1-phosphate receptor 1 (S1P1) receptor modulator, given as an oral once-daily tablet. While the cause of SLE is not fully known, T and B-lymphocytes are considered the key immune cells playing a role in the development of SLE. T and B-lymphocytes have a cell surface receptor called S1P1. These receptors enable T and B-lymphocytes to detect the signaling molecule S1P - sphingosine 1 phosphate - which is responsible for lymphocyte trafficking from the lymph nodes to the circulation. By binding to S1P1 receptors, a receptor modulator can trigger the internalization of those receptors. This effectively blinds T and B lymphocytes to the S1P gradient, thereby holding them in the lymph nodes and reducing autoreactive T and B cells in the circulation and, consequently, also in the tissues. In December 2017, the US FDA designated the investigation of cenerimod for the treatment of SLE as a fast-track development program. Currently it is in Phase III of its clinical development.

Litifilimab: Biogen

Litifilimab is a humanized IgG1 monoclonal antibody (mAb) targeting BDCA2 and is being investigated for the potential treatment of SLE and cutaneous lupus erythematosus (CLE). BDCA2 is a receptor that is predominantly expressed on a subset of human immune cells called Plasmacytoid Dendritic Cells (pDCs). The binding of litifilimab to BDCA2 has been shown to reduce the production of pro-inflammatory molecules by pDCs, including type-I interferon (IFN-I) as well as other cytokines and chemokines. Currently it is in Phase III of its clinical development.

Systemic Lupus Erythematosus Market Outlook

Key players, such as Novartis/MorphoSys, Idorsia Pharmaceuticals/Viatris, RemeGen, Biogen, and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of systemic lupus erythematosus.

• The market size of systemic lupus erythematosus in the seven major markets was around USD 3.20 billion in 2023.
• The United States accounts for the largest market size (around USD 2.60 billion) of systemic lupus erythematosus, in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
• Among EU4 and the UK, Spain had the highest market size followed by the UK.

Systemic Lupus Erythematosus Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024-2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Systemic Lupus Erythematosus Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Systemic Lupus Erythematosus emerging therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility.

The analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging treatment patterns of systemic lupus erythematosus. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The treatment for systemic lupus erythematosus is mostly covered under the patients’ insurance policy, either private or government. The companies like Genentech and AstraZeneca are also putting an effort in increasing the sales and market of their approved therapies by providing various kinds of financial assistance and reimbursement support to SLE patients. Moreover, as some of the emerging therapies are already approved for other indications, their respective companies provide some reimbursement or financial assistance to the patients. Therefore, it can be expected that once these therapies get approved for SLE, patients with SLE will also be able to avail these facilities and support without much delay or waiting time for the reimbursement to be approved by the government agencies.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of systemic lupus erythematosus, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country specific treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the systemic lupus erythematosus market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM systemic lupus erythematosus market.

Systemic Lupus Erythematosus Report Insights

• Patient Population
• Therapeutic Approaches
• Systemic lupus erythematosus Pipeline Analysis
• Systemic lupus erythematosus Market Size and Trends
• Existing and future Market Opportunity

Systemic Lupus Erythematosus Report Key Strengths

• Ten Years Forecast
• 7MM Coverage
• Systemic lupus erythematosus Epidemiology Segmentation
• Inclusion of Country specific treatment guidelines
• KOL’s feedback on approved and emerging therapies
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Systemic Lupus Erythematosus Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What is the growth rate of the 7MM systemic lupus erythematosus treatment market?
• What was the systemic lupus erythematosus total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
• Is there any unexplored patient setting that can open the window for growth in the future?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the current and emerging options for the treatment of systemic lupus erythematosus?
• How many companies are developing therapies for the treatment of systemic lupus erythematosus?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios.
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the systemic lupus erythematosus Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.