Systemic Lupus Erythematosus Market - Growth, Trends, and Forecasts (2023 - 2028)

The systemic lupus erythematosus market is poised to grow at a CAGR of 7.1% during the forecast period.

The emergence of the COVID-19 pandemic had an adverse effect on the world economy and the healthcare system. The lockdown all over the globe has affected the supply chain of pharmaceuticals, medical devices, and biotechnological products. The severe impact of the SARS-CoV-2 virus on people with existing autoimmune diseases further increased the risk for the target population. According to the study "Impact of the COVID-19 Pandemic in Patients with Systemic Lupus Erythematosus throughout One Year," published in the Jornal of "Clinical Immunology" in October 2021, according to the findings, the impact of the COVID-19 pandemic on patients with SLE is significant and is influenced by the general population's response to the virus. In the study, older age and family contact with COVID-19 cases were key risk factors for infection, similar to the general population. However, a large number of patients did not develop COVID-19 despite having infected family members. In patients with SLE, treatment escalation, particularly with corticosteroids, is another risk linked to COVID-19.

As per the study "COVID-19 and Systemic Lupus Erythematosus: Focus on Immune Response and Therapeutics" published in October 2020, patients with autoimmune disorders, such as lupus, are prone to infections not only because of the disease's abnormal immunological responses, but also because they are frequently treated with steroids, other immune-suppressants, and immune-modulator medicines. These factors add to a weakened immune system and an increased risk of infection. Many characteristics of lupus and COVID-19 are similar, such as patient demographics and abnormal immune responses, while others, such as gender bias, are starkly different, with lupus mostly affecting women and COVID-19 having worse outcomes in men. Lymphopenia, proinflammatory cytokines, and abnormal B and T cell responses, among other cellular, humoral, and cytokine immunological responses, may likely influence the severity and clinical consequences of COVID-19 in humans. As a result, patients with autoimmune rheumatoid arthritis have been identified as a vulnerable group at risk of severe COVID-19 infection. Hence, these factors are expected to impact the target market growth in the given timeframe.

In the past decades, growth was observed in the use of corticosteroids and conventional immunosuppressive drugs; however, the unmet need for drugs with better efficacy and safety profile is still there. The major traction to this market is the continuous involvement of big biopharmaceutical companies in drugs presently in clinical trials, which boosts the growth of this market. As per the study "Updates on Clinical Trials in Systemic Lupus Erythematosus," published in 2021, due to the complexity of systemic lupus erythematosus (SLE), researchers utilize a variety of approaches while looking for new therapeutic molecules to treat the condition. In recent clinical trials, the main focus has been on B cells and type I interferons. Small molecule inhibitors of JAK, Tyk, and Btk are presently being studied for their potential therapeutic implications in treating SLE. Low-dose IL-2 and CD40 ligand blockade are used to investigate the immunoregulation of T cell activation in SLE. Bispecific antibodies having binding specificities for two different target molecules associated with T- and B-cell activation or with different elements of B-cell activation are being studied in clinical trials. A combination therapy method is also being investigated. New SLE therapy chemicals are being tested in clinical trials. Thus, possible treatments have created lucrative opportunities for the global systemic lupus erythematosus market growth in the studied period.

However, the cost restraint and stringent regulatory guidelines for new drugs are expected to be the primary hindrances.

Systemic Lupus Erythematosus Market Trends

Biologics is Expected to Witness Better Growth Over the Forecast Period

Treatment advancements in recent decades, such as the use of corticosteroids and traditional immunosuppressive drugs, have increased the life expectancy of SLE patients. Unfortunately, effective SLE management is still frequently associated with substantial drug-induced toxicity, which adds to organ function degradation and infectious complications, especially in patients with refractory disease and/or lupus nephritis. As a result, there is a gap in the market for drugs with improved efficacy and safety profiles.

Various biologic agents have been developed and tested in clinical trials, focusing on this subset of individuals whose condition is uncontrollable by current treatment regimens. Unfortunately, the majority of these studies have yielded negative results, leaving belimumab as the solely targeted therapy recognized for the treatment of SLE so far. Despite these limitations, clinical trials for various innovative biologic medicines targeting B cells, T cells, or cytokines are ongoing. When paired with established medicines, they appear to improve therapeutic efficacy. These efforts indicate that innovative drugs for people with refractory SLE will be introduced soon. According to the study "Biologics in Systemic Lupus Erythematosus (SLE)," published in March 2022, The first biological medication approved for the treatment of SLE is belimumab (anti-BlyS). More recent research shows that adding belimumab to the standard of therapy in lupus nephritis improves the renal response rate. In randomized placebo-controlled clinical studies in SLE, other biological treatments targeting B cells (such as obinutuzumab, a newer generation anti-CD20) and the type I interferon pathway (such as anifrolumab) have also shown promise. As a result, biologics will play an increasingly important role in treating SLE in the coming years.

As a result, the aforementioned reasons will likely contribute to this segment's strong growth over the forecast period.

North America is Expected to Hold a Significant Share in the Market

North America is expected to hold a major market share in the global systemic lupus erythematosus market owing to increased awareness about the disease, better healthcare infrastructure, and a growing number of foundations and independent venture groups supporting the biopharmaceutical manufacturers. Several companies have released general awareness programs such as the Chronic Disease Self-Management Program regarding the diagnosis, misconceptions, and treatment of the disease across the North American region. This is primarily boosted by the many non-profit organizations and funding communities supporting the cause. For instance, in December 2020, The HealthWell Foundation, an independent non-profit that provides financial assistance to underinsured Americans, announced that its fund for those suffering from Systemic Lupus Erythematosus had been reopened (SLE). Thus, it is expected to fuel the overall market growth during the forecast period.

In addition, the burden of growing autoimmune diseases also fuels the growth of the systemic lupus erythematosus market. As per the study "Prevalence of Systemic Lupus Erythematosus in the United States: Estimates From a Meta-Analysis of the Centers for Disease Control and Prevention National Lupus Registries," published in April 2021, the number of systemic lupus erythematosus cases in the United States was 72.8 per 100,000 person-years. Therefore, the growing prevalence rate of systemic lupus erythematosus among people is expected to increase the demand for effective treatment, fueling the target market growth during the forecast period.

Systemic Lupus Erythematosus Market Competitor Analysis

With a wide range of corticosteroids and immunosuppressants already in the market, there is a growing focus on collaborative drug development programs among the global players and new players in the particular geographic region. Many drugs in clinical trials also attract several funding partners and manufacturers to head for market approval during the forecast period. Some major companies in this segment include GlaxoSmithKline, F. Hoffmann-La Roche AG, Pfizer Limited, Sanofi SA, Eli Lilly & Company, Viatris Inc., Novartis AG, ImmuPharma PLC, AstraZeneca, Merck & Co., Inc., and Bristl Myers Squibb Company.

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