What is Systemic Lupus Erythematosus Market?

Systemic lupus erythematosus, (SLE, Lupus) is a chronic (long-term) disease that causes systemic inflammation which affects multiple organs. In addition to affecting the skin and joints, it can affect other organs in the body such as the kidneys, the tissue lining the lungs (pleura), heart (pericardium), and brain. Many patients experience fatigue, weight loss, and fever.

Lupus flares vary from mild to severe. SLE is most commonly seen in women in the reproductive age group (frequently starting at childbearing age), although lupus is increasingly recognized after the age of 40 years, particularly in the Europeans. The cause of lupus in most cases, however, is unknown.

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Some potential triggers include sunlight, genetic link, infections, and medicines. Common symptoms of SLE include tiredness, joint pain or swelling, fever, skin rash, mouth sores, and hair loss. In childhood-onset SLE, there are several clinical symptoms more commonly found than in adults, including malar rash, ulcer, renal involvement, proteinuria, seizures, thrombocytopenia, hemolytic anemia, fever, and lymphadenopathy.

The diagnosis of systemic lupus erythematosus is based on clinical and laboratory criteria, however, SLE is difficult to diagnose in primary care because many of thesymptoms (e.g., fatigue, rash, joint pain) are nonspecific and overlap with those of more common conditions. Furthermore, biomarkers are often negative or normal, early in the course of the illness. The most common presenting symptoms are constitutional, such as fatigue, weight loss, and fever without a focal infection, occurring in up to 90% of patients.

The severity of SLE is based mainly on two clinical tools, namely ‘The British Society of Rheumatology (BILAG)’ which is measured as: A grade = 9 points, B = 3, C = 1, D = 0, E = 0 and as ‘SLEDAI : Systemic Lupus Erythematosus Disease Activity Index’ which assess as less than 6 as being mild, 6-12 moderate and more than 12 as severe.

Among the severity specific cases, maximum belongs to the mild and moderate than to severe SLE. As per DelveInsight’s assessments, there were 103,790 cases of Mild, 103,790 Moderate and 51,895 Severe SLE cases in 2017.

Systemic Lupus Erythematosus (SLE) is a complex autoimmune disorder that affects multiple organ systems- the skin, kidneys, lungs, blood and, in the most severe cases, the brain. The therapeutic goals are individualized with the intention of achieving remission, preventing further organ damage, and improving the patient’s quality of life (QoL). As per DelveInsight assessments, among 7MM, the United States accounts for the highest market size of SLE in comparison with EU5 and Japan.

In EU5, the market size of SLE in the UK was the highest while Spain had the lowest market size of SLE. However, the market size of SLE in Japan was found to decent in 2017. The current market of SLE is majorly driven by Corticosteroids, Immunosuppressants, Antimalarials (Plaquenil) and Biologics (Rituximab, Belimumab). Nonsteroidal anti- inflammatory drugs (NSAIDs) may also be used to treat inflammation and pain. Among these, Hydroxychloroquine (Plaquenil) and Belimumab (Benlysta) are approved therapies for the treatment of SLE in the US.

Corticosteroids continue to be the mainstay in the management of SLE, particularly when an immediate aid is required. Low doses are usually adequate for managing mild disease; however, the dose can be increased for moderately active disease. The most commonly used corticosteroids are Prednisolone and Prednisone. Despite being the basic prescribed therapy, Corticosteroids are associated with substantial adverse effects and this often demands the introduction of Immunosuppressants such as Azathioprine, Cyclophosphamide or Mycophenolate mofetil for long-term management, in an effort to control disease and to reduce the cumulative exposure to steroids.

Antimalarial drugs, such as Plaquenil is used to treat cutaneous manifestations and arthralgia, as well as active renal disease, with concomitant immunosuppressive treatment. It is often administered with systemic glucocorticoid agents as first-line treatment to improve long-term outcomes and overall survival. If patients are unresponsive to HCQ, Chloroquine may be considered; however, it carries a higher risk of retinopathy and should be closely monitored.

Benlysta (belimumab), is a human IgG1λ monoclonal antibody specific for B-lymphocyte stimulator (BLyS)-specific inhibitor specified for the treatment of patients aged 5 years and older with active, autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy. Being the only approved disease-modifying biologic for SLE, Belimumab is an expensive therapy which is one of the major restraints for the drug’s market share. Overall, development of new biomarkers is important in order to follow the course of the disease and make sure that activity is treated appropriately. For example, neuropsychiatric symptoms occur in a large proportion of patients with SLE, but are usually not due to active disease and do not require increased immunosuppression. Although a variety of different serological and imaging tests have been suggested as aids to diagnosing which patients have true neuropsychiatric SLE, none has achieved sufficient specificity or sensitivity to be adopted into clinical practice. Equally, no serum or urine biomarkers are sufficiently accurate in the diagnosis of incipient or relapsing lupus nephritis that renal biopsies can be replaced.

Thus, based on the observed unmet need in the SLE market such as study population, outcome measures, and study endpoints of trial there is an immediate need to have more efficient therapies in this space. The launch of various multiple-stage pipeline products will significantly revolutionize the SLE market dynamics in the near future.

The dynamics of the SLE market is anticipated to change in the coming years owing to the expected launch of emerging therapies during the forecasted period 2020–2030. Anifrolumab (AstraZeneca), Lupuzor (ImmuPharma), Baricitinib (Eli Lilly), Stelara (Janssen Pharmaceutical), Atacicept (Merck KGaA), ILT-101 (ILTOO Pharma), BIIB059 (Biogen), CC-220 (Celgene), Dapirolizumab pegol (UCB Pharma/Biogen), IFNα Kinoid (Neovacs), Cenerimod (Idorsia Pharmaceuticals), KZR-616 (Kezar Life Sciences), Lulizumab pegol (Bristol-Myers Squibb), XmAb5871 (Xencor),and others are currently under development for the treatment of SLE.