Systemic Lupus Erythematosus Market
DelveInsight’s ‘Systemic Lupus Erythematosus - Market Insights, Epidemiology and Market Forecast– 2030’ report delivers an in-depth understanding of the Systemic Lupus Erythematosus, historical and forecasted epidemiology as well as the Systemic Lupus Erythematosus market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), And Japan.
The Systemic Lupus Erythematosus market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Systemic Lupus Erythematosus market size from 2018 to 2030. The report also covers current Systemic Lupus Erythematosus treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
- The United States
- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Study Period: 2018–2030
Systemic Lupus Erythematosus Disease Understanding
Systemic Lupus Erythematosus Overview
According to the American College of Rheumatology “Systemic Lupus Erythematosus, referred to as SLE or 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 serious. Most patients have times when the disease is active, followed by times when the disease is mostly quiet - referred to as a remission. Yet, there is much reason for hope.”
The primary pathological findings in patients with SLE are those of inflammation, vasculitis, immune complex deposition, and vasculopathy. Lupus nephritis is a common and potentially disturbing sign of lupus. It is a leading cause of morbidity and mortality in patients with SLE. It leads to inflammation of small blood vessels which play an important role in filtering waste materials in the kidney.
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 disease is prone to relapses and remissions, resulting in considerable morbidity due to flares of disease activity and accumulated organ damage, and an increased risk of premature death, mostly due to infection or cardiovascular disease. SLE initially appears with symptoms such as drowsiness, illness, loss of appetite, and fever. Most of the affected patients also suffer from joint pain which typically affects the same joint on both sides of the body, weakness and muscle pain. The signs and symptoms of SLE vary among affected individuals and can involve many organs and systems, including the skin, joints, kidneys, lungs, central nervous system, and blood-forming (hematopoietic) system.
Also, some of the novel observations have provided an improved understanding of the contribution of tissue-specific factors and associated damage, T and B lymphocytes, as well as innate immune cell subsets and their corresponding abnormalities. SLE associated with intense polyclonal B-cell activation, with a population shift towards immature B cells. Memory B cells with increased CD27+/IgD are less disposed to immunosuppression. CD27-/IgD- memory B cells are related to increased disease activity and renal lupus. T cells that lead to the regulation of B-cell responses and helps in the infiltration of target tissues help to reduce the defects in signaling, adhesion, co-stimulation, gene transcription, and alternative splicing. The cytokines B-lymphocyte stimulator (BLys), interleukin 6, interleukin 17, interleukin 18, type I interferons, and tumor necrosis factor α (TNFα) are involved in the inflammatory process and are potential therapeutic targets.
Systemic Lupus Erythematosus Diagnosis
Systemic Lupus Erythematosus is a multisystem inflammatory disease that is often difficult to diagnose. It presents differently in every person, with varying degrees of organ and system involvement. Organ systems affected include the skin, joints, kidneys, lungs, central nervous system (CNS), and hematopoietic system. Owing to these variabilities in presentation, it may take years to reach a diagnosis, leading to increased morbidities and a decline in patient-reported quality of life.
The diagnosis of Systemic Lupus Erythematosus is based on clinical and laboratory criteria. SLE is difficult to diagnose in primary care because many of the symptoms (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.
Systemic Lupus Erythematosus Treatment
There is no complete cure for SLE currently, but there are many treatments available to help particular symptoms. The disease involves a wide range of clinical features that encompasses vascular, immune and fibrotic manifestations along-with the involvement of many organs.
Treatments of Systemic Lupus Erythematosus include NSAIDs and antimalarial agents, which are the first-line therapies for mild SLE. In addition, glucocorticoids and cytotoxic or immunosuppressive agents—such as azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine, and methotrexate —are used for SLE with organ involvement.
Systemic Lupus Erythematosus Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Population of SLE, Age-specific Prevalent Population of SLE, Gender-specific Prevalent Population of SLE, and Severity-specific Prevalent Population of SLE in the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom), and Japan.
This section provides glimpse of the SLE epidemiology in the 7MM.
- The total diagnosed prevalent population of Systemic Lupus Erythematosus (SLE) in the 7MM ranges from 651,965 in 2020
- Epidemiology assessed for SLE showed that the US, in 2020, accounted for approximately 351,176 prevalent cases of SLE.
- In the United States, in 2020, there were 240, 1,070, 3,654, 7,283 and 8,181 cases, in the age groups 0–49 years, 50–59 years, 60–69 years, 70–79 years, and 80+ years, respectively.
- In the United States, in 2020, the highest proportion of age-specific cases were observed in 40-59 years, followed by age groups of 19-39 years and 60+ years.
- As per the analysis, a higher percentage of mild SLE was observed in the 7MM, followed by moderate SLE and severe SLE in 2020. In the US, moderate SLE accounted for the highest cases in 2020, followed by mild SLE with 161,541 and 112,376 cases, respectively. Whereas the lowest cases were observed in severe SLE, with 77,259 cases, in 2020.
- Among the gender-specific prevalent contribution, females are affected more with SLE than male. In 2020, there were 34,837 prevalent cases of SLE in males and 316,339 prevalent cases in females in the US.
- Among the EU-5 countries in 2020, the UK had the highest diagnosed prevalent population of SLE patients with 68,702 cases, followed by Germany (46,634) and Italy (42,767). In contrast, Spain had the lowest cases (35,662) in 2020.
- As per the estimates, Japan accounted for 68,443 prevalent SLE cases in 2020.
Country Wise- Systemic Lupus Erythematosus Epidemiology
The epidemiology segment also provides the Systemic Lupus Erythematosus epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
Systemic Lupus Erythematosus Drug Chapters
The drug chapter segment of the Systemic Lupus Erythematosus report encloses the detailed analysis of SLE mid and late-stage pipeline drugs. It also helps to understand the SLE clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug and the latest news and press releases.
Systemic Lupus Erythematosus Marketed Drugs
Benlysta, developed by GlaxoSmithKline, 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, SLE who are receiving standard therapy. It is provided as a lyophilized powder (120 mg or 400 mg) in a single-use vial for intravenous infusion and is also available as a subcutaneous formulation. The subcutaneous formulation was approved for use in the 2017 in US, EU5 and Japan. These Subcutaneous presentations enable patients to self-administer their medicine at home after initial supervision from their clinical team if considered appropriate.
Product details in the report…
Saphnelo, developed by AstraZeneca, is a fully human monoclonal antibody that binds to subunit 1 of the Type I IFN receptor, deterring the activity of all Type I IFNs including IFN-α, IFN-β, and IFN-ω. In August 2021, US FDA approved Saphnelo (anifrolumab-fnia) to treat adult patients with moderate to severe SLE who are receiving standard therapy. In the second half of 2020, AstraZeneca received regulatory submission acceptances for the drug from the EMA and PDMA Japan for the treatment of adult patients with moderate-to-severe SLE. In 2015, the US FDA granted Anifrolumab Fast-Track designation for SLE
Product details in the report…
Systemic Lupus Erythematosus Emerging Drugs
Olumiant (baricitinib): Eli Lilly
Eli Lilly is developing Olumiant (baricitinib) in collaboration with Incyte Corporation. It is an oral, small-molecule inhibitor of Janus kinase (JAK 1 and JAK 2). The drug has been approved by EMA for the treatment of moderate to severe rheumatoid arthritis and atopic dermatitis in adult patients with the brand name Olumiant. It is being evaluated in Phase III clinical trials for SLE. In December 2018, Eli Lilly and Incyte announced that the US FDA had granted Fast Track designation to Baricitinib, which is being studied for the treatment of SLE
Product details in the report…
Lupuzor (also known as regiremod; IPP-201101), being developed by ImmuPharma, is a 21-mer linear peptide fragment analog. It has a novel mechanism of action aimed at modulating the body’s immune system so that it does not attack healthy cells and avoids causing adverse side effects. The unique mechanism of action involves modulating the activation of auto-reactive T-cells. This targeted approach marks a paradigm shift in treating autoimmune diseases. ImmuPharma has completed the Phase III clinical trial for the treatment of SLE. The therapeutic candidate has received the Fast Track designation and Special Protocol Assessment (SPA) by the FDA for SLE treatment.
Product details in the report…
Biogen is developing, BIIB059, is an investigational humanized monoclonal antibody that specifically recognizes and binds to blood DC antigen 2 (BDCA2), a pDC-specific receptor that inhibits the production of IFN-I and other inflammatory mediators when ligated. BDCA2 is uniquely expressed on the surface of human pDCs (plasmacytoid dendritic cells). Biogen is conducting a Phase III clinical trial for the treatment of patients receiving Active SLE receiving background nonbiologic lupus standard of care.
Product details in the report…
Dapirolizumab pegol: UCB Pharma
Dapirolizumab pegol, developed by UCB Pharma and their partner Biogen. It is an investigational humanized anti-CD40L antibody fragment that acts by preventing the interaction between CD40L on T-cells with CD40 on antigen-presenting cells through interactions with its receptor-CD40. The drug failed to meet its primary endpoint in the Phase II trial. However, the company continued the development of dapirolizumab pegol. The product is currently being developed jointly by UCB and Biogen to treat SLE in a Phase III trial.
Product details in the report…
Gazyva/Gazyvaro (obinutuzumab): Hoffmann-La Roche
Hoffmann-La Roche is developing Gazyva/Gazyvaro (obinutuzumab), an engineered monoclonal antibody designed to attach to CD20, a protein expressed on certain B-cells but not on stem cells or plasma cells. Recently, in August 2021, the company initiated a Phase III trial (ALLEGORY) evaluating the efficacy and safety of obinutuzumab in participants with SLE. Additionally, in September 2019 FDA granted Breakthrough Therapy designation to the drug to treat lupus nephritis.
Product details in the report…
Cenerimod: Idorsia Pharmaceuticals
Cenerimod, developed by Idorsia Pharmaceuticals, is an oral, selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, which potentially offers a novel approach for SLE. S1P1 modulator binds to the S1P1 receptor on the surface of T and B lymphocytes. In December 2018, the company initiated a Phase II (CARE) multiple-dose efficacy and safety study with cenerimod for the treatment of adult patients with moderately to severely active autoantibody-positive SLE. In December 2017, the US Food and Drug Administration (FDA) had granted cenerimod Fast Track designation for the SLE treatment. The results for the CARE Phase IIb study are expected in Q4 2021.
Product details in the report…
Systemic Lupus Erythematosus Market Outlook
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 to achieve remission, prevent further organ damage, and improve patient quality of life (QoL).
SLE treatment is dependent on the presentation of symptoms. Available options include antimalarials, glucocorticoids, immunosuppressants, and biologics, along with nonsteroidal anti-inflammatory drugs (NSAIDs), which may also be used to treat inflammation and pain. In addition to these, Plaquenil and Benlysta are the few approved treatments for SLE, including the very recently approved Saphnelo.
More than five decades ago, Plaquenil (hydroxychloroquine (HCQ); Sanofi-Aventis), an antimalarial drug, was approved by US FDA in 1955 for the treatment of SLE. Since then, no drug had received approval for SLE treatment until 2011, when GlaxoSmithKline came up with the first-ever targeted therapy for SLE treatment, i.e., Benlysta (belimumab).
With the approval of these therapies, the outlook for patients SLE improved from a 4-year survival rate of ~50% in 1950 to a 15-year survival rate of ~85% by 2013.
Among the targeted therapies, biological agents used in treating SLE include rituximab and belimumab; both are monoclonal antibodies. Rituximab targets B-cells and is used to treat renal and CNS presentations of SLE. This agent is recognized as a second- or third-line agent for active disease. Belimumab targets the B-cell activating factor B-lymphocyte stimulator (BLyS) and is the approved drug for SLE in the 7MM. It was the first drug to be approved in over 50 years as an add‐on treatment for SLE. The launch of belimumab in 2011 came as a ray of hope for the researchers, and the opportunity window for targeted therapies became wide open, resulting in many companies investing their resources in developing targeted drug candidates for SLE treatment.
Being the only approved disease-modifying biologic for SLE until recently, belimumab is an expensive therapy, one of the major restraints for the drug’s market share.
Other than these current therapies, the SLE pipeline is robust and possesses multiple potential drugs in the late, mid, and early stages of developments, yet to be launched. The potential therapies expected to be launched in the forecast period include Saphnelo (AstraZeneca), Lupuzor (ImmuPharma), baricitinib (Eli Lilly), dapirolizumab pegol (UCB Pharma/ Biogen), iberdomide (Bristol-Myers Squibb/Celgene), obinutuzumab (Hoffmann-La Roche), BIIB059 (Biogen), obexelimab (Xencor), cenerimod (Idorsia Pharmaceuticals) tofacitinib (Pfizer), RSLV-132 (Resolve therapeutics), and others. The launch of these therapies may increase market size in the coming years, assisted by an increasing the SLE patient pool. The launch of these therapies may increase market size in the coming years, assisted by an increase in the SLE patient pool.
This section includes a glimpse of the SLE 7MM market.
- The total market size is calculated by including the market size of both emerging and current therapies. The total market size in the 7MM for SLE was estimated to be USD 1,462.5 million in 2020 during the study period 2018–2030.
- The United States accounted for the largest market size of SLE in comparison to the EU5 (Germany, France, Italy, the United Kingdom, and Spain) and Japan. In the United States, the market size of SLE is USD 1,181.2 million in 2020.
- Among the EU5 countries, UK had the largest market size with USD 64.4 million in 2020, while Spain had the smallest market size of SLE with USD 33.4 million in 2020.
- In 2020, Japan accounted for market size of SLE with USD 63.5 million.
The United States Market Outlook
This section provides the total Systemic Lupus Erythematosus market size and market size by therapies in the United States.
EU-5 Market Outlook
The total Systemic Lupus Erythematosus market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
Japan Market Outlook
The total Systemic Lupus Erythematosus market size and market size by therapies in Japan are provided.
Systemic Lupus Erythematosus Drugs Uptake
This section focuses on the rate of uptake of the potential drugs recently launched in the SLE market or expected to get launched in the market during the study period 2018–2030. The analysis covers SLE market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Systemic Lupus Erythematosus Development Activities
The report provides insights into different therapeutic candidates in phase II, and phase III stages. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for SLE emerging therapies.
Competitive Intelligence Analysis
We perform competitive and market Intelligence analysis of the Systemic Lupus Erythematosus market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
- The report covers the descriptive overview of SLE, explaining its causes, signs and symptoms, pathogenesis and currently available therapies.
- Comprehensive insight has been provided into the SLE epidemiology and treatment.
- •Additionally, an all-inclusive account of both the current and emerging therapies for SLE are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
- A detailed review of the SLE; historical and forecasted is included in the report, covering the 7MM drug outreach.
- The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM SLE Injury market.
- Ten Year Forecast of Systemic Lupus Erythematosus
- 7MM Coverage
- Delvelnsight has analysed prevalent population of Systemic Lupus Erythematosus in the 7MM which suggests that the patient pool will increase during the forecast period of 2021–2030.
- Age-specific data of SLE suggests that prevalence of SLE in the US, was highest in the age group of 40-59 years, followed by age groups of 19-39 years and 60+ years.
- The scope of the report also encompasses another major segment, i.e., severity-specific prevalence of SLE, wherein higher percentage of mild SLE was observed in the 7MM, followed by moderate SLE and severe SLE in 2020. In the US, moderate SLE accounted for the highest cases in 2020, followed by mild SLE. Whereas the lowest cases were found in severe SLE in 2020.
- Among the gender-specific prevalent contribution, females are affected more with SLE than male.
- Current treatment space comprise of antimalarials, corticosteroid, or immunosuppressant as monotherapy or in combination with each other, along with Benlysta (belimumab) and others (rituximab, calcineurin, NSAIDs, etc.).
- The potential therapies expected to be launched in the forecast period include Saphnelo (AstraZeneca), Lupuzor (ImmuPharma), baricitinib (Eli Lilly), dapirolizumab pegol (UCB Pharma/ Biogen), iberdomide (Bristol-Myers Squibb/Celgene), obinutuzumab (Hoffmann-La Roche), BIIB059 (Biogen), obexelimab (Xencor), cenerimod (Idorsia Pharmaceuticals) tofacitinib (Pfizer), RSLV-132 (Resolve therapeutics), and others. The launch of these therapies may increase market size in the coming years, assisted by an increasing the SLE patient pool.
- United States has shown an increasing trend toward SLE for past years, observable in the reported studies. SLE is more prevalent in women than men across all age groups and populations; the female-to-male ratio is highest at reproductive age.
- Among EU5 countries, the United Kingdom has the highest prevalent population of SLE. Patients with late-onset SLE (≥ 50 years) tend to have a more insidious onset of disease with severe manifestations being infrequent.
- SLE is a prototypic systemic autoimmune disease characterized by a broad spectrum of clinical manifestations and diverse immunological disorders. Japan has also shown the increasing trend of SLE like the US and EU5. Every year new cases are added, which correspond to a new rate of incidence and prevalence.
- Corticosteroids is the most frequently used drug class in newly diagnosed SLE patients; prednisone is most commonly prescribed corticosteroid with the longest duration of therapy.
- While 10.2% of patients had no evidence of prescription pharmacotherapy for SLE, a quarter of patients had monotherapy, and about two-thirds of patients had evidence of treatment with more than one class of SLE treatments.
- Benlysta’s approval and its subsequent expansion to a subcutaneous dose in children have made it the market leader with no competitor, until the recent approval of Saphnelo. However, as per latest news, NICE stand against on its use in children ≥5 in the UK. Besides, although there are no other drugs targeting children presently, Benlysta may face competition from other companies that will try to enter this segment in the future.
- Out of all the emerging therapies, we believe that the key contenders include Lilly's Baricitinib, Biogen's BIIBO59, Roche's Gazyva and ImmuPharma's Lupuzor, where the first mover advantage and potential efficacy of ImmuPharma's Lupuzor can help in creating a strong competition with Benlysta and Saphnelo.
Systemic Lupus Erythematosus Report Insights
- Patient Population
- Therapeutic Approaches
- Systemic Lupus Erythematosus Pipeline Analysis
- Systemic Lupus Erythematosus Market Size and Trends
- Market Opportunities
- Impact of upcoming Therapies
Systemic Lupus Erythematosus Report Key Strengths
- Ten Years Forecast
- 7MM Coverage
- Systemic Lupus Erythematosus Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Market
- Drugs Uptake
Systemic Lupus Erythematosus Report Assessment
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- Market Drivers and Barriers
- What was the Systemic Lupus Erythematosus market share (%) distribution in 2018 and how it would look like in 2030?
- What would be the Systemic Lupus Erythematosus total market size as well as market size by therapies across the 7MM during the forecast period (2021–2030)?
- What are the key findings pertaining to the market across the 7MM
- Which country will have the largest Systemic Lupus Erythematosus market size during the forecast period (2021–2030)?
- At what CAGR, the Systemic Lupus Erythematosus market is expected to grow in the 7MM during the forecast period (2021–2030)?
- What would be the Systemic Lupus Erythematosus market outlook across the 7MM during the forecast period (2021–2030)?
- What would be the Systemic Lupus Erythematosus market growth till 2030 and what will be the resultant market size in the year 2030?
- How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
- What is the disease risk, burden and unmet needs of Systemic Lupus Erythematosus?
- What is the historical Systemic Lupus Erythematosus patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK) and Japan?
- What would be the forecasted patient pool of Systemic Lupus Erythematosus at the 7MM?
- What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Systemic Lupus Erythematosus?
- Out of the above-mentioned countries, which country would have the highest incident population of Systemic Lupus Erythematosus during the forecast period (2021–2030)?
- At what CAGR the population is expected to grow across the 7MM during the forecast period (2021–2030)?
Current Treatment Scenario, Marketed Drugs and Emerging Therapies:
- What are the current options for the treatment of Systemic Lupus Erythematosus along with the approved therapy?
- What are the current treatment guidelines for the treatment of Systemic Lupus Erythematosus in the US, Europe and Japan?
- What are the Systemic Lupus Erythematosus marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
- How many companies are developing therapies for the treatment of Systemic Lupus Erythematosus?
- How many therapies are developed by each company for the treatment of Systemic Lupus Erythematosus?
- How many emerging therapies are in the mid-stage and late stage of development for the treatment of Systemic Lupus Erythematosus?
- What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Systemic Lupus Erythematosus therapies?
- What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for Systemic Lupus Erythematosus and their status?
- What are the key designations that have been granted for the emerging therapies for Systemic Lupus Erythematosus?
- What are the 7MM historical and forecasted market of Systemic Lupus Erythematosus?
Reasons to buy
- The report will help in developing business strategies by understanding trends shaping and driving Systemic Lupus Erythematosus.
- To understand the future market competition in the Systemic Lupus Erythematosus market and an Insightful review of the key market drivers and barriers.
- Organize sales and marketing efforts by identifying the best opportunities for Systemic Lupus Erythematosus in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), And Japan.
- Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
- Organize sales and marketing efforts by identifying the best opportunities for the Systemic Lupus Erythematosus market.
- To understand the future market competition in the Systemic Lupus Erythematosus market.