Lupus Disease

Published Date : Aug 2023
Category : Infectious Diseases
Delivery Timeline : 48 hrs
Buy NowOrder by POGet a quote
Login To Access

Lupus Disease- Revenue Generator for Healthcare Industry

“Lupus disease can be recognized as a notable contributor to the growing autoimmune diseases and associated treatments”.

Lupus is a chronic autoimmune disease that produces multisystemic inflammation and abnormal immune responses, wreaking havoc on multiple organs.

The types of Lupus reported & elaborated are as follows -

  • Neonatal & Paediatric Lupus Erythematosus (NLE)-

Around 1% of NLE affects the skin, liver, and blood, and is detected in infants. It is triggered by maternal autoantibodies that penetrate the placenta. NLE responds to the therapy in between 3 and 4 months.

  • Discoid Lupus Erythematosus (DLE)-

People between the ages of 30 and 40 years are affected by DLE. Chronic scarring and atrophic photosensitive dermatosis are two DLE symptoms that are susceptible to SLE.

  • Drug-Induced Lupus (DIL)

DIL is established as a result of drug exposure that sets off an immunological response. Widely referred to as lupus, DIL is typically diagnosed in 20–150 people per 100,000 and affects women who are of reproductive maturity.

  • Systemic Lupus Erythematosus (SLE) –

The SLE is most common and most serious type of lupus. SLE dominates among the populations across Native Americans, Asians, African Americans, and Hispanics. Also, 15–30% of SLE patients with an early diagnosis have Lupus Nephritis (LN) and 30–50% develop LN as the disease progresses. Due to the genetic predisposition, abnormalities in the lymphocytes and autoantibody production significantly increase kidney failure. Furthermore, Lupus hepatitis (LH) is commonly associated with SLE and is usually asymptomatic. Lupus hepatitis reported in patients diagnosed with SLE is nearly about 3-23%.

Lupus disease associated with immune system dysfunction involves autoantibodies that target healthy immune cells & somatic cells. Autoantibodies are antinuclear antibodies (ANA) that target the nucleus of cells. These antibodies bind to self-antigen, such as DNA or proteins, forming immune complexes that circulate in the bloodstream and deposit in various tissues. This process triggers inflammation & tissue damage. The activated immune cells & immune complexes release pro-inflammatory cytokines, including tumour necrosis factor-alpha (TNF-Alpha) & interleukin, leading to further inflammation & immune cell recruitment. Additionally, individuals with lupus often experience increased production of type I interferons, which regulate immune responses.

Lupus has poor clearance of apoptotic cells, which leads to their buildup and subsequent immunological response and autoantibody formation. Lupus is caused by hereditary factors, and specific genetic abnormalities have been linked to an increased risk of developing the illness. Though the specific etiology of Lupus Erythematosus is unknown, it is thought to include a complex combination of genetic, environmental, and hormonal variables.

Shaping A Healthier World: DiseaseLandscape Insights (DLI) Empowers Epidemiology Intelligence for Safer Communities

The Lupus Foundation of America estimates that the condition affects ~ 5 million individuals globally and 1.5 million in the United States. Additionally, 90% of lupus patients between the ages of 15 and 44 years are female. Furthermore, 10 to 15% of individuals die from complications from early lupus.

The incidence and prevalence rate for lupus disease varies in every country. For instance, in the United States, DLI estimates that the rate of Systemic Lupus Erythematosus (SLE) is 54 per 100,000 persons. Whereas, Ukraine and Africa have the lowest incidence and prevalence rates of lupus disease.

Lupus affects multiple organs and tissues in the body. Though the exact cause of lupus is not known, it is believed to involve a complex interplay of genetic, environmental & hormonal factors associated with the cause of Lupus Erythematosus. The exact pathogenesis is not yet known since several findings are reported.

Diagnostic Analysis -

DiseaseLandscape Insights’ Services Transform Dynamic Diagnostic Techniques & Surge Demands

Systemic lupus erythematosus (SLE) is unable to diagnose easily since each type of Lupus has similar signs, symptoms & conditions. The SLE diagnosis is difficult because symptoms vary greatly from person to person and change over time. Early symptoms are undetectable & further converted into severe symptoms. Delay in the diagnosis further leads towards the chronic stage of disease, hence the early diagnosis is required.

The common tests used to diagnose lupus disease are -

  • Blood Test:

Erythrocytes from the blood sample are examined for their rate of sedimentation to diagnose lupus.

  • Erythrocyte Sedimentation Rate (ESR) test:

Erythrocyte sedimentation rate is an indirect indicator of inflammation. The test measures the red blood cell (Erythrocyte) settlement rate in the test tube of the blood. As cells can stick together & settle more quickly than individual cells, inflammation is a positive Lupus disease.

  • Anti-Nuclear Antibody Test (ANA):

ANA, or immune system-attacking antibodies, examined as 0–4 in lupus disease, are produced by the body. Higher titers suggest a greater chance of autoimmune illness. Lupus frequently has positive ANA results, although this is not a diagnosis. About 10% of those without autoimmune diseases could have weaker, positive ANA. The ANA test has a 98% specificity and 97% sensitivity for the diagnosis of SLE. An anti-DNA test, also known as an Anti-DNA antibody test, identifies different types of antibodies in our blood. The majority of those who take this test are found to have SLE in about 70% of cases.

  • Skin & Liver Biopsy:

A piece of tissue is extracted with a needle or by a small incision and examined under a microscope. The tissue exhibits a variety of autoimmune disease symptoms. A liver biopsy is used to diagnose lupus hepatitis.

  • Imaging test:

  • Chest X-ray:

    An imaging of your chest shows typical shadows that indicate fluid or inflammation in your lungs. Because of the many clinical signs of this approach, the identification of SLE is poor.
  • Computerized CT:

    High-resolution CT can be used to diagnose SLE patients at an early stage. In adults, 70% of patients displayed diverse clinical signs associated with various disorders.
  • Urinalysis:

    Because SLE patients have additional kidney problems, urine examination indicates an elevated protein content of red blood cells. As a result, it demonstrates the impact of lupus on the kidneys.

Prominent Market Player in The Diagnostic Industry:

Diagnostic Techniques Market Player

Imaging Devices

Chest X-ray

Computerized CT

Seimens Healthiners

Sanying Precision Instruments Co., Ltd

GE Healthcare

WENZEL Metrology GmbH

Philips Healthcare

Royma Tech (Suzhou) Precision Co., Ltd

Fujifilm Medical System

ZEISS Industrial Metrology

Canon Medical System

Bruker AXS GmbH

Hitachi Medical System

Waygate Technologies

Shimadzu Corporation

Comet Yxlon GmbH




Diagnostic Product

Imaging Devices

Chest X-ray

Computerized CT


Phoenix V|tome|x M300

Definium™ 646 HD X-ray system


Radiography 7000 C — DigitalDiagnost C90


FDR Smart f

CT computed tomography system FF20 CT

Zexira i9

CT computed tomography system nanoVoxel-1000


CT computed tomography machine exaCT U series

Digital Radiographic Mobile X-ray System - MobileDaRt Evolution MX8 Version

CT computed tomography machine RMCT1000



Treatment Analysis-

Supportive Therapeutics Against Lupus Disease Convert Patients’ Life into Healthy Life

Lupus disease, which can be remedied, weakens the immune system and dermal systems. Anti-inflammatory medications, antimalarial medications, corticosteroids, and immunosuppressants are instances of NSAIDs. As a result, multiple treatments are employed which can benefit both the treatment industry and the patients.

  • Nonsteroidal Anti-Inflammatory Drugs (NSAIDs):

The non-steroidal anti-inflammatory drugs, comprising Naproxen sodium (Aleve) & Ibuprofen (Advil, Motrin IB), are given over the counter and are used to treat pain, swelling, and fever caused due to Lupus disease.

  • Antimalarial Drugs:

The antimalarial drugs are also capable to treat Lupus disease. Antimalarial drugs like hydroxychloroquine (Plaquenil) & chloroquine phosphate (Aralen) minimize lupus infection by showing effect on patient’s immune system.

  • Corticosteroids:

Lupus is treated with Prednisolone analogs, mainly methylprednisolone (Medrol). Internal inflammation in such conditions is reduced by these medications.

  • Monoclonal Antibodies:

These medications reduce the amount of aberrant B cells (immune system cells that produce antibodies) present in people with lupus. Belimumab, a typical form of BLyS-specific inhibitor used to treat lupus symptoms, inhibits the function of a particular protein in the body that is involved in the immune response. Infusions of monoclonal antibodies are offered to treat Lupus.

For the treatment of Lupus, biologicals such as Belimumab and Rituximab are injected intravenously. Belimumab (Benlysta®) was authorized in 2019 for paediatric SLE and in 2020 for Lupus Nephritis. Voclosporin (LupkynisTM) is an FDA-approved lupus therapy.

  • Immunosuppressants:

Immunosuppressive medications like Azathioprine, Mycophenolate, Methotrexate, & Lefluniamide can encourage the immune system, which reduces the severity of sickness.

Below Table Shows Therapeutics Used to Treat Lupus Disease, with Their Mode of Action, Typical Dose, Formulation & Side Effects:


Mode of Action

Typical Dosing


Side Effects

NSAIDS (Including salicylates)

Blocks PG synthesis by inhibiting the COX-I enzyme

Various dosages & various agents

Oral dosage Tablets

Gastrointestinal irritation & bleeding, renal toxicity, hepatic toxicity

Corticosteroid (Prednisolone)

Inhibition of cytokine activation & inhibiting Interleukin & by TNF-α inhibiting

0.5–1 mg/kg prednisone equivalent with or without initial pulse intravenous (IV) methylprednisolone

IV, Topical

Glucocorticoids analogue

Weight gain, hypertension, hyperglycemia, hyperlipidemia, osteoporosis, cataracts, edema,

hypokalemia, muscle

weakness, growth suppression, increased risk

of infection, glaucoma



Interfere with T-cell Activation & inhibit cytokine activity

Hydroxychloroquine oral 200-400 mg/daily

Tablet; Oral route

Muscular damage, muscle weakness

Immunosuppressants (Azathioprine)

Reduction of T-cell & B-cells proliferation.

DNA & RNA disruptions

Azathioprine Oral 1-3mg/kg per day

Tablet; Oral route

Renal dysfunction, myelosuppression, infertility, risk of cancer

Monoclonal Antibodies (Belimumab)

BLyS-specific inhibitor i.e., acts on B lymphocyte stimulator

Belimumab IV 10mg/kg (Over a period of 1hr), every 2 weeks for the first three doses, then every 4 weeks

I.V. Infusion, or Subcutaneous Injection.

Nausea, diarrhea, pyrexia, nasopharyngitis, insomnia


Key Market Players in the Pharmaceutical Therapeutics Industry for Lupus Disease:

Treatment Market Players

Topical Therapy

Orally Active Therapy

Biological Products

Ajanta Pharma Ltd

Pfizer Ltd

Pfizer Ltd

Abbott pharmaceuticals

Panacea Biotech Ltd

Neiss Labs Pvt Ltd

Macleod’s Pharmaceuticals Pvt Ltd

RPG Life Sciences Ltd

Kabir Life Sciences

Intas Pharmaceuticals Ltd

Cipla Ltd

Beulah Bio Medics Ltd

Ipca Laboratories Ltd

Roche Products India Pvt Ltd

BMW Pharmaco India Pvt. Ltd


Ipca Laboratories Ltd

Asterisk Laboratories India Pvt Ltd


Wallace Pharmaceuticals Pvt Ltd

Syndicate Life Sciences Pvt Ltd


Novartis India Ltd

Ipca Laboratories Ltd


Cian Health Care Pvt Ltd

Novartis India Ltd



Horizion therapeutics





The Therapeutic Range of Products for The Treatment of Lupus Disease:

Treatment products

Topical Therapy

Orally Active Therapy

Immunological Therapy

Softcor MP Cream

Medrol 8mg Tablet

Solu-Medrol 1gm Injection


Imuza Tablet

Nispred 500mg Injection

Omnacortil 0.1% Cream

Azoran Tablet

Merilone 40mg Injection

Apderm Cream

Thiazprine 50mg Tablet

Biopred 1000mg Injection

Trexjoy Gel

Innomune Tablet

Nayapred 40mg Injection

Folitrax LP Gel

Cellcept 500mg Tablet

MRD-S Injection

Rextop 1% Gel

Mycept 250 Capsule

Wellpred 40 Injection


Mycept Suspension

Folitrax 20 Injection


Folitrax 20 Tablet

Sandimmun Injection


Mext 15 Tablet

Antima 100mg Syrup


Sandimmun Neoral 50mg Soft Gelatin Capsule



HCQS 200 Tablet



Ciaclor 200mg Tablet






The Mechanism of Action of The Lupkynis:

Lupkynis interacts with the calcineurin protein, which activates T-cells within the immune system. This activation helps to decrease inflammation in the kidney. Further, it stimulates an autoimmune response in the immune system. Lupkynis (Voclosporin) was approved by the U.S. Food & Drug Administration (FDA) for the treatment of Lupus Nephritis in January 2021. Aurinia Pharmaceuticals, Inc based in Vancouver, British Columbia, Canada, developed Lupkynis as a treatment for LN.

Emerging Therapies:

Revolutionizing Lupus Treatment: Unleashing the Power of Innovative Pharmacotherapeutics!

New medicines that target entirely novel immune cells for treatment are currently being developed. The Plasmacytoid Dendritic Cells (pDCs) can drive Cutaneous Lupus Erythematous (CLE) pathogenesis. Majorly, these cells are found in CLE tissue after sun exposure & secrete proinflammatory cytokinins & chemokines which drive the severity of the disease.

Two potential therapies, Litifilimab & Daxilimab are currently in exploratory & preclinical phases of clinical trials, respectively. These molecules are being investigated by Biogen & Horizion Therapeutics for the clinical efficacy response & reduction of the severity of lupus symptoms.

In the future, a potential treatment for lupus may include targeted antibodies against specific proteins in the immune system. Litiflimab, an antibody against BDCA2, could disrupt interferon production, which links to the lupus disease activity. Another antibody, Dapirolizumab pegol, blocks CD40L, a protein in B & T cells that regulates the immune system and declines the severity of lupus disease.

Additionally, the Telitacicept activates the B cell activating factor inhibitor and an immunomodulator. The Telitacicept treatment, developed by RemeaGen & RC Pharma, shows potential in modulating the immune system in lupus disease.

As such, the successful commercialization of Litiflimab, Daxilimab, Dapirolizumab pegol, & Telitacicept could result in substantial revenue growth for the companies, while also providing a much-needed solution for lupus patients.

Ongoing Clinical Trials:

DiseaseLandscape Insights Services Aid in Planning and Conducting Clinical Trials for New Drugs and Therapies, Patient Recruitment Strategies, Regulatory Compliance, Ensuring Successful Trial Outcomes, Etc.

Below is a table showcasing ongoing clinical trials with their study titles and the phases in which they are being conducted –

Phase 1

Phase 2

Phase 3

Phase 4

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Lupus

A Phase Ib Study of Nivolumab in Patients with Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)

A Multicentre Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients with Active Proliferative Lupus Nephritis

Pilot Trial of Belimumab in Early Lupus

Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus (ALE11)

A Phase 1b/2, Double-Blind, Placebo-Controlled, Randomized, Parallel-Arm Study to Explore the Safety, Pharmacokinetics, and Proof of Biological Activity of DS-7011a in Patients with Systemic Lupus Erythematosus and Active Cutaneous Lupus Erythematosus

A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multicenter Phase 3 Trial to Evaluate Efficacy, Safety, and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Participants with Active Lupus Nephritis (SIRIUS-LN)

Minimizing Glucocorticoid Administration in Patients with Proliferative Lupus Nephritis During the Induction of Remission Period-EUROLUPUS vs. RITUXILUP Regimen: A Randomized Study

An Open-label, Multi-center, Phase 1/2 Study to Assess the Safety, Efficacy, and Cellular Kinetics of YTB323 in Participants with Severe, Refractory Systemic Lupus Erythematosus

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients with Active Class III or IV Lupus Nephritis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants with Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care


Open-label Prospective Randomized Study to Determine the Efficacy and Safety of Two Dosing Regimens of ACTHar in the Treatment of Proliferative Lupus Nephritis

A Single-Arm, Phase 1b, Open-Label Study to Assess the Safety, Tolerability, and Pharmacodynamics of Repeat-Doses of Subcutaneous ANX009 With Standard of Care Therapy in Adult Participants with Lupus Nephritis

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Investigate the Efficacy and Safety of Daxdilimab Subcutaneous Injection in Reducing Disease Activity in Adult Participants with Moderate-to-Severe Primary Discoid Lupus Erythematosus

Induction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open-Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF

A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison with Mycophenolate Mofetil and Corticosteroids in Subjects with Class III/IV±V Lupus Nephritis

The discovery of these innovative medicines provides substantial financial potential for the pharmaceutical sector. If successful, these treatments have the potential to address a substantial unmet medical need in the lupus therapeutics market portfolio.

Why DLI?

DiseaseLandscape Insights offers a variety of business information services to the healthcare sector. We have highly skilled and experienced industry specialists on staff to provide you with the best services available anywhere in the globe. Our bits of intelligence are offered in a variety of disease verticals, including infectious illness, chronic disease, genetic disease, autoimmune disease, mental health problems, and environmental diseases.

DiseaseLandscape Insights provides significant services like Disease Intelligence, Market Research Services and Consulting Services, Global Pricing, Market Access, Epidemiology Study, Product Portfolio, and Pipeline Services.

We provide critical help to all stakeholders in the Healthcare industry, supporting them in developing a stronger presence and understanding market dynamics.

Vishal SawantBusiness Development

How we can help?

  • 1-888-853-7040 - U.S. (TOLL FREE)
  • +44-1173181773 - U.K. OFFICE
  • +91-7447409162 - INDIA OFFICE
1Chat With UsBook AppointmentBook 15 min Free Analyst Call
We are always looking to hire talented individuals with equal and extraordinary proportions of industry expertise, problem solving ability and inclination interested? please email us
  • FAQ
Disease Landscape Insights LLP
6th Floor, Sr No.207, Office A H 6070 Phase 1, Solitaire Business Hub, Viman Nagar, Pune, Maharashtra, 411014
1-888-853-7040 - U.S. (TOLL FREE)+44-1173181773 - U.K. OFFICE+91-7447409162 - INDIA OFFICE
© Copyright 2024-25 Disease Landscape Insights LLP. All Rights Reserved | Designed by Disease Landscape