Lupus Nephritis (LN) is the most feared and common complication of systemic lupus erythematosus (SLE) and is responsible for the major share of morbidity and mortality of this disease. It affects around half of the systemic lupus erythematosus patients, and in ~35% of patients, lupus nephritis is the presenting feature at the time of systemic lupus erythematosus diagnosis. The disease is characterized by accumulating immune complexes in glomeruli and often an inflammatory response in all kidney compartments. Over time inflammation leads to chronic damage of the renal parenchyma and loss of kidney function.

Signs and lupus nephritis symptoms vary highly and may differ for everyone. The most frequent lupus nephritis symptoms include joint pain or swelling, muscle pain, or fever with no known cause. Clinical signs such as hematuria and proteinuria suggest lupus nephritis in patients with systemic lupus erythematosus. Kidney biopsy remains the only confirmatory test for establishing the lupus nephritis diagnosis. Active surveillance is recommended in systemic lupus erythematosus patients at high risk of kidney involvement (males, juvenile lupus onset, and serologically active disease).

Among the adults, systemic lupus erythematosus patients ~40–50% develop lupus nephritis. However, it has been widely known that juvenile onset of lupus results in a more aggressive disease, and ~60–80% of juvenile systemic lupus erythematosus patients develop lupus nephritis. 

As per a recent analysis by DelveInsight, in the 7MM, the total prevalent cases of lupus nephritis in 2021 were approximately 260K cases. The growth in the lupus nephritis treatment market can be attributed to the aging population and increased exposure to pollutants, industrial agents, UV light, etc. The increasing use of hormonal drugs has also been identified as a risk factor among females.

What are the currently available lupus nephritis treatment options for patients?

Lupus nephritis treatment recommendations are dependent on the degree of histological kidney involvement. Currently, patients with Class I/II (ISN/RPS 2003 criteria) are mostly monitored and do not need immunosuppressants. Patients with Class VI LN have ≥90% glomerular sclerosis and are unlikely to respond to medical therapy. For such patients, dialysis or complete renal replacement are the only available options. Patients with Class III/IV ± V LN (also known as proliferative LN ± membranous nephropathy), which account for ~80% of all lupus nephritis patients, are recommended pharmacological therapy

For decades, rheumatologists and nephrologists have had to manage lupus nephritis patients solely through immunosuppressants and corticosteroids. The lupus nephritis treatment armamentarium was finally expanded by GSK’s Benlysta (belimumab) approval in 2020. Benlysta became the first drug approved for managing adult patients with active lupus nephritis who receive standard therapy.

In 2021, Aurinia Pharmaceutical gained US FDA approval for Lupkynis (voclosporin), a calcineurin inhibitor,  in combination with a background immunosuppressive therapy regimen to treat adult patients with lupus nephritis for Class III, IV-S, IV-G (±V) (ISN/RPS 2003 criteria).

Lupus Nephritis Market Assessment
Lupus Nephritis Market Scenario

What is the unmet need for the current lupus nephritis treatment market?

Lupus nephritis remains a kidney disease with significant unmet medical needs despite extensive clinical and translational research. These include

  • Novel diagnostic biomarkers for early diagnosis
  • Therapeutic options for patients who do not respond to or are unfit for immunosuppressive therapies
  • Steroid/immunosuppressant-sparing drugs can provide sustained remission
  • Improve the design of randomized clinical trials so that effective drugs demonstrate efficacy

Scope of upcoming lupus nephritis therapies

Although there has been a history of high trial failure rates in lupus nephritis, the approval of Benlyta and Lupkynis has given hope of light and significant lupus nephritis pipeline activity. Here is a list of major key players and competitors in the lupus nephritis treatment market:

Upcoming Therapies and Key Companies

Key Insights

Gazyva (Obinutuzumab): Roche
  • Obinutuzumab is a humanized, monoclonal type II CD20 antibody marketed for chronic lymphocytic leukemia and follicular lymphoma.
  • Currently, the drug is being evaluated in two Phase III (NCT04221477, NCT04702256) for adults.
  • Received Breakthrough Therapy Designation by the US FDA for Lupus Nephritis.

Ianalumab (VAY736): Novartis/MorphoSys
  • Subcutaneously administered BAFF-R antagonist.
  • Currently, in Phase III (NCT05126277) trial for the treatment of adults.

Cosentyx (secukinumab): Novartis
  • Novartis is testing its IV-administered IL-17A antagonist, marketed for multiple autoimmune diseases (Plaque psoriasis, ankylosing spondylitis, axial spondyloarthritis etc.) in adults with Class III/IV ± V LN.
  • Currently, the drug is being evaluated in two Phase III (NCT05232864, NCT04181762) clinical trials.

Saphnelo (anifrolumab): AstraZeneca
  • It is an intravenously administered INF-α/β receptor antagonist
  • In Phase II (TULIP-LN1; NCT02547922) trial, the drug was not able to meet the PE (Urine Protein to Creatinine Ratio (UPCR); however, the drug was associated with numeric improvements across all clinical endpoints vs. placebo.
  • AstraZeneca is hopeful that higher dosing might be effective and has initiated a Phase III trial (NCT05138133) for the treatment in adult subjects with Class III/IV ± V active proliferative LN. The trial was expected to start in H2 2022.

Other notable players like Kezar Life Sciences (KZR-616 in PI/II), Johnson & Johnson (Nipocalimab and Guselkumab in PII), Novartis (CFZ533 [iscalimab] in PII), Boehringer Ingelheim (BI 655064 in PII), AstraZeneca (Ravulizumab and ALXN2050 [Vemircopan] in PII), Biocon/Equillium (Itolizumab in PI), and Omeros Corporation (OMS721 [narsoplimab] in PII) are enriching the robust lupus nephritis pipeline.

The lupus nephritis treatment market is expected to grow at a CAGR of 8.4% from 2021 and generate approx. USD 3 billion in revenue in the seven major markets (the United States, Germany, France, Italy, Spain, UK, and Japan) by 2032 owing to the uptake of Lupkynis (voclosporin) and Benlysta (belimumab), expected approvals of the emerging lupus nephritis therapies.

Less competitive scenarios, increasing government initiatives to create public awareness, and increasing systemic lupus erythematosus patients will also positively impact the growth of the lupus nephritis treatment market.

Lupus nephritis market outlook

FAQs

1. What is lupus nephritis?

Lupus Nephritis (LN) is the most feared and common complication of systemic lupus erythematosus (SLE) and is responsible for the major share of morbidity and mortality of this disease.

2. What are the lupus nephritis symptoms?

Signs and lupus nephritis symptoms vary highly and may differ for everyone. The most frequent lupus nephritis symptoms include joint pain or swelling, muscle pain, or fever with no known cause.

3. How is lupus nephritis diagnosed?

Kidney biopsy remains the only confirmatory test for establishing the lupus nephritis diagnosis. Active surveillance is recommended in systemic lupus erythematosus patients at high risk of kidney involvement (males, juvenile lupus onset, and serologically active disease).

4. What are the current lupus nephritis treatment options?

Lupus nephritis treatment recommendations are dependent on the degree of histological kidney involvement. Currently, patients with Class I/II (ISN/RPS 2003 criteria) are mostly monitored and do not need immunosuppressants. Patients with Class VI LN have ≥90% glomerular sclerosis and are unlikely to respond to medical therapy.

5. Which pharma companies are working in the lupus nephritis treatment market?

Leading companies such as Aurinia Pharmaceuticals, Roche, AstraZeneca, Boehringer Ingelheim, Novartis, and others are developing therapies for lupus nephritis treatment.