Lupus nephritis is a frequent complication detected in people suffering from systemic lupus erythematosus (SLE)-commonly known as lupus. It is an autoimmune disease causing patient's own immune system to produce proteins called auto antibodies that attack patient's tissue and organs, including the kidneys. Lupus nephritis occurs when lupus auto antibodies affect structures in patients own kidneys that filters waste. This causes kidney inflammation that leads to blood in urine, protein in the urine, high blood pressure, impaired kidney function, or even kidney failure. As per the estimates released by the U.S. Department of Health and Human Services National Institutes of Health, lupus nephritis affects between 322,000 and 1.5 million people in the United States. Females develop SLE about nine times more often than males. It is more prevalent in younger women, peaking during the childbearing years, however, and 20% of lupus nephritis cases occur in people over the age of 50.

Market Drivers

Rising prevalence of lupus nephritis among patient pool propels the growth of the overall market

Lupus nephritis is a disease of the immune system that is estimated to affect more than 20,000 people in Australia and New Zealand according to the estimates released by the Australasian Society of Clinical Immunology and Allergy. Additionally, 90% of the people with lupus nephritis are women and the majority develops such condition between 15 and 45 years. The causes associated involve joint pain or swelling is witnessed in ~50% of the people suffering from lupus nephritis. Moreover, skin rashes that get worse with sun exposure observed in ~20% of the people with lupus nephritis. Furthermore, fatigue, weakness, ad lethargy affects ~10% of the people with lupus nephritis that acts severely. Apart from that statistics released by Lupus Canada., women of child-bearing age (15 to 45) are majorly affected. In fact, in such particular age group, lupus nephritis is 8 to 13 times more common in women than in men.

As per the Lupus Foundation of America, of the 500,000 Americans is expected to have the SLE, the disease is prevalent in 1 of every 600 white women of child-bearing age and 1 of every 200 black women. In Canada, estimates of the number of lupus nephritis patient ranges from 15,000 (based on the number of patients followed in various University Hospital Lupus Clinics throughout the country) to 50,000 (based on the figures used by the Lupus Foundation of America, adjusted to the Canadian population)

Surge in the number of clinical trials conducted by the prominent players coupled with the launching of new biologic drugs bolster the growth of the overall market

Janssen Research & Development, LLC is evaluating the efficacy of Guselkumab Dose 1 in participants with active lupus nephritis (LN). Currently, the drug is under Phase 2. The actual start date of the clinical trial was September 2020 and estimated completion date is March 2023. In December 2020, the Food and Drug Administration (FDA), GlaxoSmithKline plc announced approval of the drug BENLYSTA (belimumab) for treatment of adult patients with active lupus nephritis (LN) receiving standard therapy. The BLISS-LN study is the largest and longest phase 3 study conducted in active LN, comprising 448 adults. Additionally, BeiGene, drug namely, “Zanubrutinib” is under phase 2 clinical trials for the treatment of lupus nephritis. As per the reports by Clinicaltrials.gov the actual start date is December 2020 and estimated completion date is December 2023.

Segmental Analysis

The lupus nephritis market is segmented based on drug class and route of administration. Drug class is segmented into NSAIDs, corticosteroids, anti malarial, immunosuppressant’s, and biologics. By route of administration, the market is segmented as oral, intravenous, and subcutaneous.

Based on drug class, immunosuppressants hold the largest market revenue share in the past and will continue the same trend in the forthcoming years. Since the past two decades, immunosuppressive drugs namely, azathioprine and cyclophosphamide have gained wide prominence in the treatment of patients suffering from lupus nephritis according to the American Journal of Kidney Diseases. As their toxicity levels are well known they are mostly preferred due to time dependant dosage. According to the John Hopkins Lupus Center immunosuppressive medications acts positively for controlling more serious lupus activity that affects major organs, including the kidney, brains, cardiovascular systems, and lungs. Moreover, these drugs are sometimes called "steroid-sparing" medications or "adjuvant"(helping) drugs. Additionally, biologics is projected to record remarkable CAGR during the forecast period. Rising number of clinical trials conducted by the prominent players and launching of new drugs is augmenting the growth of global lupus nephritis market globally. For instance, “Belimumab” is the first biologic agent approved for the treatment of lupus nephritis and has the recommendation of first line treatment that is approved in over 50 years offering the new option over non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids.

By route of administration, the oral segment represents dominating segment in the forthcoming years. On January 2021, the US Food and Drug Administration (USFDA) approved first oral treatment for lupus nephritis. Aurinia Pharmaceuticals that received authorization from the FDA to market the new drug namely, "Lupkynis (voclosporin)”, had reported positive data from a late-stage clinical study representing as a superior to standard of care for treating lupus nephritis. The segment is followed by intravenous route of administration. Small molecule drugs can be easily administered and remains as the mainstream treatment for patients suffering from lupus nephritis.

Regional Landscape

North America is expected to dominate the overall lupus nephritis market in the forecast period. Rising prevalence of lupus nephritis in this region has propelled the growth of the regional market. Also, high prevalence of lupus nephritis coupled with coverage of specialty drugs and better healthcare infrastructure contributes the growth of the North America region for the lupus nephritis market. As per the estimates released by the Lupus Foundation of America, 1.5 million Americans, and at least 5 million people globally suffer from lupus nephritis. Ninety percent (90%) of people living with lupus nephritis are women. The prevalence of lupus nephritis is 16,000 new cases are recorded annually. Europe was the second largest market in the past and will show its prominence in the forthcoming years.

This is highly supported due to fast product approvals and therapy for the treatment of lupus nephritis. “Benlysta" is the first medicine approved for the treatment of systemic lupus and adults suffering with active lupus nephritis. It is recommended as an important treatment for patients with incurable autoimmune diseases.

Competitive Landscape

The leading players in the global lupus nephritis market involve GlaxoSmithKline plc, F. Hoffmann-La Roche Ltd, Pfizer Inc., Novartis AG, Bayer AG, Sanofi, and among others.

Market Segmentation

Market By Drug Class
NSAIDs
Corticosteroids
Anti Malarial
Immunosuppressant’s
Biologics

Market By Route of Administration
Oral
Intravenous
Subcutaneous

Market By Geography

North America

• U.S.
• Canada

Europe

• U.K.
• Germany
• France
• Spain
• Rest of Europe

Asia-Pacific

• China
• Japan
• India
• Australia
• South Korea
• Rest of Asia-Pacific

Latin America

• Brazil
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC
• South Africa
• Rest of Middle East & Africa