Lupus Nephritis Market Size, Share, and Industry Analysis, By Drug Type (Monoclonal Antibody, Immunosuppressants, Corticosteroids, Antineoplastic Agents, and Others), By Route of Administration (Parenteral and Oral), By Disease Type (Class 1 (Minimal Mesangial Glomerulonephritis), Class 2 (Mesangial Proliferative Glomerulonephritis), Class 3, Class 4 (Advanced Sclerotic)), By Distribution Channel (Hospital Pharmacies, Drug Stores & Retail Pharmacies, and Online Pharmacies), and Regional Forecast, 2025-2032

The global lupus nephritis market is witnessing significant growth due to the increasing prevalence of systemic lupus erythematosus, which is leading to the rising cases of the condition globally. Lupus nephritis is an inflammatory disease of the kidney caused by the systemic lupus erythematosus (SLE). SLE is also called lupus, which is an autoimmune disorder, in which the body's immune system attacks its cells and organs.

In lupus nephritis, the autoantibodies that are developed as an immune response to lupus, attack the kidneys and disrupt their functioning. The condition leads to the swelling and irritation of the kidneys and leads to conditions such as proteinuria, hematuria, high blood pressure, and even, in some conditions, also kidney failure.

• For instance, in 2021, according to the Lupus Foundation of America, it was estimated that 1.5 million people in America, and at least 5.0 million people worldwide, have lupus, and around 40.0% to 60.0% of people with SLE, generated lupus nephritis.

Such a rising number of cases associated with SLE leading to lupus nephritis requires advanced treatment options to control the situation and propels the growth of the market.

Lupus Nephritis Market Driver

Rising Number of Clinical Trials for Innovative Drug Development Propels Market Growth

The rising demand for dedicated treatment options for lupus nephritis leads to an increase in the number of initiatives for clinical trials for the launches of new drugs. This has led to an increase in the shift of focus of companies toward the development of new drugs and associated clinical trials to expand their footprint in the market.

• For instance, in June 2024, Nkarta, Inc., a biopharmaceutical company, announced the initiation of Ntrust-1, a multi-center clinical trial of NKX019 in lupus nephritis. NKX019 is an allogeneic, off-the-shelf, chimeric antigen receptor (CAR) natural killer-cell therapy. The company announced the U.S. Food and Drug Administration (FDA) clearance for its second investigational new drug (IND) application for NKX019 for the autoimmune disease. Such scenarios drive the growth of the global market.

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According to data published by the Department of Health & Human Services, U.S., a survey was conducted under the title of, “Incidence, Prevalence, and Mortality of Lupus Nephritis: A Population-Based Study over Four Decades.” This study stated that the incidence of lupus nephritis increased from 0.7 per 100,000 to 1.3 per 100,000 from 1976 to 2018.

Lupus Nephritis Market Restraint

Discontinuation of Clinical Trials by Companies to Hamper Market Growth

Despite the need for advanced and dedicated treatment options for lupus nephritis, the discontinuation of clinical trials have hampered the approval process. The failure of the clinical trial process due to various analytical efficacy issues impacts the product entry into the market. Such factors limit the market growth.

• For instance, in January 2022, Eli Lilly and Company announced the Phase 3 trial results for OLUMIANT (baricitinib), which was being studied for the adults with active systemic lupus erythematosus. Based on the top-line efficacy results from two pivotal Phase 3 trials (SLE-BRAVE-I and II), the company decided to discontinue the Phase 3 development program for OLUMIANT in lupus as it failed to meet the primary endpoint response. Such discontinuation of the clinical trial programs for lupus, hampers the growth of the lupus nephritis market.

Lupus Nephritis Market Opportunity

Rising Advancements in Cell and Gene Therapy to Provide Lucrative Growth Opportunities

In recent years, the advancements in the cell and gene therapy have positively bolstered the scenario for the treatment of autoimmune disorders. The emphasis of the biopharmaceutical companies on the development of novel therapy options using cells and genes to recover from autoimmune disorders such as lupus nephritis is expected to propel the growth of the market.

• In November 2022, Kyverna Therapeutics announced the first Investigational New Drug (IND) application clearance by the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial of KYV-101, a novel therapy for the treatment of lupus nephritis. Such developments promote the growth of the market during the forecast period.

Key Insights

The report covers the following key insights:

• Prevalence of Lupus Nephritis, By Key Countries/Regions, 2023


• Pipeline Analysis, By Key Players


• Overview: Regulatory and Reimbursement Scenario, By Key Countries/Regions


• Key Industry Developments: Mergers, Acquisitions, Partnerships, Launches


• Impact of COVID-19 on the Market

Segmentation

Analysis by Drug Type

Based on drug type, the market is segmented into monoclonal antibody, immunosuppressants, corticosteroids, antineoplastic agents, and others.

The monoclonal antibody segment held a substantial share of the market. The monoclonal antibody is proven to be a groundbreaking tool in terms of therapeutic management and significantly reduces the underlying inflammation present in patients with lupus nephritis. Further, various key players are focusing on launching monoclonal antibodies for the treatment of condition, which is promoting the growth of the segment.

• For instance, in December 2020, GSK plc. announced that BENLYSTA (belimumab) became the first approved drug by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with active lupus nephritis (LN) who were receiving standard therapy. Such approvals and launches promote the growth of the segment in the market.

Analysis by Route of Administration

Based on the route of administration, the market is categorized into parenteral and oral.

The parenteral segment held a significant share of the global lupus nephritis market. The growth of the segment is attributed to the benefits associated with the parenteral route of administration, which is that the rapid onset of action allows for the direct delivery of medication into the bloodstream, ensuring faster and more efficient absorption. Many approved formulations for lupus nephritis are present in intravenous injection forms, such as Benlysta by GSK plc, CellCept by F. Hoffmann-La Roche Ltd, and others, propelling the growth of the segment in the market.

Analysis by Disease Type

Based on disease type, the market is categorized into Class 1 (Minimal mesangial glomerulonephritis), Class 2 (Mesangial proliferative glomerulonephritis), Class 3 (Focal glomerulonephritis), Class 4 (Diffuse proliferative nephritis), Class 5 (Membranous glomerulonephritis), Class 6 (Advanced sclerotic).

The Class 5 (Membranous glomerulonephritis) segment held a substantial share of the global market. The growth of the segment is augmented by the severity of the condition that happens to the patients in these classes. In this class, the thickening and scarring of the kidney occur and a person experiences high levels of blood, protein, or both in their urine as well as high blood pressure. Also, in some cases, the patient may require dialysis or a kidney transplant. Thus, to avoid the life-threatening issues related to class 5 lupus nephritis, adequate treatment is required. Such scenarios promote the adoption of the drugs and boost the growth of the segment in the market.

Analysis by Distribution Channel

Based on distribution channel, the market is divided into hospital pharmacies, drug stores & retail pharmacies, and online pharmacies.

The hospital pharmacies segment held a significant portion of the market. The growth of the segment is attributed to the shift of patients toward hospitals for treating conditions such as autoimmune disorders due to advanced facilities and skilled professionals. The drugs required for the treatment of such diseases are provided under prescription after proper medical screening.

Moreover, the presence of active reimbursement policies and insurance coverage for the drugs and the treatment of autoimmune disorders led to the growth of the hospital pharmacies segment in the market.

• For instance, in December 2023, the National Health Care Institute, Netherlands, advised the Minister of Health, Welfare, and Sport (VWS) for the reimbursement of voclosporin (Lupkynis), a drug used in certain patients with rare kidney inflammation from the basic health care package. Such policies are expected to propel the segment growth.

Regional Analysis

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Based on region, the market has been studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America accounted for a substantial share of the global market in 2023. The growth of the market in the region is attributed to the increasing prevalence of lupus nephritis. There is a presence of key players in the region with strong research and development capabilities to launch novel therapies for the treatment of lupus nephritis. Such scenarios promote the growth of the region in the market.

• For instance, in April 2024, Artiva Biotherapeutics, Inc. announced that it dosed the first patient in the Phase 1 trial of AlloNK (also known as AB-101) in combination with monoclonal antibodies for the treatment of lupus nephritis. Such increasing research and development activities propel the growth of the region in the market.

Europe has a considerable share of the lupus nephritis market. The regional growth is augmented by the rising prevalence of autoimmune disorders and the presence of advanced facilities for patient care. Further, the presence of key players with advanced product offerings and robust reimbursement policies for the treatment of autoimmune diseases such as SLE and lupus nephritis associated with it is promoting the regional growth.

Moreover, Asia Pacific region is expected to grow during the forecast period. The growth is attributed to the rising research and development activities by key pharmaceutical and biopharmaceutical companies with product launches for lupus nephritis treatment. These scenarios promote the growth of the market during the forecast period.

• For instance, in December 2023, Everest Medicines, a biopharmaceutical company, announced the approval of an investigational new drug (IND) application for zetomipzomib in China by the National Medical Products Administration (NMPA). Zetomipzomib is a selective immunoproteasome inhibitor evaluated for a range of immune-mediated disorders, including lupus nephritis (LN). Such approvals promote the growth of the region in the market.

Key Players Covered

The global market has a presence of a considerable number of competitors, with several companies having established drugs as a part of their product portfolio. However, this market also has the presence of emerging players, with innovative pipeline products in the various stages of clinical trials.

The report includes the profiles of the following key players:

• GSK plc. (U.K.)


• F. Hoffmann-La Roche Ltd (U.S.)


• Biocon (India)


• Sanofi (France)


• Pfizer Inc. (U.S.)


• Novartis AG (Switzerland)


• Aurinia Pharmaceuticals Inc. (Canada)


• Dr. Reddy’s Laboratories Ltd. (India)


• Abbott (U.S.)

Key Industry Developments

• In May 2024, GSK plc. announced the approval of the U.S. Food and Drugs Administration for Benlysta (belimumab), 200 mg subcutaneous route of administration, to be used in patients with systemic autoimmune diseases such as systemic lupus erythematosus (SLE) and lupus nephritis (LN).


• In December 2021, Biocon, in collaboration with Equillium Inc., expanded the EQUILASE study for Itolizumab FOR Systemic Lupus Erythematosus (SLE) and Lupus Nephritis in the clinical centers of India.


• In December 2020, Lupin Limited launched Mycophenolate Mofetil Tablets USP, 500 mg, the generic version of CellCept Tablets.