Lupus Nephritis - Market Insight, Epidemiology and Market Forecast - 2032

Key Highlights

• In 2022, the market size of lupus nephritis was highest in the US among the 7MM, accounting for approximately USD 745 million, which is further expected to increase by 2032.
• In the 7MM, BENLYSTA accounted for the largest market size in 2022 with approximately USD 290 million.
• The gold-standard treatment for lupus nephritis includes mycophenolate mofetil (MMF), corticosteroids, and cyclophosphamide (CYC).
• Despite gaining approval a year earlier, BENLYSTA still appears inferior to LUPKYNIS in terms of efficacy.
• Roche's obinutuzumab is anticipated to be the first to enter the market among the upcoming therapies, giving it a competitive edge over other emerging assets.
• In November 2023, Otsuka Pharmaceutical announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labour, and Welfare for the manufacture and sale of voclosporin in Japan for the treatment of lupus nephritis.
• As per Novartis' Q2 2023 investor presentation, the company intends to file the submission of ianalumab beyond 2026 and has terminated COSENTYX for lupus nephritis.

This “Lupus Nephritis - Market Insights, Epidemiology and Market Forecast - 2032” report delivers an in-depth understanding of the lupus nephritis, historical and forecasted epidemiology as well as the lupus nephritis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The lupus nephritis market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM lupus nephritis market size from 2019 to 2032. The report also covers current lupus nephritis treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's underlying potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2019-2032

Lupus Nephritis Disease Understanding and Treatment Algorithm

Lupus Nephritis Overview

There are two types of lupus. Systemic lupus erythematosus (SLE) is a form of lupus that can harm the skin, joints, kidneys, and brain and may be fatal. The other form of lupus is called “discoid” lupus erythematosus, which affects only the skin. When SLE affects the kidneys, it is called lupus nephritis. Lupus is an “autoimmune” disease, meaning the immune system (body's defense system), which usually protects the body from disease, turns against the body. This causes harm to organs and tissues, like kidneys. It results in inflammation (swelling or scarring) of the small blood vessels that filter wastes in the kidney (glomeruli). Lupus nephritis can be classified as follows: Class I, minimal mesangial lupus nephritis; Class II, mesangial proliferative lupus nephritis; Class III, focal lupus nephritis (active and chronic, proliferative and sclerosing); Class IV, diffuse lupus nephritis (active and chronic, proliferative and sclerosing, segmental and global); Class V, membranous lupus nephritis; Class VI: advanced sclerosis lupus nephritis.

Lupus Nephritis Diagnosis

Lupus nephritis is diagnosed through urine and blood tests and a kidney biopsy. One of the first signs of lupus nephritis is blood in the urine or extremely foamy urine. High blood pressure and swelling in the feet also might indicate lupus nephritis. Tests that will help the doctor make a diagnosis include the following: blood tests, urine tests, including a 24-hour urine collection, kidney ultrasound, kidney biopsy, etc.

Lupus Nephritis Treatment

Treatment of lupus nephritis includes the induction and maintenance phases using immunosuppressive and non-immunosuppressive therapies. The induction phase primarily elicits a renal response through immunosuppressive agents and anti-inflammatory medications. After obtaining a renal response, maintenance therapy is used for a prolonged period with immunosuppressives and non-immunosuppressive agents. This prevents relapse but requires regular monitoring while on the therapy. During induction therapy, prophylaxis against pneumocystis pneumonia should be given. A concern with chronic glucocorticoid use is a loss of bone density. Taking appropriate measures to prevent bone density loss with appropriate supplementation and a baseline DEXA scan is important.

Further details related to diagnosis and treatment are provided in the report.

Lupus Nephritis Epidemiology

As the market is derived using a patient-based model, the lupus nephritis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of SLE, total prevalent cases of lupus nephritis, and total diagnosed of lupus nephritis and total treated cases of lupus nephritis in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2019 to 2032.

• The total diagnosed prevalent cases of SLE in the 7MM comprised approximately 657,000 cases in 2022 and are projected to increase during the forecast period.
• The United States contributed to the largest prevalent cases of lupus nephritis, accounting for approximately 50% of the 7MM in 2022. Whereas EU4 the UK, and Japan accounted for around 36% and 14% of the total population share, respectively, in 2022.
• The total diagnosed of lupus nephritis in the US comprised of nearly 130,500 cases in 2022.
• Among EU4 and the UK, the UK accounted for the largest number of lupus nephritis cases, followed by Germany, whereas France accounted for the lowest number of cases in 2022.

Lupus Nephritis Drug Chapters

The drug chapter segment of lupus nephritis report encloses a detailed analysis of lupus nephritis marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the lupus nephritis pivotal clinical trial details, recent and expected market approvals, patent details, advantages and disadvantages of each included drug, the latest news, and recent deals and collaborations.

Marketed Drug

BENLYSTA (belimumab): GlaxoSmithKline

BENLYSTA (belimumab) is an intravenous and subcutaneously administered, fully-humanized monoclonal antibody that binds and inactivates B-lymphocyte stimulator (a cytokine expressed by B-cell lineage cells that activates B cells and stimulates their proliferation and differentiation), inhibiting B-lymphocyte proliferation and differentiation It is the first and only biologic approved for both the chronic autoimmune disease systemic lupus erythematosus (SLE) and lupus nephritis. The drug received FDA approval in December 2020 for adults and in July 2022 for children aged 5-17 with active lupus nephritis.

LUPKYNIS (voclosporin): Aurinia Pharmaceuticals/Otsuka Pharmaceutical

LUPKYNIS (voclosporin) is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The drug has improved near and long-term outcomes in lupus nephritis when combined with a background immunosuppressive therapy regimen for treating adult patients with active lupus nephritis. The drug received FDA approval in January 2021 in combination with a background immunosuppressive therapy regimen to treat adult patients with lupus nephritis.

Emerging Drug

Ianalumab (VAY736): Novartis/MorphoSys

Ianalumab (VAY736) is a subcutaneously administered fully human HuCAL antibody that targets BAFF-R and is being investigated by Novartis for the treatment of autoimmune hepatitis, idiopathic pulmonary fibrosis, SLE, and LN. It is an anti-B-cell activating factor (BAFF) receptor fully human monoclonal antibody engineered for direct ADCC-mediated B-cell depletion.

Currently, the drug is being studied in Phase III (NCT05126277) to evaluate the efficacy, safety, and tolerability of SC ianalumab given every 4 weeks or every 12 weeks compared to placebo, in combination with SoC, in adult participants with active lupus nephritis. The company anticipates data readout in 2027. First planned submissions are expected by =2026.

GAZYVA/GAZYVARO (obinutuzumab): Roche

GAZYVA/GAZYVARO (obinutuzumab), is an engineered monoclonal antibody that targets a protein called CD20 on the surface of the lymphoma and leukemia cells. It binds to type II CD20 antibodies. This allows obinutuzumab to have a much higher induction of antibody-dependent cytotoxicity and a higher direct cytotoxic effect than the classic CD20 antibodies. Upon binding to CD20, it mediates B-cell lysis through the engagement of immune effector cells by directly activating intracellular death signaling pathways and/or activation of the complement cascade. In September 2019, the US FDA granted Breakthrough Therapy Designation (BTD) to GAZYVA for adults with lupus nephritis
Currently, the drug is being evaluated in two Phase III (NCT04221477, NCT04702256) for the treatment of lupus nephritis. In addition, obinutuzumab is also being evaluated in a Phase II (NCT03870334) trial to evaluate its efficacy, safety, and pharmacokinetics in adolescents with active Class III or IV lupus nephritis and safety and pharmacokinetics in pediatric participants.

Drug Class Insights

Currently, only two FDA-approved medications are available for the treatment of lupus nephritis, BENLYSTA (belimumab), and LUPKYNIS (voclosporin). Roche's CellCept (mycophenolate mofetil), Astellas Pharma's PROGRAF (tacrolimus), and Asahi Kasei Pharma's mizoribine were approved for the treatment of lupus nephritis in Japan. LUPKYNIS (voclosporin) is a calcineurin inhibitor (CNI) immunosuppressant developed by Aurinia Pharmaceuticals. It has demonstrated improvement in near and long-term outcomes in lupus nephritis when combined with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis. LUPKYNIS reduces cytokine activation by inhibiting calcineurin and blocks interleukin IL-2 expression and T-cell-mediated immune responses. BENLYSTA (belimumab) is an intravenous and subcutaneously administered, fully-humanized monoclonal antibody that binds and inactivates B-lymphocyte stimulator (a cytokine expressed by B-cell lineage cells that activates B cells and stimulates their proliferation and differentiation), inhibiting B-lymphocyte proliferation and differentiation, developed by GlaxoSmithKline. The utilization of glucocorticoids is nearly twice as prevalent in patients with active disease compared to those with low disease activity. The rate of mycophenolate mofetil (MMF) is about four times higher in patients with active disease and five times higher in ESRD patients compared to those with low disease activity.

Lupus Nephritis Market Outlook

The optimal treatment of lupus nephritis varies with the classification of the morphological findings in kidney biopsy. Immunosuppressive therapy is used to treat active focal (class III) or diffuse (class IV) lupus nephritis or lupus membranous nephropathy (class V), whereas it is not usually used to treat minimal mesangial (class I), mesangial proliferative (class II), or advanced sclerosing (class VI) lupus nephritis. The treatment of focal or diffuse lupus nephritis has two main components: initial therapy with anti-inflammatory and immunosuppressive agents to slow or halt kidney injury, followed by long-term subsequent immunosuppressive therapy to control the chronic autoimmune processes of systemic lupus erythematosus and to foster repair of damaged nephrons. Corticosteroids have been the mainstay of the treatment of lupus nephritis. These effectively control renal flares but alone cannot improve long-term outcomes. The landmark studies done by the National Institutes of Health (NIH) established the role of cyclophosphamide in maintaining long-term remission and preservation of renal function. The FDA-approved medications are available for the treatment of lupus nephritis, one being BENLYSTA (belimumab) (as either an IV infusion or subcutaneous injection) and the other, LUPKYNIS (voclosporin), the only oral option, a novel calcineurin inhibitor. Apart from this, in Japan, Roche's CellCept (mycophenolate mofetil), Astellas Pharma's PROGRAF (tacrolimus), and Asahi Kasei Pharma's mizoribine were approved for the treatment of lupus nephritis. The horizon for novel drugs in lupus nephritis appears optimistic, with emerging treatments like anifrolumab, obinituzumab, and complement inhibitors poised to enhance therapeutic approaches and deepen the understanding of disease mechanisms. Furthermore, underscoring the significance of biomarkers in identifying disease activity, gauging treatment response, and early detection of non-response should not be underestimated.

As per the report estimates, the potential drugs that can mark a significant change in the forecast period includes BENLYSTA, LUPKYNIS, Ianalumab (VAY736), GAZYVA/GAZYVARO (obinutuzumab), and others.

• The total market size of lupus nephritis in the 7MM is approximately USD 1,120 million in 2022 and is projected to increase during the forecast period (2023-2032).
• Among EU4 and the UK, UK accounted for the maximum market size in 2022, while France occupies the bottom of the ladder.
• Among the emerging therapies, LUPKYNIS is expected to generate the highest revenue in the 7MM by 2032.

Lupus Nephritis Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019-2032.

Further detailed analysis of emerging therapies drug uptake in the report.

Lupus Nephritis Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for lupus nephritis emerging therapy.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts contacted for insights on lupus nephritis evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, and drug uptake, along with challenges related to accessibility, include Medical/scientific writers; National Kidney Foundation; Rheumatologist and Professors; MD, FACS, Chair of the Department of Department of Nephrology and Rheumatology Surgery, and Kidney Disease Center; and others.

This analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the Center for Kidney Diseases, Department of Rheumatology, Department of Nephrology, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or lupus nephritis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

The publisher performs Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis, and Analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

The analyst views analyze multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.

In efficacy, the trial's primary and secondary outcome measures are evaluated. Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.

Market Access and Reimbursement

Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders. The payment models are based on clinical outcomes, annuity payments, and expanded risk pools. The Health Benefit Price Benchmarks (HBPBs) for a drug is defined as the price range that would achieve incremental cost-effectiveness ratios between USD 100,000 and USD 150,000 per QALY or per evLYG gained. As per the estimates, the HBPB for belimumab ranges from USD 45,000 to USD 61,000 and that the HBPB for voclosporin ranges from USD 72,000 to USD 101,000.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of lupus nephritis, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the lupus nephritis market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM lupus nephritis market.

Lupus Nephritis Report Insights

• Patient Population
• Therapeutic Approaches
• Lupus Nephritis Pipeline Analysis
• Lupus Nephritis Market Size and Trends
• Existing and future Market Opportunity

Lupus Nephritis Report Key Strengths

• Ten Years Forecast
• The 7MM Coverage
• Lupus Nephritis Epidemiology Segmentation
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

Lupus Nephritis Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What was the lupus nephritis total market size, the market size by therapies, market share (%) distribution in 2019, and what would it look like in 2032? What are the contributing factors for this growth?
• Which class is going to be the largest contributor in 2032?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the disease risk, burdens, and unmet needs of lupus nephritis? What will be the growth opportunities across the 7MM concerning the patient population of lupus nephritis?
• What is the historical and forecasted lupus nephritis patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• What are the current options for the treatment of lupus nephritis? What are the current guidelines for treating lupus nephritis in the US and Europe?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of lupus nephritis?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies?
• What key designations have been granted for the emerging therapies for lupus nephritis?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, current therapies? Focusing on the reimbursement policies.

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the lupus nephritis market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the Analyst view section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of current therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.