PUBLISHER: DelveInsight | PRODUCT CODE: 1415482
PUBLISHER: DelveInsight | PRODUCT CODE: 1415482
DelveInsight's "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.
Study Period: 2019-2032.
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 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.
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.
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 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.
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) 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.
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), 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.
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.
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 DelveInsight's estimates, the potential drugs that can mark a significant change in the forecast period includes BENLYSTA, LUPKYNIS, Ianalumab (VAY736), GAZYVA/GAZYVARO (obinutuzumab), and others.
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019-2032.
The report provides insights into different therapeutic candidates in Phase III and Phase II. It also analyzes key players involved in developing targeted therapeutics.
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for lupus nephritis emerging therapy.
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.
DelveInsight's 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.
We perform 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.
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.