루푸스 신염 : 시장 인사이트, 역학, 시장 예측(2034년)

Key Highlights:

• Lupus nephritis is a severe, organ-threatening manifestation of systemic lupus erythematosus (SLE), developed in 40-60% of patients with SLE. Signs of lupus nephritis include hematuria (blood in the urine) and proteinuria (protein in the urine). Lupus nephritis is more common in women and occurs in patients aged 20-40.
• The optimal treatment of lupus nephritis varies with the classification of the morphological findings in kidney biopsy. Corticosteroids combined with immunosuppressants have been the mainstay of treating lupus nephritis. Common immunosuppressive medications include cyclophosphamide, mycophenolate mofetil, azathioprine, and calcineurin inhibitors.
• Currently, only two FDA-approved medications for the treatment of lupus nephritis exist. BENLYSTA (belimumab) received approval in December 2020 for adults and in July 2022 for children aged 5-17 with active lupus nephritis, available in both IV infusion and subcutaneous injection forms. Whereas, LUPKYNIS (voclosporin) got approved in January 2021, marking the first oral treatment for lupus nephritis and representing a significant milestone for people living with lupus-related kidney disease.
• The emerging pipeline for lupus nephritis includes several potential drugs in late and early stages (Phase III, II/III, II, and I/II) that include ianalumab (VAY736), zetomipzomib (KZR-616), GAZYVA/GAZYVARO (obinutuzumab), SAPHNELO (anifrolumab), iptacopan, ULTOMIRIS (ravulizumab), and others, which can bring about significant change in the market during the forecast period.
• In September 2024, Roche announced positive topline results from the Phase III REGENCY study of GAZYVA/GAZYVARO (obinutuzumab) in lupus nephritis. Data is being shared with health authorities, including the US FDA and the EMA.
• As per AstraZeneca's 2024 second-quarter corporate presentation, the data anticipated for the Phase III IRIS trial of SAPHNELO (anifrolumab) is to be announced > in 2025.
• In the total market size of Lupus Nephritis in the 7MM, the United States accounted for the highest market share that is more than 80% in 2023, followed by Japan and the Spain.
• In the United States, Class IV accounts for the highest number of cases of Lupus Nephritis in 2023.
• Japan accounts for the second-highest number of prevalent cases of Lupus Nephritis in 2023.

Report Summary

• The report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase III and Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
• The report also encompasses a comprehensive analysis of the LN market, providing an in-depth examination of its historical and projected market size (2020-2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
• The report includes qualitative insights that provide an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM LN market.

Market

Various key players are leading the treatment landscape of Lupus Nephritis, such as Aurinia Pharmaceuticals, GlaxoSmithKline, Novartis, AstraZeneca, and Roche. The details of the country-wise and therapy-wise market size have been provided below.

• In the total market size of Lupus Nephritis in the 7MM, the United States accounted for the highest market share, i.e. more than 80% in 2023, followed by Japan and the Spain.
• Among EU4 and the UK, Spain accounted for more than 30% of the market size in 2023.
• The United States accounted for approximately USD 1,500 million in 2023.
• Among the emerging therapies, GAZYVA/GAZYVARO (obinutuzumab) and SAPHNELO (anifrolumab) appear to be the drugs that can potentially transform the LN market.
• By 2034, among the emerging therapies, the highest revenue is expected to be generated by SAPHNELO (anifrolumab), i.e., more than USD 300 million in the United States.

Lupus Nephritis (LN) Drug Chapters

The section dedicated to drugs in the Lupus Nephritis report provides an in-depth evaluation of late-stage pipeline drugs (Phase III and Phase II) related to Lupus Nephritis. The drug chapters section provides valuable information on various aspects related to clinical trials of Lupus Nephritis, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting Lupus Nephritis.

Marketed Therapies

LUPKYNIS (voclosporin): Aurinia Pharmaceuticals/Otsuka Pharmaceutical

LUPKYNIS 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. In January 2021, Aurinia Pharmaceuticals received US FDA approval for LUPKYNIS to treat adult lupus nephritis patients in combination with immunosuppressive therapy. In September 2022, the European Commission approved LUPKYNIS for active Class III, IV, or V Lupus Nephritis, and in September 2024, Japan's Ministry of Health approved it for Lupus Nephritis treatment alongside mycophenolate mofetil.

BENLYSTA (belimumab): GlaxoSmithKline

BENLYSTA 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 activate B-cells and stimulate 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 (LN), the kidney inflammation caused by lupus. In December 2020, the US FDA approved BENLYSTA for adult lupus nephritis, followed by pediatric approval in July 2022. In May 2021, the European Commission approved BENLYSTA for adult Lupus Nephritis, and Japan approved it for adult Lupus Nephritis the same year.

Emerging Therapies

SAPHNELO (anifrolumab): AstraZeneca

SAPHNELO, being developed by AstraZeneca, is an intravenously administered, fully human monoclonal antibody that binds to subunit 1 of the Type I IFN receptor, blocking the activity of Type I IFN. Anifrolumab induces rapid internalization of IFNAR1 from the surface of monocytes, thereby reducing heterodimerization with IFNAR2 and the setting up of the IFN signaling complex. By antagonizing the binding of the different IFNs to the IFNAR1 receptor, anifrolumab blocks STAT1 phosphorylation and IFN-stimulated Response Element (ISRE) activity. SAPHNELO is already approved for the treatment of adult patients with moderate to severe SLE. Currently, the company is evaluating the drug in the Phase III IRIS trial to treat adult subjects with active proliferative Lupus Nephritis.

GAZYVA/GAZYVARO (obinutuzumab): Roche

GAZYVA/GAZYVARO (obinutuzumab) injection, for intravenous use, 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. GAZYVA is marketed as GAZYVARO in Europe. Currently, the drug is being evaluated in two Phase III trials for the treatment of Lupus Nephritis. In September 2019, the US FDA granted Breakthrough Therapy Designation (BTD) to GAZYVA for adults with lupus nephritis.

Lupus Nephritis (LN) Market Outlook

Rituximab is currently the most commonly used monoclonal antibody (mAb) for lupus nephritis, favored for its steroid-sparing properties and effectiveness in refractory or relapsing cases. Currently, only two FDA-approved treatments for lupus nephritis exist BENLYSTA (belimumab), available as an IV infusion or SC injection, and LUPKYNIS (voclosporin), the only oral treatment and a novel calcineurin inhibitor.

Several companies, including Novartis, AstraZeneca, Roche, and Kezar Life Sciences, are developing new drug candidates that could reshape the lupus nephritis treatment landscape. These approaches include B-cell depletion (obinutuzumab), anti-B-cell activation (ianalumab), selective immune-proteasome inhibitors (zetomipzomib), and interferon-alpha-beta receptor antagonists (anifrolumab). Additionally, recent clinical cases suggest that anti-CD19 CAR-T cell therapies could significantly impact LN treatment. Novartis, in particular, is investigating YTB323 (Rapcabtagene autoleucel), an anti-CD19 CAR-T cell therapy, as a potential option for lupus nephritis.

In a nutshell, many potential therapies are being investigated to manage lupus nephritis. Even though it is too soon to comment on the above-mentioned promising candidate to enter the market during the forecast period (2024-2034), it is safe to assume that the future of this market is bright. Eventually, these drugs will create a significant difference in the landscape of LN in the coming years. The treatment space is expected to experience a significant positive shift in the coming years owing to the improvement in healthcare spending worldwide.

Lupus Nephritis (LN) Disease Understanding and Treatment

Lupus Nephritis (LN) Overview

Lupus nephritis is a common manifestation of Systemic lupus erythematosus and is primarily caused by a Type 3 hypersensitivity reaction that leads to immune complex formation. Anti-double-stranded DNA (anti-dsDNA) antibodies bind to DNA, creating immune complexes that deposit in the kidney, triggering inflammation and activating the complement pathway. This results in an influx of neutrophils and inflammatory cells. While lupus nephritis is autoimmune, genetic factors may predispose certain Systemic lupus erythematosus patients to its development. Lupus nephritis can cause various symptoms, including blood (hematuria) and protein (proteinuria) in the urine, often leading to pink or foamy urine. Other signs include edema, weight gain due to fluid retention, and high blood pressure. Kidney issues may occur alongside lupus symptoms like joint and muscle pain, unexplained fever, and a red "butterfly" rash across the nose and cheeks.

Lupus Nephritis (LN) Diagnosis

Lupus nephritis is diagnosed using urine and blood tests along with a kidney biopsy. Blood tests check kidney function by measuring creatinine, which rises as kidney disease worsens. A 24-hour urine collection measures protein levels to assess kidney filtering ability. Urine tests look for blood and protein, indicating kidney damage. A kidney biopsy, guided by imaging, involves examining a small tissue sample to confirm lupus nephritis and assess disease progression.

Lupus Nephritis (LN) Treatment

Treatment for lupus nephritis depends on its classification. Classes 1 and 2 generally require only monitoring, while Classes 3 and 4 need immunosuppressive and steroid therapy. In Class 6, where most glomeruli are scarred, renal replacement therapy may be necessary. Treatment is divided into two phases: induction and maintenance. The induction phase aims to achieve a renal response using immunosuppressive and anti-inflammatory medications. Once this response is achieved, maintenance therapy, involving both immunosuppressive and non-immunosuppressive agents, is used over a prolonged period to sustain kidney function.

Lupus Nephritis (LN) Epidemiology

The Lupus Nephritis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases, diagnosed cases, total treated cases, age-specific cases, and class-specific cases of Lupus Nephritis in the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.

• Among the 7MM, the United States accounted for the highest number of cases of LN in 2023, nearly 211,300 cases. These cases are anticipated to increase by 2034.
• In the United States, the Adolescents and adult population accounted for ~90% of total cases of LN in 2023.
• Among EU4 and the UK, Spain accounted for the highest number of prevalent cases in 2023, while France accounted for the least.

KOL Views

To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.

We have reached out to industry experts to gather insights on various aspects of Lupus Nephritis, including the evolving treatment landscape, patients' reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.

Our team of analysts at Delveinsight connected with more than 15 KOLs across the 7MM. We contacted institutions such as the University of Munich, the University of Tokyo, the European Dialysis and Transplant Association, the American Society of Nephrology, etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the Lupus Nephritis market, which will assist our clients in analyzing the overall epidemiology and market scenario.

Qualitative Analysis

We perform Qualitative and Market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. 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.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in trials for Lupus Nephritis, one of the most important primary endpoints was achieving hemolysis control, LDH normalization, etc. Based on these, the overall efficacy is 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. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.

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.

Lupus Nephritis (LN) Report Insights

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

Lupus Nephritis (LN) Report Key Strengths

• Eleven-year Forecast
• The 7MM Coverage
• Lupus Nephritis Epidemiology Segmentation
• Key Cross Competition

Lupus Nephritis (LN) Report Assessment

• Current Treatment Practices
• Reimbursements
• Market Attractiveness
• Qualitative Analysis (SWOT, Conjoint Analysis, Unmet needs)

Key Questions:

• Would there be any changes observed in the current treatment approach?
• Will there be any improvements in Lupus Nephritis management recommendations?
• Would research and development advances pave the way for future tests and therapies for Lupus Nephritis?
• Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of Lupus Nephritis?
• What kind of uptake will the new therapies witness in the coming years in Lupus Nephritis patients?

Table of Contents

1. Key Insights

2. Report Introduction

3. Lupus Nephritis Market Overview at a Glance

• 3.1. Market Share Distribution (%) in the 7MM in 2020
• 3.2. Market Share Distribution (%) in the 7MM in 2034

4. Executive Summary of Lupus Nephritis

5. Key Events

6. Epidemiology and Market Forecast Methodology

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Types of Hemolytic Uremic Syndrome
• 7.3. Risk Factors and Causes of Lupus Nephritis
• 7.4. Signs and Symptoms of LUPUS NEPHRITIS
• 7.5. Pathophysiology of LUPUS NEPHRITIS
• 7.6. Complement Protein Mutations
• 7.7. Clinical Manifestations of Lupus Nephritis
• 7.8. Diagnosis and Differential Diagnosis of Lupus Nephritis
  • 7.8.1. Diagnostic Algorithm of Lupus Nephritis
  • 7.8.2. Blood Tests
  • 7.8.3. Specific Testing
  • 7.8.4. Genetic Testing
  • 7.8.5. Differential Diagnosis
  • 7.8.6. Diagnostic Guidelines

8. Current Treatment Practices of Lupus Nephritis

• 8.1. Treatment Algorithm of Lupus Nephritis
  • 8.1.1. Plasma Exchange
  • 8.1.2. Eculizumab
  • 8.1.3. Ravulizumab
  • 8.1.4. Kidney Transplant
  • 8.1.5. Liver Transplantation
• 8.2. Treatment Guidelines
  • 8.2.1. The European Rare Kidney Disease Reference Network Guidelines for the Management of Lupus Nephritis in Children
  • 8.2.2. Clinical Practice Guidelines for the Management of Lupus Nephritis in the United Kingdom
  • 8.2.3. National Institute for Health and Research

9. Patient Journey

10. Epidemiology and Patient Population

• 10.1. Key Findings
• 10.2. Assumptions and Rationale for Lupus Nephritis
• 10.3. Prevalent Cases of Lupus Nephritis in the 7MM
• 10.4. Diagnosed Cases of Lupus Nephritis in the 7MM
• 10.5. The United States
  • 10.5.1. Prevalent Cases of Lupus Nephritis in the United States
  • 10.5.2. Diagnosed Cases of Lupus Nephritis in the United States
  • 10.5.3. Age group-specific Cases of Lupus Nephritis in the United States
  • 10.5.4. Treated Cases of Lupus Nephritis in the United States
• 10.6. EU4 and the UK
  • 10.6.1. Prevalent Cases of Lupus Nephritis in EU4 and the UK
  • 10.6.2. Diagnosed Cases of Lupus Nephritis in EU4 and the UK
  • 10.6.3. Age group-specific Cases of Lupus Nephritis in EU4 and the UK
  • 10.6.4. Treated Cases of Lupus Nephritis in EU4 and the UK
• 10.7. Japan
  • 10.7.1. Prevalent Cases of Lupus Nephritis in Japan
  • 10.7.2. Diagnosed Cases of Lupus Nephritis in Japan
  • 10.7.3. Age group-specific Cases of Lupus Nephritis in Japan
  • 10.7.4. Treated Cases of Lupus Nephritis in Japan

11. Marketed Therapies

• 11.1. Key Cross of Marketed Therapies
• 11.2. SOLIRIS (eculizumab): Alexion Pharmaceuticals
  • 11.2.1. Product Description
  • 11.2.2. Regulatory Milestones
  • 11.2.3. Other Developmental Activity
  • 11.2.4. Clinical Development
  • 11.2.5. Safety and Efficacy
• 11.3. ULTOMIRIS (ravulizumab-cwvz): Alexion Pharmaceuticals
  • 11.3.1. Product Description
  • 11.3.2. Regulatory Milestones
  • 11.3.3. Other Developmental Activity
  • 11.3.4. Clinical Development
  • 11.3.5. Safety and Efficacy

12. Emerging Therapies

• 12.1. Key Cross of Emerging Therapies
• 12.2. Crovalimab (RG6107; SKY59): Hoffmann-La Roche/Chugai Pharmaceutical
  • 12.2.1. Product Description
  • 12.2.2. Clinical Development
• 12.3. Iptacopan (Lupus NephritisP023): Novartis Pharmaceuticals
  • 12.3.1. Product Description
  • 12.3.2. Clinical Development

13. Lupus Nephritis: Seven Major Market Analysis

• 13.1. Key Findings
• 13.2. Market Outlook
• 13.3. Conjoint Analysis
• 13.4. Key Market Forecast Assumptions
  • 13.4.1. Cost Assumptions and Rebate
  • 13.4.2. Pricing Trends
  • 13.4.3. Analogue assessment
  • 13.4.4. Launch Year and Therapy Uptake
• 13.5. Total Market Size of Lupus Nephritis in the 7MM in USD million (2020 - 2034)
• 13.6. Market Size of Lupus Nephritis by Therapies in the 7MM
• 13.7. United States Market Size
  • 13.7.1. Total Market Size of Lupus Nephritis in the United States
  • 13.7.2. Market Size of Lupus Nephritis by Therapies in the United States
• 13.8. EU4 and the UK Market Size
  • 13.8.1. Total Market Size of Lupus Nephritis in EU4 and the UK
  • 13.8.2. Market Size of Lupus Nephritis by Therapies in EU4 and the UK
• 13.9. Japan Market Size
  • 13.9.1. Total Market Size of Lupus Nephritis in Japan
  • 13.9.2. Market Size of Lupus Nephritis by Therapies in Japan

14. Unmet Needs

15. SWOT Analysis

16. KOL Views

17. Market Access and Reimbursement

• 17.1. United States
  • 17.1.1. Centre for Medicare and Medicaid Services (CMS)
• 17.2. EU4 and the UK
  • 17.2.1. Germany
  • 17.2.2. France
  • 17.2.3. Italy
  • 17.2.4. Spain
  • 17.2.5. United Kingdom
• 17.3. Japan
  • 17.3.1. MHLW
• 17.4. Reimbursement Scenario and Key HTA Decisions in Lupus Nephritis
  • 17.4.1. Patient Access Programs
  • 17.4.2. HTA Decisions

18. Appendix

• 18.1. Acronyms and Abbreviations
• 18.2. Bibliography
• 18.3. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight