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Membranous Nephropathy Market Industry Analysis by Size, Share, Growth, Sourcing Strategy, Scope, Demand and Forecast to 2034

08-08-2025 01:06 PM CET | Business, Economy, Finances, Banking & Insurance

Press release from: Exactitiude Consultancy

Membranous Nephropathy Market

Membranous Nephropathy Market

Membranous Nephropathy (MN) is a rare autoimmune kidney disorder characterized by thickening of the glomerular basement membrane, leading to proteinuria, edema, and progressive kidney failure. The disease is either primary (idiopathic) or secondary to conditions like lupus, hepatitis B/C, or cancer.

With an increasing number of autoimmune diagnoses, a rise in biomarker testing, and early intervention protocols, the MN market has been expanding. In 2024, the global market stood at USD 98.46 million and is projected to reach USD 174.71 million by 2034, growing at a CAGR of 5.9%.

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Market Overview
This market includes diagnostics, immunosuppressive drugs, biologics, supportive therapies, and monitoring technologies. Despite being a rare disease, interest has surged due to the growing burden of chronic kidney disorders, especially among the aging population and those with autoimmune comorbidities.
Moreover, research advancements in PLA2R antibody detection, next-gen nephrology platforms, and clinical trials in biologics are shaping future care pathways.

Key Market Drivers
a) Rise in Autoimmune Disorders
Increasing global incidence of systemic autoimmune diseases, including lupus, rheumatoid arthritis, and Sjögren's syndrome, is indirectly fueling membranous nephropathy cases.
b) Advancements in Diagnostic Technologies
Early and accurate diagnosis using anti-PLA2R antibody testing and kidney biopsies with immunofluorescence improves treatment outcomes, expanding demand for high-precision diagnostics.
c) Innovation in Immunosuppressive and Biologic Therapies
Introduction of Rituximab, Cyclophosphamide, and ACTH analogs has shown significant promise in managing MN. New biologics and mAbs targeting B-cells are undergoing trials.
d) Global Awareness Campaigns
Rare disease awareness initiatives by nephrology associations and pharma companies have improved early identification and referrals, especially in North America and Europe.

Key Restraints and Challenges
a) Limited Disease Awareness Among Physicians
Due to its rarity, MN often goes misdiagnosed or undiagnosed, particularly in rural and under-resourced health systems.
b) High Treatment Costs
Biologic therapies and long-term immunosuppressants carry high costs, limiting access in low-income regions.
c) Risk of Treatment-Related Side Effects
Chronic use of immunosuppressants increases risks of infections, cancers, and metabolic disturbances.
d) Low Commercial Incentive for Pharma
Being a rare disease, the market offers limited ROI, reducing commercial interest for large-scale drug development outside orphan drug routes.

Opportunities & Trends
a) Personalized Therapy Based on Anti-PLA2R Status
New protocols recommend biomarker-based treatment stratification, allowing low-risk patients to avoid overtreatment and high-risk ones to be targeted aggressively.
b) Expansion of Orphan Drug Designation
Governments are supporting orphan drug approvals, fast-tracking novel MN therapies via incentives and reduced clinical burdens.
c) Integration of AI in Nephrology Diagnostics
AI is being adopted in digital pathology for glomerular classification, assisting in quicker MN diagnoses.
d) Development of B-cell and Complement-Targeted Therapies
Novel monoclonal antibodies and complement inhibitors are showing strong trial results, potentially replacing older cytotoxic regimens.

Market Segmentation
By Type:
• Primary Membranous Nephropathy
• Secondary Membranous Nephropathy (associated with Lupus, Hepatitis B/C, Malignancies)
Primary MN is the most prevalent subtype, driven by PLA2R and THSD7A antibodies.

By Diagnosis:
• Serological Tests (Anti-PLA2R Antibodies)
• Kidney Biopsy
• Imaging Techniques (Ultrasound, MRI)
• Urine and Blood Tests
Serological testing is gaining ground due to its non-invasive nature and specificity.

By Treatment:
• Immunosuppressive Therapy (Corticosteroids, Cyclophosphamide, Rituximab)
• Supportive Therapy (ACE inhibitors, ARBs, Diuretics)
• Biologics and Monoclonal Antibodies
• Plasmapheresis and Complement Inhibitors
Immunosuppressive therapy remains the first line, but Rituximab and biologics are fast becoming preferred due to efficacy and fewer side effects.

By End-User:
• Hospitals
• Specialty Clinics
• Diagnostic Centers
• Academic & Research Institutions
Hospitals and specialty nephrology clinics hold the majority share, supported by biopsy
infrastructure and specialist availability.

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Regional Insights
North America
• Leading market with advanced diagnostic access, high autoimmune disease incidence, and strong presence of key pharma players.
• Growing use of Rituximab and participation in rare disease trials.
Europe
• High adoption of biomarker-based therapy stratification.
• Germany, UK, and France actively engage in orphan drug programs and patient registries.
Asia-Pacific
• Rapidly expanding healthcare systems in China, India, and South Korea.
• Improving nephrology services and biologic drug accessibility.
Latin America
• Moderate growth led by public sector nephrology centers and increased diagnosis of autoimmune and chronic renal conditions.
Middle East & Africa
• Slower uptake but improving access due to international rare disease collaborations, especially in UAE and South Africa.

Competitive Landscape
The membranous nephropathy market is competitive but specialized, with major players focusing on orphan drug programs, clinical research, and biologic innovation.

Key Players (2025):
• Pfizer Inc.
• Novartis AG
• Bristol Myers Squibb
• Teva Pharmaceuticals
• GlaxoSmithKline (GSK)
• Otsuka Holdings
• Astellas Pharma
• Retrophin Inc.
• Alexion Pharmaceuticals
• Baxalta (now Takeda)

These companies are engaged in:
• Biologic drug development (e.g., Rituximab biosimilars)
• Collaborations with nephrology research institutes
• Regulatory fast-tracking for orphan approvals
• Diagnostic partnerships to support PLA2R testing access

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Recent Developments (2025)
1. Pfizer Inc. - January 2025
Announced Phase III results of an anti-CD20 monoclonal antibody showing superior efficacy in treating PLA2R-positive MN patients.
2. Bristol Myers Squibb - February 2025
Initiated global Phase II trial for a complement pathway inhibitor, targeting refractory membranous nephropathy cases.
3. Novartis AG - March 2025
Launched a clinical decision support platform integrating anti-PLA2R titer trends to personalize MN treatment plans.
4. Otsuka Holdings - April 2025
Entered a strategic collaboration with Japan Nephrology Foundation for MN patient tracking and early diagnostic access.
5. GlaxoSmithKline - May 2025
Acquired a rare renal disease startup working on biomarker-guided immunotherapies, with MN as a primary indication.

Events and Implications
• Greater emphasis on treatment individualization using antibody status
• Development of steroid-sparing regimens with fewer toxicities
• Increase in clinical trials across North America and Europe
• Pharma partnerships with academic nephrology centers for pipeline development
• Regulatory focus on streamlining rare disease drug approvals

Conclusion
Membranous nephropathy is gaining global recognition as a serious, treatable autoimmune kidney disorder. With advancing diagnostic methods, personalized treatment options, and biologic drug pipelines, the market is entering a phase of clinical and commercial transformation.

By 2034, the global market is expected to cross USD 174.71 million, powered by innovations in biomarker-based treatment, rare disease policy frameworks, and digital nephrology care.

Companies that invest in early-stage research, collaborative care ecosystems, and patient-centered solutions will be at the forefront of reshaping the MN treatment paradigm over the next decade.

This report is also available in the following languages : Japanese (膜性腎症市場), Korean (막성 신병증 시장), Chinese (膜性肾病市场), French (Marché de la néphropathie membraneuse), German (Markt für membranöse Nephropathie), and Italian (Mercato della nefropatia membranosa), etc.

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