IC-MPGN Therapeutics Market Expected to Grow With Complement Inhibitor Therapies: First FDA Approvals, Clinical Pipeline
The IC-MPGN market, valued at USD 12M in the US in 2023, is set to grow significantly by 2034, with ~7K cases across the 7MM. Novartis Pharmaceuticals and Apellis Pharmaceuticals lead innovation with iptacopan (LNP023) and pegcetacoplan (APL-2/EMPAVELI). In Aug 2025, the FDA approved Apellis' EMPAVELI as the first IC-MPGN therapy, marking a major milestone in treating this ultra-rare kidney disease.
DelveInsight's ' Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Market Insights, Epidemiology, and Market Forecast – 2034 ' report delivers a comprehensive analysis of the IC-MPGN market, covering historical and forecasted patient pools, current treatment practices, emerging drugs, and market size trends across the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
Key Takeaways
Market size projection: As per DelveInsight's analysis, the total market size of IC-MPGN in the 7MM is expected to surge significantly by 2034, with the United States market alone growing significantly from approximately USD 12 million in 2023.
Patient population data: The report provides the total IC-MPGN potential pool of more than 7K diagnosed prevalent cases across the 7MM in 2023, with the United States representing about 55% of these cases at approximately 3,770 diagnosed patients.
Key companies: Leading IC-MPGN companies, such as Novartis Pharmaceuticals, Apellis Pharmaceuticals, and others, are driving innovation in this ultra-rare kidney disease therapeutic area.
Pipeline assets: Some of the key IC-MPGN pipeline therapies include Iptacopan (LNP023) from Novartis, Pegcetacoplan (APL-2) from Apellis Pharmaceuticals, and others targeting complement pathway inhibition.
In August 2025, the FDA approved pegcetacoplan (EMPAVELI) by Apellis Pharmaceuticals as the first treatment specifically for patients 12 years and older with primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). The approval was based on the Phase 3 VALIANT trial (NCT05067127), which demonstrated significant clinical benefits.
Furthermore, Iptacopan (LNP023) is currently being evaluated in a multicenter, randomized, double-blind, placebo-controlled Phase 3 study specifically for idiopathic IC-MPGN.
Discover recent advancements in the IC-MPGN treatment landscape @ IC-MPGN Recent Developments.
IC-MPGN Market Dynamics
The IC-MPGN market represents an ultra-rare therapeutic area with significant unmet medical needs and substantial growth potential. Currently valued at approximately USD 12 million in the United States in 2023, the market is characterized by the lack of approved medications specifically indicated for IC-MPGN, creating a substantial demand for treatments that address the root cause of this progressive kidney disease.
IC-MPGN market drivers include increasing awareness of complement-mediated diseases, advances in understanding the pathophysiology of IC-MPGN, and the development of targeted complement inhibitors. The FDA approval of pegcetacoplan (EMPAVELI) by Apellis Pharmaceuticals, the first drug specifically approved for IC-MPGN heightens the optimisim in this landscape, further propelling the market.
The disease is characterized by immune complex deposition in the glomeruli, triggering inflammation and damage that can lead to kidney failure within 5-10 years of diagnosis. Current treatment strategies involve supportive measures with or without traditional immunosuppression, showing limited effectiveness in slowing disease progression.
IC-MPGN epidemiology includes moe than 7K diagnosed prevalent cases across the 7MM, with adults representing about 90% of all cases, typically resulting from chronic infections, autoimmune disorders, or underlying conditions such as hepatitis C, systemic lupus erythematosus (SLE), or monoclonal gammopathy.
Clinical development activity is intensifying, with key assets advancing through Phase III trials. The IC-MPGN emerging therapies centers on targeted complement inhibition, addressing the underlying pathophysiology of IC-MPGN.
The IC-MPGN competitive landscape features established pharmaceutical companies leveraging their expertise in nephrology and complement biology. Currently the market currently relies heavily on off-label prescription medications, creating opportunities for companies developing targeted therapies. However, challenges exist in developing effective complement inhibitors due to the complexity of the complement system and its adaptive capabilities.
Furthermore, the IC-MPGN market outlook remains positive, driven by the anticipated launch of targeted therapies, increasing diagnosis rates, and growing recognition of complement-mediated kidney diseases. The market is expected to experience significant growth through 2034, supported by the entry of novel therapeutics that address the underlying disease mechanisms rather than merely providing symptomatic relief.
Download the IC-MPGN Market report to understand which factors are driving the therapeutic market @ IC-MPGN Market Trends.
IC-MPGN Epidemiology
The IC-MPGN epidemiology across the 7MM reveals a rare but significant patient population requiring specialized therapeutic intervention. In 2023, more 7K diagnosed prevalent cases were identified across the seven major markets, representing a substantial patient population affected by this ultra-rare kidney disease. The United States dominates the global patient population, accounting for approximately 55% of all cases with around 3,770 diagnosed patients, followed by Japan as the second-largest market.
The IC-MPGN epidemiology geographic distribution shows notable variations across the 7MM regions. Within the EU4 countries and the United Kingdom, Germany represents the largest patient population, followed by Spain, while Italy demonstrates the lowest number of cases. This distribution pattern reflects both demographic factors and potentially differential diagnostic capabilities across these regions. Japan shows a distinct age distribution pattern, with adults being significantly more prevalent compared to the pediatric population, consistent with the global trend of adult predominance in IC-MPGN cases.
The IC-MPGN epidemiology age-specific segmentation reveals that approximately 90% of all IC-MPGN cases occur in adults, primarily due to underlying conditions that develop over time, including chronic infections, autoimmune disorders, hepatitis C, systemic lupus erythematosus, and monoclonal gammopathy. These conditions lead to persistent immune complex formation, triggering complement system activation and resulting in progressive kidney damage. The pediatric population represents a smaller but clinically significant segment requiring specialized care approaches.
Additionally, DelveInsight's gender-specific analysis indicates a relatively balanced distribution between male and female patients, though specific regional variations exist across the 7MM. The total treated cases represent a subset of the diagnosed prevalent population, reflecting current treatment limitations and the challenge of managing this progressive disease with existing therapeutic options. The forecast period from 2024 to 2034 anticipates gradual growth in diagnosed cases, driven by improved awareness, enhanced diagnostic capabilities, and better recognition of IC-MPGN as a distinct clinical entity separate from other forms of membranoproliferative glomerulonephritis.
Discover evolving trends in the IC-MPGN patient pool forecasts @ IC-MPGN Epidemiology Analysis.
Key IC-MPGN Companies and Treatment Market
The clinical and regulatory IC-MPGN landscape is evolving rapidly, with current treatment options limited to supportive care and off-label immunosuppressive therapies. Traditional approaches include renin-angiotensin-aldosterone system inhibitors, immunosuppressants such as corticosteroids, calcineurin inhibitors, and mycophenolate mofetil-based treatments, though these show limited effectiveness in slowing disease progression. The limited IC-MPGN approved therapies has created a significant treatment gap that emerging complement inhibitors aim to address.
The IC-MPGN clinical pipeline activity is concentrated around complement pathway modulation, with two leading companies advancing promising therapeutics through late-stage development. Key players include Novartis Pharmaceuticals (stock symbol: NVS) with iptacopan (LNP023) and Apellis Pharmaceuticals (stock symbol: APLS) with pegcetacoplan (APL-2), both targeting different aspects of the complement cascade to address the underlying pathophysiology of IC-MPGN.
Market positioning of these pipeline assets represents a paradigm shift from symptomatic management to targeted disease modification. Iptacopan functions as an investigational, first-in-class, orally administered factor B inhibitor of the alternative complement pathway, discovered at the Novartis Institutes for BioMedical Research. Currently in Phase III clinical development, the drug has the potential to become the first targeted therapy to delay progression to dialysis in complement-related kidney diseases. Pegcetacoplan operates as a targeted C3 inhibitor designed to regulate excessive complement activation, utilizing a unique 15-amino acid cyclic peptide conjugated to polyethylene glycol that binds to C3 and C3b, directly preventing activation of C3, C5, and the alternative pathway.
Commercial arrangements include strategic collaborations, with Apellis partnering with Sobi for the VALIANT study results announcement. Both companies have established comprehensive development programs spanning multiple complement-related diseases, positioning their assets for potential label expansions beyond IC-MPGN. The regulatory pathway for these novel therapies benefits from the rare disease designation and the significant unmet medical need, potentially facilitating accelerated development timelines and priority review processes.
Discover which companies are innovating in the IC-MPGN treatment landscape @ IC-MPGN Competitive Landscape.
Conclusion
DelveInsight's comprehensive analysis of the IC-MPGN market reveals a therapeutic area poised for transformation through targeted complement inhibition. With approximately 7,100 patients across the 7MM currently lacking effective treatment options, the anticipated market growth driven by iptacopan and pegcetacoplan represents a significant advancement for this ultra-rare kidney disease. The convergence of improved understanding of complement-mediated pathophysiology, positive late-stage clinical results, and the substantial unmet medical need positions the IC-MPGN market for meaningful expansion through 2034. As these innovative therapies progress toward regulatory approval and commercial launch, they offer the potential to fundamentally change the treatment paradigm and improve outcomes for patients suffering from this progressive and debilitating condition.
Table of Contents
1. Key Insights
2. Executive Summary of IC-MPGN
3. Competitive Intelligence Analysis for IC-MPGN
4. IC-MPGN Market Overview at a Glance
5. IC-MPGN: Disease Background and Overview
6. IC-MPGN Patient Journey
7. IC-MPGN Epidemiology and Patient Population
8. Treatment Algorithm, Current Treatment, and Medical Practices
9. IC-MPGN Unmet Needs
10. Key Endpoints of IC-MPGN Treatment
11. IC-MPGN Marketed Products
12. IC-MPGN Emerging Therapies
13. IC-MPGN: Seven Major Market Analysis
14. Attribute analysis
15. 7MM: Market Outlook
16. Access and Reimbursement Overview of IC-MPGN
17. KOL Views
18. IC-MPGN Market Drivers
19. IC-MPGN Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer
23. About DelveInsight
About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.
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Company Name: DelveInsight Business Research LLP
Contact Person: Arpit Anand
Email: Send Email
Phone: +14699457679
Address: 304 S. Jones Blvd #2432
City: Las Vegas
State: Nevada
Country: United States
Website: https://www.delveinsight.com/consulting/due-diligence-services
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