(Albany, US), October 27, 2026 – DelveInsight’s “Complement 3 Glomerulopathy Market Insights, Epidemiology and Market Forecast – 2036” report delivers an in-depth understanding of Complement 3 Glomerulopathy (C3G), historical and forecasted epidemiology, as well as the C3 glomerulopathy market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

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Key Takeaways from the Complement 3 Glomerulopathy Market Report

• In January 2026, Sobi announced that the European Commission had approved ASPAVELI for the treatment of adult and adolescent patients aged 12 to 17 years with C3G or primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) in combination with a Renin-Angiotensin System (RAS) inhibitor, unless RAS inhibitor treatment is not tolerated or contraindicated.

• According to DelveInsight’s analysis, the US accounts for the largest share of the complement 3 glomerulopathy market, at ~70% of the 7MM.

• The Complement 3 Glomerulopathy Market in the 7MM is projected to reach ~USD 1 billion by 2036, growing at a CAGR of ~28% during 2026-2036.

• The Complement 3 Glomerulopathy Diagnosed Prevalent Population in the 7MM was around 6,000 in 2025 and is expected to rise through 2036.

• Approximately 30–50% of patients with C3G develop End-stage Kidney Disease within 10 years of diagnosis, highlighting the progressive course of the disease and the strong demand for effective treatments.

• FABHALTA became the first therapy approved for C3G, followed by EMPAVELI/ASPAVELI from Apellis Pharmaceuticals and Sobi, marking a significant expansion of targeted options in the glomerulonephritis market.

• The leading Complement 3 Glomerulopathy Companies include Novartis, Apellis Pharmaceuticals, Sobi, Kira Pharmaceuticals, Novo Nordisk/Omeros Corporation, Arrowhead Pharmaceuticals, and others.

• Promising Complement 3 Glomerulopathy Therapies include FABHALTA, EMPAVELI/ASPAVELI, KP104, Zaltenibart, ARO-C3, and others.

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Complement 3 Glomerulopathy Overview

Complement 3 Glomerulopathy, a term established by expert consensus in 2013, refers to a group of rare kidney diseases caused by dysregulation of the alternative complement pathway. It is characterized by predominant C3 deposition in the glomeruli with minimal or absent immunoglobulin, C1q, and C4, which is the key diagnostic feature in patients presenting with glomerulonephritis. Clinically, C3G presents with proteinuria, hematuria, reduced urine output, low blood protein levels, and edema. Diagnosis typically requires a kidney biopsy evaluated through light microscopy, immunofluorescence (showing dominant C3 staining), and electron microscopy, which further classifies the disease into Dense Deposit Disease (DDD) or C3 Glomerulonephritis (C3GN). Additional assessments include urine and blood tests and glomerular filtration rate (GFR) measurement. The features of DDD tend to appear earlier than those of C3GN, usually in adolescence.

Complement 3 Glomerulopathy Epidemiology Segmentation in the 7MM

• Total Complement 3 Glomerulopathy Diagnosed Prevalent Population

• Complement 3 Glomerulopathy Type-specific Diagnosed Prevalent Population

• Complement 3 Glomerulopathy Age-specific Diagnosed Prevalent Population

• Total Complement 3 Glomerulopathy Treated Cases

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Complement 3 Glomerulopathy Epidemiology Key Findings

• In 2025, the Complement 3 Glomerulopathy Diagnosed Prevalent Population in the 7MM was around 6,000. This number is expected to rise through 2036, driven by advances in complement biology, improved diagnostics, and wider use of genetic testing, complement assays, and multidisciplinary biopsy evaluation.

• The Complement 3 Glomerulopathy Diagnosed Prevalent Population in the US was around 3,500 in 2025.

• In 2025, C3G predominantly affected adults in the US, with 90% of the cases, while the paediatric population accounted for the remaining 10%.

• In Japan, adults are more prevalent in C3G compared to paediatrics.

Approved Therapies for Complement 3 Glomerulopathy

• Iptacopan (FABHALTA/FABIHARTA): Novartis – an oral Factor B inhibitor of the alternative complement pathway. It received US FDA approval for adults with C3G in March 2025, and the CHMP of the EMA adopted a positive opinion in April 2025.

• Pegcetacoplan (EMPAVELI/ASPAVELI): Apellis Pharmaceuticals and Sobi – a targeted C3 therapy approved in the US in July 2025 for C3G or primary IC-MPGN in patients 12 years of age and older. In January 2026, the European Commission approved it for adult and adolescent patients aged 12 to 17 years with C3G in combination with a RAS inhibitor.

• However, a significant challenge remains in the form of a black box warning for life-threatening infections caused by encapsulated organisms, necessitating vaccination at least 2 weeks before treatment initiation.

Complement 3 Glomerulopathy Pipeline Analysis

• KP104: Kira Pharmaceuticals – a first-in-class bifunctional biologic designed to simultaneously and selectively block the alternative and terminal pathways. KP104 is entering Phase II proof-of-concept trials across multiple indications, including IgAN, C3G, SLE-TMA, and PNH, with trials conducted globally, including in the US, China, Australia, and South Korea.

• Zaltenibart (OMS906): Novo Nordisk/Omeros Corporation – an investigational human monoclonal antibody targeting MASP-3, the key and most proximal activator of the alternative pathway. Following completion of the Phase II study, and assuming strong evidence of efficacy, Omeros Corporation plans to initiate a Phase III trial in C3G.

• ARO-C3: Arrowhead Pharmaceuticals – an RNA interference (RNAi) therapeutic targeting complement C3, currently in Phase I/IIa.

Discover more about therapies set to grab Major Complement 3 Glomerulopathy Market Share @ Complement Inhibitors Market Drivers and Barriers

Complement 3 Glomerulopathy Market Outlook

The management of C3G is predominantly reliant on off-label use of various prescription drugs, reflecting the unmet need for approved, targeted therapies. The treatment landscape saw a breakthrough in March 2025 with the FDA approval of Iptacopan, the first targeted therapy for this condition, followed by pegcetacoplan in July 2025. EMPAVELI/ASPAVELI presents a promising option by targeting C3 directly and proximally within the complement cascade, and has demonstrated clinical efficacy nearly doubling the outcomes observed with FABHALTA. Emerging therapies targeting novel mechanisms, including dual complement inhibitors (C5 and Factor H), MASP-3 inhibitors, and RNAi therapeutics targeting complement C3, are showing promise and are expected to create an upward shift in the complement inhibitors market and the broader next generation complement therapeutics market after their launch in the coming years. The US accounts for the largest share of the glomerular disease therapeutic market for C3G, at ~70% of the 7MM.

Complement 3 Glomerulopathy Market Drivers

• A deeper understanding of complement dysregulation has led to more targeted and innovative therapies

• Widespread use of complement assays, genetic testing, and renal biopsy interpretation enabling earlier and more accurate diagnoses

• Increased reporting and retrospective chart reviews suggesting C3G is more common than previously believed

• High progression rates to ESKD and lack of approved therapies, highlighting strong demand for effective treatments

Complement 3 Glomerulopathy Market Barriers

• Black box warning for life-threatening infections caused by encapsulated organisms with approved complement inhibitors

• Overlap with other glomerulopathies, with a significant chance of misdiagnosis due to similarities with IC-MPGN and lupus nephritis

• Absence of a reliable noninvasive biomarker for early or subclinical detection

• Limited long-term real-world evidence of efficacy

• High disease burden associated with C3G progression, with substantial physical and emotional impact on patients and caregivers

Complement 3 Glomerulopathy Treatment Landscape

Optimal Complement 3 Glomerulopathy treatment has not been established yet. All patients diagnosed with C3G should be treated with renoprotective measures, including lifestyle advice, an ACE inhibitor or angiotensin-receptor blocker to control hypertension and proteinuria, and lipid-lowering treatment. The regimen focuses on slowing kidney damage and may include corticosteroids, immunosuppressive drugs, ACE inhibitors and ARBs, diet changes, and complement inhibitors. Off-label options include calcineurin inhibitors and monoclonal antibodies such as eculizumab and rituximab, which target the terminal complement pathway by inactivating C5 and can improve renal function and reduce proteinuria.

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Scope of the Complement 3 Glomerulopathy Market Report

• Coverage- 7MM

• Study Period- 2022-2036

• Forecast Period- 2026-2036

• Complement 3 Glomerulopathy Market CAGR (2022-2036)- 27.4%

• Complement 3 Glomerulopathy Companies- Novartis, Apellis Pharmaceuticals, Sobi, Kira Pharmaceuticals, Novo Nordisk/Omeros Corporation, Arrowhead Pharmaceuticals, and others.

• Complement 3 Glomerulopathy Therapies- FABHALTA, EMPAVELI/ASPAVELI, KP104, Zaltenibart, ARO-C3, and others.

• Complement 3 Glomerulopathy Market Dynamics: Complement 3 Glomerulopathy market drivers and market barriers

• Complement 3 Glomerulopathy Competitive Intelligence Analysis: SWOT Analysis, Conjoint Analysis

• Complement 3 Glomerulopathy Unmet Needs, KOL Views, Reimbursement

Table of Contents

1. Key Insights of C3G

2. Report Introduction of C3G

3. Executive Summary of C3G

4. Key Events of C3G

5. Epidemiology and Market Forecast Methodology of C3G

6. C3G Market Overview at a Glance

7. Disease Background and Overview of C3G

8. Treatment of C3G

9. Epidemiology and Patient Population of C3G

10. Patient Journey of C3G

11. Marketed Therapies

12. Emerging Drugs

13. C3G: 7MM Analysis

14. Unmet Needs of C3G

15. SWOT Analysis of C3G

16. KOL Views of C3G

17. Market Access and Reimbursement of C3G

18. Appendix

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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