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(Albany, US) On November 11, 2026, DelveInsight’s “Complement Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036” report provides comprehensive insights into the Complement Inhibitors market and pipeline landscape across the 7MM. It covers marketed and emerging drug profiles and examines the target patient pool, treatment landscape, and competitive dynamics shaping the space.

Discover the latest drugs and treatment options in the Complement Inhibitors Market @ https://www.delveinsight.com/report-store/complement-inhibitors-c3-c5-market-forecast

Key Takeaways from the Complement Inhibitors Report

• In February 2026, the US FDA granted a label expansion for Astellas’ IZERVAY in geographic atrophy secondary to AMD, extending approved dosing beyond 12 months.

• In January 2026, Sobi announced that the European Commission approved ASPAVELI (pegcetacoplan) for adults and adolescents aged 12–17 years with C3 glomerulopathy (C3G) or primary IC-MPGN, to be used with a renin–angiotensin system inhibitor unless contraindicated or not tolerated.

• In July 2025, the US FDA approved EMPAVELI as the first treatment for C3G and primary IC-MPGN in patients aged 12 years and older to reduce proteinuria.

• In March 2025, the US FDA approved oral FABHALTA (iptacopan) for adults with C3G to reduce proteinuria, the first approved treatment for the condition. FABHALTA was also granted accelerated approval in August 2024 for reducing proteinuria in primary IgAN.

• In May 2025, NovelMed announced positive 12-week interim Phase II results for ruxoprubart in adults with PNH.

• In the US in 2025, males accounted for nearly 3,800 PNH cases and females for nearly 3,200.

• There were nearly 110 thousand diagnosed prevalent cases of IgAN in EU4 and the UK in 2025, with Germany accounting for the highest number.

• DelveInsight’s report depicts a rapidly evolving market, with approved agents targeting distinct components such as C5, C3, Factor B, and Factor D.

• Key marketed players include AstraZeneca (ULTOMIRIS), Astellas (IZERVAY), Novartis (FABHALTA), and Apellis/Sobi (EMPAVELI/ASPAVELI), and others.

• Promising emerging therapies include sefaxersen (Roche/Ionis), riliprubart (Sanofi), ruxoprubart (NovelMed Therapeutics), OMS-906 (Omeros), and others.

Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Complement Inhibitors Treatment Drugs

Complement Inhibitors Overview

Complement inhibitors are immunotherapeutic agents that modulate the innate immune response by targeting the complement system. They offer therapeutic benefit in inflammatory conditions affecting organs such as the lungs, kidneys, and multiple systems.

Inhibiting C3 activation blocks the pro-inflammatory C3a anaphylatoxin but may increase infection risk by reducing C3b opsonization. Targeting C5 convertases offers a balanced approach, preventing C5a and MAC formation while preserving upstream immune functions.

Complement Inhibitors Marketed Drugs

FABHALTA (iptacopan): Novartis FABHALTA is a targeted inhibitor of Factor B in the alternative complement pathway, modulating C3 cleavage, downstream effector generation, and terminal pathway amplification. It was initially approved by the FDA in 2023 for adults with PNH.

EMPAVELI/ASPAVELI (pegcetacoplan): Apellis/Sobi Pegcetacoplan is a C3-targeted complement inhibitor that acts upstream of C5, offering a differentiated mechanism from C5 inhibitors. It is approved in the US and Europe (as ASPAVELI) for adults with PNH and may address residual disease activity seen with C5-targeted therapies.

IZERVAY (avacincaptad pegol): Astellas IZERVAY is a PEGylated RNA aptamer that inhibits complement protein C5, limiting C5a and C5b generation and reducing MAC formation. Approved by the FDA in August 2023, it may slow the progression of geographic atrophy in advanced AMD.

Learn about new drugs, pipeline developments, and key players with DelveInsight’s expert analysis @ Complement Inhibitors Market Insights

Complement Inhibitors Emerging Drugs Profile

Sefaxersen (RG6299): Roche/Ionis Pharmaceuticals Sefaxersen is an antisense oligonucleotide that selectively reduces complement factor B expression by binding to its mRNA. Currently in Phase III for IgAN following successful Phase II results, it has regulatory submission anticipated post-2027.

Riliprubart: Sanofi Riliprubart is an investigational humanized IgG4 monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway. It is in Phase III for CIDP in patients refractory to standard of care and those undergoing IVIg therapy. In June 2025, Japan’s MHLW granted it orphan drug designation for CIDP. In June 2024, the company reported improved or stable disease in patients switching from standard of care, with benefits sustained up to 48 weeks.

Ruxoprubart (NM8074): NovelMed Therapeutics Ruxoprubart is a humanized anti-Bb monoclonal antibody that blocks the alternative pathway. It is in Phase II in treatment-naïve PNH patients, and the US FDA granted it orphan drug designation for PNH in February 2024.

Explore groundbreaking therapies and clinical trials in the Complement Inhibitors Market @ Complement Inhibitors Treatment Drugs

Target Patient Pool Highlights

• A secondary analysis across European countries estimated the pooled prevalence of IgAN at 2.53 per 10,000 population, with Spain lowest at 1.14 per 10,000. Prevalence was lower in children (0.12 per 10,000) and higher in the elderly (0.36 per 10,000).

• In the US, the estimated prevalence of PNH ranges from 1 to 9 cases per 100,000 individuals.

• In 2025, among EU4 and the UK, Germany reported the highest number of aHUS cases, followed by France, with Spain the lowest.

Scope of the Complement Inhibitors Report

• Coverage: 7MM (US, EU4, UK, Japan)

• Companies: AstraZeneca, Astellas Pharma, Novartis, Apellis, Sobi, Sanofi, NovelMed Therapeutics, Roche, Ionis Pharmaceuticals, Omeros, and others

• Therapies: ULTOMIRIS, IZERVAY, FABHALTA, EMPAVELI/ASPAVELI, sefaxersen, riliprubart, ruxoprubart (NM8074), OMS-906, and others

• Study Period: 2022–2036

• Analysis: Target patient pool, market size by therapy and indication, drug uptake, KOL views, SWOT, analyst views, market access and reimbursement, unmet needs

Download DelveInsight’s in-depth Complement Inhibitors report today! @ Complement Inhibitors Companies

Table of Contents

1. Introduction

2. Executive Summary

3. Complement Inhibitors: Overview

4. Target Patient Pool Analysis

5. Marketed Therapies

6. Emerging Therapies

7. Key Companies

8. Market Outlook

9. Drug Uptake

10. Market Access and Reimbursement

11. KOL Views

12. Qualitative Analysis (SWOT and Analyst Views)

13. Unmet Needs

14. Appendix

15. About Us

About DelveInsight

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe.

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