보체 억제제 : 시장 규모, 대상 환자층, 경쟁 구도 및 시장 예측(2036년)

Key Highlights:

• Currently, a growing number of complement inhibitors have gained approval for the treatment of complement-mediated disorders, while numerous other companies are actively developing additional therapies to broaden the treatment landscape.
• The complement inhibitor market is evolving rapidly, with multiple approved agents targeting distinct components such as C5, C3, Factor B, and Factor D, reflecting tailored approaches to complement-driven diseases. Key players include AstraZeneca's ULTOMIRIS, Astellas Pharma's IZERVAY, Novartis FABHALTA, EMPAVELI/ASPAVELI by Apellis/Sobi and others.
• A few of the potential emerging complement inhibitors are Riliprubart (Sanofi), Ruxoprubart (NM8074) (NovelMed Therapeutics), Sefaxersen by Roche/Ionis Pharmaceuticals, OMS-906 (Omeros), among others.

DelveInsight's "Complement Inhibitors (C3/C5) Market Size, Target Population, Competitive Landscape & Market Forecast - 2036" report delivers an in-depth understanding of Complement Inhibitors (C3/C5), addressable patient pool, competitive landscape, and future market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the UK, and Japan.

The Complement Inhibitors (C3/C5) market report provides insights around existing treatment practices in patients with Complement Inhibitors (C3/C5), approved (if any) and emerging Complement Inhibitors (C3/C5), market share of individual therapies, patient pool eligible for treatment with Complement Inhibitors (C3/C5), along with current and forecasted 7MM Complement Inhibitors (C3/C5) market size from 2022-2036 by therapies and by indication. The report also covers current unmet needs and challenges while incorporating new classes in treatment paradigm, variations in accessibility and acceptability of new Complement Inhibitors (C3/C5) in different geographies, along with insights on Complement Inhibitors (C3/C5) pricing reimbursements to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain), and the UK
• Japan

Study Period: 2022-2036

Complement Inhibitors (C3/C5) Overview

Complement inhibitors are immunotherapeutic agents that modulate the innate immune response by targeting the complement system, offering 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.

Target Patient Pool Analysis

• There were nearly ~110 thousand diagnosed prevalent cases of IgAN in EU4 and the UK in 2025. Among EU4 and the UK, Germany accounted for the highest number of cases.
• A secondary analysis across European countries estimated the pooled prevalence of IgAN at 2.53 per 10,000 population, with notable variation-Spain reported the lowest at 1.14 per 10,000. Age-specific data revealed significantly lower prevalence among children (0.12 per 10,000) and a higher burden in the elderly (0.36 per 10,000), highlighting both demographic disparities and potential underdiagnosis in younger populations.
• Among the gender-specific cases of PNH, males accounted for nearly 3,800 cases, and females accounted for nearly 3,200 cases in the US in 2025.
• In 2025, among the EU4 and the UK, Germany reported the highest number of aHUS cases, followed by France, while Spain had the lowest reported case count-reflecting regional variation in disease burden and possibly diagnostic practices.
• According to our secondary analysis, in the United States, the estimated prevalence of PNH ranges from 1 to 9 cases per 100,000 individuals. This highlights the rarity of PNH and underscores the importance of specialized diagnostic approaches and targeted therapies for effective disease management

Complement Inhibitors (C3/C5) Drug Chapters

The drug chapter segment of the Complement Inhibitors (C3/C5) report encloses a detailed analysis of marketed therapies and late-stage (Phase III and Phase II) therapies. It also helps understand the Complement Inhibitors (C3/C5) clinical trial details, pharmacological action, agreements and collaborations related to Complement Inhibitors (C3/C5), their approval timelines, patent details, advantages and disadvantages, latest news and press releases.

Complement Inhibitors (C3/C5) Marketed Drugs

FABHALTA: Novartis

FABHALTA (iptacopan) is a targeted inhibitor of Factor B in the alternative complement pathway, modulating C3 cleavage, downstream effector generation, and terminal pathway amplification. Initially approved by the FDA in 2023 for treating adults with PNH, it also received accelerated approval in August 2024 for reducing proteinuria in patients with primary IgAN. In March 2025, Novartis announced that the US FDA approved oral FABHALTA (iptacopan) for adults with C3G to reduce proteinuria, making it the first approved treatment for this condition.

EMPAVELI/ASPAVELI: Apellis/Sobi

EMPAVELI/ASPAVELI (pegcetacoplan) is a C3-targeted complement inhibitor that acts upstream of C5, offering a differentiated mechanism compared with C5 inhibitors. Approved in the US and Europe (as ASPAVELI) for adults with paroxysmal nocturnal hemoglobinuria (PNH), it may address residual disease activity seen with C5-targeted therapies. In July 2025, the US FDA also approved EMPAVELI as the first treatment for C3G and primary IC-MPGN in patients aged 12 years and older to reduce proteinuria. In January 2026, Sobi received European Commission approval for ASPAVELI (pegcetacoplan) for the treatment of C3G and primary IC-MPGN.

IZERVAY: Astellas

IZERVAY (avacincaptad pegol) is a PEGylated RNA aptamer designed to inhibit complement protein C5, thereby limiting the generation of C5a and C5b and reducing MAC formation. By modulating this pathway, the therapy may slow the progression of geographic atrophy. Approved by the FDA in August 2023, IZERVAY represents a significant therapeutic advance for patients with this advanced stage of AMD. In February 2026, the US FDA has granted label expansion for Astellas' IZERVAY in geographic atrophy secondary to AMD, extending approved dosing beyond 12 months.

Complement Inhibitors (C3/C5) Emerging Drugs

Sefaxersen: Roche/Ionis Pharmaceuticals

Sefaxersen also known as RG6299, an antisense oligonucleotide developed by Roche, selectively targets and reduces complement factor B expression by binding to its mRNA.

By modulating the alternative complement pathway, it holds promise for addressing complement-mediated kidney damage.

Currently in Phase III development for IgAN following successful Phase II results.

With its differentiated mechanism and disease-modifying potential, it may offer a novel therapeutic option for IgAN, with regulatory submission anticipated post-2027.

Riliprubart: Sanofi

Riliprubart, an investigational humanized IgG4 monoclonal antibody developed by Sanofi, selectively inhibits activated C1s, a serine protease in the classical complement pathway.

Currently, riliprubart is in the company's Phase III pipeline, targeting the treatment of CIDP in patients refractory to Standard of Care (SoC) and those undergoing Intravenous Immunoglobulin (IVIg) therapy.

In June 2025, Japan's Ministry of Health, Labour and Welfare (MHLW) granted orphan drug designation to riliprubart for the treatment of CIDP.

In June 2024, the company reported that riliprubart demonstrated promising disease control, with improved or stable disease in patients switching from SOC. It also showed sustained benefits up to 48 weeks, improving fatigue, quality of life, and CIDP biomarkers.

Ruxoprubart (NM8074): NovelMed Therapeutics

Ruxoprubart selectively binds to protein Bb of the alternative pathway. This humanized anti-Bb monoclonal antibody serves as a potent blocker of the alternative pathway.

Ruxoprubart is currently undergoing a Phase II trial in treatment-naive PNH patients, which aims to evaluate the safety and efficacy of the drug.

In May 2025, NovelMed announced positive 12-week interim results from its ongoing multi-dose Phase II clinical trial evaluating Ruxoprubart in adult patients with PNH.

In February 2024, the US FDA granted orphan drug designation to ruxoprubart for the treatment of PNH.

Recent Developments in the Complement Inhibitor Market

• In February 2026, the US FDA has granted 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 also approved EMPAVELI as the first treatment for C3G and primary IC-MPGN in patients aged 12 years and older to reduce proteinuria. In January 2026, Sobi received European Commission approval for ASPAVELI (pegcetacoplan) for the treatment of C3G and primary IC-MPGN

Drug Class Insights

The Drug Class Insights section will provide comprehensive information on Complement Inhibitors (C3/C5) as a class. This will include a broad overview of the class and its role in treating specific conditions. Insights may cover the historical clinical development of Complement Inhibitors (C3/C5), their mechanism of action, their subtypes and future commercial prospects. Additionally, the section will provide detailed information about current trends, challenges, and future prospects for this class of drugs.

Complement Inhibitors (C3/C5) Market Outlook

This section will include details on changing Complement Inhibitors (C3/C5) market dynamics post initiation of clinical development activities of the inhibitor. It will also provide a detailed summary and comparison of all the therapies being developed by leading players in this space. This section will highlight the advantages of one therapy over the other after assessment based on parameters such as data availability in the form of safety and efficacy, number of patients enrolled in each trial, and trial's inclusion criteria. There will be a Key focus on the importance of development and need for the commercial success of these targeted therapies to achieve treatment goals that physicians and patients are looking for. It will also sum up all the early stage players active in this space.

Complement Inhibitors (C3/C5) Drugs Uptake

This section focuses on the uptake rate of potential Complement Inhibitors (C3/C5) already launched and expected to be launched in the market during 2022-2036, which depends on the competitive landscape, safety, efficacy data, and order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Complement Inhibitors (C3/C5) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.

Complement Inhibitors (C3/C5) Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Complement Inhibitors (C3/C5).

KOL Views

To keep up with current and future market trends, we incorporate Key physicians, Therapy Area Researcher's, and other Industry Experts' opinions working in the domain through primary research to fill in the data gaps and validate our secondary research. 25+ Key Opinion Leaders (KOLs) were contacted for insights on Complement Inhibitors (C3/C5)' incorporation in the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along with challenges related to accessibility.

Qualitative Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the analyst's discretion and assessment of the cost analysis and existing and evolving treatment landscape.

Market Access and Reimbursement

This section will include insights around the standard HTA pricing, recent reformations in 2024 and modifications in reimbursement process in the 7MM. For example, In the United States, a multi payer model exists when it comes to drug pricing regime, which is currently undergoing significant changes, with recent federal legislation, such as the Prescription Drug Pricing Reform provisions of the Inflation Reduction Act, significantly altering the pricing regime under certain federal programs. Whereas in Germany, the market access differs from the systems followed in many other countries as no pricing and reimbursement approval is required during launch of a new therapy.

Moreover, this section will also provide details on reimbursement of approved therapy, if any.

Scope of the Report:

• The report covers a segment of key events, an executive summary, target patient pool, epidemiology and market forecasts, information around patient journey and varying biomarker testing rates
• Additionally, an all-inclusive account of the current and emerging therapies drug chapters, insights on Complement Inhibitors (C3/C5) addressable patient pool
• A detailed review of the Complement Inhibitors (C3/C5) market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, and treatment preferences that help in shaping and driving the 7MM Complement Inhibitors (C3/C5) market.
• Market Size of Inhibitors by therapies and indication will be provided

Complement Inhibitors (C3/C5) Report Key Strengths

• 11 Years Complement Inhibitors (C3/C5) Market Forecast
• The 7MM Coverage
• Complement Inhibitors (C3/C5) Competitive Landscape of current and emerging therapies
• Complement Inhibitors (C3/C5) Total Addressable patient population
• Drugs Uptake and Key Market Forecast Assumptions
• Approved and Emerging therapy Profiles
• Physician's perspectives/KOL opinions
• Biomarker testing and Patient journey
• Qualitative Analysis (SWOT and Analyst Views)
• Complement Inhibitors (C3/C5) Market Size by therapy and indication
• Existing and Future Market Opportunity
• Unmet Needs

FAQs:

• What was the Complement Inhibitors (C3/C5) total market size, the market size by therapies, market share (%) distribution in 2022, and what would it look like by 2036? What are the contributing factors for Complement Inhibitors (C3/C5) market growth?
• Which Complement Inhibitor is going to be the largest contributor by 2036?
• What is the market access and reimbursement scenario of Complement Inhibitors (C3/C5)?
• What are the pricing variations among different geographies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?

Reasons to Buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Complement Inhibitors (C3/C5) Market.
• Understand the existing Complement Inhibitors (C3/C5) market opportunities and future trends in varying geographies
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility and acceptability of emerging treatment options along with unmet need of current therapies
• Details on report methodology, top indications covered, market assumptions, patient journey and KOLs to strengthen the pharmaceutical companies' development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Complement Inhibitors (C3/C5)

4. Key Events

5. Complement Inhibitors (C3/C5) Market Overview At A Glance

• 5.1. Market Share (%) Distribution of Complement Inhibitors (C3/C5) By Therapy in 2025
• 5.2. Market Share (%) Distribution of Complement Inhibitors (C3/C5) By Therapy in 2036

6. Background And Overview

7. Target Population

8. Complement Inhibitors (C3/C5) Marketed Drugs

• 8.1. Key Competitors
  • 8.1.1. Product Description
  • 8.1.2. Regulatory Milestones
  • 8.1.3. Other Developmental Activities
  • 8.1.4. Ongoing Clinical Development
  • 8.1.5. Safety and Efficacy

9. Complement Inhibitors (C3/C5) Emerging Drugs

• 9.1. Key Competitors
  • 9.1.1. Product Description
  • 9.1.2. Other Development Activities
  • 9.1.3. Clinical Development
    • 9.1.3.1. Clinical Trials Information
  • 9.1.4. Safety and Efficacy

10. Complement Inhibitors (C3/C5): The 7MM Analysis

• 10.1. Key Findings
• 10.2. Market Outlook
• 10.3. Key Market Forecast Assumptions
• 10.4. Total Market Size of Complement Inhibitors (C3/C5) in the 7MM
  • 10.4.1. Market Size of Complement Inhibitors (C3/C5) By Therapies In the 7MM
  • 10.4.2. Market Size of Complement Inhibitors (C3/C5) By Indication In the 7MM
• 10.6. United States Market
  • 10.6.1. Total Market Size of Complement Inhibitors (C3/C5) in the United States
  • 10.6.2. Market Size of Complement Inhibitors (C3/C5) By Therapies in the United States
• 10.7. EU4 and the UK Market
  • 10.7.1. Total Market Size of Complement Inhibitors (C3/C5) in EU4 and the UK
  • 10.7.2. Market Size of Complement Inhibitors (C3/C5) By Therapies in EU4 and the UK
• 10.8. Japan Market
  • 10.8.1. Total Market Size of Complement Inhibitors (C3/C5) in Japan
  • 10.8.2. Market Size of Complement Inhibitors (C3/C5) By Therapies in Japan

11. Unmet Needs

12. SWOT Analysis

13. KOL Views

14. Market Access and Reimbursement

• 14.1. United States
  • 14.1.1. Centre for Medicare & Medicaid Services (CMS)
• 14.2. EU4 and the UK
  • 14.2.1. Germany
  • 14.2.2. France
  • 14.2.3. Italy
  • 14.2.4. Spain
  • 14.2.5. United Kingdom
• 14.3. Japan
  • 14.3.1. MHLW

15. Appendix

• 15.1. Bibliography
• 15.2. Report Methodology

16. Delveinsight Capabilities

17. Disclaimer

18. About DelveInsight