Atypical Hemolytic Uremic Syndrome Market: Epidemiology, Therapies, Companies, DelveInsight | Alexion Pharmaceuticals, Omeros Corporation, Novartis Pharmaceuticals, Hoffmann-La Roche, Chugai Pharmaceutical

Atypical Hemolytic Uremic Syndrome therapies, such as Crovalimab (RG6107; SKY59), FABHALTA (iptacopan), and others, are expected to boost the Atypical Hemolytic Uremic Syndrome Market in the upcoming years.

DelveInsight has launched a new report on "Atypical Hemolytic Uremic Syndrome - Market Insights, Epidemiology, and Market Forecast-2034" that delivers an in-depth understanding of the Atypical Hemolytic Uremic Syndrome, historical and forecasted epidemiology as well as the Atypical Hemolytic Uremic Syndrome market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

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Some of the key facts of the Atypical Hemolytic Uremic Syndrome Market Report:

In 2023, the United States held the largest market share for Atypical Hemolytic Uremic Syndrome (aHUS) among the 7MM, with the market expected to grow at a compound annual growth rate (CAGR) of approximately 4% through 2034. aHUS is a rare condition characterized by the formation of abnormal blood clots in small blood vessels, primarily in the kidneys, leading to complications such as hemolytic anemia, thrombocytopenia, and kidney failure.
The disease typically presents with symptoms like confusion, seizures, strokes, high blood pressure, and organ damage. While aHUS can occur at any age, it is more prevalent in adolescents and adults. In 2023, there were an estimated 4,800 diagnosed cases across the 7MM, with around 4,000 in adolescents and adults and 700 in children. aHUS differs from typical HUS, which is usually caused by infections such as E. coli, whereas aHUS is often linked to genetic mutations that require a triggering event, such as infections, pregnancy, cancer, or certain medications, to activate the disease.
Currently, only two FDA-approved treatments exist, eculizumab and ravulizumab, both developed by Alexion Pharmaceuticals (acquired by AstraZeneca in 2021). These treatments are effective but limited by high costs and safety concerns. Novartis's iptacopan (LNP023), an oral therapy currently in Phase III trials, is poised to become a more convenient and potentially preferred treatment option, with projected sales exceeding USD 500 million by 2034.
However, despite advancements, several challenges remain in the aHUS market, including high drug prices, limited diagnostic clarity, safety concerns, and the threat of generic competition, all of which could impact market expansion in the coming years.
Several major players are shaping the treatment landscape for Atypical Hemolytic Uremic Syndrome (aHUS), including Alexion Pharmaceuticals, Novartis, and Roche. Country-specific and therapy-specific market size insights are outlined below.
Based on DelveInsight's patient-based forecasting model, the total aHUS market across the 7 major markets (7MM) was valued at approximately USD 1.3 billion in 2023. This figure is expected to rise substantially over the forecast period, driven by the introduction of new therapies.
Among the 7MM, the United States represented the largest share of the aHUS market in 2023, accounting for around 70% of the total market value, followed by Germany and France.
In April 2025, Teva and Samsung Bioepis introduced Epysqli (eculizumab‐aagh), a biosimilar to Soliris, now available in the U.S. for treating aHUS (alongside PNH and gMG). Offered at a 30% discount compared to Soliris, this biosimilar aims to alleviate treatment affordability concerns
While iptacopan (Fabhalta) hasn't received FDA approval for aHUS yet, it has achieved multiple approvals in related complement-mediated kidney diseases, most recently for C3 glomerulopathy in March 2025. Additionally, the FDA released draft guidance in May 2025 addressing iptacopan hydrocholoride, signaling progress toward potential anticomplement treatment approval pathways.
Key Atypical Hemolytic Uremic Syndrome companies such as Alexion Pharmaceuticals, Omeros Corporation, Novartis Pharmaceuticals, Hoffmann-La Roche, Chugai Pharmaceutical, and others are evaluating new drugs for Atypical Hemolytic Uremic Syndrome to improve the treatment landscape.
Promising Atypical Hemolytic Uremic Syndrome therapies include Crovalimab (RG6107; SKY59), FABHALTA (iptacopan), and others.

Atypical Hemolytic Uremic Syndrome Overview

Atypical Hemolytic Uremic Syndrome is the most common type of central nervous system (CNS) tumor, originating from glial cells. These tumors are highly invasive, spreading extensively into surrounding brain tissue. Atypical Hemolytic Uremic Syndromes are generally classified into three main types based on the characteristics of their cells: astrocytomas, ependymomas, and oligodendrotypical Hemolytic Uremic Syndromes. They develop due to genetic mutations accumulating in glial stem or progenitor cells, causing uncontrolled cell growth. Atypical Hemolytic Uremic Syndromes are graded on a scale from I to IV, with glioblastoma (GBM, Grade IV) being the most aggressive and pilocytic astrocytomas (Grade I) being the least malignant. Common mutated genes associated with Atypical Hemolytic Uremic Syndromes include tumor suppressors like TP53 and PTEN, growth-related genes like BRAF, and metabolism-related genes such as IDH1.

Atypical Hemolytic Uremic Syndrome Market Outlook

The incorporation of complement C5 inhibitors has notably enhanced outcomes and quality of life (QoL) for patients with atypical hemolytic uremic syndrome (aHUS). The two key therapies currently available across the 7 major markets (7MM) are SOLIRIS (eculizumab) and ULTOMIRIS (ravulizumab), both developed by Alexion Pharmaceuticals, which was acquired by AstraZeneca in 2021.

A common treatment approach involves transitioning patients from eculizumab to ravulizumab, as the latter offers a reduced dosing frequency. This shift not only decreases the economic burden of frequent infusions but also improves overall patient convenience and quality of life.

Despite the effectiveness and safety of these therapies, their high cost presents a major barrier to widespread use. As a result, there remains a pressing need for more accessible and effective treatment options, particularly for managing the most severe stages of aHUS.

In summary, while a few promising therapies are under investigation, it is still too early to predict their market entry. However, the outlook for the aHUS treatment landscape appears positive, with expected advancements driven by increased global healthcare investment and innovation. These developments are likely to bring meaningful improvements to patient care in the years ahead.

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Atypical Hemolytic Uremic Syndrome Marketed Drugs
ULTOMIRIS (ravulizumab): Alexion Pharmaceuticals
SOLIRIS (eculizumab): Alexion Pharmaceuticals

Atypical Hemolytic Uremic Syndrome Emerging Drugs

Crovalimab (RG6107; SKY59): Hoffmann-La Roche/Chugai Pharmaceutical
FABHALTA (iptacopan): Novartis Pharmaceuticals

Scope of the Atypical Hemolytic Uremic Syndrome Market Report
Study Period: 2020-2034
Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Key Atypical Hemolytic Uremic Syndrome Companies: Alexion Pharmaceuticals, Omeros Corporation, Novartis Pharmaceuticals, Hoffmann-La Roche, Chugai Pharmaceutical, and others
Atypical Hemolytic Uremic Syndrome Therapies: Crovalimab (RG6107; SKY59), FABHALTA (iptacopan), and others.
Atypical Hemolytic Uremic Syndrome Therapeutic Assessment: Atypical Hemolytic Uremic Syndrome current marketed and Atypical Hemolytic Uremic Syndrome emerging therapies
Atypical Hemolytic Uremic Syndrome Market Dynamics: Atypical Hemolytic Uremic Syndrome market drivers and Atypical Hemolytic Uremic Syndrome market barriers
Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
Atypical Hemolytic Uremic Syndrome Unmet Needs, KOL's views, Analyst's views, Atypical Hemolytic Uremic Syndrome Market Access and Reimbursement

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Key benefits of the Atypical Hemolytic Uremic Syndrome Market Report:
Atypical Hemolytic Uremic Syndrome market report covers a descriptive overview and comprehensive insight of the Atypical Hemolytic Uremic Syndrome Epidemiology and Atypical Hemolytic Uremic Syndrome market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).
The Atypical Hemolytic Uremic Syndrome market report provides insights into the current and emerging therapies.
The Atypical Hemolytic Uremic Syndrome market report provides a global historical and forecasted market covering drug outreach in 7MM.
The Atypical Hemolytic Uremic Syndrome market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Atypical Hemolytic Uremic Syndrome market.

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Table of Contents

1. Report Introduction
2. Executive Summary
3. SWOT analysis
4. Atypical Hemolytic Uremic Syndrome Patient Share (%) Overview at a Glance
5. Atypical Hemolytic Uremic Syndrome Market Overview at a Glance
6. Atypical Hemolytic Uremic Syndrome Disease Background and Overview
7. Atypical Hemolytic Uremic Syndrome Epidemiology and Patient Population
8. Country-Specific Patient Population of Atypical Hemolytic Uremic Syndrome
9. Atypical Hemolytic Uremic Syndrome Current Treatment and Medical Practices
10. Unmet Needs
11. Atypical Hemolytic Uremic Syndrome Emerging Therapies
12. Atypical Hemolytic Uremic Syndrome Market Outlook
13. Country-Wise Atypical Hemolytic Uremic Syndrome Market Analysis (2020-2034)
14. Market Access and Reimbursement of Therapies
15. Market drivers
16. Market barriers
17. Appendix
18. Atypical Hemolytic Uremic Syndrome Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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Related Reports:

Atypical Hemolytic Uremic Syndrome Pipeline Insights, DelveInsight

"Atypical Hemolytic Uremic Syndrome Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Atypical Hemolytic Uremic Syndrome market. A detailed picture of the Atypical Hemolytic Uremic Syndrome pipeline landscape is provided, which includes the disease overview and Atypical Hemolytic Uremic Syndrome treatment guidelines.

Contact Info:

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About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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