Atypical Hemolytic Uremic Syndrome Market Size in the 7MM was USD 1,300 million in 2023 which is expected to Rise by 2034, estimates DelveInsight

DelveInsight's "Atypical Hemolytic Uremic Syndrome Market Insights, Epidemiology, and Market Forecast 2034" report delivers an in-depth understanding of Atypical Hemolytic Uremic Syndrome, historical and forecasted epidemiology as well as Atypical Hemolytic Uremic Syndrome therapeutics market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

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Key Takeaways from Atypical Hemolytic Uremic Syndrome Market Report
• On December 11, 2025- Novartis Pharmaceuticals initiated a study is designed as a multicenter, single-arm, open label study to demonstrate the efficacy and safety of LNP023 (iptacopan) at a dose of 200 mg b.i.d. in adult patients with aHUS who are treatment naive to complement inhibitor therapy (including anti-C5 antibody). The study will enroll approximately 50 participants and assess the effects of iptacopan on a range of efficacy assessments relevant to aHUS including hematological and kidney parameters, dialysis requirement, changes in chronic kidney disease (CKD) stage, as well as patient reported outcomes (PRO) for fatigue and quality of life.
• On December 08, 2025- Alexion Pharmaceuticals Inc. announced a Phase 3b study to evaluate the efficacy and safety of eculizumab in participants with aHUS in China. The study will be conducted in participants of any age who weigh ≥ 5 kg and who previously have not been treated with complement inhibitors. The study consists of an up to 7-day Screening Period and a 26-week Treatment Period. An 8-week Safety Follow-up Phone Call will be required only for participants who discontinue eculizumab treatment during the study or for participants who will not receive continued access to eculizumab after completing study treatment. Approximately 25 eligible participants in China will be enrolled.
• According to DelveInsight's epidemiology model, the total diagnosed cases of aHUS in the 7MM was ~4,800 in 2023 which is further expected to increase over the forecast period.
• Among the 7MM, the United States accounted for the highest number of prevalent cases of aHUS in 2023, nearly 3,500 cases. These cases are anticipated to increase by 2034.
• In 7MM, Adolescents and adults population accounted for the ~80% of diagnosed cases in 2023.
• Among EU4 and the UK, Germany accounted for the highest number of prevalent cases in 2023, while Spain accounted for the least.
• The leading Atypical Hemolytic Uremic Syndrome Companies such as Novartis Pharmaceuticals, Hoffmann-La Roche, Chugai Pharmaceutical and others.
• Promising Atypical Hemolytic Uremic Syndrome Therapies such as Eculizumab, Crovalimab, Iptacopan, NM8074, Ravulizumab, and others.

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Atypical Hemolytic Uremic Syndrome Overview
Atypical Hemolytic Uremic Syndrome (aHUS) is a rare, life-threatening thrombotic microangiopathy characterized by uncontrolled activation of the alternative complement pathway, leading to widespread endothelial damage, microvascular thrombosis, hemolytic anemia, thrombocytopenia, and acute kidney injury. Unlike typical HUS, which is commonly associated with Shiga toxin-producing bacterial infections, aHUS is primarily driven by genetic mutations or acquired autoantibodies affecting complement regulatory proteins, resulting in chronic or relapsing disease.

Atypical Hemolytic Uremic Syndrome Epidemiology Segmentation in the 7MM
• Total Atypical Hemolytic Uremic Syndrome Prevalent Cases
• Atypical Hemolytic Uremic Syndrome Diagnosed Cases
• Atypical Hemolytic Uremic Syndrome Age-specific Cases
• Atypical Hemolytic Uremic Syndrome Treated Cases in the US

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Marketed Atypical Hemolytic Uremic Syndrome Therapies
• ULTOMIRIS (ravulizumab): Alexion Pharmaceuticals
Ravulizumab-cwvz, a complement inhibitor, is a humanized monoclonal antibody (mAb) produced in Chinese hamster (CHO) cells. ULTOMIRIS is indicated for the treatment of adult and pediatric patients 1 month of age and older with aHUS to inhibit complement-mediated thrombotic microangiopathy (TMA). In September 2020, Alexion Pharmaceuticals announced that Japan's MHLW had approved ULTOMIRIS (ravulizumab) for adults and children living with aHUS.

• SOLIRIS (eculizumab): Alexion Pharmaceuticals
Eculizumab, a complement inhibitor, is a recombinant humanized monoclonal IgG2/4κ antibody produced by murine myeloma cell culture and purified by standard bioprocess technology. Eculizumab contains human constant regions from human IgG2 sequences, human IgG4 sequences, and murine complementarity-determining regions grafted onto the human framework light and heavy-chain variable regions. SOLIRIS is indicated for the treatment of patients with aHUS to inhibit complement-mediated thrombotic microangiopathy. Both of the approved drugs, ULTOMIRIS and SOLIRIS, come with black box warning as they increase the risk of serious and life-threatening infections caused by Neisseria meningitides. Owing to the higher risk of serious meningococcal infections, ULTOMIRIS and SOLIRIS are available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).

Emerging Atypical Hemolytic Uremic Syndrome Therapies
• Crovalimab (RG6107; SKY59): Hoffmann-La Roche/Chugai Pharmaceutical
Crovalimab (RG6107) is a humanized complement inhibitor C5 monoclonal antibody discovered by Chugai using recycling antibody technology. Blocking the cleavage of C5 to C5a and C5b is expected to inhibit complement activation, which is the cause of several diseases. As the complement system is a key innate immune defense mechanism, it is planned to study the potential of this antibody in a broader range of complement-mediated diseases. Currently, the drug is in Phase III clinical developmental stage for treating aHUS. It is being investigated in two Phase III clinical trials starting in October and November 2021. Both these trials are a Phase III, multicenter, single-arm study evaluating the efficacy, safety, pharmacokinetics, and pharmacodynamics of Crovalimab in adult and adolescent patients with aHUS and are expected to be completed by March 2024 and December 2025, respectively.

• FABHALTA (iptacopan): Novartis Pharmaceuticals
Iptacopan, also known as LNP023, is a first-in-class, orally-administered, small-molecule, potent, and highly selective factor B (FB) inhibitor, a key serine protease of the alternative pathway of the complement cascade. Currently, iptacopan is in the Phase III development stage. The ongoing Phase III clinical trial is a multicenter, single-arm, open-label trial to evaluate the efficacy and safety of oral, twice-daily LNP023 in adult aHUS patients who are naive to complement inhibitor therapy and is expected to be completed by December 2024.

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Atypical Hemolytic Uremic Syndrome Market Outlook
The introduction of complement C5 inhibition into the treatment landscape has significantly improved patient prognosis and QoL. Currently available complement C5 inhibitors across the 7MM are SOLIRIS (eculizumab) and ULTOMIRIS (ravulizumab), both Alexion Pharmaceuticals products. Alexion Pharmaceuticals was acquired by AstraZeneca in 2021. The treatment transition of patients being treated with eculizumab to ravulizumab has been established as a viable treatment strategy, as this would lead to a reduction in the dosing frequency, which would then lead to a significant reduction of economic burden (treatment-related costs of repeated infusions) and improve the overall QoL of patients.

Atypical Hemolytic Uremic Syndrome Companies
Novartis Pharmaceuticals, Hoffmann-La Roche, Chugai Pharmaceutical and others.

Scope of the Atypical Hemolytic Uremic Syndrome Market Report
• Coverage- 7MM
• Study Period- 2020-2034
• Atypical Hemolytic Uremic Syndrome Companies- Novartis Pharmaceuticals, Hoffmann-La Roche, Chugai Pharmaceutical and others.
• Atypical Hemolytic Uremic Syndrome Therapies- Eculizumab, Crovalimab, Iptacopan, NM8074, Ravulizumab, 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
• Atypical Hemolytic Uremic Syndrome 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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Table of Contents
1. Key Insights
2. Atypical Hemolytic Uremic Syndrome Market Report Introduction
3. Executive Summary
4. Atypical Hemolytic Uremic Syndrome Market Overview at A Glance
5. Key Atypical Hemolytic Uremic Syndrome Events
6. Atypical Hemolytic Uremic Syndrome Epidemiology and Market Methodology
7. Atypical Hemolytic Uremic Syndrome Background and Overview
8. Atypical Hemolytic Uremic Syndrome Treatment and Management
9. Atypical Hemolytic Uremic Syndrome Epidemiology and Patient Population
10. Atypical Hemolytic Uremic Syndrome Patient Journey
11. Atypical Hemolytic Uremic Syndrome Marketed Drugs
12. Atypical Hemolytic Uremic Syndrome Discontinued Product
13. Atypical Hemolytic Uremic Syndrome Emerging Drugs
14. Atypical Hemolytic Uremic Syndrome: Seven Major Market Analysis
15. Atypical Hemolytic Uremic Syndrome Unmet Needs
16. Atypical Hemolytic Uremic Syndrome SWOT Analysis
17. Atypical Hemolytic Uremic Syndrome KOL Views
18. Atypical Hemolytic Uremic Syndrome Market Access and Reimbursement
19. Appendix
20. Delveinsight Capabilities
21. Disclaimer
22. About Delveinsight

About Us

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