DelveInsight's comprehensive "Atypical Hemolytic Uremic Syndrome Market Insights, Epidemiology, and Market Forecast 2034" analysis delivers extensive understanding of Atypical Hemolytic Uremic Syndrome, historical and projected epidemiology alongside Atypical Hemolytic Uremic Syndrome therapeutics market trends across the United States, EU4 nations (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

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Major Highlights from Atypical Hemolytic Uremic Syndrome Market Analysis

• As of December 11, 2025 - Novartis Pharmaceuticals launched a study designed as a multicenter, single-arm, open label investigation to demonstrate the efficacy and safety of LNP023 (iptacopan) at a dose of 200 mg b.i.d. in adult patients diagnosed with aHUS who are treatment naive to complement inhibitor therapy (including anti-C5 antibody). The investigation 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.

• As of December 08, 2025 - Alexion Pharmaceuticals Inc. disclosed a Phase 3b study to evaluate the efficacy and safety of eculizumab in participants diagnosed with aHUS in China. The investigation will be conducted in participants of any age who weigh ≥ 5 kg and who previously have not been treated with complement inhibitors. The investigation 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 investigation 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 approximately 4,800 in 2023 which is further anticipated to increase over the forecast period.

• Among the 7MM, the United States demonstrated the highest number of prevalent cases of aHUS in 2023, nearly 3,500 cases. These cases are projected to increase by 2034.

• In 7MM, Adolescents and adults population represented approximately 80% of diagnosed cases in 2023.

• Among EU4 and the UK, Germany demonstrated the highest number of prevalent cases in 2023, while Spain recorded the least.

• Leading Atypical Hemolytic Uremic Syndrome pharmaceutical organizations include Novartis Pharmaceuticals, Hoffmann-La Roche, Chugai Pharmaceutical, among others.

• Notable Atypical Hemolytic Uremic Syndrome investigational agents include Eculizumab, Crovalimab, Iptacopan, NM8074, Ravulizumab, among others.

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Atypical Hemolytic Uremic Syndrome Disease Background

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

Atypical Hemolytic Uremic Syndrome Epidemiology Classification 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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Commercialized Atypical Hemolytic Uremic Syndrome Therapeutic Agents

ULTOMIRIS (ravulizumab): Alexion Pharmaceuticals

Ravulizumab-cwvz, a complement inhibitor, represents a humanized monoclonal antibody (mAb) produced in Chinese hamster (CHO) cells. ULTOMIRIS is indicated for managing adult and pediatric patients 1 month of age and older diagnosed with aHUS to inhibit complement-mediated thrombotic microangiopathy (TMA). During September 2020, Alexion Pharmaceuticals disclosed that Japan's MHLW had authorized ULTOMIRIS (ravulizumab) for adults and children living with aHUS.

SOLIRIS (eculizumab): Alexion Pharmaceuticals

Eculizumab, a complement inhibitor, represents 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 managing patients diagnosed with aHUS to inhibit complement-mediated thrombotic microangiopathy. Both authorized 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 elevated risk of serious meningococcal infections, ULTOMIRIS and SOLIRIS are available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).

Investigational Atypical Hemolytic Uremic Syndrome Therapeutic Agents

Crovalimab (RG6107; SKY59): Hoffmann-La Roche/Chugai Pharmaceutical

Crovalimab (RG6107) represents a humanized complement inhibitor C5 monoclonal antibody discovered by Chugai using recycling antibody technology. Blocking the cleavage of C5 to C5a and C5b is anticipated to inhibit complement activation, which is the cause of several diseases. As the complement system represents 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, this drug is in Phase III clinical developmental stage for managing aHUS. It is under investigation in two Phase III clinical trials starting in October and November 2021. Both these trials represent Phase III, multicenter, single-arm studies evaluating the efficacy, safety, pharmacokinetics, and pharmacodynamics of Crovalimab in adult and adolescent patients diagnosed with aHUS and are anticipated to be completed by March 2024 and December 2025, respectively.

FABHALTA (iptacopan): Novartis Pharmaceuticals

Iptacopan, also designated as LNP023, represents 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 Phase III development stage. The ongoing Phase III clinical investigation represents 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 anticipated to be completed by December 2024.

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Atypical Hemolytic Uremic Syndrome Market Perspective

The introduction of complement C5 inhibition into the treatment landscape has substantially improved patient prognosis and quality of life. Currently available complement C5 inhibitors across the 7MM include 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 result in a reduction in dosing frequency, which would then produce a significant reduction of economic burden (treatment-related costs of repeated infusions) and improve the overall quality of life of patients.

Atypical Hemolytic Uremic Syndrome Pharmaceutical Organizations

Novartis Pharmaceuticals, Hoffmann-La Roche, Chugai Pharmaceutical, among others.

Coverage of the Atypical Hemolytic Uremic Syndrome Market Analysis

• Coverage: 7MM

• Analysis Period: 2020-2034

• Atypical Hemolytic Uremic Syndrome Pharmaceutical Organizations: Novartis Pharmaceuticals, Hoffmann-La Roche, Chugai Pharmaceutical, among others.

• Atypical Hemolytic Uremic Syndrome Therapeutic Agents: Eculizumab, Crovalimab, Iptacopan, NM8074, Ravulizumab, among others.

• Atypical Hemolytic Uremic Syndrome Therapeutic Evaluation: Atypical Hemolytic Uremic Syndrome current commercialized and Atypical Hemolytic Uremic Syndrome investigational therapies

• Atypical Hemolytic Uremic Syndrome Market Dynamics: Atypical Hemolytic Uremic Syndrome market growth factors and Atypical Hemolytic Uremic Syndrome market obstacles

• Atypical Hemolytic Uremic Syndrome Competitive Intelligence Evaluation: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry methodologies

• Atypical Hemolytic Uremic Syndrome Unmet Requirements, KOL perspectives, Analyst perspectives, Atypical Hemolytic Uremic Syndrome Market Access and Reimbursement

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Report Structure

1. Key Insights

2. Atypical Hemolytic Uremic Syndrome Market Analysis 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 DelveInsight

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