DelveInsight’s “Warm Autoimmune Hemolytic Anemia Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of the Warm Autoimmune Hemolytic Anemia, historical and forecasted epidemiology and the Warm Autoimmune Hemolytic Anemia 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 the Warm Autoimmune Hemolytic Anemia Market Report

• On January 27, 2026- Incyte Corporation initiated a study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.
• On January 16, 2026- Janssen Research & Development LLC announced a study consists of a 24-week double-blind, placebo control period, a 144-week open-label extension period and follow-up period of 8 weeks after last study drug administration. Eligible participants will be randomized to placebo or nipocalimab (2 dose levels) during the double-blind period and nipocalimab (2 dose levels) during the open-label extension period.
• On January 15, 2026- Novartis Pharmaceuticals conducted a study is to evaluate efficacy and safety of ianalumab compared to placebo in patients with warm autoimmune hemolytic anemia, who failed at least one line of treatment. The primary objective is to demonstrate that either dose of ianalumab induces a durable hemoglobin response compared to placebo in patients with wAIHA. The study consists of the treatment period, efficacy and safety follow-up periods. The visit frequency will be every other week during the treatment and primary endpoint follow up period; for safety monitoring monthly during the first 20 weeks after last dose and afterwards quarterly up to 2 years from the last dose. For participants in durable response, additional visits for efficacy will occur monthly during the first 2 years after the last dose, and afterwards quarterly until loss of response or end of study, latest until up to 39 months post randomization of the last participant.
• Among the 7MM, the US accounted for the highest prevalent cases of autoimmune hemolytic anemia in 2023, with around 57,000 cases; these cases are expected to increase during the forecast period.
• Among gender-specific prevalent cases of wAIHA, females stand out as major contributors. In 2023, Females accounted for up to 60% cases of wAIHA. These cases are anticipated to increase by 2034 in the US.
• Amongst EU4 and the UK, the total prevalent cases of wAIHA were highest in Germany, while the lowest number of cases were in Spain in 2023.
• According to the estimates, in Japan, it is observed that wAIHA was most prevalent in the =65 year’s age group, accounting for over 64% of total cases in 2023.
• The leading Warm Autoimmune Hemolytic AnemiaCompanies such as Rigel Pharmaceuticals, Apellis Pharmaceuticals, Inc., Johnson & Johnson, Sanofi, Incyte Corporation, Annexon and others.
• Promising Warm Autoimmune Hemolytic Anemia Therapies such as INCA000585, Povetacicept, Ianalumab, APL-2, Fostamatinib Disodium, ANX005, Fostamatinib 150 mg bid, Rilzabrutinib, HMPL-523(300mg PO QD) and others.

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Warm Autoimmune Hemolytic Anemia Epidemiology Segmentation in the 7MM

• Total diagnosed prevalent cases of autoimmune hemolytic anemia
• Total prevalent cases of wAIHA
• Type-specific cases of wAIHA
• Gender-specific cases of wAIHA
• Age-specific cases of wAIHA

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Warm Autoimmune Hemolytic Anemia Treatment Landscape

The treatment of warm autoimmune hemolytic anemia (wAIHA) aims to suppress the autoimmune response, alleviate symptoms, and manage complications. Corticosteroids, such as prednisone, are often the first-line therapy, as they help suppress the immune system’s abnormal activity and reduce red blood cell destruction. In cases where corticosteroids are ineffective or poorly tolerated, other immunosuppressive medications may be used, including azathioprine, rituximab, mycophenolate mofetil, or cyclophosphamide. Intravenous immunoglobulin (IVIG) therapy may also be considered for rapid symptom relief in severe cases. In some instances, splenectomy (surgical removal of the spleen) may be recommended, particularly if other treatments fail or are contraindicated. However, splenectomy carries risks and is generally reserved for refractory cases. Additionally, supportive care measures, such as blood transfusions to alleviate severe anemia and folic acid supplementation to support red blood cell production, may be necessary. Long-term management involves monitoring for disease activity, adjusting treatment as needed, and addressing any underlying conditions contributing to wAIHA. Collaboration with hematologists and rheumatologists is essential to develop individualized treatment plans and optimize outcomes for patients with wAIHA.

Warm Autoimmune Hemolytic Anemia Emerging Therapies

• Obexelimab (ZB012): Zenas BioPharma

Obexelimab is a novel bifunctional antibody with first-in-class potential that inhibits B-cell lineages that express CD19. Simultaneous binding to CD19 and Fc?RIIB by obexelimab mimics a naturalantigen–antibody complex and downregulates B-cell activity. In early-stage clinical studies, obexelimab effectively demonstrated inhibition of B-cell function without depleting the cells and generated an encouraging treatment effect in patients with multiple autoimmune diseases. Currently, the drug is being evaluated in Phase III (SApHiAre trial) clinical stage of development.

• Nipocalimab (M281): Johnson & Johnson Innovative Medicine

Nipocalimab is a fully human monoclonal antibody that targets the neonatal crystallizable fragment receptor (FcRn) with potential immunomodulating activity. Upon administration, nipocalimab targets and binds to FcRn at the IgG binding site, thereby preventing the interaction between FcRn and the serum protein IgG. By preventing FcRn/IgG binding, nipocalimab blocks the FcRn-mediated rescue of IgG, enables IgG degradation, and prevents IgG-mediated inflammation. Nipocalimab was granted FTD for wAIHA in July 2019 and ODD in December 2019. Currently, the drug is being evaluated in Phase II/III (NCT04119050) clinical stage of development.

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Warm Autoimmune Hemolytic Anemia Companies

Rigel Pharmaceuticals, Apellis Pharmaceuticals, Inc., Johnson & Johnson, Sanofi, Incyte Corporation, Annexon and others.

Warm Autoimmune Hemolytic Anemia Market Outlook

The most common therapy and the cornerstone of treatment for Warm Autoimmune Hemolytic Anemia are corticosteroids. If these are ineffective, a splenectomy can be considered. Rituximab has become an option in refractory disease, and the use of immunosuppressors can be helpful in chronic severe refractory cases. While glucocorticoids are considered the first-line treatment in WAIHA, this was empirically derived. Mechanisms of actions include suppression of autoantibody production, reduction in autoantibody affinity, and decreased destruction of erythrocytes by splenic macrophages, perhaps by diminished expression of Fc? receptors. Rituximab is used in diagnosed severe cases or in cases where long-term corticosteroids should be avoided. Although rituximab (an anti-CD20 antibody) is considered a second-line treatment, the combination of rituximab and prednisone at relatively low doses (100 mg once weekly, four times) is increasingly becoming a first-line treatment. With the advent of rituximab, azathioprine, cyclophosphamide, cyclosporine, and intravenous immunoglobulin became second or third-line treatments.

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Scope of the Warm Autoimmune Hemolytic Anemia Market Report

• Coverage- 7MM
• Study Period- 2020-2034
• Warm Autoimmune Hemolytic Anemia Companies- Rigel Pharmaceuticals, Apellis Pharmaceuticals, Inc., Johnson & Johnson, Sanofi, Incyte Corporation, Annexon and others.
• Warm Autoimmune Hemolytic Anemia Therapies-
• Warm Autoimmune Hemolytic Anemia Therapeutic Assessment: Warm Autoimmune Hemolytic Anemia Current marketed and Warm Autoimmune Hemolytic Anemia Emerging Therapies
• Warm Autoimmune Hemolytic Anemia Market Dynamics: Warm Autoimmune Hemolytic Anemia market drivers and Warm Autoimmune Hemolytic Anemia market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
• Warm Autoimmune Hemolytic Anemia Unmet Needs, KOL’s views, Analyst’s views, Warm Autoimmune Hemolytic Anemia Market Access and Reimbursement

Table of Contents

1 Key Insights

2 Report Introduction

3 PNH Market Overview at a Glance

4 Epidemiology and Market Forecast Methodology

5 Executive Summary of PNH

6 Key Events

7 Disease Background and Overview

8 Treatment and Management

9 Epidemiology and Patient Population

10 Patient Journey

11 Marketed Therapies

12 Emerging Therapies

13 PNH: 7 Major Market Analysis

14 KOL Views

15 SWOT Analysis

16 Unmet Needs

17 Reimbursement Scenario in PNH

18 Appendix

19 DelveInsight Capabilities

20 Disclaimer

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