Warm Autoimmune Hemolytic Anemia Market: Insights into Epidemiology, Treatment Options, and Key Players | DelveInsight | Rigel Pharmaceuticals, Apellis Pharmaceuticals, Inc., Johnson & Johnson, Sanofi

In 2023, in the 7MM the total wAIHA market size was ~ USD 300 million.

Emerging therapies for Warm Autoimmune Hemolytic Anemia, including Obexelimab (ZB012), Nipocalimab (M281), and others, are expected to drive significant growth in the market in the coming years.

DelveInsight has released a new report, "Warm Autoimmune Hemolytic Anemia - Market Insights, Epidemiology, and Market Forecast-2034", providing comprehensive insights into the disease, historical and projected epidemiology, and market trends across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

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Some of the key facts of the Warm autoimmune hemolytic anemia Market Report:

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In 2023, the global warm autoimmune hemolytic anemia (wAIHA) market across the seven major markets (7MM) was estimated at approximately USD 300 million. wAIHA is the most common form of autoimmune hemolytic anemia, accounting for around 70-80% of adult cases and 50% of pediatric cases. Although it can arise at any age, the median onset age is 52 years.

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Corticosteroids remain the first-line therapy for wAIHA, with splenectomy considered for patients who do not respond. Rituximab has proven effective in resistant cases, while immunosuppressive drugs such as azathioprine, cyclophosphamide, and mycophenolate mofetil are frequently used as adjunct therapies, particularly in chronic, severe, or refractory cases. Patients with relapsed or refractory disease often undergo multiple sequential lines of treatment. Despite these options, managing wAIHA remains challenging, highlighting the need for new therapies.

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There is a strong demand for targeted therapies addressing the underlying mechanisms of wAIHA, as no therapy is currently formally approved specifically for this condition. Promising candidates include B-cell and plasma cell-targeting agents, complement inhibitors, and drugs that remove harmful autoantibodies via neonatal Fc receptor blockade. Novel therapies such as Obexelimab, Ianalumab, Nipocalimab, Rilzabrutinib, and Povetacicept are anticipated to expand treatment options, especially for patients who relapse after or do not respond to rituximab, or for those with severe or acute disease.

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Given the lack of approved therapies, the wAIHA market offers significant growth opportunities. Current treatments are limited by reduced efficacy over time and side effects, creating a high unmet medical need. New drug approvals could capture substantial market share due to limited competition.

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In 2023, the United States recorded the highest number of autoimmune hemolytic anemia cases among the 7MM, with roughly 57,000 prevalent cases, a number expected to rise over the forecast period. Females represent approximately 60% of cases in 2023, and this female predominance is projected to continue through 2034.

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Rituximab continues to be the most widely used therapy. Among emerging options, rilzabrutinib, an oral BTK inhibitor by Novartis and MorphoSys, shows promise. In April 2025, the FDA granted orphan drug designation to rilzabrutinib for wAIHA. Additionally, in March 2025, Johnson & Johnson received Fast Track designation for nipocalimab (IMAAVY Trademark ), an FcRn blocker, to accelerate its development for serious or life-threatening cases.

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Major companies such as Rigel Pharmaceuticals, Apellis Pharmaceuticals, Inc., Johnson & Johnson, Sanofi, Incyte Corporation, Annexon, and others are actively developing new therapies to improve the wAIHA treatment landscape. Emerging therapies include Obexelimab (ZB012), Nipocalimab (M281), and other investigational agents.

Warm autoimmune hemolytic anemia Overview

Warm autoimmune hemolytic anemia (wAIHA) is an autoimmune condition in which the body's immune system erroneously targets and destroys its own red blood cells. In this disorder, antibodies attach to red blood cells at normal body temperature ("warm"), marking them for removal by the spleen and other organs. The destruction of these cells leads to anemia, resulting in symptoms such as fatigue, weakness, pale skin, shortness of breath, and jaundice (yellowing of the skin and eyes).

wAIHA can arise as a primary (idiopathic) condition or develop secondary to other disorders, including autoimmune diseases, infections, lymphoproliferative disorders, or as a side effect of certain medications. Diagnosis is typically made through blood tests, and treatment generally involves immunosuppressive therapies to modulate the immune response and manage symptoms.

Warm autoimmune hemolytic anemia Market Outlook

Corticosteroids remain the primary and most widely used treatment for Warm Autoimmune Hemolytic Anemia (wAIHA). When patients do not respond to corticosteroids, splenectomy may be considered as an alternative. Rituximab has become a key option for refractory cases, while other immunosuppressive agents are used to manage chronic, severe, or treatment-resistant disease.

Although glucocorticoids are the standard first-line therapy, their use was initially guided by empirical evidence. They work by suppressing autoantibody production, reducing autoantibody affinity, and limiting red blood cell destruction by splenic macrophages, potentially through decreased Fc receptor expression. Rituximab, an anti-CD20 antibody, is generally reserved for severe cases or situations where long-term corticosteroid use is undesirable. While traditionally considered a second-line therapy, combining rituximab with low-dose prednisone (100 mg weekly for four weeks) is increasingly being adopted as a first-line strategy. Following the introduction of rituximab, medications such as azathioprine, cyclophosphamide, cyclosporine, and intravenous immunoglobulin (IVIG) are now frequently employed as second- or third-line treatments.

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Warm autoimmune hemolytic anemia Emerging Drugs

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Obexelimab (ZB012): Zenas BioPharma

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Nipocalimab (M281): Johnson & Johnson Innovative Medicine

Scope of the Warm autoimmune hemolytic anemia Market Report

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Study Period: 2020-2034

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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

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Key Warm autoimmune hemolytic anemia Companies: Rigel Pharmaceuticals, Apellis Pharmaceuticals, Inc., Johnson & Johnson, Sanofi, Incyte Corporation, Annexon, and others

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Key Warm autoimmune hemolytic anemia Therapies: Obexelimab (ZB012), Nipocalimab (M281), and others

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Warm autoimmune hemolytic anemia Therapeutic Assessment: Warm autoimmune hemolytic anemia current marketed and Warm autoimmune hemolytic anemia emerging therapies

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Warm autoimmune hemolytic anemia Market Dynamics: Warm autoimmune hemolytic anemia market drivers and Warm autoimmune hemolytic anemia market barriers

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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies

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Warm autoimmune hemolytic anemia Unmet Needs, KOL's views, Analyst's views, Warm autoimmune hemolytic anemia Market Access and Reimbursement

To know what's more in our Warm autoimmune hemolytic anemia report, visit https://www.delveinsight.com/report-store/warm-autoimmune-hemolytic-anemia-waiha-market?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr

Key benefits of the Warm autoimmune hemolytic anemia Market Report:

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Warm autoimmune hemolytic anemia market report covers a descriptive overview and comprehensive insight of the Warm autoimmune hemolytic anemia Epidemiology and Warm autoimmune hemolytic anemia market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).

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The Warm autoimmune hemolytic anemia market report provides insights into the current and emerging therapies.

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The Warm autoimmune hemolytic anemia market report provides a global historical and forecasted market covering drug outreach in 7MM.

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The Warm autoimmune hemolytic anemia market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Warm autoimmune hemolytic anemia market.

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Table of Contents

1. Report Introduction

2. Executive Summary

3. SWOT analysis

4. Warm autoimmune hemolytic anemia Patient Share (%) Overview at a Glance

5. Warm autoimmune hemolytic anemia Market Overview at a Glance

6. Warm autoimmune hemolytic anemia Disease Background and Overview

7. Warm autoimmune hemolytic anemia Epidemiology and Patient Population

8. Country-Specific Patient Population of Warm autoimmune hemolytic anemia

9. Warm autoimmune hemolytic anemia Current Treatment and Medical Practices

10. Unmet Needs

11. Warm autoimmune hemolytic anemia Emerging Therapies

12. Warm autoimmune hemolytic anemia Market Outlook

13. Country-Wise Warm autoimmune hemolytic anemia Market Analysis (2020-2034)

14. Market Access and Reimbursement of Therapies

15. Market drivers

16. Market barriers

17. Appendix

18. Warm autoimmune hemolytic anemia Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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Related Reports:

Warm autoimmune hemolytic anemia Pipeline Insights, DelveInsight

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

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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