Warm autoimmune hemolytic anemia Market: Epidemiology, Therapies, Companies, DelveInsight | Rigel Pharmaceuticals, Apellis Pharmaceuticals, Inc., Johnson & Johnson, Sanofi, Incyte Corporation, Annexon

Warm autoimmune hemolytic anemia emerging therapies, such as Obexelimab (ZB012), Nipocalimab (M281), and others, are expected to boost the Warm autoimmune hemolytic anemia Market in the upcoming years.

DelveInsight has launched a new report on "Warm autoimmune hemolytic anemia - Market Insights, Epidemiology, and Market Forecast-2034" that delivers an in-depth understanding of the Warm autoimmune hemolytic anemia, historical and forecasted epidemiology as well as the Warm autoimmune hemolytic anemia 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 Warm autoimmune hemolytic anemia Market Report:
In 2023, the total market size for warm autoimmune hemolytic anemia (wAIHA) across the seven major markets (7MM) was approximately USD 300 million. wAIHA is the most prevalent form of autoimmune hemolytic anemia, accounting for about 70-80% of adult cases and 50% of pediatric cases. Although it can develop at any age, the median age of onset is 52 years.
The primary treatment for wAIHA is corticosteroids, which remain the mainstay therapy. When corticosteroids fail, splenectomy is considered as an alternative option. Rituximab has emerged as an effective treatment for cases resistant to traditional therapies. Additionally, immunosuppressive drugs such as azathioprine, cyclophosphamide, and mycophenolate mofetil are often used as adjunctive treatments, particularly in chronic, severe, and refractory cases.
For patients with refractory or relapsed disease, multiple sequential lines of therapy are employed. Despite existing treatments, managing AIHA remains challenging, emphasizing the need for ongoing research into new therapeutic options.
There is a pressing demand for innovative targeted therapies that address the underlying mechanisms of wAIHA, as no treatment has yet received formal approval specifically for this disease. Promising new therapies include agents targeting B-cells and plasma cells, complement inhibitors, and drugs that eliminate harmful autoantibodies through neonatal Fc receptor blockade.
Novel agents such as Obexelimab, Ianalumab, Nipocalimab, Rilzabrutinib, and Povetacicept are expected to expand the treatment landscape and potentially address the needs of patients who relapse after or do not respond to rituximab. These new targeted treatments may also provide critical options for patients with very acute or severe disease.
Since there are currently no approved therapies for wAIHA, the market holds significant potential. Existing treatments are limited by diminishing effectiveness over time and side effects that contribute to patient burden. New drugs gaining approval for this indication could capture a substantial market share due to limited competition and high unmet medical need.
In 2023, the United States had the highest number of autoimmune hemolytic anemia cases among the seven major markets (7MM), with approximately 57,000 prevalent cases, and this number is projected to grow over the forecast period. Regarding gender-specific prevalence of wAIHA, females represent the majority, accounting for about 60% of cases in 2023. This female predominance is expected to continue, with case numbers increasing by 2034 in the US.
Rituximab remains the most widely used and effective treatment in the wAIHA market. Among emerging therapies, rilzabrutinib-an oral BTK inhibitor developed by Novartis and MorphoSys-stands out as a promising option tailored for immune-mediated diseases in this setting.
In April 2025, the U.S. FDA granted orphan drug designation to rilzabrutinib, an investigational oral Bruton's tyrosine kinase (BTK) inhibitor, for the treatment of wAIHA. This designation underscores the potential of rilzabrutinib to address the unmet medical needs in this rare autoimmune disorder.
In March 2025, Johnson & Johnson received Fast Track designation from the FDA for nipocalimab (IMAAVYTM), an FcRn blocker, for the treatment of wAIHA. This designation aims to expedite the development and review of nipocalimab, reflecting its potential to address serious or life-threatening conditions.

Key Warm autoimmune hemolytic anemia companies such as Rigel Pharmaceuticals, Apellis Pharmaceuticals, Inc., Johnson & Johnson, Sanofi, Incyte Corporation, Annexon, and others are evaluating new drugs for Warm autoimmune hemolytic anemia to improve the treatment landscape.
Promising Warm autoimmune hemolytic anemia therapies include Obexelimab (ZB012), Nipocalimab (M281), and others.

Warm autoimmune hemolytic anemia Overview

Warm autoimmune hemolytic anemia (wAIHA) is an autoimmune disorder in which the body's immune system mistakenly attacks and destroys its own red blood cells. In this condition, antibodies bind to red blood cells at normal body temperature ("warm"), signaling their removal by the spleen and other organs. This destruction reduces the number of circulating red blood cells, causing anemia. Common symptoms include fatigue, weakness, pale skin, shortness of breath, and jaundice (yellowing of the skin and eyes). wAIHA can occur as a primary (idiopathic) disorder or secondary to other conditions like autoimmune diseases, infections, lymphoproliferative disorders, or certain medications. Diagnosis is made through blood tests, and treatment generally involves immunosuppressive drugs to control the immune system and relieve symptoms.

Warm autoimmune hemolytic anemia Market Outlook

Corticosteroids are the most commonly used and fundamental treatment for Warm Autoimmune Hemolytic Anemia (wAIHA). When corticosteroids are ineffective, splenectomy may be considered as an alternative. Rituximab has emerged as a treatment option for refractory cases, while immunosuppressive agents can be beneficial in managing chronic, severe, and treatment-resistant cases.

Although glucocorticoids are the standard first-line therapy for wAIHA, this approach was initially based on empirical evidence. Their mechanisms include suppressing autoantibody production, lowering autoantibody affinity, and reducing the destruction of red blood cells by splenic macrophages, possibly through decreased Fcγ receptor expression. Rituximab, an anti-CD20 antibody, is typically reserved for severe cases or situations where long-term corticosteroid use is undesirable. While rituximab is traditionally viewed as a second-line treatment, combining it with low-dose prednisone (100 mg once weekly for four weeks) is increasingly being adopted as a first-line approach. Following the introduction of rituximab, drugs like azathioprine, cyclophosphamide, cyclosporine, and intravenous immunoglobulin have become second- or third-line therapies.

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Warm autoimmune hemolytic anemia Emerging Drugs
Obexelimab (ZB012): Zenas BioPharma
Nipocalimab (M281): Johnson & Johnson Innovative Medicine

Scope of the Warm autoimmune hemolytic anemia Market Report
Study Period: 2020-2034
Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Key Warm autoimmune hemolytic anemia Companies: Rigel Pharmaceuticals, Apellis Pharmaceuticals, Inc., Johnson & Johnson, Sanofi, Incyte Corporation, Annexon, and others
Key Warm autoimmune hemolytic anemia Therapies: Obexelimab (ZB012), Nipocalimab (M281), and others
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

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Key benefits of the Warm autoimmune hemolytic anemia Market Report:
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).
The Warm autoimmune hemolytic anemia market report provides insights into the current and emerging therapies.
The Warm autoimmune hemolytic anemia market report provides a global historical and forecasted market covering drug outreach in 7MM.
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.

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About DelveInsight

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