Warm Autoimmune Hemolytic Anemia (WAIHA) Market Size, Epidemiology, In-Market Drugs Sales, Pipeline Therapies, and Regional Outlook 2025-2035

Market Overview: 

The warm autoimmune hemolytic anemia (WAIHA) market reached a value of USD 842.3 Million across the top 7 markets (US, EU4, UK, and Japan) in 2024. Looking forward, IMARC Group expects the top 7 major markets to reach USD 4,084.6 Million by 2035, exhibiting a growth rate (CAGR) of 15.45% during 2025-2035.

The warm autoimmune hemolytic anemia (WAIHA) market has been comprehensively analyzed in IMARC's new report titled "Warm Autoimmune Hemolytic Anemia (WAIHA) Market Size, Epidemiology, In-Market Drugs Sales, Pipeline Therapies, and Regional Outlook 2025-2035". Warm autoimmune hemolytic anemia (WAIHA) is a rare autoimmune disorder characterized by the destruction of red blood cells by the body's immune system. The symptoms of the ailment can vary depending on the severity of the condition but typically include fatigue, weakness, shortness of breath, etc. Various other indications are pallor, jaundice, rapid heartbeat, dark urine, an enlarged spleen, etc. In severe cases, WAIHA can lead to acute hemolytic crisis, characterized by the sudden onset of anemia, and can be life-threatening. The diagnosis of WAIHA usually begins with a physical exam and medical history evaluation. A complete blood count (CBC) is the first step, which can reveal a low red blood cell count (anemia) and a high number of reticulocytes (young red blood cells). Various additional blood tests may be ordered to look for antibodies that attack red blood cells and rule out other causes of anemia. Besides this, a bone marrow biopsy is also performed to help confirm the diagnosis. Numerous imaging tests, such as ultrasound and CT scan, are done to check for an enlarged spleen, which is a common complication of WAIHA.

The rising cases of variations in genes that regulate immune system function are primarily driving the warm autoimmune hemolytic anemia (WAIHA) market. In addition to this, the increasing prevalence of several triggering factors, such as viral and bacterial infections, autoimmune diseases like lupus and rheumatoid arthritis, fluctuations in hormones, etc., is also bolstering the market growth. Moreover, the escalating utilization of intravenous immunoglobulin (IVIG) treatment, which involves infusing high levels of immunoglobulin into the bloodstream to control the autoimmune response and reduce the destruction of red blood cells, is acting as another significant growth-inducing factor. Apart from this, the widespread adoption of supportive therapies, such as iron supplementation, folic acid supplementation, erythropoietin, etc., to manage the symptoms of anemia and improve the quality of life in patients is further propelling the market growth. Additionally, numerous key players are making extensive investments in R&D activities to identify several potential pathways and molecules, including the B-cell receptor (BCR) signaling pathway and complement system proteins like C1s and C5, that could be targeted to treat WAIHA. This, in turn, is also creating a positive outlook for the market. Furthermore, the emerging popularity of rituximab for targeting and eliminating B cells in patients who do not respond to or cannot tolerate corticosteroids or immunosuppressants is expected to drive the warm autoimmune hemolytic anemia (WAIHA) market in the coming years.

IMARC Group's new report provides an exhaustive analysis of the warm autoimmune hemolytic anemia (WAIHA) market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for warm autoimmune hemolytic anemia (WAIHA) and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc., have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the warm autoimmune hemolytic anemia (WAIHA) market in any manner.

Recent Developments:

• In April 2025, Sanofi announced that the U.S. FDA had granted orphan drug designation to rilzabrutinib, an investigational, novel, advanced, oral, reversible Bruton’s tyrosine kinase inhibitor, for two rare diseases, warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD).

Key Highlights:

• WAIHA is the most common form (60-70%) of autoimmune hemolytic anemia (AIHA).
• WAIHA is a rare condition affecting around 45,000 persons in the United States.
• WAIHA can affect people of any age, including children, but it is more common in adults, with a peak prevalence between 50 and 70 years.
• Depending on its causative factors, WAIHA can be classified as primary and secondary.
• Primary WAIHA is considered to be significantly less frequent than secondary WAIHA, with an estimated distribution of 35-50% of all WAIHA being primary instances.

Drugs:

M281 (Nipocalimab) is a human recombinant monoclonal IgG1 antibody that targets the neonatal Fc receptor (FcRn). In warm autoimmune hemolytic anemia (wAIHA), M281 works by binding to FcRn, which then blocks the receptor's ability to recycle immunoglobulin G (IgG) antibodies. This leads to a reduction in the overall levels of circulating IgG antibodies, including the pathogenic autoantibodies that are attacking red blood cells in wAIHA. By reducing these autoantibodies, M281 aims to decrease the destruction of red blood cells and alleviate the symptoms of anemia.

Ianalumab works to treat warm autoimmune hemolytic anemia (WAIHA) by targeting and depleting B cells through two key mechanisms: antibody-dependent cellular cytotoxicity (ADCC) and blocking B cell-activating factor receptor (BAFF-R) signaling. This dual approach aims to reduce the number of autoreactive B cells, which are responsible for producing antibodies that attack red blood cells in WAIHA, leading to anemia.

Rilzabrutinib, a reversible Bruton tyrosine kinase (BTK) inhibitor, is being investigated for warm autoimmune hemolytic anemia (WAIHA). Its mechanism involves inhibiting B-cell activation, reducing autoantibody production, and decreasing red blood cell (RBC) destruction by macrophages, ultimately aiming to increase hemoglobin levels and reduce hemolysis.

Time Period of the Study

• Base Year: 2024
• Historical Period: 2019-2024
• Market Forecast: 2025-2035

Countries Covered

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan

Analysis Covered Across Each Country

• Historical, current, and future epidemiology scenario
• Historical, current, and future performance of the warm autoimmune hemolytic anemia (WAIHA) market
• Historical, current, and future performance of various therapeutic categories in the market
• Sales of various drugs across the warm autoimmune hemolytic anemia (WAIHA) market
• Reimbursement scenario in the market
• In-market and pipeline drugs

Competitive Landscape:

This report also provides a detailed analysis of the current warm autoimmune hemolytic anemia (WAIHA) marketed drugs and late-stage pipeline drugs.

In-Market Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance

Late-Stage Pipeline Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.

Key Questions Answered in this Report:

Market Insights

• How has the warm autoimmune hemolytic anemia (WAIHA) market performed so far and how will it perform in the coming years?
• What are the markets shares of various therapeutic segments in 2024 and how are they expected to perform till 2035?
• What was the country-wise size of the warm autoimmune hemolytic anemia (WAIHA) across the seven major markets in 2024 and what will it look like in 2024?
• What is the growth rate of the warm autoimmune hemolytic anemia (WAIHA) across the seven major markets and what will be the expected growth over the next ten years?
• What are the key unmet needs in the market?

Epidemiology Insights

• What is the number of prevalent cases (2019-2035) of warm autoimmune hemolytic anemia (WAIHA) across the seven major markets?
• What is the number of prevalent cases (2019-2035) of warm autoimmune hemolytic anemia (WAIHA) by age across the seven major markets?
• What is the number of prevalent cases (2019-2035) of warm autoimmune hemolytic anemia (WAIHA) by gender across the seven major markets?
• What is the number of prevalent cases (2019-2035) of warm autoimmune hemolytic anemia (WAIHA) by type across the seven major markets?
• How many patients are diagnosed (2019-2035) with warm autoimmune hemolytic anemia (WAIHA) across the seven major markets?
• What is the size of the warm autoimmune hemolytic anemia (WAIHA) patient pool (2019-2024) across the seven major markets?
• What would be the forecasted patient pool (2025-2035) across the seven major markets?
• What are the key factors driving the epidemiological trend warm autoimmune hemolytic anemia (WAIHA) of?
• What will be the growth rate of patients across the seven major markets?

Warm Autoimmune Hemolytic Anemia (WAIHA): Current Treatment Scenario, Marketed Drugs and Emerging Therapies

• What are the current marketed drugs and what are their market performance?
• What are the key pipeline drugs and how are they expected to perform in the coming years?
• How safe are the current marketed drugs and what are their efficacies?
• How safe are the late-stage pipeline drugs and what are their efficacies?
• What are the current treatment guidelines for warm autoimmune hemolytic anemia (WAIHA) drugs across the seven major markets?
• Who are the key companies in the market and what are their market shares?
• What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the warm autoimmune hemolytic anemia (WAIHA) market?
• What are the key regulatory events related to the warm autoimmune hemolytic anemia (WAIHA) market?
• What is the structure of clinical trial landscape by status related to the warm autoimmune hemolytic anemia (WAIHA) market?
• What is the structure of clinical trial landscape by phase related to the warm autoimmune hemolytic anemia (WAIHA) market?
• What is the structure of clinical trial landscape by route of administration related to the warm autoimmune hemolytic anemia (WAIHA) market?