warm auoimmune hemolytic anemia waiha epidemiology insights

Key Highlights

• wAIHA is the most common type of autoimmune hemolytic anemia. People of any age, including children, may develop wAIHA, but it is more common among adults, with a peak incidence between 50 and 70 years. The median age at onset is 52 years.
• As per the secondary research, the prevalence of wAIHA is 1 per 8,000, and accounts for 70–75% of the total AIHA cases.
• wAIHA is possibly slightly more common in women compared to men.
• As per secondary research, approximately half of the cases of wAIHA are primary (idiopathic), while the other half are secondary to an underlying condition, frequently chronic lymphocytic leukemia, or an autoimmune systemic disease such as systemic lupus erythematosus.
• In 2023, the total diagnosed prevalent cases of wAIHA in Japan were around 1,300 cases, and these cases are expected to increase during the forecast period.

 

Key Factors Driving Warm Autoimmune Hemolytic Anemia (WAIHA) Market 

Rising Burden of wAIHA

In 2023, the total market size of wAIHA in the 7MM was approximately USD 300 million. wAIHA accounts for nearly 70–80% of all adult autoimmune hemolytic anemia cases and about 50% of pediatric cases. While it can develop at any age, the median onset is 52 years, and the incidence is expected to grow, adding to the disease burden.

Standard of Care Limitations

Corticosteroids remain the first-line therapy, but many patients relapse or develop resistance, requiring additional interventions such as splenectomy, rituximab, or immunosuppressive agents like azathioprine, cyclophosphamide, and mycophenolate mofetil. Despite their use, treatment durability is limited, adverse effects are significant, and refractory cases remain a major challenge.

Unmet Need for Novel Therapies

There are currently no approved therapies for wAIHA, highlighting a large unmet need. The lack of licensed treatments creates significant market opportunities, as innovative agents that provide durable responses and improved safety profiles could quickly gain traction in this underserved space.

Expanding Pipeline of Targeted Therapies

Novel treatment strategies are emerging, focusing on B-cell/plasma-cell depletion, complement inhibition, and neonatal Fc receptor (FcRn) blockade to reduce pathogenic autoantibodies. Pipeline candidates such as Obexelimab (ZB012; Zenas BioPharma), Ianalumab (Novartis/MorphoSys), Nipocalimab (M281; Johnson & Johnson Innovative Medicine), Povetacicept (Alpine Immune Sciences), and others aim to address relapsed/refractory cases and expand therapeutic options.

Launch of Emerging wAIHA Drugs

Among the most notable developments, rilzabrutinib (Novartis/MorphoSys), an oral BTK inhibitor, is advancing in clinical development for immune-mediated diseases and could play a pivotal role in reshaping the wAIHA treatment landscape. These upcoming therapies are anticipated to diversify the therapeutic armamentarium and meet the significant unmet needs of patients with refractory or severe wAIHA.

 

DelveInsight’s “Warm Autoimmune Hemolytic Anemia (wAIHA) – Epidemiology – 2034” report delivers an in-depth understanding of wAIHA, historical and forecasted epidemiology of wAIHA in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2021-2034

Warm Autoimmune Hemolytic Anemia (wAIHA) Disease Understanding

wAIHA Overview

Warm autoimmune hemolytic anemia (wAIHA) is a type of autoimmune disorder characterized by the destruction of red blood cells (hemolysis) due to the body's immune system mistakenly targeting its red blood cells. In wAIHA, the antibodies produced by the immune system bind to red blood cells at body temperature (hence "warm") and mark them for destruction by the spleen and other organs. This leads to a decrease in the number of circulating red blood cells, resulting in anemia. Symptoms of wAIHA can vary but often include fatigue, weakness, pallor, shortness of breath, and jaundice (yellowing of the skin and eyes). The condition can be primary (idiopathic) or secondary to underlying conditions such as autoimmune diseases, infections, lymphoproliferative disorders, or certain medications.

 

wAIHA Diagnosis

Diagnosing wAIHA involves several steps to confirm the presence of hemolysis (destruction of red blood cells) and to identify the underlying cause. Initially, a complete blood count (CBC) is conducted to assess hemoglobin levels, red blood cell count, and other parameters indicative of anemia. Peripheral blood smear examination may reveal signs of hemolysis, such as red blood cell destruction and the presence of spherocytes (abnormally shaped red blood cells). Direct antiglobulin test (DAT), also known as the Coombs test, is performed to detect antibodies or complement proteins bound to the surface of red blood cells. A positive DAT result confirms the presence of autoimmune-mediated hemolysis. Further tests, including serum protein electrophoresis, autoimmune serology, and bone marrow examination, may be conducted to identify underlying conditions associated with wAIHA, such as autoimmune diseases, infections, or malignancies. Overall, a combination of clinical findings and laboratory tests is crucial for the accurate diagnosis of wAIHA.

Further details related to diagnosis are provided in the report…

Warm Autoimmune Hemolytic Anemia (wAIHA) Epidemiology

The wAIHA epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the total diagnosed prevalent cases of autoimmune hemolytic anemia, total prevalent cases of wAIHA, type-specific cases of wAIHA, gender-specific cases of wAIHA, and age-specific cases of wAIHA in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2021 to 2034.

• Among the 7MM, the US accounted for the highest prevalent cases of wAIHA in 2023, with around 42,000 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% of 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 years age group, accounting for over 64% of total cases in 2023.

KOL Views

To keep up with current epidemiology trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts contacted for insights on the wAIHA evolving epidemiology landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Hematologists, Rheumatologist, Hematology-Oncology Specialist, and others.

 

DelveInsight’s analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as the University of California Los Angeles Medical Center, Professor of Massachusetts General Hospital, MD, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), etc., were contacted. Their opinion helps understand and validate the epidemiology trend in different geographies.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of wAIHA, explaining its causes, signs and symptoms, pathogenesis, and diagnosis.
• Comprehensive insight into the epidemiology segments and forecasts and disease progression has been provided.
• The report provides an edge while developing business strategies, understanding trends, expert insights/KOL views, and patient journeys in the s.
• A detailed review of current challenges in establishing the diagnosis.

Warm Autoimmune Hemolytic Anemia (wAIHA) Report Insights

• Patient Population
• Country-wise Epidemiology Distribution
• Age-wise cases of wAIHA

Warm Autoimmune Hemolytic Anemia (wAIHA) Report Key Strengths

• Eleven Years Forecast
• The 7MM Coverage
• wAIHA Epidemiology Segmentation

Warm Autoimmune Hemolytic Anemia (wAIHA) Report Assessment

• Current Diagnostic Practices

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of wAIHA? What will be the growth opportunities across the 7MM concerning the patient population with wAIHA?
• What is the historical and forecasted wAIHA patient pool in the United States, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan?
• Which age group of wAIHA has a high patient share?

Reasons to Buy

• Insights on patient burden/disease, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the age-specific wAIHA prevalence cases in varying geographies over the coming years.
• To understand the perspective of key opinion leaders around the current challenges with establishing the diagnosis and insights on the treatment-eligible patient pool.
• Detailed insights on various factors hampering disease diagnosis and other existing diagnostic challenges.