The global warm autoimmune hemolytic anemia (WAIHA) market size is estimated to be valued at USD 4.98 Billion in 2025. It is forecasted to reach a valuation of USD 7.24 Billion by 2032, exhibiting a CAGR of 5.5% throughout the forecast period (2025-2032).
WAIHA is a rare blood disorder that destroys healthy red blood cells. The use of monoclonal antibodies (mAb) and corticosteroids for the treatment of WAIHA can drive the market growth significantly. Moreover, the prevalence of the disorders in females above the age of 65 can fuel research initiatives in the market over the forecast period.
However, thrombotic complications associated with the disorder can restrict the market growth.
Key Market Insights
The warm autoimmune hemolytic anemia (WAIHA) market is anticipated to be shaped by immune therapies and precision medicine.
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Warm Autoimmune Hemolytic Anemia (WAIHA) Market Report Coverage
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Report Coverage |
Details |
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Market Revenue in 2025 |
USD 4.98 Billion |
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Estimated Value by 2032 |
USD 7.24 Billion |
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Growth Rate |
5.5% |
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Historical Data |
2020–2024 |
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Forecast Period |
2025–2032 |
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Forecast Units |
Value (USD billion) |
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Report Coverage |
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends |
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Segments Covered |
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Geographies Covered |
North America (U.S. and Canada), Latin America (Brazil, Argentina, Mexico, and Rest of Latin America), Europe (Italy, Spain, U.K., Germany, France, Russia, and Rest of Europe), Asia Pacific (China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific), Middle East (GCC Countries, Israel, and Rest of Middle East), and Africa (South Africa, North Africa, and Central Africa) |
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Growth Drivers |
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Opportunities |
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Trends |
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Restraints & Challenges |
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Market Dynamics
The use of complement inhibitors like pegcetacoplan for improving hemoglobin levels can drive the market growth significantly. The use of these drugs to curb intravascular and extravascular hemolysis can drive the demand for disease-modifying therapies.
Targeted therapies centering on the neonatal Fc receptor (FcRn) for reducing immunoglobulin (IgG) levels without compromising the immune system can bolster the market growth. The approval of Nipocalimab (manufactured by Johnson & Johnson) by the U.S. FDA as an Orphan Drug highlights the demand for less invasive and effective treatments. Furthermore, the need for additional research for maintaining immune functions without the dependence on blood transfusions can pave the way for new treatments.
Market Opportunity: BTK Inhibitors
Bruton’s tyrosine kinase (BTK) inhibitors and their development show effective potential in treatment of the disorder. According to a multicenter, open-label Phase 2b study published in Ash Publications in November 2024, rilzabrutinib, a BTK inhibitor, achieved a hemoglobin response rate in more than 60% of the patients. The ability of the drug to suppress antibody-producing B cells and reduce the destruction of red blood cells can drive the market growth. A commercial strategy for providing access to the drug and its coverage by prominent insurance providers can be lucrative to the warm autoimmune hemolytic anemia (WAIHA) market.
Market Challenge: Significant Knowledge Gap about the Disorder
The lack of pathophysiologic understanding and clinical awareness of the autoimmune blood disorder can pose a major challenge to the market growth. The scientific ambiguity of symptoms and their unavailability in large patient cohorts can lead to ineffective treatments. Furthermore, a clear outline of guidelines on the treatment of the disorder can limit the market growth.
Analyst’s View
Recent Developments
Sanofi gained approval for Rilzabrutinib, an oral Bruton’s tyrosine kinase (BTK) inhibitor, from the U.S. Food & Drug Administration (FDA) on April 03, 2025. The drug was granted an Orphan Drug designation due to showing improvements in curbing disease flare and treatment outcomes.
Competitor Insights
Market Segmentation
Regional Insights
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