The Acquired (Autoimmune) Hemolytic Anemia Market is expected to reach USD 1,016 million by 2032 due to improving diagnostic capabilities and emerging targeted therapies

The global acquired (autoimmune) hemolytic anemia market size was evaluated at $752 million in 2023 and is slated to hit $1,016 million by the end of 2032 with a CAGR of nearly 7% between 2024 and 2032.

Acquired hemolytic anemia is a condition where red blood cells are destroyed faster than the body can replace them because the immune system attacks them by mistake. This damage happens when antibodies attach to red blood cells and signal organs such as the spleen to remove them. Unlike inherited types, acquired hemolytic anemia develops later in life due to infections, medicines, autoimmune disorders, or certain cancers. The condition appears in two main forms: warm antibody hemolytic anemia, which occurs at normal body temperature, and cold antibody hemolytic anemia, which becomes active in cooler conditions. Common symptoms include tiredness, pale skin, yellowing of the eyes or skin, dark urine, shortness of breath, and a fast heartbeat. Doctors confirm the diagnosis through blood tests that measure hemoglobin, reticulocytes, and antibodies. Treatment includes steroids, immunosuppressants, IVIG, and sometimes spleen removal, with newer biological drugs helping difficult cases.

Browse the full “Acquired (Autoimmune) Hemolytic Anemia Market By Type (Warm Autoimmune Hemolytic Anemia and Cold Agglutinin Disease), By Treatment (Rituximab, Corticosteroids, Splenectomy, Immunosuppressants, and Blood Transfusions), By End-User (Hospitals, Homecare Settings, and Clinics), and By Region - Global and Regional Industry Overview, Market Intelligence, Comprehensive Analysis, Historical Data, and Forecasts 2024 - 2032” Report at https://www.zionmarketresearch.com/report/acquired-autoimmune-hemolytic-anemia-market

The acquired (autoimmune) hemolytic anemia market growth is primarily driven by increasing awareness among healthcare providers about rare blood disorders, advances in immunotherapy development, and improved diagnostic testing methods enabling earlier disease detection.

Market Growth Factors

Several factors are propelling the expansion of the acquired (autoimmune) hemolytic anemia market.

• Rising diagnosis rates: Doctors understand autoimmune blood disorders more clearly, leading to more cases of hemolytic anemia being recognized as improved tests help separate it from other anemia types.
• Biological therapy innovation: New monoclonal antibodies and targeted immune medicines give patients fresh treatment choices when standard steroids do not work well or cause strong side effects.
• Aging population growth: Older adults have a higher chance of developing autoimmune issues, including hemolytic anemia, creating growing patient groups needing long-term care and regular monitoring for complications.

Restraints

• High treatment costs: Advanced biological medicines and special blood products are very expensive, limiting access for patients without strong insurance support and creating financial strain even with partial coverage.
• Diagnostic complexity: Hemolytic anemia signs resemble many other illnesses, causing delays in correct diagnosis and treatment, especially in places without blood specialists or advanced laboratory testing.

Acquired (Autoimmune) Hemolytic Anemia Market: Report Scope

Market Segmentation

The acquired (autoimmune) hemolytic anemia market can be segmented by disease type, treatment type, route of administration, end user, and region.

Based on disease type, the market is divided into warm antibody hemolytic anemia, cold antibody hemolytic anemia, paroxysmal cold hemoglobinuria, drug-induced hemolytic anemia, and mixed-type hemolytic anemia. Warm antibody hemolytic anemia is expected to maintain a significant market share during the forecast period due to its higher prevalence compared to other forms and the availability of multiple treatment approaches.

Based on treatment type, the acquired (autoimmune) hemolytic anemia market is segmented into corticosteroids, immunosuppressive agents, intravenous immunoglobulin, biological therapies, blood transfusions, and surgical interventions. Corticosteroids are expected to lead the market during the forecast period due to their established efficacy as first-line therapy and widespread clinical acceptance.

Based on route of administration, the acquired (autoimmune) hemolytic anemia industry is categorized into oral medications, intravenous infusions, subcutaneous injections, and intramuscular injections. Oral medications lead the market due to patient preference for convenient home administration and suitability for long-term maintenance therapy.

Based on end user, the acquired (autoimmune) hemolytic anemia market is classified into hospitals, specialty hematology clinics, ambulatory infusion centers, and retail pharmacies. Hospitals lead the market by managing acute hemolytic crises and performing complex diagnostic workups requiring specialized laboratory facilities.

North America leads the acquired (autoimmune) hemolytic anemia market because it has strong healthcare systems and a major focus on research for rare blood conditions. The region benefits from skilled hematology departments in large medical centers with experience in diagnosing complex immune-related blood problems. Broad insurance coverage often supports costly biological medicines and specialized treatments used for autoimmune diseases. Patient support groups increase awareness of hemolytic anemia and help fund research for better therapies. The United States Food and Drug Administration offers programs for orphan drug development, encouraging companies to create treatments for rare blood disorders. Academic hospitals run clinical trials testing new treatment methods and help improve medical guidelines. Healthcare teams use advanced laboratory tools, including flow cytometry and detailed antibody testing for accurate diagnosis. The region also uses disease registries to study outcomes and improve understanding of long-term treatment success.

Key Market Players

Leading companies operating in the global acquired (autoimmune) hemolytic anemia market include:

• Nanjing IASO Biotherapeutics
• Incyte Corporation
• Teva Pharmaceutical Industries Ltd.
• Novartis AG
• F. Hoffmann-La Roche Ltd.
• Sanofi SA
• Lupin Pharmaceuticals
• Viatris Inc.
• Bristol Myers Squibb
• Johnson & Johnson Services Inc.
• Rigel Pharmaceuticals Inc.
• Alpine Immune Sciences
• Cellics Therapeutics.

Recent Developments

• In March 2025, a new drug candidate called sovleplenib, developed by the biopharmaceutical company Hutchmed, underwent a phase 2 clinical trial in adults with warm-antibody autoimmune hemolytic anemia (wAIHA) who failed steroid therapy. After 8 weeks, 44% of treated patients showed a meaningful hemoglobin rise (≥10 g/dL), and by week 24, the overall response rate reached 67%.

The global acquired (autoimmune) hemolytic anemia market is segmented as follows:

By Type

• Warm Autoimmune Hemolytic Anemia
• Cold Agglutinin Disease

By Treatment

• Rituximab
• Corticosteroids
• Splenectomy
• Immunosuppressants
• Blood Transfusions

By End-User

• Hospitals
• Homecare Settings
• Clinics

​By Region

• North America
  • The U.S.
  • Canada
• Europe
  • France
  • The UK
  • Spain
  • Germany
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Southeast Asia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • South Africa
  • Rest of Middle East & Africa

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