Authored By: Sarah
11 Jul 2024

 Autoimmune Hemolytic Anemia Therapeutics Market Size to grow by USD 301.7 million between 2024-2028

According to a research report “ Autoimmune Hemolytic Anemia Therapeutics Market” by Product (Corticosteroids, Monoclonal antibodies, Others) Geography (North America, Europe, Asia, Rest of World (ROW))- Global Forecast to 2028 published by Technavio, the market size is estimated to grow by USD 301.7 million, at a CAGR of  10.03% during the forecast period. Autoimmune hemolytic anemia (AIHA) is a rare and complex blood disorder characterized by the destruction of red blood cells due to an abnormal immune response. The incidence of AIHA in North America and Western Europe is estimated to be a mere 0.003% of the population. Due to the rarity of the disease, sponsorship for research and development of therapeutics is limited, making it a significant challenge for the pharmaceutical industry. To incentivize research and development, regulatory authorities, such as the US Food and Drug Administration (FDA), grant special designations, like Orphan Drug Designation, which offers financial incentives, including tax credits for clinical trials and market exclusivity for seven years upon regulatory approval. In a recent development, the FDA approved Enjaymo (sutimlimab-jome), an infusion therapy, for adults with cold agglutinin disease (CAD) to decrease the need for red blood cell transfusions due to hemolysis. This approval marks a significant step forward in the treatment of AIHA and underscores the importance of continued research and investment in rare disease therapies.

Browse market data tables, figures, and in-depth TOC on “Autoimmune Hemolytic Anemia Therapeutics Market” by Product (Corticosteroids, Monoclonal antibodies, Others) Geography (North America, Europe, Asia, Rest of World (ROW)) Global Forecast to 2028. Download Free Sample


By Product, the Corticosteroids segment is projected to dominate the market size in 2024


By Geography, North America  segment is expected to hold the largest market size for the year 2024

In the realm of autoimmune hemolytic anemia therapeutics, corticosteroids hold significant importance. These medications inhibit the production of autoantibodies by B-cells and decrease the density of Fc-gamma receptors on phagocytes in the spleen. Prednisone, a corticosteroid, is commonly utilized as a first-line treatment for this disorder. The initial dosage is typically 1 mg/kg/day for 1-3 weeks, aiming to elevate hemoglobin levels above 10 gm/dL. Post-stabilization, prednisone is tapered off gradually at 10-15 mg weekly, followed by 2.5 mg every 1-2 weeks, and finally, 2 mg daily. Corticosteroids' ability to induce partial remission in the majority of patients makes them a crucial intervention in managing autoimmune hemolytic anemia.

North America is forecasted to hold the largest market size by region in 2024

The Autoimmune Hemolytic Anemia (AIHA) Therapeutics market represents a significant business opportunity due to the increasing prevalence of this autoimmune disorder. Key players in this market are developing innovative solutions to address the unmet medical needs of AIHA patients. These include immunosuppressive therapies, intravenous immunoglobulins, and corticosteroids. The market is expected to grow steadily, driven by rising awareness, advances in diagnostics, and the development of novel therapeutic approaches.

The Autoimmune Hemolytic Anemia Therapeutics Market growth and forecasting report also includes detailed analyses of the competitive landscape of the market growth and forecasting and information about 20 market companies, including:

  • AstraZeneca Plc
  • Amneal Pharmaceuticals Inc.
  • ANI Pharmaceuticals Inc.
  • Apellis Pharmaceuticals Inc.
  • argenx SE
  • Baxter International Inc.
  • Cipla Inc.
  • Concord Biotech Ltd.
  • F. Hoffmann La Roche Ltd.
  • Hikma Pharmaceuticals Plc
  • Incyte Corp.
  • Kezar Life Sciences Inc.
  • Nichi Iko Pharmaceutical Co. Ltd.
  • Rigel Pharmaceuticals Inc.
  • Sanofi SA
  • Teva Pharmaceutical Industries Ltd.
  • Viatris Inc.

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Research Analysis Overview

Autoimmune Hemolytic Anemia (AIHA) is a rare blood disorder characterized by the destruction of red blood cells by the immune system. Orphan drug development for AIHA is gaining momentum due to the high unmet medical need and potential for innovative therapeutic approaches. Diagnostic techniques such as direct and indirect Coombs tests are used to identify AIHA. Targeted treatments including biologics like Rituximab and Corticosteroid medications such as Prednisone and Hydrocortisone are commonly used. Specific drugs like Methotrexate and Sutimlimab are also being explored. Causes of AIHA include infections, genetic disorders, and certain medications. The disease affects both females and the geriatric population, with an increased prevalence in aging people and those with underlying conditions like cancer. Treatment options include Blood transfusions, Corticosteroids, and other specific drugs. The Spleen plays a role in the development of AIHA, and its removal may be considered in severe cases. Medical research continues to explore new therapeutic approaches to address the complexities of this disease.

Market Research Overview

Autoimmune Hemolytic Anemia (AIHA) is a type of anemia characterized by the destruction of red blood cells by the immune system. Telemedicine and online pharmacy segments are transforming the therapeutics market for AIHA, enabling easier access to essential medications like folic acids, biological drugs, and other drug classes. Disease management is a priority, with healthcare expenditure on the rise due to research and development in orphan drugs and personalized medicine. Biologic therapies, such as monoclonal antibodies, are increasingly popular, with drugs like Sovelima and Rituximab offering innovative therapeutic approaches. Reimbursement policies, diagnostic techniques, and targeted treatments are crucial in managing AIHA. Coombs Test and Blood Tests are essential for diagnosis, while Splenectomy, Surgery, and Blood Transfusion remain traditional treatments. AIHA affects various populations, including patients with Cold Agglutinin Disease, Ulcerative colitis, Hashimoto's disease, Thyroid disease, Sjogren's syndrome, Rheumatoid arthritis, and even Iron-deficiency anemia. Immunosuppressive agents like Cyclosporine, Hydroxyurea, and Corticosteroid medications are common treatments. Infections and genetic disorders can also cause AIHA. Specific drugs like sutimlimab are under development for AIHA, and financial crisis and sedentary lifestyle can exacerbate its prevalence. Specialty healthcare delivery through hospitals, specialty clinics, and homecare is essential. AIHA affects females and geriatric populations, and cancer and aging people are also at risk. Overall, the AIHA therapeutics market is evolving rapidly, with a focus on improving patient care and outcomes.


Technavio Research
Jesse Maida
Media & Marketing Executive
US: +1 844 364 1100
UK: +44 203 893 3200

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