Europe Autoimmune Hemolytic Anemia Therapeutics Market - 2024-2031

Europe Autoimmune Hemolytic Anemia Therapeutics Market - 2024-2031

The Europe autoimmune hemolytic anemia therapeutics market reached US$ 184.4 million in 2023 and is expected to reach US$ 309.7 million by 2031, growing at a CAGR of 6.7% during the forecast period 2024-2031.

Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that lead to the destruction of the body's red blood cells. It is of two types warm AIHA and cold AIHA. Warm antibody AIHA (wAIHA), the most common form of AIHA, is characterized by antibodies that react with the red blood cell surface at body temperature. No disease-targeted therapies are approved for wAIHA, despite the unmet medical needs of these patients.

Cold Agglutinin Disease (CAD) is an uncommon autoimmune hemolytic anemia in which a well-defined, clonal low-grade lymphoproliferative disorder of the bone marrow results in erythrocyte destruction mediated by the classical complement pathway.

It is mediated by cold agglutinins (CA), without any underlying disease such as aggressive lymphoma, other overt malignancies, or specific infections. CA can agglutinate red blood cells (RBC) at an optimum temperature of 3–4°C, but are also active at higher temperatures, depending on the thermal amplitude. Cold agglutinin disease symptoms get worse in cold weather.

Market Dynamics: Drivers

Rising prevalence of autoimmune diseases

The demand for the European autoimmune hemolytic anemia therapeutics market is driven by multiple factors. The prevalence of autoimmune diseases, including autoimmune hemolytic anemia (AIHA), has been on the rise in Europe. This is due to a combination of genetic, environmental, and lifestyle factors that contribute to the development of these conditions. According to ASH publications in November 2023, the incidence of AIHA ranged from 15 to 60 per 1,000,000.

The standardized point prevalence of AIHA in Europe ranges from 60 to 210 per 1,000,000 population across different databases and studies. The prevalence of AIHA is generally higher in older age groups, with point prevalence ranging from 30 to 220 per 1,000,000 in those under 45 years, and 120 to 360 per 1,000,000 in those over 65 years. The prevalence of AIHA is also higher among females compared to males in Europe.

Moreover, major players in the region focus on research & development and the rising number of clinical trials on the treatment of autoimmune hemolytic anemia that would propel this market growth. For instance, in December 2023, Agios presented positive results from the phase 2 portion of the RISE UP pivotal study in sickle cell disease at the 65th Ash annual meeting and exposition. PYRUKYND is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency in the United States and the treatment of PK deficiency in adult patients in the European Union.

Also, in June 2022, Rigel announced top-line results from the forward phase 3 clinical trial of Fostamatinib in patients with warm autoimmune hemolytic anemia.

Similarly, in June 2023, the Janssen Pharmaceutical Companies of Johnson & Johnson announced positive results from the proof-of-concept Phase 2 open-label UNITY clinical trial for the treatment of pregnant individuals at high risk of early-onset severe (EOS) hemolytic disease of the fetus and newborn (HDFN).

High treatment cost

The high treatment cost, side effects associated with the treatment, limited awareness & diagnosis, lack of skilled professionals, regulatory & reimbursement challenges, and limited treatment options & lack of approved treatment are expected to hamper the market.

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Segment Analysis

The Europe autoimmune hemolytic anemia therapeutics market is segmented based on drug class, disease type, route of administration, and distribution channel.

The corticosteroids segment accounted for approximately 45.4% of the Europe autoimmune hemolytic anemia therapeutics market share.

The corticosteroids segment is expected to hold the largest market share over the forecast period. Corticosteroids have anti-inflammatory properties and cause profound and varied metabolic effects. These agents modify the immune response of the body to diverse stimuli. Glucocorticoids, such as prednisone, are usually the first line of treatment in autoimmune hemolytic anemia (AIHA).

According to Frontier's research publication in April 2023, inhibitors of cellular mediators of phagocytosis are currently being investigated for AIHA treatment. The drug Fostamatinib is currently approved in the US and Europe for the treatment of immune thrombocytopenia. A phase 3 trial in wAIHA has finished inclusion (117), and an open-label extension study is also being performed. While still investigational, fostamatinib may turn out to be an option in the third line.

Moreover, ongoing research studies in the treatment of AIHA and EU national drug launches & approvals would propel this segment's growth in the market. For instance, in March 2024, Novartis announced the study of the efficacy and safety of ianalumab in previously treated patients with warm autoimmune hemolytic anemia. A phase 3, randomized, double-blind, study to assess the effectiveness and safety of ianalumab (VAY736) versus placebo in warm autoimmune hemolytic anemia (wAIHA) patients who failed at least one line of treatment.

Also, in November 2022, The European Commission (EC) granted marketing authorization for Enjaymo (sutimlimab) for the treatment of hemolytic anemia in adult patients with cold agglutinin disease (CAD), a rare, serious, and chronic autoimmune hemolytic anemia, where the body’s immune system mistakenly attacks healthy red blood cells and causes their rupture, known as hemolysis.

Similarly, in February 2022, Agios announced FDA approval of PYRUKYND (mitapivat) as the first disease-modifying therapy for hemolytic anemia in adults with pyruvate kinase deficiency. A full analysis of these data was presented at the 2021 European Hematology Association (EHA) Virtual Congress. PYRUKYND is also under review by the European Medicines Agency (EMA) as a potential treatment for adults with PK deficiency, and Agios expects a regulatory decision in the EU by the end of 2022.

Market Segmentation

By Drug Class
• Corticosteroids
• Immunosuppressive agents
• Others

By Disease Type
• Warm Autoimmune Hemolytic Anemia
• Cold Autoimmune Hemolytic Anemia
• Others

By Route of Administration
• Injectable
• Oral
• Others

By Drug Class
• Hospital Pharmacies
• Online Pharmacies
• Retail Pharmacies

Competitive Landscape

The major players in the Europe autoimmune hemolytic anemia market include Sanofi, Grifols, Apellis Pharmaceuticals, Inc., Rigel Pharmaceuticals, Inc., Zenas BioPharma, Johnson & Johnson Services, Inc., Agios Pharmaceuticals, Inc, Novartis AG, Hoffmann-La Roche Limited and Incyte among others.

Key Developments

 In April 2024, AstraZeneca announced that Voydeya (danicopan) has been approved in the European Union (EU) as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have residual hemolytic anemia.

 In February 2024, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for nipocalimab for the treatment of alloimmunizeda pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN).

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• To visualize the Europe autoimmune hemolytic anemia therapeutics market segmentation based on drug class, disease type, route of administration, and distribution channel, understand key commercial assets and players.
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The Europe autoimmune hemolytic anemia therapeutics market report would provide approximately 42 tables, 30 figures, and 172 Pages.

Target Audience 2024
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies