Autoimmune Hemolytic Anemia Treatment Market Report 2025

The autoimmune hemolytic anemia treatment market size has grown strongly in recent years. It will grow from $1.3 billion in 2024 to $1.4 billion in 2025 at a compound annual growth rate (CAGR) of 8%. The growth in the historic period can be attributed to increasing disease awareness among healthcare providers, rising incidence of autoimmune disorders, growth in hospital infrastructure, growing number of published clinical studies, and rising incidence of infections.

The autoimmune hemolytic anemia treatment market size is expected to see strong growth in the next few years. It will grow to $1.95 billion in 2029 at a compound annual growth rate (CAGR) of 8.6%. The growth in the forecast period can be attributed to increasing incidence of AIHA worldwide, rising demand for targeted therapies, growing focus on personalized medicine, increasing investment in autoimmune disease research, and growing healthcare access in developing regions. Major trends in the forecast period include technological advancements in diagnostics, digital health and telemedicine integration, advancements in targeted therapies, AI-powered diagnostics and drug discovery, and novel immunosuppressive strategies.

The forecast of 8.6% growth over the next five years reflects a modest reduction of 0.3% from the previous estimate for this market. This reduction is primarily due to the impact of tariffs between the US and other countries. Trade tensions could hinder U.S. hematology clinics by inflating prices of rituximab biosimilars and immunosuppressants manufactured in South Korea and India, resulting in delayed warm antibody autoimmune hemolytic anemia management and higher blood disorder treatment costs. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.

The rising prevalence of autoimmune diseases is expected to drive the growth of the autoimmune hemolytic anemia treatment market in the coming years. Autoimmune disorders occur when the immune system mistakenly attacks the body’s own tissues, resulting in inflammation and tissue damage. This growing prevalence is largely influenced by genetic susceptibility, which increases the likelihood of developing such conditions. Autoimmune hemolytic anemia treatments are vital in managing these disorders by minimizing red blood cell destruction caused by immune system activity. For example, in May 2023, the National Institute for Health and Care Research (NIHR), a UK-based organization dedicated to advancing health research, reported that autoimmune disorders now affect about one in ten individuals, with 19 different autoimmune diseases impacting approximately 10% of the population - 13% of women and 7% of men. Therefore, the increasing occurrence of autoimmune diseases is driving the growth of the autoimmune hemolytic anemia treatment market.

Major companies in the autoimmune hemolytic anemia treatment market are advancing targeted therapies, such as first-in-class monoclonal antibodies, which selectively block specific immune pathways such as the classical complement system to reduce red blood cell destruction while minimizing adverse effects. These monoclonal antibodies represent novel therapies that engage unique mechanisms or pathways not previously addressed by existing treatments. For instance, in November 2022, Sanofi S.A., a healthcare company based in France, received marketing approval from the European Commission for Enjaymo (sutimlimab), a monoclonal antibody that inhibits the C1s protein in the classical complement pathway. This drug is used to treat hemolytic anemia in adults with Cold Agglutinin Disease (CAD), a rare autoimmune condition in which the immune system attacks healthy red blood cells, leading to hemolysis. Enjaymo provides a targeted approach to reducing red blood cell destruction in this form of autoimmune hemolytic anemia.

In October 2024, Recordati, a pharmaceutical company headquartered in Italy, acquired global rights to Enjaymo from Sanofi for $825 million. This acquisition is part of Recordati’s strategy to strengthen its rare disease portfolio by securing a therapy for Cold Agglutinin Disease (CAD), a rare subtype of autoimmune hemolytic anemia, thereby enhancing its presence in the specialty pharmaceutical sector. Sanofi S.A. is a France-based biopharmaceutical company known for developing innovative treatments across diverse therapeutic areas.

Major players in the autoimmune hemolytic anemia treatment market are Johnson & Johnson, F. Hoffmann-La Roche Ltd., AbbVie Inc., Sanofi SA, Novartis AG, Amgen Inc., Incyte Corporation, Alexion Pharmaceuticals Inc., Hutchison China MediTech Limited, BioCryst Pharmaceuticals Inc., Annexon Inc., Rigel Pharmaceuticals Inc., Nanjing IASO Biotherapeutics Co. Ltd., Apellis Pharmaceuticals Inc., Momenta Pharmaceuticals Inc., Zenas BioPharma Inc., Immunovant Sciences GmbH, Alpine Immune Sciences Inc., Agios Pharmaceuticals Inc., Kezar Life Sciences Inc.

North America was the largest region in the autoimmune hemolytic anemia treatment market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in autoimmune hemolytic anemia treatment report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the autoimmune hemolytic anemia treatment market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The autoimmune hemolytic anemia treatment market consists of sales of monoclonal antibodies, complement inhibitors, blood transfusions, and biosimilars. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the resulting trade tensions in spring 2025 are having a significant impact on the pharmaceutical sector. Companies are grappling with higher costs on imported active pharmaceutical ingredients (APIs), glass vials, and laboratory equipment - many of which have limited alternative sources. Generic drug manufacturers, already operating with minimal profit margins, are particularly affected, with some scaling back production of low-margin medications. Biotech firms are also experiencing delays in clinical trials due to shortages of specialized reagents linked to tariffs. In response, the industry is shifting API production to regions like India and Europe, building up inventory reserves, and advocating for tariff exemptions on essential medicines.

The autoimmune hemolytic anemia treatment market research report is one of a series of new reports that provides autoimmune hemolytic anemia treatment market statistics, including the autoimmune hemolytic anemia treatment industry global market size, regional shares, competitors with the autoimmune hemolytic anemia treatment market share, detailed autoimmune hemolytic anemia treatment market segments, market trends, and opportunities, and any further data you may need to thrive in the autoimmune hemolytic anemia treatment industry. This autoimmune hemolytic anemia treatment market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

Autoimmune Hemolytic Anemia (AIHA) treatment consists of medications and therapies designed to prevent the immune system from destroying the body’s own red blood cells. The primary goals of treatment are to decrease red blood cell destruction, alleviate symptoms of anemia, and avoid potential complications.

The main forms of autoimmune hemolytic anemia treatment include warm autoimmune hemolytic anemia, cold autoimmune hemolytic anemia, and other types. Warm autoimmune hemolytic anemia occurs when the immune system mistakenly attacks red blood cells at normal body temperatures, resulting in anemia. Treatment involves various classes of drugs such as corticosteroids, immunosuppressive agents, and other therapeutic options. These medications are delivered through several administration routes, including injectable, oral, and other methods. Distribution channels for these treatments include hospital pharmacies, retail pharmacies, and online pharmacies.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values and are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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