Warm Autoimmune Hemolytic Anemia (WAIHA) Treatment Market Report 2025

The warm autoimmune hemolytic anemia (waiha) treatment market size has grown strongly in recent years. It will grow from $0.55 billion in 2024 to $0.6 billion in 2025 at a compound annual growth rate (CAGR) of 8.7%. The growth in the historic period can be attributed to rising healthcare expenditure, increasing clinical trials focused on rare hematologic diseases, growing patient support and advocacy networks, and rising geriatric population.

The warm autoimmune hemolytic anemia (waiha) treatment market size is expected to see strong growth in the next few years. It will grow to $0.85 billion in 2029 at a compound annual growth rate (CAGR) of 9.2%. The growth in the forecast period can be attributed to increasing prevalence of autoimmune disorders, growing awareness among healthcare professionals, rising adoption of biologics and targeted therapies, and growing use of off-label drugs in autoimmune conditions. Major trends in the forecast period include advancements in monoclonal antibody therapies, integration of next-generation sequencing (NGS) in diagnostics, advancements in immunology research, and technology-enabled drug discovery platforms.

The forecast of 9.2% 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 barriers may disrupt U.S. hematology clinics by increasing costs of rituximab biosimilars and complement inhibitor therapies sourced from South Korea and Germany, potentially delaying treatment for antibody-mediated red blood cells destruction and raising rare blood disorder management 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 growing healthcare expenditure is expected to drive the expansion of the warm autoimmune hemolytic anemia (WAIHA) treatment market in the coming years. Healthcare expenditure encompasses the total resources spent on health services, including prevention, diagnosis, treatment, and disease management, by individuals, governments, and organizations. Advancements in medical technology are contributing to increased healthcare spending, as the development, implementation, and ongoing care of newer diagnostic tools and treatments typically incur higher costs. Healthcare expenditure supports WAIHA treatment by funding research, facilitating access to advanced diagnostic tools, and ensuring the availability of specialized therapies that manage and control the disease. For example, in May 2024, the UK’s Office for National Statistics reported that real-term health and social care expenditures grew by 2.8% in 2022, with overall healthcare spending rising by 5.6% in 2023. Thus, the rising healthcare expenditure is a key factor driving the growth of the WAIHA treatment market.

Innovations in monoclonal antibody therapies are driving progress in the treatment of warm autoimmune hemolytic anemia (WAIHA), with key companies in the market focused on developing cutting-edge solutions to meet unmet clinical needs and enhance patient outcomes. Monoclonal antibodies are laboratory-made proteins designed to target specific immune cells or pathways, aiming to reduce the destruction of red blood cells in WAIHA. For example, in July 2023, IASO Biotechnology, a biopharmaceutical company based in China, announced that the U.S. Food and Drug Administration (FDA) had approved IASO-782 Injection for clinical studies in autoimmune hematological conditions in the U.S., including WAIHA and primary immune thrombocytopenia (ITP). This fully human monoclonal antibody targets CD19 and incorporates Fc mutations to boost ADCC activity while preserving other Fc functions. It specifically depletes CD19+ B cells, plasma blasts, and certain plasma cells responsible for producing auto-reactive antibodies. With its unique mechanism, IASO-782 has potential for treating autoimmune disorders driven by pathogenic B and plasma cells, such as ITP and autoimmune hemolytic anemia (AIHA).

In September 2023, Zenas BioPharma Inc., a biotechnology company from the United States, partnered with Bristol Myers Squibb to develop and distribute the obexelimab antibody, a treatment for autoimmune diseases. This collaboration aims to create and bring to market effective new therapies for autoimmune disorders in key Asia-Pacific regions, addressing significant unmet medical needs and enhancing patient outcomes. Bristol Myers Squibb is a US-based pharmaceutical company, known for its expertise in treating warm autoimmune hemolytic anemia (WAIHA).

Major players in the warm autoimmune hemolytic anemia (WAIHA) treatment market are Johnson & Johnson, F. Hoffmann-La Roche Ltd., Sanofi S.A., AstraZeneca Plc, Novartis AG, Takeda Pharmaceutical Company Limited, Teva Pharmaceutical Industries Ltd., Agios Pharmaceuticals Inc., Incyte corporation, Mallinckrodt Pharmaceuticals, Hutchison Medipharma Limited, BioCryst Pharmaceuticals Inc., Xencor Inc., Annexon Inc., Rigel Pharmaceuticals Inc., Apellis Pharmaceuticals Inc., Momenta Pharmaceuticals Inc., Immunovant Inc., Zenas BioPharma Inc., Alexion Pharmaceuticals Inc., and Mitsubishi Tanabe Pharma Corporation.

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

The warm autoimmune hemolytic anemia (WAIHA) treatment market consists of revenues earned by entities by providing services such as diagnostic testing services, immune system monitoring, personalized treatment planning and care coordination services. The market value includes the value of related goods sold by the service provider or included within the service offering. The warm autoimmune hemolytic anemia (WAIHA) treatment market also includes sales of diagnostic kits, immunomodulatory agents, hematology analyzers and red blood cell monitoring tools. 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 warm autoimmune hemolytic anemia (WAIHA) treatment market research report is one of a series of new reports that provides warm autoimmune hemolytic anemia (WAIHA) treatment market statistics, including warm autoimmune hemolytic anemia (WAIHA) treatment industry global market size, regional shares, competitors with a warm autoimmune hemolytic anemia (WAIHA) treatment market share, detailed warm autoimmune hemolytic anemia (WAIHA) treatment market segments, market trends and opportunities, and any further data you may need to thrive in the warm autoimmune hemolytic anemia (WAIHA) treatment industry. This warm autoimmune hemolytic anemia (WAIHA) treatment market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Treatment for warm autoimmune hemolytic anemia (WAIHA) centers on addressing the immune system’s abnormal behavior, which causes the body to attack and destroy red blood cells at normal body temperatures. The main objective is to minimize or stop this immune-driven destruction, restore healthy red blood cell counts, and alleviate symptoms including fatigue, shortness of breath, and pallor.

The key treatment options for WAIHA include corticosteroids, monoclonal antibodies, intravenous immunoglobulin (IVIG), blood transfusions, and splenectomy. Corticosteroids are anti-inflammatory medications used to suppress the immune response and reduce inflammation. They can be administered orally, intravenously, or subcutaneously, and are suitable for children, adults, and older patients. These drugs are utilized for primary and secondary autoimmune disorders, as well as those related to genetic predisposition, and are available through hospital, retail, 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 that 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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