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US Hematologists Express High Unmet Need in Treatments for Warm Autoimmune Hemolytic Anemia and Cold Agglutinin Disease 

With few treatment options for patients, hematologists look to pipeline agents such as Johnson & Johnson’s nipocalimab and Novartis’ ianalumab to improve patient outcomes, according to Spherix Global Insights. 

EXTON, PA., July 24, 2024 – Autoimmune hemolytic anemia (AIHA) encompasses a group of rare disorders characterized by the destruction of red blood cells due to autoantibodies. Among these, warm autoimmune hemolytic anemia (w-AIHA) stands out as the most common form, representing 70-80% of all AIHA cases, with cold agglutinin disease (CAD), making up most of the remaining cases.1 While there is one approved agent to treat CAD – Enjaymo by Sanofi, there are no approved products yet to treat w-AIHA, leading to a high unmet need for effective treatment options across both conditions. 

Spherix Global Insights’ latest Market Dynamix™ (US) research on AIHA – diving into w-AIHA and CAD specifically – highlights challenges in the treatment landscape from the perspective of hematologists (n=58). The studies reveal that the majority of respondents identify a high unmet need in AIHA treatments overall, with nearly two-thirds emphasizing the need for new therapies specifically for w-AIHA. This represents the highest unmet need among all AIHA conditions, with CAD also among the top three. 

The most frequently expressed concerns among hematologists include the lack of effective treatment options and the challenges associated with long-term steroid use. Steroids, while a common treatment, come with significant drawbacks that often lead to the need for second-line therapies such as rituximab. Consequently, there is a clear and pressing demand for new treatments that offer better efficacy and a more favorable safety profile. 

In addition to these treatment challenges, hematologists also emphasize the need for high-quality evidence to support AIHA treatment guidelines. Nearly all respondents agree on the importance of generating robust clinical data to guide treatment decisions and improve patient care. Furthermore, the study highlights that the most desired attributes for new AIHA therapies include the ability to avoid long-term steroid use and the absence of severe adverse effects. 

Overall, the AIHA treatment pipeline has many opportunities, with numerous upcoming therapies – especially in w-AIHA – expected to bring meaningful advancements to the management of these challenging conditions. Assets under development and included in the study include Johnson & Johnson’s nipocalimab, Novartis’ ianalumab, Zenas BioPharma’s obexelimab, and Sanofi’s rilzabrutinib, among others. This excitement for emerging therapies highlights a dynamic and promising future for the AIHA treatment landscape, brimming with potential for breakthroughs and innovations in the near future. 

The full findings from Spherix Global Insights’ Market Dynamix™: AIHA (US) 2024 study was released earlier this week to subscribed clients, offering an in-depth analysis of these trends and providing valuable insights into the future of AIHA treatment. 

Market Dynamix™ is an independent service providing analysis of markets anticipated to experience a paradigm shift within the next three to five years. Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents. 

1Kalfa TA. Warm antibody autoimmune hemolytic anemia. Hematology Am Soc Hematol Educ Program. 2016;1:690-697. 

About Spherix Global Insights  

Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle.  

The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, and ophthalmology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. 

As a trusted advisor and industry thought leader, Spherix’s unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. 

To learn more about Spherix Global Insights, visit spherixglobalinsights.com or connect through LinkedIn.  

For more details on Spherix’s primary market research reports and interactive dashboard offerings, visit or register here: https://clientportal.spherixglobalinsights.com  

Spherix Global Insights Contacts  

Tucker Hurtado, Hematology Launch Franchise Head 

tucker.hurtado@spherixglobalinsights.com  

NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight’s analysis and do not imply a relationship with or endorse. 

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