The iron deficiency anemia (IDA) therapeutics market is witnessing significant activity with the development of novel therapies and ongoing clinical trials. According to a recent report by DelveInsight, the IDA market size in the 7MM (United States, EU4, the United Kingdom, and Japan) was approximately USD 1,400 million in 2023, highlighting the substantial need for effective treatments.
Current Treatment Landscape
Currently, the primary approach to treating IDA involves identifying and addressing the underlying cause of iron deficiency, alongside dietary adjustments and iron supplementation. Oral iron supplements are typically the first-line treatment for patients without contraindications. However, intravenous (IV) iron therapy, blood transfusions, and surgery are also utilized based on the patient's condition. Erythropoiesis-stimulating agents (ESAs) may be recommended for patients with IDA and chronic kidney disease (CKD).
Emerging Therapies
Several companies are actively developing innovative IDA therapies. MegaPro Biomedical is developing MPB-1514 (IOP Injection), a non-sugar iron injection designed for IDA treatment. This therapy is coated with PEG to enhance macrophage phagocytic results, allowing for high doses to be injected without frequent administrations. Phase II clinical trials for MPB-1514 have been completed in the United States.
Nemysis is working on IDAX (IHAT-02), a novel oral iron formulation that mimics natural ferritin. This formulation uses a tartrate salt to "dope" the ferrihydrite nanocore of ferritin in an adipate buffer. IHAT is designed for efficient absorption and to preserve the gut microbiome, potentially reducing gastrointestinal side effects. A Phase II clinical trial is currently evaluating IHAT for IDA treatment.
Pharmacosmos Therapeutics' Monoferric (ferric derisomaltose) is an IV iron replacement product approved in the US in 2020 and in Japan under the name MONOVER in March 2022. It is a complex of iron (III) hydroxide and derisomaltose, facilitating iron transport to erythroid precursor cells for hemoglobin incorporation.
Shield Therapeutics offers FERACCRU/ACCRUFeR (ferric maltol), an oral product intended for patients who cannot tolerate existing oral iron products. Approved by the US FDA in July 2019 for treating iron deficiency in adults, it provides an alternative to IV iron therapy.
Ongoing Clinical Trials
Several clinical trials are underway to further evaluate IDA treatments. A double-blind, randomized, placebo-controlled trial is assessing orally-dosed IHAT at two different doses compared to placebo for increasing serum ferritin levels in iron-deficient premenopausal women over 12 weeks. Another trial is investigating the effect of intravenous iron on disability 90 days after cardiac surgery in patients with postoperative iron deficiency anemia.
Market Dynamics and Epidemiology
In the United States, the total prevalent cases of IDA were approximately 9,510,600 in 2023. Among EU4 and the UK, the UK had the highest number of diagnosed prevalent cases, while France had the fewest. Approximately two-thirds of diagnosed IDA cases are considered mild, and the condition is more prevalent in females, accounting for about 65% of cases. In the United States, IDA associated with chronic kidney disease accounted for the highest proportion of IDA cases by pathology in 2023, at around 30%.
