Iron Deficiency Anemia Market

• Iron Deficiency Anemia (IDA) is the most common form of anemia worldwide and is responsible for around 50% of all anemia. IDA is a disorder in which the body’s iron stores are depleted, resulting in a decrease in RBCs. The primary cause of IDA is low iron levels, which can result from various factors such as blood loss, insufficient dietary iron, poor iron absorption, and increased iron requirements, particularly during pregnancy
• Currently, the drugs used for the treatment of IDA are AURYXIA (Akebia), INJECTAFER (Vifor), VENOFER (Vifor), FERAHEME (AMAG), FERACCRU (Shield), and others.
• The development pipeline for IDA remains relatively limited in terms of promising candidates. Nevertheless, IHAT-02, developed by Nemysis, has successfully progressed to Phase III clinical trials- an important advancement that underscores its strong potential for future regulatory approval.
• The upcoming therapies for IDA are expected to combat the current unmet needs faced by the patients and add to the overall growth of the iron deficiency anemia market size. 

DelveInsight’s “Iron Deficiency Anemia (IDA)– Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of IDA, historical and forecasted epidemiology as well as IDA Market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The IDA market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM IDA market size from 2020 to 2034. The report also covers current IDA treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Iron Deficiency Anemia Understanding and Treatment Algorithm

Iron Deficiency Anemia Overview

IDA is a common type of anemia—a condition in which blood lacks adequate healthy red blood cells (RBCs). RBCs carry oxygen to the body's tissues. IDA is due to insufficient iron. Without enough iron, the body can't produce enough of a substance in RBCs that enables them to carry oxygen (hemoglobin). As a result, IDA may leave tired and leads to shortness of breath. IDA can be so mild that it goes unnoticed. But as the body becomes more deficient in iron and anemia worsens, the signs and symptoms intensify.

IDA signs and symptoms may include: extreme fatigue, weakness ,pale skin, chest pain, fast heartbeat or shortness of breath, headache, dizziness or lightheadedness, cold hands and feet, inflammation or soreness of your tongue, brittle nails, unusual cravings for non-nutritive substances, such as ice, dirt or starch, poor appetite, especially in infants and children with IDA. 

Iron Deficiency Anemia Diagnosis

IDA is diagnosed by blood tests that should include a complete blood count (CBC). Additional tests may be ordered to evaluate the levels of serum ferritin, iron, total iron-binding capacity, and/or transferrin. In an individual who is anemic from iron deficiency, these tests usually show the following results: Low hemoglobin (Hg) and hematocrit (HCT), low Mean Cellular Volume (MCV), Low ferritin, low serum iron (Fe), high transferrin or Total Iron-binding Capacity (TIBC), low iron saturation. The peripheral smear or blood slide may show small, oval-shaped cells with pale centers. In severe iron deficiency, the white blood count (WBC) may be low and the platelet count may be high or low

Further details related to diagnosis are provided in the report…

Iron Deficiency Anemia Treatment

Treatment for IDA depends on its cause and severity. Treatments may include iron supplements, procedures, surgery, and dietary changes. Severe IDA may require intravenous (IV) iron therapy or a blood transfusion. The goals of treating IDA are to treat its underlying cause and restore normal levels of red blood cells, hemoglobin, and iron. 

In November 2017, the US FDA approved AURYXIA (Riona; KRX-0502; Ferric Citrate: Akebia Therapeutics) to treat IDA in adults with CKD, not on dialysis. AURYXIA is iron-based, noncalcium, nonchewable compound with distinctive chemical characteristics and the active ingredient present in the drug is ferric citrate. 

Further details related to treatment are provided in the report…

Iron Deficiency Anemia Epidemiology

The Iron deficiency anemia epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Cases of Iron Deficiency Anemia, Diagnosed Prevalent Cases of Iron Deficiency Anemia, Severity-specific Diagnosed Prevalent Cases of Iron Deficiency Anemia, Pathology-specific Diagnosed Prevalent Cases of Iron Deficiency Anemia, Gender-specific Diagnosed Prevalent Cases of Iron Deficiency Anemia, Total Treated Cases of Iron Deficiency Anemia in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034. 

• The prevalence of anemia was 9.3% in the US population aged 2 years and older. Males had a lower prevalence of anemia than females.
• In the 7MM, Japan reported the highest prevalent cases of Iron deficiency anemia  of the total 7MM cases, followed by the US  in the year 2024
• Among the EU4 and the UK, the highest number of cases of Iron deficiency anemia was in the UK and the lowest in France in 2024.
•  In 2024, nearly 1,300 severe cases were estimated across the 7MM, highlighting a significant public health challenge. Projections indicate that this number is poised to rise dramatically by 2034, underscoring the urgent need for innovative strategies and interventions to address this growing crisis. 

Iron Deficiency Anemia Recent Developments

• In September 2025, Shield Therapeutics plc announced that the U.S. FDA accepted its clinical supplement for ACCRUFeR®/FeRACCRU® (ferric maltol) and granted Priority Review to extend its indication to adolescents aged 10 and above. This follows positive Phase 3 trial results demonstrating efficacy, safety, and tolerability of the new oral liquid formulation for pediatric iron deficiency anemia (IDA). Approval is anticipated in 2026.

Iron Deficiency Anemia Drug Chapters

The drug chapter segment of the iron deficiency anemia report encloses a detailed analysis of the marketed and the late, mid, and early stage (Phase III, Phase II, and Phase I/II) pipeline drugs. The marketed drugs segment encloses drugs such as AURYXIA (Ferric citrate), INJECTAFER, and others. The drug chapter also helps understand the iron deficiency anemia clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, and the latest news and press releases.

Marketed Drugs

AURYXIA (ferric citrate): Akebia Therapeutics

 In November 2017, the US FDA approved AURYXIA from Akebia Therapeutics to address IDA in adults with chronic kidney disease (CKD) who are not on dialysis. AURYXIA is a unique iron-based compound that is non-calcium and non-chewable, distinguished by its chemical properties, with ferric citrate as its active ingredient. More recently, in March 2021, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan approved Riona Tablets 250 mg, marking a significant milestone in the treatment of IDA for adult patients in Japan. 

 INJECTAFER (ferric carboxymaltose): CSL Vifor/ American Regent

In June 2007, INJECTAFER developed by American Regent/Vifor Pharma/JW Pharmaceutical, gained approval in Europe. The drug's active ingredient, ferric carboxymaltose, features a poly-nuclear iron core encased in a carboxymaltose shell, optimizing iron utilization. In May 2021, the US FDA approved a single 1000 mg dose of INJECTAFER for treating IDA in adult patients who cannot tolerate oral iron, have experienced unsatisfactory responses to oral iron, or have non-dialysis-dependent chronic kidney disease. INJECTAFER was initially approved by the US FDA in 2013 for a 1500 mg treatment course, administered in two doses of up to 750 mg each, separated by a week. In June 2023, FDA approved INJECTAFER (ferric carboxymaltose injection) for the treatment of iron deficiency in adult patients with heart failure.

Note: Detailed list will be provided in the final report.

Emerging Drugs

IDAX (IHAT-02): Nemysis 

IHAT is a nanoparticulate ferric iron supplement developed to mimic the body's natural iron absorption mechanisms. Modeled after dietary ferritin—an iron-storage protein—IHAT features a nanoparticulate iron core and is absorbed in the intestine as intact particles, thereby avoiding the release of ‘free’ iron, which is associated with gastrointestinal side effects in traditional iron supplements. By eliminating the redox-active free iron, IHAT offers a safer and more tolerable alternative, without negatively affecting the gut microbiome. Nemysis is advancing IHAT-02 (also known as IDAX), a novel oral formulation targeting IDA, marking a significant innovation in this therapeutic space.

In March 2025, Nemysis announced the signing of a Distribution and Supply Agreement for its unique oral iron supplement, IHAT, with Avia Pharma AB, which will act as distributor.

As of June 2024, IHAT-02 has advanced to Phase III clinical trials, marking a significant step forward in its development and indicating strong potential for regulatory approval. This progress is driven by its excellent safety and efficacy profile observed in earlier studies. IHAT-02 is designed to mimic ferritin, the body’s natural iron storage protein, offering improved bioavailability and greater tolerability compared to traditional iron supplements.

In May 2024, a new patent (WO2021204705) was granted in Europe for the use of IHAT in treating and preventing iron deficiency associated with liver disease. This application is well-supported by experimental and toxicological data demonstrating that orally administered IHAT does not lead to hepatic iron overload. 

With a remarkable 100% success rate among Phase III candidates for IDA, IHAT-02 is positioned as a leading contender for regulatory approval. This advancement not only enhances available therapeutic options for IDA but also signifies a major step forward in patient care, potentially reshaping the future of iron deficiency treatment. This innovative formulation addresses common issues such as poor absorption and gastrointestinal side effects. Notably, in trials like IHAT-Gut, IHAT-02 demonstrated superior effectiveness in resolving IDA with fewer side effects than ferrous sulfate or placebo.

Note: Detailed list will be provided in the final report.

Drug Class Insights

Iron Replacement – Oral Iron Salts and Chelated Complexes

Oral iron salts and chelated complexes remain the foundational therapy for the management of mild to moderate iron deficiency anemia (IDA), offering a convenient and cost-effective approach for iron repletion. These agents act by delivering elemental iron—either as ferrous (Fe²⁺) or ferric (Fe³⁺) compounds—which are absorbed in the small intestine, primarily via the DMT1 transporter in the duodenum. Once absorbed, the iron is incorporated into hemoglobin during erythropoiesis. First-generation ferrous salts such as ferrous sulfate, ferrous gluconate, and ferrous fumarate are among the most widely prescribed formulations; however, their clinical utility is often limited by gastrointestinal side effects, including nausea, constipation, and poor tolerability, which can negatively impact adherence. Newer chelated ferric compounds have been developed to address these limitations. AURYXIA (Ferric Citrate), approved for IDA in non-dialysis CKD patients, not only provides ferric iron for absorption but also serves as a phosphate binder, making it particularly beneficial in patients with overlapping mineral metabolism disorders. Similarly, ACCRUFER / FERACCRU (Ferric Maltol), a ferric iron preparation chelated with maltol, is designed to enhance bioavailability while minimizing gastrointestinal irritation, offering an improved safety and tolerability profile for long-term use. Overall, oral iron formulations are best suited for patients with stable, non-urgent IDA, normal gastrointestinal function, and lower risk of malabsorption or inflammation-induced hepcidin elevation. 

Note: Detailed insights will be provided in the final report.

Iron Deficiency Anemia Market Outlook

Treatment for IDA depends on its cause and severity. Treatments may include iron supplements, procedures, surgery, and dietary changes. Severe IDA may require intravenous (IV) iron therapy or a blood transfusion. The goals of treating IDA are to treat its underlying cause and restore normal levels of red blood cells, hemoglobin, and iron. 

In November 2017, the US FDA approved AURYXIA (Riona; KRX-0502; Ferric Citrate: Akebia Therapeutics) to treat IDA in adults with CKD, not on dialysis. AURYXIA is iron-based, non-calcium, non-chewable compound with distinctive chemical characteristics and the active ingredient present in the drug is ferric citrate.

In June 2007, INJECTAFER (Ferinject; ferric carboxymaltose; VIT-45: American Regent/Vifor Pharma/JW pharmaceutical) received approval in Europe. The active ingredient of the drug, ferric carboxymaltose, is composed of a poly-nuclear iron core stabilized by a carboxymaltose shell that ensures effective iron utilization. In May 2021, the US FDA approved a single 1000 mg dose option of INJECTAFER for the treatment of IDA in adult patients who have an intolerance to oral iron, have had unsatisfactory response to oral iron, or have non-dialysis dependent CKD. Another intravenously administered drug is FERAHEME (ferumoxytol injection; Ferumoxytol; Rienso: AMAG Pharmaceuticals) which was first approved by the US FDA in June 2009 for the treatment of IDA in adult patients with CKD. FERAHEME is an iron replacement product containing ferumoxytol, non-stoichiometric magnetite (superparamagnetic iron oxide) coated with polyglucose sorbitol carboxymethyl ether. In the same year, in November 2009, Monoferric (ferric derisomaltose: Pharmacosmos Therapeutics) was first approved outside North America in the EU as MONOFER (iron isomaltoside 1000 injection) and is currently marketed in more than 30 countries. MONOFER contains a combination of iron and isomaltoside 1000. The type of iron in MONOFER is the same as that found naturally in the body called ‘ferritin.’

Iron Deficiency Anemia Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025–2034. The landscape of iron deficiency anemia treatment has experienced a profound transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians. 

Further detailed analysis of emerging therapies drug uptake in the report…

Iron Deficiency Anemia Pipeline Development Activities

The report provides insights into therapeutic candidates in Phase III, Phase II, and Phase I/II. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for iron deficiency anemia emerging therapy.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on IDA evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including gastroenterologist, hematologist, primary care physician or a general practitioner, and others.

Delveinsight’s analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as MD, Harvard Medical School, US, and PhD University of Nottingham, UK, and others. Their opinion helps understand and validate current and emerging therapy treatment patterns or iron deficiency anemia market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival. 

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Globally, iron deficiency anemia patient families spend an essential proportion of their household income on iron deficiency anemia care. Iron deficiency anemia patients have to face a huge economic burden alone without any healthcare coverage or proper reimbursement policies.

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Further detailed analysis of emerging therapies drug uptake in the report…

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of iron deficiency anemia, explaining its causes, signs, symptoms, pathogenesis, and currently used therapies.
• Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of the emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the iron deficiency anemia market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM iron deficiency anemia market.

Iron deficiency anemia Report Insights

• Patient Population
• Therapeutic Approaches
• Iron deficiency Anemia Pipeline Analysis
• Iron Deficiency Anemia Market Size and Trends
• Existing and Future Market Opportunity 

Iron deficiency anemia Report Key Strengths

• Ten Years Forecast
• The 7MM Coverage 
• Iron Deficiency Anemia Epidemiology Segmentation
• Key Cross Competition 
• Drugs Uptake and Key Market Forecast Assumptions

Iron deficiency anemia Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT Analysis and Conjoint Analysis)

FAQs

• What was the iron deficiency anemia market size, the market size by therapies, market share (%) distribution in 2023, and what would it look like by 2034? What are the contributing factors for this growth?
• What are the pricing variations among different geographies for approved therapies?
• What can be the future treatment paradigm of iron deficiency anemia?
• What are the disease risks, burdens, and unmet needs of iron deficiency anemia? What will be the growth opportunities across the 7MM concerning the patient population with iron deficiency anemia?
• Who is the major competitor of statins in the market and how the competitors will affect their market share?

• What are the current options for the treatment of iron deficiency anemia? What are the current guidelines for treating iron deficiency anemia in the US, Europe, and Japan?

• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies? 

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the iron deficiency anemia market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the analyst view section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of current therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.