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철 결핍성 빈혈 : 시장 인사이트, 역학 및 시장 예측(2036년)

Iron Deficiency Anemia - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 200 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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철 결핍성 빈혈(IDA)에 대한 인사이트와 동향

  • DelveInsight의 분석에 따르면, 2025년 주요 시장(미국, EU 4개국(독일, 프랑스, 이탈리아, 스페인), 영국, 일본)의 철 결핍성 빈혈(IDA) 시장 규모는 약 16억 달러인 것으로 나타났습니다.
  • IDA의 상당 부분은 만성 신장질환, 암, 만성 심부전, 염증성 장질환, 셀리악병, 여성 건강 관련 요인 등의 동반 질환과 관련이 있으며, 그중에서도 만성 신장질환이 가장 큰 비중을 차지하고 있습니다. 이는 합병증을 줄이고 환자의 예후를 개선하기 위해서는 통합적인 질환 관리, 조기 선별 검사 및 표적 치료 접근법이 필요함을 여실히 보여주고 있습니다.
  • 주요 7개국 IDA 시장에서, 신속하고 효과적인 철분 보충이 필요한 중등도에서 중증 환자에 대한 광범위한 사용에 힘입어, 카르복시말토스 철(INJECTAFER/FERINJECT)이 치료 옵션 중 가장 큰 점유율을 차지하고 있습니다.
  • 현재 철 결핍성 빈혈(IDA) 시장에서는 황산제1철, 푸마르산 제1철, 글루콘산 제1철과 같은 저비용 경구용 철제제(OFP)가 널리 사용되고 있는 반면, 중등도에서 중증 환자에 대한 유효성 향상, 보다 신속한 철분 보충, 그리고 내약성 개선이라는 요구를 배경으로, FERACCRU/ACCRUFER, AURYXIA/RIONA, 그리고 INJECTAFER/FERINJECT 및 MONOFER와 같은 정맥내 철 제제를 포함한 고비용의 첨단 치료법으로의 전환이 진행되고 있다는 점이 특징입니다.
  • 철 결핍성 빈혈(IDA)의 치료 환경에는 다이이치 산쿄(INJECTAFER/FERINJECT), 파마코스모스(MONOFERRIC), 록웰 메디컬(TRIFERIC)을 비롯한 주요 기업들이 개발한 경구제 및 정맥주사제를 아우르는 폭넓은 시판 철분 보충 요법이 포함되어 있으며, 이는 IDA 치료 분야의 지속적인 혁신과 경쟁을 반영하는 것으로, 안전성 향상, 신속한 철분 보충, 그리고 환자 편의성에 대한 관심이 높아지고 있습니다.
  • 한편, 개발 중인 IDA 치료제 파이프라인은 여전히 비교적 제한적이지만, 임상시험 단계에 있는 IDA 치료제로는 IDAX(IHAT-02)(Nemysis사)나 MPB-1514(IOP Injection)(MegaPro Biomedical사) 등이 주목받고 있습니다.

G7 국가들의 철 결핍성 빈혈(IDA) 시장 규모 및 전망

  • 2025년 IDA 시장 규모 : 약 16억 달러
  • IDA 성장률(2026-2036년) : 연평균 성장률(CAGR) 약 1.5%

본 IDA 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 상황에 대한 종합적인 분석을 제공합니다. 또한, IDA 환자의 부담 추이, 수익 및 시장 점유율 추이, 피크 시기의 환자 점유율 및 치료 도입 현황에 대한 분석을 평가하여, 전 세계 각 지역의 시장 규모에 대한 상세한 평가와 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제시하고 있습니다. 본 보고서에서는 IDA 분야의 주요 미충족 요구 사항을 부각시키고, 경쟁 구도 및 임상 현황을 분석하여 고부가가치 기회를 도출하는 한편, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

철 결핍성 빈혈(IDA) 시장을 주도하는 주요 요인

IDA 발병률의 증가

특히 여성에서 IDA 유병률의 증가는 IDA 시장의 성장을 이끄는 주요 요인입니다. 미국에서는 2025년에 약 963만 9,000건의 IDA 확진 사례가 확인되었습니다.

표적 철분 요법의 적용 기회 확대

기존 치료법에 비해 새로운 철분 제제의 유효성과 안전성이 향상되었다는 새로운 증거가 밝혀짐에 따라, 제약 개발 기업들에게는 철분 흡수를 높이고 이용률을 최적화하며, 철 결핍성 빈혈(IDA)의 지속적인 개선을 보장하는 접근 방식에 주력할 기회가 확대되고 있습니다.

철 결핍성 빈혈(IDA)의 이해와 치료 알고리즘

철 결핍성 빈혈(IDA)의 개요와 진단

IDA는 가장 흔한 빈혈의 일종으로, 철분 농도가 낮아져 헤모글로빈 생성이 감소하고, 이로 인해 체내의 산소 운반 기능이 저하되면서 발병합니다. 그 중증도는 경증에서 중증까지 다양하며, 특히 진행된 단계에서는 피로, 무력감, 호흡 곤란 등의 증상이 나타납니다. IDA의 주요 원인은 철분 섭취 부족, 출혈 또는 흡수 장애입니다. 진단은 혈액 검사를 바탕으로 이루어지며, 치료에는 일반적으로 경구 또는 정맥 주사를 통한 철분 보충이 이루어지지만, 중증의 경우 수혈이 필요합니다.

철 결핍성 빈혈(IDA)의 진단

IDA는 신체 검사와 혈액 검사를 통해 진단되며, 대부분의 경우 정기 건강검진 시 발견됩니다. 주요 검사로는 전혈구계수(CBC)가 있으며, 이를 통해 헤모글로빈 수치와 헤마토크리트 수치의 저하, 적혈구의 소형화가 확인됩니다. 혈청 철분, 페리틴, 총 철 결합 능력(TIBC) 등의 추가 검사를 통해 철분 결핍이 확인됩니다. 필요한 경우, 내출혈 등의 근본적인 원인을 파악하기 위해 대변 검사나 내시경 검사 등의 추가 검사가 실시됩니다.

철 결핍성 빈혈(IDA)의 치료

철 결핍성 빈혈(IDA) 치료의 주요 목표는 철분 저장량을 보충하고, 헤모글로빈 수치를 회복시키며, 피로와 무력감 등의 증상을 완화하고, 근본적인 원인(예 : 출혈이나 흡수 장애)을 해결하며, 재발을 예방하는 것입니다. 치료는 주로 약물 요법을 통해 이루어지며, 단계적인 접근 방식이 채택됩니다. 구하기 쉽고 비용 대비 효과가 높기 때문에 황산제1철, 푸마르산제1철, 글루콘산제1철 등의 경구용 철제제(OFP)가 1차 선택 약물로 사용됩니다. 내약성, 흡수 장애 또는 반응이 불충분한 환자의 경우, FERACCRU/ACCRUFER나 AURYXIA/RIONA와 같은 대체 경구제 투여를 고려할 수 있습니다. 카르복시말토스 철(INJECTAFER/FERINJECT)이나 델리소말토스 철(Monofer)과 같은 정맥내 철 제제는 중등도에서 중증의 환자나 만성 신장질환 및 염증성 질환 등의 만성 질환을 앓고 있는 환자에게 신속한 철분 보충을 위해 사용됩니다. 지속적인 혈액학적 안정성을 확보하고 재발 위험을 줄이기 위해서는 식이요법 조정 및 기저 질환 치료를 포함한 지지요법이 필수적입니다.

철 결핍성 빈혈(IDA)의 역학

철 결핍성 빈혈(IDA)의 역학적 분석 및 예측에 관한 주요 조사 결과

  • DelveInsight사의 추산에 따르면, 2025년 주요 7개국에서 철 결핍성 빈혈(IDA)의 총 환자 수는 약 3,137만 명이었습니다.
  • EU4 국가 중 2025년 IDA 유병자 수가 가장 많았던 곳은 독일이었고, 그 다음은 스페인이었으며, 프랑스는 가장 적었습니다.
  • 철 결핍성 빈혈(IDA)의 경우, 여성의 발병률이 높고 발병 연령도 이른 경향이 확인되고 있으며, 특히 감수성 패턴을 파악하고 장기적인 합병증을 예방하기 위해 발병 초기부터 대처해야 한다는 점에서, 성별에 따른 선별 검사 및 조기 개입 전략의 중요성이 부각되고 있습니다.
  • 미국에서 2세 이상 인구의 빈혈 유병률은 9.3%였습니다. 남성의 빈혈 유병률이 여성보다 낮았습니다.

철 결핍성 빈혈(IDA) 시장의 전망

IDA 시장은 급격한 변화를 겪고 있으며, 기존의 경구용 철염이나 일반적인 건강기능식품에서 벗어나, 보다 첨단적이고 표적 치료가 가능하며 환자에게 부담이 적은 치료법으로 전환되고 있습니다. 펠릭 마르톨(Felix Martol)과 같은 신약 제형이나 나노입자 기반 철분 전달 시스템(예 : IHAT)과 같은 혁신적인 접근법의 채택 확대는 흡수성 향상, 위장관 부작용 완화, 그리고 환자의 복약 순응도 향상을 위한 변화를 반영하고 있습니다. 이러한 진전은 철분의 생체 이용률과 내약성을 최적화하는 데 초점을 맞춘 메커니즘 주도형 전략의 유효성을 입증하는 동시에, 차세대 철분 요법에 대한 임상적·규제적 신뢰를 강화하고 경쟁 구도를 재편하고 있습니다.

카르복시말토스 철 제제 등의 정맥내 철 제제와, 안전성 및 유효성 프로파일 개선을 목적으로 개발 중인 후보 약물을 포함한 신규 약물의 개발이 지속되는 가운데, 철 결핍성 빈혈(IDA)의 치료 환경은 혁신이 치료법의 추가 확대를 주도하는 다른 고부담 만성 질환과 마찬가지로 진화하고 있습니다. 일본은 EU4, 영국, 미국과 비교했을 때 진단율이 높고, 첨단 치료에 대한 접근성이 우수하며, 인지도가 높고, 새로운 치료법의 도입이 빠르기 때문에 여전히 최대의 IDA 시장으로 자리 잡고 있습니다.

전반적으로, 차별화된 치료법의 도입, 경구 및 정맥 투여 부문에 걸친 치료 선택지의 확대, 선별 검사 방법의 개선, 그리고 특히 여성이나 만성 질환 환자 등 고위험 집단에서의 인식 제고가 2022년부터 2036년까지 주요 7개국 규모의 IDA 시장에서 꾸준한 성장을 견인할 것으로 예상되며, 승인된 제품과 개발 중인 후보 약물 모두에 큰 상업적 기회가 창출될 전망입니다.

  • 추산에 따르면, IDA 시장에서 가장 큰 시장 규모를 차지하는 곳은 미국이며, 2025년에는 약 13억 달러에 달할 것으로 전망됩니다.
  • IDA 시장은 치료의 초점이 기존의 경구용 철제제(황산제1철, 푸마르산제1철, 글루콘산제1철)에서 보다 진보적이고 내약성이 높은 치료법으로 전환됨에 따라 진화하고 있습니다. FERACCRU/ACCRUFER와 같은 신규 경구제 및 INJECTAFER/FERINJECT, MONOFER와 같은 정맥주사제가 효능과 내약성의 향상, 그리고 폭넓은 환자층에서의 사용 확대를 통해 시장 도입을 주도하고 있습니다.
  • 지역별 시장 동향을 살펴보면, 매출액 면에서는 미국이 1위를 차지하고 있는 반면, 일본 및 EU 시장에서는 진단율 향상, 소아 환자 대상 접근성 확대, 그리고 새로운 작용 기전의 도입 증가를 반영하여 꾸준한 성장세를 보이고 있습니다.
  • 기존의 경구용 철분제 요법 : 황산제1철, 푸마르산제1철, 글루콘산제1철 등의 약제는 여전히 널리 1차 치료제로 사용되고 있으며, 비용 대비 효과가 높은 철분 보충을 제공하지만, 위장관 부작용이나 낮은 복약 순응도로 인해 제한을 받는 경우가 많습니다.
  • 신규 경구 제제인 FERACCRU/ACCRUFER는 철분의 흡수 및 내약성을 높이기 위해 설계된 차세대 경구 요법으로, 환자의 복약 순응도를 개선하고 더 폭넓은 환자층으로의 사용 확대를 뒷받침하며, 작용 기전에 기반한 제제로의 전환을 입증하고 있습니다.
  • 정맥내 철분 제제 요법 : INJECTAFER/FERINJECT 및 MONOFER와 같은 제품은 특히 중증 철분 결핍증, 만성 질환 환자 또는 경구 요법에 내성이 있는 환자에서 신속하고 효율적인 철분 보충을 실현함으로써, 질환 관리에 있어 중요한 선택지로서의 역할을 강화하고 있습니다.
  • 보조 요법 및 비약물 요법 : 영양 보충제나 보조 요법은 특히 경증에서 중등도의 증례나 예방 의료의 상황에서 철분 수치의 회복과 유지를 돕습니다.

정맥내 요법과 새로운 경구 요법이 결합되어, 철 결핍성 빈혈(IDA) 분야의 핵심적인 혁신의 전체적인 그림을 그려내고 있습니다. 정맥 주사제는 임상적·상업적으로 확고한 입지를 다지고 있는 반면, 개선된 경구용 제제와 신기술이 차세대 시장 성장을 주도하고 있습니다.

자주 묻는 질문

  • 2025년 철 결핍성 빈혈(IDA) 시장 규모는 어떻게 되나요?
  • 철 결핍성 빈혈(IDA) 시장의 연평균 성장률(CAGR)은 어떻게 되나요?
  • 철 결핍성 빈혈(IDA) 치료에 사용되는 주요 약물은 무엇인가요?
  • 철 결핍성 빈혈(IDA)의 주요 원인은 무엇인가요?
  • 2025년 주요 7개국에서 철 결핍성 빈혈(IDA) 환자 수는 얼마나 되나요?
  • 여성에서 철 결핍성 빈혈(IDA) 유병률이 증가하는 이유는 무엇인가요?
  • 철 결핍성 빈혈(IDA) 치료의 주요 목표는 무엇인가요?

목차

제1장 주요 인사이트

제2장 소개

제3장 주요 요약

제4장 주요 사건

제5장 철 결핍성 빈혈 : 역학 및 시장 예측 조사 방법

제6장 철 결핍성 빈혈 : 시장 개요

제7장 철 결핍성 빈혈 : 질환 배경과 개요

제8장 치료

제9장 철 결핍성 빈혈 : 역학 및 환자 인구

제10장 철 결핍성 빈혈 : 환자 경과

제11장 시판 치료제

제12장 신흥 치료제

제13장 철 결핍성 빈혈 : 주요 7개국 분석

제14장 철 결핍성 빈혈 : 미충족 수요

제15장 철 결핍성 빈혈 : SWOT 분석

제16장 철 결핍성 빈혈 : KOL의 견해

제17장 철 결핍성 빈혈 : 시장 진입 및 상환

제18장 부록

제19장 DelveInsight의 서비스 내용

제20장 면책사항

제21장 DelveInsight 소개

KSM 26.07.20

Iron Deficiency Anemia (IDA) Insights and Trends

  • According to DelveInsight's analysis, IDA market size was found to be ~USD 1,600 million in the leading markets (the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan) in 2025.
  • A significant proportion of IDA burden is associated with comorbid conditions such as chronic kidney disease, cancer, chronic heart failure, inflammatory bowel disease, celiac disease, and women's health-related factors, with chronic kidney disease contributing the largest share, highlighting the need for integrated disease management, early screening, and targeted treatment approaches to reduce complications and improve patient outcomes.
  • In the IDA market across the 7MM, ferric carboxymaltose (INJECTAFER/FERINJECT) accounts for the largest share among treatment options, driven by its widespread use in moderate-to-severe patients requiring rapid and effective iron repletion.
  • The current IDA market is characterized by widespread use of low-cost Oral Ferrous Products (OFPs) such as ferrous sulphate, ferrous fumarate, and ferrous gluconate, alongside a growing shift toward higher-cost advanced therapies including FERACCRU/ACCRUFER, AURYXIA/RIONA, and intravenous iron formulations like INJECTAFER/FERINJECT, and MONOFER, driven by the need for improved efficacy, faster replenishment, and better tolerability in moderate-to-severe patients.
  • IDA treatment landscape includes a broad range of marketed iron replacement therapies across oral and intravenous formulations, developed by leading pharmaceutical companies, including Daiichi Sankyo (INJECTAFER/FERINJECT), Pharmacosmos (MONOFERRIC), and Rockwell Medical (TRIFERIC) reflecting continued innovation and competition in the IDA therapeutic space, with a growing focus on improved safety, rapid iron repletion, and patient convenience.
  • Whereas the emerging IDA pipeline remains relatively limited, some of the IDA drugs in clinical trials include IDAX (IHAT-02) (Nemysis), MPB-1514 (IOP Injection) (MegaPro Biomedical) are being evaluated.

Iron Deficiency Anemia (IDA) Market Size and Forecast in the 7MM

  • 2025 IDA Market Size: ~USD 1,600 million
  • IDA Growth Rate (2026-2036): ~1.5% CAGR

DelveInsight's 'Iron Deficiency Anemia (IDA) - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the IDA, historical and forecasted epidemiology, as well as the IDA market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The IDA market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, IDA patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in IDA and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Iron Deficiency Anemia (IDA) Market

Rising IDA Incidence

The increasing prevalence of IDA, particularly among females, is a primary driver of IDA market expansion. In the US, in 2025, there were ~9,639,000 prevalent cases of IDA.

Rising Opportunities in Targeted Iron Therapies

Emerging evidence of improved efficacy and safety of novel iron formulations over conventional therapies highlights a growing opportunity for drug developers to focus on approaches that enhance iron absorption, optimize utilization, and ensure sustained correction of anemia in IDA.

Emerging IDA Competitive Landscape

Pipeline for ROP is limited. Some of the IDA drugs in clinical trials include IDAX (IHAT-02) (Nemysis), MPB-1514 (IOP Injection) (MegaPro Biomedical), and others.

Iron Deficiency Anemia (IDA) Understanding and Treatment Algorithm

Iron Deficiency Anemia (IDA) Overview and Diagnosis

IDA is the most common form of anemia, occurring when low iron levels reduce hemoglobin production and impair oxygen transport in the body. It can range from mild to severe, with symptoms such as fatigue, weakness, and shortness of breath, especially in advanced stages. IDA is mainly caused by poor iron intake, blood loss, or reduced absorption. Diagnosis is based on blood tests, and treatment typically involves oral or intravenous iron supplementation, with transfusion required in severe cases.

Iron Deficiency Anemia (IDA) Diagnosis

IDA is diagnosed through physical examination and blood tests, often detected during routine checkups. A complete blood count (CBC) is the primary test, showing low hemoglobin, hematocrit, and smaller red blood cells. Additional tests such as serum iron, ferritin, and total iron-binding capacity (TIBC) confirm iron deficiency. If needed, further investigations like stool tests or endoscopy are done to identify underlying causes such as internal bleeding.

Iron Deficiency Anemia (IDA) Treatment

The primary goals of IDA treatment are to replenish iron stores, restore hemoglobin levels, alleviate symptoms such as fatigue and weakness, address underlying causes (e.g., blood loss or malabsorption), and prevent recurrence. Management is largely pharmacologic and follows a step-wise approach, with Oral Ferrous Products (OFPs) such as ferrous sulphate, ferrous fumarate, and ferrous gluconate used as first-line therapy due to their accessibility and cost-effectiveness. In patients with intolerance, poor absorption, or inadequate response, alternative oral agents such as FERACCRU/ACCRUFER and AURYXIA/RIONA may be considered. Intravenous iron formulations, including ferric carboxymaltose (INJECTAFER/FERINJECT), and ferric derisomaltose (Monofer) are utilized for rapid repletion in moderate-to-severe cases or in those with chronic conditions such as chronic kidney disease or inflammatory disorders. Supportive strategies, including dietary modification and treatment of underlying etiologies, are essential to ensure sustained hematologic stability and reduce the risk of relapse.

Iron Deficiency Anemia (IDA) Unmet Needs

The section "unmet needs of IDA" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Challenges in accurate and timely diagnosis

2. Impacted patient's quality of life (QoL)

3. Pregnancy and effects of IDA

4. Issues with existing treatment options, and others.....

Comprehensive unmet needs insights in Iron Deficiency Anemia (IDA) and their strategic implications are provided in the full report.

Iron Deficiency Anemia (IDA) Epidemiology

Key Findings from Iron Deficiency Anemia (IDA) Epidemiological Analysis and Forecast

  • According to DelveInsight's estimates, the total prevalent cases of IDA in the 7MM were approximately 31,370,000 in 2025.
  • Among the EU4, Germany accounted for the highest number of prevalent cases of IDA, followed by Spain, whereas France accounted for the lowest number of cases in 2025.
  • The observed female predominance and earlier onset of IDA highlight the importance of sex-specific screening and early intervention strategies, particularly in recognizing susceptibility patterns and addressing disease at onset to prevent long-term complications.
  • 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.

Iron Deficiency Anemia (IDA) Drug Chapters & Competitive Analysis

The IDA drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the IDA treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the IDA therapeutics market.

Approved Therapies for Iron Deficiency Anemia (IDA)

Ferric Citrate (AURYXIA): Akebia Therapeutics

Ferric Citrate (AURYXIA), developed by Akebia Therapeutics (through its subsidiary Keryx Biopharmaceuticals), is an oral, non-calcium, iron-based small molecule with a dual mechanism of action, initially approved by the U.S. FDA in 2014 for hyperphosphatemia in chronic kidney disease and later in 2017 for the treatment of adult patients with IDA. By providing bioavailable iron while also acting as a phosphate binder, AURYXIA supports hemoglobin improvement and iron repletion, particularly in CKD patients, reflecting its differentiated therapeutic profile. In Japan, it is marketed as RIONA by Japan Tobacco and Torii Pharmaceutical, with approval for IDA granted in 2021, highlighting its global clinical utility and lifecycle expansion.

Ferric Maltol (FERACCRU/ACCRUFER): Shield Therapeutics

Ferric Maltol/ ST10 (FERACCRU/ACCRUFER), developed by Shield Therapeutics, is a novel oral iron therapy designed for patients with IDA who are intolerant to conventional oral ferrous products or seek an alternative to intravenous iron. Formulated as a stable ferric maltol complex containing 30 mg of iron, it enables targeted delivery and absorption in the duodenum while minimizing free iron-related gastrointestinal side effects. By remaining tightly bound, unabsorbed iron passes through the digestive system without dissociation, improving tolerability and safety. This mechanism supports effective iron repletion while offering a convenient, well-tolerated, and non-invasive alternative to hospital-based IV therapies, addressing a key unmet need in IDA management.

Iron Deficiency Anemia (IDA) Pipeline Analysis

IDAX (IHAT-02): Nemysis

IDAX (IHAT-02), developed by Nemysis, HAT-02/IDAX (Nemysis) is a novel oral iron formulation (IHAT) designed as a natural ferritin mimic, enabling efficient iron absorption as intact nanoparticles without requiring gastric solubilization. It closely replicates physiological iron uptake, improves iron deficiency markers, and minimizes gastrointestinal side effects. By preventing the release of free iron in the gut, it helps preserve the microbiome while maintaining normal iron homeostasis after absorption.

Iron Deficiency Anemia (IDA) Key Players, Market Leaders and Emerging Companies

  • Akebia Therapeutics
  • Shield Therapeutics
  • American Regent
  • Zeria
  • Pharmacosmos
  • MegaPro Biomedical
  • Nemysis, and others

Iron Deficiency Anemia (IDA) Drug Updates

  • In March 2026, Shield Therapeutics announced that the European Medicines Agency (EMA), via Committee for Medicinal Products (CHMP) for Human Use, issued a positive opinion to extend the indication of FERACCRU to adolescents, now indicated for iron deficiency in patients >=12 years, with all Pediatric Investigation Plan requirements fulfilled.
  • In Dec 2025, the US FDA approved label expansion of ACCRUFER to include adolescents, now indicated for iron deficiency in patients >=10 years.
  • In November 2025, Nemysis Limited announced a Subscription Agreement under which Kolinpharma, via its parent IGEA Holding, invested in Nemysis' capital.

Drug Class Insights

Iron Deficiency Anemia (IDA) Market Outlook

The IDA market is undergoing a notable transformation, moving beyond traditional oral iron salts and conventional supplementation toward more advanced, targeted, and patient-friendly therapies. The growing adoption of novel formulations such as ferric maltol and innovative approaches like nanoparticle-based iron delivery systems (e.g., IHAT) reflects a shift toward improved absorption, reduced gastrointestinal side effects, and enhanced patient compliance. These advancements validate mechanism-driven strategies focused on optimizing iron bioavailability and tolerability, while strengthening clinical and regulatory confidence in next-generation iron therapies and reshaping the competitive landscape.

With the continued development of novel agents, including intravenous iron formulations such as ferric carboxymaltose and pipeline candidates targeting improved safety and efficacy profiles, the IDA treatment landscape is evolving similarly to other high-burden chronic conditions, where innovation drives broader therapeutic expansion. The Japan remains the largest IDA market, supported by higher diagnosis rates, better access to advanced therapies, strong awareness, and faster adoption of novel treatments compared with the EU4, the United Kingdom, and the US.

Overall, the introduction of differentiated therapies, expanding treatment options across oral and intravenous segments, improved screening practices, and rising awareness particularly among high-risk populations such as women and patients with chronic diseases-are expected to drive steady growth in the 7MM IDA market from 2022-2036, with significant commercial opportunities for both approved products and emerging pipeline candidates.

  • According to the estimates, the largest market size of IDA was captured by the United States, i.e., ~USD 1,300 million in 2025.
  • The IDA market is evolving as treatment focus shifts from conventional oral ferrous products (e.g., ferrous sulphate, ferrous fumarate, and ferrous gluconate) toward more advanced and better-tolerated therapies, with novel oral agents such as FERACCRU/ACCRUFER and intravenous formulations including INJECTAFER/FERINJECT, and MONOFER driving adoption due to improved efficacy, tolerability, and broader use across patient populations.
  • Regional market dynamics show the US leading in revenue, while Japan and EU markets demonstrate steady growth, reflecting increasing diagnosis rates, broader pediatric access, and rising adoption of novel mechanisms.

Drug Class/Insights into Leading Emerging and Marketed Therapies in Iron Deficiency Anemia (IDA) (2022-2036 Forecast)

The IDA market comprises conventional oral iron therapies, novel oral agents, intravenous iron formulations, and supportive/non-drug products, each addressing distinct aspects of iron absorption, bioavailability, and tolerability in iron deficiency anemia.

  • Conventional oral iron therapies: Agents such as ferrous sulphate, ferrous fumarate, and ferrous gluconate remain widely used first-line treatments, providing cost-effective iron replenishment but often limited by gastrointestinal side effects and poor adherence.
  • Novel oral agents: FERACCRU / ACCRUFER represent next-generation oral therapies designed to enhance iron absorption and tolerability, validating the shift toward mechanism-driven formulations that improve patient compliance and expand use in broader populations.
  • Intravenous iron therapies: Products such as INJECTAFER / FERINJECT, and MONOFER deliver rapid and efficient iron repletion, particularly in patients with severe deficiency, chronic diseases, or intolerance to oral therapies, reinforcing their role as key disease-management options.
  • Supportive and non-drug products: Nutritional supplements and adjunctive therapies support iron restoration and maintenance, particularly in mild-to-moderate cases and preventive care settings.

Intravenous and novel oral therapies together define the core innovation landscape in IDA, with IV formulations well established clinically and commercially, while improved oral agents and emerging technologies are driving next-generation market growth.

Iron Deficiency Anemia (IDA) Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the IDA market's uptake by drugs, patient uptake by therapy, and sales of each drug.

The uptake of therapies in IDA is expected to vary across oral iron formulations, intravenous (IV) iron therapies, and emerging novel agents. Recently approved or widely used IV iron therapies such as ferric carboxymaltose and ferric derisomaltose demonstrate moderate to high uptake, while newer agents like ferric pyrophosphate citrate (TRIFERIC) and investigational products are anticipated to show progressive uptake, supported by improved safety profiles, convenience of administration, and rapid replenishment of iron stores. Their adoption is likely to be driven by the limitations of conventional oral iron therapies, including poor gastrointestinal tolerability, low adherence, and delayed efficacy, particularly in patients with chronic conditions or severe anemia. In comparison, other next-generation therapies and novel delivery approaches are expected to witness gradual but steady uptake as clinical evidence expands and these agents are increasingly incorporated into treatment guidelines across diverse IDA patient populations.

Iron Deficiency Anemia (IDA) Therapies Price Scenario & Trends

Pricing and analogue assessment of IDA therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.

Further details are provided in the final report....

Industry Experts and Physician Views for Iron deficiency anemia (IDA)

To keep up with IDA market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the IDA emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in IDA, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as the Harvard Medical School, University of Nottingham, and Japanese Red Cross Central Blood Institute, etc. were contacted. Their opinion helps understand and validate current and emerging IDA therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in IDA.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of Iron deficiency anemia (IDA), 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.

Conjoint analysis analyzes 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.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, 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.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, a descriptive overview of IDA, explaining its causes, signs and symptoms, pathogenesis, and currently available treatments.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
  • A detailed review of the IDA 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 in shaping and driving the 7MM IDA market.

Report Insights

  • Iron Deficiency Anemia (IDA) Patient Population Forecast
  • Iron Deficiency Anemia (IDA) Therapeutics Market Size
  • Iron Deficiency Anemia (IDA) Pipeline Analysis
  • Iron Deficiency Anemia (IDA) Market Size and Trends
  • Iron Deficiency Anemia (IDA) Market Opportunity (Current and forecasted)

Report Key Strengths

  • Epidemiology-based (Epi-based) Bottom-up Forecasting
  • Artificial Intelligence (AI)-enabled Market Research Report
  • 11-year Forecast
  • Iron Deficiency Anemia (IDA) Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (by geography)
  • Iron Deficiency Anemia (IDA) Treatment Addressable Market (TAM)
  • Iron Deficiency Anemia (IDA) Competitive Landscape
  • Iron Deficiency Anemia (IDA) Major Companies Insights
  • Iron Deficiency Anemia (IDA) Price Trends and Analogue Assessment
  • Iron Deficiency Anemia (IDA) Therapies Drug Adoption/Uptake
  • Iron Deficiency Anemia (IDA) Therapies Peak Patient Share analysis

Report Assessment

  • Iron Deficiency Anemia (IDA) Current Treatment Practices
  • Iron Deficiency Anemia (IDA) Unmet Needs
  • Iron Deficiency Anemia (IDA) Clinical Development Analysis
  • Iron Deficiency Anemia (IDA) Emerging Drugs Product Profiles
  • Iron Deficiency Anemia (IDA) Market Attractiveness
  • Iron Deficiency Anemia (IDA) Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

  • What was the Iron Deficiency Anemia (IDA) market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
  • What can be the future treatment paradigm of Iron deficiency anemia (IDA)?
  • What are the disease risks, burdens, and unmet needs of Iron deficiency anemia (IDA)? What will be the growth opportunities across the 7MM concerning the patient population with Iron deficiency anemia (IDA)?
  • Who is the major future competitor in the market, and how will the competitors affect their market share?
  • What are the current options for the treatment of Iron deficiency anemia (IDA)? What are the current guidelines for treating Iron Deficiency Anemia (IDA) in the US, Europe, and Japan?

Reasons to Buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Iron Deficiency Anemia (IDA) market.
  • Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
  • Insights on patient burden/disease incidence, 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.
  • 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 conjoint analysis section to provide visibility around leading classes.
  • To understand KOLs' perspectives on 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.
  • This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets within the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Key Events

  • 4.1. Upcoming Key Catalysts
  • 4.2. Key Transactions And Collaborations
  • 4.3. News Flow
  • 4.4. Key Conference Highlights

5. Epidemiology and Market Forecast Methodology of Iron Deficiency Anemia (IDA)

6. Iron Deficiency Anemia (IDA) Market Overview at a Glance

  • 6.1. Clinical Landscape Analysis (By Phase, Molecule Type, and RoA)
  • 6.2. Market Share (%) Distribution of IDA By Therapies in the 7MM, in 2025
  • 6.3. Market Share (%) Distribution of IDA By Therapies in the 7MM, in 2036

7. Disease Background and Overview of Iron Deficiency Anemia (IDA)

  • 7.1. Introduction
  • 7.2. Anemia
    • 7.2.1. Types of Anemia
  • 7.3. IDA
  • 7.4. Signs and Symptoms of IDA
  • 7.5. Causes of IDA
  • 7.6. Risk factors of IDA
  • 7.7. Pathophysiology of IDA
    • 7.7.1. Iron Cycle
    • 7.7.2. Stages of Iron Deficiency
  • 7.8. Diagnosis of IDA
    • 7.8.1. Differential Diagnosis
    • 7.8.2. Diagnostic Algorithm of IDA
    • 7.8.3. Academy of Family Physicians (AAFP) Guidelines for the Diagnosis of IDA
    • 7.8.4. British Society of Gastroenterology Guidelines for the Diagnosis of IDA in Gastrointestinal (GI) Diseases
    • 7.8.5. UK National Screening Committee (NSC) Screening Recommendation

8. Treatment

  • 8.1. Algorithm for the Treatment of IDA
  • 8.2. Guidelines for the treatment of IDA
    • 8.2.1. Treatment of IDA During Pregnancy
    • 8.2.2. British Society of Gastroenterology Guidelines on the Treatment of IDA
    • 8.2.3. WHO Guideline: Use of Ferritin Concentrations to Assess Iron Status in Individuals and Populations
    • 8.2.4. WHO Guideline: Daily Iron Supplementation in Adult Women and Adolescent Girls
    • 8.2.5. Guidelines on Prevention and Treatment of IDA in Infants and Young Children
    • 8.2.6. European Society for Medical Oncology (ESMO) Guidelines for the Management of Anemia and Iron Deficiency in Patients with Cancer
    • 8.2.7. European Crohn's and Colitis Organization Guidelines for IDA

9. Epidemiology and Patient Population of Iron Deficiency Anemia (IDA)

  • 9.1. Key Findings
  • 9.2. Assumptions and Rationale
  • 9.3. Diagnosed Prevalent Cases of IDA in the 7MM
  • 9.4. The United States
    • 9.4.1. Total Prevalent Cases of Iron Deficiency Anemia (IDA) in US
    • 9.4.2. Total Diagnosed Prevalent Cases of Iron Deficiency Anemia (IDA) in US
    • 9.4.3. Gender-Specific Diagnosed Prevalent Cases of Iron Deficiency Anemia (IDA) in US
    • 9.4.4. Pathology-Specific Diagnosed Prevalent Cases of Iron Deficiency Anemia (IDA) in US
    • 9.4.5. Severity-specific Diagnosed Prevalent Cases of Iron Deficiency Anemia (IDA) in US
    • 9.4.6. Total treated Cases of Iron Deficiency Anemia (IDA) in US
  • 9.5. EU4 and the UK
    • 9.5.1. Total Prevalent Cases of Iron Deficiency Anemia (IDA) in EU4 and the UK
    • 9.5.2. Total Diagnosed Prevalent Cases of Iron Deficiency Anemia (IDA) in EU4 and the UK
    • 9.5.3. Gender-Specific Diagnosed Prevalent Cases of Iron Deficiency Anemia (IDA) in EU4 and the UK
    • 9.5.4. Pathology-Specific Diagnosed Prevalent Cases of Iron Deficiency Anemia (IDA) in EU4 and the UK
    • 9.5.5. Severity-specific Diagnosed Prevalent Cases of Iron Deficiency Anemia (IDA) in EU4 and the UK
    • 9.5.6. Total treated Cases of Iron Deficiency Anemia (IDA)
  • 9.6. Japan
    • 9.6.1. Total Prevalent Cases of Iron Deficiency Anemia (IDA) in Japan
    • 9.6.2. Total Diagnosed Prevalent Cases of Iron Deficiency Anemia (IDA) in Japan
    • 9.6.3. Gender-Specific Diagnosed Prevalent Cases of Iron Deficiency Anemia (IDA) in Japan
    • 9.6.4. Pathology-Specific Diagnosed Prevalent Cases of Iron Deficiency Anemia (IDA) in Japan
    • 9.6.5. Severity-specific Diagnosed Prevalent Cases of Iron Deficiency Anemia (IDA) in Japan
    • 9.6.6. Total treated Cases of Iron Deficiency Anemia (IDA) in Japan

10. Patient Journey of Iron Deficiency Anemia (IDA)

11. Marketed Therapies

  • 11.1. Marketed Competitive Landscape of Iron Deficiency Anemia (IDA)
  • 11.2. Riona/ KRX-0502/Ferric Citrate (AURYXIA): Akebia Therapeutics
    • 11.2.1. Drug Description
    • 11.2.2. Regulatory Milestones
    • 11.2.3. Other Developmental Activities
    • 11.2.4. Summary of Pivotal Trials
    • 11.2.5. Clinical Development
      • 11.2.5.1. Clinical Trial Information
    • 11.2.6. Analyst's Views
  • 11.3. Ferric Maltol/ ST10 (FERACCRU/ACCRUFER): Shield Therapeutics
    • 11.3.1. Drug Description
    • 11.3.2. Regulatory Milestones
    • 11.3.3. Other Developmental Activities
    • 11.3.4. Summary of Pivotal Trials
    • 11.3.5. Clinical Development
      • 11.3.5.1. Clinical Trial Information
    • 11.3.6. Analyst's Views
  • 11.4. Iron Isomaltoside 1000/ Monoferric/ ferric derisomaltose/ NS-32 (MONOFER): Pharmacosmos Therapeutics
    • 11.4.1. Drug Description
    • 11.4.2. Regulatory Milestones
    • 11.4.3. Other Developmental Activities
    • 11.4.4. Summary of Pivotal Trials
    • 11.4.5. Clinical Development
      • 11.4.5.1. Clinical Trial Information
    • 11.4.6. Analyst's Views
  • 11.5. Ferric carboxymaltose/ VIT-45 (FERINJECT/INJECTAFER): American Regent/Vifor Pharma/JW pharmaceutical Pharma/Zeria
    • 11.5.1. Drug Description
    • 11.5.2. Regulatory Milestones
    • 11.5.3. Other Developmental Activities
    • 11.5.4. Summary of Pivotal Trials
    • 11.5.5. Analyst's Views

12. Emerging Drugs

  • 12.1. Emerging Competitive Landscape of Iron Deficiency Anemia (IDA)
  • 12.2. IDAX (IHAT-02): Nemysis
    • 12.2.1. Drug Description
    • 12.2.2. Other Developmental Activities
    • 12.2.3. Clinical Development
      • 12.2.3.1. Clinical Trials Information
    • 12.2.4. Analyst's Views

13. Iron Deficiency Anemia (IDA): 7MM Analysis

  • 13.1. Key Findings
  • 13.2. Market Outlook of Iron Deficiency Anemia (IDA)
  • 13.3. Key Market Forecast Assumptions
    • 13.3.1. Cost Assumptions
    • 13.3.2. Pricing Trends
    • 13.3.3. Analogue Assessment
    • 13.3.4. Launch Year and Therapy Uptakes
  • 13.4. Conjoint Analysis of Iron Deficiency Anemia (IDA)
  • 13.5. Total Market Size of IDA in the 7MM
  • 13.6. Total Market Size of IDA by Therapies in the 7MM
  • 13.7. The United States
    • 13.7.1. Total Market Size of IDA in the United States
    • 13.7.2. Total Market Size of IDA by Therapies in the United States
  • 13.8. EU4 and the UK
    • 13.8.1. Total Market Size of IDA in EU4 and the UK
    • 13.8.2. Total Market Size of IDA by Therapies in EU4 and the UK
  • 13.9. Japan
    • 13.9.1. Total Market Size of IDA in Japan
    • 13.9.2. Total Market Size of IDA by Therapies in Japan

14. Unmet Needs of Iron Deficiency Anemia (IDA)

15. SWOT Analysis of Iron Deficiency Anemia (IDA)

16. KOL Views of Iron Deficiency Anemia (IDA)

17. Market Access and Reimbursement of Iron Deficiency Anemia (IDA)

  • 17.1. The United States
  • 17.2. EU4 and the UK
    • 17.2.1. Germany
    • 17.2.2. France
    • 17.2.3. Italy
    • 17.2.4. Spain
    • 17.2.5. United Kingdom
  • 17.3. Japan
  • 17.4. Summary and comparison of Market Access and Pricing Policy Developments in 2025
  • 17.5. Market Access and Reimbursement of IDA Therapies

18. Appendix

  • 18.1. Bibliography
  • 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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