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빈혈 : 시장 인사이트, 역학 및 시장 예측(2036년)

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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빈혈에 대한 인사이트와 동향

  • 빈혈은 특히 유아와 임산부 사이에서 전 세계 공중보건상의 중대한 과제가 되고 있습니다. WHO에 따르면, 전 세계적으로 5세 미만 아동의 약 42%, 임산부의 약 40%가 빈혈을 앓고 있는 것으로 추정됩니다.
  • 빈혈을 효과적으로 선별하고 적시에 치료하기 위해서는 현지 상황과 위험 요인을 이해해야 하며, 공중보건 계획 및 개입을 개선하기 위해서는 정확한 유병률 데이터가 중요합니다.
  • 자가면역성 용혈성 빈혈(AIHA)은 희귀질환으로, 연간 발생률은 10만 명당 약 1-3건으로 추정됩니다. 고령 환자의 경우, 골수 예비능의 저하, 에리스로포이에틴에 대한 반응성 저하, 노화에 따른 면역계 노화, 그리고 동반 질환의 유병률이 높다는 점 등으로 인해 진단 및 관리에 어려움이 발생할 수 있습니다.
  • 온형 자가면역 용혈성 빈혈(wAIHA)은 병원성 면역글로불린 G(IgG) 자가항체가 적혈구를 표적으로 삼아 파괴하는 중증 질환입니다. 현재의 치료는 주로 광범위한 면역억제 요법에 의존하고 있지만, 이러한 요법들은 근본적인 질병 기전을 해결하는 것은 아니며, wAIHA에 대한 안전하고 효과적인 치료법으로 구체적으로 승인된 것도 아닙니다.
  • 최근 AGA 임상 실무 업데이트에 따르면, 황산제1철은 가격이 저렴하기 때문에 철분 보충 요법으로 권장되고 있습니다. 그러나 지침에서는 특정 형태의 철분 보충 요법이 다른 형태보다 뛰어난 효능을 보였습니다는 보고는 없습니다고 지적하고 있습니다.
  • 경구용 철분제 요법은 정맥 내(IV) 요법에 비해 구하기 쉽고 비용도 저렴하지만, 복약 순응도가 낮고 효과가 들쑥날쑥하며 위장관 관련 이상반응(AE)이 발생하기 때문에 그 유효성이 제한되는 경우가 많으며, 그 결과 환자가 치료에 대한 신뢰도가 떨어질 가능성이 있습니다.
  • 판코니 빈혈은 20개 이상의 유전자와 관련된 희귀 유전병으로, 골수 기능 부전에 따른 모든 혈액 세포 계통의 생성 저하를 특징으로 합니다. 치료는 주로 조혈모세포 이식(HSCT)을 중심으로 이루어지며, 이를 통해 골수 부전이나 혈액 악성 종양을 치료할 수 있지만, 모든 환자에게 효과가 있는 것은 아닙니다.
  • 다이아몬드-블랙 팬 빈혈 증례의 약 75%에서 리보솜 단백질 유전자에 이형접합 돌연변이가 확인되며, 이 질환은 리보솜 질환으로 분류됩니다. 그 중에서도 RPS19는 변이가 가장 빈번하게 나타나는 유전자입니다.
  • 중증 재생불량성 빈혈(SAA)에 관한 최신 ASH 지침에서는 성인 및 소아 모두에서 혈구 수치를 개선하기 위해 표준 면역억제 요법에 엘트롬보파그를 추가할 것을 권장하고 있습니다.

'빈혈' 시장 보고서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재 시장 상황에 대한 종합적인 분석을 제공합니다. 본 보고서에서는 빈혈 환자의 부담 추이, 수익 및 시장 점유율 추이, 피크 시기의 환자 점유율 및 치료 도입 현황에 대한 분석을 평가함과 동시에, 전 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 전망(과거 데이터 및 2022년-2036년 전망)을 제시하고 있습니다. 본 보고서는 빈혈 분야에서 충족되지 않은 주요 요구 사항을 부각시키고, 경쟁 환경 및 임상 상황을 분석하여 고부가가치의 성장 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

빈혈 시장을 주도하는 주요 요인

  • 치료법의 혁신에 따라 정맥 내 철분 제제에서 새로운 경구 제제로의 전환이 진행되고 있습니다.

경구용 철분제의 한계와 비경구 요법의 활용 확대에 따라 시장이 재편되고 있습니다. INJECTAFER 및 MONOFERRIC의 FDA 승인 표기는 경구용 철분제 내성이 없는 환자나 경구 요법만으로는 충분한 효과를 얻지 못하는 환자를 특히 대상으로 하고 있으며, 이는 실제 임상 현장에서 경구 요법만으로는 충분하지 않은 사례가 얼마나 많은지를 보여줍니다. 만성 신장 질환(CKD) 분야에서는 경구용 HIF-PH 억제제가 치료 선택의 폭을 넓혀 주며, 수혈 의존에서 벗어나는 데 기여하고 있습니다. 철 결핍증 분야에서는 만성 신장 질환(CKD), 경구용 철제제 불내성 환자 및 기타 치료 수요가 높은 환자군을 대상으로 한 주사용 철제제의 FDA 승인 적응증 확대로 인해, 치료 대상이 되는 환자층이 꾸준히 확대되고 있습니다.

  • 대규모이며 지속적인 미치료로 인한 부담

빈혈은 전 세계적으로 여전히 막대한 부담을 주고 있기 때문에 광범위한 치료 기반을 지속적으로 창출하고 있습니다. WHO의 추산에 따르면, 6-59개월 영유아의 40%, 임산부의 37%, 15-49세 여성의 30%가 빈혈을 앓고 있습니다. 또한 WHO는 빈혈로 인해 약 5,000만 건강수명년이 상실되고 있는 것으로 추정하고 있으며, 그 주요 원인 중 하나로 식이성 철분 결핍을 꼽고 있습니다.

빈혈에 대한 이해와 치료 알고리즘

빈혈의 개요와 진단

빈혈이란 적혈구 수나 헤모글로빈 농도가 정상치보다 낮아져, 조직으로 산소를 운반하는 혈액의 능력이 저하된 상태를 말합니다. 특히 여성과 어린이에게서 많이 나타나며, 중증의 경우 어린이의 인지 기능이나 운동 기능 발달에 지장을 주거나, 임산부와 태아에게 합병증을 유발할 가능성이 있습니다. 이러한 상태는 영양실조, 감염증, 만성 질환, 과다월경, 임신 관련 문제, 유전적 소인 등 여러 요인에 의해 유발되지만, 철분 결핍이 여전히 가장 흔한 원인입니다.

빈혈 진단은 임상 평가와 검사 결과를 바탕으로 이루어집니다. 의사는 피로감, 무기력감, 안색 불량, 숨가쁨, 현기증 등의 증상 외에도 병력, 식습관, 생리 주기, 만성 질환 등을 평가합니다. 또한, 신체 검사 시 안색이 나쁘거나 심박수가 증가하는 등의 징후가 나타날 수 있습니다. 확정 진단은 주로 전혈구 계수(CBC)를 통해 이루어집니다. 이는 헤모글로빈, 적혈구 수, 헤마토크리트 수치를 측정하는 것으로, 헤모글로빈 수치의 저하가 주요 지표가 됩니다. 또한, 적혈구 지수도 빈혈의 유형을 파악하는 데 도움이 됩니다. 철분 검사, 비타민 B12 및 엽산 농도 측정, 망상 적혈구 수 측정 등의 추가 검사는 근본적인 원인을 파악하는 데 도움이 됩니다. 또한 경우에 따라 대변 검사, 신장 기능 검사, 혹은 만성 질환 선별 검사 등의 추가 검사가 필요할 수도 있습니다. 치료는 빈혈 개선뿐만 아니라 근본적인 질환에 대한 대처에도 중점을 두기 때문에 근본 원인을 파악하는 것이 필수적입니다.

빈혈 치료

빈혈의 치료는 그 원인, 중증도 및 환자의 전반적인 건강 상태에 따라 달라집니다. 철결핍성 빈혈(IDA)은 일반적으로 철분제 투여나 철분 섭취량을 늘리기 위한 식이요법으로 치료되지만, 비타민 C를 병용하면 철분 흡수가 개선되는 경우가 있습니다. 경구용 철제제가 효과를 보이지 않거나 내약성이 낮은 경우에는 정맥 주사용 철제제가 사용되기도 합니다. 비타민 B12나 엽산 결핍으로 인한 빈혈은 영양제나 주사를 통해 치료되지만, 만성 질환과 관련된 빈혈의 경우 기저 질환을 관리해야 하며, 경우에 따라 적혈구 생성을 촉진하는 치료법이 사용되기도 합니다. 중증인 경우, 환자의 상태를 안정시키기 위해 수혈이 필요할 수도 있습니다. 과도한 월경 출혈, 감염증, 영양실조 등의 요인을 해결하는 것도 중요합니다. 효과적인 치료란 증상을 완화하는 것뿐만 아니라, 재발을 방지하기 위해 근본적인 원인을 바로잡는 데 중점을 두는 것이기 때문입니다.

빈혈의 역학

빈혈의 역학적 분석 및 예측에 관한 주요 조사 결과

  • 전 세계적으로 볼 때, 6-59개월 영유아의 약 40%, 임산부의 약 37%, 15-49세 여성의 약 30%가 빈혈을 앓고 있는 것으로 추정됩니다.
  • 철분 결핍은 여전히 전 세계적으로 빈혈의 주요 원인이며, 전체 사례의 약 절반을 차지하고 있습니다. 50세 미만 여성에게서 유난히 많이 나타나며, 이 연령대가 가장 큰 영향을 받고 있는 인구 집단입니다.
  • 2025년, 주요 7개국에서 재생불량성 빈혈의 환자 수는 약 2,600건이었습니다.
  • 빈혈 유병률은 2-11세 소아에서 가장 낮았고(약 5%), 60세 이상 성인에서 가장 높았습니다(약 13%).
  • 2025년, 일본에서는 철결핍성 빈혈(IDA) 환자 수가 약 1,200만 건에 달했습니다.

빈혈 시장 전망

빈혈 치료제 시장은 주로 지지 요법이 중심이었던 영역에서 작용기전을 중시하고 혁신이 주도하는 혈액학 분야로 진화해 왔습니다. 그동안 치료는 영양 보충이나 수혈에 기반한 접근법, 특히 경구용 철분제나 수혈에 의존해 왔으며, 이러한 치료법은 근본적인 질환의 생물학적 기전보다는 주로 증상 완화를 목적으로 했습니다. 적혈구 생성 자극 인자의 도입은 큰 도약이 되었으며, 만성 신장 질환 및 종양학 분야에서 빈혈 관리의 생물학적 기반을 확립했습니다. 또한, 임상 현장에서 인지도가 높기 때문에 이러한 치료법들은 현재도 표준 치료법으로 자리 잡고 있습니다. 시간이 지남에 따라 시장은 정맥 내 철 제제의 개선과 같은 점진적인 혁신을 통해 성숙해 왔으나, 안전성 우려와 바이오시밀러와의 경쟁으로 인해 이러한 기존 부문에서는 가격과 사용 현황에 압박이 가해지고 있습니다.

지난 10년 동안 시장은 독자적인 작용기전을 가진 표적 치료로 전환되어 왔습니다. HIF-PH 억제제의 등장으로, 저산소 신호 전달 경로를 통해 내인성 에리스로포이에틴의 생성을 촉진하는 경구용 치료제가 도입되면서, 주사제 치료에 국한되지 않는 치료 선택지가 확대되었습니다. 이와 동시에, 루스파텔셉트 등의 적혈구 성숙 촉진제는 특히 골수이형성증후군이나 베타 지중해 빈혈 등 적혈구 생성 부전을 특징으로 하는 질환의 치료 방식을 재정의했습니다. 게다가 최근에는 유전자 치료와 세포 치료가 유전성 빈혈에 대한 잠재적인 근치적 접근법을 제시함으로써 치료 양상을 새롭게 바꾸기 시작했으며, 이는 만성적인 관리에서 장기적인 질환 경과 조절로의 전환을 시사하고 있습니다.

  • 철결핍성 빈혈 시장 규모는 2036년까지 주요 7개국에서 20억 달러를 넘어설 것으로 전망됩니다.
  • 무형성성 빈혈 시장은 PROMACTA의 제네릭 의약품이 시장에 진입할 것으로 예상에 따라, 2026년 이후 축소될 것으로 전망됩니다.
  • 글루코코르티코스테로이드는 널리 사용되고 있지만, 특히 장기 치료에 더 이상 반응하지 않는 환자의 경우 시간이 지남에 따라 효과가 감소할 가능성이 있습니다. 또한, 글루코코르티코스테로이드를 이용한 장기 또는 고용량 치료는 골다공증, 피부 위축, 당뇨병, 복부 비만, 녹내장, 백내장, 무혈관성 괴사, 감염증, 성장 지연, 고혈압 등 다양한 부작용을 유발할 가능성이 있습니다.
  • 고령자의 SAA 치료는 치료와 관련된 위험을 최소화하기 위해 질환의 특성과 환자의 건강 상태를 모두 고려해야 하므로, 불확실한 측면이 있습니다. 조혈모세포 이식(HCT)은 고령의 SAA 환자에게 있어 종종 두 번째 선택지가 됩니다.
  • 유전자 치료, 특히 렌티바이러스 벡터를 이용한 접근 방식의 최근 발전은 변이된 유전자의 기능적 사본을 환자의 세포에 도입함으로써 다이아몬드-블랙팬 빈혈에 대한 유망한 가능성을 보여주고 있습니다. CRISPR/Cas9를 활용한 유전자 편집 전략을 포함한 현재 진행 중인 연구는 이 질환을 유발하는 근본적인 유전적 결함을 교정하는 것을 목표로 하고 있습니다.

엘트롬보파그·콜린 등의 트롬보포이에틴(TPO) 수용체 작용제는 골수 내 조혈모세포 및 전구세포 표면의 c-Mpl(TPO) 수용체를 활성화하여 세포의 증식과 분화를 촉진합니다. SAA 등의 질환에서 이러한 활성화로 인해 삼계 조혈이 촉진되어 적혈구, 백혈구, 혈소판의 생성이 증가합니다. 그 결과, 적혈구 생성이 개선되고 골수 기능이 회복되며 헤모글로빈 수치가 상승함으로써 빈혈이 호전됩니다.

미타피바트 등의 피루브산 키나아제 활성화제는 당분해 경로의 핵심 효소인 적혈구의 피루브산 키나아제 활성을 알로스테릭 방식으로 증강시킵니다. 효소 활성 증가로 인해 적혈구 내 ATP 생성이 촉진되어, 적혈구의 에너지 균형, 세포막의 무결성 및 생존율이 향상됩니다. 사라세미아와 같은 용혈성 및 비효율적 적혈구 생성 장애에서 이 기전은 적혈구의 파괴를 억제하고 보다 효율적인 적혈구 생성을 촉진함으로써 헤모글로빈 수치의 상승과 수혈 부담의 경감으로 이어집니다.

자주 묻는 질문

  • 빈혈의 유병률은 어떻게 되나요?
  • 빈혈 치료제 시장 규모는 어떻게 예측되나요?
  • 자가면역성 용혈성 빈혈(AIHA)의 발생률은 어떻게 되나요?
  • 빈혈의 주요 원인은 무엇인가요?
  • 빈혈 치료에 있어 경구용 철분제의 한계는 무엇인가요?
  • 중증 재생불량성 빈혈(SAA) 치료에 대한 최신 지침은 무엇인가요?
  • 빈혈 치료의 주요 접근법은 무엇인가요?

목차

제1장 주요 인사이트

제2장 서론

제3장 빈혈 : 주요 요약

제4장 주요 이벤트

제5장 빈혈 : 역학 및 시장 예측 조사 방법

제6장 빈혈 : 시장 개요

제7장 빈혈 : 질환 배경과 개요

제8장 빈혈 : 가이드라인

제9장 빈혈 : 역학 및 환자 인구

제10장 빈혈 : 환자 경과

제11장 빈혈 : 시판 치료제

제12장 빈혈 : 신흥 치료제

제13장 빈혈 : 주요 7개국 분석

제14장 빈혈 : 미충족 요구

제15장 빈혈 : SWOT 분석

제16장 빈혈 : KOL(Key Opinion Leader)의 견해

제17장 빈혈 : 시장 참여 및 상환

제18장 부록

제19장 DelveInsight의 서비스 내용

제20장 면책사항

제21장 DelveInsight에 대해

LSH 26.07.27

Anemia Insights and Trends

  • Anemia is a major global public health concern, especially among young children and pregnant women. According to the WHO, an estimated 42% of children under five years of age and 40% of pregnant women worldwide are affected by anemia.
  • Effective screening and timely treatment of anemia require an understanding of local conditions and risk factors, making accurate prevalence data important for better public health planning and intervention.
  • Autoimmune hemolytic anemia (AIHA) is a rare condition, with an estimated incidence of about 1 to 3 cases per 100,000 people annually. In elderly patients, diagnosis and management can be more challenging because of reduced bone marrow reserve, diminished erythropoietin responsiveness, age-related immune senescence, and a higher prevalence of comorbidities.
  • Warm autoimmune hemolytic anemia (wAIHA) is a serious disorder in which pathogenic immunoglobulin G (IgG) autoantibodies target and destroy red blood cells. Current management primarily relies on broad immunosuppressive therapies that do not address the underlying disease mechanism and are not specifically approved as safe or effective treatments for wAIHA.
  • According to a recent AGA Clinical Practice Update, ferrous sulfate is the preferred form of iron replacement because of its affordability. However, the guidelines indicate that no specific form of iron supplementation has demonstrated superior effectiveness.
  • Although oral iron therapy is more accessible and less expensive than intravenous (IV) therapy, its effectiveness is often limited by poor adherence, inconsistent efficacy, and gastrointestinal adverse events (AEs), which can reduce patient confidence in treatment.
  • Fanconi anemia is a rare genetic disorder associated with more than 20 genes and characterized by reduced production of all blood cell lineages due to bone marrow dysfunction. Management is primarily centered on hematopoietic stem cell transplantation (HSCT), which can cure bone marrow failure and hematologic malignancies, although it is not effective for all patients.
  • Approximately 75% of Diamond-Blackfan anemia cases involve heterozygous mutations in ribosomal protein genes, classifying the condition as a ribosomopathy. Among these, RPS19 is the most frequently mutated gene.
  • The latest ASH guidelines for severe aplastic anemia (SAA) recommend the addition of eltrombopag to standard immunosuppressive therapy to improve blood cell counts in both adults and children.

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

The Anemia market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates Anemia 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 Anemia 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 Anemia Market

  • Treatment innovation is shifting care toward IV iron and new oral mechanisms

The market is being reshaped by the limits of oral iron and the growing use of parenteral options. FDA labeling for INJECTAFER and MONOFERRIC specifically targets patients who are intolerant of oral iron or who have an unsatisfactory response, showing how often oral therapy is insufficient in real-world practice. On the Chronic Kidney Disease (CKD) side, oral HIF-PH inhibitors are widening the treatment arsenal and supporting a shift away from transfusion dependence. On the iron-deficiency side, the FDA's expanded indications for injectable iron across CKD, oral-iron intolerance, and other high-need groups are steadily broadening the treated population.

  • Large and persistent untreated burden

Anemia continues to generate a broad treatment base because the global burden remains substantial, with WHO estimating that 40% of children 6-59 months, 37% of pregnant women, and 30% of women aged 15-49 are affected. WHO also attributes about 50 million healthy life years lost to anemia, with dietary iron deficiency among the leading causes.

Anemia Understanding and Treatment Algorithm

Anemia Overview and Diagnosis

Anemia is a condition marked by a lower-than-normal number of red blood cells or haemoglobin, reducing the blood's ability to carry oxygen to tissues. It disproportionately affects women and children and, in severe cases, can impair cognitive and motor development in children and lead to complications for pregnant women and their babies. The condition arises from multiple factors, including poor nutrition, infections, chronic diseases, heavy menstrual bleeding, pregnancy-related issues, and genetic predisposition, though iron deficiency remains the most common cause.

Anemia is diagnosed through clinical evaluation and laboratory tests. Doctors assess symptoms such as fatigue, weakness, pale skin, shortness of breath, and dizziness, along with medical history, diet, menstrual patterns, and chronic illnesses, while physical examination may reveal signs like pallor or rapid heartbeat. Confirmation is mainly done through a complete blood count (CBC), which measures hemoglobin, red blood cell count, and hematocrit, with low hemoglobin being the key indicator; red cell indices also help identify the type of anemia. Additional tests, including iron studies, vitamin B12 and folate levels, and reticulocyte count, help determine the underlying cause, while further investigations such as stool tests, kidney function tests, or screening for chronic diseases may be needed in some cases. Identifying the root cause is essential because treatment focuses not only on correcting anemia but also on addressing the underlying condition.

Anemia Treatment

Treatment of anemia depends on its cause, severity, and the patient's overall health. Iron deficiency anemia (IDA) is usually treated with iron supplements and dietary changes to increase iron intake, while vitamin C may improve absorption; intravenous iron may be used when oral iron is ineffective or not tolerated. Anemia caused by vitamin B12 or folate deficiency is treated with supplements or injections, whereas anemia linked to chronic diseases requires management of the underlying condition, sometimes using therapies that stimulate red blood cell production. In severe cases, blood transfusions may be necessary to stabilize the patient. Addressing contributing factors such as heavy menstrual bleeding, infections, or poor nutrition is also important, as effective treatment focuses on both relieving symptoms and correcting the underlying cause to prevent recurrence.

Anemia Unmet Needs

The section "unmet needs of Anemia" 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. Diagnostic gaps due to unreliable biomarkers in inflammatory states

2. Treatment fragmentation across iron, ESA, and emerging modalities

3. Inflammation-driven iron dysregulation remains poorly addressed

4. Adherence challenges with chronic, multi-step treatment regimens, and others.....

Comprehensive unmet needs insights in Anemia and their strategic implications are provided in the full report.

Anemia Epidemiology

Key Findings from Anemia Epidemiological Analysis and Forecast

  • Globally, it is estimated that ~40% of all children aged 6-59 months, ~37% of pregnant women and ~30% of women 15-49 years of age are affected by anemia.
  • Iron deficiency remains the leading cause of anemia globally, accounting for roughly half of all cases. It disproportionately affects women under the age of 50, who represent the most impacted population group.
  • Aplastic Anemia accounted for ~2,600 cases in the 7MM in 2025.
  • Anemia prevalence was lowest in children ages 2-11 (~5%) and highest in adults 60 and older (~13%).
  • Japan accounted for approximately 12 million cases of IDA in 2025.

Anemia Drug Chapters & Competitive Analysis

The Anemia 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 Anemia treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the Anemia therapeutics market.

Approved Therapies for Anemia

Omidubicel (OMISIRGE): Ayrmid (Gamida Cell)

Omidubicel is the first HSCT therapy for patients with severe aplastic anemia (SAA). The therapy is indicated for adults and children aged six years and older who lack a compatible stem cell donor and undergo reduced-intensity conditioning. It was approved by the US FDA in December 2025. Omidubicel addresses the limitations of umbilical cord blood (UCB) as a source including delayed hematopoietic recovery and increased infections and provides additional graft options for patients with SAA who need HSCT.

Eltrombopag choline (ALVAIZ): Teva Pharmaceuticals

Eltrombopag choline is an oral thrombopoietin (TPO) receptor agonist that works to increase platelet production by interacting with the transmembrane domain of the human TPO-receptor to initiate signaling cascades that induce proliferation and differentiation of megakaryocytes. In November 2023, the US FDA approved ALVAIZ for the treatment of certain forms of thrombocytopenia and SAA. ALVAIZ has been approved for ITP, Thrombocytopenia with Hep C, and SAA.

Emerging Therapies for Anemia

Rilzabrutinib (WAYRILZ): Sanofi

Rilzabrutinib is the first BTK inhibitor for immune thrombocytopenia (ITP) that helps address the root cause of disease through multi-immune modulation. This innovative therapy is approved in the US for adults with persistent or chronic ITP who have had an insufficient response to a previous treatment. Rilzabrutinib is being studied across a variety of rare diseases, including wAIHA, IgG4-RD, and SCD. These additional indications are currently under investigation and have not been approved by regulatory authorities.

CK0801: Cellenkos

CK0801 is a first-in-class, allogeneic, cord blood-derived T-regulatory cell product, developed from Cellenkos' proprietary manufacturing platform that overcomes immune dysfunction by inhibiting key drivers of inflammation. CK0801 contains robust regulatory T-cells derived from healthy donor cord blood units. The drug CK0801 is currently undergoing evaluation in the Phase I clinical trial.

Anemia Key Players, Market Leaders and Emerging Companies

  • Ayrmid
  • Teva Pharmaceuticals
  • Agios Pharmaceuticals
  • Sanofi
  • Astellas
  • Johnson & Johnson
  • Cellenkos, and others

Anemia Drug Updates

  • In April 2026, Johnson & Johnson announced that the US FDA granted Priority Review to the supplemental Biologics License Application (sBLA) for nipocalimab (IMAAVY), confirming the urgent need for treatment options in wAIHA.
  • In February 2026, Sanofi announced rilzabrutinib, was granted Breakthrough Therapy Designation (BTD) by the US FDA for the treatment of patients with wAIHA. The Japanese Ministry of Health, Labour and Welfare has also provided rilzabrutinib an Orphan Designation (ODD) for the same condition.
  • In February 2026, Ayrmid announced presentation of additional positive results for OMISIRGE in treating SAA at TANDEM 2026.
  • In December 2025, the US FDA approved Mitapivat for the treatment of anemia in adults with alpha- or beta-thalassemia. With this approved indication, Mitapivat becomes the only FDA-approved medicine for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia.
  • In April 2025, Cellenkos announced that the US FDA had granted ODD to its novel cell therapy product, CK0801. Cellenkos was planning for a registration trial of CK0801 in H2 2025.

Drug Class Insights

Anemia Market Outlook

The Anemia therapeutics market has evolved from a largely supportive care driven space into a mechanism driven, innovation led segment of hematology. Historically, management relied on nutritional supplementation and transfusion based approaches, particularly oral iron and blood transfusions, which primarily addressed symptoms rather than underlying disease biology. The introduction of erythropoiesis stimulating agents marked a major breakthrough, establishing a biologic backbone for Anemia management in chronic kidney disease and oncology settings, and they continue to remain a standard of care due to strong clinical familiarity. Over time, the market matured with incremental innovations such as improved intravenous iron formulations, although safety concerns and biosimilar competition created pricing and utilization pressures in these legacy segments.

In the past decade, the market has shifted toward targeted therapies with distinct mechanisms of action. The emergence of HIF PH inhibitors introduced oral alternatives that stimulate endogenous erythropoietin production through hypoxia signalling pathways, expanding treatment options beyond injectable therapies. In parallel, erythroid maturation agents such as luspatercept have redefined treatment in conditions characterized by ineffective erythropoiesis, particularly in myelodysplastic syndromes and beta thalassemia. More recently, gene and cell therapies have begun to reshape the landscape by offering potential curative approaches for hereditary anemia's, signalling a transition from chronic management to long term disease modification.

  • The Iron Deficiency anemia market size is anticipated to cross USD 2 billion in the 7MM by 2036.
  • The aplastic anemia market is projected to decline from 2026 onward, driven by the anticipated entry of generic versions of PROMACTA.
  • Glucocorticosteroids, despite being commonly used, may lose effectiveness over time, particularly in patients who become non-responsive to long-term treatment. Moreover, long-term or high-dose therapies with glucocorticosteroids can lead to a range of adverse effects, including osteoporosis, skin atrophy, diabetes, abdominal obesity, glaucoma, cataracts, avascular necrosis and infection, growth retardation, and hypertension.
  • Treatment for SAA in the elderly is uncertain, considering both illness characteristics and the patient's health to minimize treatment-related risks. Hematopoietic cell transplantation (HCT) is often a second-line choice for elderly SAA patients.
  • Recent advances in gene therapy, particularly lentiviral vector-based approaches, offer promising potential for diamond blackfan anemia by delivering functional copies of mutated genes into patients' cells. Ongoing research, including CRISPR/Cas9 gene editing strategies, aims to correct the underlying genetic defects driving the disease.

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

The current anemia treatment landscape is largely driven by therapeutic classes including small molecules, hematopoietic stem cell transplantation (HSCT), BTK inhibitors, TPO receptor agonists, pyruvate kinase activators, and HIF-PH inhibitor-based approaches.

Thrombopoietin (TPO) receptor agonists such as Eltrombopag choline activate the c-Mpl (TPO) receptor on hematopoietic stem and progenitor cells in the bone marrow, stimulating cell proliferation and differentiation. In disorders such as SAA, this activation enhances trilineage hematopoiesis, increasing the production of red blood cells, white blood cells, and platelets. The resulting improvement in erythropoiesis can help correct anemia by restoring bone marrow function and increasing hemoglobin levels.

Pyruvate kinase activators such as mitapivat allosterically enhance the activity of red blood cell pyruvate kinase, a key enzyme in glycolysis. Increased enzyme activity boosts ATP production within erythrocytes, improving red blood cell energy balance, membrane integrity, and survival. In hemolytic and ineffective erythropoietic disorders such as thalassemia, this mechanism reduces red blood cell destruction and supports more effective erythropoiesis, leading to increased hemoglobin levels and reduced transfusion burden.

Anemia 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 Anemia market's uptake by drugs, patient uptake by therapy, and sales of each drug.

Market Access and Reimbursement of Anemia

  • The United States

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved 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.

Anemia Therapies Price Scenario & Trends

Pricing and analogue assessment of Anemia 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.

The Cost of Therapy is INDICATIVE and will be provided in the updated report...

Industry Experts and Physician Views for Anemia

To keep up with Anemia 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 Anemia 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 Anemia, 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 Dusseldorf Clinics Association, Hirosaki University, University Hospital Ulm, University of California, Harvard University, Kyoto University, and Tennessee State University, etc. were contacted. Their opinion helps understand and validate current and emerging Anemia therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in Anemia.

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 Anemia, 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 Anemia, 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 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 in shaping and driving the 7MM Anemia market.

Report Insights

  • Anemia Patient Population Forecast
  • Anemia Therapeutics Market Size
  • Anemia Pipeline Analysis
  • Anemia Market Size and Trends
  • Anemia 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
  • Anemia Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (by geography)
  • Anemia Treatment Addressable Market (TAM)
  • Anemia Competitive Landscape
  • Anemia Major Companies Insights
  • Anemia Price Trends and Analogue Assessment
  • Anemia Therapies Drug Adoption/Uptake
  • Anemia Therapies Peak Patient Share analysis

Report Assessment

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

FAQs:

Market Insights

  • What was the Anemia 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 Anemia?
  • What are the disease risks, burdens, and unmet needs of Anemia? What will be the growth opportunities across the 7MM concerning the patient population with Anemia?
  • 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 Anemia? What are the current guidelines for treating Anemia 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 Anemia 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 of Anemia

4. Key Events

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

5. Epidemiology and Market Forecast Methodology of Anemia

6. Anemia Market Overview at a Glance

  • 6.1. Clinical Landscape Analysis (By Phase, Molecule Type, and RoA)
  • 6.2. Market Share (%) Distribution of Anemia By Therapies in the 7MM in 2026
  • 6.3. Market Share (%) Distribution of Anemia By Therapies in the 7MM in 2036

7. Disease Background and Overview of Anemia

  • 7.1. Introduction
  • 7.2. Types
  • 7.3. Symptoms
  • 7.4. Causes
  • 7.5. Pathophysiology
  • 7.6. Diagnosis
  • 7.7. Treatment

8. Guidelines for Anemia

  • 8.1. Diagnostic Guidelines
  • 8.2. Treatment Guidelines

9. Epidemiology and Patient Population of Anemia

  • 9.1. Key Findings
  • 9.2. Assumptions and Rationale
  • 9.3. Total Diagnosed Prevalent Cases of Anemia in the 7MM
  • 9.4. The United States
    • 9.4.1. Total Prevalent Cases of Anemia in the United States
    • 9.4.2. Total Diagnosed Prevalent Cases of Anemia in the United States
    • 9.4.3. Type-specific Diagnosed Prevalent Cases of Anemia in the United States
    • 9.4.4. Gender-specific Diagnosed Prevalent Cases of Anemia in the United States
    • 9.4.5. Age-specific Diagnosed Prevalent Cases of Anemia in the United States
    • 9.4.6. Severity-specific Diagnosed Prevalent Cases of Anemia in the United States
    • 9.4.7. Total Treated Cases of Anemia in the United States
  • 9.5. EU4 and the UK
    • 9.5.1. Total Prevalent Cases of Anemia in EU4 and the UK
    • 9.5.2. Total Diagnosed Prevalent Cases of Anemia in EU4 and the UK
    • 9.5.3. Type-specific Diagnosed Prevalent Cases of Anemia in EU4 and the UK
    • 9.5.4. Gender-specific Diagnosed Prevalent Cases of Anemia in EU4 and the UK
    • 9.5.5. Age-specific Diagnosed Prevalent Cases of Anemia in EU4 and the UK
    • 9.5.6. Severity-specific Diagnosed Prevalent Cases of Anemia in EU4 and the UK
    • 9.5.7. Total Treated Cases of Anemia in EU4 and the UK
  • 9.6. Japan
    • 9.6.1. Total Prevalent Cases of Anemia in Japan
    • 9.6.2. Total Diagnosed Prevalent Cases of Anemia in Japan
    • 9.6.3. Type-specific Diagnosed Prevalent Cases of Anemia in Japan
    • 9.6.4. Gender-specific Diagnosed Prevalent Cases of Anemia in Japan
    • 9.6.5. Age-specific Diagnosed Prevalent Cases of Anemia in Japan
    • 9.6.6. Severity-specific Diagnosed Prevalent Cases of Anemia in Japan
    • 9.6.7. Total Treated Cases of Anemia in Japan

10. Patient Journey of Anemia

11. Marketed Therapies of Anemia

  • 11.1. Marketed Competitive Landscape of Anemia
  • 11.2. Omidubicel (OMISIRGE): Ayrmid (Gamida Cell)
    • 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 Views
  • 11.3. Eltrombopag choline (ALVAIZ): Teva Pharmaceuticals
    • 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 Views

12. Emerging Drugs of Anemia

  • 12.1. Emerging Competitive Landscape of Anemia
  • 12.2. Rilzabrutinib (WAYRILZ): Sanofi
    • 12.2.1. Drug Description
    • 12.2.2. Other Developmental Activity
    • 12.2.3. Clinical Development
      • 12.2.3.1. Clinical Trials Information
    • 12.2.4. Analyst Views
  • 12.3. Roxadustat: Astellas
    • 12.3.1. Drug Description
    • 12.3.2. Clinical Development
      • 12.3.2.1. Clinical Trial Information
    • 12.3.3. Safety and Efficacy
    • 12.3.4. Analyst Views
  • 12.4. CK0801: Cellenkos
    • 12.4.1. Drug Description
    • 12.4.2. Clinical Development
      • 12.4.2.1. Clinical Trial Information
    • 12.4.3. Safety and Efficacy
    • 12.4.4. Analyst Views

13. Anemia: 7MM Analysis

  • 13.1. Key Findings
  • 13.2. Market Outlook of Anemia
  • 13.3. Conjoint Analysis of Anemia
  • 13.4. Key Market Forecast Assumptions
    • 13.4.1. Cost Assumptions
    • 13.4.2. Pricing Trends
    • 13.4.3. Analogue Assessment
    • 13.4.4. Launch Year and Therapy Uptakes
  • 13.5. Total Market Size of Anemia in the 7MM
  • 13.6. Total Market Size of Anemia by Therapies in the 7MM
  • 13.7. The United States
    • 13.7.1. Total Market Size of Anemia in the United States
    • 13.7.2. Total Market Size of Anemia by Therapies in the United States
  • 13.8. EU4 and the UK
    • 13.8.1. Total Market Size of Anemia in EU4 and the UK
    • 13.8.2. Total Market Size of Anemia by Therapies in EU4 and the UK
  • 13.9. Japan
    • 13.9.1. Total Market Size of Anemia in Japan
    • 13.9.2. Total Market Size of Anemia by Therapies in Japan

14. Unmet Needs of Anemia

15. SWOT Analysis of Anemia

16. KOL Views of Anemia

17. Market Access and Reimbursement of Anemia

  • 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 Anemia Therapies

18. Appendix

  • 18.1. Bibliography
  • 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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