Aplastic anemia Market Analysis: Epidemiology Insights, Therapies, Companies, by DelveInsight | Pfizer, BioLineRx, Ltd., Regeneron Pharmaceuticals, Gamida Cell, Elixirgen, Hangzhou Zede Pharmaceutical

The United States accounted for the highest Aplastic Anemia Treatment Market Size, with nearly 70% of the Aplastic Anemia Market Share in the 7MM, as compared to EU4 and the UK and Japan in 2023.
Aplastic anemia treatments, including PF-06462700, REGN7257, BL-8040, and others, are anticipated to drive growth in the Aplastic Anemia Market in the coming years.

DelveInsight has published a new report titled "Aplastic Anemia - Market Insights, Epidemiology, and Market Forecast-2034," providing a comprehensive analysis of aplastic anemia, including historical and projected epidemiology, as well as market trends across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

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Some of the key facts of the Aplastic anemia Market Report:

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In 2023, the United States held the largest share of the Aplastic Anemia treatment market, accounting for nearly 70% of the total market across the seven major markets (7MM), surpassing the EU4, the UK, and Japan. Aplastic Anemia is a rare, serious, non-cancerous disorder in which the immune system attacks early blood-forming cells. Globally, its incidence ranges from 0.7 to 7.4 cases per million people annually, with notably higher rates in Asia compared to Europe and the U.S.

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Severe and very severe cases represent approximately 65% to 80% of the total patient population. Treatment selection largely depends on patient age and disease severity: hematopoietic stem cell transplantation (HSCT) is preferred for individuals under 40, while immunosuppressive therapy (IST) remains the standard for older patients. Younger patients generally experience better long-term outcomes, whereas those aged 60 and above have poorer prognoses, highlighting the urgent need for improved therapies for older populations.

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Among pharmacologic options, Novartis' PROMACTA (known as REVOLADE in some regions) leads in revenue, followed by immunosuppressive therapies. PROMACTA's sales are driven primarily by its use in chronic immune thrombocytopenic purpura (ITP) and severe aplastic anemia (SAA). Despite the emergence of new treatments and recent approvals, the market continues to be largely driven by ISTs and PROMACTA/REVOLADE.

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Several companies are developing innovative therapies: Regeneron Pharmaceuticals is advancing REGN7257 for patients with refractory or relapsed SAA following IST, while Gamida Cell is developing cord blood-derived stem and progenitor cell therapies to enhance transplant outcomes. Research is also exploring combinations of androgens and growth factors, such as G-CSF and erythropoietin, with standard regimens to support bone marrow recovery and blood cell production.

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Despite these developments, major challenges remain, particularly in creating effective, well-tolerated treatments for patients who do not respond to existing therapies or cannot undergo intensive procedures. In the 7MM, Japan recorded the highest number of incident Aplastic Anemia cases in 2023, representing approximately 30% of the total.

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In April 2025, the FDA granted Orphan Drug Designation to CK0801, an allogeneic cord blood-derived T regulatory (Treg) cell therapy from Cellenkos Inc., for aplastic anemia, aiming to accelerate the development of therapies for rare diseases. CK0801 is planned for a registration trial in the second half of 2025.

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Key companies in the Aplastic Anemia space include Pfizer, BioLineRx Ltd., Regeneron Pharmaceuticals, Gamida Cell, Elixirgen, Hangzhou Zede Pharmaceutical Technology, Cellenkos, Hemogenyx Pharmaceuticals, and others, all working to advance new treatment options. Promising therapies in development include PF-06462700, REGN7257, BL-8040, and others.

Aplastic anemia Overview

Myositis is a condition characterized by muscle inflammation and is commonly associated with a group of inflammatory muscle disorders, such as polymyositis, dermatomyositis, cancer-associated myositis, juvenile dermatomyositis, overlap myositis, and inclusion body myositis (IBM). While myositis specifically refers to inflammation of the muscles, myopathy is a broader term that includes any disease or disorder affecting the muscles, not limited to inflammatory causes.

This rare disorder can affect not only the muscles but also other organs, often leading to a substantial decline in quality of life. The American College of Rheumatology classifies inflammatory myopathies as autoimmune diseases in which the immune system mistakenly attacks healthy muscle tissue. Among these, dermatomyositis and polymyositis are the most commonly observed forms.

Aplastic anemia Market Outlook

The prognosis for aplastic anemia depends on the severity of the condition. While some patients respond positively to treatment, others may experience serious complications, including myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

Historically, treatment has centered on immunosuppressive therapy (IST) and bone marrow transplantation (BMT) for eligible patients. For those with severe or very severe aplastic anemia (SAA/VSAA) who qualify for transplantation, age significantly influences survival outcomes following matched sibling donor (MSD) allogeneic transplantation. Older patients, often with prior IST exposure, comorbidities, reduced performance status, and delays in BMT, face more complex treatment challenges. Fludarabine-based regimens have demonstrated some benefit in this group, though supporting evidence is largely derived from retrospective studies.

Management of non-severe aplastic anemia (NSAA) differs markedly from that of SAA/VSAA. Hematopoietic stem cell transplantation (HSCT) is not typically used for NSAA, and criteria for initiating treatment are less well-defined. Moreover, standardized guidelines for assessing and treating NSAA are lacking, with care generally guided by the expertise and protocols of individual treatment centers.

With multiple novel therapies under development, the treatment landscape for aplastic anemia is expected to undergo significant evolution between 2024 and 2034.

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Aplastic Anemia Marketed Therapies

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ALVAIZ (eltrombopag choline): Teva Pharmaceuticals

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ROMIPLATE (romiplostim; AMG531): Kyowa Kirin/Amgen

Aplastic anemia Emerging Drugs

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REGN7257: Regeneron Pharmaceuticals

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OMISIRGE (omidubicel): Gamida Cell

Scope of the Aplastic anemia Market Report

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Study Period: 2020-2034

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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

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Key Aplastic anemia Companies: Pfizer, BioLineRx, Ltd., Regeneron Pharmaceuticals, Gamida Cell, Elixirgen, Hangzhou Zede Pharmaceutical Technology, Cellenkos, Hemogenyx Pharmaceuticals, and others

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Key Aplastic anemia Therapies: PF-06462700, REGN7257, BL-8040, and others

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Aplastic anemia Therapeutic Assessment: Aplastic anemia current marketed and Aplastic anemia emerging therapies

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Aplastic anemia Market Dynamics: Aplastic anemia market drivers and Aplastic anemia market barriers

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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies

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Aplastic anemia Unmet Needs, KOL's views, Analyst's views, Aplastic anemia Market Access and Reimbursement

To know what's more in our Aplastic anemia report, visit https://www.delveinsight.com/report-store/aplastic-anemia-market?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr

Key benefits of the Aplastic anemia Market Report:

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Aplastic anemia market report covers a descriptive overview and comprehensive insight of the Aplastic anemia Epidemiology and Aplastic anemia market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).

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The Aplastic anemia market report provides insights into the current and emerging therapies.

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The Aplastic anemia market report provides a global historical and forecasted market covering drug outreach in 7MM.

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The Aplastic anemia market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Aplastic anemia market.

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Table of Contents

1. Report Introduction

2. Executive Summary

3. SWOT analysis

4. Aplastic anemia Patient Share (%) Overview at a Glance

5. Aplastic anemia Market Overview at a Glance

6. Aplastic anemia Disease Background and Overview

7. Aplastic anemia Epidemiology and Patient Population

8. Country-Specific Patient Population of Aplastic anemia

9. Aplastic anemia Current Treatment and Medical Practices

10. Unmet Needs

11. Aplastic anemia Emerging Therapies

12. Aplastic anemia Market Outlook

13. Country-Wise Aplastic anemia Market Analysis (2020-2034)

14. Market Access and Reimbursement of Therapies

15. Market drivers

16. Market barriers

17. Appendix

18. Aplastic anemia Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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Related Reports:

Aplastic anemia Pipeline Insights, DelveInsight

"Aplastic anemia Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Aplastic anemia market. A detailed picture of the Aplastic anemia pipeline landscape is provided, which includes the disease overview and Aplastic anemia treatment guidelines.

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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