Polycythemia Vera Market Expands as FDA Fast Tracks New Treatments and Clinical Trials Show Promising Results | DelveInsight

The 7MM Polycythemia Vera market size reached approximately USD 1,900 million in 2024 and is projected to grow significantly through 2034. Key players such as Incyte/Novartis, PharmaEssentia/AOP Orphan Pharmaceuticals, Protagonist Therapeutics, Merck, Italfarmaco, Ionis Pharmaceutical, Silence Therapeutics, Perseus Proteomics, AbbVie, Johnson & Johnson Innovative Medicine, Mabwell (Shanghai) Bioscience and Disc Medicine, GluBio Therapeutics, and others are spearheading innovations.
DelveInsight's report, titled "Polycythemia Vera Market Insight, Epidemiology and Market Forecast -2034 [https://www.delveinsight.com/report-store/polycythemia-vera-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr]", provides a detailed assessment of historical and projected market trends from 2020 to 2034. The analysis encompasses epidemiology segmentation, treatment paradigms, emerging therapies, and competitive dynamics, offering stakeholders actionable insights into market opportunities and challenges. The report highlights how the anticipated introduction of targeted therapies and improved diagnostic tools will reshape the PV treatment landscape over the next decade.

In 2024, the United States dominated the Polycythemia market, accounting for over 75% of the total market size, which amounts to USD 1.9 Billion across the 7MM. Among EU4 countries, Germany accounts for the maximum market size, while the United Kingdom occupies the bottom of the ladder in 2024. This trend is expected to continue reflecting disparities in treatment accessibility, Polycythemia Vera prevalence, and diagnostic rates across regions.

Download the report to understand which factors are driving the Polycythemia Vera therapeutic market @ Polycythemia Vera Market Trends [https://www.delveinsight.com/sample-request/polycythemia-vera-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr].

The report also provides historical as well as forecasted PV epidemiology segmented by Total Prevalent Population of Polycythemia Vera, Prevalent Population of Polycythemia Vera Based on Symptoms, Gender-specific Prevalence of Polycythemia Vera, Prevalence of Polycythemia Vera by Gene Mutation, Prevalence of Polycythemia Vera Based on Risk, and Age-specific Prevalence of Polycythemia Vera in the 7MM.

The report estimates that the 7MM had approximately 320,000 Polycythemia Vera cases in 2024, with numbers expected to rise steadily during the forecast period. Gender-specific data indicates that approximately 56% of the patient share in 7MM is attributed to males, whereas 44% are females. Additionally, across all races and ethnicities, the PV incidence is about 2.8 per 100,000 men and roughly 1.3 per 100,000 women.

Discover evolving trends in Polycythemia Vera patient pool forecasts @ Polycythemia Vera Epidemiology Analysis [https://www.delveinsight.com/sample-request/polycythemia-vera-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr].

Recent Developments:

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In the latest financial statement, Incyte reported strong growth for Jakafi with net revenues of $773 million in Q4 2024 and $2.79 billion for the full year.

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In March 2025, Protagonist Therapeutics and Takeda announced positive topline results from the Phase 3 VERIFY study, where rusfertide met its primary and all secondary endpoints in treating polycythemia vera. These recent developments indicate positive momentum in the Polycythemia Vera treatment market.

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Rusfertide achieved a major milestone with the presentation of Phase 3 VERIFY trial results at the ASCO Annual Meeting in June 2025. The study met its primary endpoint and all key secondary endpoints, showing that rusfertide plus current standard of care more than doubled clinical response rates across high- and low-risk PV groups compared to placebo.

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In May 2025, the FDA granted Fast Track designation to givinostat, an orally administered histone deacetylase (HDAC) inhibitor for treating patients with polycythemia vera, highlighting givinostat's potential to make a meaningful difference.

Learn more about the evolving trends in the Polycythemia Vera treatment market @ Polycythemia Vera Recent Developments [https://www.delveinsight.com/sample-request/polycythemia-vera-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr].

Polycythemia Vera management currently relies on a combination of treatments, including phlebotomy, cytoreductive agents such as hydroxyurea, and JAK inhibitors like JAKAFI (RUXOLITINIB) from Incyte/Novartis. Other notable medications used in the management of PV include BESREMi (PharmaEssentia/AOP Orphan Pharmaceuticals) and PEGASYS (pharmaand GmbH). Given its very different MoA compared to JAKAFI and BESREMi, rusfertide could become a viable alternative as an earlier line of therapy. In 2024, JAKAFI generated the highest revenue among these Polycythemia Vera therapies.

While these therapies help manage symptoms and reduce thrombotic risks, they are associated with limitations including drug resistance, long-term toxicity, and inadequate control of disease progression. DelveInsight's report emphasizes that a significant number of patients experience suboptimal responses to existing treatments, highlighting a pressing need for novel mechanisms of action.

The report highlights that the Polycythemia Vera pipeline features several investigational therapies across phases of development. Notable candidates include DIVESIRAN (Silence Therapeutics), PPMX-T003 (Perseus Proteomics), NAVITOCLAX (AbbVie), VAC85135 (Johnson & Johnson), 9MW3011/DISC-3405 (Mabwell), GLB-001 (GluBio Therapeutic) and others.

Despite progress, challenges such as delayed diagnosis, treatment-related anemia, and lack of consensus on optimal monitoring strategies persist. DelveInsight's analysis identifies biomarker development and patient-centric drug delivery systems as key areas for innovation.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Polycythemia Vera Market Overview at a Glance

5. Epidemiology and Market Forecast Methodology

6. Key Events

7. Polycythemia Vera Background and Overview

8. Polycythemia Vera Treatment

9. Polycythemia Vera Epidemiology and Patient Population in the 7MM

10. Polycythemia Vera Patient Journey

11. Polycythemia Vera Marketed Drug

12. Polycythemia Vera Emerging Drugs

13. Polycythemia Vera: 7MM Analysis

14. Unmet needs

15. SWOT Analysis

16. KOL Views

17. Market Access and Reimbursement

18. Appendix

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

Related Reports

Polycythemia Vera Pipeline Insight [https://www.delveinsight.com/report-store/polycythemia-vera-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr]

Polycythemia Vera Pipeline Insight provides comprehensive insights about the Polycythemia Vera pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the Polycythemia Vera companies, including Silence Therapeutics, Ionis Pharmaceuticals, Perseus Proteomics, Kartos Therapeutics, and Disc Medicine among others.

About DelveInsight

DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.

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