Polycythemia Vera Market

Emerging therapies for Polycythemia Vera, including Jakafi, Besremi, Rusfertide, Givinostat, and others, are anticipated to drive market growth in the coming years.

DelveInsight has introduced a new report, “Polycythemia Vera – Market Insights, Epidemiology, and Market Forecast 2034”, which provides a comprehensive overview of the disease, covering historical and projected epidemiology, along with market dynamics and 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 Polycythemia vera Market Report:

• The Polycythemia Vera (PV) market across the 7 major markets (7MM) is projected to reach approximately USD 1,900 million in 2024, with continued growth anticipated from 2025 through 2034. In 2024, JAKAFI (ruxolitinib) is expected to lead revenue among existing PV therapies, generating around USD 965 million in the U.S.

• Most PV patients are symptomatic, with an estimated 97,400 individuals in the U.S. carrying the JAK2 mutation. While there is currently no cure for PV, available treatments focus on managing the disease and its associated complications through medications, procedures, and other therapeutic approaches.

• Currently, two drugs are approved for PV: JAKAFI (ruxolitinib) and BESREMi (ropeginterferon alfa-2B/AOP2014/P1101), authorized in the U.S., Europe, and Japan. BESREMi’s broader label allows use in both first-line and subsequent therapies, giving PharmaEssentia flexibility in positioning. Although it does not directly compete with JAKAFI, BESREMi may delay patients’ progression to JAKAFI, potentially affecting its revenue.

• JAKAFI’s patent expiration in mid-2028 may challenge its market dominance. To address this, Incyte initiated the LIMBER program (Leadership in MPNs and GVHD BEyond Ruxolitinib) to explore various monotherapy and combination strategies for patients with myeloproliferative neoplasms (MPNs) and graft-versus-host disease (GVHD).

• Rusfertide, which operates via a mechanism distinct from JAKAFI and BESREMi, is emerging as a promising option for earlier-stage treatment. This therapy may become a new standard of care by reducing the need for phlebotomy without the severe side effects associated with JAK inhibitors. Protagonist anticipates regulatory approval in Q4 2026, with a commercial launch expected in 2027.

• In 2024, the U.S. accounted for the largest share of the global PV population, representing roughly 57% of cases across the 7MM. The EU4 and the UK combined accounted for approximately 32%, while Japan represented around 11% of total prevalence. The total number of PV cases in the U.S. in 2024 was estimated at 182,010.

• Additional emerging therapies include Merck’s Bomedemstat, Italfarmaco’s Givinostat, Silence Therapeutics’ Divesiran, Ionis Pharmaceuticals’ Sapablursen, and Perseus Proteomics’ PPMX-T003, all of which could significantly influence the PV market in the future.

• In March 2025, Takeda and Protagonist Therapeutics reported positive Phase III results for rusfertide, successfully achieving the primary endpoint in PV patients. The companies plan to utilize data from the VERIFY trial to support regulatory submissions for this hepcidin mimetic peptide therapy.

• In December 2024, Vanda Pharmaceuticals announced that the FDA granted orphan drug designation to VGT-1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor, for PV—a rare hematologic malignancy characterized by excessive red blood cell production.

• Leading PV-focused companies, including Incyte, Novartis, PharmaEssentia, AOP Orphan Pharmaceuticals, Protagonist Therapeutics, Merck (Imago BioSciences), Italfarmaco, Ionis Pharmaceuticals, Silence Therapeutics, Perseus Proteomics, AbbVie, Johnson & Johnson Innovative Medicine, Mabwell (Shanghai) Bioscience, Disc Medicine, and GluBio Therapeutics, are actively developing new therapies to advance the treatment landscape.

• Key promising therapies in PV include Jakafi, Besremi, Rusfertide, Givinostat, and other emerging agents.

Polycythemia vera Overview

Polycythemia Vera is a rare blood disorder characterized by the excessive production of red blood cells, often accompanied by elevated white blood cells (WBCs) and platelets. It represents the most common form of myeloproliferative neoplasm (MPN) and is unique in its association with increased red blood cell levels.

The condition is more frequently observed in older adults, where age-related factors and coexisting health conditions contribute to a higher risk of occurrence.

Polycythemia vera Market Outlook

The treatment landscape for Polycythemia Vera (PV) in the United States is evolving rapidly. Historically, options were limited and primarily focused on symptom management, using long-established therapies such as hydroxyurea, second-generation interferons, and phlebotomy, with no curative approach available. The recent approvals of BESREMi for both first- and second-line use, and JAKAFI for second-line therapy, have expanded modern treatment options, though effective third-line therapies remain limited. Low-risk patients are generally managed with low-dose aspirin and phlebotomy, whereas high-risk individuals typically receive cytoreductive therapies like hydroxyurea or interferon alpha. Notably, around 30% of hydroxyurea-treated patients develop resistance or intolerance, highlighting the ongoing need for better alternatives.

Across the 7 major markets (7MM), the current PV treatment landscape is categorized by commonly used therapeutic classes, including JAK inhibitors, interferons, hepcidin mimetics, TMPRSS6 inhibitors, CK1α inhibitors, BCL-2 inhibitors, and LSD1 inhibitors, with some regional differences in prescribing practices. With new therapies nearing approval, advances in early detection, improved integration into clinical practice, ongoing research, and heightened awareness, the PV market is expected to undergo substantial growth. Coupled with increasing global healthcare investment, these developments are likely to significantly enhance the management of Polycythemia Vera in the coming years.

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Polycythemia vera Emerging Drugs

• Rusfertide (PTG-300): Protagonist Therapeutics

• Bomedemstat (MK-3543 [IMG-7289]): Merck (Imago BioSciences)

Polycythemia vera Marketed Drugs

• JAKAFI/JAKAVI (ruxolitinib): Incyte/Novartis

• BESREMi (ropeginterferon alfa-2b): PharmaEssentia/AOP Orphan Pharmaceuticals

Scope of the Polycythemia vera Market Report

• Study Period: 2020-2034

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

• Key Polycythemia vera Companies: Incyte, Novartis, PharmaEssentia, AOP Orphan Pharmaceuticals, Protagonist Therapeutics, Merck (Imago BioSciences), Italfarmaco, Ionis Pharmaceutical, Silence Therapeutics, Perseus Proteomics, AbbVie, Johnson & Johnson Innovative Medicine, Mabwell (Shanghai) Bioscience and Disc Medicine, GluBio Therapeutics, and others

• Key Polycythemia vera Therapies: Jakafi, Besremi, Rusfertide, Givinostat, and others

• Polycythemia vera Therapeutic Assessment: Polycythemia vera current marketed and Polycythemia vera emerging therapies

• Polycythemia vera Market Dynamics: Polycythemia vera market drivers and Polycythemia vera market barriers

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

• Polycythemia vera Unmet Needs, KOL’s views, Analyst’s views, Polycythemia vera Market Access and Reimbursement

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Key benefits of the Polycythemia vera Market Report:

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

2. The Polycythemia vera market report provides insights into the current and emerging therapies.

3. The Polycythemia vera market report provides a global historical and forecasted market covering drug outreach in 7MM.

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

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Table of Contents

1. Report Introduction

2. Executive Summary

3. SWOT analysis

4. Polycythemia vera Patient Share (%) Overview at a Glance

5. Polycythemia vera Market Overview at a Glance

6. Polycythemia vera Disease Background and Overview

7. Polycythemia vera Epidemiology and Patient Population

8. Country-Specific Patient Population of Polycythemia vera

9. Polycythemia vera Current Treatment and Medical Practices

10. Unmet Needs

11. Polycythemia vera Emerging Therapies

12. Polycythemia vera Market Outlook

13. Country-Wise Polycythemia vera Market Analysis (2020–2034)

14. Market Access and Reimbursement of Therapies

15. Market drivers

16. Market barriers

17. Appendix

18. Polycythemia vera Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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Polycythemia vera Pipeline Insights, DelveInsight

“Polycythemia vera Pipeline Insight, 2024” report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Polycythemia vera market. A detailed picture of the Polycythemia vera pipeline landscape is provided, which includes the disease overview and Polycythemia vera 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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