Polycythemia vera Market: Epidemiology, Therapies, Companies, DelveInsight | Incyte, Novartis, PharmaEssentia, AOP Orphan Pharmaceuticals, Protagonist Therapeutics, Merck (Imago BioSciences), Italfarmaco, Ionis Pharmaceutical, Silence Therapeutics, Perseu

Polycythemia vera emerging therapies, such as Jakafi, Besremi, Rusfertide, Givinostat, and others, are expected to boost the Polycythemia vera Market in the upcoming years.

DelveInsight has launched a new report on "Polycythemia vera - Market Insights, Epidemiology, and Market Forecast-2034" that delivers an in-depth understanding of the Polycythemia vera, historical and forecasted epidemiology as well as the Polycythemia vera market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

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Some of the key facts of the Polycythemia vera Market Report:

The Polycythemia Vera (PV) market in the 7MM is expected to reach approximately USD 1,900 million in 2024, with further growth projected through the forecast period from 2025 to 2034. In 2024, JAKAFI (ruxolitinib) is expected to generate the highest revenue among current PV therapies, totaling around USD 965 million in the United States.
Most patients with PV are symptomatic, with an estimated 97,400 individuals in the U.S. having the JAK2 mutation. Although there is no cure for Polycythemia Vera, treatments aim to manage the disease and its complications through various procedures, medications, and other methods.
Two drugs are currently approved for PV: JAKAFI (ruxolitinib) and BESREMi (ropeginterferon alfa-2B/AOP2014/P1101), both of which are approved in the U.S., Europe, and Japan. BESREMi's broader label allows it to be used in first and subsequent lines of therapy, offering PharmaEssentia flexibility in its positioning. While not directly competing with JAKAFI, BESREMi has the potential to delay the progression of patients to JAKAFI, potentially impacting JAKAFI's revenue.
The patent expiration of JAKAFI in mid-2028 could present a significant challenge to its dominance in the PV market. To mitigate this, Incyte launched the LIMBER (Leadership in MPNs and GVHD BEyond Ruxolitinib) initiative to explore various monotherapy and combination therapies for patients with myeloproliferative neoplasms (MPNs) and graft-versus-host disease (GVHD).
Rusfertide, with a mechanism of action (MoA) distinct from JAKAFI and BESREMi, may offer a promising alternative for earlier-stage treatment. This drug shows potential to become the new standard of care, particularly as it reduces the frequency of phlebotomy without the fatal side effects associated with JAK inhibitors. Protagonist aims for regulatory approval in Q4 2026, with a commercial launch anticipated in 2027.
In 2024, the United States represented the largest portion of the global Polycythemia Vera population, accounting for approximately 57% of the total cases across the 7MM. Meanwhile, the EU4 and the UK combined, along with Japan, made up about 32% and 11% of the total prevalence, respectively. In the U.S., the total number of prevalent Polycythemia Vera cases was around 182,010 in 2024.
Other emerging therapies for Polycythemia Vera include Merck's Bomedemstat, Italfarmaco's Givinostat, Silence Therapeutics' Divesiran, Ionis Pharmaceuticals' Sapablursen, and Perseus Proteomics' PPMX-T003, all of which could significantly impact the PV market moving forward.
In March 2025, Takeda and its partner Protagonist Therapeutics announced the success of rusfertide in a Phase III trial, which achieved its primary endpoint in a study involving polycythemia vera (PV) patients. The companies plan to leverage the results from the VERIFY trial to support marketing applications for this hepcidin mimetic peptide treatment.
In December 2024, Vanda Pharmaceuticals Inc. revealed that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to VGT-1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor, for treating polycythemia vera (PV), a rare hematologic cancer that causes excessive red blood cell production in the bone marrow.
Key Polycythemia vera companies such as 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 are evaluating new drugs for Polycythemia vera to improve the treatment landscape.
Promising Polycythemia vera therapies include Jakafi, Besremi, Rusfertide, Givinostat, and others.

Polycythemia vera Overview

Polycythemia Vera is a rare disorder marked by an abnormal increase in the number of red blood cells in the bloodstream, along with a rise in white blood cells (WBC) and platelets. It is the most prevalent type of myeloproliferative neoplasm (MPN) and the only one associated with an increase in red blood cell production.

Typically, Polycythemia Vera occurs in older individuals, who are at a higher risk due to age-related factors and the increased likelihood of other associated health complications.

Polycythemia vera Market Outlook

Polycythemia Vera treatment in the United States is undergoing a transformation as the therapeutic landscape evolves. Historically, treatment options were limited, with no available cure, and the disease was primarily managed using long-established therapies like hydroxyurea, second-generation interferons, and phlebotomy. However, the approval of BESREMi for both first- and second-line use, and JAKAFI for second-line treatment, has introduced more modern options-though choices for third-line treatment remain sparse. For patients at low risk of thrombotic events, first-line therapy typically includes low-dose aspirin and phlebotomy, while high-risk patients are generally prescribed cytoreductive therapies like hydroxyurea or interferon alpha. Still, about 30% of patients on hydroxyurea become resistant or intolerant, underscoring the need for better alternatives.

The current treatment landscape across the 7MM is segmented by widely used therapeutic classes, including JAK inhibitors, interferons, hepcidin mimetics, TMPRSS6 inhibitors, CK1a inhibitors, BCL-2 inhibitors, and LSD1 inhibitors, with some regional variations in prescription patterns. As new therapies approach approval, combined with improved early screening, better integration into clinical care, ongoing research, and increased awareness, the market is poised for significant advancement. These developments, alongside rising global healthcare investment, are expected to bring meaningful improvements to the management of Polycythemia Vera in the near future.

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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:
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).
The Polycythemia vera market report provides insights into the current and emerging therapies.
The Polycythemia vera market report provides a global historical and forecasted market covering drug outreach in 7MM.
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.

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About DelveInsight

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