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Polycythemia Vera Market Expands As FDA Fast Tracks New Treatments And Clinical Trials Show Promising ResultsDelveInsight
"Polycythemia Vera Market Insight, Epidemiology and Market Forecast -2034"
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", 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.
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.
Recent Developments:
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.
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.
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.
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.
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
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.
Media ContactCompany Name:DelveInsight Business Research LLPContact Person: Arpit AnandEmail:Send EmailPhone: +14699457679Address:304 S. Jones Blvd #2432 City: Las VegasState: NevadaCountry: United StatesWebsite:https://www.Delveinsight.Com/consulting/due-diligence-services
Press Release Distributed by ABNewswire.ComTo view the original version on ABNewswire visit: Polycythemia Vera Market Expands as FDA Fast Tracks New Treatments and Clinical Trials Show Promising ResultsDelveInsight
New Therapies Advance For Rare Blood Cancer Polycythemia Vera
Emerging treatments like rusfertide may reduce phlebotomies and improve life for patients with polycythemia vera, according to Dr. Aaron Gerds.
Dr. Aaron Gerds, assistant professor of medicine at Cleveland Clinic Taussig Cancer Institute, emphasized the growing momentum in treatment development for polycythemia vera, a rare blood cancer. While the disease may not receive widespread attention, he noted that researchers are actively pursuing new therapies, including rusfertide and other agents targeting the hepcidin pathway.
Rusfertide, in particular, may reduce or eliminate the need for phlebotomies, potentially improving patients' quality of life. Gerds highlighted that multiple new therapies are being studied — such as givinostat in a phase 3 trial — and stressed that even in rare diseases, progress is being made.
What would you like patients to take away from today's conversation?
There are a couple of important things to note. One is that we are developing — and continue to develop — new therapies for polycythemia vera. Even though it's a rare disease and not often highlighted in the broader pantheon of diseases presented at ASCO, it's still a very important condition, especially for the people who have it.
There is a group of us who are very invested in this disease and are working hard to develop new therapies for it. Rusfertide isn't the only one in development — there are also other drugs targeting the hepcidin pathway, as well as agents outside that pathway. For example, givinostat is currently in a randomized phase 3 trial as well as a registration-type study, also seeking approval.
Even though it's rare, we are working hard to develop better treatment options. That's the most important takeaway.
Specifically, with rusfertide, it's exciting because it's a new therapy that reduces or even eliminates the need for phlebotomies. That can really improve patients' quality of life, which is important. Having another tool in our arsenal to care for these patients is exciting and can offer a lot to our patients.
Transcript has been edited for clarity and conciseness.
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Genetic Links To High Altitude Found To Reduce Inflammation, Speed ...
Research presented at the 66th American Society of Hematology Annual Meeting revealed that a genetic variant enriched in Andean populations, associated with reduced inflammation and improved response to ropeginterferon-α, could guide more precise treatments for polycythemia vera (PV) and essential thrombocythemia.
Questions about why an indigenous population living the Andes Mountains of South American had elevated hemoglobin led to the discovery that a variant linked to living at high altitude is also tied to reduced inflammation, as well as improved response to a therapy used to treat myeloproliferative neoplasms (MPNs).1
Jihyun Song, PhDImage credit: University of Utah
The research to be presented today at the 66th American Society of Hematology Annual Meeting & Exposition in San Diego, California, could lead to more precise treatments for polycythemia Vera (PV) and essential thrombocythemia (ET). Today, these 2 are treated with ropeginterferon-α (Besremi), and the work led by Jihyun Song, PhD, of Huntsman Cancer Institute at the University of Utah, now shows that populations with Andean enriched NFKB1 haplotype respond better to ropeginterferon-α.
The study has been accepted for publication in Nature Communications.
PV and ET are both associated with overproduction of blood cells; PV causes the bone marrow to produce too many red blood cells, while ET produces too many platelets. Both PV and ET can lead to chronic inflammation, increase the risk of blood clots, and progress to leukemia. These conditions also increase hypoxia-inducible factors (HIFs), which can impact the survival of cancer cells in low-oxygen environments.
At a press briefing prior to Song's presentation today, senior author Josef T. Prchal, MD, a physician scientist who holds the Charles A. Nugent, MD, and Margaret Nugent Endowed Professorship in Medicine/Hematology at the University of Utah, explained that the genetic variants that developed over time to allow the Aymara people survive in the Andes can be seen in some other populations—and they correlate with some differences in MPN phenotypes.
Josef Prchal, MDImage credit: Photo supplied by ASH
"Our study suggests that with genotyping, the NFKB1 variant can be used as a biomarker for determining which patients may be more or less responsive to ropeginterferon-α treatment," Prchal said.
He opened his remarks with an overview of how populations evolve with their environments; not only the Aymara but also Tibetans and Ethiopians have adapted to altitude in different ways, which he explored in earlier papers in Science2 and Nature Genetics,3 among others.
It is known that when humans spend time high altitude, their bodies adapt to reduced oxygen levels by increasing hemoglobin concentrations in the blood. This allows the body to carry more oxygen. Prchal explained how Song took this knowledge further. "We set up to try to find the gene which explains the hemoglobin," he said.
Prchal and Song were gathering blood samples in the Andes when Song determined that she should look beyond gene differences and look instead at how genes are activated. Through this approach, Song focused on alternatively spliced NFKB1 (AS-NFKB1); she identified 3 novel, alternatively spliced NFKB1 transcripts associated with inflammatory and HIF pathways, which investigators say would explain the elevated hemoglobin.1
The transcripts functioned in different ways, with the net effect of indicating "a partial or complete loss of NFKB1's function as a NF-κB suppressor."
Prchal said there were some twists along the way. There were some common genes between the Tibetans and the Aymara, he said, but the NFKB1 gene also showed up among Tibetan Chinese and in some Europeans, but was rare for Africans.
"With this knowledge, we have correlated this gene with very high hemoglobin, and we also correlated it with higher response to oxygen. But it was a puzzle that this gene actually was associated with increased inflammation," he said.
"Increased inflammation makes you tired. It also is a foundation for mutations and increases of cancer," Prchal continued. But when Song examined lab-grown cells with slightly increased inflammation, the presence of the gene caused the inflammation to go down.
"So, in fact, this gene in excessive inflammation will make it less likely, and we assumed it may be very important for cancer," he said.
Drawing on their work in MPNs, Song examined samples from patients with slightly increased inflammation to look at the inflammatory genes, and found they also had lower activity of genes which cause thrombosis. Next came a look at how patients with the NFKB1 gene responded to ropeginterferon-α.
"We looked at those people who achieved complete hematological remission and those who did not," Prchal said. He said that those who inherited the gene were much more likely to achieve complete remission, he said.
"Under TNF-induced inflammatory stress, unlike wild-type NFKB1, AS-NFKB1 suppressed inflammatory gene expression, suggesting a protective mechanism against inflammation," the investigators wrote.
Investigators have many more questions, Prchal said, such as whether the Aymara phenotype cuts the thrombotic rate or decreases myelofibrosis or acute myeloid leukemia transformation.
The National Institutes of Health sponsored the study.
Reference
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