DelveInsight’s “Polycythemia Vera Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the Polycythemia Vera, historical and forecasted epidemiology as well as the Polycythemia Vera market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.
To Know in detail about the Polycythemia Vera market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Polycythemia Vera Market Forecast
Some of the key facts of the Polycythemia Vera Market Report:
The Polycythemia Vera market size was valued approximately USD 1900 million in the 7MM in the year 2024 and is anticipated to grow with a significant CAGR during the study period (2020-2034)
In May 2025, The FDA has granted Fast Track designation to givinostat (Duvyzat) for the treatment of polycythemia vera, according to a press release from its developer, Italfarmaco. Previously, givinostat received orphan drug designation for the same indication from both the FDA and the European Medicines Agency (EMA). Additionally, the drug has been approved by the FDA and the UK’s Medicines and Healthcare Products Regulatory Agency for the treatment of Duchenne muscular dystrophy.
In March 2025, Protagonist Therapeutics, Inc. (NASDAQ: PTGX) and Takeda (TSE: 4502/NYSE: TAK) have announced positive topline results from the Phase 3 VERIFY study. The trial involved phlebotomy-dependent polycythemia vera (PV) patients, who were randomly assigned to receive either rusfertide or a placebo alongside standard care. The study successfully achieved its primary endpoint along with all four key secondary endpoints. Rusfertide, an investigational first-in-class hepcidin mimetic peptide therapeutic, has been granted Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration (FDA).
In December 2024, Silence Therapeutics plc (“Silence” or the “Company”) (Nasdaq: SLN), a global clinical-stage company focused on developing innovative siRNA (short interfering RNA) therapies, today announced the presentation of additional results from the Phase 1 open-label segment of the SANRECO study of divesiran, a siRNA targeting TMPRSS6, in patients with polycythemia vera (PV) at the American Society of Hematology (ASH) Annual Meeting.
In June 2024, AOP Orphan Pharmaceuticals GmbH (AOP Health) continues its successful hematology/oncology clinical research program with two abstracts accepted for presentation at the European Hematology Association (EHA) 2024 hybrid congress in Madrid, Spain. One abstract includes an oral presentation of the latest findings from the PROUD-PV and CONTINUATION-PV trials. The results demonstrate a link between genetic changes (molecular response) and event-free survival (EFS) in polycythemia vera (PV) patients treated with ropeginterferon alfa-2b (BESREMi®) or the best available treatment.
In February 2024, Disc Medicine has disclosed that the US FDA has awarded Orphan Drug Designation to DISC-3405 for treating patients with PV. Additionally, in September 2023, the FDA granted fast track designation to MWTX-003, also known as DISC-3405, for PV treatment.
In January 2024, Takeda and Protagonist Therapeutics have established a global licensing and collaboration agreement for rusfertide.
In 2023, the United States had the highest number of cases among the 7MM. The total number of prevalent PV cases in the US in 2023 was approximately 180,000.
In the EU4 and the UK, Germany had the highest number of PV cases, with nearly 25,000 cases in 2023, whereas Spain reported the lowest number of cases in the same year.
As per Orphanet, PV affects 30 out of every 100,000 individuals in Germany. When extrapolated to the entire population, this translates to approximately 24,000 affected people.
According to Kuykendall (2023), as many as 25% of patients develop resistance to or cannot tolerate hydroxyurea.
Key Polycythemia Vera Companies: Protagonist Therapeutics, Italfarmaco, Imago BioSciences, Silence Therapeutics, Ionis Pharmaceutical, Perseus Proteomics, Protagonist Therapeutics, Inc., Novartis, PharmaEssentia, AOP Orphan Pharmaceuticals AG, Incyte Corporation, and others
Key Polycythemia Vera Therapies: Rusfertide (PTG-300), Givinostat (ITF2357), Bomedemstat, SLN124, Sapablursen, PPMX-T003, PTG-300, SLN124, Hydroxyurea, Ropeginterferon alfa-2b, PEG-P-INF alpha-2b (P1101), Ruxolitinib, and others
The Polycythemia Vera epidemiology based on gender analyzed that mostly males are affected in case of Polycythemia Vera
The Polycythemia Vera market is expected to surge due to the disease’s increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Polycythemia Vera pipeline products will significantly revolutionize the Polycythemia Vera market dynamics.
Polycythemia Vera Overview
Polycythemia vera (PV) is a rare and chronic blood disorder characterized by the overproduction of red blood cells in the bone marrow. This excess production of red blood cells leads to an increase in blood volume and thickness, which can cause complications such as blood clots, stroke, or heart attack. PV is a type of myeloproliferative neoplasm, a group of disorders in which the bone marrow produces too many blood cells.
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Polycythemia Vera Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.
Polycythemia Vera Epidemiology Segmentation:
The Polycythemia Vera market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
Total Prevalence of Polycythemia Vera
Prevalent Cases of Polycythemia Vera by severity
Gender-specific Prevalence of Polycythemia Vera
Diagnosed Cases of Episodic and Chronic Polycythemia Vera
Download the report to understand which factors are driving Polycythemia Vera epidemiology trends @ Polycythemia Vera Epidemiology Forecast
Polycythemia Vera Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Polycythemia Vera market or expected to get launched during the study period. The analysis covers Polycythemia Vera market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Polycythemia Vera Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.
Polycythemia Vera Therapies and Key Companies
Rusfertide (PTG-300): Protagonist Therapeutics
Givinostat (ITF2357): Italfarmaco
Bomedemstat: Imago BioSciences
SLN124: Silence Therapeutics
Sapablursen: Ionis Pharmaceutical
PPMX-T003: Perseus Proteomics
PTG-300: Protagonist Therapeutics, Inc.
SLN124: Silence Therapeutics plc
Hydroxyurea: Novartis
Ropeginterferon alfa-2b: PharmaEssentia
PEG-P-INF alpha-2b (P1101): AOP Orphan Pharmaceuticals AG
Ruxolitinib: Incyte Corporation
Discover more about therapies set to grab major Polycythemia Vera market share @ Polycythemia Vera Treatment Market
Polycythemia Vera Market Strengths
The approval of BESREMi in the US and its expected approval in Japan, in both the first and second line of treatment, provides the interferon with an immense opportunity to garner a big market size in Polycythemia Vera.
Based on increasing sales of JAKAFI/JAKAVI, the drug will be a blockbuster therapy in 2L PV patients.
Polycythemia Vera Market Opportunities
An increase in strategic alliances, such as geographical alliances, and granting the designation such as BTD and FTD by the FDA are some of the factors that will drive the market growth.
Opportunity for drugs with novel and disease-modifying mechanisms and low side effect.
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]
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
To know more about Polycythemia Vera companies working in the treatment market, visit @ Polycythemia Vera Clinical Trials and Therapeutic Assessment
Table of Contents
1. Polycythemia Vera Market Report Introduction
2. Executive Summary for Polycythemia Vera
3. SWOT analysis of Polycythemia Vera
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. Polycythemia Vera Unmet Needs
11. Polycythemia Vera Emerging Therapies
12. Polycythemia Vera Market Outlook
13. Country-Wise Polycythemia Vera Market Analysis (2020–2034)
14. Polycythemia Vera Market Access and Reimbursement of Therapies
15. Polycythemia Vera Market Drivers
16. Polycythemia Vera Market Barriers
17. Polycythemia Vera Appendix
18. Polycythemia Vera Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
About DelveInsight
DelveInsight is a leading Healthcare 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.
It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.
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