Polycythemia Vera Market Positioned for Accelerated Development Through 2034, DelveInsight Finds

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.

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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 August 2025, The FDA has awarded Breakthrough Therapy Designation to rusfertide, a first-in-class hepcidin-mimetic peptide, for treating erythrocytosis in polycythemia vera (PV) patients with limited therapeutic options to reduce phlebotomy needs and improve blood count control. This designation was based on promising results from the Phase 3 VERIFY trial (NCT05210790), which compared rusfertide plus standard of care (SOC) against placebo plus SOC. In the 32-week analysis presented at the 2025 ASCO Annual Meeting, 76.9% of patients on rusfertide plus SOC (n=147) achieved a response between weeks 20 and 32, compared with 32.9% of those on placebo plus SOC (n=146; P < .0001).
• In August 2025, Vanda Pharmaceuticals revealed that the FDA has awarded Orphan Drug Designation to VGT-1849B, a JAK2 inhibitor, for the treatment of polycythemia vera (PV).
• In August 2025, Protagonist Therapeutics' rusfertide has been granted FDA Breakthrough Therapy Designation for the treatment of erythrocytosis in polycythemia vera, backed by encouraging Phase 3 VERIFY trial results presented at ASCO 2025.
• In May 2025, The FDA 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

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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

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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]
• 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
• 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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Contact Person: Gaurav Bora
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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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