Dublin, Feb. 17, 2025 (GLOBE NEWSWIRE) -- The "Polycythemia Vera - Market Insight, Epidemiology, and Market Forecast - 2034" report has been added to ResearchAndMarkets.com's offering.
The report 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, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
Most Polycythemia Vera patients are symptomatic, with approximately 97,400 patients with JAK2 mutation in the United States.
- In 2024, the market size of Polycythemia Vera was highest in the US among the 7MM, accounting for approximately USD 1.44 billion, which is further expected to increase by 2034 owing to the launch of emerging therapies, assisted by an increase in the diagnosed prevalent population of Polycythemia Vera.
- Polycythemia Vera does not have a cure; treatments can help control the disease and its complications. Polycythemia Vera is treated with procedures, medicines, and other methods. One or more treatments may be needed to manage the disease.
- Two drugs have been approved for polycythemia vera, i.e., JAKAFI (ruxolitinib) and BESREMi (ropeginterferon alfa-2B/AOP2014/P1101) and both the drugs are approved in the US, Europe, and Japan.
- Since BESREMi's label is broad (first and subsequent lines of therapy), PharmaEssentia has more leeway in positioning BESREMi in diverse therapeutic situations. Given BESREMi's position upstream of JAKAFI in the NCCN recommendations, the drug is not a direct competitor for JAKAFI. Still, it has the potential to hinder the progression of patients to JAKAFI usage, which might affect JAKAFI's overall revenue.
- The patent expiration in mid-2028 might be the most significant obstacle to JAKAFI's supremacy in the Polycythemia Vera market. To address this, Incyte introduced the LIMBER (Leadership in MPNs and GVHD BEyond Ruxolitinib) life-cycle management initiative, which was meant to explore different monotherapy and combination methods to enhance and expand therapies for patients with MPNs and GVHD.
- Given its very different MoA compared to JAKAFI and BESREMi, rusfertide could become a viable alternative as an earlier line of therapy. Rusfertide might have the edge over current treatment, considering that JAK inhibitors have side effects that can be fatal, and the data available to date shows that rusfertide can become the new standard of care as the drug substantially reduces the frequency of phlebotomy. Protagonist is targeting regulatory approval in Q4 2026 and commercial launch in 2027.
- Other emerging therapies include Merck's Bomedemstat, Italfarmaco's Givinostat, Silence Therapeutics' Divesiran, Ionis Pharmaceutical's Sapablursen, and Perseus Proteomics' PPMX-T003, which have the potential to create a significant positive shift in the Polycythemia Vera market size.
Polycythemia Vera Market Outlook
Polycythemia Vera treatment in the US is entering a new era with changing dynamics. Therapeutic options for Polycythemia Vera are limited, and no cure is available. The treatment landscape was dominated by legacy, generic therapies such as HydroxyUrea, second-generation interferon, and Phlebotomy until the approval of BESREMi as both the first and second line of treatment and JAKAFI in the second line of treatment only; options for third-line treatment are still limited. Adding onto that, Low-dose aspirin and phlebotomy are recommended as first-line treatment options for patients at low risk of thrombotic events. Cytoreductive therapy (usually hydroxyurea or interferon alpha) is recommended for high-risk patients. Polycythemia Vera treatment is still inadequate, as approximately 30% of HydroxyUrea-treated patients become resistant/intolerant.
The current market has been segmented into different commonly used therapeutic classes based on the prevailing treatment pattern across the 7MM, which presents minor variations in the overall prescription pattern. JAK inhibitor, Interferons, Hepcidin mimetics, TMPRSS6 inhibitor, CK1a, BCL-2 inhibitor, and LSDI inhibitor are the major classes covered in the forecast model.
The expected launch of upcoming therapies and greater integration of early patient screening, medication in secondary care and other clinical settings, research on best methods for implementation, and an upsurge in awareness will eventually facilitate the development of effective treatment options. However, there are a few potential therapies that are being investigated for managing Polycythemia Vera. If approved, shall create a significant difference in the landscape of Polycythemia Vera in the coming years. The treatment space is expected to experience a significant impact in the coming years, owing to the increase in healthcare spending worldwide.
Key players such as Protagonist Therapeutics (rusfertide), Merck (bomedemstat), Italfarmaco (DUVYZAT), Ionis Pharmaceutical (sapablursen), Silence Therapeutics (Divesiran) and Perseus Proteomics (PPMX-T003), and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Polycythemia Vera.
- The total market size of Polycythemia Vera in the 7MM is approximately USD 1.90 billion in 2024 and is projected to increase during the forecast period (2025-2034).
- Among EU4 countries, Germany accounts for the maximum market size in 2024, while the United Kingdom occupies the bottom of the ladder in 2024.
- In 2024, among the current therapies for Polycythemia Vera, the largest revenue was generated by JAKAFI i.e., USD ~965 million in the United States.
- By 2034, among all the emerging therapies in the EU4 and the UK, the highest revenue is expected to be generated by Rusfertide.
Key Updates
- In February 2024, the NCCN recommended BESREMi as a first-line cytoreductive therapy for patients with Polycythemia Vera in the NCCN Clinical Practice Guidelines in Oncology for MPN.
- According to Perseus Proteomics' corporate presentation published in November 2024, the company plans to out-license PPMX-T003 for the treatment of Polycythemia Vera in March 2025.
- As per Protagonist Therapeutics' pipeline activity, the company anticipates a top-line 32-week primary endpoint result of rusfertide (NCT05210790, VERIFY) in Q1 (March) 2025.
- Protagonist Therapeutics anticipates the final study report and FDA submission for rusfertide in Q1 2025. Furthermore, the company plans to present the results at the European Hematology Association (EHA) 2025 meeting in Q2 2025 and the ASH 2025 meeting in Q4 2025.
- As per Ionis Pharmaceuticals' January 2025 corporate presentation, the company anticipates launching sapablursen in 2028.
- According to Italfarmaco's pipeline activity, the company anticipates the launch of DUVYZAT in 2027 for the treatment of Polycythemia Vera.
Scope of the Report
- The report covers a segment of key events, an executive summary, descriptive overview of Polycythemia Vera, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
- Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along treatment guidelines.
- Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
- A detailed review of the Polycythemia Vera market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
- The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM Polycythemia Vera market.
Polycythemia Vera Report Insights
- Patient Population
- Therapeutic Approaches
- Polycythemia Vera Pipeline Analysis
- Polycythemia Vera Market Size and Trends
- Existing and future Market Opportunity
Polycythemia Vera Report Key Strengths
- Ten Years Forecast
- 7MM Coverage
- Polycythemia Vera Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Market
- Drugs Uptake
Polycythemia Vera Report Assessment
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- Qualitative Analysis (SWOT and Conjoint Analysis)
Company Coverage:
- 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
Key Topics Covered:
1. Key Insights
2. Report Introduction
3. Executive Summary
4. Polycythemia Vera Market Overview at a Glance
4.1. Market Share Distribution by Therapies (%) in 2020 in the 7MM
4.2. Market Share Distribution by Therapies (%) in 2034 in the 7MM
5. Epidemiology and Market Forecast Methodology
6. Key Events
7. Disease Background and Overview
7.1. Introduction
7.2. Polycythemia Vera: A Type of MPN
7.3. Signs and Symptoms of Polycythemia Vera
7.4. Causes of Polycythemia Vera
7.5. Complications due to Polycythemia Vera
7.6. Pathophysiology of Polycythemia Vera
7.7. Diagnosis of Polycythemia Vera
7.8. Diagnostic Guidelines
7.8.1. British Society for Hematology (BSH) Guidelines for Polycythemia Vera (2018)
7.8.2. WHO Diagnostic Guidelines for Polycythemia Vera (2018)
8. Treatment of Polycythemia Vera
8.1. Treatment Algorithm
8.2. Treatment Guidelines
8.2.1. NCCN Clinical Practice Guidelines for Myeloproliferative Neoplasms (2024)
8.2.2. Polycythemia Vera: Update on Disease Management (2024)
8.2.3. European LeukemiaNet (ELN) Guideline Recommendations for Polycythemia Vera (2021)
8.2.4. British Society for Hematology Guidelines for Polycythemia Vera (2018)
8.2.5. European Society for Medical Oncology (ESMO) Guidelines for Polycythemia Vera (2015)
9. Epidemiology and Patient Population of Polycythemia Vera in the 7MM
9.1. Key Findings
9.2. Assumptions and Rationale
9.3. Total Prevalent Population of Polycythemia Vera in the 7MM
9.4. Prevalent Population of Polycythemia Vera Based on Symptoms in the 7MM
9.5. The United States
9.6. EU4 and the UK
9.7. Japan
10. Patient Journey
11. Marketed Drug
11.1. Key Competitors
11.2. JAKAFI/JAKAVI (ruxolitinib): Incyte/Novartis
11.3. BESREMi (ropeginterferon Alfa-2b/AOP2014/P1101): PharmaEssentia/AOP Orphan Pharmaceuticals
11.4. PEGASYS (peginterferon alfa-2a): pharmaand GmbH
12. Emerging Drugs
12.1. Key Competitors
12.2. Rusfertide (PTG-300): Protagonist Therapeutics
12.3. Bomedemstat (MK-3543 [IMG-7289]): Merck (Imago BioSciences)
12.4. DUVYZAT (givinostat/ITF2357): Italfarmaco
12.5. Sapablursen (IONIS-TMPRSS6-LRx): Ionis Pharmaceutical
12.6. Divesiran (SLN124): Silence Therapeutics
12.7. PPMX-T003: Perseus Proteomics
13. Polycythemia Vera: 7MM Analysis
13.1. Key Findings
13.2. Market Outlook
13.3. Key Market Forecast Assumptions
13.3.1. Cost Assumptions and Rebates
13.3.2. Pricing Trends
13.3.3. Analogue Assessment
13.3.4. Launch Year and Therapy Uptake
13.4. Conjoint Analysis
13.5. Total Market Size of Polycythemia Vera in the 7MM
13.6. United States Market Size
13.7. EU4 and the UK Market Size
13.8. Japan Market Size
14. Unmet needs
15. SWOT Analysis
16. KOL Views
16.1. A Conversation with an MPN Specialist: Polycythemia Vera
17. Market Access and Reimbursement
17.1. United States
17.1.1. Centre for Medicare and Medicaid Services (CMS)
17.2. EU4 and the UK
17.2.1. Germany
17.2.2. France
17.2.3. Italy
17.2.4. Spain
17.2.5. United Kingdom
17.3. Japan
17.3.1. MHLW
17.4. Market Access and Reimbursement in Polycythemia Vera
For more information about this report visit https://www.researchandmarkets.com/r/4qjkbk
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
