Polycythemia Vera Market Size in the 7MM is ~USD 1,800 million in 2023, estimated DelveInsight

Polycythemia Vera Treatment Market is projected to witness substantial growth over the next few years, driven by advancements in treatment modalities and increasing awareness of the condition.

DelveInsight's "Polycythemia Vera Market Insights, Epidemiology and Market Forecast - 2034" 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.

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Key Takeaways from the Polycythemia Vera Market Report

* In November 2024:- PharmaEssentia Japan K.K.- The study is to evaluate the long-term safety and efficacy of P1101 in PV or ET patients who participated in Study A19-201 or Study P1101 ET. The subjects who have completed the 52-week P1101 treatment duration in Study A19-201 will start treatment with P1101 at the dose at Week 50. The subjects who have completed the follow-up/end-of-study visit in Study P1101 ET will start treatment with P1101 at the dose at Week 50. The subjects who were treated with anagrelide will start treatment with P1101 at a dose of 250 g. The dose of P1101 during this study may be increased or decreased up to 500 g depending on the condition.
* In November 2024:- Ionis Pharmaceuticals Inc.- The main purpose of this study is to evaluate the efficacy of sapablursen in reducing the frequency of phlebotomy and in improving quality of life assessments in participants with polycythemia vera. This is a Phase 2a, multi-center, randomized, open-label study of sapablursen in up to 40 participants with PD-PV. The study consists of 4 periods: 1) Screening Period: up to 7 weeks; 2) Treatment Period: 37 weeks 3) Treatment Extension Period: 36 weeks; 4) Post-treatment Period: 13 weeks.
* In November 2024:- This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with PV. The entire study period is 60 weeks, including a main treatment phase (32 weeks), an extension treatment phase (24 weeks), and a safety follow-up phase (four weeks). However, the study may be extended for additional period of treatment after Week 60 pending the primary endpoint analysis at Week 32. Approximately 70 patients with PV will be enrolled.
* In November 2024:- Novartis Pharmaceuticals- This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study Investigator to benefit from ongoing treatment.
* The United States contributed to the largest prevalent population of Polycythemia Vera, acquiring ~58% of the 7MM in 2023. Whereas EU4 and the UK, and Japan accounted for around 32% and 10% of the total population share, respectively, in 2023.
* The total number of prevalent cases of Polycythemia Vera in the United States was around 182,000 cases in 2023.
* Among the EU4 countries, Germany accounted for the largest number of Polycythemia Vera cases, followed by France, whereas Spain accounted for the lowest number of cases in 2023.
* According to DelveInsight estimates, there were around 72,000 cases of asymptomatic and 107,000 cases of symptomatic Polycythemia Vera in the United States in 2023. The prevalence is projected to increase during the forecasted period.
* Among the age-specific data, 55-64 years of age group was found to be most prevalent in Polycythemia Vera, accounting for nearly 32% of the total cases.
* In 7MM, approximately 70% of the patient share is attributed to males, whereas only 30% of females suffer from Polycythemia Vera.
* The leading Polycythemia Vera Companies such as Protagonist Therapeutics, Imago BioSciences, Italfarmaco, Silence Therapeutics, Ionis Pharmaceutical, and many others.
* Promising Polycythemia Vera therapies such as Rusfertide (PTG-300), Bomedemstat (IMG-7289), Ruxolitinib + Abemaciclib, P1101, Itacitinib, Givinostat (ITF2357), Sapablursen (IONIS-TMPRSS6-LRx), SLN124, PPMX-T003, and others.

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Polycythemia Vera Epidemiology Insights in the 7MM

* Total Polycythemia Vera Prevalent Cases
* Prevalent Population of Polycythemia Vera Based On Symptoms
* Polycythemia Vera Gender-Specific Cases
* Prevalence of Polycythemia Vera By Gene Mutation
* Prevalence of Polycythemia Vera Based On Risk
* Polycythemia Vera Age-Specific Prevalence

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Polycythemia Vera Marketed Drugs

* JAKAFI/JAKAVI (ruxolitinib): Incyte/Novartis

JAKAFI/JAKAVI (ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. It is approved for treating adult patients resistant to or intolerant of hydroxyurea. Incyte's flagship product, Jakafi, received approval as second-line therapy for Polycythemia Vera patients in December 2014 in the United States, followed by approvals in both the EU and Japan in 2015. Incyte reported that out of all the drug prescriptions, approximately 30-35% of the prescriptions were in Polycythemia Vera. This attributes to Jakafi's well-established therapeutic efficacy and traction in patients as a second-line therapy.

* BESREMi (ropeginterferon alfa-2b): PharmaEssentia/AOP Orphan Pharmaceuticals

PharmaEssentia's BESREMi, a monopegylated proline interferon is a new entrant for first as well as more advanced-line Polycythemia Vera patients without symptomatic splenomegaly; it is one of the first to be approved for condition. BESREMi was approved in Q4 2021 in the US; meaningful sales began in 2022. Before the US launch, the drug was approved in the EU in 2019 and has been available in Germany, France, and the UK since 2020, whereas in April 2022, the drug was approved for reimbursement by Italy's National Health Service (SSN).

BESREMi is a subcutaneous pen self-administered once every 2 weeks or monthly during long-term maintenance with a wholesale acquisition cost (WAC) of approximately USD 180,000 annually in the United States, whereas in certain Europe, annual pricing range from USD 60,000 to 110,000.

Emerging Polycythemia Vera Drugs

* Rusfertide (PTG-300): Protagonist Therapeutics

Rusfertide (PTG-300), which is being investigated by Protagonist Therapeutics, is a novel injectable synthetic mimetic of the natural hormone hepcidin. The drug could potentially be the next first-line therapy competitor. The Phase II REVIVE Study demonstrated very promising results in both high-and low-risk patients, whereas if Phase III VERIFY study results are successful, the drug is expected to launch in late 2024 or early 2025. Given its very different mechanism of action compared to BESREMi and JAKAFI, the drug could become a viable alternative in earlier lines. Likewise, even the key opinion Leaders (KOLs) are bullish when it comes to the conventional route of administration once a week along with the safety and efficacy of this drug, which is expected to reduce the need for Phlebotomy for patients at both low and high risk, expanding the applicability of the drug. The US FDA granted Rusfertide ODD and FTD for the treatment of Polycythemia Vera.

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Polycythemia Vera Companies

Protagonist Therapeutics, Imago BioSciences, Italfarmaco, Silence Therapeutics, Ionis Pharmaceutical, and many others.

Scope of the Polycythemia Vera Market Report

* Coverage- 7MM
* Study Period- 2020-2034
* Polycythemia Vera Companies- Protagonist Therapeutics, Imago BioSciences, Italfarmaco, Silence Therapeutics, Ionis Pharmaceutical, and many others.
* Polycythemia Vera Therapies- Rusfertide (PTG-300), Bomedemstat (IMG-7289), Ruxolitinib + Abemaciclib, P1101, Itacitinib, Givinostat (ITF2357), Sapablursen (IONIS-TMPRSS6-LRx), SLN124, PPMX-T003, and others.
* Polycythemia Vera Market Dynamics: Polycythemia Vera Market Drivers and Barriers
* Polycythemia Vera Unmet Needs, KOL's views, Analyst's views, Polycythemia Vera Market Access and Reimbursement

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Table of Content

1 Key Insights

2 Report Introduction

3 Executive Summary of Polycythemia Vera (Polycythemia Vera)

4 Key Events

5 Epidemiology and Market Methodology

6 Polycythemia Vera Market Overview at a Glance

7 Disease Background and Overview

8 Epidemiology and Patient Population of Polycythemia Vera in the 7MM

9 Patient Journey

10 Key Endpoints in Polycythemia VeraClinical Trials

11 Marketed Drugs

12 Emerging Drugs

13 Polycythemia Vera (Polycythemia Vera): 7MM Analysis

14 Unmet Needs

15 SWOT Analysis

16 KOL Views

17 KOL interviews on Polycythemia Vera

18 Polycythemia Vera (Polycythemia Vera): Market Access and Reimbursement

19 Appendix

20 DelveInsight Capabilities

21 Disclaimer

22 About DelveInsight

About Us

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