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Polycythemia Vera Market Insight, Epidemiology and Market Forecast -2034

Published Date : 2025
Pages : 226
Region : United States, Japan, EU4 & UK
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Polycythemia Vera Market Summary

  • The Polycythemia Vera Market Size in the 7MM is expected to grow from USD 2,087 million in 2025 to USD 5,257 million in 2034.
  • The Polycythemia Vera Market is projected to grow at a CAGR of 10.80% by 2034 in leading countries like the US, EU4, UK, and Japan.

Polycythemia Vera Market and Epidemiology Analysis

  • The total Polycythemia Vera market size in the 7MM is ~USD 1,900 million in 2024 and is projected to increase during the forecast period (2025–2034).
  • 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.
  • Most Polycythemia Vera patients are symptomatic, with approximately 97,400 patients with JAK2 mutation in the United States.
  • 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 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 sales revenue.
  • 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 Polycythemia Vera 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 Size and Forecast

  • 2025 Polycythemia Vera Market Size: USD 2,087 million in 2025
  • 2034 Projected Polycythemia Vera Market Size: USD 5,257 million
  • Polycythemia Vera Growth Rate (2025-2034): 10.80% CAGR
  • Largest Polycythemia Vera Market: United States

Polycythemia Vera Market Insights

Key Factors Driving the Polycythemia Vera Market

  • Prevalence driving the Polycythemia Vera market

In 2024, the total number of total prevalent Polycythemia Vera cases in leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] was 320K which are projected to rise modestly by 2034, driven by better diagnostics, growing awareness, and longer patient survival, expanding the PV market and driving demand for more effective PV treatments.

  • Polycythemia Vera treatment landscape

Current Polycythemia Vera treatment typically centers on phlebotomy, cytoreductive therapy, and JAK inhibition for hydroxyurea-intolerant patients, notably JAKAFI (Incyte), which generated the most significant revenue of USD ~965 million in 2024 in the US. These established options anchor the market while creating precise unmet needs around phlebotomy dependency and symptom control. 

  • Polycythemia Vera clinical trial analysis

Late-stage Polycythemia Vera pipeline activity, including hepcidin-mimetic and epigenetic approaches, is boosting the PV market by targeting phlebotomy burden and symptom control. Positive Phase III data for rusfertide (Protagonist/Takeda) as the drug substantially reduces the frequency of phlebotomy. Other notable therapies in development include Bomedemstat (Merck), Givinostat (Italfarmaco), Divesiran (Silence Therapeutics), Sapablursen (Ionis Pharmaceuticals), and PPMX-T003 (Perseus Proteomics), among others.

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 therapeutics market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Polycythemia Vera Market Report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Polycythemia Vera market size from 2020 to 2034. The report also covers current Polycythemia Vera treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Scope of the Polycythemia Vera Market Report

Study Period

2020–2034

Forecast Period

2025–2034

Geographies Covered

US, EU4 (Germany, France, Italy, and Spain) and the UK, and Japan

Polycythemia Vera 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
  • Age-specific Prevalence of Polycythemia Vera

Polycythemia Vera Key Companies

  • 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, and Others

Polycythemia Vera Key Therapies

  • JAKAFI/JAKAVI (ruxolitinib)
  • BESREMi (ropeginterferon alfa-2b)
  • Rusfertide (PTG-300)
  • Bomedemstat (MK-3543 [IMG-7289])
  • DUVYZAT (givinostat/ITF2357)
  • Sapablursen (TMPRSS6)
  • Divesiran (SLN124)
  • PPMX-T003
  • Navitoclax
  • VAC85135
  • 9MW3011/DISC-3405 (formerly MWTX-003)
  • GLB-001, and Others

Polycythemia Vera Market

Segmented by:

  • Region
  • Therapies

Analysis

  • KOL Views
  • SWOT Analysis
  • Reimbursement
  • Conjoint Analysis
  • Unmet needs

Polycythemia Vera Disease Understanding

Polycythemia Vera Overview

Polycythemia Vera is a rare condition characterized by the progressively increased number of red blood cells in the bloodstream, white blood cells (WBC), and platelets also increase in number in the affected people. Polycythemia Vera is the most common myeloproliferative neoplasm (MPN). Out of all the MPNs, Polycythemia Vera is the most common and the only one in which there is an increase in RBC production.

Polycythemia Vera usually occurs at an elderly age, and patients are at a higher risk than the usual percentage, as they are more prone to the risks and other comorbidities.

Polycythemia Vera Diagnosis

The diagnosis of Polycythemia Vera is based on results from tests assessing elevations in blood counts and the presence of molecular mutations associated with the disease. The initial evaluation should include a focused clinical history, physical examination, hematocrit concentration, count of RBC, WBC, platelets, serum EPO level, and cytogenetics abnormalities.

The patient's journey begins with a referral to a hematologist. However, the current approach to diagnosing these patients is quite similar as most developing countries establish a patient’s diagnosis journey using WHO criteria, which is based on a composite assessment of clinical and laboratory features, including JAK2 mutation status and serum erythropoietin level. However, when it comes to analyzing the real-world scenario in varying geographies, there are some differences in diagnostic criteria and risk stratification that other organizations in certain European countries have proposed.

For example, even though the WHO classification considers histology useful in distinguishing Polycythemia Vera from other myeloproliferative neoplasms (MPNs), the British Society for Haematology Guideline has also cited several studies that have reported high rates of failure to reach a histological diagnosis in patients with Polycythemia Vera.

Further details related to country-based variations are provided in the reported

Polycythemia Vera Treatment

Based on real-world pattern analysis, patients suffering from Polycythemia Vera receive treatment with certain drugs (myelosuppressive drugs) that suppress the formation of blood cells by the marrow. A chemotherapy drug, hydroxyurea, is most often used, along with another chemotherapy drug known as busulfan. Other drugs, such as chlorambucil and radioactive phosphorous, have also been used. JAKAFI and BESREMi are the two FDA-approved drugs for treating Polycythemia Vera.

Although medication adherence can be elusive, it has been found that the patients who were prescribed injectable cytoreductive drugs had lower adherence rates than their counterparts taking oral formulations. There are many factors when it comes to lower adherence to therapies, for instance, when patients are taking too many therapies together, facing side effects, having cost concerns, and facing issues with dosing regimens.

Over the next few years, the US Polycythemia Vera Market is expected to substantially change and experience growth, as it will be dominated by two already approved products, JAKAFI and BESREMi. In contrast, we also anticipate the launch of a third product, Rusfertide, in the US market in the coming 2–3 years. Considering that the symptomatic cases of Polycythemia Vera are the one’s which get diagnosed, which is around a moderate range of 60–70%, we expect the market to expand, especially as safer and more effective therapies enter the market.

Further details related to country-based variations are provided in the reported

Polycythemia Vera Epidemiology

As the market is derived using a patient-based model, the Polycythemia Vera epidemiology chapter in the report provides historical as well as forecasted 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 covering the United States, EU4 (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034. The total prevalent cases of Polycythemia Vera in the 7MM comprised approximately 319,500 cases in 2024 and are projected to increase during the forecasted period.

Key Findings from Polycythemia Vera Epidemiological Analyses and Forecast

  • The United States contributed to the largest prevalent population of Polycythemia Vera, acquiring ~57% of the 7MM in 2024. Whereas EU4 and the UK, and Japan accounted for around 32% and 11% of the total population share, respectively, in 2024.
  • The total number of prevalent cases of Polycythemia Vera in the United States was around 182,010 cases in 2024.
  • Among the EU4 countries, Germany accounted for the largest number of Polycythemia Vera cases based on symptoms, whereas Spain accounted for the lowest number of cases in 2024.
  • According to DelveInsight estimates, there were around 72,810 cases of asymptomatic and 109,210 cases of symptomatic Polycythemia Vera in the United States in 2024. The prevalence is projected to increase during the forecasted period.
  • In Japan among the age-specific data, the 65–74 years of age group was found to be most prevalent in Polycythemia Vera, accounting for nearly 30% of the total cases in 2024.
  • In 7MM, approximately 56% of the patient share is attributed to males, whereas only 44% of females suffer from Polycythemia Vera. 

Polycythemia Vera Epidemiology Segmentation

  • 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
  • Age-specific Prevalence of Polycythemia Vera

Polycythemia Vera Epidemiology Insights

Discover crucial insights with our Polycythemia Vera Epidemiology Forecast. Stay ahead in healthcare innovation.

Polycythemia Vera Market Recent Developments and Breakthroughs

  • In August 2025, Vanda Pharmaceuticals announced that the FDA granted Orphan Drug Designation to VGT-1849B, a JAK2 inhibitor, for the treatment of polycythemia vera (PV).
  • In Aug 2025, Protagonist Therapeutics' rusfertide received FDA Breakthrough Therapy Designation for treating erythrocytosis in polycythemia vera, supported by positive Phase 3 VERIFY study data presented at ASCO 2025.
  • In March 2025, Takeda and its partner Protagonist Therapeutics announced a Phase III success for rusfertide, which met the primary endpoint in a study involving patients with polycythemia vera (PV). The companies plan to use the results from the VERIFY trial to support marketing applications for the hepcidin mimetic peptide therapeutic.

Polycythemia Vera Drug Analysis

The drug chapter segment of the Polycythemia Vera drugs market report encloses a detailed analysis of Polycythemia Vera marketed drugs and late-stage (Phase III, Phase II, Phase I/II, and Phase I) pipeline drugs. It also helps understand the Polycythemia Vera clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Marketed Polycythemia Vera Drugs

JAKAFI/JAKAVI  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.

In December 2024, the American Society of Hematology (ASH) Annual Meeting and Exposition featured novel research on the long-term safety and efficacy of ruxolitinib for patients with polycythemia vera. The poster presentations in particular shed light on the superiority of ruxolitinib over hydroxyurea, and how ruxolitinib can allow patients to rely less on corticosteroids.

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 November 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). Later in March 2023, the Ministry of Health, Labor, and Welfare (MHLW) approved BESREMi for the treatment of Polycythemia Vera (limited to cases where existing treatments are inadequate or inappropriate)

As per news released in May 2024, BESREMi showed the greatest benefit among cytoreductive therapies in lowering the symptomatic burden of Polycythemia Vera. The results were further presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting Proceedings. 

Key Cross of Marketed Drug

Drug

Company

Indication

Molecule Type

MoA

RoA

Marketed Region

JAKAFI/JAKAVI (ruxolitinib)

Incyte/Novartis

Patients with Polycythemia Vera who have had an inadequate response to or are intolerant of hydroxyurea

Small molecule

JAK inhibitor

Oral

US: 2014

EU: 2015

JP: 2015

BESREMi (ropeginterferon alfa-2b/AOP2014/P1101)

PharmaEssentia/AOP Orphan Pharmaceuticals

Polycythemia Vera patients regardless of their treatment history

Recombinant interferon alpha subtype 2b (IFN-a2b) protein

Binds to the interferon alfa receptor (IFNAR)

SC

US: 2021

EU: 2019

JP: 2023

PEGASYS (peginterferon alfa-2a)

pharmaand GmbH

Polycythemia Vera

Type 1 interferon

Antiviral and anti-proliferative activities

SC

EU: 2024

Emerging Polycythemia Vera Drugs

Rusfertide is a novel injectable synthetic mimetic of the natural hormone hepcidin that offers greater potency, solubility, and stability, which translates to better in vivo pharmacokinetics and pharmacodynamics characteristics and manufacturability in comparison to the natural hormone. In December 2024, the final results of rusfertide from the Phase II REVIVE trial were presented at the ASH (4559) meeting. The data demonstrated that rusfertide when added to therapeutic phlebotomy with or without cytoreductive therapy, effectively controlled erythrocytosis, provided long-term durable control of hematocrit, and reduced the need for therapeutic phlebotomy in patients with Polycythemia Vera.

According to Protagonist Therapeutics’ corporate presentation published in January 2025, the company anticipates filing an NDA for rusfertide in Q4 2025, with approval expected in Q4 2026, followed by the commercialization of the product in 2027.

Bomedemstat is an investigational small molecule, irreversible Lysine-specific Demethylase 1 (LSD1) inhibitor being developed by Merck. Bomedemstat is being evaluated in a wide range of myeloproliferative neoplasms, including essential thrombocythemia, myelofibrosis, and Polycythemia Vera. Currently, an ongoing investigator-sponsored Phase III trial evaluates bomedemstat in Polycythemia Vera patients.

In January 2023, Merck announced the successful completion of its cash tender offer through a subsidiary for all outstanding shares of common stock of Imago BioSciences. Earlier in November 2022, Merck and Imago BioSciences announced that the companies had entered into a definitive agreement.

Comparison of Polycythemia Vera Emerging Drugs Under Development

Drug Name

Company

Highest Phase

Indication

RoA

MoA

Molecule Type

Rusfertide (PTG-300)

Protagonist Therapeutics

III

Polycythemia Vera in maintaining hematocrit control and in improving symptoms of polycythemia vera

SC

Iron modulator

Hepcidin mimetic peptide

Bomedemstat (MK-3543 [IMG-7289])

Merck (Imago BioSciences)

III

Polycythemia Vera

Oral

LSD1 inhibitor

Small molecule

DUVYZAT (givinostat/ITF2357)

Italfarmaco

III

JAK2V617F-positive high-risk Polycythemia Vera

Oral

Pan-HDAC inhibitor

Small molecule

Sapablursen (TMPRSS6)

Ionis Pharmaceutical

II

Phlebotomy-dependent Polycythemia Vera

SC

TMPRSS6 inhibitor

Antisense oligonucleotide

Divesiran (SLN124)

Silence Therapeutics

I/II

Polycythemia Vera

SC

TMPRSS6 inhibitor

GalNAc-siRNA conjugate  (gene silencing therapy)

PPMX-T003

Perseus Proteomics

I

Polycythemia Vera

IV infusion

Targets transferrin Receptor (TfR)

Monoclonal antibody

Navitoclax

AbbVie

I

Polycythemia Vera

Oral

BCL-2 inhibitor

Small molecule

VAC85135

Johnson & Johnson Innovative Medicine

I

Polycythemia Vera

IM

Immunostimulant

Neo-antigen Vaccine

9MW3011/DISC-3405 (formerly MWTX-003)

Mabwell (Shanghai) Bioscience and Disc Medicine

I

Polycythemia Vera

IV infusion

TMPRSS6 inhibitor

Monoclonal antibody

GLB-001

GluBio Therapeutics

I

Relapsed or refractory or intolerant Polycythemia Vera

Oral

Casein Kinase 1 Alpha (CK1α) protein inhibitor

Small molecule

Polycythemia Vera Drug Class Analysis

The existing Polycythemia Vera treatment is mainly dominated by classes such as antimetabolites, platelet-reducing agents, Interferons, and JAK inhibitors.

JAK inhibitors have been developed following the discovery of the JAK2V617F in 2005 as the driver mutation of most non-BCR-ABL1 myeloproliferative neoplasms (MPNs).  A decade after the beginning of clinical trials, only one JAK inhibitor, Jakafi, has been approved by the US Food and Drug Administration for hydroxyurea-resistant or intolerant Polycythemia Vera patients since 2014. JAKAFI competes with platelet-reducing agents (Anagrelide), Interferon alpha, and BESREMi in the second line of treatment. Even though there are safety concerns regarding JAK inhibitors, we cannot misconstrue the strong uptake of Jakafi in the already treated patients with this blood disorder.

Moving onto Interferon’s, BESREMi is not the first one being used in these patients, though it is the first approved interferon for Polycythemia Vera patients. For years, Pegasys has been commercially available which is present all along. Pegasys is a form of pegylated interferon that is used off-label by patients living with a myeloproliferative neoplasm. However, many patients have dealt with access and reimbursement issues as it is accessed off-label.

Moreover, the upcoming Polycythemia Vera treatment landscape is poised to see further expansion after the emergence of new classes such as iron modulator, LSD1 inhibitor, Pan-HDAC inhibitor, TMPRSS6 inhibitor, TfR targeting, BCL-2 inhibitor, Immunostimulant, CK1a, and others.

Polycythemia Vera Market Outlook

Polycythemia Vera Market Outlook

Polycythemia Vera treatment in the US is entering a new era with changing dynamics. Polycythemia Vera Therapeutic options are limited, and no cure is available. The Polycythemia Vera 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 Polycythemia Vera 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 Polycythemia Vera 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 Polycythemia Vera companies 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 Polycythemia Vera market size in the 7MM is approximately USD 1,900 million in 2024 and is projected to increase during the forecast period (2025–2034).
  • Among EU4 countries, Germany accounts for the maximum Polycythemia Vera 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 Polycythemia Vera therapies in the EU4 and the UK, the highest revenue is expected to be generated by Rusfertide.

Key Updates in Polycythemia Vera Clinical Trials Market

  • 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.

Polycythemia Vera Drugs Uptake

This section focuses on the uptake rate of potential Polycythemia Vera drugs expected to be launched in the Polycythemia Vera market during 2020–2034. For example, for Rusfertide, although FDA rescinded its Breakthrough Designation, we expect the drug uptake to be medium-fast with a probability-adjusted peak share of 5.4% in the first line and second line, years to the peak is expected to be 7 years from the year of launch. The drug was proven to be better among all the other therapies in terms of safety and efficacy.

Further detailed analysis of emerging therapies drug uptake in the report…

Polycythemia Vera Pipeline Development Activities

The Polycythemia Vera treatment market report provides insights into different therapeutic candidates in Phase III, Phase II, Phase I/II, and Phase I stage. It also analyzes key Polycythemia Vera companies involved in developing targeted therapeutics.

Latest KOL Views on Polycythemia Vera

To keep up with current Polycythemia Vera market trends, we take KOLs and SME's opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on Polycythemia evolving treatment landscape, patient reliance on conventional therapies, patient’s therapy switching acceptability, and drug uptake along with challenges related to accessibility, include Medical/scientific writers, Medical Oncologists, and Professors, Director of Hanns A. Pielenz Clinical Research Center, Director of the Myeloproliferative Disorders Research Program, Hematologists and Others.

Delveinsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as MD Anderson Cancer Center, Texas from UT Southwestern Medical Center in Dallas, Cancer Research UK Barts Centre in London, MD Anderson Cancer Center, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Polycythemia Vera market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Region

KOL Views

United States

“The approval of JAKAFI represents an important advance for patients with uncontrolled polycythemia vera. For the first time, we are able to provide these patients a treatment that has been shown to provide effective and consistent control of their blood counts and reduce spleen volume.”

United States

“Polycythemia Vera patients could benefit from a novel treatment option that effectively manages their condition without causing serious adverse effects. In the Phase I portion of the SANRECO study, divesiran substantially reduced the need for phlebotomy and lowered hematocrit levels following infrequent dosing in a range of Polycythemia Vera patients. The long duration of effect and clean safety/tolerability profile were impressive. These data are very exciting and support further development of divesiran in polycythemia vera.”

Polycythemia Vera Report Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple emerging and approved Polycythemia Vera therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in Polycythemia Vera  clinical trials, one of the most important primary outcome measures is the reduction in hematocrit levels to <45% while making the patient independent of Phlebotomies.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Polycythemia Vera Market Access and Reimbursement

United States

  • JAKAFI/JAKAVI (ruxolitinib)

JAKAFI is distributed primarily through a network of specialty pharmacy providers that work closely with IncyteCARES and allow efficient medication delivery by mail directly to patients or the patient’s pharmacy of choice. Our distribution process uses a well-established and familiar model for physicians who practice in oncology.

Over the 12 months (four quarters) for which price changes were assessed, the WAC for ruxolitinib increased by approximately 7.01%, while its estimated net price increased by 3.80%. This net price change over the assessed four quarters resulted in an estimated increase in drug spending of USD 78 million. All pricing information was obtained from SSR Health.

IncyteCARES for JAKAFI is committed to helping eligible patients get the necessary medicine. That is why certain programs are offered and may be able to connect one to others, which may help make the out-of-pocket costs more affordable if one qualifies. To qualify, one must meet certain eligibility requirements.

IncyteCARES for JAKAFI Patient Support Program

  • Coverage verification: Can check with a patient’s insurance plan about their coverage for JAKAFI and any out-of-pocket costs required.
  • Insurance assistance: Helps patients understand how their insurance plan works. Also, offer information about prior authorization requirements and appealing insurance denials or restrictions.
  • Delivery coordination: Arrange to have the patient’s prescription for JAKAFI filled by an approved specialty pharmacy and delivered directly to either the patient’s home or the Healthcare Professional’s office.
  • Savings program: For patients with commercial prescription drug coverage—eligible patients pay as little as USD 0 per month, subject to a certain limit.
  • Patient Assistance Program (PAP): Free product is offered to eligible patients who are uninsured or underinsured for JAKAFI.
  • Temporary coverage: For insurance coverage delays, eligible patients can receive a free short-term supply of JAKAFI.
  • Patient Education and Support: Through its call center, IncyteCARES for JAKAFI representatives can answer patient and caregiver questions about Polycythemia Vera and JAKAFI.
  • Connection to other support services: For patients who need additional support beyond what can be provided directly, IncyteCARES for JAKAFI can offer information about other independent organizations that may be able to help.
  • BESREMi (ropeginterferon alfa-2b)

Co-pay and Coinsurance Assistance Program

Eligible patients can receive BESREMi for as little as USD 0 per month. This program covers co-pay, coinsurance, or deductible expenses for those who qualify. The patient may be eligible if they meet the requirements of having commercial (private) insurance covering BESREMi, a resident of the United States or a US territory, and a valid prescription from a US physician for BESREMi. Unavailable to patients with prescription insurance plans through federal or state healthcare programs, including but not limited to Medicare, Medicaid, TRICARE, and Veterans Health Administration. This offer is not valid for cash-paying patients whose commercial insurance does not cover BESREMi or where the plan reimburses patients for the entire cost of BESREMi.

  • Patient Assistance Program (PAP)

PharmaEssentia offers BESREMi at no cost to eligible individuals, including those without insurance. The patient may be eligible if they meet requirements, such as not having prescription drug coverage or insurance not covering BESREMi, being a resident of the United States or a US territory, having a valid prescription from a US physician for BESREMi, and meeting financial eligibility criteria.

Scope of the Polycythemia Vera Market Report

  • The Polycythemia Vera market 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 Polycythemia Vera market 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 Market Report Insights

  • Polycythemia Vera Patient Population
  • Therapeutic Approaches
  • Polycythemia Vera Pipeline Analysis
  • Polycythemia Vera Market Size
  • Polycythemia Vera Market Trends
  • Existing and future Polycythemia Vera Market Opportunity

Polycythemia Vera Market Report Key Strengths

  • Ten Years Forecast
  • 7MM Coverage
  • Polycythemia Vera Epidemiology Segmentation
  • Key Cross Competition
  • Highly Analyzed Polycythemia Vera Market
  • Polycythemia Vera Drugs Uptake

Polycythemia Vera Treatment Market Report Assessment

  • Current Polycythemia Vera Treatment Practices
  • Polycythemia Vera Unmet Needs
  • Polycythemia Vera Pipeline Product Profiles
  • Polycythemia Vera Market Attractiveness
  • Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions Answered in the Polycythemia Vera Market Report

Polycythemia Vera Market Insights:

  • What was the Polycythemia Vera market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors for this growth?
  • How will interferon as a class affect the treatment paradigm in the first line of Polycythemia Vera?
  • What kind of uptake JAK inhibitor will JAKAFI witness in the already treated Polycythemia Vera patients in the coming 10 years?
  • What will be the impact of Jakafi’s expected patent expiry in 2028?
  • How will Rusfertide compete with BESREMi and JAKAFI in the first- and second-line?
  • Which class is going to be the largest contributor in 2034?
  • What are the pricing variations among different geographies for approved and off-label therapies?
  • How would the market drivers, barriers, and future opportunities affect the Polycythemia Vera market dynamics and subsequent analysis of the associated trends?

Polycythemia Vera Epidemiology Insights:

  • What are the disease risks, burdens, and unmet needs of Polycythemia Vera? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Polycythemia Vera?
  • What is the historical and forecasted Polycythemia Vera patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
  • Why do only limited patients appear with symptoms? Why is the current year diagnosis rate not high?
  • Which type of mutation is the largest contributor in patients affected with polycythemia vera?
  • What factors are affecting the increase in the diagnosis of symptomatic cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

  • What are the current options for the treatment of Polycythemia Vera? What are the current treatment guidelines for the treatment of Polycythemia Vera in the US and Europe?
  • How many Polycythemia Vera companies are developing therapies for the treatment of Polycythemia Vera?
  • How many emerging therapies are in the mid-stage and late stage of development for the treatment of Polycythemia Vera?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
  • What key designations have been granted for the emerging therapies for Polycythemia Vera?
  • What will be the impact of JAKAFI’s and BESREMi’s expected patent expiry?
  • What is the cost burden of approved Polycythemia Vera therapies on the patient?
  • Patient acceptability in terms of preferred treatment options as per real-world scenarios?
  • What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
  • What are the 7MM historical and forecasted Polycythemia Vera market?

Reasons to Buy the Polycythemia Vera Report

  • The Polycythemia Vera market report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Polycythemia Vera Market.
  • Insights on patient burden/ Polycythemia Vera prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • Distribution of historical and current Polycythemia Vera patient share based on real-world prescription data along with reported sales of approved Polycythemia Vera products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
  • Identifying strong upcoming Polycythemia Vera companies in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging Polycythemia Vera therapies under the Conjoint analysis section to provide visibility around leading classes.
  • Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
  • To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet needs of the existing market so that the upcoming Polycythemia Vera companies can strengthen their development and launch strategy.

Important Links:

Frequently Asked Questions

The total Polycythemia Vera market size accounted for USD 1,900 million in 2023 and is estimated to grow with a significant CAGR during the study period (2020-2034).
The largest Polycythemia Vera market size in the 7MM was occupied by the US in 2023.
Polycythemia Vera is a rare condition characterized by the progressively increased number of red blood cells in the bloodstream, white blood cells (WBC), and platelets also increase in number in the affected people. Polycythemia Vera is the most common myeloproliferative neoplasm (MPN).
The leading Polycythemia Vera Companies developing therapies include - 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, and others.
Key strengths of the Polycythemia Vera Market Report are 10-Year Forecast, 7MM Coverage, Epidemiology Segmentation, Market Size, Drug Uptake, Pipeline Therapies, Market Drivers, and Market Barriers, along with the upcoming market trends in the Polycythemia Vera Market.
The United States is expected to have the highest prevalence of Polycythemia Vera cases among the studied regions.
The Polycythemia Vera epidemiology covered in the Polycythemia Vera Market report provides historical as well as forecasted 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 covering the United States, EU4 (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034.

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