진성적혈구증가증 시장 : 시장 인사이트, 역학 및 시장 예측(-2034년)

Key Highlights:

• 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 1,440 million, 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.

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.

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.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Polycythemia Vera Disease Understanding and Treatment Algorithm

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.

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.

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

• 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 Drug Chapters

The drug chapter segment of the Polycythemia Vera 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 Drugs

JAKAFI/JAKAVI (ruxolitinib): Incyte/Novartis

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.

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 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.

Emerging Drugs

Rusfertide (PTG-300): Protagonist Therapeutics

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 (MK-3543 [IMG-7289]): Merck (Imago BioSciences)

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.

Drug Class Insights

The existing Polycythemia Vera treatment is mainly dominated by classes such as antimetabolites, platelet-reducing agents, Interferon's, 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 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 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 1,900 million 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.

Polycythemia Vera Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the 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.

Polycythemia Vera Pipeline Development Activities

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

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Polycythemia Vera's emerging therapies.

KOL Views

To keep up with current 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.

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 approved and emerging 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 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.

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 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)

FAQs:

Market Insights:

• What was the Polycythemia Vera total 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 market dynamics and subsequent analysis of the associated trends?

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 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 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 market of Polycythemia Vera?

Reasons to buy:

• The 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/disease 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 patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging 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 players can strengthen their development and launch strategy.

Table of Contents

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
  • 7.7.1. Diagnostic Algorithm 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
  • 9.5.1. Total Prevalent Population of Polycythemia Vera in the United States
  • 9.5.2. Prevalent Population of Polycythemia Vera Based on Symptoms in the United States
  • 9.5.3. Gender-specific Prevalence of Polycythemia Vera in the United States
  • 9.5.4. Prevalence of Polycythemia Vera by Gene Mutation in the United States
  • 9.5.5. Prevalence of Polycythemia Vera Based on Risk in the United States
  • 9.5.6. Age-specific Prevalence of Polycythemia Vera in the United States
• 9.6. EU4 and the UK
  • 9.6.1. Total Prevalent Population of Polycythemia Vera in EU4 and the UK
  • 9.6.2. Prevalent Population of Polycythemia Vera Based on Symptoms in EU4 and the UK
  • 9.6.3. Gender-specific Prevalence of Polycythemia Vera in EU4 and the UK
  • 9.6.4. Prevalence of Polycythemia Vera by Gene Mutation in EU4 and the UK
  • 9.6.5. Prevalence of Polycythemia Vera Based on Risk in EU4 and the UK
  • 9.6.6. Age-specific Prevalence of Polycythemia Vera in EU4 and the UK
• 9.7. Japan
  • 9.7.1. Total Prevalent Population of Polycythemia Vera in Japan
  • 9.7.2. Prevalent Population of Polycythemia Vera Based on Symptoms in Japan
  • 9.7.3. Gender-specific Prevalence of Polycythemia Vera in Japan
  • 9.7.4. Prevalence of Polycythemia Vera by Gene Mutation in Japan
  • 9.7.5. Prevalence of Polycythemia Vera Based on Risk in Japan
  • 9.7.6. Age-specific Prevalence of Polycythemia Vera in Japan

10. Patient Journey

11. Marketed Drug

• 11.1. Key Competitors
• 11.2. JAKAFI/JAKAVI (ruxolitinib): Incyte/Novartis
  • 11.2.1. Product Description
  • 11.2.2. Regulatory Milestones
  • 11.2.3. Other Development Activities
  • 11.2.4. Clinical Development
  • 11.2.5. Safety and Efficacy
  • 11.2.6. Analyst Views
• 11.3. BESREMi (ropeginterferon Alfa-2b/AOP2014/P1101): PharmaEssentia/AOP Orphan Pharmaceuticals
  • 11.3.1. Product Description
  • 11.3.2. Regulatory Milestones
  • 11.3.3. Other Development Activities
  • 11.3.4. Clinical Development
  • 11.3.5. Safety and Efficacy
  • 11.3.6. Analyst Views
• 11.4. PEGASYS (peginterferon alfa-2a): pharmaand GmbH
  • 11.4.1. Product Description
  • 11.4.2. Regulatory Milestones
  • 11.4.3. Other Development Activities
  • 11.4.4. Safety and Efficacy
  • 11.4.5. Analyst Views

12. Emerging Drugs

• 12.1. Key Competitors
• 12.2. Rusfertide (PTG-300): Protagonist Therapeutics
  • 12.2.1. Product Description
  • 12.2.2. Other Developmental Activities
  • 12.2.3. Clinical Development
  • 12.2.4. Safety and Efficacy
  • 12.2.5. Analyst Views
• 12.3. Bomedemstat (MK-3543 [IMG-7289]): Merck (Imago BioSciences)
  • 12.3.1. Product Description
  • 12.3.2. Other Developmental Activities
  • 12.3.3. Clinical Development
  • 12.3.4. Analyst Views
• 12.4. DUVYZAT (givinostat/ITF2357): Italfarmaco
  • 12.4.1. Product Description
  • 12.4.2. Other developmental activities
  • 12.4.3. Clinical Development
  • 12.4.4. Safety and Efficacy
  • 12.4.5. Analyst Views
• 12.5. Sapablursen (IONIS-TMPRSS6-LRx): Ionis Pharmaceutical
  • 12.5.1. Product Description
  • 12.5.2. Other Developmental Activities
  • 12.5.3. Clinical Development
  • 12.5.4. Analyst Views
• 12.6. Divesiran (SLN124): Silence Therapeutics
  • 12.6.1. Product Description
  • 12.6.2. Other development activities
  • 12.6.3. Clinical Development
  • 12.6.4. Safety and Efficacy
  • 12.6.5. Analyst Views
• 12.7. PPMX-T003: Perseus Proteomics
  • 12.7.1. Product Description
  • 12.7.2. Other Development Activities
  • 12.7.3. Clinical Development
  • 12.7.4. Safety and Efficacy
  • 12.7.5. Analyst Views

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
  • 13.6.1. Total Market Size of Polycythemia Vera in the United States
  • 13.6.2. Market Size of Polycythemia Vera by Current and Emerging Therapies in the United States
• 13.7. EU4 and the UK Market Size
  • 13.7.1. Total Market Size of Polycythemia Vera in EU4 and the UK
  • 13.7.2. Market Size of Polycythemia Vera by Current and Emerging Therapies in EU4 and the UK
• 13.8. Japan Market Size
  • 13.8.1. Total Market Size of Polycythemia Vera in Japan
  • 13.8.2. Market Size of Polycythemia Vera by Current and Emerging Therapies in Japan

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

18. Appendix

• 18.1. Bibliography
• 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight