Polycythemia Vera Market Insights, Epidemiology and Market Forecasts, 2032

Rhea-AI Summary

The report titled "Polycythemia Vera Market Insights, Epidemiology, and Market Forecast -2032" offers a comprehensive analysis of the Polycythemia Vera market. In 2022, the U.S. Polycythemia Vera market size was approximately USD 1,500 million and is projected to grow through 2032. The report highlights that PharmaEssentia's Besremi is the only first-line therapy approved, while Incyte's Jakafi is the sole second-line treatment. Additionally, competition may arise from Protagonist Therapeutics' Rusfertide and Imago Biosciences' Bomedemstat, expected to launch in late 2024 and 2026 respectively. The report also discusses emerging therapies with potential market impact, including Silence Therapeutics' SLN124.

Positive

• Polycythemia Vera market size in the U.S. reached approximately USD 1,500 million in 2022.
• Besremi is recognized as the first-line therapy and is gradually being included in various insurance coverages.
• Emerging therapies like Rusfertide and SLN124 have the potential to significantly impact market dynamics.

Negative

• Jakafi is expected to lose patent protection by mid-2028, which may impact its market share.
• Protagonist Therapeutics' Rusfertide is anticipated to compete directly with Besremi for first-line treatment.

DUBLIN, Feb. 27, 2023 /PRNewswire/ -- The "Polycythemia Vera Market Insight, Epidemiology and Market Forecast -2032" report has been added to  ResearchAndMarkets.com's offering.

This "Polycythemia Vera- Market Insights, Epidemiology and Market Forecast- 2032" 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, and market share of the individual therapies, current and forecasted 7MM Polycythemia Vera market size from 2019 to 2032. The report also covers current Polycythemia Vera treatment practice/algorithm and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Key Highlights:

• In 2022, the market size of Polycythemia Vera was highest in the US among the 7MM accounting for approximately USD 1,500 million that is further expected to increase by 2032
• PharmaEssentia's Besremi is the only approved as a first-line therapy at present, whereas Incyte's Jakafi is the only approved therapy in second-line setting
• In March 2022, NCCN guidelines recommended Besremi as a recommended therapeutic option for the treatment of both high-risk and low-risk adults with polycythemia vera, we believe this could further accelerate physician adoptions and payer reimbursements.
• Given the positioning of Besremi ahead of Jakafi in treatment guidelines, the drug is not a direct competitor for Jakafi. However, Protagonist Therapeutics' Rusfertide estimated to launch during late 2024, is expected to be competition for Besremi in first-line of treatment. Whereas, Imago Biosciences Bomedemstat is expected to compete with Jakafi in second-line post its entry in the US market by 2026.
• Jakafi is expected to lose patent protection in mid-2028.
• Besremi is being gradually included in private insurance and Medicaid coverage by some state governments. It has been also included in the US federal insurance (Medicare), which accounts for 54% of Polycythemia Vera patient insurance in the US.
• Other emerging therapies such as Italfarmaco's Givinostat, Silence Therapeutics' SLN124, Ionis Pharmaceutical's Sapablursen, and Perseus Proteomics' PPMX-T003 have the potential to create a significant positive shift in the Polycythemia Vera market size.

Polycythemia Vera Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by, total prevalent cases of Polycythemia Vera , prevalent population of Polycythemia Vera based on symptoms, gender-specific cases of Polycythemia Vera, prevalence of Polycythemia Vera by gene mutation, prevalence of Polycythemia Vera based on risk, and age-specific prevalence of Polycythemia Vera the 7MM market covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032.

Polycythemia Vera Drug Chapters

Drug chapter segment of the Polycythemia Vera report encloses the detailed analysis of Polycythemia Vera marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to 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 (ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. It is approved for the treatment of adult patients with Polycythemia Verawho are resistant to or intolerant of hydroxyurea and for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.

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

BESREMi (ropeginterferon alfa-2b) is monopegylated proline interferon approved as first-line monotherapy in adults for the treatment of polycythemia vera without symptomatic splenomegaly; it is one of the first to be approved for the condition. It is a long-acting, monopegylated proline interferon developed using PharmaEssentia's novel pegylation technology platform.

The drug has improved pharmacokinetic properties in clinical studies, including increased tolerability and convenience. BESREMi is designed to be self-administered subcutaneously with a pen once every 2 weeks or monthly during long-term maintenance. This treatment schedule is expected to improve overall safety, tolerability, and adherence compared to conventional pegylated interferons.

Emerging 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 that offers greater potency, solubility, and stability, which translates to better in vivo PK and PD characteristics and manufacturability in comparison to the natural hormone. Hepcidin is a key regulator of iron absorption, storage, and distribution in the body and thereby controls the production of red blood cells (RBC) and abnormal tissue storage of iron.

Rusfertide provides substantial benefit to patients with erythrocytosis or abnormal tissue iron overload by managing hematocrit rapidly, sustained, and durable manner, thereby dramatically decreasing the need for therapeutic phlebotomy. Rusfertide was granted ODD and FTD by the US FDA for the treatment of Polycythemia Vera.

Bomedemstat (IMG-7289): Imago BioSciences

Bomedemstat is an orally bioavailable small molecule developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A) - an enzyme vital in cancer stem/progenitor cells, particularly neoplastic bone marrow cells. LSD1 inhibition modulates the proliferation of malignant blood cells and therefore represents a viable therapeutic approach to treating Polycythemia Vera , an MPN characterized by the excessive production of red blood cells.

SLN124: Silence Therapeutics

SLN124 is a gene silencing therapy designed to temporarily block a specific gene's message that would otherwise trigger an unwanted effect. In this case, SLN124 aims to temporarily silence TMPRSS6, a gene that prevents the liver from producing a particular hormone that controls iron levels in the body called hepcidin. As hepcidin increases, iron levels in the blood are expected to decrease, which may increase the production of healthy red blood cells, thereby reducing anaemia.

Polycythemia Vera Drugs Uptake

This section focuses on the rate of uptake of the potential drugs expected to get launched in the market during the study period 2019-2032. The analysis covers Polycythemia Vera market uptake by drugs; patient uptake by therapies; and sales of each drug. For example- Rusfertide (PTG-300), which is being investigated by Protagonist Therapeutics, is a novel injectable synthetic mimetic of the natural hormone hepcidin that offers greater potency, solubility, and stability, which translates to better in vivo PK and PD characteristics and manufacturability in comparison to the natural hormone.

Hepcidin is a key regulator of iron absorption, storage, and distribution in the body and thereby controls the production of red blood cells (RBC) and abnormal tissue storage of iron. Rusfertide provides substantial benefit to patients with erythrocytosis or abnormal tissue iron overload by managing hematocrit rapidly, sustained, and durable manner, thereby dramatically decreasing the need for therapeutic phlebotomy.

Currently, the company is conducting a Phase III (VERIFY) study in patients with polycythemia vera. In June 2020, the US FDA granted Orphan Drug designation (ODD) to the rusfertide for the treatment of Polycythemia Vera. As per our analysis, rusfertide drug uptake in the US is expected to be medium-fast with a probability-adjusted peak share of 4.8% in the first line and 6% in the second line, years to peak would be 6 years.

Key Topics Covered:

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
6.1. Market Share by Therapies (%) Distribution of Polycythemia Vera in 2022
6.2. Market Share by Therapies (%) Distribution of Polycythemia Vera in 2032

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. Clinical Aspects of Polycythemia Vera
7.7. Pathophysiology of Polycythemia Vera
7.7.1. JAK2 V617F in Polycythemia Vera
7.8. Diagnosis of Polycythemia Vera
7.8.1. Diagnostic Algorithm of Polycythemia Vera
7.9. Diagnostic Guidelines
7.9.1. British Society for Hematology Guidelines for Polycythemia Vera (2018)
7.9.2. WHO Diagnostic Guidelines for Polycythemia Vera (2018)
7.10. Treatment of Polycythemia Vera
7.10.1. Treatment Algorithm
7.11. Treatment Guidelines
7.11.1. European Society for Medical Oncology Guidelines for Polycythemia Vera (2015)
7.11.2. British Society for Hematology Guidelines for Polycythemia Vera (2018)
7.11.3. National Comprehensive Cancer Network Clinical Practice Guidelines for Polycythemia Vera (2022)

8. Epidemiology and Patient Population of Polycythemia Verain the 7MM
8.1. Key Findings
8.1.1. Assumptions and Rationale
8.1.1.1. United States
8.1.1.2. EU4 and the UK
8.1.1.3. Japan
8.1.2. Total Prevalent Population of Polycythemia Vera in the 7MM

9. Patient Journey

10. Key Endpoints in Polycythemia VeraClinical Trials

11. Marketed Drugs
11.1. Key Competitors
11.2. JAKAFI/JAKAVI (ruxolitinib): Incyte/Novartis
11.3. BESREMi (ropeginterferon alfa-2b/AOP2014/P1101): PharmaEssentia/AOP Orphan Pharmaceuticals

12. Emerging Drugs
12.1. Key Competitors
12.2. Rusfertide (PTG-300): Protagonist Therapeutics
12.3. Bomedemstat (IMG-7289): Imago BioSciences
12.4. Givinostat (ITF2357): Italfarmaco
12.5. Sapablursen (IONIS-TMPRSS6-LRx): Ionis Pharmaceutical
12.6. SLN124: Silence Therapeutics
12.7. PPMX-T003: Perseus Proteomics

13. Polycythemia Vera (Polycythemia Vera): 7MM Analysis
13.1. Key Findings
13.2. Total Market Size of Polycythemia Vera in the 7MM
13.3. Market Outlook
13.4. Attribute Analysis
13.5. Key Market Forecast Assumptions

14. Unmet Needs

15. SWOT Analysis

16. KOL Views

17. KOL interviews on Polycythemia Vera

18. Polycythemia Vera (Polycythemia Vera ): Market Access and Reimbursement
18.1. JAKAFI/JAKAVI (ruxolitinib): Incyte/Novartis
18.2. BESREMi (ropeginterferon alfa-2b): PharmaEssentia/AOP Orphan Pharmaceuticals

For more information about this report visit https://www.researchandmarkets.com/r/1l6ih5-vera?w=5

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FAQ

What is the market size of Polycythemia Vera in the U.S. for 2022?

The market size for Polycythemia Vera in the U.S. for 2022 was approximately USD 1,500 million.

What therapies are currently approved for Polycythemia Vera?

The approved therapies for Polycythemia Vera include Besremi as a first-line therapy and Jakafi as a second-line treatment.

When is Rusfertide expected to launch for Polycythemia Vera?

Rusfertide is expected to launch in late 2024.

What potential market impact could Silence Therapeutics' SLN124 have?

Silence Therapeutics' SLN124 could significantly shift the Polycythemia Vera market due to its innovative gene silencing approach.