Polycythemia Vera Market Insight, Epidemiology and Market Forecast -2032

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.

DelveInsight's "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.

Geography Covered:

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

Study Period: 2019-2032.

Polycythemia Vera Disease Understanding and Treatment Algorithm

Polycythemia Vera Overview

Polycythemia Vera is a rare blood disease in which the body makes excessive red blood cells. The extra red blood cells make the blood thicker than normal Polycythemia Vera is the most common myeloproliferative neoplasm (MPN), the ultimate phenotype of the JAK2 V1617F mutation. Polycythemia Vera shares in common with its companion MPN, essential thrombocytosis (ET), and primary myelofibrosis (PMF), origin in a hematopoietic stem cell (HSC), constitutive activation of hematopoiesis with overproduction of morphologically normal blood cells, a tendency to extramedullary hematopoiesis, and transformation to bone marrow failure with myelofibrosis or acute leukemia, although at varying frequencies in each MPN, and JAK2 kinase mutation is behind the shared phenotypic features of all the above mentioned MPN's.

Many patients with Polycythemia Vera have no symptoms when they are diagnosed. Typically, these patients are identified following abnormal results from a routine full blood test for something else or some other blood-related disease. People at low risk of developing thrombosis are those aged below 60, with no history of thrombosis, and without other risk factors for cardiac diseases, such as high blood pressure, diabetes, high cholesterol, or smoking.

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. Possible risk factors of Polycythemia Vera include blood clots, splenomegaly, problems due to high levels of red blood cells, other blood disorders, etc.

Polycythemia Vera Diagnosis

The initial evaluation of a patient with a suspected Polycythemia Vera should include a focused clinical history, physical examination, hematocrit concentration, count of RBC, WBC, and platelets, serum EPO level, and cytogenetics abnormalities.

Polycythemia Vera Treatment

Many individuals with Polycythemia Vera receive treatment with certain drugs (myelosuppressive drugs) that suppress the formation of blood cells by the marrow. A chemotherapy drug known as hydroxyurea is most often used, along with another chemotherapy drug known as busulfan. Other drugs, such as chlorambucil and radioactive phosphorous, have been used. Still, these drugs, especially in individuals requiring long-term therapy, have been associated with an increased risk of leukemia. Ruxolitinib and ropeginterferon alfa-2B are the two FDA-approved drugs for the treatment of Polycythemia Vera .

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.

Key Findings

This section provides glimpse of the Polycythemia Vera epidemiology in the 7MM

Country Wise-Polycythemia Vera Epidemiology

• The epidemiology segment also provides the Polycythemia Vera epidemiology data and findings across the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan
• The total prevalent cases of Polycythemia Vera in the 7MM comprised of approximately 309,000 cases in 2022 and are projected to increase during the forecasted period
• The total prevalent cases of Polycythemia Vera in the United States were around 179,000cases in 2022
• The United States contributed to the largest prevalent population of Polycythemia Vera , acquiring ~58% of the 7MM in 2022. Whereas, EU4 and the UK, and Japan accounted for around 32% and 10% of total population share, respectively, in 2022
• Among the EU4 countries, Germany accounted for the largest number of Polycythemia Vera cases followed by France, whereas Spain accounted for the lowest cases in 2022
• According to DelveInsight estimates, there were around 72, 000 cases of asymptomatic and 107,000 cases of symptomatic Polycythemia Vera in the United States in 2022. The prevalence is projected to increase during the forecasted period
• In Japan, the prevalent Polycythemia Vera cases were around 13,000 in males and 7,000 in females in 2022

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.

Note: Detailed current therapies assessment will be provided in the full report of Polycythemia Vera.

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.

Note: Detailed emerging therapies assessment will be provided in the final report.

Polycythemia Vera Market Outlook

Patients with Polycythemia Vera (Polycythemia Vera ), a myeloproliferative neoplasm characterized by an elevated red blood cell mass, are at high risk of vascular and thrombotic complications and have reduced quality of life due to a substantial symptom burden that includes pruritus, fatigue, constitutional symptoms, microvascular disturbances, and bleeding.

Therapeutic options in Polycythemia Vera are limited, and no cure is available; it can be managed effectively for a long time. Careful medical supervision and therapy are designed to reduce hematocrit and platelet concentrations to normal or near-normal value, control Polycythemia Vera -related symptoms, decrease the risk for arterial and venous thrombotic events and other complications, and avoid leukemic transformation. Current therapies prevent thrombosis/vascular events and delay transformation to myelofibrosis (MF) or acute myeloid leukemia (AML). Conventional therapeutic options aim at reducing vascular and thrombotic risk, with low-dose aspirin and phlebotomy as first-line recommendations for patients at low risk of thrombotic events and cytoreductive therapy (usually hydroxyurea or interferon alpha) recommended for high-risk patients.

The current market has been segmented accordingly into different commonly used therapeutic classes based on the prevailing treatment pattern across the 7MM, which present itself with minor variations in the overall prescription pattern. Cytoreductive therapy, JAK inhibitor, Interferons, Hepcidin mimetics, TMPRSS6 inhibitor and LSDI inhibitor are the major classes that have been covered in the forecast model.

The dynamics of the Polycythemia Vera market are currently changing as a consequence of the recent launch of ropeginterferon alfa-2b. The expected launch of new 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. Key players such as Protagonist Therapeutics (rusfertide), Imago BioSciences (bomedemstat), Ionis Pharmaceutical (sapablursen), Silence Therapeutics (SLN124) 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 .

Key Findings

This section includes a glimpse of the Polycythemia Vera in the 7MM market.

• The total market size of Polycythemia Vera in the 7MM is approximately USD 1,800 million in 2022 and is projected to increase during the forecast period (2023-2032)
• The market size in the 7MM will increase at a CAGR of 14% due to increasing awareness of the disease and launch of the emerging therapy
• Among EU4 countries, Germany accounts for the maximum market size in 2022 while Spain occupies the bottom of the ladder in 2022
• The market size of Polycythemia Vera in Japan is USD 100 million in 2022, which is expected to rise during the forecast period (2023-2032)

The United States Market Outlook

The total market size of Polycythemia Vera in the United States is expected to increase with a CAGR of 14% during the study period (2019-2032).

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.

Polycythemia Vera Pipeline Development Activities

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

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for Polycythemia Vera emerging therapies.

KOL- Views

To keep up with current market trends, we take KOLs and SME's opinion working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders from UT Southwestern Medical Center in Dallas, Cancer Research UK Barts Centre in London, MD Anderson Cancer Center. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Polycythemia Vera market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform competitive and market Intelligence analysis of the Polycythemia Vera market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report:

• The report covers the descriptive overview of Polycythemia Vera , explaining its causes, signs and symptoms, pathogenesis and currently available therapies
• Comprehensive insight has been provided into the Polycythemia Vera epidemiology and treatment
• Additionally, an all-inclusive account of both the current and emerging therapies for Polycythemia Vera are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
• A detailed review of Polycythemia Vera market; historical and forecasted is included in the report, covering the 7MM drug outreach
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Polycythemia Vera market

Report Highlights:

• In the coming years, Polycythemia Vera market is set to change due emerging therapies in the pipeline, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
• The companies and academics are working to assess challenges and seek opportunities that could influence Polycythemia Vera R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
• As per DelveInsight's analysis, the major types of Polycythemia Vera mutation include JAK2V617F and JAK2 exon 12
• The report also encompasses other major segments, i.e., 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
• Expected launch of potential therapies such as rusfertide (Protagonist Therapeutics), bomedemstat (Imago BioSciences), SLN124 (Silence Therapeutics), and sapablursen (Ionis Pharmaceutical), might change the landscape in the treatment of Polycythemia Vera
• The US FDA-approved drugs, which are currently available, include JAKAFI and BESREMi.

Polycythemia Vera Report Insights

• Patient Population
• Therapeutic Approaches
• Polycythemia Vera Pipeline Analysis
• Polycythemia Vera Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Polycythemia Vera Report Key Strengths

• Eleven 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
• SWOT
• Attribute Analysis

Key Questions

Market Insights:

• What was the Polycythemia Vera market share (%) distribution in 2019 and how it would look like in 2032?
• What would be the Polycythemia Vera total market size as well as market size by therapies across the 7MM during the study period (2019-2032)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Polycythemia Vera market size during the study period (2019-2032)?
• At what CAGR, the Polycythemia Vera market is expected to grow at the 7MM level during the study period (2019-2032)?
• What would be the Polycythemia Vera market outlook across the 7MM during the study period (2019-2032)?
• What would be the Polycythemia Vera market growth till 2032 and what will be the resultant market size in the year 2032?
• How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What is the disease risk, burden and unmet needs of Polycythemia Vera ?
• What is the historical Polycythemia Vera patient pool in the United States, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan?
• What would be the forecasted patient pool of Polycythemia Vera at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Polycythemia Vera ?
• Out of the above-mentioned countries, which country would have the highest incident population of Polycythemia Vera during the study period (2019-2032)?
• At what CAGR the population is expected to grow across the 7MM during the study period (2019-2032)?

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?
• What are the Polycythemia Vera marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
• 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 key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Polycythemia Vera therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Polycythemia Vera and their status?
• What are the key designations that have been granted for the emerging therapies for Polycythemia Vera ?
• What are the 7MM historical and forecasted market of Polycythemia Vera ?

Reasons to buy:

• The report will help in developing business strategies by understanding trends shaping and driving the Polycythemia Vera .
• To understand the future market competition in the Polycythemia Vera market and Insightful review of the SWOT analysis of Polycythemia Vera .
• Organize sales and marketing efforts by identifying the best opportunities for Polycythemia Vera in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for Polycythemia Vera market.
• To understand the future market competition in the Polycythemia Vera market.