Polycythemia Vera Market Insights, Epidemiology, and Market Forecast-2030
DelveInsight's "Polycythemia Vera Market Insights, Epidemiology, and Market Forecast-2030" 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, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
The Polycythemia Vera market report provides current treatment practices, emerging drugs, Polycythemia Vera market share of the individual therapies, current and forecasted Polycythemia Vera market Size from 2017 to 2030 segmented by seven major markets. The Report also covers current Polycythemia Vera treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market.
The United States
EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Study Period: 2017-2030
Polycythemia Vera (PV) is a condition characterized by an increased number of red blood cells in the bloodstream (erythrocytosis) and affected people may also have excess white blood cells and platelets. Most cases of PV are not inherited and are acquired during a person's lifetime.
PV is diagnosed by testing the blood for levels of a hormone called erythropoietin as well as testing the blood for mutations in JAK2 or TET2. If mutations are not found in the red blood cells but the doctors still suspect a diagnosis of polycythemia vera, a bone marrow biopsy may be done to look for mutations in the hematopoietic blood cells which are located in the bone marrow.
The most precarious symptom of polycythemia vera is the chance for a thrombotic event that can cause a heart attack or stroke. There is also a small chance that polycythemia vera could cause an individual to develop leukemia. With proper treatment, however, these symptoms have not been shown to greatly affect the expected lifespan of a person with polycythemia vera. Another complication i.e. itching (pruritus) patients can manage with the help of various medicines.
PV is usually diagnosed in the average age of people 60-65 years. It is uncommon in people under the age of 40. PV develops more often in men than in women. Most people with PV do not have a family history of this disease. In the early stages, there are not any specific signs and symptoms. When too many RBCs and platelets build up in the blood, symptoms start to appear. Headache, dizziness, fatigue, blurred vision or blind spots, shortness of breath, itchy skin, spleen enlargement (Splenomegaly) blood clot, heavy bleeding, and others are the symptoms of PV. The diagnosis of PV is done by testing the blood for levels of a hormone called erythropoietin or testing the blood for mutations in JAK2. Bone marrow aspiration and biopsy are also done to confirm whether or not a person has PV. The diagnostic test also includes Complete blood count (CBC) to measure the number and quality of WBCs, RBCs, and platelets.
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The treatment for PV is based on the symptoms and progression, as well as, the age of the patients. The goal of treatments for PV is to control symptoms and lower the risk of complications. Treatments like phlebotomy help to make the blood thinner when there are too many red blood cells. It is done in the same way as donating blood and drugs like hydroxyurea, interferon alfa, etc. are used. Various other supportive therapies antihistamines, allopurinol, aspirin are also recommended.
For the low-risk patients (age <60years, no history of thrombosis) phlebotomy and low-dose aspirin are recommended. For the high-risk patient (age ≥60 years), the first-line of therapy is hydroxyurea or interferon. The second line of therapy for these patients include Jak2 inhibitor, busulfan, pipobroman, and 32P.
Enlargement of the spleen sometimes cause pain and problem to the patients, and for that surgery is done to remove the spleen (splenectomy). No single treatment is effective for all individuals. The prognosis of PV largely depends on whether a patient receives treatment or not. Treatment helps reduce the risk of life-threatening complications like myelofibrosis, heart attack, ischemic stroke, pulmonary embolism, portal hypertension, acute myeloid leukemia. These complications from PV are possible even with treatment, but the risk is much lower.
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Population of PV, Prevalence Population of PV Based on Symptoms, Gender-specific Symptomatic Prevalence of PV, Age-specific Symptomatic Prevalence of PV, Prevalence of PV Based on Risk, and Prevalence of PV by Gene Mutation scenario of PV in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2017 to 2030.
The total prevalent population of PV in the 7MM was 283,442 in 2017.
The estimates show the highest prevalence of PV in the United States with 157,290 cases in 2017.
DelveInsight's epidemiology model for PV estimates that out of the total population of 157,290 cases in the US for PV, 62,916 cases and 94,374 cases were contributed by asymptomatic and symptomatic, respectively.
Among the European five countries, Germany had the highest symptomatic prevalent population of PV with 14,502 cases, followed by France and the United Kingdom.
Japan had 18,954 symptomatic prevalent cases for PV in 2017.
Japan accounts second among the 7MM in terms of prevalent cases with 31,589 cases among the 7MM.
The epidemiology segment also provides the Polycythemia Vera epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
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.
Jakafi, Jakavi (Ruxolitinib): Incyte Corporation/Novartis
Jakafi is a kinase inhibitor developed by Incyte Corporation/Novartis, designated for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary myelofibrosis, post-Polycythemia Vera (PV) myelofibrosis and post-essential thrombocythemia myelofibrosis in adults. This drug is also approved for adult patients of PV who have had a poor response to hydroxyurea. It is approved in the US, EU and Japan for the treatment of PV.
Jakafi is also approved for the treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. Some trials of the Ruxolitinib are ongoing in phase III and phase II clinical trials for the treatment of PV.
Products detail in the report
Besremi: AOP Orphan Pharmaceuticals AG/ PharmaEssentia
Besremi (ropeginterferon alfa-2B/AOP2014/P1101) is mono-pegylated proline interferon approved as first-line monotherapy in adults for the treatment of PV without symptomatic splenomegaly. It is long-acting, mono-pegylated proline interferon developed using PharmaEssentia's novel pegylation technology platform.
Besremi has been shown to induce complete hematologic and high clinical response rates with good tolerability, as well as high molecular response rates and disease-modifying capabilities, which may result in a delay of disease progression. It also showed high molecular response rates, associated with the ability to reduce the allelic burden of both mutant JAK2 and importantly also non JAK2 mutations, which are believed to play a role in disease progression. It is currently approved in the EU and data from AOP´s development program will be presented to the US FDA for approval for commercialization in the US by PharmaEssentia.
Products detail in the report
Polycythemia Vera Emerging Drugs
Givinostat (ITF2357) is an orally bioavailable hydroxymate inhibitor of histone deacetylase (HDAC) with potential anti-inflammatory, anti-angiogenic, and antineoplastic activities.
Patients with PV have abnormalities in a gene that is responsible for the production of an enzyme known as Janus kinase 2 (JAK2). JAK2 is involved in the reproduction and growth of red blood cells. In PV, JAK2 is over-activated. Givinostat is thought to work by reducing the levels of JAK2. In patients with polycythemia, the reduction of mutant JAK2 concentrations by givinostat is believed to slow down the abnormal growth of erythrocytes and ameliorate the symptoms of the disease. The company is investigating givinostat in phase II clinical trials in patients with PV.
Products detail in the report
PTG-300: Protagonist Therapeutics
PTG-300 is an injectable compound that mimics the effect of the natural hormone hepcidin, but with greater potency, solubility, and stability. Hepcidin is a key hormone in regulating iron equilibrium and is critical to the proper development of red blood cells. As a hepcidin mimetic, PTG-300 may redistribute iron to the macrophages, reduce iron-induced oxidative stress in the bone marrow, and allow sufficient production of red blood cells. Also, by limiting the release of iron into the blood, PTG-300 may inhibit the damage caused by excessive absorption of iron by vital organs such as the liver and heart.
Protagonist Therapeutics is currently developing PTG-300 for beta-thalassemia (non-transfusion dependent and transfusion-dependent), polycythemia vera, hereditary hemochromatosis, and myelodysplastic syndromes. The company has announced initial phase II results of PTG-300 in the treatment of PV.
Products detail in the report
PRM-151 is a recombinant form of the endogenous human innate immunity protein pentraxin-2 (PTX-2), which is specifically active at the site of tissue damage. PRM-151 is an agonist that acts as a macrophage polarization factor to prevent and potentially reverse fibrosis (PR Newswire, 2019).
PRM-151 prevents reverse fibrosis in animal models of myelofibrosis (MF) by targeting the differentiation of fibrocytes (essential cells in the fibrotic process) from monocytes (Verstovsek et al., 2018).
Promedior is currently evaluating PRM-151 in phase II clinical trial in the subjects with primary myelofibrosis (PMF), post-polycythemia vera MF (Post-PV MF), and post-essential thrombocythemia MF (Post-ET MF).
Products detail in the report
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The therapeutic market of PV in the seven major markets was assessed to be USD 951.68 Million in 2017 and is expected to grow during the study period (2017-2030).
Cytoreductive therapies have been used in older patients and those with a history of thrombosis to achieve these goals. Hydroxyurea (HU) remains the first-line cytoreductive choice; however, up to one in four patients treated with HU over time will develop resistance or intolerance to HU and go for the second-line therapy. More importantly, patients who fail HU have a 5.6-fold increase in mortality and a 6.8-fold increased risk of transformation to myelofibrosis or AML; therefore, alternative therapies are needed for these patients. Interferon-α has been used in PV and has shown significant activity in achieving hematologic responses and decreasing the JAK2 V617F mutation allele burden. JAK inhibition has also been investigated and recently garnered regulatory approval for this indication.
The outcomes of PV patients who fail or are intolerant of hydroxyurea are poor. Although pegylated interferon can be considered in younger patients, currently, ruxolitinib is the only US FDA approved agent in this setting, representing a viable option, leading to hematocrit control and a reduction in spleen size and constitutional symptoms. Although a small number of patients achieve a molecular response with continuous treatment, the implications of such a response to the clinical outcomes are still unknown. Patients whose disease is not adequately controlled with ruxolitinib, or who lose their response, can be treated with low-dose busulfan or pipobroman; however, they should be encouraged to participate in trials with novel therapies.
The treatment for PV has been classified as first-line and second-line treatment. Of the current treatment regimens, hydroxyurea (alone or along with Phlebotomy), and aspirin constitute the first-line treatment therapies. The second-line treatment for patients who are intolerant to hydroxyurea constitutes the only approved drug in the US, Jakafi, and other therapies such as anagrelide, and interferon-alpha (such as PEG-Intron and Pegasys)
Furthermore, the second-line therapies primarily constitute the only approved drug, Jakafi, and other therapies such as anagrelide, and interferon-alpha. Among these, Jakavi contributed the highest share in the PV market in 2017 in the 7MM.
Of the emerging therapies for the second-line treatment, companies like Protagonist Therapeutics, Italfarmaco, and Imago BioSciences are expected to enter the treatment market, with their respective products, during the forecast period [2020-2030]. Givinostat and PTG-300 in the upcoming years will create a significant impact in its launch year.
Out of the emerging therapies, Besremi (AOP Orphan Pharmaceuticals AG/PharmaEssentia), which is an interferon-alpha 2b stimulant, and has already approved in the European countries, will enter the market for PV as a first-line treatment, thereby giving a stiff competition to hydroxyurea, which is the mainstay for treatment in patients with PV. It is approved recently (2019) in European countries and expected to launch in the United States and Japan by 2021 and 2022, respectively.
The market size of PV has been assessed to undergo tough competition, wherein Jakafi is likely to maintain dominance in the hydroxyurea-refractory (second line) PV market. On the other hand, Besremi represents an even small risk, as the drug is being positioned in first-line treatment for PV vs. hydroxyurea.
According to DelveInsight, the PV market is expected to change in the study period 2017-2030.
The market size of PV in the 7MM was USD 951.68 million in 2017.
Of the current treatment regimens, hydroxyurea (alone or along with Phlebotomy), and aspirin constitute the first-line treatment. Furthermore, the second-line therapies primarily constitute Jakafi (Jakavi) and other therapies such as anagrelide, and interferon-alpha. Among these, Jakafi contributed the highest share in the PV market (USD 556.54 million) in 2017 in the 7MM.
Of the emerging therapies for the second-line treatment, Protagonist Therapeutics, Italfarmaco, and Imago BioSciences are expected to enter the treatment market, with their respective products, during the forecast period [2020-2030].
This section provides the total Polycythemia Vera market size and market size by therapies in the United States.
The total Polycythemia Vera market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom is provided in this section.
The total Polycythemia Vera market size and market size by therapies in Japan is also mentioned.
This section focusses on the rate of uptake of the potential drugs recently launched in the Polycythemia Vera market or expected to get launched in the market during the study period 2017-2030. The analysis covers Polycythemia Vera market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Polycythemia Vera Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase II, and Phase III stage. It also analyses Polycythemia Vera key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing, patent details and other information for Polycythemia Vera emerging therapies.
Reimbursement Scenario in Polycythemia Vera
Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In a report, we take reimbursement into consideration to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
To keep up with current market trends, we take KOLs and SME's opinion working in Polycythemia Vera domain through primary research to fill the data gaps and validate our secondary research. 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.
The report covers the descriptive overview of Polycythemia Vera , explaining its causes, signs and symptoms, pathophysiology, diagnosis and currently available therapies
Comprehensive insight has been provided into the Polycythemia Vera epidemiology and treatment in the 7MM
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 drug outreach in the 7MM
The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Polycythemia Vera market
In the coming years, Polycythemia Vera market is set to change due to the rising awareness of the disease, 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
Major players are involved in developing therapies for Polycythemia Vera . Launch of emerging therapies will significantly impact the Polycythemia Vera market
A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Polycythemia Vera
Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities
Polycythemia Vera Pipeline Analysis
Polycythemia Vera Market Size and Trends
Impact of upcoming Therapies
Key Cross Competition
Highly Analyzed Market
Current Treatment Practices
Pipeline Product Profiles
Market Drivers and Barriers
What was the Polycythemia Vera market share (%) distribution in 2017 and how it would look like in 2030?
What would be the Polycythemia Vera total market size as well as market size by therapies across the 7MM during the forecast period (2017-2030)?
What are the key findings pertaining to the market across 7MM and which country will have the largest Polycythemia Vera market size during the forecast period (2017-2030)?
At what CAGR, the Polycythemia Vera market is expected to grow in 7MM during the forecast period (2017-2030)?
What would be the Polycythemia Vera market outlook across the 7MM during the forecast period (2017-2030)?
What would be the Polycythemia Vera market growth till 2030, and what will be the resultant market Size in the year 2030?
How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
What is the disease risk, burden and unmet needs of the Polycythemia Vera ?
What is the historical Polycythemia Vera patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
What would be the forecasted patient pool of Polycythemia Vera in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
What will be the growth opportunities in the 7MM with respect to the patient population pertaining to Polycythemia Vera ?
Out of all 7MM countries, which country would have the highest prevalent population of Polycythemia Vera during the forecast period (2017-2030)?
At what CAGR the population is expected to grow in 7MM during the forecast period (2017-2030)?
Current Treatment Scenario, Marketed Drugs and Emerging Therapies:
What are the current options for the Polycythemia Vera treatment, along with the approved therapy?
What are the current treatment guidelines for the treatment of Polycythemia Vera in the USA, Europe, and Japan?
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 therapies are developed by each company for Polycythemia Vera treatment?
How many are emerging therapies in mid-stage, and late stage of development for Polycythemia Vera treatment?
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 global historical and forecasted market of Polycythemia Vera ?
The report will help in developing business strategies by understanding trends shaping and driving the Polycythemia Vera market
To understand the future market competition in the Polycythemia Vera market and Insightful review of the key market drivers and barriers
Organize sales and marketing efforts by identifying the best opportunities for Polycythemia Vera in the US, Europe (Germany, Spain, Italy, France, and 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"