DUBLIN–(BUSINESS WIRE)–The “Polycythemia Vera Market Insights, Epidemiology, and Market Forecast-2030” drug pipelines has been added to ResearchAndMarkets.com’s offering.
This 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 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 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.
- The 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.
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.
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 AOPs development program will be presented to the US FDA for approval for commercialization in the US by PharmaEssentia.
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.
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.
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).
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- 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.
- 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].
Key Topics Covered
1. Key Insights
2. Executive Summary of Polycythemia Vera (PV)
3. Polycythemia Vera (PV) Market Overview at a Glance
3.1. Market (%) Distribution of PV in 2017
3.2. Market (%) Distribution of PV in 2030
4. Polycythemia Vera (PV): Disease Background and Overview
4.2. Polycythemia Vera: A Type of MPN
4.3. Signs and Symptoms of Polycythemia Vera
4.4. Causes of Polycythemia Vera
4.5. Complications due to Polycythemia Vera
4.6. Clinical Aspects of Polycythemia Vera
4.7. Pathophysiology of Polycythemia Vera
4.7.1. JAK2 V617F in Polycythemia Vera
4.8. Diagnosis of Polycythemia Vera
4.9. Diagnostic Guidelines
4.9.1. British Society for Haematology Guidelines for Polycythemia Vera (PV)
4.9.2. WHO Diagnostic Guidelines
4.9.3. British Society for Haematology Guideline
5. Case Reports
5.1. The role of advanced practitioners in optimizing clinical management and support of patients with polycythemia vera
5.2. A case study on polycythemia vera: diagnosis through CBC management with ruxolitinib
5.3. A case of severe dermatitis in a patient with polycythemia vera during cytoreductive therapy
5.4. Perioperative management of polycythemia vera with advanced gastric cancer: a case report
6. Epidemiology and Patient Population
6.1. Key Findings
6.2. Epidemiology Methodology
6.3. Total Prevalent Population of Polycythemia Vera in the 7MM
7. United States Epidemiology
7.1. Assumptions and Rationale
7.2. KOL Insights
7.3. Total Prevalent Population of Polycythemia Vera in the United States
7.4. Prevalent Population of Polycythemia Vera (PV) Based on Symptoms in the United States
7.5. Gender-specific Diagnosed (Symptomatic) Prevalence of Polycythemia Vera in the United States
7.6. Age-specific Diagnosed (Symptomatic) Prevalence of Polycythemia Vera in the United States
7.7. Prevalence of Polycythemia Vera (PV) Based on Risk in the United States
7.8. Prevalence of PV by Gene Mutation in the United States
8. EU5 Epidemiology
8.1. KOL Insights
8.2. Germany Epidemiology
8.2.1. Assumptions and Rationale
8.2.2. Total Prevalent Population of Polycythemia Vera in Germany
8.2.3. Prevalent Population of Polycythemia Vera (PV) Based on Symptoms in Germany
8.2.4. Gender-specific Diagnosed (Symptomatic) Prevalence of Polycythemia Vera in Germany
8.2.5. Age-specific Diagnosed (Symptomatic) Prevalence of Polycythemia Vera in Germany
8.2.6. Prevalence of Polycythemia Vera (PV) Based on Risk in Germany
8.2.7. Prevalence of PV by Gene Mutation in Germany
8.3. France Epidemiology
8.4. Italy Epidemiology
8.5. Spain Epidemiology
8.6. United Kingdom Epidemiology
9. Japan Epidemiology
9.1. Assumptions and Rationale
9.2. KOL Insights
9.3. Total Prevalent Population of Polycythemia Vera in Japan
9.4. Prevalent Population of Polycythemia Vera (PV) Based on Symptoms in Japan
9.5. Gender-specific Prevalence of Polycythemia Vera in Japan
9.6. Age-specific Prevalence of Polycythemia Vera in Japan
9.7. Prevalence of Polycythemia Vera (PV) Based on Risk in Japan
9.8. Prevalence of PV by Gene Mutation in Japan
10. Treatment Algorithm, Current Treatment, and Medical Practices
10.1. Treatment Algorithm
10.2. Proposed Guidelines for Polycythemia Vera
10.3. A British Society for Haematology Guidelines for PV
10.4. National Comprehensive Cancer Network (NCCN) Guidelines for Polycythemia Vera (PV)
10.5. European Society for Medical Oncology Guidelines for Polycythemia Vera
11. Unmet Needs
12. Marketed Products
12.1. Jakafi (Ruxolitinib): Incyte Corporation/Novartis
12.1.1. Drug Description
12.1.2. Regulatory Milestones
12.1.3. Clinical Development
12.1.4. Safety and Efficacy
12.1.5. Product Description
12.2. Besremi: AOP Orphan Pharmaceuticals AG/PharmaEssentia
13. Emerging Therapies
13.1. KRT-232: Kartos Therapeutics
13.1.1. Product Description
13.1.2. Clinical Development
13.1.3. Clinical Trials Information
13.1.4. Product Profile
13.2. Givinostat: Italfarmaco
13.3. PTG-300: Protagonist Therapeutics
13.4. PRM-151: Promedior/Roche
13.5. Imetelstat (GRN163L): Geron Corporation
13.6. Bomedemstat (IMG-7289): Imago BioSciences
14. Polycythemia Vera (PV): 7MM Market Analysis
14.1. Key Findings
14.2. Market Methodology
14.3. Market Size of Polycythemia Vera in the 7MM
14.4. Market Size of Polycythemia Vera by Therapies in the 7MM
15. United States: Market Outlook
15.1. United States Market Size
15.1.1. Total Market size of Polycythemia Vera in the United States
15.1.2. Market Size of Polycythemia Vera by Therapies in the US
16. EU-5 countries: Market Outlook
16.1. Germany Market Size
16.1.1. Total Market size of Polycythemia Vera in Germany
16.1.2. Market Size of Polycythemia Vera by therapies in Germany
16.2. France Market Size
16.3. Italy Market Size
16.4. Spain Market Size
16.5. United Kingdom Market Size
17. Japan Market Outlook
17.1. Japan Market Size
17.1.1. Total Market size of Polycythemia Vera in Japan
17.1.2. Market Size of Polycythemia Vera by therapies in Japan
18. Market Drivers
19. Market Barriers
20. SWOT Analysis
21. Reimbursement and Market Access
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