Polycythemia Vera (PV) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Polycythemia Vera (PV) Market Outlook

Thelansis’s “Polycythemia Vera (PV) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Polycythemia Vera treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Polycythemia Vera (PV) Overview

Polycythemia vera (PV) is a myeloproliferative disorder that produces excessive red blood cells, white blood cells, and platelets, leading to elevated blood viscosity and various associated symptoms. The primary cause is the uncontrolled proliferation of red blood cells, often extending to white blood cells and platelets. While the exact origin of this abnormal stem cell expansion is debated, a somatic mutation known as JAK2-V617F in the JAK2 gene (9p24) is prevalent among most patients. However, less frequently, a somatic mutation in exon 12 of JAK2 can also be found. Symptoms of PV typically manifest insidiously and include headaches, dizziness, vertigo, tinnitus, visual disturbances, and itching after bathing. Patients may also exhibit a flushed appearance in their face, palms, nailbeds, mucosa, and conjunctiva. Complications associated with PV encompass arterial thrombosis (in cerebrovascular, myocardial, or peripheral regions), angina pectoris, intermittent claudications, venous thromboses (such as deep vein thrombosis and pulmonary embolism), splanchnic thrombosis (involving the portal vein and Budd-Chiari syndrome), and bleeding issues, including gum bleeding, ecchymoses, and gastrointestinal bleeding. Splenomegaly is also common in PV. In some cases, PV may progress to myelofibrosis, acute leukemia, or myelodysplastic syndrome, typically in the later stages of the disease. Diagnosing PV relies on several criteria, including a hematocrit (Hct) greater than 52% or hemoglobin (Hb) greater than 185 g/L in males, Hct greater than 48% or Hb greater than 165 g/L in females, an increased red blood cell mass (greater than 125% of the normal value), the presence of JAK2 mutations (V617F or exon 12), low levels of circulating erythropoietin (EPO), spontaneous colony formation by erythroid progenitor cells, and, in cases where JAK2 mutation is absent, evidence of a myeloproliferative disorder through bone marrow biopsy. Differential diagnosis involves ruling out other Ph1 negative myeloproliferative diseases, such as essential thrombocytosis and agnogenic myeloid metaplasia. PV is a chronic condition, and the survival rate of treated patients can be similar to the general population or slightly reduced, with a mortality rate 1.6 times higher than that of the general population. The FDA has approved ropeginterferon alfa-2b-njft (sold as BESREMi®) for the treatment of polycythemia vera (PV).

• The prevalence of PV in the United States is estimated to be between 44 and 57 cases per 100,000 people. 

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2023-2033

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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