Polycythemia Vera’s Competitive Treatment Outlook for 2025 |...

Polycythemia Vera’s Competitive Treatment Outlook for 2025

Posted 2025-11-16 13:16:21

The therapeutic landscape for Polycythemia Vera (PV), a chronic myeloproliferative neoplasm (MPN) characterized by the overproduction of red blood cells, is undergoing a profound transformation in 2025. Once dominated by older cytoreductive agents and frequent phlebotomies, the polycythemia vera treatment market is now a dynamic battleground marked by intense competition, significant pipeline advancements, and looming patent cliffs. With the market expected to grow substantially in the coming years (potentially reaching over $5 billion by 2034 in the 7MM), the stakes are exceptionally high for established and emerging players.

JAKAFI’s Leadership and the Shadow of Generic Entry

JAKAFI (ruxolitinib), a JAK1/JAK2 inhibitor, remains the principal revenue driver and key second-line therapy for PV patients who are resistant to or intolerant of hydroxyurea. Its efficacy in managing hematocrit levels, reducing splenomegaly, and alleviating debilitating systemic symptoms has cemented its premium positioning. This is reflected in the high jakafi cost, which supports its substantial ruxolitinib sales.

However, the dominant position of JAKAFI is increasingly defined by its ruxolitinib patent expiration, with key US composition of matter patents generally expiring around mid-2028. While manufacturers are aggressively pursuing life-cycle management strategies—such as new formulations and combination therapies—to delay generic entry, the threat remains substantial. The potential launch of generic ruxolitinib will trigger a significant shift in pricing dynamics and market share distribution, intensifying the focus on cost-effectiveness debates, particularly when comparing the current price of JAKAFI versus that of BESREMI.

BESREMI: Challenging the Treatment Cascade

PharmaEssentia’s BESREMI (ropeginterferon alfa-2b) represents the first and only FDA-approved interferon specifically for PV. Positioned as a long-acting, less frequently administered therapy, BESREMI is recognized for its potential to not only achieve hematologic control but also to reduce the JAK2 V617F allele burden, suggesting a disease-modifying capability.

Unlike JAKAFI, which is approved for the second line, BESREMI holds a broad label that allows for use in both first- and subsequent-line settings. This allows PharmaEssentia to position BESREMI upstream of JAKAFI in NCCN guidelines, meaning that while it is not a direct, head-to-head competitor in the second-line setting, its adoption can delay the progression of patients to JAKAFI, potentially impacting JAKAFI’s overall revenue trajectory. The growing adoption of BESREMI, driven by discussions around its annual cost and favorable long-term safety profile, highlights the increasing segmentation of the PV treatment pathway.

Rusfertide: The Pipeline Disruptor

The most anticipated entrant in the polycythemia vera treatment market is Rusfertide (PTG-300), an investigational, first-in-class hepcidin-mimetic peptide. Its rusfertide MOA involves regulating iron metabolism to suppress red blood cell production, providing a novel, non-cytoreductive, and non-JAK-inhibitor approach to managing the disorder.

Clinical data from the Phase 3 VERIFY trial have been highly encouraging, demonstrating Rusfertide’s ability to substantially reduce or even eliminate the need for therapeutic phlebotomy—a key, burdensome aspect of PV management. This unique benefit led to the therapy receiving Breakthrough Therapy Designation from the FDA in mid-2025. With positive Phase 3 results reported and an NDA submission anticipated by the end of 2025, Rusfertide FDA approval is eagerly anticipated, potentially by late 2026. If approved, it is expected to become a new standard of care for patients with uncontrolled hematocrit, offering a significant improvement in quality of life. The market awaits final clarity on its commercial Rusfertide cost and its positioning, which could either be as an alternative to current cytoreductive therapies or as an adjunct, creating another distinct segment in the market.

Regulatory and Market Uncertainty

The competitive landscape is further complicated by recent regulatory events, such as the withdrawal of Breakthrough Therapy Designation (BTD) for certain other therapies, which introduces a degree of uncertainty in investment and adoption decisions across the entire MPN pipeline. Stakeholders are therefore closely monitoring not only the clinical data but also the regulatory timelines and final labels for all emerging alternatives.

The polycythemia vera treatment market in 2025 is characterized by a triple competitive front: JAKAFI, defending its symptom control territory; BESREMI, establishing itself in the disease-modifying space; and Rusfertide, poised to solve the patient burden of phlebotomy. Pricing, safety profiles, and long-term data will be the ultimate determinants of patient adoption and overall market growth, ensuring that innovation continues to benefit patients with PV.

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Kanishk

kkumar@delveinsight.com