Polycythemia Vera Market Set for Transformation: Key 9 Companies Expected to Enter by 2036 | DelveInsight
The polycythemia vera market is set for expansion by 2036, as new entrants such as Protagonist Therapeutics and Takeda Pharmaceuticals (rusfertide), Merck (bomedemstat), Italfarmaco (givinostat), Ionis Pharmaceuticals and Ono Pharmaceutical (sapablursen), Silence Therapeutics (Divesiran (SLN124)), Perseus Proteomics (PPMX-T003), Disc Medicines (DISC-3405), and others are evaluating their lead candidates in different stages of clinical development, respectively.
New York, USA, April 22, 2026 (GLOBE NEWSWIRE) -- Polycythemia Vera Market Set for Transformation: Key 9 Companies Expected to Enter by 2036 | DelveInsight
The polycythemia vera market is set for expansion by 2036, as new entrants such as Protagonist Therapeutics and Takeda Pharmaceuticals (rusfertide), Merck (bomedemstat), Italfarmaco (givinostat), Ionis Pharmaceuticals and Ono Pharmaceutical (sapablursen), Silence Therapeutics (Divesiran (SLN124)), Perseus Proteomics (PPMX-T003), Disc Medicines (DISC-3405), and others are evaluating their lead candidates in different stages of clinical development, respectively.
Polycythemia vera remains a chronic condition with no definitive cure, but its management landscape is steadily evolving. Current therapies focus on long-term disease control, aiming to normalize hematocrit and platelet levels while alleviating debilitating symptoms through sustained medical oversight.
Standard treatment strategies are largely risk-adapted. Low-risk patients are typically managed with low-dose aspirin and phlebotomy to minimize thrombotic complications, whereas high-risk patients require cytoreductive interventions such as hydroxyurea or interferon alpha to better control disease progression.
The approved treatment arsenal remains limited, with three key therapies shaping the current market: JAKAFI/JAKAVI (ruxolitinib), BESREMi (ropeginterferon alfa-2b), and PEGASYS (peginterferon alfa-2a). While JAKAFI and BESREMi have secured approvals across major markets, including the US, Europe, and Japan, PEGASYS remains restricted to Europe.
Despite approaching patent expiry in 2028, JAKAFI continues to demonstrate strong commercial momentum, driven by robust demand in polycythemia vera and graft-versus-host disease. In 2025, the polycythemia vera market across the 7MM (US, EU4, the UK, and Japan) was valued at approximately USD 2 billion and is poised for significant expansion at 8.9% CAGR through 2036, fueled by increasing prevalence, unmet clinical needs, and upcoming therapeutic innovations.
Discover which region dominates the PV market @ https://www.delveinsight.com/sample-request/polycythemia-vera-market
A wave of innovation is on the horizon, with several biopharma players advancing next-generation therapies. Companies such as Protagonist Therapeutics, Takeda, Italfarmaco, Ionis Pharmaceuticals, Ono Pharmaceutical, Merck (via Imago BioSciences), Silence Therapeutics, Perseus Proteomics, Disc Medicine, Hangzhou GluBio Pharmaceutical, Agios Pharmaceuticals, Alnylam Pharmaceuticals, Johnson & Johnson Innovative Medicine, Chengdu Zenitar Biomedical Technology, Prelude Therapeutics, Incyte, and Vanda Pharmaceuticals are actively progressing candidates, many of which have recently entered late-stage development, signaling a promising shift in the treatment paradigm.
Below, we highlight 9 companies with their lead assets that are expected to enter the PV market by 2036
Protagonist Therapeutics and Takeda’s Rusfertide
Iron modulator
Rusfertide is an innovative injectable synthetic analog of the natural hormone hepcidin, designed to deliver enhanced potency, solubility, and stability. These improvements result in superior in vivo pharmacokinetic and pharmacodynamic profiles, along with improved manufacturability compared to the native hormone. By effectively and consistently controlling hematocrit levels, rusfertide offers meaningful clinical benefits for patients with erythrocytosis or pathological iron overload, significantly reducing the reliance on therapeutic phlebotomy.
In December 2025, Protagonist Therapeutics and Takeda reported updated 52-week findings from the pivotal Phase III VERIFY trial of rusfertide in patients with polycythemia vera, which were presented as an oral session at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition.
According to Aparna Thakur, Assistant Project Manager of Forecasting, DelveInsight, rusfertide is poised to be the first among emerging therapies to enter the polycythemia vera market, giving it a clear first-mover advantage. Thakur further said that with the NDA already submitted and a launch expected this year, rusfertide is well-positioned to move earlier in the treatment paradigm and has the potential to meaningfully reshape the management of polycythemia vera.
Explore the rusfertide approval timeline @ Rusfertide Approval for PV
Italfarmaco’s DUVYZAT
Pan-HDAC inhibitor
Givinostat is an orally administered hydroxamate-based HDAC inhibitor with potential anti-inflammatory, anti-angiogenic, and anticancer properties. It targets both Class I and Class II HDAC enzymes, leading to the accumulation of hyperacetylated histones, which promote chromatin remodeling and changes in gene expression. Marketed as DUVYZAT, it received U.S. approval in March 2024 for treating patients aged 6 years and older with Duchenne muscular dystrophy (DMD). Italfarmaco is currently evaluating givinostat in Phase III clinical studies for polycythemia vera and aims to bring the drug to market by 2027.
Givinostat could emerge as a next-generation first-line cytoreductive option, offering a well-tolerated alternative to hydroxyurea for long-term management of polycythemia vera, as per Thakur.
Merck’s Bomedemstat
LSD 1 inhibitor
Bomedemstat is an investigational, small-molecule, irreversible inhibitor of LSD1 being developed by Merck. It is under evaluation across multiple myeloproliferative neoplasms, including essential thrombocythemia, myelofibrosis, and polycythemia vera. An ongoing investigator-sponsored Phase III trial is currently assessing bomedemstat in patients with polycythemia vera.
Sadaf Javed, Manager of Forecasting, DelveInsight, stated that bomedemstat is best viewed as a later-line or second-wave entrant in the polycythemia vera landscape, with regulatory submission and commercial launch not expected before 2029, contingent on positive Phase III outcomes and clear differentiation versus existing standards of care.
To know more about new treatments replacing ruxolitinib, visit @ Polycythemia Vera Medication
Ionis and Ono’s Sapablursen
TMPRSS6 inhibitor
Sapablursen, previously referred to as IONIS-TMPRSS6-LRx, is an experimental RNA-based therapy that targets the TMPRSS6 gene to regulate the production of hepcidin, the primary hormone responsible for maintaining iron balance in the body. By influencing hepcidin levels, sapablursen may offer therapeutic benefits for hematologic conditions such as polycythemia vera. It is currently under evaluation in a Phase II clinical trial for patients with phlebotomy-dependent polycythemia vera.
Alongside direct hepcidin mimetics such as rusfertide, Javed said sapablursen represents an indirect hepcidin-based approach, and positive upcoming readouts could position it as a differentiated option for patients with polycythemia vera who require frequent phlebotomy.
Disc Medicine’s DISC-3405
TMPRSS6 protein inhibitors
DISC-3405 is an experimental monoclonal antibody that targets TMPRSS6 (also called Matriptase-2), aiming to stimulate the body’s natural production of hepcidin. By elevating hepcidin levels and thereby lowering iron availability, this approach may help treat a broad spectrum of conditions driven by excess iron.
Previously known as MWTX-003 and licensed from Mabwell Therapeutics, DISC-3405 has completed a Phase I trial in healthy volunteers. It is currently being evaluated in a Phase II study for polycythemia vera and a Phase Ib study for sickle cell disease, with plans to expand research into other iron overload disorders.
If efficacy translates into sustained hematocrit control with a favorable tolerability profile, DISC-3405 could be particularly attractive for patients inadequately managed with phlebotomy alone or those intolerant to cytoreductive agents, as per Rajesh Kumar, functional head of Forecasting at DelveInsight.
Find out more about upcoming drugs for polycythemia vera @ Polycythemia Vera Drug Treatment
Silence Therapeutics’ Divesiran
TMPRSS6 inhibitor
Divesiran is an siRNA candidate fully owned by Silence, developed using its proprietary mRNAi GOLD platform, designed to silence TMPRSS6, a gene primarily expressed in the liver. By targeting TMPRSS6 in patients with polycythemia vera, divesiran is intended to boost hepcidin production and secretion from hepatocytes, thereby limiting iron availability to the bone marrow and reducing the overproduction of red blood cells, a process driven by iron supply.
In addition, Silence Therapeutics is currently enrolling patients in a Phase II study of subcutaneous divesiran. The trial aims to evaluate the proportion of participants who can maintain hematocrit levels at or below 45% without requiring phlebotomy between weeks 18 and 36, while also assessing the drug’s potential to alleviate symptoms associated with polycythemia vera.
According to Kumar, compared with other emerging hepcidin-pathway agents such as rusfertide and sapablursen, divesiran shares a similar therapeutic goal but differs in modality, using RNA interference rather than peptide or antisense approaches. While still early-stage, Kumar said divesiran appears well-positioned as a phlebotomy-sparing option for polycythemia vera, with its ultimate competitiveness dependent on durability, safety, and differentiation versus other iron-modulating therapies as clinical development progresses.
Perseus Proteomics’ PPMX-T003
TfR
PPMX-T003 is designed to target the transferrin receptor (TfR) on the cell membrane, a key regulator of cellular iron uptake. Using phage display technology, the company developed PPMX-T003 as a fully human antibody that demonstrates strong anticancer activity by effectively inhibiting iron uptake in tumor cells. The drug is currently being evaluated in a Phase I dose-escalation study to assess its safety and pharmacokinetic profile in polycythemia vera. The company is also seeking to out-license PPMX-T003 for the treatment of polycythemia vera.
Discover more about PV pipeline analysis 2026 @ Polycythemia Vera Clinical Trials
Source: Polycythemia Vera Gravis Market Report
Polycythemia Vera Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key polycythemia vera companies, including Protagonist Therapeutics, Takeda, Italfarmaco, Ionis Pharmaceuticals, Ono Pharmaceutical, Merck (via Imago BioSciences), Silence Therapeutics, Perseus Proteomics, Disc Medicine, Hangzhou GluBio Pharmaceutical, Agios Pharmaceuticals, Alnylam Pharmaceuticals, Johnson & Johnson Innovative Medicine, Chengdu Zenitar Biomedical Technology, Prelude Therapeutics, Incyte, Vanda Pharmaceuticals, and others.
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