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Last Updated: July 10, 2025

RUCONEST Drug Profile


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Summary for Tradename: RUCONEST
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for RUCONEST
Recent Clinical Trials for RUCONEST

Identify potential brand extensions & biosimilar entrants

SponsorPhase
University Hospital, Basel, SwitzerlandPhase 2
Swiss National Science FoundationPhase 2
IMMUNOe Research CentersPhase 4

See all RUCONEST clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for RUCONEST Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for RUCONEST Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for RUCONEST Derived from Patent Text Search

These patents were obtained by searching patent claims

Market Dynamics and Financial Trajectory of RUCONEST: A Comprehensive Analysis

Last updated: April 14, 2025

The biologic drug RUCONEST® (conestat alfa), a recombinant human C1 esterase inhibitor developed by Pharming Group N.V., has emerged as a critical therapy for acute hereditary angioedema (HAE) attacks. With its approval in the European Union in 2010 and the United States in 2014, RUCONEST® has established itself as a leading treatment in a niche but growing market. This report analyzes the drug’s market dynamics, financial performance, and future trajectory, drawing on recent data to provide a granular understanding of its commercial and clinical landscape.


Historical Market Evolution and Current Positioning

Origins and Clinical Utility

RUCONEST® was developed to address the unmet need for effective on-demand treatment of HAE, a rare genetic disorder characterized by unpredictable episodes of severe swelling. By replacing deficient or dysfunctional C1 esterase inhibitor (C1-INH), the drug mitigates excessive bradykinin production, a key mediator of HAE symptoms[4]. Its recombinant nature eliminates the risk of bloodborne pathogen transmission associated with plasma-derived alternatives, offering a safer profile for patients[4].

Market Adoption and Growth Trajectory

Since its launch, RUCONEST® has experienced steady growth, driven by increasing HAE awareness and strategic commercialization efforts. The global RUCONEST® market grew from $XX million in 2024 to $XX million in 2025 at a compound annual growth rate (CAGR) of XX%[1][6]. This growth was fueled by expanding physician prescriber bases, which increased by 13% in 2023 alone[8], and a 24% rise in new patient enrollments during 2024[7]. By the end of 2024, RUCONEST® generated record revenues of $252.2 million, an 11% year-over-year increase[7], with the U.S. market accounting for 98% of total sales[7].


Financial Performance and Operational Drivers

Revenue Acceleration and Geographic Dominance

Pharming’s financial disclosures highlight RUCONEST® as the cornerstone of its revenue stream. In Q3 2024, the drug contributed $63.6 million, a 6% increase from the same period in 2023[2]. Full-year 2024 sales reached $252.2 million, surpassing expectations due to robust unit sales growth (6%) and a 24% surge in new patient enrollments[7]. The U.S. market’s dominance (98% of revenue) underscores the success of targeted commercialization strategies, including price adjustments aligned with the Consumer Price Index (CPI) and expanded prescriber networks[2][7].

Cost Dynamics and Profitability

Gross profit for RUCONEST® rose to $261.8 million in 2024, a 19% increase from 2023, attributable to higher sales volumes[7]. However, cost of sales escalated by 40% ($35.4 million in 2024 vs. $25.2 million in 2023), driven by rising production costs and one-time inventory impairment charges[7]. Despite these pressures, operational efficiencies and scale economies enabled Pharming to maintain a healthy gross margin, supported by a 72% revenue jump from Joenja® (leniolisib), its secondary product[2][7].


Market Drivers and Competitive Differentiation

Rising HAE Prevalence and Diagnostic Advancements

The global HAE population, estimated at 1 in 50,000 individuals, remains underserved, creating sustained demand for effective therapies[4]. Improved diagnostic technologies, including genetic testing and biomarker identification, have facilitated earlier diagnosis, expanding the addressable patient pool[1][9]. RUCONEST® benefits from its designation as an orphan drug, which provides regulatory incentives and market exclusivity[5].

Cost-Effectiveness and Payer Coverage

A 2013 cost-utility analysis demonstrated RUCONEST®’s economic advantage over Berinert® P, a plasma-derived C1-INH. With an incremental cost-utility ratio (ICUR) of €15,226 per quality-adjusted life year (QALY) compared to Berinert® P’s €27,786, RUCONEST® offers superior value for healthcare payers[10]. This economic profile has bolstered formulary inclusions and reimbursement approvals, particularly in the U.S.[7][10].


Strategic Commercialization and Market Segmentation

Distribution Channels and End-User Preferences

The RUCONEST® market is segmented by distribution channel, with hospital pharmacies accounting for the majority of sales due to the drug’s administration in acute care settings[1][9]. However, the rise of homecare models and subcutaneous formulations (in development) could shift demand toward retail pharmacies and self-administration options[1][6].

Dosage Form and Clinical Indications

Powder for reconstitution remains the dominant dosage form, though pre-filled syringes are gaining traction for their convenience[1][9]. While RUCONEST® is currently approved only for acute attacks, Pharming is exploring prophylaxis applications, which could double its addressable market[11].


Challenges and Risk Mitigation

Production Cost Volatility

Rising production costs, particularly for recombinant protein synthesis, pose a persistent challenge. In 2024, Pharming incurred $4.8 million in inventory impairment charges related to RUCONEST®, highlighting supply chain vulnerabilities[7]. Diversifying manufacturing partners and investing in process optimization could mitigate these risks.

Competitive Pressures

The HAE therapy market is increasingly crowded, with oral prophylactic agents like Takhzyro® (lanadelumab) and Orladeyo® (berotralstat) gaining market share. RUCONEST® differentiates itself through its on-demand efficacy and recombinant safety profile, but maintaining growth requires continuous innovation, such as extended half-life formulations[6][9].


Future Projections and Growth Opportunities

Market Expansion and Subcutaneous Formulations

The global RUCONEST® market is projected to grow at a CAGR of XX% from 2025 to 2029, reaching $XX million by 2029[1][6]. Key growth levers include:

  • Geographic expansion: While the U.S. dominates, opportunities exist in the EU and Asia-Pacific, where HAE remains underdiagnosed[7][9].
  • Route of administration: Subcutaneous formulations, currently in development, could improve patient convenience and expand prophylaxis use[11].

Personalized Medicine and Digital Engagement

Pharming’s investment in digital platforms for patient monitoring and adherence tracking aligns with broader trends toward personalized medicine[1][6]. These tools enhance patient retention and provide real-world data to support label expansions.


Conclusion

RUCONEST® exemplifies the commercial viability of orphan drugs when supported by strategic pricing, robust clinical differentiation, and agile commercialization. Its financial trajectory reflects successful navigation of a complex rare disease market, though sustaining growth will require addressing production cost pressures and competitive threats. With prophylaxis indications and subcutaneous delivery on the horizon, RUCONEST® is poised to reinforce its position as a first-line therapy for HAE, benefiting patients and stakeholders alike.

References

  1. https://www.thebusinessresearchcompany.com/report/ruconest-global-market-report
  2. https://www.biospace.com/press-releases/pharming-group-reports-third-quarter-2024-financial-results-and-provides-business-update
  3. https://www.globenewswire.com/news-release/2024/03/14/2845977/0/en/Pharming-Group-reports-fourth-quarter-and-full-year-2023-financial-results.html
  4. https://www.rarediseaseadvisor.com/therapies/ruconest-c1-esterase-inhibitor-recombinant/
  5. https://www.pharming.com/news/pharming-announces-completion-acquisition-all-north-american-commercialisation-rights
  6. https://www.openpr.com/news/3872901/a-deep-dive-into-ruconest-market-2025-key-drivers-growth
  7. https://www.biospace.com/press-releases/pharming-group-reports-fourth-quarter-and-full-year-2024-financial-results-and-provides-business-update
  8. https://www.biospace.com/pharming-group-reports-fourth-quarter-and-full-year-2023-financial-results
  9. https://www.einpresswire.com/article/794889876/ruconest-market-report-2025-size-trends-and-growth-insights-for-global-expansion
  10. https://pmc.ncbi.nlm.nih.gov/articles/PMC3834719/
  11. https://www.pharming.com/sites/default/files/imce/Press%20releases/1%20PR%20Full%20Year%20Results%202018.pdf

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