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Last Updated: December 19, 2025

BEYFORTUS Drug Profile


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Summary for Tradename: BEYFORTUS
High Confidence Patents:0
Applicants:1
BLAs:1
Pharmacology for BEYFORTUS
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. DrugPatentWatch analysis and company disclosures
  4. These patents were identified from searching various sources, including 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 BEYFORTUS Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for BEYFORTUS Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: BEYFORTUS

Last updated: September 19, 2025

Introduction

BEYFORTUS (benralizumab) represents a pivotal advancement in biologic therapies targeting severe eosinophilic asthma. Developed by AstraZeneca, this monoclonal antibody attaches to the alpha subunit of the interleukin-5 receptor (IL-5Rα), leading to direct depletion of eosinophils—a key driver of inflammation in asthma. As biologic therapies reshape the paradigm of respiratory disease management, understanding the market dynamics and financial trajectory of BEYFORTUS is essential for stakeholders ranging from pharma investors to healthcare providers.

Market Landscape of Biologic Therapies for Asthma

The biologic treatments segment for asthma has experienced exponential growth over the past decade, driven by increasing prevalence, unmet clinical needs, and shifting guidelines favoring targeted therapies. The global asthma biologics market was valued at approximately USD 4.2 billion in 2022, with projections to reach USD 9.7 billion by 2030, growing at a CAGR of around 10% (due to rising adoption and new product launches)[1].

Key players include symptomatic biologics such as AstraZeneca’s BEYFORTUS, GSK's Nucala (mepolizumab), Teva's Cinqair (reslizumab), and Novartis’ Xolair (omalizumab). Among these, anti-IL-5 agents like benralizumab are distinguished by their mechanism of eosinophil depletion, often leading to more rapid and sustained symptom control.

Market Entry and Adoption of BEYFORTUS

Regulatory Milestones

BEYFORTUS received FDA approval in September 2017 for add-on maintenance treatment of severe eosinophilic asthma aged 12 and older. Subsequently, it obtained approval in Europe, Japan, and other jurisdictions, with indications expanding to include adolescent and adult populations. Continued approvals have been predicated on robust clinical trial data demonstrating superior eosinophil suppression and exacerbation reduction (e.g., SIROCCO, CALIMA trials).

Competitive Positioning

Positioned as a convenient, once-every-eight-week subcutaneous infusion, BEYFORTUS offers a favorable dosing profile relative to some peers requiring more frequent administrations. Early market penetration was driven by its claimed efficacy in reducing exacerbations, improving lung function, and decreasing oral corticosteroid dependency.

Physician and Payer Adoption

Real-world uptake hinges on physician familiarity, insurance reimbursement, and perceived clinical benefits. Cost considerations position BEYFORTUS as premium therapy; priced typically around USD 3,000–4,000 per dose, its adoption correlates strongly with the severity of asthma and eosinophil counts, a proxy for patient eligibility.

Market Dynamics Influencing BEYFORTUS

Unmet Medical Needs

Despite advances, many severe asthma patients remain uncontrolled worldwide, especially in regions with limited access to biologics. BEYFORTUS's efficacy in eosinophil-depleted populations offers a targeted solution, but market penetration is constrained where infrastructure or awareness is lacking.

Pricing and Reimbursement

Pricing strategies remain pivotal. AstraZeneca has adopted tiered pricing and payer negotiations to facilitate access. Reimbursement policies in mature markets like the US and EU have generally favored biologic adoption, although high costs pose barriers in emerging markets.

Pipeline and Competition

The competitive landscape is intensifying with newer agents targeting IL-5, IL-4/13 pathways, and combinational biologics. Notably, Novartis’ Xolair and GSK’s Nucala have long-standing market presence, with increasing prescriptions offset by BEYFORTUS's favorable dosing schedule and efficacy. The upcoming pipeline of biosimilars and potential next-generation biologics could pressure pricing and market share over time.

Global Market Expansion

Emerging markets, particularly in Asia-Pacific, Latin America, and Africa, represent growth vectors. Adoption depends on healthcare system evolution, regulatory approvals, and local pricing negotiations. AstraZeneca’s strategic partnerships aim to accelerate penetration in these regions.

Financial Trajectory of BEYFORTUS

Revenue Projections

Based on current market penetration and growth trends, analysts project BEYFORTUS revenues to reach approximately USD 1.2–1.5 billion globally by 2025. Its peak penetration is expected in North America, where severe asthma prevalence exceeds 10 million individuals, representing substantial revenue streams (per NHLBI estimates)[2].

Key Factors Affecting Revenue Growth

  • Market Penetration Rates: Adoption hinges on physician prescribing habits and insurance coverage.
  • Pricing Strategy: Dependence on reimbursement models and healthcare budgets.
  • Regulatory Expansions: Approval for additional indications (e.g., chronic rhinosinusitis with nasal polyps) could significantly broaden revenue base.
  • Patient Population Expansion: Identification and diagnosis of eosinophilic phenotypes remain crucial. Improved biomarker utilization enhances the precise targeting and drives sales.

Cost Considerations and Investment

AstraZeneca maintains heavy investment in clinical trials, marketing, and patient support programs. These investments are necessary to sustain growth amid increased competition and market saturation pressures.

Potential Risks

Patent expirations (predicted post-2030) and biosimilar entries could erode market share and pricing power. Additionally, skewed access in developing countries poses a longer-term threat to revenue scalability.

Future Outlook and Strategic Considerations

Market Growth Opportunities

  • Indication Expansion: Ongoing trials intend to extend BEYFORTUS applications to conditions like eosinophilic chronic obstructive pulmonary disease (COPD) and other eosinophil-mediated diseases.
  • Combination Therapies: Synergistic approaches targeting multiple pathways could expand usage.
  • Digital and Data-driven Adoption: Real-world evidence and pharmacoeconomic data will influence payer decisions and patient access.

Competitive Strategies

  • Pricing Optimization: Balancing affordability with sustainable margins.
  • Partnerships and Collaborations: Collaborating with healthcare providers and payers ensures market access.
  • Product Differentiation: Emphasizing convenience, efficacy, and patient-centric delivery models.

Conclusion

BEYFORTUS’s market and financial trajectory is characterized by rapid growth potential, driven by clinical efficacy, dosing convenience, and expanding indications. However, it faces challenges from competition, high pricing concerns, and access disparities. Strategic positioning, pipeline expansion, and market penetration efforts are critical to maximizing its commercial success. As biologic therapies for asthma continue to evolve, BEYFORTUS’s role remains highly promising, with significant revenue potential in the coming decade.

Key Takeaways

  • The global biologic asthma market is projected to nearly double by 2030, with BEYFORTUS poised to capture a significant share.
  • Adoption depends on clinical efficacy, convenience, pricing, and payer reimbursement strategies.
  • Expansion into new indications and geographies will be pivotal for sustained revenue growth.
  • Competition from existing and pipeline biologics will influence market dynamics and profitability.
  • Long-term success requires proactive management of patent landscapes, biosimilar threats, and healthcare system integration.

FAQs

1. What differentiates BEYFORTUS from other anti-IL-5 biologics?
BEYFORTUS’s key advantage is its mechanism of inducing rapid and sustained eosinophil depletion via antibody-dependent cell-mediated cytotoxicity, alongside a convenient every-eight-week dosing schedule, enhancing patient adherence compared to competitors requiring more frequent administration.

2. How does pricing influence BEYFORTUS’s market penetration?
High price points necessitate robust reimbursement and cost-effectiveness evidence. While premium pricing limits access in some regions, strategic negotiations and patient support programs have helped increase uptake in established markets.

3. What are the primary drivers of revenue growth for BEYFORTUS?
Market expansion into new geographic regions, approval for additional indications, increased diagnosis of eosinophilic asthma, and improved clinician and patient awareness are key drivers.

4. How might biosimilars impact BEYFORTUS’s future?
The entry of biosimilars post-patent expiry (expected after 2030) could pressure prices and market share, necessitating AstraZeneca to innovate through new formulations or indications to sustain revenues.

5. Which emerging markets hold the most promise for BEYFORTUS?
Asia-Pacific, Latin America, and Africa are high-growth regions due to rising asthma prevalence, improving healthcare infrastructure, and increasing awareness, representing significant future opportunities.


Sources:
[1] Grand View Research. "Asthma Treatment Market Size, Share & Trends Analysis Report." 2022.
[2] NHLBI. “Guidelines for the Diagnosis and Management of Asthma.” 2020.

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