Benralizumab - Biologic Drug Details

Summary for benralizumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for benralizumab

Recent Clinical Trials for benralizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University Hospital, Lille	PHASE2
AstraZeneca	PHASE2
Pulmonary and Respiratory Failure Department, National and Kapodistrian University of Athens	PHASE4

See all benralizumab clinical trials

Pharmacology for benralizumab

Mechanism of Action	Interleukin 5 Receptor alpha-directed Antibody Interactions
Established Pharmacologic Class	Interleukin-5 Receptor alpha-directed Cytolytic Antibody

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

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.

2. DrugPatentWatch analysis and brand-side disclosures

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.

3. Patents from broad patent text search

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 benralizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070			DrugPatentWatch analysis and company disclosures
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070			DrugPatentWatch analysis and company disclosures
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070			DrugPatentWatch analysis and company disclosures
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070			DrugPatentWatch analysis and company disclosures
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070			DrugPatentWatch analysis and company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070		2037-03-16	Patent claims search
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070		2036-08-10	Patent claims search
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070		2037-08-14	Patent claims search
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070		2037-05-24	Patent claims search
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070		2038-06-20	Patent claims search

Market Dynamics and Financial Trajectory for the Biologic Drug: Benralizumab

Last updated: July 27, 2025

Introduction

Benralizumab, marketed under the brand name Fasenra, is a monoclonal antibody developed by AstraZeneca targeting the interleukin-5 receptor alpha (IL-5Rα). Approved by the FDA in late 2017 for severe eosinophilic asthma, it underscores a significant shift toward biologics in respiratory therapeutics. Its market success hinges on an evolving landscape characterized by increasing prevalence of respiratory conditions, technological advances in biologic therapies, and strategic positioning within competitive pharmacological domains.

This analysis explores the complex market dynamics influencing benralizumab's growth and evaluates its financial trajectory, factoring in regulatory, clinical, competitive, and macroeconomic influences shaping its commercial prospects.

Market Landscape Overview

Growing Prevalence of Asthma and Eosinophilic Phenotypes

The global burden of asthma affects approximately 262 million individuals, with severe eosinophilic phenotypes accounting for nearly 10-15% of cases [1]. This subset often manifests as refractory to standard therapies, creating a pressing need for targeted biologic interventions like benralizumab. The rising prevalence amplifies demand for such therapies, positioning benralizumab favorably within the biologic segment.

Advances in Biologic Therapeutics for Respiratory Diseases

Biologics have revolutionized asthma management, shifting treatment paradigms toward precision medicine. Benralizumab's mechanism—inducing apoptosis of eosinophils via antibody-dependent cell-mediated cytotoxicity—offers a distinct advantage over other IL-5 targeting agents like mepolizumab [2]. The therapeutic differentiation fosters favourable prescribing patterns and reimbursement prospects.

Competitive Dynamics

Benralizumab faces competition from several biologics including mepolizumab (Nucala) and reslizumab (Cinqair), both targeting IL-5 pathways, and Dupilumab (Dupixent), which blocks IL-4 and IL-13 pathways. Mepolizumab, launched ahead of benralizumab, commands significant market share, but recent clinical trials demonstrating superior efficacy or reduced administration frequency bolster benralizumab's competitive positioning.

Additionally, Janssen's reslizumab and other emerging biologics aim to capture segments of the severe eosinophilic asthma market, emphasizing the importance of differentiating attributes such as efficacy, safety, dosing frequency, and cost.

Market Dynamics Influencing Benralizumab

Regulatory Landscape and Approvals

Regulatory bodies worldwide are progressively approving biologics for broader indications. Benralizumab's initial FDA approval in 2017 targeted severe eosinophilic asthma, with subsequent approvals expanding into other eosinophil-related conditions, like COPD with eosinophilic phenotype and persistent eosinophilic conditions outside respiratory domains. Regulatory support enhances accessibility, fostering market expansion.

Pricing, Reimbursement, and Market Access

Biologic pricing remains a pivotal factor in commercial success. Benralizumab's list price, roughly comparable to peers (~$37,000–$40,000 per year in the U.S.), is governed by reimbursement policies. Payers require evidence of cost-effectiveness, prompting AstraZeneca to invest in value-based pricing strategies and healthcare provider engagement to secure formulary inclusion.

Clinical and Real-World Evidence

Growing robust clinical evidence supporting benralizumab's efficacy and safety enhances its attractiveness. Real-world studies demonstrate reductions in exacerbations and oral corticosteroid dependence, positively impacting healthcare utilization costs—which indirectly support market penetration and reimbursement negotiations [3].

Pharmacovigilance and Safety Profile

Benralizumab's safety profile, marked by low incidence of adverse events, aligns with its benefits, reducing barriers to patient adherence and clinician confidence. Ongoing pharmacovigilance ensures regulatory compliance and market trust.

Supply Chain and Manufacturing

The scalability of monoclonal antibody manufacturing influences the drug's availability and cost. AstraZeneca's investments in flexible manufacturing platforms aim to meet rising global demand, minimizing supply disruptions that could hinder sales growth.

Financial Trajectory

Revenue Performance

Since its launch, benralizumab has demonstrated steady revenue growth, with reported sales surpassing $1.3 billion globally in 2022 [4]. Key markets include the U.S., Europe, and Japan, which collectively account for a significant portion of sales. The drug's growth trajectory exhibits a compound annual growth rate (CAGR) of approximately 20%, driven by increased prescriptions, expanded indications, and geographic expansion.

Market Penetration and Prescribing Trends

In the U.S. alone, prescriber adoption was initially slow but gained momentum following favorable trial data and expanded labeling. Ongoing educational initiatives and competitive pricing strategies are projected to bolster market share further.

Impact of Competitive and Macro Factors

Price erosion due to biosimilar entries remains a distant concern, as biosimilars for monoclonal antibodies like benralizumab are not yet commercially available. However, patent expirations and potential biosimilar development could influence future pricing pressures.

Global economic factors, including healthcare spending trends, inflation, and currency fluctuations, influence profitability, especially in emerging markets where cost constraints limit biologic adoption.

Forecasting Future Revenue Streams

Analysts project that benralizumab's revenues will continue to grow at a CAGR of around 15% through 2030, fueled by indication expansion, improved clinician awareness, and increasing global penetration. Market analyses anticipate revenues surpassing $2.5 billion worldwide by 2030, contingent upon competitive dynamics and healthcare infrastructure investments.

Strategic Opportunities and Challenges

Opportunities

• Indication Expansion: Trials exploring efficacy in other eosinophilic disorders (e.g., eosinophilic esophagitis, hypereosinophilic syndrome) could broaden apheresis targets.

• Geographic Expansion: Targeting emerging markets with rising asthma prevalence and improving healthcare access.

• Combination Therapies: Evaluating synergistic use with other biologics or small molecules to optimize patient outcomes.

Challenges

• Market Saturation: Increased competition may lead to consolidation, price wars, and reimbursement challenges.

• Pricing Pressures: Health system austerity and biosimilar threats could constrict profit margins.

• Clinical Trial Risks: Efficacy and safety of new indications are uncertain, potentially delaying or limiting market expansion.

Conclusion

Benralizumab’s market performance exemplifies the strategic interplay of clinical evidence, regulatory support, competitive positioning, and macroeconomic factors. Its steady revenue growth stems from its targeted mechanism and expanding indications, although future gains depend on overcoming competitive challenges and market access hurdles. Continuous innovation, execution in emerging markets, and demonstration of cost-effectiveness will underpin its financial trajectory over the next decade.

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Key Takeaways

• Benralizumab sustains strong growth driven by increasing asthma prevalence and advancements in biologic therapy acceptance.
• Competitive positioning with other IL-5 inhibitors hinges on efficacy, safety, administration convenience, and cost.
• Strategic expansion into new indications and geographies offers significant upside potential.
• Pricing strategies, reimbursement negotiations, and pharmacovigilance are central to maintaining financial stability.
• The trajectory remains positive, with projected revenues surpassing $2.5 billion by 2030, assuming market and regulatory conditions remain favorable.

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FAQs

1. What distinguishes benralizumab from other IL-5 targeting biologics?
   Benralizumab uniquely induces apoptosis of eosinophils via antibody-dependent cell-mediated cytotoxicity, potentially leading to faster and more profound eosinophil depletion than other agents like mepolizumab, which neutralize IL-5. This mechanistic difference may translate into efficacy and safety advantages in specific patient populations.

2. How does the regulatory environment impact benralizumab’s market?
   Regulatory approvals, including expanded indications, directly influence access and reimbursement strategies, enabling broader patient populations to benefit and strengthening market positioning.

3. What are the main challenges for benralizumab’s future growth?
   Key challenges include increased competition from biosimilars and other biologics, potential price erosion, clinical trial uncertainties for new indications, and reimbursement pressures from healthcare payers globally.

4. How does geographic expansion influence benralizumab’s sales?
   Emerging markets with rising asthma prevalence and improving healthcare infrastructure represent strategic growth areas, although these expansions require adaptation to local regulatory and economic conditions.

5. What is the outlook for biosimilar competition affecting benralizumab?
   Currently, biosimilars for benralizumab are not available, but patent expirations could eventually open this segment, potentially reducing prices and profit margins unless mitigated by differentiation strategies.

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Sources

[1] Global Initiative for Asthma (GINA). "Global Strategy for Asthma Management and Prevention," 2022.
[2] Pavord, Ian D., et al. "Efficacy and safety of benralizumab in patients with severe eosinophilic asthma: a systematic review." European Respiratory Journal, 2020.
[3] Bleecker ER, et al. "Real-World Evidence of Benralizumab in Asthma Management." Journal of Allergy and Clinical Immunology, 2022.
[4] AstraZeneca Annual Report 2022.