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Last Updated: February 8, 2025

Benralizumab - Biologic Drug Details


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Summary for benralizumab
Tradenames:1
High Confidence Patents:0
Applicants:1
BLAs:1
Suppliers: see list1
Recent Clinical Trials: See clinical trials for benralizumab
Recent Clinical Trials for benralizumab

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Novartis PharmaceuticalsPhase 2
Charite University, Berlin, GermanyPhase 2
Temple UniversityPhase 2

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Pharmacology for benralizumab
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 benralizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Benralizumab

Introduction

Benralizumab, marketed as Fasenra, is a biologic drug that has made significant strides in the treatment of severe asthma and other eosinophilic conditions. This article delves into the market dynamics and financial trajectory of benralizumab, highlighting its current market position, growth drivers, challenges, and future outlook.

Market Position of Benralizumab

Benralizumab has established itself as a leading treatment for severe, uncontrolled eosinophilic asthma. The drug received FDA approval in 2017 for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype[4].

Dominance in the Hypereosinophilic Syndrome Market

Benralizumab holds a prominent market share in the hypereosinophilic syndrome market, primarily due to its widespread use as the first line of treatment for eosinophilia. This dominance is expected to continue during the forecast period, driven by its efficacy and the growing awareness of eosinophilic conditions[1].

Growth Drivers

Several factors contribute to the growth of the benralizumab market:

Increasing Awareness and Prevalence

The rise in awareness about eosinophilic conditions, such as severe asthma and hypereosinophilic syndrome, is a significant growth driver. Approximately 315 million individuals worldwide suffer from asthma, with up to 10% having severe, uncontrolled asthma[4].

Government Initiatives and Investments

Government initiatives and increased investments by major pharmaceutical companies are boosting the market. These investments are focused on research and development, leading to a rich product pipeline and improved healthcare infrastructure[1].

Technological Advancements

Technological advancements, particularly in developing countries, are enhancing the accessibility and affordability of biologic treatments like benralizumab. This is evident in the Asia Pacific region, where the market is expected to expand at a significant CAGR[1].

Financial Performance

The financial performance of benralizumab is robust, driven by its clinical efficacy and market demand.

Cost-Effectiveness

Despite the higher cost of benralizumab compared to traditional treatments, it has been shown to be cost-effective in the long term. Studies indicate that benralizumab reduces the annual asthma exacerbation rate and decreases the use of oral and inhaled corticosteroids, leading to overall cost savings[5].

Revenue Growth

Benralizumab's approval and subsequent launches in various markets have contributed significantly to the revenue growth of its manufacturer, AstraZeneca. The drug's inclusion in AstraZeneca's respiratory biologics portfolio has been a key factor in the company's pipeline-driven transformation[4].

Challenges

While benralizumab has a strong market position, several challenges need to be addressed:

High Treatment Costs

The high cost of benralizumab is a significant barrier, especially in developing regions where healthcare infrastructure is poor. This limits the drug's accessibility to a broader patient population[1].

Biosimilar Competition

The looming threat of biosimilars could impact the market share of benralizumab. As biosimilars become more competitive, pharmaceutical companies will need to innovate and adapt their business models to maintain market share[3].

Regulatory and Market Access Issues

Regulatory hurdles and market access challenges in different regions can slow down the adoption of benralizumab. For instance, the drug is still under regulatory review in several countries, which can delay its market entry[4].

Future Outlook

The future outlook for benralizumab is promising, driven by several factors:

Expanding Indications

Research is ongoing to explore the use of benralizumab in other eosinophilic conditions, which could expand its market potential. The drug's efficacy in reducing eosinophil counts makes it a candidate for treating various diseases characterized by eosinophilia[1].

Emerging Markets

The growth potential in emerging markets, such as China and India, is significant. As these markets develop and healthcare expenditure increases, the demand for biologic treatments like benralizumab is expected to rise[3].

Innovation and Follow-On Products

To mitigate the impact of biosimilars, pharmaceutical companies are focusing on follow-on innovations. For example, AstraZeneca's continuous investment in its biologics pipeline ensures that new products and formulations can maintain market competitiveness[3].

Key Players

Major players in the global hypereosinophilic syndrome market, including those involved with benralizumab, are:

  • GlaxoSmithKline plc
  • Bristol-Myers Squibb Company
  • Kyowa Hakko Kirin Co., Ltd.
  • Knopp Biosciences LLC
  • Stemline Therapeutics, Inc.
  • F. Hoffmann-La Roche Ltd
  • Novartis AG
  • AstraZeneca[1]

Clinical Efficacy and Patient Outcomes

Benralizumab has demonstrated significant clinical efficacy in treating severe asthma and other eosinophilic conditions.

Reduction in Asthma Exacerbations

Clinical trials, such as the SIROCCO and CALIMA studies, have shown that benralizumab can reduce the annual asthma exacerbation rate by up to 51% compared to placebo. This improvement is seen as early as 4 weeks after the first dose[4].

Improvement in Lung Function

The drug also improves lung function, as measured by forced expiratory volume in one second (FEV1), by up to 159 mL versus placebo. These improvements contribute to better patient outcomes and quality of life[4].

Regulatory Approvals and Expansion

Benralizumab has received regulatory approvals in several regions, including the US and Europe. It is also under review in other countries, which will further expand its market reach.

"The FDA approval is based on results from the WINDWARD programme, including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and the Phase III oral corticosteroid (OCS)-sparing trial, ZONDA."[4]

Conclusion

Benralizumab is a pivotal biologic drug in the treatment of severe asthma and other eosinophilic conditions. Its market dominance, driven by clinical efficacy and growing awareness, is expected to continue. However, challenges such as high treatment costs and biosimilar competition must be addressed. The future outlook is promising, with potential expansions into emerging markets and ongoing innovations to maintain market competitiveness.

Key Takeaways

  • Market Dominance: Benralizumab holds a prominent market share in the hypereosinophilic syndrome market.
  • Growth Drivers: Increasing awareness, government initiatives, and technological advancements drive the market.
  • Financial Performance: Benralizumab is cost-effective despite higher costs, contributing to revenue growth for AstraZeneca.
  • Challenges: High treatment costs, biosimilar competition, and regulatory hurdles are significant challenges.
  • Future Outlook: Expanding indications, emerging markets, and follow-on innovations are key to future growth.

FAQs

What is benralizumab used for?

Benralizumab is used for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

How effective is benralizumab in reducing asthma exacerbations?

Benralizumab can reduce the annual asthma exacerbation rate by up to 51% compared to placebo, as shown in clinical trials like SIROCCO and CALIMA.

What are the main challenges facing the benralizumab market?

The main challenges include high treatment costs, biosimilar competition, and regulatory and market access issues in different regions.

Which companies are major players in the benralizumab market?

Major players include GlaxoSmithKline plc, Bristol-Myers Squibb Company, Kyowa Hakko Kirin Co., Ltd., and AstraZeneca, among others.

Is benralizumab cost-effective despite its high price?

Yes, benralizumab has been shown to be cost-effective in the long term by reducing the use of oral and inhaled corticosteroids and decreasing the number of asthma exacerbations.

Sources

  1. Hypereosinophilic Syndrome Market: The Benralizumab Segment Held a Prominent Market Share During the Forecast Period. Biospace, 2022.
  2. Q1 2017 Results | AstraZeneca. AstraZeneca, 2017.
  3. The Rise of Biologics: Emerging Trends and Opportunities. CAS.org, 2021.
  4. Fasenra (benralizumab) receives US FDA approval for severe, uncontrolled eosinophilic asthma. AstraZeneca, 2017.
  5. Real-life cost-effectiveness of benralizumab in patients with severe asthma. PubMed, 2021.

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