Raxibacumab - Biologic Drug Details

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Summary for raxibacumab

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

Recent Clinical Trials for raxibacumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Emergent BioSolutions	Phase 4
GlaxoSmithKline	Phase 4
Human Genome Sciences Inc., a GSK Company	Phase 3

See all raxibacumab clinical trials

Pharmacology for raxibacumab

Mechanism of Action	Anthrax Protective Antigen-directed Antibody Interactions
Established Pharmacologic Class	Anthrax Protective Antigen-directed 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:

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.

General 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.

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 raxibacumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Raxibacumab

Introduction

Raxibacumab, a monoclonal antibody, has been a significant player in the treatment and prophylaxis of inhalational anthrax caused by Bacillus anthracis. Approved by the FDA in 2012, this biologic drug has undergone substantial development and has shown promising market growth. Here, we delve into the market dynamics and financial trajectory of raxibacumab.

Approval and Regulatory Framework

Raxibacumab was the first monoclonal antibody product developed under Project BioShield to achieve FDA approval, and it was approved through the FDA's Animal Rule due to the ethical and practical challenges of conducting human efficacy trials for anthrax treatments[2][5].

Market Size and Forecast

The global raxibacumab market is anticipated to experience robust growth. From 2023 to 2031, the market is projected to expand significantly, driven by the growing threat of bioterrorism and the need for effective anthrax treatments. The market size is expected to grow from USD 101.5 million in 2024 to USD 257.11 million by 2031, with a Compound Annual Growth Rate (CAGR) of 14.20%[4].

Segmentation and Market Outlook

The raxibacumab market is segmented based on application, product type, and geographical regions. Key segments include:

Application: Hospitals, drug stores, and other healthcare facilities.
Product Type: Treatment of inhalational anthrax and prevention of inhalational anthrax.
Geographical Regions: North America, Europe, Asia-Pacific, South America, and the Middle East & Africa[1][4].

Growth Drivers

Several factors are driving the growth of the raxibacumab market:

Bioterrorism Threat: The increasing threat of bioterrorism has heightened the need for effective treatments against anthrax, a potential bioterrorism agent.
Efficacy and Safety: Raxibacumab has demonstrated significant efficacy in treating and preventing inhalational anthrax, especially when used in combination with antibacterial drugs[2][5].
Regulatory Support: The FDA's approval under the Animal Rule has paved the way for raxibacumab's market entry and expansion.

Challenges and Restraints

Despite the positive outlook, the market faces several challenges:

Clinical Evidence: The lack of clinical evidence for efficacy in humans, due to the ethical and practical limitations of conducting human trials, necessitates significant post-marketing commitments to collect data[2].
Regulatory Hurdles: The developmental process for raxibacumab involved numerous studies and regulatory evaluations, adding time and cost to the approval process[2].

Competitive Scenario

The market for raxibacumab is dominated by key players such as GlaxoSmithKline (GSK), which acquired Human Genome Sciences (HGS) in 2012 and assumed the product license and post-marketing commitments for raxibacumab[1][2].

Financial Performance

The financial trajectory of raxibacumab is marked by significant growth projections. Here are some key financial highlights:

Market Size: Expected to reach USD 257.11 million by 2031 from USD 101.5 million in 2024.
CAGR: 14.20% from 2024 to 2031.
Revenue Streams: Primarily driven by sales in hospitals and drug stores, with a growing presence in other healthcare facilities[4].

Regional Analysis

The global market for raxibacumab is geographically diverse, with different regions contributing to its growth:

North America: A leading region due to advanced healthcare infrastructure and high awareness of bioterrorism threats.
Europe and Asia-Pacific: These regions are also expected to contribute significantly to the market growth, driven by increasing healthcare spending and the need for advanced biologic treatments[1][4].

Porter's 5 Forces Analysis

To understand the competitive landscape, a Porter's 5 Forces analysis is crucial:

Threat of New Entrants: High barriers to entry due to regulatory and technological complexities.
Bargaining Power of Suppliers: Moderate, as the supply chain is relatively stable but dependent on a few key players.
Bargaining Power of Buyers: Low to moderate, as buyers are largely dependent on the limited number of effective anthrax treatments available.
Threat of Substitute Products: Low, given the specificity and efficacy of raxibacumab in treating inhalational anthrax.
Competitive Rivalry Among Existing Competitors: Moderate, with GSK being the dominant player but potential for other biologic treatments to emerge[1].

Pharmacology and Mechanism of Action

Raxibacumab is a human IgG1λ monoclonal antibody that binds to the protective antigen (PA) component of B. anthracis toxin, thereby neutralizing its toxic effects. It is produced by recombinant DNA technology in a murine cell expression system[5].

Clinical Studies and Efficacy

Clinical and preclinical studies have demonstrated the efficacy of raxibacumab in treating and preventing inhalational anthrax. Studies in animals, such as rabbits and nonhuman primates, have shown significant survival rates when treated with raxibacumab in combination with antibiotics[2].

Adverse Effects and Safety Profile

Raxibacumab has been shown to be safe at the approved dose of 40 mg/kg. Common adverse reactions include rash, pain in extremity, pruritus, and somnolence. The drug does not cross the blood-brain barrier, and its pharmacokinetic parameters indicate a half-life of 15-19 days for both intramuscular and intravenous doses[5].

Conclusion

The market for raxibacumab is poised for significant growth, driven by its efficacy in treating and preventing inhalational anthrax, the growing threat of bioterrorism, and regulatory support. Despite challenges such as the need for post-marketing data collection, the financial trajectory of raxibacumab indicates a robust expansion in the coming years.

Key Takeaways

Market Growth: Expected to grow from USD 101.5 million in 2024 to USD 257.11 million by 2031.
CAGR: 14.20% from 2024 to 2031.
Dominant Region: North America, with significant contributions from Europe and Asia-Pacific.
Key Player: GlaxoSmithKline (GSK).
Efficacy: Proven efficacy in treating and preventing inhalational anthrax in combination with antibiotics.
Regulatory Framework: Approved under the FDA's Animal Rule.

FAQs

Q: What is raxibacumab used for? A: Raxibacumab is used for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis and for prophylaxis of inhalational anthrax when alternative therapies are not available or not appropriate[2][5].

Q: Who is the primary manufacturer of raxibacumab? A: GlaxoSmithKline (GSK) is the primary manufacturer, having acquired Human Genome Sciences (HGS) in 2012[1][2].

Q: What is the expected CAGR of the raxibacumab market from 2024 to 2031? A: The expected CAGR is 14.20%[4].

Q: What are the common adverse reactions associated with raxibacumab? A: Common adverse reactions include rash, pain in extremity, pruritus, and somnolence[5].

Q: How does raxibacumab work? A: Raxibacumab is a monoclonal antibody that binds to the protective antigen (PA) component of B. anthracis toxin, neutralizing its toxic effects[5].

Sources

Market Research Intellect: Global raxibacumab market size and forecast.
Frontiers in Microbiology: Approval of Raxibacumab for the Treatment of Inhalation Anthrax.
NIH: Generic Preclinical Development Plan for Human Monoclonal Antibody Products.
Cognitive Market Research: Raxibacumab Market Report 2024 (Global Edition).
DrugBank: Raxibacumab: Uses, Interactions, Mechanism of Action.

Last updated: 2024-12-16

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