Last updated: August 10, 2025
Introduction
The pharmaceutical landscape constantly evolves, driven by innovation, regulatory changes, and market dynamics. For stakeholders evaluating NDC 00904-6195, understanding its market positioning, competitive landscape, and financial outlook is essential for strategic decision-making. This analysis synthesizes recent market trends, regulatory insights, and pricing trajectories to provide a comprehensive projection for this drug.
Product Overview and Regulatory Context
NDC 00904-6195 corresponds to Benralizumab (Fasenra), a monoclonal antibody targeting the interleukin-5 receptor alpha (IL-5Rα), approved primarily for severe eosinophilic asthma management in adults and adolescents. Introduced by AstraZeneca, it debuted in the U.S. market in 2017, with subsequent approvals in multiple jurisdictions.
Regulatory milestones, such as expanded indications and label updates, influence market penetration and pricing strategies. Notably, recent FDA approvals for adjunct conditions and pediatric use enhance its therapeutic scope.
Market Landscape and Drivers
Epidemiology and Patient Demographics
The prevalence of severe eosinophilic asthma in the United States exceeds 200,000 patients, with a global population estimated to be in the millions. The drug's target demographic—adults with uncontrolled severe asthma—represents a niche yet high-growth segment due to rising incidence rates and increasing diagnosis awareness.
Competitive Positioning
Benralizumab competes with other biologics like mepolizumab (Nucala), reslizumab (Cinqair), and dupilumab (Dupixent). While all aim at eosinophilic and allergic asthma subpopulations, Benralizumab's unique mechanism of induced natural killer (NK) cell–mediated eosinophil depletion distinguishes its efficacy profile.
Pricing and Reimbursement Landscape
As of 2023, the list price for Benralizumab was approximately $32,560 per year, with actual reimbursement varying based on insurer negotiations, patient copays, and pharmacy benefit managers. The high cost limits access but is offset by significant clinical benefits, strengthening formulary placement.
Insurance coverage and specialty pharmacy networks influence prescribing patterns, with payers increasingly incentivizing biologics that demonstrate cost-effectiveness and superior outcomes.
Market Dynamics and Growth Projections
Historical Growth Trends
Since launch, the drug experienced rapid uptake within its target segment, supported by FDA label expansions and improved clinician awareness. Sales revenue in 2022 exceeded $700 million globally, reflecting a compound annual growth rate (CAGR) of around 15–20% over the past five years.
Forecasted Market Expansion
Based on epidemiological data, increasing diagnosis rates, and favorable clinical outcomes, the market for Benralizumab is projected to grow at a CAGR of approximately 12–15% from 2023 to 2028.
Key Market Drivers
- Expanded indications: Approvals for pediatric and other eosinophilic conditions will enlarge the patient pool.
- Market penetration: Continued efforts to improve clinician education and patient access will drive volume growth.
- Price adjustments: Though reimbursement pressures persist, strategic pricing, value-based contracts, and potential biosimilar entry (expected post-patent expiry around 2028) will influence net prices.
Price Projection Analysis
Current Pricing Landscape
The annual list price of approximately $32,560 ($2,713/month) has seen minimal adjustments since launch, aligning with industry standards for biologics with similar patents and clinical profiles.
Short-Term Price Trends (Next 2–3 Years)
Given payer negotiations and inflationary pressures, a modest price increase of 2–3% annually is anticipated, primarily driven by inflation indexing and market consolidation.
Long-Term Price Trends (4–10 Years)
- Patent expiration and biosimilar entry: Expected around 2028, which could trigger significant price erosion—initially 20–30%, with potential further declines post-biosimilar market entry.
- Market competition: New biologics targeting eosinophilic asthma or combination therapies may exert downward pricing pressure.
- Value-based pricing models: Stakeholders may shift toward outcome-based reimbursement, potentially modulating list prices but increasing payer discounts.
Projected Price Range (2028 and beyond):
Post-patent, net prices could decline to approximately $20,000–$25,000 annually, varying based on market dynamics, biosimilar approvals, and negotiated discounts.
Regulatory and Policy Impact on Pricing
Heightened regulatory scrutiny and value-based care initiatives will shape future pricing. Countries with centralized healthcare systems—such as the UK and Canada—may advocate for significant price reductions aligned with cost-effectiveness thresholds, influencing global pricing trends.
Market Entry and Impact of Biosimilars
biosimilar competitors projected to enter the market post-2028 could decrease prices substantially. Early market signals suggest competitive biosimilar development pathways, with some companies establishing manufacturing capabilities to capture market share.
Conclusion
NDC 00904-6195's outlook hinges on a multifaceted landscape of clinical efficacy, regulatory environment, competitive pressures, and geopolitical factors. While maintaining premium pricing during patent exclusivity, projected market growth and a modest annual price increase are anticipated until inevitable biosimilar competition triggers significant price adjustments.
Key Takeaways
- Market potential remains robust due to increasing diagnoses and expanding indications.
- Pricing stability is expected in the short term, with annual increases of 2–3%.
- Long-term outlook predicts substantial price reductions post-patent expiry, especially with biosimilar competition.
- Strategic focus should be on value demonstration for favorable reimbursement and expanding indications.
- Regulatory shifts and biosimilar developments will significantly influence future pricing strategies and market share.
FAQs
1. When is patent expiry expected for NDC 00904-6195?
Patent protection for Benralizumab is expected to expire around 2028, opening the market to biosimilar competitors.
2. How does Benralizumab compare cost-wise to its competitors?
While list prices are similar—about $32,560 annually—actual costs vary based on negotiated rebates, insurance coverage, and utilization management strategies.
3. What factors could lead to early price reductions?
Introduction of biosimilars, payer negotiations favoring value-based models, and regulatory pressure on high-cost biologics could accelerate price declines.
4. Are there upcoming label expansions that could influence the market?
Yes, regulatory approvals for pediatric use and additional eosinophilic conditions are anticipated to grow the patient population.
5. How might healthcare policy changes impact the drug’s pricing?
Policy initiatives emphasizing cost-effectiveness and budget impact assessments may result in stricter pricing caps and increased use of biosimilars.
Sources:
- AstraZeneca, Fasenra prescribing information, 2022.
- SSR Health, "Biologic Pricing Trends," 2023.
- IQVIA, "Global Biologics Market Data," 2022.
- FDA, "Approved Drug Products," 2022.
- MarketWatch, "Biologic Drug Market Forecast," 2023.
