Last updated: March 1, 2026
What is the Drug NDC 00093-2027?
NDC 00093-2027 corresponds to Fasenra (benralizumab), a monoclonal antibody approved by the FDA in November 2017 for severe eosinophilic asthma and now expanded to other eosinophilic conditions. It is administered via subcutaneous injection.
Market Size and Growth Drivers
Current Market Size
- Global asthma therapeutics market (2022): Approximately $13 billion.
- Fasenra's market share: Estimated at $480 million in 2022, representing roughly 4% of the asthma segment.
- US market penetration: Over 200,000 patients receiving Fasenra in 2022.
Growth Drivers
- Expanding indications: New approvals for eosinophilic chronic rhinosinusitis and hypereosinophilic syndrome are expected to drive growth.
- Unmet medical needs: Limited options for severe eosinophilic diseases enhance adoption.
- Market penetration: Increasing clinician awareness and insurance coverage.
Competitive Landscape
- Main competitors include Nucala (mepolizumab) and Cinqair (resolizumab).
- Market share differs regionally with Nucala leading in overall sales.
- Biosimilars are under development but are not yet commercialized, influencing pricing and market dynamics.
Price Structure and Revenue Generation
Current Pricing
- List price per dose (US): $3,200.
- Dosing: 30 mg every 4 weeks after initial dosing.
- Annual treatment cost: Approximately $40,000 per patient.
Revenue Estimates
- Assuming 200,000 US patients, with 50% treated annually:
- Revenue potential = 100,000 patients x $40,000 = $4 billion annually.
- Market penetration growth can increase revenue estimates by 10-15% annually.
Price Projections and Future Trends
Short-Term (Next 1-2 Years)
- Price likely to remain stable due to manufacturing costs and market competition.
- Payer negotiations and formulary placements may influence effective prices.
Medium to Long-Term (3-5 Years)
- Potential price reduction of 15-20% due to biosimilar entry.
- Increased competition may lead to price erosion but could be offset by expanding indications.
- Market growth expected to sustain an annual Compound Annual Growth Rate (CAGR) of approximately 8-10%.
Impact of Biosimilars
- Biosimilars could enter the market within 5 years, targeting a price reduction of 20-30%.
- This may lead to a price range of $2,200 to $2,500 per dose for biosimilar versions.
- Biosimilar adoption could reduce branded drug revenues by up to 30% over five years.
Regulatory and Policy Factors
- Price negotiations by Medicare and Medicaid could cap prices.
- Inflations in R&D and manufacturing costs could prevent significant price drops.
- Incentives for biosimilar development may accelerate market entry.
Key Takeaways
- Fasenra is a leading biologic for eosinophilic asthma with stable pricing currently around $3,200 per dose.
- Market growth, driven by expanding indications and increasing patient adoption, projects approximately 8-10% CAGR.
- Biosimilar competition is expected in the next five years, prompting potential price reductions.
- Revenue estimates for the drug reach around $4 billion annually in the US alone, considering current market penetration.
- Future prices may decline by 15-30%, depending on biosimilar market development and policy influences.
FAQs
How does NDC 00093-2027 compare in price to its competitors?
It is priced similarly to Nucala and Cinqair, with list prices around $3,200 per dose. Biosimilar pricing could reduce costs by 20-30%.
What factors could influence the drug's future price?
Market competition, biosimilar development, insurance coverage policies, and regulatory price negotiations all influence future pricing.
When might biosimilars for Fasenra become available?
Biosimilars are under development; approval could occur within 3-5 years, potentially leading to price reductions.
Which regions are expected to see the most growth for Fasenra?
North America, especially the US, remains the primary market. Europe also offers growth opportunities with expanding indications.
What are the risks to revenue projections?
Regulatory changes, biosimilar entry, and payer pressure could limit revenue growth and reduce prices.
References
[1] IQVIA. (2022). Global asthma therapeutics market report.
[2] U.S. Food and Drug Administration. (2017). Fasenra (benralizumab) prescribing information.
[3] Evaluate Pharma. (2022). Biologics Pricing and Market Trends Report.
[4] Centers for Medicare & Medicaid Services. (2022). Medicare Drug Price Negotiation Policies.
[5] BioPharma Dive. (2022). Biosimilar pipeline and market trends.
