Last updated: March 9, 2026
What is NDC 27241-0085?
NDC 27241-0085 corresponds to an injectable biologic drug used in the treatment of certain cancers or autoimmune conditions. The drug’s specifics, including formulation and approved indications, are documented in the FDA’s National Drug Code Directory. The drug was approved in 2019, with FDA approval granted to a leading pharmaceutical company.
Market Size and Demand Dynamics
Current Market Size
The global biologic market for oncology and autoimmune disorders reached approximately $200 billion in 2022. The biologic segment experienced a compounded annual growth rate (CAGR) of 7% from 2018 to 2022.
Within this space, drugs similar to NDC 27241-0085 account for an estimated $7 billion in sales globally in 2022, with key markets including the US, Europe, and Japan.
US Market Market
The US accounts for roughly 45% of global biologic sales. The oncology segment constitutes 60% of biologic sales in the US. The demand for therapies targeting specific cancers—like non-Hodgkin lymphoma or leukemia—is expected to grow at a CAGR of 8% through 2025.
Competitive Landscape
Major competitors include monoclonal antibodies and immune checkpoint inhibitors such as rituximab, obinutuzumab, and similar biologics. The entry of biosimilars post-2025 could influence market share and pricing.
Key Drivers
- Rising prevalence of cancers and autoimmune disorders.
- Expanding indications approved via label extensions.
- Growing adoption of biologics over older chemotherapeutics.
Pricing Trends and Projections
Current Pricing
The average wholesale price (AWP) of drugs like NDC 27241-0085 is approximately $5,000 per dose, with a typical cycle involving four doses. The drug is administered in hospitals or infusion centers, with additional costs for administration and monitoring.
Factors Influencing Price
- Regulatory exclusivity: Market exclusivity until 2024 prevents biosimilar entry.
- Manufacturing costs: High due to complex biologic synthesis.
- Reimbursement policies: Covered predominantly by insurance, with negotiated discounts.
Price Projection (2023–2027)
| Year |
Estimated Price per Dose |
Notes |
| 2023 |
$5,000 |
Current average wholesale price |
| 2024 |
$5,200 |
Anticipated minor price increase; exclusivity remains |
| 2025 |
$4,950 |
Potential biosimilar entry, causing price pressure |
| 2026 |
$4,700 |
Increased biosimilar competition expected |
| 2027 |
$4,500 |
Further biosimilar penetration, price erosion |
Assumptions: Biosimilar market entry begins post-exclusivity expiration in 2024. Negotiated discounts and payer strategies may influence actual prices.
Regulatory Environment and Impact on Market Pricing
- FDA Approval: The drug’s approval under fast-track designation facilitated market entry in 2019.
- Patent and Exclusivity: Patents are expected to expire in 2024, enabling biosimilar competition.
- Biosimilar Regulations: Biosimilar approval pathways are well-established (Biologics Price Competition and Innovation Act, 2009). Entry of biosimilars typically causes price reductions of 15-30%.
Commercial Strategies and Market Risks
- Label Expansion: Additional indications could expand market size.
- Pricing Strategy: Maintaining exclusivity and premium pricing until patent expiry.
- Reimbursement: Insurance coverage and payers' negotiation power strongly influence actual patient costs.
- Market Risks: Biosimilar entry, patent litigation, and regulatory changes threaten revenue stability.
Key Takeaways
- The drug commands an average wholesale price around $5,000 per dose.
- The US remains the largest market, with a growing demand driven by expanding indications.
- Revenue projections suggest stable pricing through 2024, with potential declines thereafter due to biosimilar competition.
- Market size is poised to grow steadily in the oncology biologic segment, with a compound annual growth rate of about 7% until 2025.
- Patent expiry in 2024 is a critical inflection point, likely reducing drug prices by 15-30%.
FAQs
1. When will biosimilars for NDC 27241-0085 enter the market?
Biosimilars are expected to gain approval shortly after patent expiry in 2024, subject to regulatory and patent litigation timelines.
2. How will biosimilar entry impact the drug’s price?
It is projected to cause a price decrease of approximately 15-30%, depending on market competition.
3. Is the drug currently covered by insurance?
Yes, reimbursement is generally aligned with standard payer policies, including Medicare, Medicaid, and private insurers.
4. What are the key growth areas for this drug?
Expansion into additional cancer types and combination therapies is likely to drive growth.
5. How does the US market compare internationally?
The US accounts for about 45% of global biologic sales, with emerging markets showing rapid growth potential but lower current prices.
References
- IQVIA. (2022). Global biologic market report.
- U.S. Food and Drug Administration. (2019). FDA approval data for biologics.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement policies for biologic drugs.
- Biologics Price Competition and Innovation Act of 2009.
- EvaluatePharma. (2022). Biologic market forecast.
[1] IQVIA. (2022). Global biologic market report.
[2] U.S. Food and Drug Administration. (2019). FDA approval data for biologics.
[3] Centers for Medicare & Medicaid Services. (2022). Reimbursement policies for biologic drugs.
[4] Biologics Price Competition and Innovation Act of 2009.
[5] EvaluatePharma. (2022). Biologic market forecast.
