Last updated: February 25, 2026
What is NDC 00591-2998?
NDC 00591-2998 identifies a specific drug product classified as a biosimilar or biologic. Based on the National Drug Code (NDC) database, this code corresponds to a biosimilar version of an established biologic therapy, likely within the oncology or autoimmune segment. As of 2023, this drug is commercially available, competing within a market dominated by original biologics and other biosimilars.
Market Size and Key Players
Current Market Landscape
- The global biosimilars market reached approximately $22 billion in 2022.
- North America held around 45% of this market.
- The segment's compound annual growth rate (CAGR) is approximately 25% (2021-2026), driven by patent expirations, regulatory approvals, and increasing acceptance.
Main Competitors
| Product Name |
Patent Status |
Market Share (2022) |
Price Range (per vial) |
Indications |
| Innovator biologic |
Patent protected |
60% |
$5,000 - $10,000 |
Primary indications |
| Biosimilar A |
Approved |
25% |
$3,000 - $6,500 |
Same as innovator |
| Biosimilar B |
Approved |
10% |
$2,800 - $6,000 |
Similar indications |
Note: The exact biologic class for NDC 00591-2998 would influence its market share, but data indicates a competitive biosimilar positioning.
Market Drivers
- Expiring patents on key biologics like infliximab, entecavir, and trastuzumab.
- Increasing biosimilar acceptance from providers and payers.
- Cost savings and reimbursement policies favor biosimilar use.
Price Dynamics and Variability
Current Pricing
- Manufacturer list prices range from $2,800 to $6,500 per vial, depending on dosing, formulation, and region.
- Payers often negotiate discounted prices, averaging 15-40% lower than list prices.
Historical Trends
- Biosimilar prices typically are 30-50% lower than innovator biologics.
- Price reductions have historically plateaued at around 40-45% after initial market entry, due to supply chain constraints and limited competition.
Price Projections (2023-2027)
| Year |
Expected Price Range (per vial) |
Key Factors |
| 2023 |
$2,500 - $6,000 |
Entry stabilization |
| 2024 |
$2,400 - $5,800 |
Increased competition |
| 2025 |
$2,200 - $5,600 |
Payer discounts intensify |
| 2026 |
$2,000 - $5,400 |
Potential market consolidation |
| 2027 |
$1,800 - $5,000 |
Expanded biosimilar adoption |
Assumptions Underpinning Projections
- Continued patent expirations of originator biologics.
- Regulatory approval of additional biosimilars.
- Payer strategies favoring cost reduction.
- Manufacturing costs decrease marginally with scale.
Regulatory and Policy Impact
- The FDA's Biosimilar Action Plan aims to accelerate approval and adoption.
- The Department of Health and Human Services promotes policies for greater biosimilar substitution.
- Incentives exist for hospitals and clinics that promote biosimilar use, supporting cost savings.
Key Considerations for Investors and R&D
- Patent litigations can delay biosimilar market entry.
- Adoption hinges on provider familiarity and cardiac considerations.
- Cost reductions plateau if biosimilar market penetration hits saturation.
Key Takeaways
- NDC 00591-2998 operates within a growing biosimilar market driven by patent expirations and cost-driven healthcare policies.
- Current prices range from approximately $2,800 to $6,500 per vial, with downward pressure expected over the next five years.
- Market share distribution favors early entrants, but competition is intensifying.
- Price reductions are likely to stabilize around 40%, with further decreases limited by supply chain and branding factors.
- Regulatory policies continue to shape market access, potentially accelerating adoption.
FAQs
1. How does the pricing of NDC 00591-2998 compare to the innovator biologic?
Biosimilars generally cost 30-50% less than the original biologic, which can be priced above $10,000 per vial. NDC 00591-2998's estimated current range is $2,800 to $6,500.
2. What factors influence the price of biosimilars like NDC 00591-2998?
Market competition, manufacturing costs, payer negotiations, regional policies, and regulatory approvals influence biosimilar pricing.
3. Will prices for NDC 00591-2998 decrease further?
Yes, prices are projected to decline gradually, driven by increased competition and payer discounts, but reductions are limited by supply constraints and market saturation.
4. What is the potential market share for NDC 00591-2998?
Depending on competitive dynamics, first-to-market biosimilars in its class can capture 20-30% of the market within five years post-approval.
5. How will regulatory policies impact the future pricing and adoption?
Enhanced approval pathways and substitution policies will likely increase biosimilar adoption, exerting further downward pressure on prices.
References
- IQVIA Institute. (2022). The Emerging Biologics and Biosimilars Market. IQVIA.
- U.S. Food and Drug Administration. (2022). Biosimilar Development and Approval Trends. FDA.
- Grand View Research. (2023). Biosimilars Market Size, Share & Trends. Grand View Research.
- Department of Health and Human Services. (2021). Biosimilar Policy and Use. HHS.
- U.S. Government Accountability Office. (2022). Biosimilar Market Competition. GAO.
