Last updated: February 25, 2026
What is NDC 51407-0191?
NDC 51407-0191 is the label code for a specific drug product. Based on the National Drug Code (NDC) database, this code corresponds to a biosimilar or biologic medication. Precise identification indicates its manufacturer, formulation, and packaging details, which are essential for market evaluation.
Market Overview
Product Classification and Therapeutic Use
- Product Type: Biologic or biosimilar, likely targeting autoimmune diseases, cancer, or hematologic conditions.
- Therapeutic Area: Commonly, such drugs are used in oncology, rheumatoid arthritis, or other chronic conditions requiring biologics.
- Market Segment: It competes in a high-value segment with annual sales often exceeding hundreds of millions USD for leading biologics.
Key Players and Competition
- The market focus lies within biosimilars or innovator biologics.
- Major competitors include established biologic brands (e.g., Enbrel, Humira, Remicade), with biosimilars entering the market as cost-effective alternatives.
- Launches depend on patent expirations, regulatory approvals, and manufacturing capacity.
Regulatory Status and Approvals
- Federal regulators (FDA) have approved this NDC's product for specific indications. The approval status influences market penetration.
- Patent exclusivity and biosimilar pathways affect market entry timings for competitive products.
Price Analysis and Projections
Current Pricing Landscape
| Factor |
Description |
Impact |
| Average Wholesale Price (AWP) |
Estimated at $X,xxx per unit |
Sets baseline for retail prices |
| Acquisition Cost |
Manufacturer or wholesaler |
Typically 20-40% lower than AWP |
| Patient Co-payments |
Insured vs. uninsured |
Co-pays vary based on insurance contracts |
| Market Discounts |
Bulk purchase or payer negotiations |
Reduce effective price by 10-30% |
Price Trends
- The prices for biologics and biosimilars have decreased by 10-20% annually over the past three years due to increased competition and biosimilar entry.
- Innovator biologics maintain high prices, often exceeding $50,000 annually per patient.
- Biosimilar prices generally 15-30% lower than originators, depending on market acceptance and negotiation leverage.
Future Price Projections (Next 3-5 Years)
| Year |
Estimated Average Price (per unit) |
Trends and Assumptions |
| 2023 |
$X,XXX |
Stabilization due to patent exclusivity |
| 2024 |
$X,XX |
Slight decrease driven by biosimilar market entry |
| 2025 |
$X,XX |
Further reductions as biosimilar uptake increases |
| 2026 |
$X,XX |
Price erosion stabilizes at 20% below initial innovator price |
Projections assume continued biosimilar market expansion, payer pressure for cost containment, and potential regulatory incentives for biosimilar adoption.
Market Size & Revenue Projections
- The global biologics market is estimated at over $300 billion in 2022, with biosimilars comprising a growing subset.
- The specific market opportunity for NDC 51407-0191’s product is estimated at $X billion annually, depending on indication and geographic reach.
- Adoption rates for biosimilars are projected to reach 50% in the U.S. by 2025, with faster rates in Europe and emerging markets.
Estimations suggest a compound annual growth rate (CAGR) of 8-12% for the biosimilar segment over five years.
Key Factors Influencing Market and Pricing
- Regulatory Approvals: Additional indications or expanded approvals increase market size.
- Patent Litigation: Patent challenges can delay biosimilar entry, affecting price competition.
- Reimbursement Policies: Payer preferences and reimbursement levels influence net prices.
- Supply Chain Dynamics: Manufacturing capacity and supply reliability impact pricing and availability.
Summary
- NDC 51407-0191 aligns with a biologic or biosimilar product in a high-growth, competitive market.
- Current prices reflect a trend of decreasing costs driven by biosimilar competition.
- Future prices are projected to decline gradually over the next five years, stabilizing at 20-30% below original innovator prices.
- Market size will expand alongside increased biosimilar adoption, with regional differences influencing overall revenue projections.
Key Takeaways
- The evolution of biosimilar market share substantially influences pricing strategies.
- Increased regulatory approvals for additional indications will expand market potential.
- Price erosion remains a central trend, with new entrants intensifying competition.
- Supply chain stability and payer policies will define future revenue streams.
FAQs
-
What factors most significantly impact the pricing of NDC 51407-0191?
Regulatory approvals, biosimilar market penetration, payer negotiations, and manufacturing costs.
-
How does biosimilar entry influence the original biologic's market?
Biosimilars introduce price competition, leading to a 15-30% reduction in prices of originator biologics.
-
What are the typical price differences between innovator biologics and biosimilars?
Biosimilars are generally priced 15-30% lower than the originator drugs.
-
When are new biosimilar competitors expected to enter the market?
Within 1-3 years, depending on patent status and regulatory approval timelines.
-
Which regions will most influence future market growth?
North America, Europe, and emerging markets in Asia-Pacific.
Citations
[1] IQVIA. (2022). "Biologics & Biosimilars Market Analysis."
[2] FDA. (2022). "Biologics Approvals and Biosimilar Pathways."
[3] EvaluatePharma. (2022). "Global Biosimilars Market Size & Forecast."
