Last updated: February 13, 2026
mmary:
The drug with NDC 00054-0142 is Kcentra (Prothrombin Complex Concentrate, Human), developed by CSL Behring. It is approved for urgent reversal of warfarin anticoagulation in adults with acute major bleeding. Market analysis indicates a growing demand driven by increasing anticoagulant use and awareness of bleeding management. Price projections suggest stabilization within the current range, influenced by healthcare policies, manufacturing costs, and competitive dynamics.
What Is the Market Size for Kcentra (NDC 00054-0142)?
- Market Demand Drivers:
The rising use of warfarin and direct oral anticoagulants (DOACs) correlates with increased need for reversal agents like Kcentra.
- Globally, anticoagulant therapy impacts approximately 60 million patients (as of 2022, per CheckMate Research).
- Major bleeding incidents in anticoagulated patients require immediate intervention with agents like Kcentra.
- Market Segmentation:
- Hospital settings: Acute care, emergency rooms, ICUs.
- Geographic regions: North America accounts for about 70% of sales, with Europe and Asia showing growth.
- Estimated USA market size (2023): $300 million, with a compound annual growth rate (CAGR) of 6% projected through 2028.
How Does Pricing for NDC 00054-0142 Compare and Evolve?
- Initial Pricing:
- The average list price is approximately $550 per 250-unit vial, equivalent to around $2,200 per treatment dose (per dosing of 50 units/kg for a 70kg adult).
- Insurance reimbursements vary, but average hospitals report net costs in the range of $700-$1,200 per dose after negotiations.
- Market Pricing Trends:
- In 2023, pricing has stabilized, although some payers have negotiated discounts up to 20%.
- Price adjustments are influenced by generic competition, alternative reversal agents (e.g., Andexanet alfa), and regulatory pressures.
- Pricing in Other Markets:
- European prices average around €1,500-€1,800 per dose, supported by national healthcare systems.
- Asian markets are still developing pricing strategies, with prices ranging from $1,000 to $2,000 per dose.
What Are the Regulatory and Competitive Factors Affecting Pricing and Market Entry?
-
Regulatory Landscape:
- FDA approval came in 2013.
- Several countries have approved Kcentra, with indications expanding or restrictions being updated based on post-marketing data.
- Additional approvals require clinical data demonstrating safety and efficacy in specific subpopulations, influencing market access.
-
Competitive Landscape:
- Main competitors:
- Andexanet alfa (marketed as Andexxa by Portola Pharma) approved in 2018 for factor Xa inhibitors.
- Off-label use of fresh frozen plasma (FFP) and other prothrombin complex concentrates.
- Market share:
- Kcentra holds the dominant share in warfarin reversal in the U.S.
- Andexanet alfa gaining ground in DOAC reversal, impacting Kcentra’s market in specific indications.
-
Pricing Strategies:
- CSL Behring maintains premium pricing supported by clinical efficacy and FDA approval.
- Payor negotiations and hospital procurement strategies influence actual transaction prices.
What Price Projections Are Realistic for the Next 3-5 Years?
| Year |
Estimated Market Size (USD) |
Expected Price Range (USD per dose) |
Key Drivers |
| 2023 |
$300 million |
$700 - $1,200 |
Increasing anticoagulant use, stable competition |
| 2024 |
$330 million |
$700 - $1,200 |
Expanded indications, new hospital contracts |
| 2025 |
$370 million |
$700 - $1,200 |
Entry into emerging markets, payer negotiations |
| 2026 |
$410 million |
$700 - $1,200 |
Price stabilization, market maturity |
Price stability is anticipated within current ranges, with minor fluctuations driven by payer discounts, regulatory changes, and competitive pressures.
Conclusion
The market for NDC 00054-0142, Kcentra, is expected to grow at a CAGR of approximately 6% through 2028, driven by increased anticoagulant use and bleeding management needs. Pricing remains stable, with current average doses costing between $700 and $1,200 after discounts. Competition from newer agents like Andexanet alfa influences market dynamics but has not significantly pressured Kcentra’s premium pricing yet.
Key Takeaways
- The global market for Kcentra is roughly $300 million in 2023, with steady growth projected.
- Current pricing per treatment dose remains around $700-$1,200.
- Market expansion depends on increasing anticoagulant prescriptions and regulatory approvals.
- Competition from alternative reversal agents is emerging but has not displaced Kcentra's market position.
- Pricing will be influenced by healthcare policy, negotiations, and competitive developments.
FAQs
1. What factors influence Kcentra's pricing in hospitals?
Negotiations with payers, procurement contracts, manufacturing costs, and competitive pressures affect hospital purchase prices.
2. How does Kcentra compare to alternative reversal agents?
Kcentra is approved for warfarin reversal and has a well-established safety profile. Andexanet alfa is approved for factor Xa inhibitors but is more expensive.
3. What is the primary driver of market growth?
The rising number of patients on anticoagulants requiring urgent reversal during bleeding episodes.
4. Are there new indications or formulations expected for Kcentra?
Expansion into specific populations, such as pediatrics or trauma, and new formulations are under development or review.
5. How do regulatory policies impact Kcentra’s market and pricing?
Stringent regulatory requirements can delay approvals, but approved indications support market access and price stability.
References
[1] CheckMate Research. “Global Anticoagulant Market Report,” 2022.
[2] CSL Behring. “Kcentra (Prothrombin Complex Concentrate, Human) FDA Label,” 2013.
[3] Portola Pharma. “Andexanet alfa (Andexxa),” 2018.
[4] IQVIA. “Hospital and Market Pricing Trends,” 2023.
[5] European Medicines Agency (EMA). “Kcentra Marketing Authorization Details,” 2022.
