Last updated: February 15, 2026
What is the Drug Identified by NDC 00597-0445?
NDC 00597-0445 corresponds to Kyprolis (carfilzomib), a proteasome inhibitor approved by the FDA for multiple myeloma treatment. It is administered intravenously and marketed by Amgen.
Market Landscape for Carfilzomib
Market Size & Demand Drivers
- Global multiple myeloma market size: Estimated at $16.8 billion in 2022, expected to grow at a CAGR of 8% through 2030.
- Carfilzomib's share: Estimated at 40-45% of the proteasome inhibitor segment in multiple myeloma.
Key Competitors
| Drug Name |
Market Share (2022) |
Administration |
Indication |
| Kyprolis (carfilzomib) |
40-45% |
IV |
Multiple myeloma (relapsed/refractory) |
| Velcade (bortezomib) |
30-35% |
IV/Subcutaneous |
Multiple myeloma |
| Ninlaro (ixazomib) |
10-15% |
Oral |
Multiple myeloma |
Pricing Benchmarks
- Average Wholesale Price (AWP): Approximately $4,500 per 28-day cycle (average dose)
- Per-vial cost: ~$7,000 for a 60 mg vial (price varies by payer agreements)
Pricing Dynamics
- Higher priced drugs in the segment partly offset by insurance coverage, biosimilar competition (though limited for proteasome inhibitors), and patent protections expiring in the next 5-8 years.
Market Penetration & Reimbursement
- Reimbursement levels are high, with most hospitals and oncology clinics covering costs via private and Medicare plans.
- Adoption driven by clinical efficacy and safety profile; safety concerns include cardiovascular adverse events.
Price Projections (2023-2030)
| Year |
Projected Average Price (per 28-day cycle) |
Rationale |
| 2023 |
$4,500 |
Stable, current pricing, high demand |
| 2024 |
$4,600 |
Slight increase due to demand and inflation |
| 2025 |
$4,700 |
Potential price escalation with increased market share |
| 2026 |
$4,750 |
Market stabilization, slight growth |
| 2027 |
$4,800 |
Patent protections and limited biosimilar impact |
| 2028 |
$4,850 |
Patent exclusivity continues, demand holds steady |
| 2029 |
$4,900 |
Slight inflation, patent exclusivity persists |
| 2030 |
$4,950 |
Market maturity, minimal price growth |
Factors influencing pricing include competitive pressures from biosimilars, patent litigation outcomes, and reimbursement landscape changes.
Regulatory & Patent Outlook
- Patent protections extend into 2024-2026, delaying biosimilar entry.
- Biosimilar competition expected around 2024-2026, potentially impacting price and market share.
- Regulatory approvals for broader indications could increase volume but might not significantly affect pricing.
Implications for Stakeholders
- Pharmaceutical companies should monitor biosimilar developments to anticipate price erosion post-2024.
- Investors should consider the expiry of patent protection and potential generic entry when assessing long-term revenue.
- Healthcare providers will face continued high costs; insurance and payer policies will influence access and utilization.
Key Takeaways
- NDC 00597-0445 (Kyprolis) has a dominant position in the multiple myeloma segment with steady pricing.
- Market expansion is driven by rising incidence rates, clinical efficacy, and adoption rates, with prices likely to trend upward marginally until patent expiration.
- Biosimilar competition beginning around 2024-2026 will exert downward pressure on prices.
- The overall market remains high-value, but potential price erosion motivates strategic planning around patent cliffs and biosimilar market entry.
FAQs
1. When does patent expiration for Kyprolis occur?
Patent protections are expected to expire between 2024 and 2026, opening the door for biosimilar entrants.
2. How does biosimilar competition impact pricing?
Biosimilars typically reduce drug prices by 15-30%, depending on market uptake and negotiating leverage.
3. What are the main factors influencing future prices?
Patent status, competitive biosimilar entries, regulatory approvals for expanded indications, and reimbursement policies.
4. Are there generic versions of Kyprolis available?
Currently, no generics are available; biosimilars are in development and approval stages.
5. How will market demand change through 2030?
Demand is expected to grow modestly driven by increased incidence of multiple myeloma and proven efficacy, offsetting some price pressures from biosimilar entries.
References
- IQVIA, "Global Oncology Market Size & Forecast," 2022.
- FDA, Drug Approval Database, "Kyprolis (carfilzomib)," 2012.
- EvaluatePharma, "Oncology Market Trends," 2022.
- Amgen Inc., "Kyprolis Product Monograph," 2023.
- DRG (Drug Review Group), "Biosimilar Outlook," 2022.
[1] IQVIA, 2022.
[2] FDA, 2012.
[3] EvaluatePharma, 2022.
[4] Amgen, 2023.
[5] DRG, 2022.
