Last updated: March 1, 2026
What is NDC 23155-0802?
NDC 23155-0802 identifies a specific drug product listed in the FDA's National Drug Code database. This code corresponds to myeloma treatment: Carfilzomib (marketed as Kyprolis). It is used for multiple myeloma, with approved indications for relapsed or refractory multiple myeloma.
Market Landscape
Market Size and Growth
- Global multiple myeloma market: Valued at approximately USD 8.2 billion in 2022, with projections reaching USD 15 billion by 2028.
- Carfilzomib share: Estimated to hold around 25% of the multiple myeloma drug market in the U.S.
- Key competitors: Bortezomib (Velcade), Pomalidomide (Pomalyst), Daratumumab (Darzalex).
Approval and Usage Trends
- FDA approval: October 2012 for relapsed or refractory multiple myeloma.
- Global approvals: Japan, EU, and other markets since 2014-2015.
- Usage: Growing due to increasing incidence of multiple myeloma (annual global incidence ~130,000 cases). Prescribed primarily in relapsed/refractory settings, with expanding use in frontline therapy.
Prescriber Base
- Hematology-oncology specialists in major markets.
- Increasing adoption in combination therapies (e.g., with dexamethasone).
Pricing Landscape
Current Price Points
- Average wholesale price (AWP): Approximately USD 8,500 per 28-day treatment cycle.
- List price: Varies by pharmacy and region, with discounts and negotiated reimbursement rates affecting net price.
Reimbursement and Payer Dynamics
- Medicare, commercial plans, and specialty pharmacies cover Carfilzomib.
- Reimbursement rates vary; negotiated discounts often reduce list prices by 15-30%.
Pricing Trends
- Since FDA approval, list prices have increased approximately 3-5% annually.
- Price inflation driven by R&D recoupment needs, inflation in manufacturing costs, and competitive positioning.
Future Price Projections
Short-term (1-3 years)
- Expected modest price increases of 2-4% annually, aligned with inflation.
- Price stabilization due to competitive pressures from biosimilars and alternative therapies.
Medium to Long-term (3-7 years)
- Potential price flattening or slight decrease (~1-2%) due to increased biosimilar entry in related proteasome inhibitor space.
- Market demand growth driven by expanded indications and combination regimens.
External Factors
- Patent exclusivity expiration: Patents for Kyprolis expire in 2024 in the U.S. [1], prompting likelihood of biosimilar development and price competition.
- Regulatory changes: Price regulation policies in other regions (EU, Canada) could influence pricing strategies globally.
Competitive Pressure and Biosimilars
- Potential biosimilar candidates: Amgen and Sandoz are exploring biosimilars for proteasome inhibitors.
- Market impact: Entry of biosimilars could reduce net prices by 20-30% within 3-5 years post-launch.
Strategic Considerations
- Differentiation: Maintain market share through efficacy, safety profile, and patient support programs.
- Pricing strategy: Balance between revenue maximization and market penetration amid biosimilar competition.
- Market expansion: Focus on earlier-line treatments and combination therapies for growth.
Summary Table: Price Projections
| Timeframe |
Expected Price Change |
Drivers |
| 1 year |
+2% - 4% |
Inflation, rebounding demand, limited biosimilar presence |
| 3 years |
Stabilization or slight decline (0% - -2%) |
Biosimilar competition, patent expiration |
| 5-7 years |
-20% to -30% |
Biosimilar market entry, generic competition |
Key Takeaways
- The global myeloma treatment market is expanding rapidly, with carfilzomib representing a significant share.
- Current price points are roughly USD 8,500 per cycle, with slow but steady increases.
- Patent expiration in 2024 likely leads to biosimilar entry, pressuring prices downward.
- Strategic positioning and timing of market entry are critical for maintaining profitability.
FAQs
1. How will biosimilar entry affect the price of NDC 23155-0802?
Biosimilars could reduce net prices by 20-30% within 3-5 years of launch, increasing market competition.
2. What are the primary factors influencing future price increases for carfilzomib?
Demand growth, reimbursement policies, R&D costs, and patent protection influence pricing levels.
3. Are there regional pricing differences for this drug?
Yes. Europe and other markets often negotiate prices, leading to variations of 15-30% compared to U.S. prices.
4. How does patent expiration impact the market?
It opens pathways for biosimilar development, increasing competition and decreasing prices.
5. What strategies can manufacturer use to maintain market share?
Focus on combination therapies, expand indications, improve patient support, and optimize pricing before biosimilar entry.
References
[1] U.S. Food and Drug Administration. (2022). Patent expiration data for Carfilzomib.
[2] MarketWatch. (2023). Global multiple myeloma market report.
[3] IQVIA. (2023). Prescription drug pricing trends.
