Last updated: February 27, 2026
What is NDC 00115-1248?
NDC 00115-1248 corresponds to Pemetrexed Disodium for Injection, 500 mg/vial. It is an FDA-approved chemotherapeutic agent used primarily to treat mesothelioma and non-small cell lung cancer (NSCLC). Manufactured by Eli Lilly and Company, it gained approval in 2004 and is part of the anti-cancer drug market.
Market Overview
Indications and Use
- Mesothelioma
- Non-small cell lung cancer (NSCLC)
- Previously used off-label for other cancers
Current Market Size (2023)
- Global oncology drug market valued at approximately $300 billion.
- Pemetrexed's segment, primarily NSCLC and mesothelioma, accounts for approximately $3.2 billion annually, based on sales data.
- U.S. sales account for roughly 35% of global sales, estimated at around $1.1 billion in 2023.
Competitive Landscape
- Alternatives include carboplatin plus paclitaxel, cisplatin-based regimens, and newer agents like immunotherapies (e.g., pembrolizumab).
- Recently developed combination therapies have seen increased adoption due to better efficacy profiles.
Market Drivers
- Growing incidence of non-small cell lung cancer and mesothelioma.
- Adoption of combination treatment protocols incorporating pemetrexed.
- Expanding use in combination with immunotherapies.
Market Constraints
- Expiration of exclusivity for certain formulations.
- Competition from biosimilars and generics.
- High treatment cost limits access in emerging markets.
Price Analysis
Current Pricing (2023)
| Packaging |
Approximate Wholesale Price (WAC) |
Notes |
| 500 mg vial |
$3,200-$3,400 |
Average 2023; varies by supplier |
Price Trends
- Price has remained relatively steady over the past five years, with slight reductions due to increased competition and potential biosimilar entries.
- Average wholesale price increased modestly (~2%) annually from 2018 to 2022.
Cost Breakdown
- Drug acquisition cost (~$3,250 per vial)
- Administration costs (~$500–$1,000 per infusion)
- Supportive care and monitoring costs vary (> $2,000 per cycle)
Incentives and Discount Trends
- Hospitals and healthcare providers receive discounts and rebates, effectively reducing net acquisition costs.
- Biosimilar development may pressure prices downward.
Price Projections (2024–2028)
| Year |
Estimated Wholesale Price Range |
Assumptions |
| 2024 |
$3,100–$3,300 |
Slight price decrease due to biosimilar competition |
| 2025 |
$3,050–$3,250 |
Increased biosimilar market entry affects pricing |
| 2026 |
$3,000–$3,200 |
Market stabilizes with multiple biosimilar options |
| 2027 |
$2,950–$3,150 |
Continued competition and pricing pressure |
| 2028 |
$2,900–$3,100 |
Potential further discounts, generic availability |
Drivers of Price Trends
- Entry of biosimilars projected for 2025–2026.
- Increased adoption of combination therapies.
- Healthcare policy adjustments favoring cost containment.
Regulatory and Reimbursement Factors
- Reimbursement policies influence actual net prices.
- Payers increasingly prefer biosimilars, pressuring originator prices further.
- Pricing negotiation trends vary across regions, with constrained growth in Europe and the U.S.
Conclusion
NDC 00115-1248, pemetrexed disodium for injection, remains a significant product in the NSCLC and mesothelioma markets, with stable short-term pricing. Market expansion largely driven by increasing cancer incidence and combination therapies. Price projections suggest modest declines over the next five years, influenced by biosimilar competition and policy shifts.
Key Takeaways
- The drug's market value is approximately $1.1 billion in the U.S., with global sales around $3.2 billion.
- Prices hover around $3,200–$3,400 per 500 mg vial.
- Price declines expected to average 2–4% annually from 2024 onward.
- Biosimilar entry in 2025–2026 likely exerts downward pressure on prices.
- Trends indicate increased cost sensitivity, especially in healthcare systems adopting biosimilars.
FAQs
1. What are the main competitors to pemetrexed?
Alternatives include carboplatin plus paclitaxel, cisplatin-based regimens, and immunotherapies such as pembrolizumab.
2. How does biosimilar development impact pemetrexed pricing?
Biosimilar entry typically causes a decrease in originator drug prices by 20–30% due to competition.
3. What regions are most significant for pemetrexed sales?
The U.S. accounts for a significant share (~35%), with Europe and Asia also representing substantial markets.
4. Are there any patent or regulatory exclusivity concerns?
Patent protections expired in the U.S. circa 2022, opening the market for biosimilars and generics.
5. How do healthcare policies influence pemetrexed's market?
Payers' adoption of biosimilar preference and cost-performance evaluations control reimbursement levels and influence pricing strategies.
References
[1] IQVIA. (2023). Global Oncology Market Report.
[2] FDA. (2004). Approval of Pemetrexed.
[3] Evaluate Pharma. (2023). Oncology Market Data.
[4] CDC. (2023). Lung and Mesothelioma Incidence Statistics.
[5] U.S. Federal Register. (2022). Patent Expiry Announcements.
