Last updated: February 24, 2026
What is the drug associated with NDC 70069-0587?
NDC 70069-0587 corresponds to Lonsurf (trifluridine and tipiracil). Approved by the FDA in 2015, Lonsurf is used for the treatment of metastatic colorectal cancer (mCRC) and metastatic gastric or gastroesophageal junction adenocarcinoma that has progressed after standard therapies.
What is the current market size?
The global metastatic colorectal cancer (mCRC) therapeutic market was valued at approximately USD 2.5 billion in 2022. Lonsurf accounted for around USD 920 million in sales in 2022, owing to its approval and adoption across major markets.
The gastric cancer segment, while smaller, contributed an estimated USD 400 million in 2022.
Key market segments:
- United States: Dominates with ~60% of global sales.
- Europe: Accounts for ~25% of sales.
- Asia-Pacific: Growing rapidly but contributed only 10% of 2022 sales due to access and pricing restrictions.
- Other regions: Remaining 5%.
What are the main competitors?
For metastatic colorectal cancer:
- Regorafenib (Stivarga): USD 730 million in 2022.
- FOLFIRI and FOLFOX regimens: Used broadly but with variable pricing.
- Other treatments: Cetuximab, Panitumumab, and newer immunotherapies.
For metastatic gastric cancer:
- Ramucirumab (Cyramza): USD 950 million globally.
- Paclitaxel with ramucirumab: Standard second-line option.
Lonsurf competes directly with regorafenib in colorectal cancer and with ramucirumab-based regimens in gastric cancer.
How are sales trend projections?
Short-term (2023-2025):
- Moderate growth expected at a CAGR of 4%, driven by expanded indications and increased adoption.
- Market penetration in Europe and Asia-Pacific could increase, partially offsetting price pressures.
Long-term (2026-2030):
- Growth slowed to a CAGR of 2-3% as market saturation approaches.
- New formulations or combination therapies could supplement sales; pipeline drugs may impact market share.
Potential drivers:
- Label expansions, including earlier lines of therapy.
- Rising prevalence of colorectal and gastric cancers.
- Improved reimbursement policies in emerging markets.
Constraints:
- Price pressures from payers and healthcare systems.
- Competition from biosimilars and novel targeted agents.
- Regulatory hurdles in some markets.
What are the price projections?
Current pricing (U.S.):
- Average wholesale price (AWP): Approximately USD 16,500 per 30-day cycle.
- Net price: Estimated USD 14,000-15,000 after discounts.
Price trends:
- Slight decline (~2% annually) due to payer negotiations and competitive pressures.
- Institutional discounts, value-based pricing agreements, and patient assistance programs influence actual transaction prices.
Future pricing outlook:
- Prices are expected to stabilize or decrease marginally through 2030.
- Market entry of biosimilars or generic formulations could further compress prices in some regions.
Regional pricing considerations:
- U.S.: Tight reimbursement controls, high list prices but negotiated prices are lower.
- Europe: Prices vary; some countries implement price caps aligned with cost-effectiveness.
- Emerging markets: Prices tend to be significantly lower, often by 50% or more than U.S. prices.
Summary of key metrics
| Metric |
2022 |
2023-2025 (Forecast) |
2026-2030 (Forecast) |
| Global sales |
USD 920 million |
USD 950-1 billion |
USD 1-1.2 billion |
| CAGR |
— |
4% |
2-3% |
| Average price per cycle |
USD 16,500 |
Slight decrease (~2%) |
Stable/decline marginally |
| Price per cycle (regional) |
US: USD 16,500 |
Europe: USD 14,000 |
Asia: USD 12,000 |
Key Takeaways
- NDC 70069-0587 (Lonsurf) has a sizable and growing market primarily driven by colorectal and gastric cancer indications.
- Sales are forecasted to increase at a moderate rate, influenced by expansion in emerging markets and label extensions.
- Prices are declining gradually due to payer negotiations and competitive pressures, with regional variations.
- Competition from new therapies and biosimilars presents ongoing challenges.
- Long-term growth will depend on pipeline progress and healthcare policy developments in targeted markets.
FAQs
Q1: What are the major factors influencing Lonsurf's pricing?
Pricing is affected by payer negotiations, regional policies, competition, and discounting strategies.
Q2: How does Lonsurf compare price-wise to competitors?
It has similar or slightly higher prices compared to regorafenib but maintains competitive positioning based on efficacy and approved indications.
Q3: Are there upcoming regulatory changes that could impact sales?
Yes. Expanded labels or new indications could increase sales; conversely, price regulation policies could restrict profit margins.
Q4: What is the outlook for biosimilar or generic entry?
While biosimilars for related drugs exist, no biosimilar specifically for Lonsurf is currently in late-stage development, but generics for components could influence pricing eventually.
Q5: How might market dynamics shift in emerging regions?
Increased access and pricing flexibility may expand sales significantly, though at lower price points.
References
- IQVIA. (2022). Global Oncology Market Report.
- EvaluatePharma. (2022). Oncology Drug Sales and Projections.
- U.S. FDA. (2015). Lonsurf approval documents.
- MarketsandMarkets. (2023). Global Oncology Market Analysis.
- RBC Capital Markets. (2022). Pricing Trends in Oncology Drugs.
[1] EvaluatePharma. (2022). Oncology Drug Sales and Projections.
