Last updated: March 8, 2026
What is the Drug Associated with NDC 23155-0848?
NDC 23155-0848 is associated with AstraZeneca’s Tagrisso (osimertinib). It is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor approved for non-small cell lung cancer (NSCLC). It is marketed primarily for patients with EGFR T790M mutation-positive metastatic NSCLC.
Market Overview
Current Market Size
The global NSCLC treatment market was valued at approximately USD 15 billion in 2022. Growing adoption of targeted therapies drives market expansion.
- Key competitors: Tagrisso, Tagamet (gefitinib), Tarceva (erlotinib), and other emerging therapies.
- Market penetration: Tagrisso holds around 35-40% market share for EGFR mutation-positive NSCLC therapies in the U.S., based on prescription data (IQVIA, 2023).
Therapeutic Adoption Drivers
- Increased detection of EGFR mutations via advanced diagnostics.
- Growing incidence of NSCLC worldwide.
- Expanded approval for first-line and subsequent lines of therapy.
- Evidence supporting improved progression-free survival (PFS) and overall survival (OS).
Regulatory and Patent Landscape
- Patent expiration is expected in 2028, with generic competition likely to emerge subsequently.
- Additional indications are in development or under regulatory review, expanding market potential.
Price Trends and Pricing Dynamics
Current Pricing
- Wholesale Acquisition Cost (WAC) in the United States (2023): Approximately USD 14,000 per month.
- Average Patient Cost: Varies based on insurance, typically USD 10,000–12,000 per month after rebates and rebates.
- Price per Treatment Course: Roughly USD 168,000 annually.
Price Comparison
| Drug |
Indication |
Monthly Cost (USD) |
Market Share (2023) |
Approval Year |
| Tagrisso (osimertinib) |
NSCLC, first and second line |
14,000 |
35-40% |
2015 |
| Gefitinib (Iressa) |
NSCLC |
10,500 |
Diminished |
2003 |
| Erlotinib (Tarceva) |
NSCLC |
11,500 |
Diminished |
2004 |
Price Trajectory Projections
Market Drivers and Challenges
Drivers
- Increasing global NSCLC prevalence.
- Approval of expanded indications.
- Advances in companion diagnostics.
Challenges
- Patent expiry and biosimilar competition.
- High therapy costs impacting reimbursement.
- Pricing pressures from payers aiming to lower drug costs.
Key Market Risks
- Slow adoption of new diagnostic tools.
- Regulatory delays or unfavorable rulings.
- Potential generic entry reducing revenue.
Investment and R&D Outlook
- Continued R&D in combination therapies may extend market viability.
- Opportunities for pipeline growth with next-generation EGFR inhibitors.
- Strategic partnerships could aid in tariff and pricing negotiations.
Key Takeaways
- NDC 23155-0848 covers AstraZeneca’s Tagrisso, a leading EGFR-targeted therapy for NSCLC.
- US retail prices hover around USD 14,000/month, with an annual treatment cost near USD 168,000.
- Market share is consolidating, but patent expiry in 2028 poses a significant price reduction risk.
- Price erosion expected post-patent, with biosimilar competition projected to slash prices by up to 60% over the next decade.
- Market growth driven by rising NSCLC cases and expanding indications, but tightly managed by payers and regulators.
FAQs
Q1: When will biosimilars for Tagrisso enter the market?
A1: Biosimilars are unlikely before 2029, following patent expiration in 2028.
Q2: What is the expected impact of biosimilars on the market?
A2: Biosimilars could reduce prices by approximately 50-60%, impacting AstraZeneca’s revenue.
Q3: How does pricing in Europe compare to the US?
A3: European prices tend to be lower, averaging EUR 10,000–12,000 per treatment month, influenced by national drug price negotiations.
Q4: Are there ongoing R&D efforts to develop next-generation EGFR inhibitors?
A4: Yes, several pipeline candidates aim to improve efficacy and reduce resistance, potentially extending market share.
Q5: How do insurance policies influence pricing and market access?
A5: Insurers negotiate rebates and formulary placement, which can significantly lower patient out-of-pocket costs and shape market dynamics.
References
- IQVIA (2023). National Prescription Data.
- U.S. Food and Drug Administration (2015). Approval document for Osimertinib (Tagrisso).
- AstraZeneca (2023). Annual Report.
- McKinsey & Company (2022). Oncology Market Trends.
