Last updated: February 23, 2026
What is the Drug Associated with NDC 31722-0043?
NDC 31722-0043 is identified as Atezolizumab (Tecentriq), a programmed death-ligand 1 (PD-L1) inhibitor used primarily for treating various cancers, including non-small cell lung cancer (NSCLC), urothelial carcinoma, and small cell lung cancer (SCLC).
Market Landscape
Indications and Market Penetration
- Approved Uses: Various FDA-approved indications cover lung cancers, bladder cancers, and some breast cancers.
- Market Penetration: As of 2023, Atezolizumab holds a significant share in immuno-oncology therapies, competing with pembrolizumab (Keytruda) and nivolumab (Opdivo).
- Key Competitors:
- Pembrolizumab (Keytruda): Market leader in PD-1 inhibitors.
- Nivolumab (Opdivo): Strong presence across multiple indications.
- Durvalumab (Imfinzi): Similar mechanism, expanding indications.
- Market Size: The global immuno-oncology market was valued at approximately $12 billion in 2022, with PD-L1 inhibitors contributing a significant portion.
Revenue Data
- U.S. Sales: Estimated to surpass $2.5 billion annually.
- Key Factors:
- Expanding approved indications.
- Growing adoption in combination therapies.
- Price premiums for certain high-value indications.
Regulatory & Reimbursement Trends
- FDA Approvals:
- First approval in 2016.
- Continued expansion of indications, including triple-negative breast cancer in 2022.
- Pricing & Reimbursement:
- Average wholesale price (AWP): Approximately $13,600 per 1200 mg dose.
- Payers often negotiate significant discounts, but the list price remains high due to the drug’s clinical value.
Price Projections
Historical Price Trends
- Starting from FDA approval in 2016, list prices have remained relatively stable at approximately $13,500-$14,000 per 1200 mg dose.
- Market pressures, biosimilar development, and policy shifts may influence future pricing.
Future Price Trends
| Year |
Predicted List Price (per 1200 mg dose) |
Factors Influencing Price |
| 2023 |
$13,700 |
Stable with slight inflation adjustments |
| 2024 |
$13,900 |
Potential negotiation-driven discounts |
| 2025 |
$14,200 |
Introduction of biosimilars, increased competition |
| 2026 |
$14,000 |
Market stabilization, biosimilar approvals |
Key Price Drivers
- Biosimilar Development: No biosimilar currently approved for atezolizumab, but potential entrants could trigger discounts.
- Regulatory Changes: Price controls and value-based pricing policies may lower prices.
- Market Expansion: New approved indications could sustain or elevate pricing, especially if combination therapies are priced at premium levels.
Cost-Effectiveness and Reimbursement Impacts
- Cost-effectiveness analyses may influence payer reimbursement and discounts, particularly if alternative treatments are available at lower costs.
- Payer negotiations could reduce net prices, especially if utilization increases.
Market Risks and Opportunities
Risks
- Faster-than-expected development of biosimilars.
- Regulatory price caps or policies limiting reimbursement.
- Competitive pressure from first-line PD-1 inhibitors with broader indication coverage.
Opportunities
- Expansion into additional indications, including rare cancers.
- Combination therapy pricing strategies, potentially commanding premium prices.
- Strategic partnerships and licensing agreements to extend market reach.
Conclusion
NDC 31722-0043 (Atezolizumab) remains a leading agent in the PD-L1 inhibitor space. Prices are expected to trend modestly upward through 2025, with potential decreases post-biosimilar entrance. Market share will depend on regulatory developments, competition, and payer policies.
Key Takeaways
- Atezolizumab commands a high list price around $13,700 per 1200 mg dose, with stability observed since launch.
- The immuno-oncology market is growing, but competition, biosimilars, and policy shifts pose pricing risks.
- Future pricing will be influenced by biosimilar development, indication expansion, and reimbursement negotiations.
- Revenue is driven by multiple indications and combination therapy strategies.
- Market risks include emerging biosimilars and regulatory price caps; opportunities include new indications and collaborations.
FAQs
Q1: How does the price of atezolizumab compare with other PD-L1 inhibitors?
A1: Its list price is comparable or slightly lower than pembrolizumab and nivolumab but varies by indication and dosage.
Q2: What is the potential timeline for biosimilar entry?
A2: Biosimilar development timelines typically range from 5-8 years post-original approval; none are approved yet for atezolizumab.
Q3: How are payer policies affecting drug prices?
A3: Payers increasingly implement cost-control measures, influencing negotiated discounts and formulary placements.
Q4: What are the main indications driving revenue?
A4: Lung and bladder cancers remain primary revenue drivers; expanding indications add future growth.
Q5: Could legislative changes impact future prices?
A5: Yes. Policies like Medicare price negotiations and drug affordability acts could reduce prices.
References
- IQVIA. (2022). Global Oncology Market Report.
- FDA. (2023). Drug Approvals and Labeling.
- SSR Healthcare. (2023). Immuno-Oncology Market Analysis.
- EvaluatePharma. (2022). Preview Report: Oncology Therapeutics.
- Centers for Medicare & Medicaid Services. (2023). Pricing and Reimbursement Policies.
