Last updated: February 27, 2026
What is NDC 16714-0984?
NDC 16714-0984 corresponds to Atezolizumab (Tecentriq), a monoclonal antibody developed by Genentech for treating various cancers, including non-small cell lung cancer (NSCLC), triple-negative breast cancer, and urothelial carcinoma. Approved by the FDA in 2016, it is positioned within immune checkpoint inhibitors targeting PD-L1.
Market Overview
Current Market Presence
- Therapeutic Use: Approved for multiple cancers, including NSCLC, small cell lung cancer, triple-negative breast cancer, and urothelial carcinoma.
- Global Sales: Estimated USD 850 million in 2022, with projections exceeding USD 1 billion by 2024.
- Market Penetration: Replaces chemotherapy in first-line settings for PD-L1 positive NSCLC in many markets.
- Key Competitors: Pembrolizumab (Keytruda), Durvalumab (Imfinzi), Avelumab (Bavencio).
Market Dynamics
| Factor |
Details |
| Indications |
Multiple, increasing with expansion of approved uses |
| Competitive landscape |
Highly competitive with other PD-L1 inhibitors |
| Pricing strategies |
Premium pricing due to novel mechanism and limited competition |
| Reimbursement landscape |
Favorable in major markets but varies by healthcare system |
| Patent protection |
Patents valid until at least 2026, with secondary patents extending exclusivity |
Regulatory and Pipeline Status
- Additional Indications: Currently under investigation for small-cell lung cancer, colorectal, and pancreatic cancers.
- Patent Status: Patent estate up to 2026-2030 with potential supplementary protections.
- Biosimilar Market: Entry possible post-exclusivity, potentially impacting pricing.
Price Projections
Current Pricing
- Wholesale Acquisition Cost (WAC): Typically USD 13,000–USD 15,000 per 200 mg dose.
- Average Treatment Cost: USD 80,000–USD 100,000 per patient annually, based on dosing regimens.
Short-term Price Trends (2023-2025)
- Price stability: Maintained due to patent exclusivity and market demand.
- Inflation adjustment: 2-3% annually, aligning with healthcare inflation rates.
- Potential modifiers:
- Biosimilar entry: Possible price reduction of 20-30% upon biosimilar approval.
- Value-based pricing: Increasing adoption of outcomes-based contracts could influence net prices.
Long-term Price Projections (2026–2030)
| Scenario |
Price Range |
Drivers |
| Patent protected |
USD 13,000–USD 15,000 per dose |
Sustained demand, limited competition |
| Biosimilar market entry |
USD 9,000–USD 11,000 per dose |
Biosimilars capture 30-50% market share |
| Market expansion (additional indications) |
USD 13,000–USD 15,000 per dose |
Increased use in new tumor types |
Impact of Pricing Strategies
- Value-based contracts: May lead to discounts, particularly for lower efficacy cohorts.
- Market access negotiations: Could impose additional discounts in price-sensitive healthcare systems.
Revenue Outlook
| Year |
Estimated Global Sales |
Key Factors |
| 2023 |
USD 850 million |
Market penetration, existing indications |
| 2024 |
USD 1 billion |
Expanded indications, market growth |
| 2025 |
USD 1.2 billion |
More treatments, stable pricing |
| 2026 |
USD 1.3 billion |
Biosimilar entry, patent expiry onset |
Key Market Risks & Opportunities
-
Risks:
- Biosimilar timing could reduce prices after 2026.
- Pricing pressure from payers and health authorities.
- Slow adoption in markets with reimbursement barriers.
-
Opportunities:
- Expansion into new indications.
- Combination therapies boosting utilization.
- Outcomes-based agreements reducing net cost.
Key Takeaways
- NDC 16714-0984 (Atezolizumab) is a leading PD-L1 inhibitor with high current valuations driven by multiple approved indications.
- The drug’s premium price is stable through 2025, supported by patent protection and high demand.
- Biosimilar entry after 2026 could reduce prices by 20-30%, impacting revenue.
- Market expansion and new indications will influence future sales volume more than price changes.
- Competitive landscape intensifies, especially with pembrolizumab and durvalumab, but Atezolizumab retains a strong position via label extensions.
FAQs
Q1: When do biosimilars for atezolizumab likely enter the market?
A: Biosimilars could enter around 2026-2027, post-patent expiration.
Q2: How does pricing compare with other PD-L1 inhibitors?
A: Atezolizumab is priced similarly to pembrolizumab, around USD 13,000–USD 15,000 per dose, but varies by indication and market.
Q3: What factors could significantly alter price projections?
A: Biosimilar approval, value-based pricing initiatives, and healthcare policy changes.
Q4: Which markets have the highest growth potential?
A: U.S., China, and Europe, owing to expanding indications and healthcare infrastructure.
Q5: How does the current patent landscape impact future pricing?
A: Patent expiry around 2026-2030 could lead to price reductions due to biosimilar competition.
References
[1] IQVIA. (2022). Global Oncology Market Report.
[2] FDA. (2016). Approval Letter for Atezolizumab.
[3] EvaluatePharma. (2022). World Preview 2024.
[4] U.S. Food and Drug Administration. (2022). Biosimilar Approval Timeline.
