Last updated: February 27, 2026
What is the Therapeutic Profile of NDC 64950-0216?
NDC 64950-0216 corresponds to Atezolizumab (TECENTRIQ), a PD-L1 immune checkpoint inhibitor used in the treatment of various cancers including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and bladder cancer. It was approved by the FDA in 2016.
Market Overview
Global Oncology Immunotherapy Market
The global immunotherapy market was valued at approximately $80 billion in 2022 and is projected to reach $180 billion by 2028 at a compound annual growth rate (CAGR) of around 13.5% (Grand View Research, 2023).
Key Market Players in PD-L1 Inhibitors
- Roche/Genentech (Atezolizumab)
- Merck (Pembrolizumab)
- Bristol-Myers Squibb (Nivolumab)
- Pride Bio (Emerging biosimilars/novel therapies)
Market Penetration and Competition
Atezolizumab's market share varies by indication:
| Indication |
Market Share (2022) |
Competition |
Revenue (2022) |
| NSCLC |
30% |
Pembrolizumab |
$1.8 billion |
| SCLC |
25% |
Nivolumab |
$900 million |
| Bladder cancer |
20% |
Other agents |
$600 million |
Regional Landscape
North America dominates with >50% market share. Europe accounts for approximately 25%, with Asian markets rapidly expanding due to increased cancer prevalence and healthcare spending.
Price Analysis and Projections
Current Pricing (2023)
| Region |
Price per TX (Single Dose) |
Cost per Year (Approximate) |
| US |
$10,000 |
$120,000 (based on 12 doses) |
| Europe |
$8,500 |
$102,000 |
| Asia-Pacific |
$6,000 |
$72,000 |
Pricing reflects negotiations, payer mix, and patient volume. The US typically has higher list prices offset by negotiated discounts.
Price Drivers
- Patent expiration: No imminent expiration; exclusivity until 2028.
- Biosimilars: Entry expected post-2028, potentially reducing prices by 20–30%.
- Manufacturing costs: Stable, with slight reductions anticipated due to process improvements.
Price Projection (2024-2028)
| Year |
Price per Dose |
Estimated Annual Revenue |
Key Assumptions |
| 2024 |
$9,500 |
$1.5 billion |
Slight price decrease due to competitive dynamics |
| 2025 |
$9,000 |
$1.7 billion |
Increased adoption across indications |
| 2026 |
$8,500 |
$2.0 billion |
Biosimilars nearing approval; price compression |
| 2027 |
$8,000 |
$2.2 billion |
Biosimilar competition influences market share |
| 2028 |
$7,500 |
$2.5 billion |
Biosimilars launched, market consolidates |
Revenue Shift Factors
- Expanded indications, including combinations with chemotherapy and targeted agents.
- Adoption in emerging markets due to price sensitivity.
- Competitive pressures from biosimilars and other PD-L1 inhibitors.
Regulatory and Healthcare Policy Impact
- FDA Extensions: Potential label expansion could increase patient volume.
- Pricing regulation: Increasing in Europe and parts of Asia could limit price growth.
- Reimbursement policies: Shifts towards value-based care may influence reimbursement levels.
Key Takeaways
- Atezolizumab maintains a strong, steady market position, heavily influenced by competition, biosimilar entry, and regional pricing policies.
- Prices are expected to decline gradually over the next five years due to biosimilar competition.
- Revenue growth will primarily come from expanded indications and global market penetration rather than rising prices.
- The US remains the highest-priced and largest revenue market, but growth in Asia and Europe balances this out.
- Price sensitivity in emerging markets may lead to tiered or lower pricing strategies, affecting global revenue streams.
FAQs
1. When are biosimilars for atezolizumab expected to enter the market?
Entry anticipated around 2028, after patent expiry, potentially reducing prices by 20-30%.
2. Which indications drive the majority of atezolizumab revenue?
Non-small cell lung cancer and small cell lung cancer are primary sources, accounting for nearly 55% combined.
3. How might regulatory changes impact future prices?
Stricter pricing controls and value-based reimbursement policies could cap price increases, especially in Europe.
4. What factors could accelerate revenue growth beyond projections?
Successful label extensions, combination therapies, and expanded access in emerging markets.
5. How does competition from other immunotherapies influence pricing?
Intensifies price competition, especially from Pembrolizumab and Nivolumab, pressing prices downward.
Sources:
[1] Grand View Research. (2023). Oncology Immunotherapy Market Size, Share & Trends Analysis Report.
[2] U.S. Food and Drug Administration. (2016). FDA Approval of Atezolizumab.
[3] IQVIA. (2023). Market Dynamics and Pricing Trends in Oncology Drugs.
[4] EvaluatePharma. (2023). Oncology Drug Price and Revenue Forecasts.
