Last updated: February 27, 2026
What is NDC 00456-1140?
NDC 00456-1140 identifies Atezolizumab (Tecentriq), a PD-L1 immune checkpoint inhibitor used primarily in immunotherapy for certain cancers. It is indicated for non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), bladder cancer, and other tumor types.
Market Size and Key Drivers
Indications and Patient Population
| Indication |
Estimated Patient Pool (US) |
Global Market Estimates |
| NSCLC |
200,000 annually |
650,000+ globally |
| SCLC |
30,000 annually |
100,000+ globally |
| Bladder cancer |
80,000 annually |
250,000+ globally |
Source: American Cancer Society (2022), MarketResearch.com (2023)
Competitive Landscape
- Key competitors: Pembrolizumab (Keytruda), Nivolumab (Opdivo), Durvalumab (Imfinzi).
- Market share dynamics: Atezolizumab has approximately 20% market share in NSCLC indications in the U.S.
Revenue Potential
| Year |
Estimated U.S. Revenue |
Global Revenue Projection |
Assumptions |
| 2023 |
$1.2 billion |
$2.3 billion |
Market penetration, pricing, approval status |
| 2024 |
$1.4 billion |
$2.8 billion |
Increased adoption, expanded indications |
Pricing Overview
Current Price Points
- Per 1200 mg dose: approximately $12,000 to $13,000 (U.S.)
- Average treatment course: $72,000 to $156,000, depending on doses and treatment duration.
Source: CMS and industry reports (2022)
Pricing Models
- Standard full wholesale acquisition cost (WAC) for one-year treatment ranges between $70,000 and $150,000.
- Discounting practices are expected to be in the 10-15% range, based on payer negotiations.
Price Trends and Projections
Short-term (Next 1-2 Years)
- Expected stability in list prices due to existing contracts.
- Likely 3-5% reduction in net pricing because of increased biosimilar activity or parallel importing in certain markets.
Medium-term (3-5 Years)
- Slight downward pressure as biosimilar and biosimilar-like products emerge.
- Price reductions of 10-15% anticipated post-patent expiry of key formulations.
Long-term (5+ Years)
- Possible further price erosion driven by biosimilars.
- Therapeutic advancements may either replace or supplement atezolizumab, influencing pricing.
Regulatory and Policy Impacts
- Recent CMS initiatives aim to boost biosimilar uptake, potentially decreasing prices.
- International policies in Europe, Asia, and Latin America favor price negotiations, influencing global pricing strategies.
Key Factors Influencing Price and Market Dynamics
- Patent exclusivity expiry: Anticipated around 2025.
- Development of biosimilars: Several are in late-phase trials, possibly introducing competitive pricing within 3-4 years.
- Line of therapy and combination regimens: Expansion to first-line treatment increases volume but may impact unit price due to payer negotiations.
- Off-label use: Potentially increases overall revenue but can lead to reimbursement pressure.
Investment and R&D Outlook
- Continued investment in combination therapies and new indications is expected.
- Market entry by biosimilars will exert downward pressure on pricing.
- Enhanced clinical data and approval for additional tumor types could sustain revenue growth.
Summary
NDC 00456-1140 (Atezolizumab) operates in a competitive immunotherapy market with substantial growth potential driven by expanding indications and patient access. While immediate pricing remains stable, long-term projections anticipate moderate declines with biosimilar competition and generics entering markets from 2025 onward.
Key Takeaways
- NDC 00456-1140 predominantly targets lung and bladder cancers with an established market share.
- Current U.S. treatment costs average between $70,000 and $150,000 annually.
- Market growth is driven by expanding indications and combination therapies.
- Price reductions are anticipated over the next 3-5 years, particularly post-patent expiration.
- Biosimilars will be primary catalysts for pricing pressures.
Frequently Asked Questions
1. When does the patent on atezolizumab expire?
Patent protection is expected to end around 2025, opening the market for biosimilars.
2. How will biosimilars impact the market?
Biosimilars are expected to introduce pricing competition, possibly reducing list and net prices by 10-15% within a few years of launch.
3. Are there approved biosimilars for atezolizumab?
As of early 2023, biosimilars are in late-stage development but not yet approved in major markets.
4. What factors could accelerate price declines?
Regulatory policies favoring biosimilar adoption, increased market competition, and patent expiry.
5. How does global pricing compare to U.S. prices?
Global prices vary significantly due to different healthcare systems; some markets see discounts up to 50% relative to U.S. prices.
References
[1] American Cancer Society. (2022). Cancer statistics for the United States.
[2] MarketResearch.com. (2023). Oncology market analysis report.
[3] Centers for Medicare & Medicaid Services. (2022). Drug pricing and reimbursement data.
