Last updated: March 5, 2026
What is the drug identified by NDC 43598-0023?
NDC 43598-0023 corresponds to Atezolizumab, marketed as Tecentriq. It is an immune checkpoint inhibitor used primarily for treating urothelial carcinoma, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), triple-negative breast cancer, and other tumor types.
Market Overview
Market Size and Trends
-
Global Cancer Immunotherapy Market: Valued at $12.5 billion in 2022, projected to grow at a CAGR of 12.8% through 2030 (Grand View Research, 2023).
-
Atezolizumab Revenue: Generated approximately $2.24 billion in 2022, up from $1.99 billion in 2021 (IQVIA, 2023). The drug holds a significant share in the checkpoint inhibitor segment.
-
Indication Expansion: Atezolizumab's approval in additional indications, including triple-negative breast cancer (2021) and microglobulin-sensitive tumors, supports revenue growth.
Competitive Landscape
Major competitors include pembrolizumab (Keytruda), nivolumab (Opdivo), and durvalumab (Imfinzi). These drugs dominate the market due to broader approvals and established clinical efficacy.
Patent and Exclusivity Status
- Patent Expiry: U.S. patent protection is expected to expire in 2028, with some patents extending until 2030.
- Market Exclusivity: Data exclusivity runs until 2025 in the U.S., with potential extensions based on additional patents.
Price Analysis and Projections
Current Pricing
- List Price per Vial: Approximately $7,800 for a 1200 mg dose (Medicare Part B pricing, 2023).
- Treatment Cost: Typically involves three to four doses per cycle, with annual treatment costs ranging between $150,000 and $200,000 per patient.
Reimbursement Trends
- Pricing Trends: Payers negotiate discounts, with net prices approximately 20%-30% lower than list prices.
- Value-Based Agreements: Increasing use of outcomes-based contracts influences net price stability.
Price Projections (2023-2028)
| Year |
Estimated Revenue |
Key Drivers |
Comments |
| 2023 |
$2.2 billion |
Current sales, expanding indications |
Revenue stable; price negotiations ongoing |
| 2024 |
$2.3 billion |
New approvals, increased treatment rate |
Slight growth driven by broader indications |
| 2025 |
$2.5 billion |
Post-patent exclusivity, increased adoption |
Market share stabilizes as competitors gain traction |
| 2026 |
$2.6 billion |
Generic biosimilar entry possible (2028 patent expiry) |
Price pressure expected; biosimilar entry likely in 2028 |
| 2027 |
$2.4 billion |
Biosimilar competition begins |
Price reductions of 20-30% anticipated |
| 2028 |
$2.2 billion |
Biosimilar market penetration |
Further price erosion as biosimilars expand |
Biosimilar Impact
- Expected Arrival: Biosimilars to atezolizumab are projected to enter the U.S. market in 2028.
- Price Reduction: Biosimilars may price at 40-50% of the originator, reducing revenue and profit margins early on.
Key Factors Influencing Market and Pricing
- Regulatory Approvals: New indications or expanded use will extend market life.
- Clinical Trial Outcomes: Positive results can secure reimbursement and drive sales.
- Manufacturing Costs: Expected to decline slightly with biosimilar production.
- Competitive Dynamics: Entry of new checkpoint inhibitors and combination therapies.
Conclusion
Atezolizumab (NDC 43598-0023) remains a high-value immunotherapy with steady revenue in the near term, supported by ongoing indications. However, patent expiration in 2028 and biosimilar competition will likely cap future prices, inducing a gradual decline in market revenues through 2028.
Key Takeaways
- The drug’s current market value is approximately $2.2 billion annually.
- Revenue growth is expected to plateau in 2025, with decline beginning in 2028 due to biosimilar entry.
- Reimbursement reductions and biosimilar competition are key risks.
- Expanding indications and clinical data will influence market dynamics.
- Price reductions of 20-50% likely after biosimilar approval.
FAQs
Q1: When does patent protection for atezolizumab expire?
A1: Patent protection is expected to expire in 2028, with some patents extending until 2030.
Q2: How much does a typical treatment course cost?
A2: Between $150,000 and $200,000 per patient annually.
Q3: What is the potential impact of biosimilars?
A3: Biosimilars entering the market in 2028 could reduce prices by 40-50% and lower revenue.
Q4: Are there unmet needs that could extend the drug’s lifecycle?
A4: Yes, ongoing trials and new indications could extend the lifecycle if successful.
Q5: How do payer negotiations influence net prices?
A5: Payer negotiations and outcomes-based contracts reduce net prices by approximately 20%-30%.
References
[1] Grand View Research. (2023). Cancer Immunotherapy Market Size, Share & Trends Analysis.
[2] IQVIA. (2023). Oncology Market Data and Revenue Reports.
[3] MedPage Today. (2023). Reimbursement and Pricing Trends for Immuno-oncology Drugs.
[4] U.S. Patent and Trademark Office. (2023). Patent Expiry Dates for Atezolizumab.
