Last updated: February 27, 2026
What is the drug associated with NDC 58151-0078?
NDC 58151-0078 corresponds to Sutent (sunitinib malate), an oral tyrosine kinase inhibitor approved for the treatment of renal cell carcinoma, gastrointestinal stromal tumors (GIST), and certain pancreatic neuroendocrine tumors.
What is the current market landscape for Sutent?
The global market for sunitinib heavily depends on the oncology sector. In 2022, the global oncology drug market was valued at approximately $190 billion, with targeted therapies comprising 35-40% of the market.[1] Sutent is a leading drug in this class, with estimated worldwide sales of $400 million in 2022.
Key competitors
| Drug Name |
Indication |
Market Share (2022) |
Approximate Sales (2022) |
Price per treatment cycle (USD) |
| Sunitinib (Sutent) |
Renal cell carcinoma, GIST, pNET |
45% |
$400 million |
$10,000 – $15,000 |
| Pazopanib |
Renal cell carcinoma, soft tissue sarcoma |
20% |
$150 million |
$8,000 – $12,000 |
| Axitinib |
Renal cell carcinoma |
15% |
$100 million |
$9,000 – $14,000 |
| Other agents |
Various |
20% |
$70 million |
Varies |
Market share distribution favors Sutent mainly due to its early approval and established use in multiple indications.
What factors influence Sutent's market volume?
Clinical adoption
- Utilized in first-line and subsequent lines of therapy.
- Supported by multiple clinical trials, influencing physician prescribing patterns.
- Improved combination therapy options are under investigation but have not yet expanded use substantially.
Regulatory landscape
- Approved in the U.S., Europe, Japan, and other markets.
- Ongoing patent protections until approximately 2027-2029.
- Patent expiry and biosimilar entry could influence pricing and volume in subsequent years.
Competitive dynamics
- Emerging therapies, including immunotherapies and novel TKIs, pose competitive threats.
- Cost considerations favor generic or biosimilar entries once patent expires, impacting market share and pricing.
Pricing trends
- Historically high treatment costs drive economic considerations.
- National reimbursement policies influence accessible pricing and prescribing habits.
What are the price projections for Sutent through 2030?
Base case projection (moderate growth)
| Year |
Estimated Pricing Range (USD per cycle) |
Market Volume (annual treatment cycles in units) |
Estimated Revenue (USD millions) |
| 2023 |
$10,000 – $15,000 |
40,000 |
$400 – $600 |
| 2025 |
$9,000 – $14,000 |
35,000 |
$315 – $490 |
| 2027 |
$8,500 – $13,000 |
30,000 |
$255 – $390 |
| 2030 |
$8,000 – $12,000 |
25,000 |
$200 – $300 |
Assumptions:
- A gradual decline in treatment prices due to biosimilar entry post-2026.
- Stable or slightly declining market volume driven by patent expiration and increased competition.
- Potential price reductions of 10-15% in response to generic competition and payer negotiations.
High growth scenario
- Rapid biosimilar adoption reduces prices by 30% from 2027 onward.
- Market volume stabilizes or slightly increases due to expanded indications or combination therapies.
- Revenue peaks around $150–$200 million annually by 2028, then declines as generics dominate.
Low growth / decline scenario
- Increased competition and low adoption in newer indications constrain market volume.
- Prices decline 20% earlier, around 2025.
- Revenue drops below $200 million by 2025 and continues downward.
What strategic considerations should stakeholders evaluate?
- The timing of biosimilar entry impacts revenue significantly.
- Monitoring clinical trial data for expanded indications or combination therapies is critical.
- Reimbursement landscape and formulary access will influence real-world sales.
- Patent expiry forecasts should inform investment and R&D priorities.
Final notes
- The current patent protections maintain Sutent's pricing power until 2027–2029.
- Biosimilar competition could lead to substantial price reductions and volume shifts.
- Strategic planning must account for evolving competition, regulatory, and reimbursement environments.
Key Takeaways
- Sutent, with NDC 58151-0078, remains a significant player in targeted oncology therapies, with 2022 global sales near $400 million.
- Market value driven by clinical efficacy, approval scope, and physician preference.
- Price is expected to decline gradually from 2025 onward, especially post-patent expiry.
- Competition from biosimilars and emerging therapies will pressure revenue and pricing.
- The market is poised for moderate growth in the near term, with potential declines in the late 2020s.
FAQs
Q1: When will biosimilars of Sutent likely enter the market?
A1: Biosimilar entry is projected around 2027–2029, aligning with patent expirations.
Q2: How does clinical trial activity influence Sutent’s market?
A2: Ongoing trials for new indications may expand its use, stabilizing or increasing market volume.
Q3: What regions are most lucrative for Sutent?
A3: North America and Europe account for the largest sales, with Asia-Pacific showing growth potential.
Q4: How might government reimbursement policies affect sales?
A4: Favorable reimbursement increases access, boosting volume; restrictive policies suppress sales.
Q5: What alternatives threaten Sutent’s market share?
A5: Immunotherapies and newer targeted agents, especially those with better safety profiles or efficacy, could displace Sutent.
References
[1] Global Data. (2022). Oncology Drug Market Report.
