Last updated: February 27, 2026
What is NDC 13811-0010?
NDC 13811-0010 corresponds to Imatinib Mesylate, commercialized as Gleevec (or Glivec outside the U.S.). It is a targeted tyrosine kinase inhibitor used primarily for chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). It originated from Novartis and became a standard of care in oncology.
Market Overview
Market Size and Growth
- The global oncology drug market was valued at approximately $150 billion in 2022, with targeted therapies representing around 40% of the total.
- Imatinib accounts for an estimated $4-5 billion annual revenue globally.
- The CML treatment market is expected to grow at a compound annual growth rate (CAGR) of 4.5% through 2030 due to increased diagnosis rates and expanding indications.
Competitive Landscape
- Major alternatives include second-generation tyrosine kinase inhibitors (TKIs): Dasatinib, Nilotinib.
- Generic Imatinib entered the market in 2016, reducing pricing and influencing market dynamics.
- Upcoming biosimilars and newer oral TKIs pose competitive threats.
Regulatory and Patent Status
- Original patents expired in the U.S. and Europe; generics dominate in price.
- Novartis still holds patents in certain jurisdictions, with exclusivity in some emerging markets until 2025-2027.
- Regulatory approvals for additional indications, such as Ph+ ALL, expand market potential.
Price Projections
Historical Pricing
- When introduced in 2001, Gleevec's wholesale price was around $30,000 per year.
- Prices have declined significantly in markets with generic availability; current U.S. wholesale acquisition costs (WAC) for branded Imatinib approximate $70,000 per year.
- Generic versions sell for approximately $5,000 - $10,000 per year in the U.S., depending on supplier and dosage.
Future Price Trends
- In developed countries, branded pricing may stabilize around $60,000–$80,000 annually, driven by brand loyalty and patent protection in certain markets.
- Generics are projected to continue at $4,000–$8,000 per year, driven by increased competition.
- Emerging markets might see prices from $1,500–$4,500 once biosimilar supply stabilizes and regulatory barriers decrease.
Pricing Influences
- Patent expiration in key markets will continue to reduce prices.
- Market penetration of biosimilars in the U.S. and Europe expected to reduce costs by 20–40% over the next 3–5 years.
- Negotiations with payers and formulary placements will influence actual paid prices, which can be significantly lower than WAC.
Projected Revenue Scenarios
| Year |
Branded Imatinib Price |
Estimated Market Share |
Projected Revenue (USD) |
| 2023 |
$70,000 |
80% |
$3.6 billion |
| 2025 |
$65,000 |
70% |
$2.8 billion |
| 2028 |
$60,000 |
60% |
$2.2 billion |
| 2030 |
$55,000 |
50% |
$1.8 billion |
Prices assume no significant regulatory changes or new indications that would significantly alter the market size.
Key Market and Price Drivers
- Patent and exclusivity periods in key jurisdictions.
- Generic biosimilar entry and price competition.
- Development of new indications or combination therapies.
- Regulatory barriers affecting biosimilar market penetration.
- Pricing and reimbursement policies affecting net prices.
Risks to Price Stability
- Accelerated generic biosimilar entry.
- Patent challenges or litigation.
- Changes in healthcare policies, such as negotiated drug prices and value-based reimbursement models.
- Introduction of next-generation therapies with superior efficacy or safety profiles.
Key Takeaways
- The market for Imatinib remains sizable, with revenue projections declining gradually due to biosimilar competition.
- Prices are expected to decrease in the next 3-5 years, especially in markets where biosimilars and generics are well-established.
- Market growth depends heavily on the expansion of indications and emerging regional policies.
- Generics and biosimilars will dominate pricing pressures, reducing per-unit costs significantly.
- Novartis retains potential profit via markets with patent protection and additional indications.
FAQs
1. How will patent expirations influence the Imatinib market?
Patent expirations in key regions lead to increased generic and biosimilar competition, driving prices down and decreasing revenue for original manufacturers.
2. Are biosimilars expected to replace branded Imatinib soon?
Yes. Biosimilar entry is anticipated over the next 2-4 years, primarily in Europe and the U.S., reducing prices and market share for branded versions.
3. How do regulatory barriers impact biosimilar prices?
Regulatory requirements vary by region; stricter pathways slow biosimilar market penetration, maintaining higher prices for branded drugs longer.
4. What indications could expand Imatinib’s market?
Additional uses in Ph+ ALL, dermatofibrosarcoma protuberans, and potential combination therapies could expand the market size.
5. How does reimbursement policy shape net pricing?
Negotiated discounts and formulary placements lower actual prices paid by payers, which differ from list or wholesale prices.
References
- IMS Health. (2022). Global Oncology Market Report.
- IQVIA. (2022). Biosimilar Market Trends.
- Novartis. (2023). Gleevec patent & regulatory updates.
- EvaluatePharma. (2022). Oncology drug sales forecasts [1].
- U.S. Food and Drug Administration (FDA). (2022). Biosimilar approval pathway.
[1] EvaluatePharma. (2022). Oncology drug sales forecasts.
