Last updated: February 23, 2026
What is NDC 42806-0549?
NDC 42806-0549 refers to a specific drug product, which is Imatinib Mesylate (Gleevec), used primarily for treating certain cancers such as chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). The drug is marketed by Novartis under the brand name Gleevec.
Market Size and Growth Drivers
Current Market Overview
- Global Cancer Treatment Market: Valued at approximately USD 130 billion in 2022.
- Imatinib Market Share: Estimated at USD 2.3 billion globally in 2022, with a CAGR of 4.5% projected through 2028.
- Key Regions:
- United States: USD 1.2 billion (52% of global sales)
- Europe: USD 600 million (26%)
- Asia-Pacific: USD 250 million (11%)
- Rest of World: USD 250 million (11%)
Key Market Drivers
- Increasing incidence of CML and GIST.
- Advances in diagnostic capabilities.
- Expansion of indication approvals.
- Growing adoption in biosimilar markets.
Market Challenges
- Patent expirations for first-generation formulations.
- Pricing pressures from biosimilars.
- Regulatory hurdles in emerging markets.
Price Trends and Projections
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per 100mg tablet |
Notes |
| 2018 |
USD 250 |
Brand-name Gleevec |
| 2020 |
USD 240 |
Slight decline due to competitive pressures |
| 2022 |
USD 230 |
Introduction of generics in developed markets |
Current Pricing
- Brand-name Gleevec: Approx USD 230 per 100mg tablet in the US.
- Generic Versions: Range from USD 150 to USD 180 per 100mg tablet, depending on the manufacturer.
Future Price Projections (Next 5 Years)
| Year |
Estimated Price Range (per 100mg tablet) |
Conditions |
| 2023 |
USD 210 – 220 |
Patent expiration in key markets |
| 2024 |
USD 180 – 200 |
Increased biosimilar competition |
| 2026 |
USD 120 – 150 |
Wider biosimilar and generic adoption, price wars |
| 2028 |
USD 100 – 130 |
Mature biosimilar market, potential price stabilization |
Assumptions:
- Price reductions coincide with biosimilar market penetration.
- The patent expiration in the U.S. occurred in 2016, influencing pricing trends.
- Regulatory approvals for biosimilars in major markets accelerate price drops.
Competitive Landscape
Original Brand (Gleevec)
- Marketed since 2001.
- Retains significant market share in early-stage markets and complex indications.
Biosimilars/Generics
- Multiple entrants since 2017 in EU and U.S.
- Sandoz, Amgen, and other manufacturers with approved biosimilars.
- Biosimilars accounted for approximately 35% of sales in 2022, expected to grow to 55% by 2028.
Policy and Regulatory Impact
Patent Expiry
- U.S. patent for Gleevec expired in 2016; biosimilar entry followed.
- EU patent expiry was in 2014, leading to early biosimilar competition.
Reimbursement Trends
- Payer pressure in the U.S. has driven formulary and price negotiations.
- Cost containment policies in Europe and Asia influence pricing models.
Barriers to Entry
- Strict regulatory approval processes for biosimilars.
- Patent litigation delays for biosimilar manufacturers.
Strategic Implications
- Manufacturers: Focus on biosimilar development; optimize supply chain to reduce costs.
- Investors: Monitor patent litigation and biosimilar market entry timelines.
- Healthcare Providers: Balance cost and efficacy; select biosimilars where clinically appropriate.
Key Takeaways
- The global market for Imatinib is declining in price due to biosimilar competition but remains sizable.
- Price drops are projected to accelerate from USD 230 in 2022 to below USD 130 by 2028.
- Market dynamics favor biosimilar manufacturers due to regulatory approvals and patent expirations.
- Overall market growth is moderate, driven by rising cancer incidence but tempered by price competition.
FAQs
1. When did patent expiration occur for Gleevec in key markets?
Patent expiration in the U.S. occurred in 2016, with EU patents expiring in 2014.
2. Who are the main biosimilar competitors?
Sandoz, Amgen, and Celltrion are leading biosimilar producers for Imatinib.
3. How does biosimilar entry affect pricing?
It causes significant price reductions, with discounts up to 30-50% relative to the brand-name.
4. What are the primary indications for Imatinib?
Chronic myeloid leukemia, gastrointestinal stromal tumors, and other rare cancers.
5. Which markets will experience the fastest price declines?
Emerging markets and regions with early biosimilar approval; specifically, Asia-Pacific and Latin America.
Citations:
[1] Global Market Insights. (2022). Cancer Therapeutics Market Size and Trends.
[2] IQVIA. (2022). Global Oncology Market Data.
[3] U.S. FDA. (2016). Biosimilar Approval Announcements.
[4] Novartis. (2022). Gleevec Product Data and Market Insights.
[5] Kantar Health. (2023). Biopharmaceutical Pricing Trends Report.
