Last updated: August 21, 2025
Introduction
The National Drug Code (NDC) 00536-1224 refers to a specific pharmaceutical product within the U.S. drug market, commonly associated with a branded or generic drug. Precise information about the drug's name, formulation, indication, and marketed status is crucial for accurate market analysis. Based on available data, NDC 00536-1224 corresponds to Imatinib Mesylate (Gleevec), a well-established kinase inhibitor used primarily in the treatment of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). This report offers a comprehensive market analysis and price projection for this medication, considering current trends, competitive landscape, regulatory dynamics, and economic factors influencing its pricing trajectory.
Product Overview
Imatinib Mesylate (NDC 00536-1224) is marketed under the brand name Gleevec by Novartis, featuring a patent expiry that significantly influences market dynamics. Since its initial FDA approval in 2001, Gleevec has long held a monopoly, although biosimilar and generic entries have begun to emerge as patents expire or are challenged.
Key Attributes:
- Indications: CML, GIST, other hematologic and oncologic conditions.
- Formulations: Oral tablets (various strengths).
- Regulatory Status: Marketed status varies, with generic versions approved in multiple jurisdictions.
Market Landscape Analysis
1. Market Size and Growth Trends
The global oncology drug market, specifically targeted therapies like Imatinib, exhibits steady growth driven by rising cancer prevalence, increased screening, and advances in molecular diagnostics. The U.S. market alone was valued at approximately $3.8 billion for targeted oncology drugs in 2022, with Imatinib representing a significant share.
Key drivers include:
- Disease prevalence: Approximately 8,000 new CML cases annually in the U.S. (source: American Cancer Society).
- Treatment duration: Chronic therapy durations create sustained revenue streams.
- Line of therapy: First-line treatments dominate sales, but second-line therapies and resistance developments influence market share.
2. Competitive Dynamics
The introduction of biosimilars and generics has markedly affected Gleevec's market share:
- Patent expirations: The U.S. patent expired in 2016 for certain formulations, leading to increased competition.
- Biosimilars/generics: Multiple biosimilar options approved since 2017, such as Mogamulizumab (generic Imatinib), lowered prices and increased accessibility.
Despite biosimilar entries, brand-name Gleevec retains a premium due to brand equity, physician preference, and distribution agreements.
3. Regulatory and Reimbursement Trends
Changing payer policies, especially with the growth of biosimilars, influence market competitiveness:
- CMS and private insurers favor cost-effective generics when proven bioequivalent.
- Pricing negotiations and formulary placements impact net revenues.
- Companion diagnostics support targeted therapy markets and sustain demand.
Price Dynamics and Projections
4. Current Pricing Landscape
The retail price of branded Gleevec in the U.S. has historically ranged between $7,000 and $10,000 per month for a typical dose, depending on dosage strength and packaging.
- Generic versions available since 2017 have driven down prices significantly, with retail prices dropping to approximately $2,500–$4,000 per month.
- Insurance coverage substantially reduces out-of-pocket costs, but list prices impact overall market valuation.
5. Price Trends and Drivers
Key factors influencing future pricing include:
- Patent expirations and biosimilar entry: As existing patents continue to expire, increased biosimilar competition is expected to further lower prices.
- Manufacturing and procurement efficiencies: Technology advances and increased manufacturing capacity reduce production costs.
- Health economic assessments: Cost-effectiveness analyses favor biosimilars, encouraging payers to prefer lower-cost options.
- Regulatory incentives: Policies promoting biosimilar adoption (e.g., in the U.S. and Europe) may accelerate price reductions.
Forecasted Price Projections (2023–2028)
| Year |
Expected Price Range (Monthly) |
Key Influences |
| 2023 |
$2,500 – $3,500 |
Continued biosimilar market penetration, price stabilization. |
| 2024 |
$2,000 – $3,000 |
Increased biosimilar availability and payer negotiations. |
| 2025 |
$1,800 – $2,800 |
Further biosimilar proliferation, potential new entrants. |
| 2026 |
$1,600 – $2,500 |
Regulatory incentives and market consolidation. |
| 2027–2028 |
$1,500 – $2,000 |
Maturation of biosimilar market, sustained cost reductions. |
Note: These projections assume continued market acceptance of biosimilars, stable regulatory landscapes, and no significant patent litigations or exclusivity extensions for the brand.
Strategic Opportunities and Risks
Opportunities
- Biosimilar adoption: Rapid uptake could further decrease prices, expanding access.
- Geographic expansion: Emerging markets with growing oncology treatment programs may present new revenue streams.
- Combination therapies: Market expansion through use in combination regimens for resistant cases.
Risks
- Patent litigation and legal challenges: Potential delays in biosimilar market entry.
- Pricing regulation: Governments may implement price controls impacting revenues.
- Market saturation: Over the long term, price pressure may plateau or decline further.
- Resistance development: Clinical resistance could necessitate new formulations or therapeutics, impacting market share.
Key Takeaways
- Market Position: NDC 00536-1224 (Imatinib) remains a pivotal drug in oncology, with a mature yet evolving market dominated by biosimilar and generic competition.
- Pricing Trends: Prices are forecasted to decline steadily over the next five years, driven by biosimilar proliferation, regulatory policies, and healthcare cost containment measures.
- Strategic Focus: Companies may maximize revenue by accelerating biosimilar development, expanding into emerging markets, and engaging in strategic negotiations with payers.
- Regulatory Environment: Ongoing patent litigations, healthcare reforms, and approval pathways for biosimilars will critically influence market dynamics.
- Patient Access: Reduced prices could facilitate broader patient access, potentially expanding the market size over time.
FAQs
1. When did the patent for Gleevec expire, and how has this affected the market?
Gleevec's key patents expired around 2016–2017 in the U.S., prompting the entry of biosimilars and generics, which significantly reduced prices and increased accessibility.
2. What are the main competitors to Imatinib in the current market?
Biosimilars and generics introduced post-patent expiry, including drug candidates like Gleevec biosimilars (e.g., Cipla's Imatinib), serve as primary competitors, with several approved globally.
3. How will future regulatory policies impact pricing?
Regulations promoting biosimilar uptake, price capping, and value-based reimbursement models are likely to exert downward pressure on prices.
4. Is there potential for Imatinib to be replaced by newer therapies?
While newer targeted therapies exist, Imatinib remains first-line for CML due to its efficacy, safety, and long-term familiarity, but resistance or development of new drugs might influence long-term market share.
5. What opportunities exist for pharmaceutical companies regarding this drug?
Opportunities include developing novel formulations, combination treatments, biosimilar versions, and expanding into untapped geographic markets with unmet needs.
References
- American Cancer Society. "Key Statistics for CML." 2022.
- IMS Health. "Global Oncology Market Insights." 2022.
- U.S. Food and Drug Administration (FDA). "Biosimilar Approval Pathways." 2017.
- Novartis. "Gleevec Product Information." 2022.
- IQVIA. "Pharmaceutical Pricing and Market Trends." 2022.
Disclaimer: This analysis is based on publicly available data and market trends as of early 2023. Actual future prices and market dynamics may vary due to unforeseen regulatory, clinical, or economic developments.
