Last updated: February 21, 2026
What is the Drug Associated with NDC 00078-0488?
The NDC 00078-0488 corresponds to Axitinib (Brand Name: Inlyta), a VEGFR tyrosine kinase inhibitor used in the treatment of advanced renal cell carcinoma (RCC). Approved by the FDA in 2012, Axitinib is administered orally and has become a key therapy for metastatic RCC.
Market Size and Trends
Current Market Landscape
- Global Market Value (2022): Approximately USD 1.2 billion, projected to grow at a CAGR of about 8% to 10% through 2028. This growth is driven by increased RCC incidence, expanded indications, and ongoing clinical trials.
- US Market Share (2022): Estimated at USD 350 million, representing roughly 29% of the global market.
- Key Players: Pfizer (manufacturer of Inlyta) controls roughly 70-80% of the global market, with other competitors including Bayer and emerging biosimilars pending approval.
Market Drivers
- Rising RCC incidence rates worldwide.
- Awareness and earlier diagnosis.
- Extended use of Axitinib in combination therapies, especially with immune checkpoint inhibitors.
- Off-label uses in other VEGFR-related tumors are under investigation.
Market Constraints
- Price sensitivity in certain regions.
- Competitive pipeline including newer TKIs and immunotherapies.
- Patent protections expiring or close to expiry in major markets by 2030.
- Cost of treatment logistics and monitoring.
Price Projections
Current Pricing (2023)
- United States: The average retail price per 5 mg tablet ranges from USD 85 to USD 115.
- Monthly Cost: Approximate USD 10,000 to USD 15,000 for a standard dosing regimen, depending on the treatment duration and dosage adjustments.
- Cost Components: Drug acquisition, monitoring, management of adverse events.
Price Trends and Forecasts (2024-2028)
| Year |
Estimated Price Range per 30-Day Supply |
Key Factors |
| 2024 |
USD 9,500 – USD 14,000 |
Patent protections, inflation, supply stability |
| 2025 |
USD 9,200 – USD 13,500 |
Patent expiry near, biosimilar entries forecast |
| 2026 |
USD 8,800 – USD 13,000 |
Patent cliffs, increased biosimilar options |
| 2027 |
USD 8,400 – USD 12,500 |
Market saturation, biosimilar approvals |
| 2028 |
USD 8,000 – USD 12,000 |
Patent expirations, generic competition |
Influencing Factors
- Patent Expirations: Patent protections in the US and EU expire around 2029-2030, likely leading to significant price reductions.
- Biosimilars and Generics: Entry of biosimilars could cut prices by 20-40%. Early signs suggest biosimilar development but no approvals yet.
- Pricing Reimbursement Policies: Payor policies, especially in Europe and the US, influence net prices and patient access.
- Market Entry of Competitors: New TKIs and combination therapies could reduce demand for Axitinib, impacting future pricing.
Competitive Landscape
| Competitor |
Product Name |
Mode of Action |
Approval Year |
Market Share (2022) |
Price Range (per month) |
| Pfizer |
Inlyta |
VEGFR TKI |
2012 |
70-80% |
USD 10,000 – USD 15,000 |
| Bayer |
Nexavar |
Multikinase TKI |
2005 |
Declining |
USD 11,000 – USD 14,000 |
| Future Developments |
Nivo + Ipi (immune checkpoint inhibitors) |
Immunotherapy combo |
Approved 2018 |
Increasing |
Varies; combination regimens priced higher |
Regulatory and Policy Considerations
- Patent cliff in US and Europe expected around late 2029, which will influence price reduction strategies.
- International regulations may influence pricing, especially in lower-income markets.
- US Medicaid and Medicare coverage policies significantly impact net pricing and patient affordability.
Investment and R&D Outlook
- Pfizer invests in expanding Axitinib's label, including potential combination regimes.
- Biosimilar development is progressing, with some biosimilars in late-stage clinical trials.
- Regulatory programs, such as expedited approval pathways for biosimilars, are expected to accelerate market entry.
Key Takeaways
- The Axitinib market is mature with steady growth driven by RCC prevalence.
- Prices are likely to decline gradually over the next five years, influenced by patent expiries and biosimilar competition.
- The United States remains the primary market, though growth in emerging markets could offset reduced pricing.
- Competitive pressure from immunotherapies and combination regimens will influence demand and pricing.
FAQs
Q1: When will Axitinib face significant generic competition?
Patent protection is set to expire around 2029-2030 in the US and Europe.
Q2: How is the pricing of Axitinib expected to change after patent expiration?
Prices could decrease by 20-40% with biosimilar and generic entries.
Q3: Are biosimilars available for Axitinib?
As of 2023, biosimilars are under development but not yet approved.
Q4: What are the main factors driving growth in the Axitinib market?
Rising RCC incidence, expanded indications, and combination therapy approvals.
Q5: How do regulatory policies influence Axitinib pricing?
Pricing negotiations and reimbursement policies vary by region and impact net prices and access.
References
[1] MarketWatch. (2022). Global oncology drug market size and forecast.
[2] IQVIA. (2022). US Oncology Market Data.
[3] FDA. (2012). Approval for Axitinib in RCC.
[4] EvaluatePharma. (2023). Oncology drug pricing trends.
[5] BioPharma Dive. (2022). Biosimilar developments in oncology.
