Market Analysis and Price Projections for Fentanyl Citrate Injection (NDC: 00409-9094)
Introduction
Fentanyl citrate injection, a potent opioid analgesic, is crucial in managing severe pain, particularly in clinical and surgical settings. The drug, identified by the NDC 00409-9094, is manufactured by Pfizer and has been a subject of interest due to recent shortages and pricing dynamics. Here, we delve into the market analysis and price projections for this essential medication.
Current Market Status
The fentanyl citrate injection market is currently affected by shortages from several manufacturers, including Hikma and Fresenius Kabi. However, Pfizer continues to supply the market with various formulations of fentanyl citrate injection[1][5].
Reasons for Shortages
- Hikma: The shortage is attributed to supply and demand issues.
- Fresenius Kabi: No specific reason has been provided.
- Akorn: Ceased operations in February 2023.
Despite these challenges, Pfizer remains a reliable supplier, offering multiple formulations such as 5 mL, 10 mL, 20 mL, and 50 mL vials[1][5].
Pricing Dynamics
Prescription drug prices in the U.S. are significantly higher compared to other countries. For instance, prices in the U.S. are 5.5 times higher than in the OECD (excluding the U.S.) and 7.7 times higher than in the rest of the world (excluding the U.S.)[4].
Historical Price Trends
Between 2017 and 2022, the average price per unit of prescription drugs in the U.S. increased by 14%, while prices in the OECD (excluding the U.S.) and the rest of the world decreased by 9% and 7%, respectively[4].
Impact of Shortages on Pricing
Shortages can lead to price volatility. However, with Pfizer maintaining a steady supply, the price of fentanyl citrate injection (NDC: 00409-9094) is less likely to experience significant spikes due to shortages alone. Instead, prices may be influenced by broader market trends and regulatory factors.
Regulatory Environment
The regulatory landscape plays a crucial role in drug pricing. Initiatives such as the Prescription Drug Price Transparency Act in Oregon aim to provide accountability by disclosing specific pricing information from pharmaceutical manufacturers, health insurers, and consumers[2].
Transparency and Affordability
Efforts to enhance transparency and implement measures like upper payment limits for certain drugs are being explored. These initiatives could potentially impact the pricing strategy for drugs like fentanyl citrate injection, although their direct impact is still speculative[2].
Market Size and Growth
The biopharma and biotech industries, which include opioid analgesics like fentanyl, are experiencing rapid growth. The biopharma market size was estimated to be over $400 billion in 2024, with a projected CAGR of 7.56% between 2024 and 2029[3].
Biologic Products
Biologic products, including some opioid formulations, have seen significant growth. In the U.S., sales revenues for biologic products grew by 61% between 2017 and 2022, indicating a strong market demand for advanced pharmaceuticals[4].
Price Projections
Given the current market dynamics, here are some key points to consider for price projections:
Stable Supply from Pfizer
Pfizer's continued supply of fentanyl citrate injection is expected to stabilize prices, preventing sharp increases due to shortages.
Regulatory Pressures
Ongoing regulatory efforts to enhance transparency and control drug prices could lead to more stable or slightly reduced prices over the long term.
Market Growth
The overall growth in the biopharma and biotech sectors suggests that while prices may not drop significantly, they are likely to be managed within a predictable range.
Implications for Patient Care
The availability of fentanyl citrate injection from Pfizer mitigates some of the risks associated with shortages. However, healthcare providers must remain vigilant about potential price fluctuations and ensure that patient care is not compromised due to cost or availability issues.
Key Takeaways
- Stable Supply: Pfizer's supply ensures that prices for fentanyl citrate injection (NDC: 00409-9094) are less likely to spike due to shortages.
- Regulatory Environment: Ongoing regulatory efforts aim to enhance transparency and control prices, which could stabilize or reduce prices.
- Market Growth: The biopharma and biotech sectors are growing, but this growth is unlikely to lead to significant price increases for fentanyl citrate injection.
- Patient Care: Ensuring stable access to this medication is crucial for maintaining high standards of patient care.
FAQs
Q: Why is there a shortage of fentanyl citrate injection from some manufacturers?
A: The shortage is due to various reasons including Akorn ceasing operations, Fresenius Kabi not providing a reason, and Hikma facing supply and demand issues[1][5].
Q: How does the regulatory environment impact drug pricing?
A: Regulatory efforts such as the Prescription Drug Price Transparency Act aim to enhance transparency and control prices, potentially stabilizing or reducing them[2].
Q: What is the projected growth rate of the biopharma market?
A: The biopharma market is projected to grow at a CAGR of 7.56% between 2024 and 2029[3].
Q: How do biologic products contribute to the overall market growth?
A: Biologic products have seen significant growth, with U.S. sales revenues increasing by 61% between 2017 and 2022[4].
Q: What are the implications of price trends for patient care?
A: Stable prices and availability ensure that patient care is not compromised due to cost or availability issues, maintaining high standards of care.
Sources
- Drugs.com - Fentanyl Citrate Injection Shortage
- Oregon’s Prescription Drug Price Transparency Program - Annual Report 2022
- TFS CRO - 5 Predictions for the Biopharma and Biotech Industries in 2025
- ASPE - International Market Size and Prices
- ASHP - Drug Shortage Detail: Fentanyl Citrate Injection
