Market Dynamics and Financial Trajectory for Aminosyn II 10% in Plastic Containers
Overview of Aminosyn II
Aminosyn II is a sterile, nonpyrogenic amino acid injection designed for intravenous infusion, providing essential and nonessential amino acids for nutritional support. It is available in 10% and 15% concentrations, packaged in 2000 mL flexible plastic containers[2][3].
Market Demand
The demand for parenteral nutrition solutions like Aminosyn II is driven by the need for nutritional support in patients who cannot receive nutrition through the gastrointestinal tract. This includes critically ill patients, those undergoing surgery, and individuals with certain gastrointestinal disorders. The market demand is steady, with an increasing trend due to the growing number of patients requiring intensive care and nutritional support.
Supply Chain and Availability
Currently, the market for Aminosyn II is affected by supply chain disruptions. ICU Medical, the manufacturer, has reported manufacturing delays and shortages of active ingredients, leading to backorders for the 10% and 15% Aminosyn II solutions in 2000 mL containers. These shortages are expected to be resolved by mid-December 2024[5].
Competitive Landscape
The market for amino acid injections is competitive, with several manufacturers providing similar products. Key competitors include Baxter, B. Braun, and ICU Medical. B. Braun, for instance, offers Plenamine and TrophAmine, while Baxter has all amino acid presentations on allocation due to increased demand[5].
Pricing and Cost
The cost of Aminosyn II can vary depending on the pharmacy and the quantity purchased. For a supply of 12000 milliliters (6 x 2000 mL containers), the cost is approximately $211 for cash-paying customers. This price does not include insurance plans and can be reduced using discount cards[4].
Financial Trajectory
Revenue
The revenue generated from Aminosyn II is significant due to its widespread use in hospitals and healthcare facilities. Despite the current shortages, the demand remains high, ensuring a stable revenue stream once the supply issues are resolved.
Cost Factors
The cost of production for Aminosyn II includes the cost of raw materials, manufacturing, and packaging. The use of flexible plastic containers, which are fabricated from specially formulated polyvinylchloride, adds to the production costs. Additionally, the need for refrigeration and the short shelf life of admixtures prepared from Aminosyn II can increase logistical costs[2][3].
Profit Margins
Profit margins for Aminosyn II are influenced by the production costs, market demand, and competition. Given the essential nature of the product, manufacturers can maintain relatively stable profit margins even in the face of supply chain challenges.
Regulatory Environment
Aminosyn II is regulated by health authorities such as the FDA, which oversees the safety, efficacy, and manufacturing standards of the product. Compliance with these regulations is crucial for maintaining market presence and ensuring patient safety. For example, Aminosyn II is classified under Pregnancy Category C, indicating that it should be used in pregnant women only if clearly needed due to the lack of animal reproduction studies[2][3].
Clinical Use and Administration
Aminosyn II is administered peripherally with dilute dextrose solutions and intravenous fat emulsions as part of nutritional support. The solution must be inspected visually for particulate matter and discoloration before administration. Admixtures prepared from Aminosyn II must be stored under refrigeration and used within 24 hours[2][3].
Patient Impact
For patients, the availability of Aminosyn II is critical for their nutritional well-being, especially in cases where oral or enteral nutrition is not feasible. The current shortages can impact patient care, highlighting the need for reliable supply chains and alternative products when necessary.
Future Outlook
The future outlook for Aminosyn II is positive, driven by the ongoing need for parenteral nutrition solutions. Once the current supply chain issues are resolved, the market is expected to stabilize, and demand is likely to remain strong. Manufacturers will need to focus on maintaining production capacity and ensuring the quality and safety of the product to meet this demand.
Key Takeaways
- Market Demand: Steady demand driven by the need for nutritional support in critically ill patients.
- Supply Chain: Current shortages due to manufacturing delays and active ingredient shortages.
- Pricing: Approximately $211 for 12000 milliliters, with potential discounts using coupon cards.
- Financial Trajectory: Stable revenue stream with moderate profit margins.
- Regulatory Environment: Strict compliance with FDA regulations necessary.
- Clinical Use: Essential for nutritional support, with specific administration and storage requirements.
FAQs
What is Aminosyn II used for?
Aminosyn II is used as a parenteral nutrition solution to provide essential and nonessential amino acids for patients who cannot receive nutrition through the gastrointestinal tract.
Why is Aminosyn II currently in short supply?
Aminosyn II is currently in short supply due to manufacturing delays and shortages of active ingredients.
How is Aminosyn II administered?
Aminosyn II is administered peripherally with dilute dextrose solutions and intravenous fat emulsions as part of nutritional support.
What are the storage requirements for Aminosyn II admixtures?
Admixtures prepared from Aminosyn II must be stored under refrigeration and used within 24 hours.
Can Aminosyn II be used in pregnant women?
Aminosyn II should be used in pregnant women only if clearly needed, as it is classified under Pregnancy Category C.
Sources
- ICU Medical: Aminosyn™ II, Sulfite-Free.
- Pfizer Labeling: AMINOSYN® II AN AMINO ACID INJECTION.
- DailyMed: AMINOSYN II- isoleucine, leucine, lysine acetate, methionine.
- Drugs.com: Aminosyn II Prices, Coupons, Copay Cards & Patient Assistance.
- ASHP: Drug Shortage Detail: Amino Acid Products.
