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Market Analysis and Price Projections for NDC 31722-0230
Last updated: March 13, 2026
What is NDC 31722-0230?
NDC 31722-0230 is the human insulin product, marketed as Humulin R U-500 (insulin human injection, U-500). It is indicated for patients with severe insulin resistance requiring high doses of insulin.
Market Overview
Product Details
Type: Human insulin, U-500 formulation
Approved: 2017 by the FDA
Manufacturer: Eli Lilly and Company
Therapeutic class: Basal-bolus insulin therapy for diabetes mellitus
Market Size
Global insulin market: Valued at approximately USD 36 billion in 2022.
U.S. insulin market: Estimated at USD 15 billion in 2022, representing around 42% of global sales.
U-500 insulin segment: Accounts for roughly 2-3% of total insulin prescriptions but has seen growth driven by rising cases of severe insulin resistance.
Key Drivers
Rising prevalence of Type 2 diabetes (estimated 37 million Americans in 2022)
Increased adoption of high-dose insulins in resistant patient populations
Growing awareness of insulin therapy options
Market Competition
Other U-500 formulations: Humulin R U-500, Humulin R, Tresiba (insulin degludec)
Demand stabilization, continued inflation adjustments
2027
$150–$200
Patent landscape shifts, market maturation
Potential Influences on Price Development
Entry of biosimilars or generic versions could reduce prices by 10–20% within five years.
Policy changes encouraging biosimilar adoption could accelerate price reductions.
Manufacturing costs are projected to stay stable or slightly increase, limiting steep price falls unless market competition intensifies.
Market Risks
Pricing pressures from biosimilars or generics.
Changes in reimbursement policies affecting patient access.
Patent law disputes or litigation affecting market exclusivity.
Competitive Outlook
Eli Lilly leads the high-dose insulin segment with continued R&D investment.
Entry of biosimilar insulins could alter market dynamics, providing competitively priced alternatives.
Adoption of insulin pumps and alternative delivery methods could influence demand.
Key Takeaways
NDC 31722-0230 (Humulin R U-500) targets a niche market within high-dose insulin therapy.
Current market price ranges from USD 125 to USD 175 per vial, with stable trends noted over recent years.
Price projections indicate moderate increases through 2028, influenced by inflation, competition, and policy shifts.
Biosimilar entrants pose a significant risk to price reduction, potentially disrupting current market shares.
The growing prevalence of severe insulin resistance maintains steady demand, supporting stable pricing.
FAQs
What clinical indications justify the use of NDC 31722-0230?
It is indicated for patients with severe insulin resistance requiring high doses of insulin, typically above 200 units per day.
Are biosimilars available for U-500 insulin?
As of now, no biosimilar has received FDA approval for U-500 insulin; however, several biosimilar candidates are progressing through development.
What are the main factors influencing the cost of high-dose insulin?
Manufacturing complexity, regulatory expenses, market demand, and patent protections primarily drive pricing.
How does the price of U-500 insulin compare to traditional U-100 insulins?
U-500 insulin costs roughly double or triple per unit compared to U-100 formulations, justified by dosing efficiency for certain patients.
What are the reimbursement challenges for high-dose insulin therapies?
Reimbursement depends on formulary coverage, patient insurance plans, and negotiated discounts, which may limit patient out-of-pocket expenses but can restrict market access.
References
[1] IQVIA. (2022). Global insulin market report.
[2] FDA. (2017). Approval of Humulin R U-500.
[3] Centers for Disease Control and Prevention. (2022). National Diabetes Statistics Report.
[4] Statista. (2022). U.S. insulin market value.
[5] EvaluatePharma. (2022). Biosimilar insulin market overview.
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