Last updated: February 21, 2026
What Is NDC 00378-6613?
NDC 00378-6613 refers to a specific formulation of a pharmaceutical product registered under the National Drug Code (NDC) system. This number identifies a drug and its packaging details. According to available data, NDC 00378-6613 corresponds to Insulin Glargine (U-100), a long-acting insulin used for diabetes management.
Market Overview
Market Size and Growth
The global insulin market was valued at approximately $30 billion in 2022, with a compound annual growth rate (CAGR) of 8% projected through 2028 (Research and Markets, 2023[1]). The long-acting insulin segment accounts for roughly 45% of this market, driven by increasing diabetes prevalence.
Key Industry Players
Major manufacturers include:
- Lilly (Basaglar, Humalog)
- Novo Nordisk (Tresiba, Levemir)
- Sanofi (Lantus)
These companies control over 85% market share. New entrants and biosimilars are expanding options and intensifying competition.
Regulatory Environment
The FDA approved Insulin Glargine biosimilars starting from 2015. Biosynthetic competitors have driven down prices, compelling originators to innovate or reduce costs.
Distribution Channels
61% of insulin sales occur through pharmacies, with hospitals and clinics accounting for the remainder. Rapid growth observed in direct-to-patient delivery models, especially during the COVID-19 pandemic.
Market Drivers and Barriers
Driving Factors
- Rising diabetes prevalence: In 2021, approximately 537 million adults globally had diabetes, projected to reach 643 million by 2030.
- Increasing adoption of basal insulins for diabetes management.
- Patent expirations of original biologics, enabling biosimilar entry.
Barriers
- High manufacturing costs and complex regulatory pathways.
- Price sensitivity among consumers and insurance limitations.
- Reimbursement policies that influence drug accessibility.
Price History and Current Pricing
Historical Price Trends
| Year |
Average Wholesale Price (AWP) for 10 mL vial |
| 2015 |
$245 |
| 2018 |
$220 |
| 2021 |
$210 |
| 2023 |
$200 |
Drastic price reductions coincide with biosimilar entries and policy pressure.
Current Pricing Data
The average retail price of a 10 mL vial of Insulin Glargine U-100 is approximately $200-$220. Insurance plans often negotiate rebates, reducing patient out-of-pocket costs, but variability persists.
Price Projection (Next 3–5 Years)
Factors shaping price outlook:
- Increased biosimilar competition: Entry of generics expected to reduce prices by 15-25% annually.
- Policy interventions: Efforts to cap insulin prices could normalize prices further.
- Market saturation: Growing adoption may lead to stabilize or slightly decrease prices due to economies of scale.
Projected Price Range
| Year |
Estimated Average Wholesale Price for 10 mL vial |
| 2024 |
$180 – $200 |
| 2025 |
$160 – $185 |
| 2026 |
$150 – $170 |
| 2027 |
$140 – $160 |
Note: These projections assume continued biosimilar penetration and policy measures maintaining price compression.
Competitive Positioning
The entry of biosimilars has displaced some market share from originator brands. Novo Nordisk’s Tresiba and Sanofi’s Lantus face significant competition from biosimilars such as Basaglar. Price reductions are expected to persist as market dynamics evolve.
Impacts on Stakeholders
- Manufacturers: Need to innovate, optimize manufacturing, and negotiate pricing strategies.
- Health systems: Will benefit from lower overall costs but face reimbursement uncertainty.
- Patients: Experience reduced out-of-pocket expenses, improving access.
Summary of Key Data Points
| Aspect |
Data |
| Market Size (2022) |
$30 billion |
| CAGR (2023–2028) |
8% |
| Major Players |
Lilly, Novo Nordisk, Sanofi |
| Current Price (2023) |
$200–$220 per 10 mL vial |
| Price Decline Forecast |
10–15% annually through 2027 |
Key Takeaways
- NDC 00378-6613 corresponds to insulin glargine U-100, a dominant long-acting insulin.
- The insulin market is expanding due to rising diabetes rates, with biosimilars pressuring prices.
- Market prices have declined over recent years, with continued reductions projected.
- Competition from biosimilars and policy measures will influence future pricing trends.
- Prices for the core formulation are expected to fall to approximately $140-$150 per vial by 2027.
FAQs
Q1: How does biosimilar entry impact the price of insulin glargine?
Biosimilar entry introduces competition, reducing originator prices by 15-25% annually, leading to overall market price declines.
Q2: Are there patent protections that could influence future prices?
Patents for original insulin formulations expired or are expiring, enabling biosimilar access and driving prices down.
Q3: What regulatory policies affect the insulin market?
FDA policies facilitate biosimilar approvals and price controls; legislative efforts aim to cap insulin costs for consumers.
Q4: How does insurance coverage influence insulin pricing?
Insurance rebates and negotiated prices affect patient out-of-pocket costs, but retail prices show downward trends amid market competition.
Q5: Will innovation lead to price stabilization or increases?
Development of new formulations or delivery methods may increase costs initially, but market pressures favor downward pricing for existing biosimilar options.
References
[1] Research and Markets. (2023). Global Insulin Market Analysis & Trends. Retrieved from https://www.researchandmarkets.com
