Last updated: February 15, 2026
What is NDC 00078-0902?
NDC 00078-0902 refers to a formulation of insulin glargine, a long-acting insulin used to manage blood glucose levels in diabetes mellitus patients. It is marketed by Sanofi as Lantus and by Aventis as Toujeo (in its concentrated form).
Market Overview
Market Size and Adoption
The global insulin market exceeded USD 22 billion in 2022, projected to grow at a CAGR of roughly 7% through 2028.[1] Key drivers include rising diabetes prevalence, aging populations, and increased awareness.
The United States accounts for approximately 45% of the global insulin market.[2] Market penetration of long-acting insulins like insulin glargine is over 60% within the U.S. insulin therapy market, reflecting widespread adoption.
Competitive Landscape
Major competitors:
- Novo Nordisk's Levemir (insulin detemir)
- Eli Lilly's Basaglar (biosimilar insulin glargine)
- Sanofi's Lantus and Toujeo
- Emerging biosimilar products from Biocon and others
The biosimilar insulin glargine US approvals began in 2021, intensifying price competition.
Regulatory Environment
The FDA approved the first biosimilar insulin glargine in 2021, expanding options and pressure on pricing for original products.[3] Biosimilars are priced 15-30% lower than originators, affecting market share and revenue.
Price Projections
Current Pricing Landscape
- Brand-name Lantus (original insulin glargine): Wholesale Acquisition Cost (WAC) around USD 255 per 10 mL vial (100 units/mL)[4]
- Toujeo (concentrated insulin glargine): WAC approximately USD 290 per 3 mL pen
- Biosimilar insulins: WAC around USD 190-220 per 10 mL vial
Insurance and pharmacy benefit managers (PBMs) often negotiate discounts, reducing patient costs significantly.
Short-term (Next 1-2 Years) Outlook
- Prices of original insulin glargine products likely to decline 10-15% due to biosimilar competition.
- Biosimilars gaining market share, projected to account for 20-30% of insulin glargine sales by 2025.
- Manufacturer discounts and rebates can lower effective consumer prices further.
Medium- to Long-term (3-5 Years) Outlook
- Industry forecasts indicate further price erosion of 20-25% for original products amid biosimilar and potential interchangeable biosimilar entries.
- Innovation in basal insulin formulations (e.g., ultra-long acting or combination products) may influence market share and pricing strategies.
- Policy shifts towards value-based reimbursement, potential price caps, or increased biosimilar uptake could accelerate price declines.
Factors Influencing Price Trends
- Biosimilar Market Penetration: Entry since 2021 has begun reducing prices, with biosimilar insulin glargine capturing market share.
- Policy and Rebate Dynamics: US drug pricing negotiations and rebate strategies pressurize manufacturer prices.
- Patent Expirations and Legal Challenges: Patent expires for original insulin formulations typically occur in 2025-2027, allowing biosimilar competition to intensify.
- Innovation and Formulation Shifts: New formulations could reposition current insulins in the market, influencing pricing and demand.
Strategic Implications
- Companies with insulin glargine products should prepare for sustained pricing pressure.
- Biosimilar entrants provide revenue opportunities through aggressive pricing but threaten traditional market dominance.
- Payers and providers increasingly favor biosimilars, influencing formulary decisions and patient access programs.
Summary Table
| Parameter |
Current Status |
Short-term Projection (2023-2024) |
Long-term Projection (2025-2028) |
| Brand-name insulin glargine |
USD 255–290 per 10 mL vial |
Down 10-15% due to biosimilar entry |
Down an additional 20-25% |
| Biosimilar insulin glargine |
USD 190–220 per 10 mL vial |
Gains 20-30% market share |
May capture majority of market share |
| Impact of policy changes |
Pending; potential for price caps |
Increased biosimilar adoption |
Further market consolidation |
Key Takeaways
- The insulin glargine market is shifting toward biosimilar competition, exerting downward pressure on prices.
- Original product prices are expected to decrease by up to 25% over five years.
- Biosimilar products will capture an increasing share, further reducing revenue for incumbent brands.
- Price reductions will be cushioned by discounts and rebates, impacting net revenues.
- Regulatory and policy developments remain key catalysts for future pricing trends.
5 FAQs
1. When will biosimilar insulin glargine products become widely available?
Biosimilar insulin glargine products received FDA approval starting in 2021, with increased market penetration expected through 2024-2025.
2. How much can prices decline due to biosimilar competition?
Over five years, prices are projected to decline by up to 25% for original formulations, with biosimilars priced 15-30% lower than the original insulin.
3. What role do insurance companies play in pricing?
Insurance companies and PBMs negotiate rebates and discounts, often resulting in significant reductions in patient out-of-pocket costs, which also influence manufacturer pricing strategies.
4. Will innovation in insulin formulations affect current insulin glargine markets?
Yes. New ultra-long-acting or combination products could capture market share, further pressuring existing products' prices.
5. How does patent expiration impact pricing?
Patent expiry (likely between 2025 and 2027) opens the market for biosimilar competition, leading to price reductions and increased market share for generics and biosimilars.
Citations
- Research and Markets, "Global Insulin Market Outlook," 2022.
- IQVIA, "US Insulin Market Analysis," 2022.
- FDA, "Approval of Insulin Glargine Biosimilar," 2021.
- GoodRx, "Insulin Prices," 2023.
