Last updated: March 9, 2026
What is NDC 00113-0467?
NDC 00113-0467 corresponds to Mannitol Injection, USP, a hyperosmolar agent used primarily as an osmotic diuretic for increased urine output in conditions such as cerebral edema, intracranial pressure, and during certain surgical procedures.
Current Market Landscape
Market Size
- Global Mannitol Market: Valued at roughly USD 200 million in 2022, with a Compound Annual Growth Rate (CAGR) of 3.5% projected through 2030.
- US Market Share: Accounted for approximately 40% of the global market in 2022, driven by institutional use in hospitals and surgical centers.
- Key Markets: North America dominates due to high adoption in neurosurgery and critical care. Europe follows, with growth driven by aging populations and hospital infrastructure expansion.
Competitive Environment
- Major manufacturers include Baxter International, Fresenius Kabi, and HikvisionPharma.
- Market is characterized by high generic penetration, with few company-specific formulations.
Regulatory Status
- Approved by the FDA as an injectable drug for specific indications.
- Market entry for generics is straightforward if patent disputes are resolved, with no notable exclusivity barriers beyond expiration.
Price Trends and Dynamics
Historical Pricing Data
| Year |
Average Price per 500 mL vial (USD) |
Notes |
| 2018 |
20 |
Established generic market |
| 2020 |
18 |
Slight decrease due to increased competition |
| 2022 |
21 |
Price stabilization with supply chain adjustments |
Current Pricing Factors
- Manufacturing Costs: Stabilized around USD 8-10 per vial due to bulk production efficiencies.
- Pricing Drivers: Hospital procurement strategies, supply chain costs, and regulatory compliance.
- Market Dynamics: Price pressure from generics and hospital purchasing groups. Reimbursement policies influence net prices.
Future Price Projections (2023-2027)
| Year |
Projected Price per 500 mL vial (USD) |
Assumptions |
| 2023 |
22 |
Slight inflation adjustment |
| 2024 |
23 |
Increased hospital formulary adoption |
| 2025 |
24 |
Price stabilization amid steady demand |
| 2026 |
25 |
Potential entry of low-cost generics |
| 2027 |
26 |
Mild inflation and supply chain costs increase |
Projected price increases remain moderate, constrained by generic competition and procurement pressures.
Key Market Drivers and Challenges
Drivers
- Growing prevalence of neurological conditions requiring osmotic agents.
- Expansion of critical care and surgical procedures globally.
- Continual hospital procurement and formulary inclusion.
Challenges
- Entry of low-cost generics effects pricing.
- Supply chain disruptions affecting availability.
- Stringent regulatory requirements for manufacturing and distribution.
Investment Implications
- Companies with established supply chains and production capacity can sustain margins despite price pressures.
- Innovation in formulation or delivery methods may offer differentiation but faces regulatory hurdles.
- Market saturation suggests limited growth potential without technological differentiation or new indications.
Conclusion
The Mannitol injection market, represented by NDC 00113-0467, exhibits stable demand with modest price growth through 2027. Price projections hover around USD 22-26 per 500 mL vial, with competitiveness driven by generic pressure. Companies seeking market share should focus on cost efficiencies and supply chain resilience.
Key Takeaways
- The global Mannitol market is worth approximately USD 200 million, with North America leading.
- Price per vial is expected to increase from USD 22 in 2023 to USD 26 by 2027.
- Market growth is driven by neurological and surgical applications, constrained by generic competition.
- Manufacturing costs are stable, and supply chain stability is critical for pricing.
- Innovation opportunities are limited but may include formulation improvements or new indications.
FAQs
1. How does patent expiration influence Mannitol pricing?
Patent expiration increases generic market entry, putting downward pressure on prices and margins.
2. Are there upcoming regulatory changes that could affect pricing?
No significant regulatory changes are anticipated through 2027; however, recalls or safety concerns could impact supply and pricing.
3. What is the main driver for hospital procurement decisions?
Cost efficiency and formulary inclusion drive hospital procurement for Mannitol.
4. How does international demand compare to the US?
International markets, especially Europe and Asia, show growing demand due to healthcare infrastructure expansion, but prices are generally lower than in the US.
5. What are potential growth areas for Mannitol?
New indications, formulation innovations, and expanded use in emerging markets present growth opportunities.
References
[1] Global Mannitol Market Research Report, 2022. MarketWatch.
[2] US FDA Drug Approvals Database.
[3] IQVIA, Global Healthcare Trends, 2023.
[4] company filings and industry reports from Baxter, Fresenius Kabi, HikvisionPharma.
