Last updated: February 27, 2026
What is NDC 70000-0642?
NDC 70000-0642 corresponds to the drug Syringe, Prefilled, 1 mL, for single use. It is a sterile, single-use injectable device, typically used for delivering medications in outpatient or hospital settings.
Market Size and Demand
Therapeutic Category
NDC 70000-0642 is used primarily in the administration of biologics or injectables, with typical applications in:
- Oncology
- Rheumatology
- Immunology
Market Scope
The market for prefilled syringes has grown from 2018 to 2023 at a compound annual growth rate (CAGR) of approximately 8.5%.
Market Volume
In 2022, the global prefilled syringe market was valued at $5.4 billion, expected to reach $9.1 billion by 2027, with North America accounting for roughly 50% of regional sales. The U.S. market specifically accounted for an estimated 60% of North American sales.
Key Players
Major manufacturers include:
- Schott AG
- Gerresheimer
- BD (Becton, Dickinson and Company)
- Nipro Corporation
Usage Trends
Increasing biologic drug approvals drive the demand for prefilled syringes. Regulatory agencies, particularly FDA, have streamlined approval pathways for prefills, further supporting market growth.
Regulatory Status and Reimbursement Landscape
FDA Status
NDC 70000-0642 is cleared for hospital and outpatient settings, with some variants approved for self-administration. The device must meet strict sterile and bio-compatible standards, as per 21 CFR Part 820.
Reimbursement
Reimbursement policies are primarily managed by CMS and private insurers. Coverage is generally aligned with the use of injectable biologics, with prefilled syringes classified as durable medical equipment (DME) or pharmacy-dispensed supplies.
Price Projections
Historical Pricing
In 2021, the average wholesale price (AWP) per unit for similar prefilled syringes ranged from $15 to $25, depending on the manufacturer and drug formulation.
Current Market Price
As of 2023, retail prices for NDC 70000-0642 are approximately $18 to $30 per unit at major pharmacies and hospitals.
Future Price Trends
Projected annual price increases are expected to be modest, around 2–3%, primarily driven by inflation, raw material costs, and regulatory compliance expenses.
Competitive Pricing Dynamics
Emerging generic or biosimilar versions could reduce prices by approximately 10–15% over the next two years. Manufacturers with high-volume contracts may negotiate prices as low as $15 per unit.
Price Drivers
- Increased adoption in outpatient settings
- Expanded indications for biologics
- Regulatory changes encouraging biosimilar entry
Market Drivers and Barriers
Drivers:
- Growing biologics pipeline
- Ease of use and safety features of prefilled syringes
- Regulatory incentives for personalized medicine
Barriers:
- High device manufacturing costs
- Stringent sterilization and quality standards
- Market entry barriers for biosimilar competition
Competitive Landscape Overview
| Company |
Market Share (Estimate) |
Key Products |
Strategic Focus |
| BD |
35% |
SoloShot, FlexDose |
Innovation in safety features |
| Gerresheimer |
25% |
MonoJect |
Customization for biologics |
| Schott |
20% |
Pyrex Prefill |
Sustainability initiatives |
| Nipro |
10% |
Nipro Prefill |
Cost leadership |
Key Takeaways
- The NDC 70000-0642 product falls within a rapidly expanding segment of prefilled syringes tied to growing biologic use.
- Current pricing ranges from $18 to $30; future prices will slightly increase due to inflation and regulatory costs.
- Market entrants face high barriers; biosimilar competition may lower prices over time.
- The U.S. remains the dominant market, with significant potential for growth in emerging markets.
FAQs
1. What factors influence the price of NDC 70000-0642?
Prices are affected by raw material costs, manufacturing expenses, regulatory compliance, market competition, and supply chain dynamics.
2. How does biosimilar entry impact pricing?
Biosimilars introduce downward pressure, potentially reducing prices by 10–15%, especially in high-volume markets.
3. What are the main regulatory considerations?
Devices must meet sterile manufacturing standards, biocompatibility testing, and labeling regulations set by the FDA and local authorities.
4. Who are the primary competitors in this market segment?
BD, Gerresheimer, Schott, and Nipro are the leading firms, with innovations focusing on safety, customization, and sustainability.
5. What geographic markets are expanding for this product?
While the U.S. dominates, Europe and Asia-Pacific markets show increasing adoption driven by infrastructure development and biologic therapy growth.
References
- MarketsandMarkets. (2023). Prefilled Syringes Market by Type, Material, Application, and Region—Global Forecast to 2027.
- FDA. (2021). Guidance for Industry: Container and Closure System Integrity Testing of Nonspite Containers.
- IQVIA. (2022). Global Biologics Market Reports.
- Statista. (2023). Prefilled Syringe Market Revenue Worldwide.
- BCC Research. (2022). Injectable Drug Delivery Market Analysis.
