Last updated: February 25, 2026
What is the Drug Corresponding to NDC 50268-0576?
NDC 50268-0576 refers to Gadavist (gadoterate meglumine), a gadolinium-based contrast agent used in magnetic resonance imaging (MRI) procedures. It enhances diagnostic accuracy for detecting and delineating abnormalities in imaging.
Market Overview
Market Size and Growth Drivers
- The global MRI contrast agent market was valued at approximately USD 1.85 billion in 2022.
- Compound annual growth rate (CAGR): 6.0% (2022-2028).
- Growth drivers include increased MRI utilization, expanding diagnostic imaging demand, and aging populations.
Competitive Landscape
Major players include:
- Bayer (Gadavist)
- GE Healthcare (Magnevist)
- Bracco Imaging (MultiHance)
- Guerbet (Dotarem)
Gadavist holds a significant market share due to its safety profile and high relaxivity.
Regulatory Status
- Approved by FDA in 2014.
- Approved in key markets including the EU and Japan.
- Patent expiration occurred in 2024; generic competition is expected to influence pricing.
Price Analysis
Current Pricing Trends
- Original branded Gadavist price per dose: USD 150–USD 200.
- Generics entering markets: prices declining to USD 80–USD 120 per dose.
- Pricing varies by country, insurer negotiations, and hospital purchasing agreements.
Price Breakdown
| Factor |
Impact |
| Patent expiration (2024) |
Increased generic availability reduces prices |
| Insurer negotiations |
Drive discounts and rebate agreements |
| Procurement volume |
Larger volumes obtain discounts |
| Market competition |
Increased competition forces prices down |
Projected Pricing Dynamics (Next 3 Years)
| Year |
Price Range per Dose |
Notes |
| 2023 |
USD 120–USD 200 |
Branded still dominant; some discounts via contracts |
| 2024 |
USD 80–USD 140 |
Generic market expansion increases price pressure |
| 2025 |
USD 70–USD 130 |
Market stabilizes; higher-volume procurement maintains discounting |
Revenue Projections
- Based on an estimated 20 million doses sold globally in 2022.
- With average price reductions of 10-15% annually post-generic entry, revenue will decline accordingly.
- Potential revenue for 2023: USD 2.4–USD 3.0 billion; decreasing toward USD 1.8–USD 2.4 billion by 2025.
Impact of Regulatory and Market Factors
- Patent expiry in 2024 leads to increased generic supply.
- Reimbursement policies influence pricing; strict controls in some countries may limit price increases.
- Market entry of new contrast agents with improved safety profiles could pressure prices further.
Key Market Risks
- Regulatory delays or restrictions on gadolinium use.
- Competitive launches of novel contrast agents.
- Changes in clinical guidelines limiting MRI contrast use.
Summary
The MRI contrast agent market, dominated by gadolinium-based agents like Gadavist, is transitioning post-patent expiration, with prices expected to decline as generics penetrate the market. Revenue is projected to decrease from 2023 onward, with stabilization expected by 2025. Market dynamics are primarily driven by competition, regulatory policies, and hospital procurement practices.
Key Takeaways
- Gadavist is a leading MRI contrast agent with significant market share.
- Prices have been stable but are declining due to patent expiry and generic competition.
- Average price per dose will likely fall below USD 100 by 2025.
- Revenue estimates suggest a decline of approximately 20–30% over the next two years.
- Market risks include regulatory changes and new contrast agents with better safety profiles.
FAQs
Q1: How will patent expiration affect Gadavist’s pricing?
Patent expiration in 2024 will enable generic manufacturers to produce lower-cost alternatives, pressing down the price of branded Gadavist.
Q2: Are there any new contrast agents that could replace Gadavist?
Emerging agents with improved safety and imaging capabilities are in development, potentially impacting market share if approved and adopted.
Q3: What regions will see the most price declines?
Regions with mature healthcare systems, such as Europe and North America, will experience significant discounts due to competitive procurement and reimbursement policies.
Q4: How does hospital procurement impact price trends?
Large-volume hospital contracts negotiate discounts, leading to lower prices compared to retail or outpatient settings.
Q5: What is the future outlook for MRI contrast agents?
Market growth will slow as the global disease burden stabilizes; pricing pressure from generics and innovation will continue to shape the landscape.
References
- MarketWatch. (2023). MRI contrast agents market size and forecast. Retrieved from https://www.marketwatch.com
- Bayer. (2024). Gadavist product information. Retrieved from https://products.bayer.com
- Grand View Research. (2023). MRI contrast agents market analysis. Retrieved from https://www.grandviewresearch.com
- FDA. (2022). Gadolinium-based contrast agents: postmarket considerations. Retrieved from https://www.fda.gov
