Last updated: February 15, 2026
Overview of the Drug
NDC 00173-0916 corresponds to Gadobutrol Injection, a gadolinium-based contrast agent used primarily for MRI imaging. It is marketed under the brand name Gadovist (or Gadavist in some regions). The drug gained approval from the FDA in 2011 for use in contrast-enhanced MRI exams of the central nervous system, and other body areas.
Market Size and Dynamics
Market Segments:
- Geography: Primarily U.S. and European markets, with growing penetration in Asia-Pacific.
- Applications: Primarily neuroimaging, with expanding use in cardiac and other vascular imaging.
- Healthcare Settings: Hospitals, outpatient imaging centers, and radiology clinics.
Market Data:
- The global MRI contrast agent market was valued at approximately $2.2 billion in 2022.
- It is projected to grow at a compound annual growth rate (CAGR) of about 4-6% from 2023 to 2028.
- The U.S. market encompasses roughly 40% of global sales, driven by high MRI utilization rates and the adoption of advanced contrast agents like gadolinium-based compounds.
Competitive Landscape:
- Major competitors include Bayer’s Gadavist (marketed as Gadovist internally), GE Healthcare’s Dotarem, and Bracco’s ProHance.
- Market share for gadobutrol (NDC 00173-0916) is estimated at 25-30%, with the remainder split among other's agents and generic alternatives.
Pricing Trends
Historical Pricing Data:
- Average wholesale price (AWP) per vial (about 10 mL) ranged from $150 to $250 in the U.S. as of 2022.
- Reimbursement rates in Medicare and private insurance typically add 20-30% markup.
Pricing Factors:
- Price variance driven by healthcare provider contracts and formulary placements.
- Gadolinium-based agents are generally priced higher than older agents like Magnevist.
- Patent protections for gadobutrol expired in 2019 in the U.S., but the drug remains under some market exclusivity through brand recognition and formulary agreements.
Price Projections (2023-2028)
| Year |
Estimated Price per Vial (USD) |
Notes |
| 2023 |
$180 - $220 |
Stable, slight increase due to inflation and supply chain factors. |
| 2024 |
$185 - $225 |
Slight uptick as demand grows in emerging markets. |
| 2025 |
$190 - $230 |
Increased competition from generics in late 2024 may put downward pressure, but brand loyalty and provider contracts support stable prices. |
| 2026 |
$185 - $225 |
Market saturation with generics may cause slight reduction in average price. |
| 2027 |
$180 - $220 |
Continued generic penetration, some price erosion expected. |
| 2028 |
$180 |
Stabilization at lower end of range if generic adoption persists. |
Factors Impacting Price Projections
- Generic Competition: Post-patent expiration, generic gadobutrol producers enter the market, reducing prices.
- Regulatory and Safety Concerns: Ongoing investigations into gadolinium retention could impact future regulations, affecting manufacturing costs and pricing.
- Market Growth: Increased MRI usage, especially in emerging markets, sustains demand but exerts pressure on prices to remain competitive.
- Supply Chain: Manufacturing costs, raw material prices, and global logistics influence pricing stability.
Key Market Risks
- Evolving regulatory standards, especially concerning gadolinium retention and safety.
- Faster-than-anticipated market penetration of generics.
- Changes in reimbursement policies, particularly in the U.S.
Strategic Recommendations
- For Manufacturers: Focus on cost efficiency and differentiation, e.g., through enhanced imaging protocols or combining with therapeutic agents.
- For Investors: Monitor patent expiration timelines and generic manufacturer activities.
- For Healthcare Providers: Evaluate cost-effectiveness, considering total costs for MRI procedures, including contrast agent expenses.
Summary
NDC 00173-0916, gadobutrol injection, faces a mature yet competitive market with stable demand trends. Prices are constrained by patent expiration and rising generic competition but remain supported by physician preference, safety profile, and formulary placements. Price erosion is expected post-2024, stabilizing around $180 per vial through 2028, with upside potential if new indications or safety advantages emerge.
Key Takeaways
- The global MRI contrast agent market is valued at over $2 billion, growing at 4-6% CAGR.
- Gadobutrol (NDC 00173-0916) holds a significant share, but patent expiry has increased generic competition.
- Average price per vial is currently around $200, with a projected slight decline following patent expiration.
- Price decline will be moderated by brand recognition, safety profile, and formulary preferences.
- Market risks include regulatory shifts and healthcare reimbursement policies.
FAQs
1. How does patent expiration affect pricing for gadobutrol?
Patent expiration increases generic competition, typically leading to lower prices due to market entry by multiple manufacturers.
2. What are the main competitors to NDC 00173-0916?
Major competitors include Bayer’s Gadavist, GE Healthcare’s Dotarem, and Bracco’s ProHance.
3. What factors could increase the price of gadobutrol in the future?
Development of new, FDA-approved indications, improvements in safety profile, or supply constraints could potentially raise prices.
4. How do reimbursement policies impact the pricing of MRI contrast agents?
Reimbursement rates influence hospital and imaging center purchasing decisions, indirectly affecting drug prices through negotiated contracts.
5. Is there growth potential in emerging markets?
Yes, increased MRI utilization and expanding healthcare infrastructure in Asia-Pacific and Latin America could boost demand and stabilize or increase prices locally.
References
[1] Market research data on MRI contrast agents, 2022.
[2] FDA approval and market reports for gadobutrol, 2011.
[3] Industry analyst reports on patent expiry and generic competition, 2023.
