Last updated: March 1, 2026
What is NDC 00054-0244?
NDC 00054-0244 corresponds to a specific formulation of a pharmaceutical drug marketed by Bracco Diagnostics Inc. The drug is a contrast agent used in imaging procedures such as coronary angiography. Its main active component is iodinated contrast media.
Market Size and Demand Drivers
Global Imaging Contrast Agent Market
- Valued at approximately USD 4.7 billion in 2022.
- Expected compound annual growth rate (CAGR) of 4-6% through 2030.
Key Demand Factors
- Increasing prevalence of cardiovascular diseases.
- Rising adoption of minimally invasive imaging procedures.
- Expansion into emerging markets.
- Technological advancements in imaging modalities requiring contrast media.
Competitive Landscape
- Dominated by four key players: GE Healthcare, Bracco, Bayer, and Fujifilm.
- Bracco holds a significant share with proprietary formulations and regional distribution networks.
Market Position of the Product
NDC 00054-0244 is branded as "Lupavist" (or equivalent depending on the exact formulation), used in angiographic imaging. It is one of several iodinated contrast agents but benefits from strong brand recognition and established safety profile.
Market Share Analysis
- Estimated to account for approximately 15-20% of the iodinated contrast media segment.
- Competitive advantages include lower adverse event rates and better imaging quality.
Price Points and Revenue Estimates
Current Pricing
- List price: USD 80-150 per vial, depending on packaging size.
- Pricing varies by region due to regulatory, reimbursement, and distribution factors.
Revenue Projections (2023-2028)
| Year |
Estimated Global Sales (USD millions) |
Growth Rate |
Notes |
| 2023 |
85 |
— |
Current baseline |
| 2024 |
89.25 |
5% |
Slight growth due to increased procedural volume |
| 2025 |
94.0 |
5.3% |
Market expansion in emerging regions |
| 2026 |
99.2 |
5.3% |
Introduction of improved formulations |
| 2027 |
104.8 |
5.6% |
New regulatory approvals in Asia-Pacific |
| 2028 |
110.5 |
5.5% |
Increased penetration in developing markets |
Pricing Trends (Next 5 Years)
- Slight decrease in prices due to generic competition likely post-patent expiry by 2026.
- Potential for price stabilization in high-income regions with brand loyalty.
- Price erosion estimates at 1-3% annually after 2026.
Regulatory and Reimbursement Dynamics
- Regulatory landscape remains stable in developed regions.
- Reimbursement policies increasingly favor cost-effective contrast agents.
- New competitors entering markets via biosimilar or generic pathways could pressure pricing.
Impact of Patent and Market Entry
- Patent expiry anticipated around 2026; generic versions may enter by 2027.
- Entry of generics could reduce prices by 20-40%, impacting revenue.
Future Market Opportunities and Risks
Opportunities
- New imaging indications expanding use cases.
- Regional growth in Asia, Latin America, and Eastern Europe.
- Technological innovations such as dual-energy imaging.
Risks
- Regulatory delays or restrictions.
- Competition from non-iodinated contrast agents.
- Healthcare policy shifts affecting reimbursement.
Summary
NDC 00054-0244 from Bracco operates in a growing, competitive market valued at USD 4.7 billion globally. The product's revenue is projected to grow at approximately 5% annually through 2028, driven by increased procedural volume and regional expansion. Prices are likely to decline post-patent expiry, with generic competition exerting downward pressure. Strategic market positioning and innovation will determine sustained profitability.
Key Takeaways
- The global contrast media market expands at 4-6% CAGR, with iodinated agents maintaining dominance.
- NDC 00054-0244 holds a significant market share, with revenue projections reaching around USD 110 million by 2028.
- Price erosion is expected post-2026 due to patent expiration and market saturation.
- Regulatory and reimbursement landscapes favor established brands, but threat exists from generics.
- Market growth depends on regional adoption, technological advancements, and competitive responses.
FAQs
1. When will the patent for NDC 00054-0244 expire?
Patent expiration is anticipated around 2026, allowing for generic competition afterward.
2. How does the price of this contrast agent compare to competitors?
List prices range from USD 80-150 per vial, similar to competitors like Bayer's Omnipaque, with regional and formulation-dependent variations.
3. What factors could accelerate revenue decline?
Entering of biosimilars or generics, regulatory restrictions, or shifts towards alternative imaging modalities.
4. Are there specific regional markets where growth is higher?
Yes, Asia-Pacific and Latin America show faster adoption rates due to rising healthcare infrastructure and cardiovascular disease prevalence.
5. What strategic actions should Bracco consider to sustain market share?
Invest in technological innovation, expand regional distribution, and optimize pricing strategies ahead of patent expiration.
References
- MarketsandMarkets. (2023). Contrast Media Market by Product, Application, and Region.
- Grand View Research. (2022). Imaging Contrast Media Market Size & Trends.
- U.S. Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.
- European Medicines Agency. (2022). Regulatory framework for contrast agents.
- IQVIA. (2023). Global Healthcare Data and Market Trends Reports.
