Mechanism of Action: X-Ray Contrast Activity

Drugs with Mechanism of Action: X-Ray Contrast Activity

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	CYSTOGRAFIN	diatrizoate meglumine	SOLUTION;URETHRAL	010040-018	Approved Prior to Jan 1, 1982		RX	Yes	No
Bracco	CYSTOGRAFIN DILUTE	diatrizoate meglumine	SOLUTION;URETHRAL	010040-022	Nov 9, 1982		RX	Yes	No
Liebel-flarsheim	CONRAY	iothalamate meglumine	INJECTABLE;INJECTION	013295-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Liebel-flarsheim	CONRAY 43	iothalamate meglumine	INJECTABLE;INJECTION	013295-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Liebel-flarsheim	CYSTO-CONRAY II	iothalamate meglumine	SOLUTION;INTRAVESICAL	017057-002	Approved Prior to Jan 1, 1982		RX	No	No

X-Ray Contrast Activity Market Analysis and Financial Projection

The X-ray contrast agents market is poised for steady growth driven by diagnostic imaging demands, while patent landscapes reveal shifts toward safer formulations and emerging technologies. Below is a detailed analysis of market dynamics and intellectual property trends:

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Market Dynamics Overview

The global X-ray contrast agents market was valued at $1.8 billion in 2024, projected to reach $2.9 billion by 2033 at a 5.4% CAGR[1][3]. In North America, iodinated contrast media alone accounted for $1.24 billion in 2024, with a forecasted 5.8% CAGR through 2032[4]. Key drivers include:

• Rising chronic diseases: Cardiovascular and cancer diagnostics fuel demand, with chronic conditions linked to 60% of global deaths[1][15].
• Aging populations: Increased imaging needs for age-related conditions like vascular and neurological disorders[6][16].
• Technological advancements: AI-enhanced imaging systems and high-contrast laser-Compton X-ray sources improve diagnostic precision[7][15].

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Segmentation and Key Players

By Agent Type

• Iodinated agents: Dominate 63% of the U.S. market (2022) due to cost-efficiency and compatibility with CT/X-ray[2][6].
• Barium-based agents: Used in gastrointestinal imaging but losing ground to non-ionic alternatives[1][15].

By Modality

• X-ray/CT: Holds 65% market share (2022) owing to procedural volume and high-resolution imaging[2][6].

Major Companies

• Bayer AG, GE Healthcare, and Bracco SpA lead the market, focusing on R&D for next-gen agents like manganese-based MRI contrast media[6][13][15].

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Patent Landscape Trends

Historical Focus

• Early patents (e.g., DE-2162110-C3, 1970) focused on iodinated formulations for stability and opacity[13].
• Propyliodone (V08AD03) saw expired patents, reducing barriers for generics[13][16].

Modern Innovations

• Non-ionic agents: Iohexol and iopromide dominate recent patents, emphasizing reduced nephrotoxicity and isotonic properties[15].
• Targeted imaging: Patents like EP-2243496-A3 (GE Healthcare) cover extracellular matrix-targeting agents for precision diagnostics[8].
• AI integration: Subtle Medical’s patented AI reduces contrast dosage by 90%, potentially lowering toxicity risks[15].

Geographical Activity

• U.S., Europe, and China lead R&D, with WIPO reports highlighting concentrated innovation hubs[13][15].

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Challenges and Risks

• Regulatory pressures: Stricter FDA/EU guidelines on nephrotoxicity and gadolinium retention[15].
• Supply chain vulnerabilities: Iodine shortages during events like the 2022 Shanghai lockdowns disrupted production[15].
• Price competition: Patent expirations (e.g., Bayer’s Gadovist) enable generics, squeezing profit margins[14][16].

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Future Outlook

Growth Opportunities

• AI-driven imaging: Enhances diagnostic accuracy while reducing contrast volume[15].
• Biocompatible formulations: Investments in nanoparticle systems (liposomes, silica) improve safety[2][6].

Market Threats

• Phase-contrast X-ray: Emerging modalities (e.g., NIST’s patents 10,889,908 and 11,579,344) enable agent-free soft-tissue imaging[15].
• Sustainability demands: Eco-friendly production and waste reduction are becoming R&D priorities[14][15].

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"Non-watersoluble contrast agents remain vital for specific diagnostic challenges, but their role is increasingly overshadowed by next-generation alternatives." – Industry Expert[13]

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Key Takeaways

• The X-ray contrast market grows at 5.4% CAGR, bolstered by chronic disease diagnostics and aging demographics.
• Patent landscapes prioritize non-ionic agents and AI integration, while generics threaten legacy products.
• Emerging technologies and sustainability mandates will redefine competitive strategies by 2030.

References

1. https://www.verifiedmarketreports.com/product/x-ray-contrast-agents-market-size-and-forecast/
2. https://www.grandviewresearch.com/industry-analysis/us-contrast-media-market-report
3. https://www.marketresearchintellect.com/product/global-x-ray-contrast-agents-market/
4. https://link.epo.org/web/publications/studies/en-patents-and-innovation-against-cancer-study.pdf
5. https://www.databridgemarketresearch.com/reports/north-america-iodinated-contrast-media-in-interventional-x-ray-market
6. https://www.itnonline.com/article/look-inside-contrast-media-market
7. https://www.osti.gov/biblio/1893021
8. https://pubchem.ncbi.nlm.nih.gov/patent/EP-2243496-A3
9. https://patents.google.com/patent/EP0498482A2/en
10. https://academicentrepreneurship.pubpub.org/pub/tn8b15jm
11. https://patents.google.com/patent/EP0108638A1/en
12. https://www.epo.org/en/boards-of-appeal/decisions/t920655ex1
13. https://www.drugpatentwatch.com/p/atc-class/V08AD
14. https://www.lnk-med.com/news/exploring-the-dynamics-of-the-contrast-media-market/
15. https://www.drugpatentwatch.com/p/atc-class/V08A
16. https://www.zionmarketresearch.com/report/contrast-media-contrast-agent-market
17. https://exactitudeconsultancy.com/reports/7789/contrast-media-contrast-agent-market