Radiographic Contrast Agent Drug Class List

Drugs in Drug Class: Radiographic Contrast Agent

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
Bracco	DIATRIZOATE MEGLUMINE	diatrizoate meglumine	INJECTABLE;INJECTION	010040-017	Approved Prior to Jan 1, 1982		DISCN	No	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

Radiographic Contrast Agent Market Analysis and Financial Projection

The radiographic contrast agent market is experiencing robust growth driven by technological advancements and increasing diagnostic needs, while its patent landscape reveals intense innovation and strategic intellectual property management. Here's a detailed analysis:

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Market Dynamics

Growth Projections

• The global market is projected to reach $9.7 billion by 2029 (CAGR: 7.5%)[1], with alternative estimates suggesting $9.04 billion by 2034 (CAGR: 4.1%)[7] and $16.53 billion by 2037 (CAGR: 7%)[10].
• Key drivers include:
  • Rising prevalence of chronic diseases (e.g., cardiovascular disorders, cancer)[1][15].
  • Expanding diagnostic imaging infrastructure (e.g., 160 NHS Community Diagnostic Centres in the UK by 2025)[14].
  • Product approvals (e.g., Bayer’s Ultravist for mammography in 2023)[7].

Regional Trends

• North America dominates (44% of GE Healthcare’s revenue)[1], with the U.S. market projected to grow at 4.7% CAGR to $2.97 billion by 2034[7].
• Asia-Pacific is the fastest-growing region:
  • China’s market could reach $795.2 million by 2034 (6.2% CAGR)[7], driven by cardiovascular diagnostics and MRI adoption.
  • India and Japan are advancing due to healthcare reforms and aging populations[11][15].

Key Players and Strategies

• Top Companies: Bayer AG, GE Healthcare, Bracco Imaging, Guerbet, and Lantheus[1][5].
• Strategic moves include:
  • Product Launches: Guerbet’s FDA-approved Elucirem (2023)[1].
  • Capacity Expansions: Bayer’s dominance in MRI contrast media with Gadovist[1].
  • Regulatory Milestones: FDA’s 2022 mandate regulating all contrast agents as drugs[6].

Segment Analysis

• By Type:
  • Gadolinium-based agents dominate MRI contrast (projected $1.91 billion by 2029)[15].
  • Iodinated agents lead CT/X-ray imaging (60% usage in neurological exams)[14].
• By Modality: CT/X-ray holds the largest share due to cost efficiency[16].

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Patent Landscape

Innovation Trends

• Core Technologies: Patents focus on chemical formulations (e.g., iodinated polymers[8]), targeted applications (e.g., postmortem angiography[13]), and safety profiles.
• Key Patents:
  • WO2014041150A1: Broad claims for "contrast agent and its use for imaging"[2].
  • US8173105B2: Methods for preparing contrast agents[2].
  • US4406878A: Iodinated polymers for enhanced radiodensity[8].

Legal and Regulatory Challenges

• Diagnostic Method Exclusions: European Patent Office Case T 0655/92 clarified that novel use claims must avoid non-patentable diagnostic methods under Article 52(4) EPC[3].
• Safety-Driven IP: Macrocyclic gadolinium agents (e.g., Gadovist) address retention concerns, reflected in newer patents[15].

Collaboration Trends

• Academia-industry partnerships are critical for niche agents (e.g., molecular imaging)[2].
• Example: GE Healthcare’s Phase 1 trial of a manganese-based MRI agent (2023)[16].

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Challenges and Opportunities

Market Barriers

• Safety Concerns: Gadolinium retention in tissues[15] and nephrotoxicity of iodinated agents.
• Regulatory Costs: FDA’s 2022 drug classification increases development expenses[6].

Emerging Opportunities

• AI Integration: Enhanced imaging accuracy through AI-enabled platforms[11].
• Asia-Pacific Expansion: China’s $795.2 million market potential by 2034[7].
• Novel Agents: GE Healthcare’s manganese-based contrast media to reduce gadolinium dependence[16].

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Industry Insight: "The convergence of AI and advanced imaging technologies is revolutionizing diagnostic precision, creating a $13.9 billion radiopharmaceutical and contrast media market by 2030"[11].

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Key Takeaways

1. The market grows at 5–7.5% CAGR, fueled by chronic diseases and imaging advancements.
2. Bayer and GE Healthcare lead through R&D and strategic approvals.
3. Asia-Pacific is pivotal for future growth, especially in China and India.
4. Patent strategies focus on novel formulations and regulatory compliance.
5. Safety innovations (e.g., macrocyclic gadolinium) address long-term retention risks.

References

1. https://www.marketsandmarkets.com/ResearchInsight/contrast-media-market.asp
2. https://academicentrepreneurship.pubpub.org/pub/tn8b15jm
3. https://www.epo.org/en/boards-of-appeal/decisions/t920655ex1
4. https://www.industryarc.com/Report/16791/contrast-mediacontrast-agent-market.html
5. https://www.imarcgroup.com/contrast-media-market
6. https://www.fdli.org/2023/03/regulating-contrast-agents-as-drugs-whats-next-for-fda/
7. https://www.factmr.com/report/contrast-media-market
8. https://patents.google.com/patent/US4406878A/en
9. https://www.osti.gov/biblio/1893021
10. https://www.researchnester.com/reports/contrast-media-market/4917
11. https://www.mordorintelligence.com/industry-reports/diagnostic-radiopharmaceuticals-contrast-media-market
12. https://patents.google.com/patent/US3196080
13. https://patents.google.com/patent/US8367041B2/en
14. https://www.grandviewresearch.com/industry-analysis/ct-mri-contrast-agents-market-report
15. https://www.mordorintelligence.com/industry-reports/global-contrast-media-market-industry
16. https://www.itnonline.com/article/look-inside-contrast-media-market
17. https://www.marketsandmarkets.com/Market-Reports/contrast-media-market-911.html