Drugs in ATC Class V08AB

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Up to V - Various

Up to V08 - CONTRAST MEDIA

Up to V08A - X-RAY CONTRAST MEDIA, IODINATED

Drugs in ATC Class: V08AB - Watersoluble, nephrotropic, low osmolar X-ray contrast media

Tradename	Generic Name
AMIPAQUE	metrizamide
OMNIPAQUE 140	iohexol
OMNIPAQUE 180	iohexol
OMNIPAQUE 210	iohexol
OMNIPAQUE 350	iohexol
ORALTAG	iohexol

V08AB Market Analysis and Financial Projection

The market dynamics and patent landscape for ATC Class V08AB (watersoluble, nephrotropic, low-osmolar X-ray contrast media) reflect a balance of clinical demand, pricing pressures, and evolving intellectual property strategies. Here's a detailed analysis:

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Market Dynamics

Growth Drivers

1. Rising Diagnostic Imaging Demand:
   Increased prevalence of chronic diseases (e.g., cardiovascular, cancer) and aging populations are driving demand for advanced imaging modalities like CT and angiography[11][16][19]. The global contrast media market is projected to grow from $6.86B (2024) to $15.88B by 2037, with a CAGR of 6.8%[19].

2. Shift to Safer Agents:
   Low-osmolar contrast media (LOCM) dominate due to reduced adverse effects compared to ionic agents. In India, LOCM accounted for $126.5M in 2023, growing at 4.9% CAGR[18]. Key agents like iopromide and iohexol are preferred for their safety profiles[1][13].

3. Technological Advancements:
   Innovations in formulations (e.g., lower osmolality, reduced nephrotoxicity) and diversification into oncology/neurology applications are expanding market opportunities[12][16].

4. Emerging Markets:
   Asia-Pacific, particularly India, is a high-growth region due to improving healthcare infrastructure and affordability[18].

Challenges

• Price Pressures:
  Nonionic agents like iopamidol saw prices drop 70% post-patent expiration (1996), squeezing margins and forcing mergers/acquisitions[3][12]. Generic competition intensifies cost pressures, though clinical adoption remains tied to safety over price[3][18].
• Adverse Events:
  Allergic reactions (urticaria, hypotension) and nephrotoxicity persist, necessitating ongoing safety refinements[1][13].

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Patent Landscape

Key Patents and Innovations

1. Synthesis and Purification:

   • US6500341B2: Chromatographic purification of water-soluble non-ionic agents (e.g., iopamidol), improving yield and reducing costs[4].
   • WO2005032369A1: Low-concentration contrast media for enhanced bowel imaging[5].

2. Formulation Expansions:
   Patents cover barium-based, iodine-based, and gadolinium agents for diverse applications (CT, MRI, ultrasound)[5][14].

Patent Expirations and Generics

• Iopromide and iohexol dominate post-patent markets, benefiting from decades of clinical use[1][13].
• Patent cliffs (e.g., iopamidol, 1996) enabled generics, accelerating price erosion but improving accessibility[3][12].

Emerging Trends

• Collaborations: Partnerships focus on next-gen agents (e.g., microbubble contrast for ultrasound)[16].
• AI-Driven Research: Patent filings for AI-optimized contrast media formulations are rising, though not yet dominant[2].

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Competitive Landscape

• Major Players: Bayer, Bracco, GE HealthCare, and Guerbet lead through R&D and strategic acquisitions[11][16].
• Generic Entrants: Companies like Smita Thakur note generic competition has reduced nonionic agent prices to $30/100mL (vs. $100 historically)[3][12].

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Regional Insights

• North America: Largest market share due to high procedural volumes and early adoption of nonionic agents[16].
• Asia-Pacific: Fastest growth (India’s market to hit $220.8M by 2032)[18], driven by healthcare expansion and LOCM adoption.

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Future Outlook

• R&D Priorities: Focus on reducing adverse events (e.g., nephropathy) and expanding into molecular imaging[12][16].
• Regulatory Shifts: Expiring patents (e.g., iobitridol) will further lower costs, enabling broader access in developing regions[17][18].

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"The expiration of patents held by major companies is anticipated to pave the way for generic pharmaceutical producers, potentially reducing costs and making the technology more accessible."[16]

In summary, the V08AB market thrives on clinical demand for safer imaging agents but faces headwinds from pricing pressures and patent expirations. Innovation in synthesis, formulation, and regional expansion will define its trajectory.

References

1. https://pmc.ncbi.nlm.nih.gov/articles/PMC3857363/
2. https://www.wipo.int/web-publications/patent-landscape-report-generative-artificial-intelligence-genai/en/index.html
3. https://www.diagnosticimaging.com/view/x-ray-contrast-media-firms-struggle-continued-price-pressure-us
4. https://patents.google.com/patent/US6500341B2/en
5. https://patents.google.com/patent/WO2005032369A1/en
6. https://list.essentialmeds.org/files/trs/uM2drf3qopwZIceChtyH0tqRGk7c86aLZRZYZimX.pdf
7. https://www.pharmacompass.com/active-pharmaceutical-ingredients/iopromide
8. https://pubchem.ncbi.nlm.nih.gov/compound/Iopamidol
9. https://www.openpr.com/news/3752629/air-traffic-control-atc-market-is-booming-so-rapidly-navblue
10. https://www.knowmade.com/patent-analytics-services/patent-report/life-sciences-patent-landscape/allogeneic-car-patent-landscape-analysis-2023/
11. https://www.itnonline.com/article/look-inside-contrast-media-market
12. https://www.databridgemarketresearch.com/reports/global-iodinated-contrast-media-in-interventional-x-ray-market
13. https://pubmed.ncbi.nlm.nih.gov/8071050/
14. https://www.businesswire.com/news/home/20200602005605/en/Global-Air-Traffic-Control-Market-Forecast-to-2025---Rapid-Advances-in-Technologies-Used-in-ATC-Systems---ResearchAndMarkets.com
15. https://www.biorxiv.org/content/10.1101/483826v1
16. https://www.lnk-med.com/news/exploring-the-dynamics-of-the-contrast-media-market/
17. https://pubchem.ncbi.nlm.nih.gov/compound/Iobitridol
18. https://www.astuteanalytica.com/industry-report/india-contrast-media-market
19. https://www.researchnester.com/reports/contrast-media-market/4917