Drugs in ATC Class S01J

Up to Top Level ATC Classes

Up to S - Sensory organs

Up to S01 - OPHTHALMOLOGICALS

Subclasses in ATC: S01J - DIAGNOSTIC AGENTS

S01JA - Colouring agents

S01J Market Analysis and Financial Projection

The ATC Class S01J (Diagnostic Agents) encompasses topical ophthalmological agents used to diagnose eye conditions, including coloring agents (e.g., rose bengal sodium) and imaging tools for detecting corneal abnormalities, dry eye disease, and foreign bodies[1][4][7]. Below is an analysis of its market dynamics and patent landscape:

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Market Overview

• Market Growth:
  The global radiotheranostics market (which includes diagnostic agents like S01J) was valued at $7.51 billion in 2022, projected to grow at a 13.49% CAGR through 2030[2]. Rising demand for precision diagnostics, particularly in oncology and chronic eye diseases, is a key driver.

  • Ophthalmological diagnostic agents are buoyed by increasing prevalence of conditions like diabetic retinopathy, glaucoma, and age-related macular degeneration[10][15].
  • The microbubbles/ultrasound contrast agents market, critical for imaging, is expected to grow at 25.20% CAGR (2024–2031), driven by advancements in diagnostic accuracy[5].

• Key Segments:

  • Lutetium-177 dominates radiotheranostics (40.91% revenue share in 2022), while Gallium-68 is rising due to personalized diagnostics[2][8].
  • Oncology accounts for 72.93% of radiotheranostics use, reflecting demand for targeted diagnostics[2].

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Growth Drivers

1. Aging Population:
   Age-related eye diseases (e.g., macular degeneration) are projected to double by 2050, necessitating advanced diagnostics[10].
2. Technological Innovation:
   • Integration of AI in devices like EEG and MEG for neuro-ophthalmology[3].
   • Novel agents like Axim Biotechnologies’ dual IgE/MMP-9 rapid test (provisional patent filed in 2022)[11].
3. Precision Medicine:
   Customizable radiopharmaceuticals (e.g., Ga-68) enable targeted receptor imaging[2][15].

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Challenges

• High Costs: Radiotheranostics procedures remain expensive, limiting accessibility[8].
• Regulatory Hurdles: Stringent approvals delay commercialization of new agents[6].
• Short Isotope Half-Lives: Logistical challenges in storage/distribution (e.g., Lutetium-177 has a 6.7-day half-life)[2].

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Patent Landscape

• Trends:

  • Over 21,000 ophthalmology-related patents were granted (2005–2020), with retina/cornea subspecialties showing the steepest growth[10].
  • Key innovations include biocompatible intraocular implants and AI-enhanced diagnostic systems[3][13].

• Key Players:	Company	Focus Area	Example Patents/Innovations
  Allergan	Drug-delivery systems	Controlled-release implants for glaucoma[10]
  Novartis	Radioligand therapies	Pluvicto® for prostate cancer imaging[2][8]
  Axim Biotechnologies	Rapid diagnostic tests	Dual IgE/MMP-9 test for ocular allergies[11]

• Geographic Hotspots:

  • U.S.: Leads with 3,000+ patents, emphasizing AI integration[3][10].
  • Asia-Pacific: Fastest-growing region due to healthcare investments[5][16].

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Regional Insights

• North America: Dominates radiotheranostics (40%+ share), driven by FDA approvals and R&D investments[2][8].
• Europe: Focus on regulatory-compliant, interoperable devices (e.g., Germany’s AI-driven systems)[3].
• Asia-Pacific: Expected 11.6% CAGR in neurodiagnostic patents (2024–2032) due to cost-effective solutions[3][5].

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Future Outlook

• Emerging Technologies: Non-invasive Portable devices (e.g., Brainscope’s EEG systems) and poloxamer-based eye drops for enhanced patient comfort[14].
• Strategic Collaborations: Partnerships like Radiopharm Theranostics and TerThera for isotope supply will bolster diagnostic capabilities[2].

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Key Takeaway: The S01J diagnostic agents market is buoyed by aging populations and AI-driven innovations, though cost and regulatory gaps pose challenges. Patent activity highlights a shift toward biocompatible, personalized solutions, with Asia-Pacific emerging as a high-growth frontier.

References

1. https://atcddd.fhi.no/atc_ddd_index/?code=S01J&showdescription=yes
2. https://www.grandviewresearch.com/industry-analysis/radiotheranostics-market-report
3. https://www.globenewswire.com/news-release/2025/02/18/3027990/28124/en/Neurodiagnostic-and-Monitoring-Devices-Patent-Landscape-Report-2024-2032-Profiles-of-Medtronic-Spinal-Modulation-Ovid-Therapeutics-Neurosigma-Brainscope-Univ-California-and-Cerner-.html
4. https://www.drugpatentwatch.com/p/atc-class/S01
5. https://www.verifiedmarketresearch.com/product/microbubbles-ultrasound-contrast-agents-market/
6. https://msfaccess.org/sites/default/files/2020-05/Patent%20Landscape%20Analysis%20-%202017%20-%20final%20report.pdf
7. https://go.drugbank.com/drugs/DB11182
8. https://www.insightaceanalytic.com/report/global-radiotheranostics-market/1499
9. https://www.marketsandmarkets.com/Market-Reports/air-traffic-control-equipment-market-159216929.html
10. https://pmc.ncbi.nlm.nih.gov/articles/PMC11391888/
11. https://www.ophthalmologytimes.com/view/axim-biotechnologies-develops-novel-dual-ige-mmp-9-rapid-ophthalmological-diagnostic-test-files-provisional-patent
12. https://www.alliedmarketresearch.com/air-traffic-control-equipment-market
13. https://pubchem.ncbi.nlm.nih.gov/patent/US-6523954-B1
14. https://www.ophthalmologytimes.com/view/patents-granted-for-combination-antibiotics-with-steroids-as-topical-eye-drops
15. https://www.gminsights.com/industry-analysis/imaging-agents-market
16. https://www.databridgemarketresearch.com/reports/global-diagnostic-reagents-market