Drugs in ATC Class S01JA

Up to Top Level ATC Classes

Up to S - Sensory organs

Up to S01 - OPHTHALMOLOGICALS

Up to S01J - DIAGNOSTIC AGENTS

Drugs in ATC Class: S01JA - Colouring agents

Tradename	Generic Name
AK-FLUOR 10%	fluorescein sodium
AK-FLUOR 25%	fluorescein sodium
ALTAFLUOR BENOX	benoxinate hydrochloride; fluorescein sodium
FLUORESCEIN SODIUM	fluorescein sodium
FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	benoxinate hydrochloride; fluorescein sodium
FLUORESCITE	fluorescein sodium
FUNDUSCEIN-25	fluorescein sodium

S01JA Market Analysis and Financial Projection

The ATC Class S01JA (Colouring Agents) encompasses diagnostic dyes crucial for ophthalmological procedures, particularly fluorescein (S01JA01) and rose bengal sodium (S01JA02). These agents enable visualization of ocular structures for conditions like diabetic retinopathy, glaucoma, and retinal vascular disorders[1][4][6]. Below is an analysis of their market dynamics and patent landscape.

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Market Dynamics

Growth Drivers

• Rising Prevalence of Eye Diseases: Age-related macular degeneration (AMD), glaucoma, and diabetic retinopathy are driving demand. Over 34 million Europeans alone suffer from AMD, fueling diagnostic needs[17][19].
• Aging Population: By 2050, 2 billion people globally will be over 60, increasing susceptibility to ocular disorders[17][18].
• Technological Advancements: Fluorescein dominates due to its efficacy in angiography, holding >50% market share. Its availability in strips/drops simplifies diagnostics[17][19].

Market Size

• The global colorants market (including ophthalmic dyes) is projected to grow from $48.42B in 2025 to $79.47B by 2034 (CAGR 5.7%)[3][5].
• The ophthalmic dye subset will expand from $1.45B in 2024 to $2.67B by 2033 (CAGR 7.5%), led by fluorescein and trypan blue[17][18].

Regional Insights

• North America leads due to advanced healthcare infrastructure and high AMD rates[18][19].
• Asia-Pacific shows rapid growth, driven by pollution-related eye disorders and expanding healthcare access[3][7].

Challenges

• Regulatory Hurdles: Strict FDA/EMA approvals delay product launches[17][18].
• Non-Invasive Alternatives: Optical coherence tomography (OCT) threatens traditional dye-based methods[18].

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Patent Landscape

Key Innovations

• Targeted Therapies: Patents for dye-assisted photodestruction of vitreous opacities using trypan blue or indocyanine green with laser irradiation[12][16].
• AI Integration: iHealthScreen’s iPredict models combine fluorescein angiography with AI for early glaucoma/AMD detection[11].

Recent Grants

• Trypan Blue (S01KX02): Used in cataract surgery and vitreous opacity treatment[12][16].
• Indocyanine Green: Gold standard for choroidal vasculature imaging[15].

Competitive Strategies

• Companies like Novartis and Bausch Health focus on sustainable formulations and bio-based dyes to meet eco-friendly demands[3][7].
• Startups leverage AI for automated dye-based diagnostics, reducing training time to <1 hour[11].

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Future Trends

1. Shift to Bio-Based Agents: Plant-derived dyes (e.g., anthocyanins) gain traction in response to environmental concerns[3][7].
2. Personalized Diagnostics: Custom dye formulations for precision imaging in complex cases like polypoidal choroidal vasculopathy[15].
3. Combination Therapies: Dyes paired with gene therapies (e.g., voretigene neparvovec for retinal dystrophy)[1][18].

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Key Takeaways

• S01JA agents remain indispensable in ocular diagnostics, with fluorescein as the backbone.
• Patent activity emphasizes minimally invasive treatments and AI-driven diagnostics.
• Sustainability and regional healthcare expansion will shape long-term market growth.

References

1. https://canadian-pill-identifier.com/en/atc-drug-classification-class/S
2. https://www.doc-developpement-durable.org/file/sante-hygiene-medecine/guides-medicaux/the%20selection%20and%20use%20of%20essential%20medicines%202009%20-%20WHO.pdf
3. https://www.polarismarketresearch.com/industry-analysis/colorants-market
4. https://www.wikidoc.org/index.php/ATC_code_S01
5. https://www.maximizemarketresearch.com/market-report/global-colorants-market/4033/
6. https://en.wikipedia.org/wiki/ATC_code_S01
7. https://www.theinsightpartners.com/reports/colorants-market
8. https://www.kegg.jp/entry/D05762
9. https://sagaciousresearch.com/patent-landscape-analysis-search-report/
10. https://worldradiohistory.com/UK/Music-Week/1985/Music-Week-1985-09-07.pdf
11. https://www.optometrytimes.com/view/ihealthscreen-awarded-us-patent-for-ipredict-glaucoma-detection-model
12. https://patents.justia.com/patent/20230256095
13. https://www.wipo.int/en/web/patent-analytics
14. https://www.fhi.no/contentassets/1b4b603c4ecf410588d584d5062cc9b8/legemiddelforbruket-i-norge-20172021.pdf
15. https://diagnosticgreen.com/am/wp-content/uploads/sites/4/2020/08/Diagnostic-Green-Ophthalmology-Brochure-US.pdf
16. https://pubmed.ncbi.nlm.nih.gov/15844039/
17. https://www.verifiedmarketreports.com/product/ophthalmic-dye-market/
18. https://www.persistencemarketresearch.com/market-research/ophthalmic-dye-market.asp
19. https://www.biospace.com/ocular-diagnostic-agents-market-fluorescein-dye-segment-is-likely-to-expand-at-a-significant-pace-during-the-forecast-period