Table 3 Comparison between rare disorders with follow-on and no follow-on OMPs: Descriptive statistics and univariate analyses
From: Does market exclusivity hinder the development of Follow-on Orphan Medicinal Products in Europe?
Characteristic | Indicator | Rare disorders | Â | ||
|---|---|---|---|---|---|
| Â | Â | Total N = 44 | 'Follow-on' Group N = 26 | 'No Follow-on' Group N = 18 | Odds Ratio (95% Confidence Interval) |
Market-related | |||||
   prevalence | < 1 per 100,000 | 9 | 0* | 9 | reference level |
| Â | between 1 - 50 per 100,000 | 34 | 26 | 8 | not applicable |
   turnover first | < 50 mil. US $ | 11 | 4 | 7 | reference level |
   OMP | > 50 mil. US $ | 26 | 19 | 7 | 4.8 (1.1-21.4) |
   designated outside | no | 8 | 5 | 3 | reference level |
   EU | yes | 36 | 21 | 15 | 0.8 (0.2-4.1) |
   approved outside | no | 11 | 7 | 4 | reference level |
   EU | yes | 33 | 19 | 14 | 0.8 (0.2-3.2) |
Product-related | |||||
   pharmaceutical | parenteral | 20 | 9 | 11 | reference level |
   formulation | oral | 24 | 17 | 7 | 3.0 (0.9-10.3) |
Disease-related | |||||
   disease class | other ICD-10 classes | 29 | 13 | 16 | reference level |
| Â | C00-D48 | 15 | 13 | 2 | 8.0 (1.5-42.0) |
   disease-specific | < 450 publications | 10 | 1 | 9 | reference level |
   scientific output | > 450 publications | 34 | 25 | 9 | 25.0 (2.8-226.1) |
   childhood | adulthood | 22 | 17 | 5 | reference level |
| Â | childhood | 17 | 7 | 10 | 0.2 (0.1-0.8) |
   chronic | non-chronic | 5 | 3 | 2 | reference level |
| Â | chronic | 34 | 19 | 15 | 0.8 (0.1-5.7) |
   inheritable | non-inheritable | 28 | 18 | 10 | reference level |
| Â | inheritable | 16 | 8 | 8 | 0.6 (0.2-1.9) |