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Table 1 Comparison product type, applicant categorization, prevalence segmentation and consideration of significant benefit criterion for products that obtained OMP designations for rare neoplastic disorders and products that obtained OMP designation for other rare conditions

From: Are products with an orphan designation for oncology indications different from products for other rare indications? A retrospective analysis of European orphan designations granted between 2002-2012

  Rare neoplastic disorders (N = 269) Other rare conditions (N = 461)
Product type
 Synthetic/extractive agent 53.5% (144) 53.8% (248)
 Biotechnology 46.5% (125) 46.2% (213)
Applicant categorization
 Academia/Public body 0% (0)a 4% (20)a
 Consulting 9% (25) 11% (52)
 Physical person 2% (6)a 6% (27)a
 SME 56% (150)a 47% (216)a
 Intermediate sized company 13% (35) 16% (75)
 Large Pharma 13% (35)a 7% (31)a
 Very large Pharma 7% (18) 9% (40)
Prevalence segmentation
  < 1/10,000 19% (51) 47.7%(220)
 1–3/10,000 69.1% (186)a 41.4% (191)a
  > 3/10,000 11.9% (32)a 10.8% (50)a
Consideration of significant benefit criterion
 Yes 75.1% (202)a 44.3% (204)a
  1. aIndicates difference at 0.05 level based on Chi2 test