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

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

	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

ISSN: 1750-1172