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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

Ā 

Rare neoplastic disorders (Nā€‰=ā€‰269)

Other rare conditions (Nā€‰=ā€‰461)

Product type

ā€ƒSynthetic/extractive agent

53.5% (144)

53.8% (248)

ā€ƒBiotechnology

46.5% (125)

46.2% (213)

Applicant categorization

ā€ƒAcademia/Public body

0% (0)a

4% (20)a

ā€ƒConsulting

9% (25)

11% (52)

ā€ƒPhysical person

2% (6)a

6% (27)a

ā€ƒSME

56% (150)a

47% (216)a

ā€ƒIntermediate sized company

13% (35)

16% (75)

ā€ƒLarge Pharma

13% (35)a

7% (31)a

ā€ƒVery large Pharma

7% (18)

9% (40)

Prevalence segmentation

ā€ƒā€‰<ā€‰1/10,000

19% (51)

47.7%(220)

ā€ƒ1ā€“3/10,000

69.1% (186)a

41.4% (191)a

ā€ƒā€‰>ā€‰3/10,000

11.9% (32)a

10.8% (50)a

Consideration of significant benefit criterion

ā€ƒYes

75.1% (202)a

44.3% (204)a

  1. aIndicates difference at 0.05 level based on Chi2 test