Table 6.1Costs of Developing Selected TB Diagnostics (US$)

Type of test
Item Nucleic acid amplification Screening test Drug susceptibility testing
Location of companyRest of worldUnited States and European UnionUnited States and European UnionUnited States and European UnionUnited States and European Union
Market research costs10,000100,00050,000500,000500,000
Technology acquisition and patent fees275,000250,00050,000200,000
Development of prototype3,775,0004,000,0004,662,0002,825,000
Consumables used during development1,575,00075,000150,000
Scale-up and validation600,000200,000200,000
Total product development costs575,0005,625,0004,850,0004,987,0003,375,000
Total costs of clinical trials(location of study sites)180,000 (disease-endemic countries)1,450,000 (United States and European Union)2,000,000 (United States and European Union)294,000 (disease-endemic countries)
Regulatory approval costs (agencies)100,000 (FDA, European Union)800,000 (United States)454,000
Marketing and launch support costs80,0001,500,000200,000
Product support costs for one year50,0001,125,00020,000

From: Chapter 6, Product Development Priorities

Cover of Disease Control Priorities in Developing Countries
Disease Control Priorities in Developing Countries. 2nd edition.
Jamison DT, Breman JG, Measham AR, et al., editors.
Washington (DC): World Bank; 2006.
Copyright © 2006, The International Bank for Reconstruction and Development/The World Bank Group.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.