title: Potential market for novel tuberculosis diagnostics: worth the investment?
abstract: BACKGROUND
  The potential available market (PAM) for new diagnostics for tuberculosis that meet the specifications of the high-priority target product profiles (TPPs) is currently unknown.
  
  
  METHODS
  We estimated the PAM in 2020 in 4 high-burden countries (South Africa, Brazil, China, and India) for tests that meet the specifications outlined in the TPPs. The yearly PAM was estimated for the most likely application of each TPP.
  
  
  RESULTS
  In 2020 the PAM for all 4 countries together was estimated to be (1) 12M tests/year with a value of 48M-71M USD for a sputum smear-replacement test; (2) 16M tests/year with a value of 65M-97M USD for a biomarker test; (3) 18M tests/year with a value of 18M-35M USD for a triage test; (4) 12M tests/year with a value of 59M-2238M USD for a tuberculosis detection plus drug susceptibility test (DST) all-in-one or 1.5M tests/year for a DST that follows a positive tuberculosis detection test with a corresponding value of 75M-121M for both tuberculosis detection and DST.
  
  
  CONCLUSIONS
  Although there is a considerable potential market for novel tuberculosis diagnostics that fit the specification of the TPPs in the 4 high-burden countries, the actual market for an individual product remains uncertain.
authors.affiliation: McGill International TB Centre and Department of Epidemiology and Biostatistics, McGill University.
authors.forename: Sandra V
authors.initials: SV
authors.lastname: Kik
authors.affiliation: McGill International TB Centre and Department of Epidemiology and Biostatistics, McGill University Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Denkinger
authors.affiliation: Independent Consultant, Pennsylvania.
authors.forename: Carole
authors.initials: C
authors.lastname: Jefferson
authors.affiliation: UNITAID, Geneva, Switzerland.
authors.forename: Janet
authors.initials: J
authors.lastname: Ginnard
authors.affiliation: McGill International TB Centre and Department of Epidemiology and Biostatistics, McGill University.
authors.forename: Madhukar
authors.initials: M
authors.lastname: Pai
mesh_terms: D035843:Biomedical Research / Q000191:economics* / Q000639:trends; D001938:Brazil; D002681:China; D003955:Diagnostic Tests, Routine / Q000191:economics / Q000379:methods*; D019981:Health Care Sector; D006801:Humans; D007194:India; D025202:Molecular Diagnostic Techniques / Q000191:economics / Q000379:methods*; D013019:South Africa; D014376:Tuberculosis / Q000175:diagnosis* / Q000453:epidemiology
keywords: cost; diagnostics; market analysis; market projection; target product profiles; tests; tuberculosis