Sandra V Kik1, Claudia M Denkinger2, Carole Jefferson3, Janet Ginnard4, Madhukar Pai1. 1. McGill International TB Centre and Department of Epidemiology and Biostatistics, McGill University. 2. McGill International TB Centre and Department of Epidemiology and Biostatistics, McGill University Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland. 3. Independent Consultant, Pennsylvania. 4. UNITAID, Geneva, Switzerland.
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.
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: Alison Jones; Mark Pitts; Juma'a R Al Dulayymi; James Gibbons; Andrew Ramsay; Delia Goletti; Christopher D Gwenin; Mark S Baird Journal: PLoS One Date: 2017-08-14 Impact factor: 3.240
Authors: Prem Perumal; Mohamed Bilal Abdullatif; Harriet N Garlant; Isobella Honeyborne; Marc Lipman; Timothy D McHugh; Jo Southern; Ronan Breen; George Santis; Kalaiarasan Ellappan; Saka Vinod Kumar; Harish Belgode; Ibrahim Abubakar; Sanjeev Sinha; Seshadri S Vasan; Noyal Joseph; Karen E Kempsell Journal: Front Immunol Date: 2021-03-16 Impact factor: 7.561