新型结核病诊断方法的潜在市场：值得投资吗？

Potential market for novel tuberculosis diagnostics: worth the investment?

作者信息

Kik Sandra V, Denkinger Claudia M, Jefferson Carole, Ginnard Janet, Pai Madhukar

机构信息

McGill International TB Centre and Department of Epidemiology and Biostatistics, McGill University.

McGill International TB Centre and Department of Epidemiology and Biostatistics, McGill University Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.

出版信息

J Infect Dis. 2015 Apr 1;211 Suppl 2:S58-66. doi: 10.1093/infdis/jiu817.

DOI:10.1093/infdis/jiu817

PMID:25765107

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.

摘要

背景

符合高优先级目标产品简介（TPP）规格的新型结核病诊断方法的潜在可用市场（PAM）目前尚不清楚。

方法

我们估计了2020年4个高负担国家（南非、巴西、中国和印度）中符合TPP规格的检测方法的PAM。针对每个TPP最可能的应用场景估计了年度PAM。

结果

2020年，这4个国家的PAM总计估计为：（1）痰涂片替代检测每年1200万次，价值4800万至7100万美元；（2）生物标志物检测每年1600万次，价值6500万至9700万美元；（3）分流检测每年1800万次，价值1800万至3500万美元；（4）结核检测加药敏试验（DST）一体化检测每年1200万次，价值5900万至2.238亿美元，或者结核检测呈阳性后进行DST检测每年150万次，结核检测和DST的相应价值为7500万至1.21亿美元。