Introduction of novel diagnostic tools and devices within the developing geographies, such as Brazil, India, South Africa, and China, are anticipated to witness an alarming rise in the volume of tuberculosis cases, which is expected to unleash the tuberculosis diagnostics market potential.
The industry is working relentlessly toward developing novel diagnostic tools and tests to meet the key Target Product Profile (TPP) characteristics. Additionally, support extended by the government authorities and various NGOs, such as the World Health Organization, United Nations Children's Emergency Fund, FIND, UNITAID, and McGill International TB Center, are anticipated to cause a surge in the global diagnostic rate for tuberculosis, thereby boosting the market growth. For instance, the WHO has been endorsing Cepheid’s Xpert MTB/RIF since 2010 leading to a sale of over 10 million of these testing kits.
Technologies expected to gain momentum with TPPs are:
The sputum test (a replacement for the smear test)
Biomarker test (a non-sputum-based diagnostic test)
Triage test (community-based test designed to identify individuals requiring further diagnosis)
Next generation sequencing test (part of the universal Drug Susceptibility Testing (DST))
The sputum test is expected to replace the smear test, which is examined to provide low levels of sensitivity and reliability in case of drug resistance and extrapulmonary tuberculosis. The sputum test aims to facilitate ease of performance, higher reliability, and faster processing of results, thereby driving the market.
As of 2015, over 35 assays are in the pipeline, ranging in their spectra of complexity and technology. For instance, Roche is working toward the development of a DST assay. This product is currently in the early development stages and holds strong potential as a novel diagnostic tool.
Regions such as South Africa, India, China, and Brazil present a lucrative market potential of over 12 million tests for the sputum-based detection tool, employed to diagnose pulmonary TB. These estimations have been concluded by the WHO and UNITAID after a thorough analysis of the following considerations: current disease burden, presently available diagnostic technologies, and the high demand for peripheral settings-based detection. A similar analysis for the other three technologies was also performed presenting a potential market opportunity of over USD 200 million across these four regions.
Development of tests for the aforementioned technologies that effectively address the test-specific TPP requirements is expected to spearhead innovation in the industry toward the introduction of novel and efficient diagnostic tools over the forecast period. These trends coupled with the presence of high opportunities are expected to invite a number of new entrants into the sector seeking in-depth analysis of the current market size, technological developments, and innovation progress over the next 7 years. Our report will help such entrants identify their investment opportunities thereby channeling their efforts to bear fruitful results.
In-depth report on global tuberculosis diagnostics market by Grand View Research: