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Sunday 23rd October 2016

Huge market for TB tests

25th October 2006

07092006_tbpatient2.jpgA significant and largely untapped global market exists for more effective and affordable tests to diagnose tuberculosis in low and middle income countries, where most TB cases today occur.

This is the major finding of a new report, Diagnostics for Tuberculosis: Global Demand and Market Potential, released today by the Special Programme for Tropical Disease Research and Training (WHO/ TDR) and the Foundation for Innovative New Diagnostics (FIND).

Most people in the world who have tuberculosis, or live in TB risk areas, do not have good access to rapid and accurate testing, states the report, the most comprehensive review of the TB diagnostics market to date. Improved tests could bolster international TB control efforts and respond to a significant market demand, adds the report, calling for industry investment in new diagnostic tools targeted to low and middle income countries.

One third of the world’s population is infected with latent TB, and at risk of developing the active disease. HIV is fuelling TB epidemics in many countries and multi-drug resistance is a growing threat. 1.7 million people a year die from TB, many because the infection goes undiagnosed, or is diagnosed too late to be cured.

Of the estimated 9 million people who develop active TB every year, most still do not receive a laboratory-confirmed diagnosis. Only about 2.2 million TB cases annually are diagnosed and reported with sputum smear microscopy, the most widely available test. Other cases are diagnosed through an often inefficient and sometimes wasteful combination of chest x-rays, bacterial cultures and guesswork.

The global market for TB diagnostics is more than twice that of the market for drugs used to treat the disease. Worldwide, about US$1 billion is spent on TB tests and evaluations, which screen some 100 million people annually; around US $300 million is spent on drugs for treatment.

In low and middle income countries where three-quarters of the TB tests and screenings are carried out, around US$326 million annually is spent on TB diagnostics – and an even larger potential market exists for more effective and affordable tools. Between 70-90% of the potential available market for new TB diagnostics is concentrated in 22 countries with the highest burden of TB.

Despite increased global funding for TB control, and the emergence of public-private partnerships to support product development, commercial interest in TB diagnostics has been limited by a dearth of information on the size and character of the TB diagnostics market, especially in the developing world, the report states. The majority of recently developed tests serve sophisticated laboratories in industrialized countries, where less than 5% of global tuberculosis cases are found.

In middle and low income countries alone, over 66 million sputum microscopy examinations, 39 million chest x-rays, and 8.5 million cultures are performed each year on suspected TB patients – using technologies developed 50-100 years ago. The report found striking regional variations in testing, with Russia, India and South Africa together accounting for 91% of TB cultures performed in TB-endemic countries, and Asia making up 68% of the global chest x-ray market.

Compared to vaccines and medicines, the cost of developing new diagnostics and adapting existing ones is relatively low – about US $1-10 million per technology platform, the report notes. It projects demand for seven hypothetical products that could feasibly be developed within such an investment scale.

A test that detects latent infection and predicts progression to active disease could see the greatest use, with a potential available market of some 204 million patient evaluations a year. If widely implemented and accompanied by successful treatment, such a test could revolutionize TB control.


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