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World Health Organization logo. (PRNewsFoto)[RV TK]
GENEVA, Oct. 25 /Xinhua-PRNewswire/ -- A 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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20040610/CNTH001LOGO )
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 (TB), 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
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.
"The TB and HIV threat continues to grow in many parts of the world,
and governments need high quality diagnostics to help manage these
epidemics," says Dr. Robert Ridley, director of TDR. "We need simple tests
to accurately screen for, and identify, active tuberculosis. New tests also
are needed to monitor treatment response, to identify bacterial drug
resistance, and to detect latent infection in people at greatest risk for
progression to active TB."
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.
High-tech molecular and rapid culture diagnostics available in
developed countries are too complex and costly for many settings where TB
is most prevalent, the report notes. Yet traditional sputum smear, x-ray
and culture tests may not accurately identify active TB, particularly in
HIV-positive patients. Such diagnostics also may fail to make critical
distinctions between latent and active TB, and between drug sensitive and
drug resistant forms of the disease.
''The technology exists to make better TB tools, and this report leaves
no doubt that there is a large global market,'' said Dr Giorgio Roscigno,
Chief Executive Officer of FIND. ''There is a huge opportunity for
diagnostics developers to expand their investments to meet this very real
need. We need to use this market analysis to encourage the development of
accurate, affordable and easy-to-use diagnostics for developing countries."
The report represents the first time an international network of
researchers and policy experts has examined the full range of tests
available on the market for: active disease; latent infection; drug
resistance; and treatment response. The report was financed by the Bill and
Melinda Gates Foundation, and involved more than 100 public health and
industry experts as well as several international agencies.
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.
''The world urgently needs new, safe and affordable diagnostics to
simplify case detection,'' said Dr Mario Raviglione, Director of WHO's Stop
TB Department. ''Despite scientific progress that is rapidly changing other
fields, most of the world's TB patients have access only to conventional
microscopy which requires repeated testing, may miss half the cases, and
which works especially poorly for HIV co-infected patients."
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
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, the report concludes stating:
"Such a test, if widely implemented and accompanied by successful
treatment, could revolutionize TB control."
Large markets also exist for:
-- point-of-care screening -- (at clinics and health posts) with a
potential available market of some 79 million patient evaluations a
-- less revolutionary 'replacement' technologies for smear, culture, and
drug susceptibility testing. These have potential annual markets of 49
million, 20 million, and 23 million patient evaluations respectively.
Jean-Francois de Lavison, President of the European Diagnostics
Manufacturers Association, called the report "ground-breaking" and
highlighted how it "sets out clearly the problems surrounding the existing
tests and explains what kinds of improved diagnostic tools are needed and
where they could have their greatest impact."
TDR works with its sponsors UNICEF, UNDP, the World Bank and the World
Health Organization, as well as with public-private partnerships like FIND,
to help coordinate a health research approach that serves developing
countries. FIND is a non-profit organization dedicated solely to the
development of rapid, accurate and affordable diagnostic tests for
poverty-related diseases in the developing world.
The Special Programme for Research and Training in Tropical Diseases
(TDR) is a global program of scientific collaboration established in 1975,
sponsored by the World Health Organization, World Bank, United Nations
Development Programme and United Nations Children's Fund, and based in
Geneva, Switzerland. Its focus is research into neglected diseases of the
poor, with the goal of improving existing approaches and developing new
ways to prevent, diagnose, treat and control these diseases. For more
information, visit them online at http://www.who.int/tdr .
For more information contact:
TDR, WHO Geneva
Samantha Bolton/Jewel Thomas
Stop TB Partnership, WHO Geneva
SOURCE World Health Organization