A Large, Untapped Global Market Exists for Improved TB Tests

US$1 Billion Is Already Spent Every Year on TB Diagnostics Still Millions

of Cases in Developing Countries Are Never Diagnosed

Oct 25, 2006, 01:00 ET from World Health Organization

    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
 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, 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.
     About WHO/TDR
     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:
      Jamie Guth
      TDR, WHO Geneva
      Mobile:  +41-79-441-2289
      Email:   guthj@who.int
      Samantha Bolton/Jewel Thomas
      FIND, Geneva
      Mobile:  +41-79-239-2366
      Email:   media@finddiagnostics.org
      Glenn Thomas
      Stop TB Partnership, WHO Geneva
      Mobile:  +41-79-13893
      Email:   Thomasg@who.int

SOURCE World Health Organization