A Large, Untapped Global Market Exists for Improved TB Tests

A Large, Untapped Global Market Exists for Improved TB Tests

October 26, 2006

US$1 Billion Is Already Spent Every Year on TB Diagnostics Still Millions of Cases in Developing Countries Are Never Diagnosed

 
    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 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. 

    "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 
       year.

    -- 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:  [phone]
     Email:   [e-mail]
 
     Samantha Bolton/Jewel Thomas
     FIND, Geneva
     Mobile:  [phone]
     Email:   [e-mail] 

     Glenn Thomas
     Stop TB Partnership, WHO Geneva
     Mobile:  [phone]
     Email:   [e-mail]  

SOURCE  World Health Organization