Business Development and Marketing Support in Healthcare
 

        "Never mistake motion for action." Ernest Hemingway

    

Testing Infectious Diseases – Action or Reaction

Author Dr. Martin Pfister – Consultant

Microbes live in every conceivable ecological niche on the planet and have inhabited the earth for hundreds of millions of years. In fact, microbes are highly adaptable to external forces and may be the most abundant life form by mass. The vast majority of microbes are essential to human, animal, and plant life. Occasionally however, a microbe is identified as a pathogen because it causes acute infectious diseases or triggers a pathway to chronic diseases, including some cancers.

Even with modern medicine, the full scope of diseases caused by microbial threats is not known, as only a small portion of all microbes have been identified by currently available technologies. More than 30 new microorganisms of clinical significance have appeared since 1967, with notable inclusions being HIV, West Nile virus, and Neisseria meningitis. Despite major therapeutic advances, infectious diseases remain highly problematic: microbial threats continue to emerge, re-emerge, and persist. The worldwide resurgence of long-recognized infectious diseases such as tuberculosis, malaria, or cholera has gained in force. In addition, antibiotic resistance is a growing issue, due to both over-use of antibiotic therapy and to the widespread use of antibiotics in the food chain.

The growing mobility of the population is yet another factor contributing to the spread of infectious diseases that were once unknown outside of certain regions of the world. Some former regionally restricted microbes cause newly recognized diseases in humans; others are previously known pathogens that are infecting new or larger population groups.

The spread of infectious diseases does not take one direction only. On the one side, diseases once thought endemic to less developed areas of the world have established fronts in developed countries. On the other hand, infectious diseases are responsible for one in every two deaths in developing countries - and are the leading cause of death for children and young adults (source: WHO, 1999 and 2000). It has been estimated that every hour, 1500 people die from an infectious disease; over half of them are children under 5 years of age. Ninety percent of deaths from infectious diseases worldwide are due to respiratory infections. These statistics point to a genuine need for the development and commercialisation of a range of diagnostic tests that are:

  • Reliable
  • Sensitive/precise
  • Easy to handle
  • Fast
    • A reasonable price and can be acceptably reimbursed.

HBS Consulting has conducted a study on product usage of molecular diagnostic tests for 43 infectious pathogens in 11 European countries*. Included within the study are already established tests like those for STD related pathogens such as HIV, HCV or Chlamydia, and tests for rare or new infectious pathogens causing viral meningitis/encephalitis, TBE or SARS. In the study, the base population is all of the microbiology laboratories per country, segmented by the attributes size (measured in the number of employees) and their ownership status, as well as the ability to perform molecular tests. Thus the research sample reflects the infectious disease diagnostic landscape as it relates,

  • precisely for the laboratories that do nucleic acid testing (NAT) such as PCR, Hybridowell™, TMA, HCA and other;
  • indicatively to laboratories performing conventional testing methods exclusively (serology, culture, strips etc.)

We assume that the answers of the surveyed sample reflect general market patterns. Those laboratories that do conventional testing methods only have been excluded from the study.

The following data provides exemplary findings for one of the most abundant tests, Chlamydia trachomatis, summarized for 5 out of 11 surveyed European countries.

From the above table it becomes clear that the European market for infectious disease testing is highly dependent on national influences. Among the big five European countries, Spanish microbiology laboratories run about 130,000 Chlamydia test per year with one fifth of the performed tests using PCR. The supplier market in Spain is highly segmented, a fact that leads to large prize differences. In the UK, a centralized and organized laboratory infrastructure leads to a small number of used manufacturers and, compared to Spain, nationwide screening programs for Chlamydia lead to more than one order of magnitude more tests per year. Consequently, high test numbers are one factor that lead to lower prices per test.

The share of NAT among all techniques applied to a test for Chlamydia is depicted in the following figure (projection based on sample population).

The usage of molecular tests (MT) not only depends on the country looked at, but - as expected - differs between pathogens. If no commercial molecular tests are available but relatively high tests numbers are run, self made “homebrew” tests make up a considerable share of the total PCR tests. One example would be MRSA testing in France: to test for the antibiotic susceptibility, 60% of PCR tests performed run “homebrew” tests.

The clinical microbiology laboratory in Europe is still undergoing the major technology-driven transformation that was started some ten years ago. The introduction of techniques that have allowed significant improvement in the ability to rapidly diagnose and characterize infections include:

  • advances in automation,
  • the widespread adoption of molecular testing technologies

While newer molecular technologies have attracted the most attention, advances in conventional microbiology testing, including growth-based testing technologies and immunoassay methods, have produced significant benefits for the laboratory as well – mainly based on automation. The time required to obtain results for a blood culture specimen has dropped to less than a week and susceptibility testing turnaround times went down from 24 hours to about four hours.

Most of the growth in the market for products used in microbiological testing however is in the molecular diagnostics segment. Infectious disease testing was the first major clinical application to develop for molecular diagnostics in the clinical lab and continues to dominate the market. As can be seen above, almost two thirds of the interviewed laboratories expect STD related pathogen tests to grow within the next three to five years.

Tests for the antibiotic resistance of pathogens like Streptococcus or Enterococcus are also within the top three of growth segments experiencing an increase in demand for microbiology NAT. There is plenty of potential in that segment. Among the laboratories surveyed, only 4 of 11 countries use molecular techniques to test for MRSA or VRE routinely today.

The sensitivity of nucIeic acid-based tests has been identified as the most favourable characteristics that drive the increased use of molecular tests for infectious pathogens. The share of the other top three ranked drivers, calculated among all 11 surveyed countries is depicted in the following chart.

There is no doubt that the market testing of infectious diseases and antibiotic susceptibility is experiencing a big change towards molecular diagnostics in the years to come. There are however a number of factors that still apply restraint on an even larger increase in, and more widespread use of NAT in infectious pathogen testing. HBS Consulting has identified factors such as:

  • the current prices charged per test (mentioned in the top three of answers by 9/11 surveyed countries)
  • the unsatisfying reimbursement situation
  • the lack of standardisation
  • the fact that the applied technique is demanding in both the skills required of the user and the laboratory space in which the tests are carried out.

Scientists in both the academic and industrial setting are armed sufficiently to react to the demands of new or re-emerging infectious diseases. It is up to the healthcare authorities, the insurance companies and the governments to take actions that guarantee new technologies like NAT are installed so as to fully make use of its potential as a saver of lives, resources and costs.

* Evaluation of Product Usage for Molecular Testing – Infectious Diseases.