Promise of Fast Growth Propels Molecular Technologies in Fighting Infections

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Infectious Disease Molecular IVD Market: Fastest Growth of Any Molecular Test Segment

Infectious Disease is the best-selling and fastest-growing part of molecular testing, as Kalorama notes in its report Infectious Disease Diagnostics.     Molecular diagnostics’ performance and applicability is unparalleled among IVD technologies in the market for infectious disease testing and the overall healthcare market. Microarray, next-generation sequencing and development-stage isothermal amplification methods represent promising contributions to the molecular diagnostics market.

Several trends make molecular diagnostics the most dynamic segment of the infectious disease diagnostics market:

  • Decentralization of testing to include hospital labs and near-patient points using sample-to-answer or integrated analyzers
  • Development of molecular assays as a first response for testing of emerging disease threats
  • Rising availability of antiviral therapies, both in commercial therapies introduced and worldwide public health campaigns
  • Aggressive healthcare response to nosocomial or hospital-acquired infections (HAIs)
  • Penetration of next-generation sequencing (NGS) into healthcare with potential for clinical sequencing in the area of critical infections

Regional Market Share in Molecular Diagnostics Used for Infectious Disease Detection

The regional market picture is important in consideration of molecular diagnostics.  Kalorama Information estimates that developed markets of the United States, Europe and Japan account for roughly 90% of the global molecular infectious disease test market.  The U.S. market is expected to significantly outperform the European and Japanese markets based on its unique growth factors including strong demand for hepatitis testing and care among retirees and younger at-risk populations; molecular respiratory infection screening including multiplex ID panels and rapid near-patient assays; development of the molecular POC market; and the continued penetration of stand-alone HPV screens. Macroeconomic and demographic conditions in Japan and Western Europe have also inhibited demand for new molecular diagnostic technologies in infectious disease.

Outside of the success of vendors such as Cepheid with its HBDC program, the developing world is relatively limited as a market for molecular infectious disease tests. Middle-income countries such as China, Brazil and others in East Asia and Latin America are leading targets for market development. National priorities in the improvement of healthcare systems and healthcare availability could lift testing markets relating to antiviral therapy, molecular screening, and inpatient care. The low relative weight of these regions in the global market has been the result of low reliance on molecular testing methods and the prevalence of “homebrew” testing to meet limited demand concentrated among reference labs and medical hubs.

The rest of the world (ROW) – outside of the largest developed markets, China and Latin America – currently represents only 2% of the global market for molecular infectious disease diagnostics. However, low-income developing countries have potential as markets for molecular POC platforms, especially those incorporating isothermal or alternative amplification methods and other low-cost detection components. To successfully penetrate developing world markets, molecular POC platforms will need to make significant reductions in reagent and instrument component costs and be distributed with concessional pricing for public health programs. The over market projected for molecular infectious disease diagnostics in ROW countries by 2021 will feature a heavy mix of molecular POC products for HIV, TB, malaria, HPV, hepatitis C, and other tropical and neglected diseases.

Molecular Diagnostic Technologies in Infectious Disease Testing

In the healthcare market the pace of technological development in clinical molecular diagnostics has kept clinicians, payers, and regulars struggling to keep up. Because of an explosion of clinical molecular tests into the U.S. marketplace an overhaul in billing codes was instated to provide payers greater transparency into what is being ordered for which patients.   Confronted with major healthcare cost drivers in demographic aging and the introduction of medical technologies, payers often subject molecular diagnostic tests to a great deal of scrutiny, temporarily halting payments, or ending coverage for whole groups of tests. Payments continue where definitive clinical utility has been found, particularly for prognostic and companion assays in oncology. Proponents in the industry argue for an expanded definition of clinical utility used to make coverage decisions and are working to succeed with tests that offer accurate predictive capacities. Labs and other test develops hope to overcome regulatory hurdles for innovative molecular testing by introducing tests as services or “lab developed tests” rather than test kits or medical devices.

Molecular Infectious Disease Testing: Both a Revolutionary Technology and an Established One

Despite its prospects as an evolving and performance-leading field, with a fair amount of potential in many areas, molecular testing holds several established positions in developed healthcare systems:

  • Molecular assays play a crucial role in antiviral therapy monitoring because of their unmatched quantitative performance of real-time PCR in viral load testing. The value of antiviral therapy is still being realized in emerging markets and the developing world, providing continued market growth.
  • Other major application markets for molecular diagnostics and infectious disease testing include HAI/AMR testing and HPV. The decoupling of routine HPV testing from the traditional Pap smear as well as improved clinician and payer reception to the preventive health benefits o HPV screening have been breakthroughs for the molecular HPV market, and the commercialization of high-throughput molecular screening assays for HPV have supplanted prior FISH HPV assays and contributed significant market value.
  • Respiratory tract infections represent the newest major application market for molecular diagnostics used in infectious disease testing. The market for rapid respiratory assays at outpatient points of care and hospitals is currently served primarily by immunoassays.

The introduction of CLIA-waived molecular assays for the most market-significant respiratory infections – influenza and strep A – qualifies molecular diagnostics in rapid testing markets, but higher test costs remain a deterrent to client conversion to rapid molecular methods, and currently targeting the molecular conversion of the entire rapid respiratory test market is too ambitious when using current products.