Top Infectious Diseases in the IVD Market - Respiratory Tract Infections

Top Infectious Diseases in the IVD Market - Respiratory Tract Infections

The following analysis is derived from Kalorama Information’s recently released global market research report:The Worldwide Market for Infectious Disease Diagnostic Tests.

This is the first in a series of five posts outlining the leading infectious diseases or disease groups in terms of IVD market sales - beginning with tests for respiratory tract infections.

At well over $1 billion in IVD market space, tests for respiratory tract infections are supported by all three of the major diagnostics groups used for infectious disease testing - ID/AST, immunoassays, and molecular assays.  Despite seemingly innocuous consequences in terms of patient health relative to other infectious diseases such as HIV, hepatitis, healthcare-acquired infections and sexually transmitted diseases, respiratory infections represent a significant burden worldwide in terms of morbidity and lost productivity.

Respiratory infections represent a leading disease burden in developing countries and emerging markets. The WHO has estimated the two leading disease groups in terms of disability-adjusted life years (DALY; combining years lost to disability and premature mortality) are lower respiratory infections and diarrheal diseases at 94.5 million and 72.8 million DALYs; approximately 80% (or 76.9 million DALYs) of the global lower respiratory infection burden is in low-income countries.

Despite the disproportionate burden of respiratory infections in low-income countries, the majority of the global respiratory infection test market is sourced from testing in the developed world for common infections such as influenza (flu), group A streptococcus (strep A), and respiratory syncytial virus (RSV). However, platforms developed for rapid testing in the U.S. market could be significant in addressing near-patient testing needs in low-income countries and emerging markets.

The first CLIA-waived (lowest complexity test category in the United States) molecular assays on the market have been for respiratory diseases - influenza and strep A - on point-of-care (POC) or near-patient platforms from Alere (Alere i) and Roche Diagnostics (Liat). These and similar platforms should prove applicable to the developing world owing to their small footprint, easy operation, and rapid results. Competitive barriers to rapid molecular testing relate primarily to the costs of such assays at three times or more the costs of rapid immunoassays similarly applied in decentralized and POC testing. Isothermal amplification methods and microfluidics design may contribute to lower cost reagent mixes for rapid molecular testing in the future.

Rapid testing for respiratory viruses is a well-established market led by rapid influenza diagnostic tests (RIDTs). The rapid POC identification of seasonally prevalent respiratory viruses can mitigate unnecessary usage of antibiotics, or inform the prescription of antivirals (rapid influenza testing is standard with Tamiflu prescription in Japanese outpatient care). Competitors are seeking to increase market share and the market value of their product lines with the introduction of higher-priced molecular systems. Market success for new rapid molecular respiratory tests will be determined by client evaluation of the trade-off between test price and improved performance on rapid molecular assays.

Otherwise, the market space for respiratory tract infections is not likely to see major additions in terms of disease threats. Bordetella pertussis, the pathogen behind whooping cough, has been a common target of assay development, but realized market sales will be marginal next to flu and strep A tests due to its lesser incidence. The specificity of RIDTs for the identification of flu strains is a key advance in the product space, but with only marginal market impact barring another pandemic such as the 2009 H1N1 strain. Despite the probable absence of a new major disease threat leading to added consistent testing volume through 2020, respiratory tract infections represent a key point of business development for decentralized infectious disease tests and molecular diagnostics market expansion.