July 1, 2010 (Vol. 30, No. 13)

Point-of-care testing (POCT) includes professional-grade in vitro diagnostic tests completed in close proximity to patients. By performing diagnostic tests closer to patients and obtaining results directly at the point-of-care, primary care providers can immediately diagnose and treat patients for improved outcomes.

Studies have shown that rapid turnaround times can improve patient outcomes by avoiding inefficiencies in administrative follow-ups and minimizing delays in treatments that could otherwise result in adverse complications and costly consequences. These types of studies continue to support the value of POCT and drive adoption.

An example of how POCT can improve clinical outcomes with immediate diagnosis is illustrated in the cardiac market. When patients visit the emergency room with chest pain, determining the cause must be done as quickly as possible. Doctors typically conduct an ECG (electrocardiogram) and begin testing for biomarkers. The American Heart Association has stated that the results of these tests are needed in less than 60 minutes.

A study done by the University of Connecticut Health Center found that hospitals struggle to get results within an hour when using hospital laboratories. When doctors used point-of-care tests, results were available in less than 30 minutes over 80% of the time and under an hour 98% of the time. In comparison, results from the hospital laboratory were available under one hour only 50% of the time.

The value of immediate results is also evident in testing for infectious diseases where rapid diagnosis can limit the spread of disease and lead to prompt initiation of therapy. For serious diseases such as the human immunodeficiency virus (HIV), the ability to rapidly detect the virus in a single physician visit is crucial in initiating therapy as quickly as possible and ensuring that patients are aware of their test results. A U.S. Centers for Disease Control study in 2004 found that 35% of those tested for HIV using nonrapid methods did not return for test results.

Although the benefits of POCT are clear, this industry is not without challenges. Tests performed on clinical laboratory analyzers continue to be perceived as superior to POCT. Companies entering the POCT market must demonstrate that their tests have more clinical utility than those performed in laboratories.

The convenience and speed of POCT are typically the most attractive features that stimulate market growth; however, there are segments that are saturated with little left for further growth. In addition, competition is intense in emerging markets as more companies recognize the growth potential.

Considering these issues, the opportunities remain vast for industry participants to capitalize on the growing demand for POCT.

The revenues generated from the sales of POCT products in the U.S. totaled $2,128.8 million in 2009. Dramatic growth in 2009 was primarily from increases in influenza testing and patient self testing for coagulation therapy. Influenza testing rapidly expanded in response to the 2009 H1N1 pandemic and the coagulation testing segment continued to grow strongly due to additional Centers for Medicare & Medicaid Services reimbursement in 2008 for coagulation self monitoring of patients with chronic atrial fibrillation and deep vein thrombosis.

The extended reimbursement has also driven dramatic growth of groups called in vitro diagnostic testing facilities, which provide services for self-testing patients. Additionally, the overall POCT market was also supported by strong growth in the larger cardiac biomarkers and blood gas and electrolyte segments. These rapidly growing segments are expected to drive the market to revenues of $3,934.7 million in 2016 with an estimated compound annual growth rate of 9.2% from 2006 to 2016.

Total point-of-care testing market: revenues by segment (U.S.)

Isaac Middendorf ([email protected]) is a senior analyst in the drug discovery technologies and clinical diagnostics group of Frost & Sullivan.

Previous articleCelgene Shells Out $2.9B for Abraxis BioScience
Next articleSAIC-Frederick and Fluidigm to Decode Genome of Epstein-Barr Virus