A report issued by  Kalorama Information (New York City) characterizes the physician-office-lab (POL) testing market as “wide and diverse as one can imagine” and “an emerging tool for more efficient diagnosis and patient evaluation.”

The report, “Physician Office Laboratory Markets,” published in November 2010, analyzes how the market for POL testing has evolved since 2007. It places the world market for POL diagnostics in 2009 at an estimated $2 billion. The highly developed and industrialized United States, Europe, and Japan account for 97% of the POL market; this figure is likely to remain unchanged through 2013. Kalorama expects the POL market to grow 5% per year worldwide to reach $2.6 billion in 2014.

The report defines POL tests broadly as those that are performed in a non-hospital setting at the time of consultation with the physician or another healthcare professional, and that provide a result to be interpreted and worked with during the office visit. POL tests are issued for screening, diagnosis, or monitoring purposes. They can be divided into two groups: routine lab tests performed on small-format lab instruments, and rapid lateral-flow tests. The field for POL test devices is crowded, the report’s author writes. More than 100 companies worldwide market tests using “the whole gamut of instruments and technologies.” It is a very competitive and challenging market segment, Kalorama reports, comprising more than 90 companies and hundreds of tests. Asix-Shield, Alere, Becton Dickinson, Trinity, and Meridian hold “significant positions in niched segments.”

Growth in this type of testing is caused by the increasing popularity of preventive medicine and “proactive approaches in treating the increasing number of diagnosed diabetics,” as well as the globalization of infectious diseases and the necessary monitoring of individuals with cardiovascular disease and other chronic conditions. 

Globally, the author reports, there is a “huge” demand for decentralized diagnostic testing and, in China, India, and Latin America, for Western-style health services among the middle class. There is also growing demand for “small, easy-to-use and -maintain systems for near-patient sites and small clinical labs worldwide,” according to the report. These include tests for glucose, HbA1c, cholesterol, and other routine chemistries. 

The author reports that POL testing has not achieved the 10-15% growth predicted fifteen or so years ago, and POL test penetration of the IVD market in general has been weak, remaining at 8-9% of the total number of lab tests performed during the past 10 years. Previously, Kalorama reports, “infrastructure and reimbursement barriers” were faulted for this stagnation-but these barriers are now coming down. There was also “some anticipation that rapid tests for H. pylori, Lyme disease, and some STDs would become part of a physicians’ care routine. This has not been the case.”

Properly managed, Kalorama concludes, POL testing “contributes to better patient outcomes through faster test turnaround and more efficient delivery of health care. This ultimately translates to reduced overall expenses for treatment as well as the capacity to handle more patients and generate more revenue.”

Additional information about this report is available at www.kaloramainformation.com.