Vol. 24 • Issue 6 • Page 27
Point-of-Care Testing
While tea leaves suggest another slow year for the American economy in 2015, the global point-of-care market is another story altogether.
According to Ryan Schmidt, vice president of infectious disease marketing at Alere, projections of the global POC diagnostics market over the forecast period of 2013 to 2018 say it’s poised to grow at a CAGR of 9.3% percent from 2013 to 2018, to reach $27.5 billion by 2018.
Schmidt said North America holds the largest market share, but Asia and Latin America should also experience high growth.
“This large share is primarily attributed to the huge and increasing addressable patient population base. Moreover, the development of accurate and rapid testing kits is further fueling the growth of the POC diagnostics market in North America,” he noted.
Specifically, the global POC diagnostics market is categorized into several segments, such as infectious diseases testing kits, ðglucose monitoring kits, coagulation monitoring kits, urinalysis ðtesting kits, hematology testing kits, cholesterol test strips, drugs of abuse testing kits, cardiac markers, blood gas/electrolytes testing kits, tumor/cancer markers, pregnancy and fertility testing kits, fecal occult testing kits, food pathogens testing kits and others. In addition, based on the type of end users, the global POC diagnostics market has been segmented into patient professional monitoring kits and patient self-monitoring kits. Furthermore, based on the prescription mode, the global POC diagnostics market has been segmented into OTC and prescription-based POC diagnostics market.
Developing Countries
The Asia-Pacific POC diagnostics market is expected to witness the highest growth in the forecast period. A number of factors, such as rising and huge incidences of infectious and lifestyle diseases, increasing funding and investment toward the development of POC products, growing focus of both international and domestic players on the Asia-Pacific POC diagnostics market and large number of R&D activities, are propelling the demand for POC testing products in the Asia-Pacific region, said Schmidt.
According to Schmidt, Alere’s focusing intently on African, Asian and Latin American markets. The company’s newest HIV detect assays for molecular diagnosis at the point-of-care that identifies HIV-1 and HIV-2 in less than an hour is focused initially on sub-Sahara African nations with commercialization in Europe, Asia and Latin America to follow later this year. The company also launched a rapid point-of-care 4th generation HIV test, detecting HIV- ½ antibodies and the HIV-1 p24 antigen to detect all known HIV subtypes and recombinants of the virus sooner in Africa, Asia, Europe and Latin America. Other products targeting the same countries will utilize molecular testing of HIV nucleic acids for accurate detection as well as Early Infant Diagnosis (EID). Currently, Schmidt explained, antibody POC tests cannot discriminate between a mother’s and an infant’s antibodies to learn if a newborn is infected with the HIV virus. Alere’s also expanding their CD4 monitoring platform for HIV management designed for developing countries.
“We are working with global funders to bring innovative diagnostics in the field of malaria and neglected tropical diseases, specifically targeted for developing countries,” Schmidt said.
Lifestyle Factors in the U.S.
One force driving point-of-care products in the U.S. is the increase in cardiac diseases and diabetes. An analysis by the market research firm Frost & Sullivan revealed that the market for self-monitoring blood glucose products earned $4.04 billion in revenue in 2014 and could reach $4.18 billion in 2016. The strips market contributed to over 90 percent of the revenues.
“The rising incidences of these critical lifestyle diseases, (cardiac disease and diabetes), combined with the rising usage of POC devices and technological advancements with regard to development of advanced, faster and easy-to-use devices, will continue to stimulate the market globally,” Schmidt remarked.
According to a study by the International Diabetes Foundation, the number of patients diagnosed with diabetes will double by 2035. Early diabetes diagnosis and even self-diagnosis will drive the diabetes point-of-care market. The necessary constant detection of sugar levels in the blood will likely ensure growth the hospital glucose testing market for decades to come.
While the pundits debate the direction of the global economy, there’s almost unanimous certainty about the profitable future of the point-of-care market.
“We believe that there will be strong growth in the diagnostic point-of-care marketing in the coming years,” stated Paul Brown, head of Roche Molecular Diagnostics. “This belief was a key driver in our acquisition of IQuum, which brings PCR technology and assays to the POC marketplace. As POC testing becomes more mature and our PCR tests and platform are CLIA waived, we will be able to provide fast, lab like quality results within the physician’s office. We believe this will help to improve treatment decisions and, ultimately, patient outcomes.”
Robin Hocevar is on staff at ADVANCE.