This article was prepared by Frost & Sullivan.
Point of care testing (POCT) instruments are a combination of multi analytical, self-contained portable devices which are employed in direct usage for detection and diagnosis. The molecular testing involves the evaluation of molecule level estimation of DNA/RNA. The amalgamation of molecular level detection and point of care testing is currently the most effective, rapid, point of need in patient bedside care. Point of Care aspects in modern diagnosis enable continuous monitoring of all relevant parameters in either a minimally invasive or noninvasive way, in an environment that is most convenient to patients.
At Frost & Sullivan, our findings reflect that the global molecular diagnostics market was valued at $6.4 billion in 2015. The US region dominates the market by accounting for the major portion of the global molecular diagnostics market, followed by Europe and the APAC regions. Similarly, the global POCT market accounts for 13 percent of the global IVD market in 2015.
The molecular diagnostics market is witnessing a shift in focus from the infectious disease segment to immediate care in bedside testing, which involves patient monitoring during drug intake and response. Despite advances in diagnosis routines, key challenges remain in POC molecular testing such as sample preparation and nucleic acid extraction that are necessary to obtain a molecular level sample for MDx.
The ability to centralize multiple tests in a single diagnosis routine has firmly placed the European POCT market in the growth phase. This has also led to expansion of newer applications in defence forensics and in chronic settings such as oncology. From a M&A perspective, the centralized testing trend continues to be a driving factor, which contributes to the development of new technologies, new product offerings and an increase in market presence. POCT has opened doors to non-healthcare companies and OEMs in connected health that help interoperability and data management of POCT with other upstream and downstream systems.
Market participants focusing on strengthening their presence in POCT should employ a diverse set of digital strategies and connectivity solutions rather than relying on comprehensive product portfolio-OEM integration with data connectivity providers. This is particularly crucial considering the lack of uniform reimbursement across the European Union, which is a deterrent for companies seeking to establish strong foothold across the region. Disparity in reimbursement among Western European countries leads to non-linear adoption across segments and non-uniform pricing models.
In the European region, POCT devices are regulated under the 1998 European Directive 98/79/EC on in vitro diagnostic medical devices. The latest amended directive was in 2011 (2011/100/EU). Recently, an international standard (ISO 22870:2006) giving specific requirements applicable to POCT was introduced, and this is intended to be used in conjunction with ISO 15189, which describes the general requirements for the competence and quality of medical laboratories. Patient self-testing in a home or community setting is not covered by these ISO standards.
Emergence of iPOCT is the next evolution, which is Technology-based and Need-driven, meeting the requirement of real-time analysis, dynamic patient verification at the device level, integration into data management systems, automation of data analysis, report generation/distribution and IT solutions to facilitate communication by sending messages to certain units or users through the POCT device.
As part of the clinical routine in diagnosis the need of the hour is to identify and develop a technology which is portable, affordable, hand-held, molecular level analytical system, with shorter turnaround time, that produces efficient results comparable to mutation detection, sequencing, and infectious agent identification, and improves patient care throughout.
Mohamad Sulaikha is a Research Analyst, Transformational Health at Frost & Sullivan.