The Market and Potential for Molecular Point of Care Diagnostic Tests

Among the various technologies and products of the global in vitro diagnostics (IVD) market, molecular diagnostics performed at the point of care or near the patient are regarded as a leading expansion market. Molecular point-of-care (POC) diagnostics are able to improve the sensitivity and specificity of existing near-patient and rapid tests and also expand the diagnostic capabilities at points of care such as hospital critical care units, physician offices, outpatient clinics, and community health posts in the developing world. Existing POC diagnostics range from urinalysis dipsticks performed in physician office laboratories (POLs) through rapid infectious disease tests used to quickly diagnose admitted patients. 

There have been many projections made about molecular point care.  This report provides consensus market views and realistic estimates for this novel field.  Kalorama Information produced two definitive market studies of this market in 2013, prior to significant product development, and 2016 as the first products - Alere i, BioFire Film Array, and cobas Liat appeared on the scene.  Now, with more market track records and approvals, mPOC products competing with traditional systems, Kalorama has updated its findings with the latest information.  Who is leading?  Where is investment in mPOC systems?  Who has products in development?  What companies are lagging?   What can we expect in the future.  This report answers these questions and more.  

 Profiled companies include those with clinical molecular diagnostic systems applicable to POC testing markets; molecular diagnostic systems applicable to hospital lab molecular testing; development-stage molecular diagnostic systems for decentralized testing; molecular diagnostic products for use primarily in emerging markets of the developing world and for field testing; companies with original equipment manufacturer (OEM) platforms and component technologies that could be featured in the molecular POC diagnostics market; and other companies that have been involved in molecular POC diagnostics through investment, collaborative research or technology development that could allow them to enter the market. Companies profiled include:

The market introduction of POC diagnostics or tests (POCTs) often follows a period of technological maturation or refinement of an existing laboratory diagnostic modality or platform. One of the major enabling technologies for POC testing with molecular diagnostics is real-time polymerase chain reaction (qPCR) testing that eliminated the need for post-amplification electrophoresis and integrated detection within the same instrument that performed amplification. Advances and innovations in microfluidics; isothermal and other alternative amplification chemistries; test automation; primers and probes; and next-generation sequencing (NGS) methods have been the most significant to the development of decentralized molecular diagnostics. In many cases, these technologies work together to facilitate clinical molecular testing in an automated manner within a smaller device.

Companies profiled in this report include: