Description

Accelerated reforms due to COVID-19 and technologically advanced sample-in-answer-out portable, web-connected, encrypted devices that provide results in a few minutes changed the diagnostic healthcare industry. Decentralized testing empowers clinicians to make lifesaving decisions for the patient. It shortens supply chain lag time, saves costs of in-person clinical examination, reduces the length of hospital stay and wait lines, and helps improve access to rural and semi-urban settings for timely healthcare intervention.

The next-generation point-of-care diagnostics is at an inflection point and is transforming patient care in emergency, acute, chronic, and specialized care with platforms capable of monitoring/measuring a wide range of disease markers with laboratory precision. The diagnostic innovation of assays for rapid detection, miniaturization of portable devices, and automation of workflows serves the broad spectrum of setting and shift toward hyper-scaling of access and comprehensive test designs.

The study showcases several diagnostic technologies, such as a microfluidic-based hand-held portable device (lab-on-a-chip device) designed to provide atraumatic, end-to-end point-of-care automated and integrated diagnostic solution, with its sample-on-chip preparation and nucleic acid analysis assay.
•     The recent paper-based devices with Nucleic Acid Testing (NAT) have shown great promise for infectious diseases and detection etiology of
infection (bacterial, viral, or fungal) with its cost-effective, bio-compatible, disposable on-site monitoring/testing.
•     Lateral flow devices with sensor technology enable rapid analysis of blood samples for many critical care assays. These include blood
gases/electrolytes, cardiac markers, cholesterol/lipids, coagulation monitoring, glucose monitoring, hematology, infectious diseases,
pregnancy and fertility, tumor/cancer markers, urinalysis, other chemistries (magnesium, lactate, micro-albumin, creatinine), and more.
•     Decentralized clinical diagnostics continue to innovate a wide range of systems and assays with rapid test analyzers, instruments, reagents,
strips, and cartridges. The electronic services complement it with automation, cloud computing, and deep learning for rapid and accurate
results.

Digital technology is accelerating the adoption of decentralization in clinical practice as the workflows integrate with POC at-home systems delivering lab results on smartphones. Integrated, comprehensive diagnostic services are key differentiators for stakeholders, which vary in their offering to enterprises (labs, physician offices, or hospital emergency units) or patients. These services will enhance patient-centered access to care and help physicians close the diagnostic loop of the healthcare continuum.

The regulatory environment analysis of the study provides insight into policies in the US, Europe, and the UK that are currently shaping the implementation of decentralized clinical diagnostics and influencing market adoption.

The study, with an in-depth analysis of the industry environment and its participants, such as clinical laboratories, diagnostic/technology companies, retail, pharmacies, and start-ups, proposes a market model for connected healthcare and the prospective growth opportunities for stakeholders.

Frost & Sullivan predicts the decentralized diagnostic testing market and services to grow exponentially in the next 5 years. This forecast
considers structural shifts and economic uncertainties, rising costs, decreasing volumes of COVID-19 tests, government regulations encouraging decentralized care adoption, the discovery of critical assays augmented with AI automation, digital integration, participation of nontraditional players in technology and retail, and more.