By Joe Guterl
More than $72 billion – that is what some researchers estimate will be the global point-of-care (POC) biochemical diagnostic testing market size in 2027, up from $36 billion in 2021.1,2 The POC molecular diagnostics market is expected to reach $4-$5 billion in the same timeframe, up from about $3 billion in the 2020/2021 timeframe.2,3
The COVID-19 pandemic has dramatically changed the way we engage with healthcare, but other trends in disease, technology innovation, and healthcare infrastructure are also presenting new drivers and challenges to this tremendous growth. Point-of-care instrument providers that can offer more accurate, precise, flexible, and faster tools will be in the best position to leverage the drivers, mitigate the challenges, and capture POC market share.
The most fundamental benefit of point-of-care testing is providing healthcare providers and patients with faster, more cost-effective access to specific, actionable results early when treatment can be most effective. When potentially life-changing clinical decisions hang on laboratory testing, fast, high-performance POC liquid handling instruments may enable quicker and more accurate diagnosis and treatment.
Situations such as emergency care, public health outbreaks, rapid screening of infectious diseases, cardiovascular events, and adverse drug reactions all rely on speedy diagnosis for the best chance of positive outcomes. Other testing needs such as fertility testing, blood monitoring, ongoing disease management, or routine wellness panels may not require speed, but they do demand precise, reproducible, and reliable data regardless of the testing location. Flexible POC liquid handling technologies that can support different test modalities can play a significant role in improving patient care.
Advancements in device miniaturization, sample multiplexing, disposables technology, higher sensitivity optics and chemistries, increased data processing, sensors, component reliability, and cloud-based data storage and analysis are enabling a remarkable reshaping of both biochemical and molecular disease diagnosis. Point-of-care liquid handling instrument designs that leverage these advancements will be best positioned to gain advantage in the POC market.
Increased R&D funding for technologies that will reduce clinical diagnostic testing time is driving additional growth in the POC testing market.4 Notably, the COVID-19 pandemic has driven greater willingness by regulatory authorities to fast-track approval of diagnostic products. For example, in April 2020, the US National Institutes of Health (NIH) Point-of-Care Technologies Research Network (POCTRN) launched the Rapid Acceleration of Diagnostics (RADxSM) initiative.5
The intention of the initiative is to accelerate the development, validation, and commercialization of innovative point-of-care and home-based tests, as well as improvements to clinical laboratory tests, that can directly detect SARS-CoV-2. Although the RADx model was established to support development of SARS-CoV-2 tests, it may be more broadly applied to speed development of novel point-of-care tests for a wider variety of diseases.6
Flexibility of liquid handling systems to enable different types of testing modalities can provide POC instrument providers with broader market access. Two examples of emerging liquid handling systems that support POC facilities offer quite different purposes.
Liquid handling instruments that ensure sample purity and zero carry-over are essential in preventing erroneous PCR amplification from contaminating sequences in sequencing sample library preparation and many other genetic tests. The market for point-of-care diagnostic testing using next-generation sequencing (NGS) and other genetic technologies is poised for steady growth with the emergence of new applications in areas such as non-invasive prenatal testing and oncology.3,7,8
Rising focus on decentralized healthcare is another dominant driver in the growing POC instruments market. Clinical testing instrument providers that can help bring essential clinical care nearer to patients will be best able to benefit from market decentralization trends. POC instrumentation to support smaller, decentralized facilities must be compact and potentially portable without sacrificing performance specifications, In remote facilities, exceptional reliability can be vital to enable long-term use with limited maintenance resources. It can also be highly valuable if results from POC systems can be retrieved by providers located anywhere in the world.
In March of 2020 in response to the COVID-19 pandemic, the US Centers for Medicare & Medicaid Services (CMS) established the ‘Hospitals Without Walls’ initiative, whereby the definition of a hospital is not bound by physical space.9 The initiative allows hospitals to use ambulatory care facilities (ACFs), inpatient rehabilitation clinics, and even hotels and dorms, as hospital sites.
Under this new initiative, ACFs in particular can be certified as hospitals and provide inpatient care for longer periods than previously allowed. Communities will have additional access points for surgical capacity and other life-saving care.8 However, this also means that these decentralized facilities must be equipped with some of the same testing and monitoring capabilities as a larger hospital and for longer-term patients, but possibly with much less space to accommodate new equipment.
Effective decentralization of healthcare is also essential in developing countries where, in many regions, proximity to healthcare is inadequate. For example, a study in sub-Saharan Africa concluded that one in eight people in those countries is at least one hour away from the nearest health center via local transportation.10 To meet commonly accepted universal healthcare accessibility targets, those countries will need to build about 6,200 new facilities by 2030. Demand such as this has the potential to drive tremendous growth in POC technology markets.
The way medical care is delivered is changing rapidly and driving significant market growth. The COVID-19 pandemic, increased prevalence of chronic diseases that require long-term outpatient care, shifts in government and research funding, and exciting advancements in life science technologies are all generating needs and enabling solutions to bring clinical care closer to patients. This is a long list of powerful factors that are driving the long-term growth and opportunity for POC diagnostic testing markets. Point-of-care system designers who can deliver solutions to new POC challenges will be in the strongest position to benefit from POC growth opportunities.