General remarks about human diagnostic testing
The field of human diagnostic testing, primarily performed outside the body, is large and ever-expanding. Recent estimates put the value of this business at around USD 100 billion. This business is commonly referred to as In Vitro Diagnostic testing (IVD), although more and more non-invasive tests are entering the market.
Centralised Laboratory IVD testing
This area is the traditional testing venue, and has been since the earliest days of clinical chemistry, bacteriology, haematology and blood bank testing. Almost all workflows for most sample types can now be automated, improving result accuracy and integrity while speeding turn-around times for clinicians.
These modern analytical systems are capital intensive and require specialised service to keep them running well. Customers expect a wide range of tests on these systems, with built-in QC and sample-integrity capabilities, often supported by 24/7 service. These requirements have reduced the number of suppliers, as smaller companies merged to meet the increased expectations of laboratories, clinicians and regulatory authorities.
Notably, even the current main suppliers still rely on specialist (often quite small) companies to provide some products, which they then sell under their own brand and are classed as the legal manufacturer under EU and FDA regulations. These products are made for the company under licence or licenced by the company, so the same product could be on the market under more than one brand. This is especially true for special antibodies, latex particles, and QC materials.
A recent estimate puts the total contract manufacturing market for IVD materials at around US$ 20 billion and growing at about 5% per year; this includes devices, reagents and control sera.
Point-of-Care (POC), or rather, Near-Patient Testing (NPT)
This area of in vitro diagnostic (IVD) testing is growing in clinical and economic interest.
Some tests are well established, such as home glucose monitoring and pregnancy testing, whereas others are fairly new, such as lateral-flow strips for COVID and influenza.
Interest is increasing in tests that professionals can do outside the typical laboratory environment. These tests may be done in a doctor's office, in a hospital accident/emergency department, or even in the ambulance bringing a patient to the hospital; for example, a troponin cardiac test.
As with all testing, erroneous results must be minimised, and in non-laboratory testing this can be difficult to achieve because traditional laboratory Quality Control systems (QCS) are impractical to apply. For glucose monitoring, pre-calibrated strips can check the glucose meter's readings, and for COVID strips, an inbuilt marker window can show that the sample has been properly applied.
For more recent test developments, QC can still pose a problem, as can special storage requirements (refrigeration/freezing) and how long a test device can be left at room temperature before it becomes unreliable. Over time, these problems will be solved as this area of testing continues to grow.
Wearables
Currently, the main clinically important wearable devices are continuous glucose monitoring devices, in which a sticky patch is applied to the skin, allowing direct measurement of interstitial glucose. The device readings can be read at any time using a smartphone, and long-term graphs can show the degree of control achieved by the patient. It is also possible to link the device output to an insulin pump, allowing better control of glucose levels.
In hospital situations, continuous monitoring of oxygen saturation levels is commonplace, as is 24-hour electrocardiogram recording. Monitoring hormones or therapeutic drugs may be possible in the not-too-distant future, but these will initially, at least, be under direct clinician care.
A whole host of wearable devices are currently available, including smartwatches and various fitness bands. At the current time, these devices are primarily directed at people who are interested in controlling their lifestyle/wellness and are mainly not considered to be clinically ready for medical use. This is changing fast, and some devices offer sophisticated cardiac data that could support faster diagnosis and treatment.
Sources for the contract manufacturing estimate: Kenneth Research, IVD Contract Manufacturing Market, Size and Share by End User (September 2026); Kings Research, IVD Contract Manufacturing Market.