Biosensors for Point-of-Care Diagnostics 2022-2032: Technology, Opportunities, Players and Forecasts

The market for medical diagnostics is shifting from conventional, laboratory-based testing towards testing directly at the point of care. No time has this shift been so vital as now, during the COVID-19 pandemic. In this report, IDTechEx discusses the growth of point-of-care biosensors, the emerging trends within the industry and what opportunities new technologies will present. We forecast the trajectory that these will take the industry.

 

Point-of-care testing (POCT) refers to diagnostics at the bedside or near the patient. This can be in hospital wards, physician's offices, retail clinics, and at home. By providing rapid results, POCT allows faster clinical action to be taken. By eliminating the need to send samples to conventional laboratories for testing, POCT solves the clinical issues around follow-ups and resources/time commitment. Furthermore, at-home testing allows patients to directly test for disease/health conditions without the need to visit a physician, which is critical for monitoring chronic diseases such as diabetes.

 

Our changing population demographics are increasing the pressure on healthcare systems. Today, healthcare spending makes up about 14% of the world GDP. In developed economies, there are rising cases of chronic diseases, driven by the aging population, and by more sedentary lifestyles. The demand for healthcare in emerging economies grows too, accelerated by an expanding population size. The need to bring diagnostics to resource limited settings drives POCT in these regions. Overall, cases of infectious disease and the frequency of emerging epidemics are growing too, driven by increasing urban density and a warming climate. Together, these factors are driving the point-of-care biosensor industry to grow towards $29.5 billion by 2032.

 

 

With the onset of COVID-19, the diagnostics industry ramped up manufacturing capacity for COVID-19 test products. Testing has been critical to tracking an infection which is asymptomatic for most of the population, allowing people to manage the spread of the virus. While conventional testing using PCR within the laboratory remains the gold-standard of testing accuracy, the emergence of at-home COVID-19 tests has increased testing accessibility and allowed individuals to use it at a higher frequency. In 2021, the US government invested $1 billion in increasing the supply of at-home tests, enabling the rise of production volume to approximately 200 million tests per month. This opportunity has been a key booster on several fronts for the industry. Cue Health, who developed a molecular COVID-19 at-home test, received a $400m contract from the US Department of Defense in 2021; versus a total revenue of $23m the year before. For POCT cartridge products, install-base has grown massively: BD's Veritor device almost tripled its USA install base, to 70,000, in six months, while Quidel's Sofia similarly installed over 75,000 units in 2021. This established user base facilitates future market expansion. The virus has also allowed start-ups to seed the market by pivoting the platforms they were developing into COVID-19 testing applications, such as Visby Medical who have developed a single-use, miniaturized PCR for the point-of-care.

 

In this report, IDTechEx divides the POC biosensor into its components of bioreceptors and transducers to explore the key and novel technologies within these segments. We analyse the techniques designed to miniaturize nucleic acid amplification and bring it towards point-of-care, such as PCR, LAMP, and NEAR. The report also explores emerging approaches to transducing biological signals, including the use of graphene and carbon nanotubes in electrochemical transduction, and the use of fluorescent organic dyes and quantum dots in optical transducers.

 

However, many of the biosensor technologies at point-of-care are mature with limited innovation. Lateral flow tests have been commercialised for half a century, yet they remain limited by the accuracy of their readings. Part of this problem is being resolved by a growing trend of using readers and smartphone-camera readers to digitalize and connect the results of these tests, eliminating inaccuracy such as misinterpreting faint lines by eye. Yet, the technology is fundamentally limited by the sensitivity and the specificity of their bioreceptors, which are usually antibodies.

 

Despite the excitement around many emerging technologies for biosensing, there are still several problems to solve. While the properties of CRIPSR/Cas make it good for diagnostics, with potential for excellent accuracy, the reality is that the technology is still immature. The technology does not see many players for a point-of-care diagnostics application, with many more focused on other applications such as therapeutics. Similarly, we ask what constraints are limiting carbon-based nanomaterials from their commercialization in transducers today, despite their suitability.

 

The report segments and discusses the market by applications, looking at the drivers and constraints of each segment, as well as the key diseases and disease biomarkers that industry players target. We also segment by the format of the biosensor and evaluate the importance of formats to bring different biosensors to the point-of-care. These segments are extrapolated in our 10-year forecast, to explore the make-up of applications and formats and how they might change in time.

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