The Future of Point-of-Care Diagnostics.

The value of the point-of-care (POC) diagnostics market has been steadily increasing for the past 40 years, but we’ve seen exponential growth in the last 2. POC analysis offers several advantages to laboratory-based tests, given that they are normally portable, inexpensive, fast and easy to use, which means that expert help is no longer necessary.

In recent times, we’ve also seen the emphasis of care has shift more toward the prevention and early detection of disease because people want the ability to get involved and diagnose themselves.

This desire to self-monitor and diagnose fits better with some people than others, and a particularly dominant area in POC is in glucose monitoring. The need for diabetes patients to regularly test themselves means that the ease of access to, and functionality of, POC testing is perfectly suited to their conditions. However, I would argue that the commoditisation of glucose monitoring devices has shifted that test into a medical device, as opposed to the specialist scientific diagnostic testing areas that I am accustomed to working with. Therefore, for the rest of this article, I’ll mainly be looking at POC testing for infectious diseases.

One reason for the recent growth in POC testing is the emergence of wearable devices, smartphones and lab-on-a-chip technology. These three factors on their own have completely transformed the landscape of the market. I’ll look at the financial implications later, but the portability and usability of these devices also means that this testing has huge potential from a humanitarian perspective.

In low income countries where there is a lack of lab-based diagnostic testing available, the use of smartphones to diagnose infectious disease is a huge advancement. It is now well within the realms of possibility that we could see a POC test for HIV, TB or malaria from a smartphone, enabling patients to diagnose themselves – avoiding lengthy trips to hospitals or healthcare providers. In hard-hit areas of Central Africa, a quicker, cheaper diagnosis of life threatening disease could be life changing or lifesaving for literally millions of people.

Today, POC diagnostics has huge potential to improve the management of a variety of diseases and conditions, especially in the resource-limited settings where healthcare infrastructure is weak and access to high-quality and timely medical care is a real challenge. Access to this kind of healthcare has, without doubt, already improved the health of many people and will continue to do so for the foreseeable future.

Whilst the usage of the tests could have a home in Africa, in 2017 it’s still unlikely that we’ll see production shift there - at the moment there’s a US domination of the POC market, however whilst that is the case for now, the emerging markets in MEA and APAC are areas to watch as potential areas for growth.

Humanitarian benefits aside, of course the advent of POC in wearables has created a huge economic incentive for those companies able to enter the space. As the below graph demonstrates, the aforementioned infectious disease POC testing has been growing a rapid rate. This has led to a lot of companies trying to get involved.

According to the National Centre of Biotechnology Information (NCBI), in 2011 the POC testing market was worth approximately $15 Billion. All signs are pointing to this growth continuing too.

A watershed moment came in 2015 within molecular diagnostics, as it marked MD moving out of the lab. That year saw the FDA grant Alere’s first CLIA waiver for a nucleic acid-based test, which was quickly followed up by Roche’s own FDA approval with the expansion of their Cobas menu.

Then things started to move quickly.

By 2016 many more companies including the likes of Cepheid received CLIA waivers and it is now anticipated that the big players who are yet to enter the Molecular POC market, such as Siemens, BD and Hologic, are preparing to wade in. All three of those players have devices in development and are likely to reach the commercial market within the next few years.

Looking at market share in 2017, according to Kalorama Information, Roche, Alere (soon to be Abbott) and Siemens lead the way in POC. Along with Abbott, they make up 3 quarters of the market. However, as a specialist in this area, it’s the emerging smaller players that I’m excited about. 

Companies such as Chembio, Sekisui, Trinity Biotech, Meridian Biosciences and Quidel are all quickly establishing themselves as innovators in the infectious POC diagnostic space. 

The volume of testing performed outside the conventional laboratory will undoubtedly grow, and will continue to be driven by the need to deliver care closer to the patient at a lower cost. Although the benefits of POC are clear, the industry is certainly not without its challenges. According to GEN, tests performed on clinical laboratory analysers continue to be perceived as superior to POC. This raises the pressure on companies entering the market as they must demonstrate their tests have more, or at least as much, clinical utility than those performed in labs.

With the emergence of molecular diagnostics and the well documented need for more infectious disease testing in the developing world it will be interesting to see how much of this projected growth will take place in point of care locations, rather than the central laboratory.

In 2011 NCBI predicted compound annual growth of 4%, and for the POC market to reach a value of $18 Billion by 2016. However, having looked a little deeper in to this, the growth has been significantly higher with the market being rated at $23 Billion by Allied Market Research last year – almost 3 times the projected growth back in 2011.

It’s been a fantastic thing to be a part of and promises to be an exciting next few years watching the rest of this drama unfold.