As the point-of-care biosensor market is expected to expand to $33 billion by 2027, investing in the right technology and business model now is paramount to success over the next decade.
The glucose testing sector dominates the market for point-of-care biosensors, with an estimated market value of $6 billion in 2017. As the market for disposable biosensors expands, the race is on to find the next glucose test - but is this really a sensible strategy?
With over 20 billion glucose test strips being produced each year, for around $0.10 each, we can understand why there is such a desire to develop a test that mimics the glucose testing model. In practice, this is not a trivial task.
What is often overlooked is that the glucose testing market presents an unusual case, primarily due to three factors:
- The test is a necessity for patients to manage diabetes.
- A high test volume is carried out, with 3-8 disposable strips used per patient each day.
- The mechanism used to detect glucose is very simple, cheap and easy to produce in high volumes.
The biosensor industry is pushing hard to find a new test which relies on the principles of glucose testing - printed thin film electrodes upon which antibodies are deposited. However, the reality is that most tests for an analyte require a more complicated setup. This may be because multiple reactions are required, rather than just one reaction with an antibody, or, the analyte may not be present in high amounts in the body, making it harder to detect.
Ultimately, even if we can find a test which is cheap and simple both to produce and conduct, the demand must still be there for it. It is rare that a disease or health condition requires multiple tests to be carried out each day. As the size and cost of disposable biosensors decreases, we are seeing an increasing demand for biosensors at the point-of-care due to the high value they bring, both by patients and healthcare providers.
Increasingly, these disposable tests conducted at the point-of-care are also much more complicated, so called lab-on-a-chip biosensors, as they are essentially miniaturized laboratories. This new wave of tests includes molecular diagnostics, the ability to conduct genetic tests on a portable machine in as little as 8 minutes. Such tests are more expensive than traditional technologies such as the electrochemical test strips used in glucose testing, but provide the capacity to conduct tests at the point-of-care which have never been possible before.
While the industry poises itself for an easy win, it may not be a winning strategy. It may be tempting to re-hash older, cheaper and more established technologies, but even in the high-volume glucose testing market we are seeing profit margins being squeezed.
One example of a tried attempt to utilize electrochemical test strips on a large scale is for home cholesterol monitoring, however, for a number of reasons, these tests are not entirely necessary:
- Most readily available (and affordable) tests only measure total cholesterol. A full understanding of your cholesterol profile requires measurements of HDL, LDL, and triglycerides as well.
- Even with a sophisticated cholesterol test, a doctor needs to review results in combination with other risk factors -- such as family history, nutritional habits, age, and gender -- to really understand your risk for cardiovascular disease.
- Blood cholesterol, unlike glucose, doesn't change on a day to day or week to week basis. Doctors recommend having a cholesterol test every five years. People with higher cholesterol levels or risk factors for cardiovascular disease may need to be tested more often, but testing at home is usually unnecessary.
As a result of the low volume demand and the high price of cholesterol sensors ($4 per sensor, compared with $0.10 per glucose sensor), there has been little growth over the last 10 years in point-of-care cholesterol monitoring.
Perhaps the best advice is to go for the road less travelled - with newer technologies that command higher prices. Especially when the volumes demanded are unlikely to be in the same order of magnitude as we see for glucose testing.
The new report Biosensors for Point-of-Care Testing 2017-2027, from IDTechEx, gives a complete analysis of the important trends in the field of medical biosensors, and lists the new technologies and devices which are likely to be highly disruptive to the in vitro diagnostics market.