Technological Advances Expected to Drive Huge Growth in Diabetes Testing

Diabetes remains a major clinical challenge that generates $760 billion in global spending per year. Diagnostic testing is expected to reach $18.9 billion in 2021, a total that is likely to grow significantly in the years ahead thanks to new technological advances in diabetes testing. That is the finding of a new report from leading health care financial market analysis firm Kalorama Information.

The Diabetes Testing Market

Growing incidence rates have made diabetes a problem of global concern, especially in less developed countries. According to the World Health Organization (WHO), 470 million people around the world had diabetes in 2020, with deaths related to diabetes projected to increase by over 50 percent in the next 10 years.

The International Diabetes Federation (IDF) estimates that annual health care spending on diabetes, which currently totals $760 billion, will likely rise to $927 billion by 2035. In addition, there are an estimated 240 million around the world whose diabetes cases have not been diagnosed, mostly in low- and middle-income countries where access to medical care is limited.

But there is more to the opportunity than just the disease data and demographics; technology is also driving growth in diabetes testing. While most patients still rely on traditional testing methods using test strips and monitors to test blood sugar levels, the Kalorama report points to two technological advances likely to make a major impact on the diabetes testing market: continuous glucose monitoring (CGM) and hemoglobin A1c (HbA1c) testing.

CGM Testing

Described as the most important breakthrough in diabetes management in the past four decades, CGM uses tiny sensors inserted under the skin to measure levels of interstitial glucose located in the fluid between cells, enabling patients to track their blood glucose at a glance—day and night—and make informed decisions about what to eat, what medications to use, when to engage in physical activities, etc.

The ultimate goal for insulin-dependent diabetics is a closed-loop pump monitor system that automatically reads CGM data to determine how much insulin to deliver. The Kalorama analysis notes that three companies—Abbott, Medtronic, and Dexcom—are currently working with sixth-generation devices to provide closed-loop CGM systems comprised of a sensor, transmitter, and insulin pump. While Kalorama estimates that these three firms currently account for 80 percent of the market, it also notes that increasing numbers of new companies are entering the segment, including Tandem Diabetes Care, which received US Food and Drug Administration clearance for its Control-IQ artificial pancreas in 2020. In June 2020, Tandem partnered with Abbott to integrate the latter’s FreeStyle Libre CGM with its own insulin delivery products.

HbA1c Testing

The HbA1c test is a common test used to both diagnose and manage type 1 and type 2 diabetes by monitoring glycated hemoglobin blood sugar levels in a patient’s blood. Unlike traditional glucose testing, HbA1c testing can be done at any time of day or night, without the patient having to fast. HbA1c test values also vary less than fasting plasma glucose values and offer a picture of a patient’s average blood glucose level over the preceding two to three months. There are two basic types of HbA1c tests:

• High-performance liquid chromatography (HPLC) tests that measure molecular charge; and
• Immunoassays and affinity chromatography tests that measure molecular structure.

According to Kalorama, immunoassay and point-of-care tests have recently increased in usage because they are simpler and more widely available than HPLC tests. Kalorama suggests that HbA1c testing is likely to become popular with outpatient clinics, physician office labs and small hospital-based laboratories.

Eventually, the report suggests, the HbA1c testing market will likely evolve to include self-tests using mail-in, home-collected sample laboratory services, enabling testing without the patient’s having to leave home.