CHICAGO (Reuters) - Abbott Laboratories ABT.N plans to ramp up manufacturing capacity for its lower-cost continuous glucose monitor, the FreeStyle Libre, by three to five times in the next few years, aiming to reach millions more patients worldwide, the company told Reuters.

Abbott's FreeStyle Libre 14 day system, which is used to identify continuous glucose levels, trends, and an eight-hour history of glucose patterns in diabetes patients, is pictured in this undated handout photo obtained by Reuters July 15, 2019. Abbott/Handout via REUTERS

Abbott executives said the increase in manufacturing capacity will begin in the second half of this year and make room for the expected U.S. launch of the FreeStyle Libre 2. This next-generation device has been approved in Europe and is now under U.S. regulatory review.

Abbott’s plans for Libre, its fastest-growing diabetes product, used by 1.5 million people worldwide, will be in focus when the company reports quarterly earnings on Wednesday.

Jared Watkin, Abbott’s senior vice president for Diabetes Care, said in an interview that scale is a “huge part” of the company’s strategy for its glucose monitors. “When you’re making disposable diagnostic products, the more you can make, the lower the cost you can produce them at.”

While the Libre 2 has more features, including alarms for when blood sugar levels swing too low or high, Abbott plans to keep the U.S. price the same as its predecessor, Watkin said.

Abbott started in diabetes care as a maker of inexpensive test strips and glucose meters. More recently, the company has sought to expand access to its so-called continuous glucose monitoring (CGM) devices - traditionally sold to type 1 diabetics in markets with generous insurance coverage.

“It’s not good enough to bring this to a small, wealthy population. Diabetes is such a global epidemic that you need to bring products that can really make a dent in that,” Watkin said.

Launched in Europe in 2014 and in the United States three years later, the FreeStyle Libre allows people with diabetes to track blood sugar levels without multiple daily finger sticks.

A sensor attached to the back of the upper arm uses a thin filament under the skin to measure glucose every minute. Users check their blood sugar levels throughout the day by waving a reader, or smartphone, over the sensor. Major competitors Medtronic Plc MDT.N and Dexcom Inc DXCM.O critique the current Libre's lack of automatic alerts that can help diabetics manage their disease. Yet they also are taking steps to introduce cheaper models themselves, executives told Reuters.

Libre’s sales are expected to reach $1.5 billion this year, the company said. In April, Goldman Sachs estimated the global CGM market could reach $5 billion by 2021, up from $3.7 billion in 2019. Goldman projected Abbott’s 2021 sales at $2.7 billion compared to $1.7 billion for Dexcom and $894 million for Medtronic.

‘SCRATCHING THE SURFACE’

In the past, CGMs were used almost exclusively by type 1 diabetics, whose bodies do not make insulin and who must inject themselves with the blood-sugar regulating hormone to survive.

Increasingly, people with type 2 diabetes - the kind driven by obesity, lack of exercise and genetics - must also closely monitor their blood glucose and use insulin to manage their disease when it is not controlled by other medications and lifestyle changes.

For now, Libre users include 1 million type 1 diabetic patients and half a million type 2. That’s a tiny sliver of the 425 million people with diabetes worldwide.

Although not all diabetics need glucose monitors, “there is an element of scratching the surface at this point,” Watkin said. “The need to invest and bring up capacity is, we believe, going to be an ongoing activity for us.”

Two 14-day Libre sensors, a month’s supply, retail for $109. Abbott says most of its patients are commercially insured, and many pay as little as $10 out of pocket.

In the United States, the company says, more than half of people in commercial health plans are covered, as well as any eligible diabetic person on Medicare, the federal program for the elderly and disabled. The device is also approved in 45 other countries, including Germany, Japan, Brazil, China and the United Arab Emirates.

Medtronic told Reuters it offers a discounted price of $345 per month for uninsured patients. The company estimates that the typical insured patient pays $50 a month. Medicare does not cover the device.

Dexcom’s G6 sensors retail online, with a discount, at around $350 for a month’s supply. Dexcom says 98 percent of all U.S. private insurers cover the device, and patients covered by commercial insurance pay an average of $50-$80 per month for sensors through pharmacies or durable medical equipment suppliers. It is covered by Medicare.

Libre’s 14-day sensor is also longer-lasting. Dexcom’s sensors work for 10 days, and Medtronic’s for up to 7. Abbott was also the first company to introduce a product that can be used without routine finger stick tests to validate the sensor’s readings – a feature Dexcom later matched and Medtronic has not.

Dr. Roy Beck, an endocrinologist at the Jaeb Center for Health Research in Tampa, Florida, said that Abbott's FreeStyle Libre is "an excellent sensor" but not as accurate at detecting very low blood sugar as the devices from Dexcom, Medtronic or an implantable CGM made by Senseonics SENS.A.

That makes it less desirable for patients for whom this is a major issue, he said. Beck’s center has received research funding from Abbott and Dexcom.

Medtronic and Dexcom executives say the current Libre does not compare with their devices when it comes to features such as alerting users to dangerous blood sugar changes and providing comprehensive trend data.

“It’s the cheapest, but it’s not exactly in the same category,” said Mike Hill, vice president and general manager of Medtronic’s sensor business.

Abbott countered that its sensor has best-in-class accuracy, and noted that the next-generation Libre 2 does have optional alarms.

Still, Medtronic is considering making a cheaper sensor for patients who don't need all the features of its current continuous monitor, Hill said. And next year, Dexcom plans to launch a cheaper, smaller, 14-day sensor developed in partnership with Verily, Alphabet Inc's GOOGL.O life sciences division.

Dexcom Chief Executive Kevin Sayer acknowledged that Abbott’s pricing strategy will affect the global market over time, and that Dexcom expects its own prices to come down. “We’ve planned for this,” he said.