Three companies lead the continuous glucose monitor (CGM) market: Abbott, Dexcom, and MiniMed (formerly Medtronic Diabetes). Their reported results show how large it has become. Abbott’s CGM sales reached $7.6 billion in 2025, Dexcom’s revenue reached $4.66 billion, and MiniMed reported $1.55 billion in CGM revenue for its fiscal year ended April 2026. Together, based on our calculations from company filings, that is more than $13.8 billion a year, not including smaller and international makers.
The market is also widening. Over-the-counter (OTC) CGMs for people who do not use insulin, implantable and needle-free sensors, and new indications for type 2 diabetes have all reached the US market since 2024. This guide covers the CGM companies, how the FDA classifies their devices, what the numbers show, and what it all means for companies building CGM hardware and software.
CGM companies at a glance
Company | Main CGM products | US regulatory status | Latest annual results |
|---|---|---|---|
Abbott | FreeStyle Libre 2 and 3 family; Lingo and Libre Rio (OTC); Instinct sensor for MiniMed | 510(k) (iCGM and OTC product codes) | CGM sales $7.6 billion (2025), used by about 8 million people in more than 60 countries |
Dexcom | G6, G7, G7 15 Day; Stelo (OTC) | De Novo for G6 (2018); 510(k) for G7, G7 15 Day, and Stelo | Total revenue $4.66 billion (2025), up 16% |
MiniMed | Simplera, Simplera Sync, Guardian 4 | Premarket approval (PMA) | CGM revenue $1.55 billion (fiscal year ended April 2026), up 18% |
Senseonics | Eversense 365 (implantable, one-year sensor) | 510(k), its own classification (2024) | Revenue $35.3 million (2025), up 57% |
Biolinq | Biolinq Shine (intradermal, needle-free) | De Novo (September 2025) | Private |
Signos | Signos Glucose Monitoring System (OTC, weight management) | 510(k) (March 2025) | Private |
Sources: Abbott 2025 10-K, Dexcom FY2025 results, MiniMed FY2026 results, Senseonics 2025 results, and FDA’s 510(k) and De Novo databases.
Abbott
Abbott is the largest CGM maker by sales. Its CGM sales grew from $6.4 billion in 2024 to $7.6 billion in 2025, and its Diabetes Care business reached about $8.0 billion. The FreeStyle Libre family covers people with diabetes on and off insulin, and in June 2024 Abbott received FDA clearance for two OTC systems: Lingo, a wellness product, and Libre Rio, for adults with type 2 diabetes who do not use insulin. Abbott also makes the Instinct sensor used with MiniMed’s insulin pump systems.
Dexcom
Dexcom reported 2025 revenue of $4.66 billion, with about 72% from the US, and guided to $5.16 billion to $5.25 billion for 2026. Its G6 was the first CGM authorized as an integrated CGM (iCGM) in 2018. The G7 15 Day, cleared in April 2025, extends wear to 15.5 days. Stelo, cleared in March 2024, was the first FDA-cleared OTC CGM.
MiniMed
MiniMed, Medtronic’s former diabetes business, became a separate public company in 2026. It completed an IPO in March 2026, and Medtronic completed the split-off in October 2026. Its CGM sensors, including Simplera Sync, approved in April 2025 for use with the MiniMed 780G, reach the market through PMA. MiniMed’s 780G system also works with Abbott’s Instinct sensor.
Senseonics, Biolinq, and other new entrants
- Senseonics makes Eversense 365, an implantable sensor that lasts a year. It was cleared in September 2024 under its own regulation, 21 CFR 862.1357. Senseonics took back commercialization of Eversense from its former partner Ascensia from January 2026.
- Biolinq received a De Novo grant in September 2025 for Biolinq Shine, a needle-free intradermal sensor for adults not on insulin. FDA created a new classification for it, the “glucose range monitoring system.”
- Signos received 510(k) clearance in March 2025 for an OTC glucose monitoring system aimed at weight management.
- Roche received a CE mark for its Accu-Chek SmartGuide CGM in Europe in July 2024. We found no FDA clearance for it.
- Sinocare withdrew its US 510(k) submission for the iCan i3 in 2025 and plans a new clinical program.
The CGM market in numbers
Market research firms publish many different estimates of the CGM market, and they disagree widely. Company filings give a firmer floor.
Measure | Figure | Basis |
|---|---|---|
Abbott CGM sales, 2025 | $7.6 billion | Abbott 2025 10-K |
Dexcom revenue, 2025 | $4.66 billion | Dexcom FY2025 results |
MiniMed CGM revenue, fiscal 2026 | $1.55 billion | MiniMed FY2026 results (year ended April 2026) |
Abbott and Dexcom combined, 2025 | About $12.3 billion | Our calculation |
Abbott and Dexcom combined, 2024 | About $10.4 billion | Our calculation |
All four US-listed makers | More than $13.8 billion | Our calculation, mixing calendar and fiscal years |
Those combined figures leave out Roche, Chinese and Korean makers, and private companies, so the real market is larger. Growth is strong at all three leaders: Abbott’s CGM sales grew about 19% in 2025, Dexcom’s revenue 16%, and MiniMed’s CGM revenue 18%.
The figures also show where demand comes from. Dexcom earns about 72% of its revenue in the US, while about 60% of Abbott’s Diabetes Care sales are outside the US. A device maker planning a launch should look at both.
How FDA classifies CGMs
CGMs reach the US market through several regulatory paths, and the path shapes everything from the clinical study to the software documentation.
Classification | Regulation | Examples |
|---|---|---|
Integrated CGM (iCGM), Class II, 510(k) | 21 CFR 862.1355 | Dexcom G7 and G7 15 Day, FreeStyle Libre 2 and 3 (product code QBJ) |
OTC CGM, Class II, 510(k) | 21 CFR 862.1355 | Stelo, Lingo, Signos (SAF); Libre Rio (SBH) |
Implantable iCGM, Class II | 21 CFR 862.1357 | Eversense 365 |
Glucose range monitoring system, Class II | 21 CFR 862.1359 | Biolinq Shine |
Glucose sensor as part of an insulin pump system, Class III | PMA | MiniMed Simplera Sync |
Most new CGMs follow an existing classification and use a 510(k). A device with new technology or an intended use, such as Biolinq’s sensor, may require a De Novo request, which creates a new classification. For the accuracy requirements and special controls behind the iCGM classification, see our guide to iCGM, ACE pump, and iAGC classifications.
Connected CGMs are generally “cyber devices” under section 524B of the FD&C Act, in effect since March 2023, so their submissions must include cybersecurity documentation, such as a software bill of materials and a plan for monitoring vulnerabilities. See our guide to medical device cybersecurity.
Coverage and reimbursement
Medicare coverage shapes the US market. Under Medicare’s CGM coverage policy (LCD L33822), a CGM is covered for people with diabetes who are insulin-treated or who have a history of problematic hypoglycemia. The CGM must be prescribed according to its FDA indications, and the beneficiary needs a visit with their clinician within six months before the order and every six months after.
Medicare distinguishes between non-adjunctive CGMs, which replace fingerstick testing (billed under E2103 for the receiver and A4239 for monthly supplies), and adjunctive CGMs, which do not (E2102 and A4238). People who do not use insulin and have no history of problematic lows are not covered, which is part of why OTC CGMs, sold directly to consumers, became their own market segment. For CPT and HCPCS details, see our guide to CGM billing codes.
Trends shaping the CGM market
- OTC and wellness CGMs. Stelo, Lingo, Libre Rio, and Signos opened a direct-to-consumer market for people who do not use insulin. These products compete on apps, insights, and price as much as on the sensor.
- Longer wear and new formats. Dexcom’s 15-day G7 and the one-year Eversense 365 extend wear time, and Biolinq’s needle-free sensor shows new form factors can reach the market.
- Type 2 diabetes. Automated insulin delivery systems from Insulet, Tandem, and MiniMed gained type 2 indications between 2024 and 2025, widening the CGM user base. See our overview of the diabetes technology ecosystem.
- Partnerships across companies. Sensors from one company increasingly work with pumps, pens, and apps from another, such as Abbott’s Instinct sensor with MiniMed’s 780G system. Interoperability is now a commercial requirement, not just a technical one.
- Data and software. CGM data now flows into electronic health records, remote monitoring programs, and wellness apps. See our guide to CGM data integration.
- AI features. CGM makers are adding generative AI insights and predictive features to their apps. See how FDA regulates these in our guide to AI in diabetes devices.
What this means for CGM device makers
For a company bringing a new CGM to market, the leaders set the bar on three fronts.
- The sensor is only part of the product. Users expect a companion app with real-time readings, trend arrows, alerts, data sharing, and reports such as time in range and the ambulatory glucose profile. Clinicians expect dashboards and EHR integration.
- Interoperability decides the addressable market. A sensor cleared as an iCGM and connected to insulin pumps and partner apps reaches far more users than a standalone device.
- Regulatory strategy comes before architecture. Your target classification, iCGM, OTC, or a new De Novo category, determines your accuracy study, labeling, cybersecurity documentation, and software lifecycle requirements.
The software layer is often the longest part of the path. Apps, cloud, dashboards, pairing, and their design documentation must be built and validated under IEC 62304 alongside the sensor. Starting from a prebuilt platform, such as Sequenex’s NEX platform, lets hardware teams focus on the sensor. For full CGM app and cloud development, see our biosensor and CGM software development services.
Frequently asked questions
What companies make CGMs?
The largest CGM makers are Abbott (FreeStyle Libre, Lingo, Libre Rio), Dexcom (G7, Stelo), and MiniMed, formerly Medtronic Diabetes (Simplera). Senseonics makes the implantable Eversense 365, Biolinq makes the needle-free Biolinq Shine, and Signos sells an OTC system for weight management. Roche sells the Accu-Chek SmartGuide CGM in Europe.
How big is the CGM market?
Company filings put it above $13.8 billion a year. Abbott reported $7.6 billion in CGM sales for 2025, Dexcom $4.66 billion in revenue, and MiniMed $1.55 billion in CGM revenue for its fiscal year ended April 2026, before counting smaller and international makers.
Who has the largest share of the CGM market?
By reported sales, Abbott is the largest CGM maker, with $7.6 billion in CGM sales in 2025, followed by Dexcom with $4.66 billion in revenue. Abbott says about 8 million people use its Libre systems in more than 60 countries.
How are CGMs regulated by the FDA?
Most CGMs are Class II devices cleared through a 510(k), including integrated CGMs (iCGMs) and OTC CGMs under 21 CFR 862.1355. Some new technologies use a De Novo request, and CGM sensors in some insulin pump systems require premarket approval (PMA) as Class III devices.
Does Medicare cover CGMs?
Yes, for people with diabetes who use insulin or have a history of problematic hypoglycemia, under Medicare’s CGM coverage policy (LCD L33822). The CGM must be used according to its FDA indications, and beneficiaries need regular visits with their clinician to keep coverage.
Build CGM software with Sequenex
The CGM market rewards companies that pair a good sensor with software users and clinicians trust: apps, data platforms, integrations, and the documentation FDA reviews.
Sequenex builds mobile and cloud software for biosensor and CGM products using a design-first, IEC 62304 process, starting with the NEX platform. See our biosensor and CGM software development services, or contact us to discuss your program.
