The EU counted 63,227 enterprises in the related industry class.
What this market covers
Wearable pumps that give insulin continuously through a tube and cannula, with extra doses at meals. Many models link to glucose sensors for automatic dose changes.
Typical segments
- Tubed pumps
- Patch pumps
- Automated insulin delivery systems
- Pump infusion sets
Why this market is moving now
- US employment in the core industry rose 4% since 2020.
Key figures
Each figure names the source it came from. Open the source list below to read the quoted line.
| Figure | Value | Year | Source |
|---|---|---|---|
| The EU had 63,227 enterprises in NACE class C3250 (Manufacture of medical and dental instruments and supplies) in 2023. | 63,227 enterprises | 2023 | Eurostat |
| EU enterprises in NACE class C3250 had net turnover of €105.31 billion in 2021. | 105.31 EUR billion | 2021 | Eurostat |
| NACE class C3250 employed 600,000 people across the EU in 2023. | 600,000 persons employed | 2023 | Eurostat |
| The US had 4,547 private establishments in NAICS 339112 (Surgical and medical instrument manufacturing) in 2025. | 4,547 establishments | 2025 | U.S. Bureau of Labor Statistics |
| NAICS 339112 employed an average of 140,413 people in US private industry in 2025. | 140,413 jobs | 2025 | U.S. Bureau of Labor Statistics |
| US employment in NAICS 339112 changed by +4% between 2020 (135,655 jobs) and 2025, calculated from BLS figures. | +4 % since 2020 | 2025 | U.S. Bureau of Labor Statistics |
| Average annual pay in US NAICS 339112 was $109,475 in 2025. | 109,475 USD per year | 2025 | U.S. Bureau of Labor Statistics |
| The FDA has recorded 15 510(k) clearances for devices named "insulin infusion pump". | 15 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Disetronic Medical Systems holds 4 510(k) clearances for devices named "insulin infusion pump". | 4 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Disetronic Medical Systems Ag holds 3 510(k) clearances for devices named "insulin infusion pump". | 3 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Smiths Medical Md, Inc. holds 2 510(k) clearances for devices named "insulin infusion pump". | 2 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Animas Corp. holds 1 510(k) clearances for devices named "insulin infusion pump". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| C.R. Bard, Inc. holds 1 510(k) clearances for devices named "insulin infusion pump". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Caridac Pacemakers, Inc. holds 1 510(k) clearances for devices named "insulin infusion pump". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| PubMed indexed 279 papers mentioning "insulin pump" in the title or abstract in 2025. | 279 papers | 2025 | U.S. National Library of Medicine |
Sources and method
The figures on this page come from the public sources listed below. Read how we work.
- Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)
Quoted lines
- Figure 1
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs ENT_NR, 2023, 63227
- Figure 2
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs NETTUR_MEUR, 2021, 105308
- Figure 3
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs EMP_NR, 2023, 600000
- Figure 1
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339112, 2025 (2026-11-04)
Quoted lines
- Figure 4
QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_estabs 4547
- Figure 5
QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_emplvl 140413
- Figure 6
QCEW 2020 annual_avg_emplvl 135655; 2025 annual_avg_emplvl 140413
- Figure 7
QCEW 2025 annual, US000, private, NAICS 339112, avg_annual_pay 109475
- Figure 4
- U.S. Food and Drug Administration: openFDA 510(k) clearances, device_name "insulin infusion pump" (2026-11-04)
Quoted lines
- Figure 8
openFDA device/510k device_name:"insulin infusion pump", sum of counts by decision_date = 15
- Figure 8
- U.S. Food and Drug Administration: openFDA 510(k) clearances by applicant, device_name "insulin infusion pump" (2026-11-04)
Quoted lines
- Figure 9
applicant.exact "Disetronic Medical Systems" count 4
- Figure 10
applicant.exact "Disetronic Medical Systems AG" count 3
- Figure 11
applicant.exact "Smiths Medical MD, Inc." count 2
- Figure 12
applicant.exact "Animas Corp." count 1
- Figure 13
applicant.exact "C.R. Bard, Inc." count 1
- Figure 14
applicant.exact "Caridac Pacemakers, Inc." count 1
- Figure 9
- U.S. National Library of Medicine: PubMed search "insulin pump"[tiab] AND 2025[dp] (2026-11-04)
Quoted lines
- Figure 15
esearch count 279
- Figure 15
Buyers and suppliers
Who buys
- Patients and caregivers
- Endocrinology clinics
- Health insurers
Companies to watch
Disetronic Medical Systems
4 FDA 510(k) clearances for devices named "insulin infusion pump".
Disetronic Medical Systems Ag
3 FDA 510(k) clearances for devices named "insulin infusion pump".
Smiths Medical Md, Inc.
2 FDA 510(k) clearances for devices named "insulin infusion pump".
Animas Corp.
1 FDA 510(k) clearances for devices named "insulin infusion pump".
C.R. Bard, Inc.
1 FDA 510(k) clearances for devices named "insulin infusion pump".
Caridac Pacemakers, Inc.
1 FDA 510(k) clearances for devices named "insulin infusion pump".
What the full report covers
- 01Executive summary
The answer in one page: size, direction and what moves it - 02Market definition and scope
What is in and out of the United States market - 03Market size, 2021 to 2025
Historical series and growth rates - 04Outlook to 2031
Base, low and high scenarios with stated assumptions - 05Rules, policy and deadlines
Regulation and programmes that change demand - 06Drivers and barriers
What accelerates or slows adoption, by customer segment - 07Prices, costs and margins
Unit economics where public data allows - 08Competitive landscape
8 to 12 company profiles with recent moves - 09Opportunities and risks
For new entrants, suppliers and investors - 10Method and sources
Every assumption and source, listed
Included with the full report
- PDF report, 40 to 60 pages
- Excel data pack
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- Method note and assumptions
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Frequently asked questions
How many insulin pump devices are cleared by the FDA?
openFDA lists 15 510(k) clearances for devices named insulin infusion pump.
Which companies hold the most FDA clearances for insulin pump?
By 510(k) count: Disetronic Medical Systems, Disetronic Medical Systems Ag, Smiths Medical Md, Inc., Animas Corp..
How many US companies are in the insulin pump industry?
BLS counts 4,547 private establishments in NAICS 339112 (Surgical and medical instrument manufacturing), the closest official industry.
How many EU companies are in the insulin pump industry?
Eurostat counts 63,227 enterprises in NACE class C3250 (Manufacture of medical and dental instruments and supplies).
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