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Healthcare & Life SciencesUnited StatesUpdated

Insulin pump Market 2026: trade data and key figures

The FDA has 15 510(k) clearances on record for insulin pump devices. In the US, the core industry (Surgical and medical instrument manufacturing) had 4,547 establishments in 2025.

63,227enterprises

The EU had 63,227 enterprises in NACE class C3250

€105.31billion

EU enterprises in NACE class C3250 had net turnover of €105.31 billion in 2021

600,000persons employed

NACE class C3250 employed 600,000 people across the EU in 2023

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
ChartPubMed papers per year mentioning insulin pump
PubMed papers per year mentioning insulin pump01002003002020: 246 papers24620202021: 298 papers29820212022: 264 papers26420222023: 258 papers25820232024: 258 papers25820242025: 279 papers2792025

Source: U.S. National Library of Medicine

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.

FigureValueYearSource
The EU had 63,227 enterprises in NACE class C3250 (Manufacture of medical and dental instruments and supplies) in 2023.63,227 enterprises2023Eurostat
EU enterprises in NACE class C3250 had net turnover of €105.31 billion in 2021.105.31 EUR billion2021Eurostat
NACE class C3250 employed 600,000 people across the EU in 2023.600,000 persons employed2023Eurostat
The US had 4,547 private establishments in NAICS 339112 (Surgical and medical instrument manufacturing) in 2025.4,547 establishments2025U.S. Bureau of Labor Statistics
NAICS 339112 employed an average of 140,413 people in US private industry in 2025.140,413 jobs2025U.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 20202025U.S. Bureau of Labor Statistics
Average annual pay in US NAICS 339112 was $109,475 in 2025.109,475 USD per year2025U.S. Bureau of Labor Statistics
The FDA has recorded 15 510(k) clearances for devices named "insulin infusion pump".15 510(k) clearances2026U.S. Food and Drug Administration
Disetronic Medical Systems holds 4 510(k) clearances for devices named "insulin infusion pump".4 510(k) clearances2026U.S. Food and Drug Administration
Disetronic Medical Systems Ag holds 3 510(k) clearances for devices named "insulin infusion pump".3 510(k) clearances2026U.S. Food and Drug Administration
Smiths Medical Md, Inc. holds 2 510(k) clearances for devices named "insulin infusion pump".2 510(k) clearances2026U.S. Food and Drug Administration
Animas Corp. holds 1 510(k) clearances for devices named "insulin infusion pump".1 510(k) clearances2026U.S. Food and Drug Administration
C.R. Bard, Inc. holds 1 510(k) clearances for devices named "insulin infusion pump".1 510(k) clearances2026U.S. Food and Drug Administration
Caridac Pacemakers, Inc. holds 1 510(k) clearances for devices named "insulin infusion pump".1 510(k) clearances2026U.S. Food and Drug Administration
PubMed indexed 279 papers mentioning "insulin pump" in the title or abstract in 2025.279 papers2025U.S. National Library of Medicine

Sources and method

The figures on this page come from the public sources listed below. Read how we work.

  1. Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)
    Quoted lines
    • Figure 1sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs ENT_NR, 2023, 63227
    • Figure 2sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs NETTUR_MEUR, 2021, 105308
    • Figure 3sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs EMP_NR, 2023, 600000
  2. U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339112, 2025 (2026-11-04)
    Quoted lines
    • Figure 4QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_estabs 4547
    • Figure 5QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_emplvl 140413
    • Figure 6QCEW 2020 annual_avg_emplvl 135655; 2025 annual_avg_emplvl 140413
    • Figure 7QCEW 2025 annual, US000, private, NAICS 339112, avg_annual_pay 109475
  3. U.S. Food and Drug Administration: openFDA 510(k) clearances, device_name "insulin infusion pump" (2026-11-04)
    Quoted lines
    • Figure 8openFDA device/510k device_name:"insulin infusion pump", sum of counts by decision_date = 15
  4. U.S. Food and Drug Administration: openFDA 510(k) clearances by applicant, device_name "insulin infusion pump" (2026-11-04)
    Quoted lines
    • Figure 9applicant.exact "Disetronic Medical Systems" count 4
    • Figure 10applicant.exact "Disetronic Medical Systems AG" count 3
    • Figure 11applicant.exact "Smiths Medical MD, Inc." count 2
    • Figure 12applicant.exact "Animas Corp." count 1
    • Figure 13applicant.exact "C.R. Bard, Inc." count 1
    • Figure 14applicant.exact "Caridac Pacemakers, Inc." count 1
  5. U.S. National Library of Medicine: PubMed search "insulin pump"[tiab] AND 2025[dp] (2026-11-04)
    Quoted lines
    • Figure 15esearch count 279

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

  1. 01Executive summary
    The answer in one page: size, direction and what moves it
  2. 02Market definition and scope
    What is in and out of the United States market
  3. 03Market size, 2021 to 2025
    Historical series and growth rates
  4. 04Outlook to 2031
    Base, low and high scenarios with stated assumptions
  5. 05Rules, policy and deadlines
    Regulation and programmes that change demand
  6. 06Drivers and barriers
    What accelerates or slows adoption, by customer segment
  7. 07Prices, costs and margins
    Unit economics where public data allows
  8. 08Competitive landscape
    8 to 12 company profiles with recent moves
  9. 09Opportunities and risks
    For new entrants, suppliers and investors
  10. 10Method and sources
    Every assumption and source, listed

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  • Ready-to-use charts
  • Method note and assumptions
  • Written to order in 5 working days
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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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