Singapore was the largest outside supplier.
What this market covers
Machines that blow air at steady pressure through a mask to keep airways open during sleep. They are the main treatment for obstructive sleep apnoea.
Typical segments
- CPAP machines
- Auto adjusting CPAP
- BiPAP machines
- Masks and accessories
Source: Eurostat
Why this market is moving now
- Extra-EU import value rose 77% from 2021 to 2025, a direct read on EU demand for sourced supply.
- Supply is concentrated: one country provided a large share of extra-EU imports in 2025.
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 imported €246.4 million of products under CN code 90192020 (Mechanical ventilation apparatus, non-invasive) from outside the EU in 2025. | 246.4 EUR million | 2025 | Eurostat |
| Extra-EU imports of CN 90192020 were up 77% in 2025 compared with 2021 (€139.2 million), calculated from Eurostat values. | +77 % since 2021 | 2025 | Eurostat |
| EU exports of CN 90192020 to countries outside the EU were worth €233.0 million in 2025. | 233.0 EUR million | 2025 | Eurostat |
| Trade between EU member states in CN 90192020 (intra-EU arrivals) came to €255.4 million in 2025. | 255.4 EUR million | 2025 | Eurostat |
| Singapore was the largest non-EU supplier of CN 90192020 to the EU in 2025, with €117.1 million, or 48% of extra-EU imports. | 117.1 EUR million | 2025 | Eurostat |
| EU exports of CN 90192020 to the United States were €63.6 million in 2025. | 63.6 EUR million | 2025 | Eurostat |
| The average value of extra-EU imports of CN 90192020 was €59.49 per kilogram in 2025, calculated from Eurostat value and weight. | 59.49 EUR per kg | 2025 | Eurostat |
| Ireland was the largest EU exporter of CN 90192020 to non-EU countries in 2025, at €76.5 million. | 76.5 EUR million | 2025 | Eurostat |
| 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 154 510(k) clearances for devices named "cpap". | 154 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| 3 of those clearances were issued from 2021 to 2025. | 3 510(k) clearances | 2025 | U.S. Food and Drug Administration |
| Respironics, Inc. holds 14 510(k) clearances for devices named "cpap". | 14 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Apex Medical Corp. holds 10 510(k) clearances for devices named "cpap". | 10 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Puritan Bennett Corp. holds 7 510(k) clearances for devices named "cpap". | 7 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Resmed, Ltd. holds 7 510(k) clearances for devices named "cpap". | 7 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Fisher & Paykel Healthcare, Ltd. holds 5 510(k) clearances for devices named "cpap". | 5 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| 3B Medical, Inc. holds 4 510(k) clearances for devices named "cpap". | 4 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| PubMed indexed 1,100 papers mentioning "positive airway pressure" in the title or abstract in 2025. | 1,100 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: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
Quoted lines
- Figure 1
DS-045409, reporter EU27_2020, product 90192020, partner EXT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 246421486
- Figure 2
DS-045409, reporter EU27_2020, product 90192020, flow import, 2021 VALUE_IN_EUROS 139213368; 2025 VALUE_IN_EUROS 246421486
- Figure 3
DS-045409, reporter EU27_2020, product 90192020, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 233001769
- Figure 4
DS-045409, reporter EU27_2020, product 90192020, partner INT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 255444914
- Figure 5
DS-045409, reporter EU27_2020, product 90192020, partner SG, flow import, 2025, VALUE_IN_EUROS 117078675
- Figure 6
DS-045409, reporter EU27_2020, product 90192020, partner US, flow export, 2025, VALUE_IN_EUROS 63637079
- Figure 7
DS-045409, reporter EU27_2020, product 90192020, flow import, 2025, VALUE_IN_EUROS 246421486, QUANTITY_IN_100KG 41419
- Figure 1
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
Quoted lines
- Figure 8
DS-045409, reporter IE, product 90192020, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 76479309
- Figure 8
- Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)
Quoted lines
- Figure 9
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs ENT_NR, 2023, 63227
- Figure 10
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs NETTUR_MEUR, 2021, 105308
- Figure 11
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs EMP_NR, 2023, 600000
- Figure 9
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339112, 2025 (2026-11-04)
Quoted lines
- Figure 12
QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_estabs 4547
- Figure 13
QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_emplvl 140413
- Figure 14
QCEW 2020 annual_avg_emplvl 135655; 2025 annual_avg_emplvl 140413
- Figure 15
QCEW 2025 annual, US000, private, NAICS 339112, avg_annual_pay 109475
- Figure 12
- U.S. Food and Drug Administration: openFDA 510(k) clearances, device_name "cpap" (2026-11-04)
Quoted lines
- Figure 16
openFDA device/510k device_name:"cpap", sum of counts by decision_date = 154
- Figure 17
openFDA device/510k decision_date 2021-2025 count = 3
- Figure 16
- U.S. Food and Drug Administration: openFDA 510(k) clearances by applicant, device_name "cpap" (2026-11-04)
Quoted lines
- Figure 18
applicant.exact "Respironics, Inc." count 14
- Figure 19
applicant.exact "Apex Medical Corp." count 10
- Figure 20
applicant.exact "Puritan Bennett Corp." count 7
- Figure 21
applicant.exact "Resmed, Ltd." count 7
- Figure 22
applicant.exact "Fisher & Paykel Healthcare, Ltd." count 5
- Figure 23
applicant.exact "3B Medical, Inc." count 4
- Figure 18
- U.S. National Library of Medicine: PubMed search "positive airway pressure"[tiab] AND 2025[dp] (2026-11-04)
Quoted lines
- Figure 24
esearch count 1100
- Figure 24
Buyers and suppliers
Who buys
- Sleep clinics
- Home care providers
- Patients
Large non-EU suppliers to the EU
Companies to watch
Respironics, Inc.
14 FDA 510(k) clearances for devices named "cpap".
Apex Medical Corp.
10 FDA 510(k) clearances for devices named "cpap".
Puritan Bennett Corp.
7 FDA 510(k) clearances for devices named "cpap".
Resmed, Ltd.
7 FDA 510(k) clearances for devices named "cpap".
Fisher & Paykel Healthcare, Ltd.
5 FDA 510(k) clearances for devices named "cpap".
3B Medical, Inc.
4 FDA 510(k) clearances for devices named "cpap".
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 European Union 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
- Ready-to-use charts
- Method note and assumptions
- Written to order in 5 working days
Frequently asked questions
How big is the EU positive airway pressure devices market?
There is no single official market total. Eurostat trade data shows the EU imported €246.4 million of goods under CN 90192020 from outside the EU in 2025 and exported €233.0 million.
Where does the EU import positive airway pressure devices from?
Singapore was the largest non-EU supplier in 2025. Other large suppliers included Australia, China, United States.
What is the average import price of positive airway pressure devices in the EU?
Dividing Eurostat import value by weight gives about €59.49 per kilogram for CN 90192020 in 2025.
Which EU countries export the most positive airway pressure devices?
Ireland led EU exports to non-EU countries in 2025, followed by Germany, Netherlands.
How many positive airway pressure devices devices are cleared by the FDA?
openFDA lists 154 510(k) clearances for devices named cpap.
Which companies hold the most FDA clearances for positive airway pressure devices?
By 510(k) count: Respironics, Inc., Apex Medical Corp., Puritan Bennett Corp., Resmed, Ltd..
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