United States was the largest outside supplier.
What this market covers
Laboratory instruments that count and classify blood cells from a patient sample. Buyers are hospital laboratories, diagnostic chains and physician offices.
Typical segments
- Three part differential analyzers
- Five part differential analyzers
- Point of care analyzers
- Automated slide systems
- Veterinary analyzers
Source: Eurostat
Why this market is moving now
- Extra-EU import value rose 3% from 2022 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 €1.26 billion of products under CN code 90278990 (Instruments and apparatus for physical or chemical analysis or for determining surface) from outside the EU in 2025. | 1.26 EUR billion | 2025 | Eurostat |
| Extra-EU imports of CN 90278990 were up 3% in 2025 compared with 2022 (€1.23 billion), calculated from Eurostat values. | +3 % since 2022 | 2025 | Eurostat |
| EU exports of CN 90278990 to countries outside the EU were worth €1.83 billion in 2025. | 1.83 EUR billion | 2025 | Eurostat |
| Trade between EU member states in CN 90278990 (intra-EU arrivals) came to €991.4 million in 2025. | 991.4 EUR million | 2025 | Eurostat |
| United States was the largest non-EU supplier of CN 90278990 to the EU in 2025, with €469.3 million, or 37% of extra-EU imports. | 469.3 EUR million | 2025 | Eurostat |
| EU exports of CN 90278990 to the United States were €394.1 million in 2025. | 394.1 EUR million | 2025 | Eurostat |
| The average value of extra-EU imports of CN 90278990 was €204.94 per kilogram in 2025, calculated from Eurostat value and weight. | 204.94 EUR per kg | 2025 | Eurostat |
| Germany was the largest EU exporter of CN 90278990 to non-EU countries in 2025, at €734.5 million. | 734.5 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 1,326 private establishments in NAICS 334516 (Analytical laboratory instrument manufacturing) in 2025. | 1,326 establishments | 2025 | U.S. Bureau of Labor Statistics |
| NAICS 334516 employed an average of 42,896 people in US private industry in 2025. | 42,896 jobs | 2025 | U.S. Bureau of Labor Statistics |
| US employment in NAICS 334516 changed by +10% between 2020 (39,065 jobs) and 2025, calculated from BLS figures. | +10 % since 2020 | 2025 | U.S. Bureau of Labor Statistics |
| Average annual pay in US NAICS 334516 was $121,324 in 2025. | 121,324 USD per year | 2025 | U.S. Bureau of Labor Statistics |
| The FDA has recorded 25 510(k) clearances for devices named "automated hematology analyzer". | 25 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| 4 of those clearances were issued from 2021 to 2025. | 4 510(k) clearances | 2025 | U.S. Food and Drug Administration |
| Sysmex America, Inc. holds 16 510(k) clearances for devices named "automated hematology analyzer". | 16 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Abbott Laboratories holds 3 510(k) clearances for devices named "automated hematology analyzer". | 3 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Abx Diagnostics holds 2 510(k) clearances for devices named "automated hematology analyzer". | 2 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Abbott Diagnostics holds 1 510(k) clearances for devices named "automated hematology analyzer". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Cellavision Ab holds 1 510(k) clearances for devices named "automated hematology analyzer". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Sysmex Corp. holds 1 510(k) clearances for devices named "automated hematology analyzer". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| PubMed indexed 132 papers mentioning "hematology analyzer" in the title or abstract in 2025. | 132 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 90278990, partner EXT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 1264034765
- Figure 2
DS-045409, reporter EU27_2020, product 90278990, flow import, 2022 VALUE_IN_EUROS 1227921780; 2025 VALUE_IN_EUROS 1264034765
- Figure 3
DS-045409, reporter EU27_2020, product 90278990, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 1832182817
- Figure 4
DS-045409, reporter EU27_2020, product 90278990, partner INT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 991394666
- Figure 5
DS-045409, reporter EU27_2020, product 90278990, partner US, flow import, 2025, VALUE_IN_EUROS 469305707
- Figure 6
DS-045409, reporter EU27_2020, product 90278990, partner US, flow export, 2025, VALUE_IN_EUROS 394116665
- Figure 7
DS-045409, reporter EU27_2020, product 90278990, flow import, 2025, VALUE_IN_EUROS 1264034765, QUANTITY_IN_100KG 61678
- 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 DE, product 90278990, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 734487088
- 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 334516, 2025 (2026-11-04)
Quoted lines
- Figure 12
QCEW 2025 annual, US000, private, NAICS 334516, annual_avg_estabs 1326
- Figure 13
QCEW 2025 annual, US000, private, NAICS 334516, annual_avg_emplvl 42896
- Figure 14
QCEW 2020 annual_avg_emplvl 39065; 2025 annual_avg_emplvl 42896
- Figure 15
QCEW 2025 annual, US000, private, NAICS 334516, avg_annual_pay 121324
- Figure 12
- U.S. Food and Drug Administration: openFDA 510(k) clearances, device_name "automated hematology analyzer" (2026-11-04)
Quoted lines
- Figure 16
openFDA device/510k device_name:"automated hematology analyzer", sum of counts by decision_date = 25
- Figure 17
openFDA device/510k decision_date 2021-2025 count = 4
- Figure 16
- U.S. Food and Drug Administration: openFDA 510(k) clearances by applicant, device_name "automated hematology analyzer" (2026-11-04)
Quoted lines
- Figure 18
applicant.exact "Sysmex America, Inc." count 16
- Figure 19
applicant.exact "Abbott Laboratories" count 3
- Figure 20
applicant.exact "Abx Diagnostics" count 2
- Figure 21
applicant.exact "Abbott Diagnostics" count 1
- Figure 22
applicant.exact "CellaVision AB" count 1
- Figure 23
applicant.exact "Sysmex Corp." count 1
- Figure 18
- U.S. National Library of Medicine: PubMed search "hematology analyzer"[tiab] AND 2025[dp] (2026-11-04)
Quoted lines
- Figure 24
esearch count 132
- Figure 24
Buyers and suppliers
Who buys
- Hospital laboratories
- Diagnostic chains
- Physician offices
Large non-EU suppliers to the EU
Companies to watch
Sysmex America, Inc.
16 FDA 510(k) clearances for devices named "automated hematology analyzer".
Abbott Laboratories
3 FDA 510(k) clearances for devices named "automated hematology analyzer".
Abx Diagnostics
2 FDA 510(k) clearances for devices named "automated hematology analyzer".
Abbott Diagnostics
1 FDA 510(k) clearances for devices named "automated hematology analyzer".
Cellavision Ab
1 FDA 510(k) clearances for devices named "automated hematology analyzer".
Sysmex Corp.
1 FDA 510(k) clearances for devices named "automated hematology analyzer".
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 hematology analyzer market?
There is no single official market total. Eurostat trade data shows the EU imported €1.26 billion of goods under CN 90278990 from outside the EU in 2025 and exported €1.83 billion.
Where does the EU import hematology analyzer from?
United States was the largest non-EU supplier in 2025. Other large suppliers included Switzerland, China, Japan.
What is the average import price of hematology analyzer in the EU?
Dividing Eurostat import value by weight gives about €204.94 per kilogram for CN 90278990 in 2025.
Which EU countries export the most hematology analyzer?
Germany led EU exports to non-EU countries in 2025, followed by Netherlands, France.
How many hematology analyzer devices are cleared by the FDA?
openFDA lists 25 510(k) clearances for devices named automated hematology analyzer.
Which companies hold the most FDA clearances for hematology analyzer?
By 510(k) count: Sysmex America, Inc., Abbott Laboratories, Abx Diagnostics, Abbott Diagnostics.
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