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Healthcare & Life SciencesEuropean UnionUpdated

Hematology analyzer Market 2026: trade data and key figures

The EU imported €1.26 billion of hematology analyzer and related goods (CN 90278990) from outside the EU in 2025. That was 3% more than in 2022.

+3% since 2022

Extra-EU imports of CN 90278990 were up 3% in 2025 compared with 2022 (€1.23 billion)

€1.83billion

EU exports of CN 90278990 to countries outside the EU were worth €1.83 billion in 2025

€991.4million

Trade between EU member states in CN 90278990 (intra-EU arrivals) came to €991.4 million in 2025

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
ChartExtra-EU imports of CN 90278990, EUR million
Extra-EU imports of CN 90278990, EUR million05001,0001,5002022: 1,228 EUR million1,22820222023: 1,305 EUR million1,30520232024: 1,468 EUR million1,46820242025: 1,264 EUR million1,2642025

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.

FigureValueYearSource
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 billion2025Eurostat
Extra-EU imports of CN 90278990 were up 3% in 2025 compared with 2022 (€1.23 billion), calculated from Eurostat values.+3 % since 20222025Eurostat
EU exports of CN 90278990 to countries outside the EU were worth €1.83 billion in 2025.1.83 EUR billion2025Eurostat
Trade between EU member states in CN 90278990 (intra-EU arrivals) came to €991.4 million in 2025.991.4 EUR million2025Eurostat
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 million2025Eurostat
EU exports of CN 90278990 to the United States were €394.1 million in 2025.394.1 EUR million2025Eurostat
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 kg2025Eurostat
Germany was the largest EU exporter of CN 90278990 to non-EU countries in 2025, at €734.5 million.734.5 EUR million2025Eurostat
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 1,326 private establishments in NAICS 334516 (Analytical laboratory instrument manufacturing) in 2025.1,326 establishments2025U.S. Bureau of Labor Statistics
NAICS 334516 employed an average of 42,896 people in US private industry in 2025.42,896 jobs2025U.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 20202025U.S. Bureau of Labor Statistics
Average annual pay in US NAICS 334516 was $121,324 in 2025.121,324 USD per year2025U.S. Bureau of Labor Statistics
The FDA has recorded 25 510(k) clearances for devices named "automated hematology analyzer".25 510(k) clearances2026U.S. Food and Drug Administration
4 of those clearances were issued from 2021 to 2025.4 510(k) clearances2025U.S. Food and Drug Administration
Sysmex America, Inc. holds 16 510(k) clearances for devices named "automated hematology analyzer".16 510(k) clearances2026U.S. Food and Drug Administration
Abbott Laboratories holds 3 510(k) clearances for devices named "automated hematology analyzer".3 510(k) clearances2026U.S. Food and Drug Administration
Abx Diagnostics holds 2 510(k) clearances for devices named "automated hematology analyzer".2 510(k) clearances2026U.S. Food and Drug Administration
Abbott Diagnostics holds 1 510(k) clearances for devices named "automated hematology analyzer".1 510(k) clearances2026U.S. Food and Drug Administration
Cellavision Ab holds 1 510(k) clearances for devices named "automated hematology analyzer".1 510(k) clearances2026U.S. Food and Drug Administration
Sysmex Corp. holds 1 510(k) clearances for devices named "automated hematology analyzer".1 510(k) clearances2026U.S. Food and Drug Administration
PubMed indexed 132 papers mentioning "hematology analyzer" in the title or abstract in 2025.132 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: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
    Quoted lines
    • Figure 1DS-045409, reporter EU27_2020, product 90278990, partner EXT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 1264034765
    • Figure 2DS-045409, reporter EU27_2020, product 90278990, flow import, 2022 VALUE_IN_EUROS 1227921780; 2025 VALUE_IN_EUROS 1264034765
    • Figure 3DS-045409, reporter EU27_2020, product 90278990, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 1832182817
    • Figure 4DS-045409, reporter EU27_2020, product 90278990, partner INT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 991394666
    • Figure 5DS-045409, reporter EU27_2020, product 90278990, partner US, flow import, 2025, VALUE_IN_EUROS 469305707
    • Figure 6DS-045409, reporter EU27_2020, product 90278990, partner US, flow export, 2025, VALUE_IN_EUROS 394116665
    • Figure 7DS-045409, reporter EU27_2020, product 90278990, flow import, 2025, VALUE_IN_EUROS 1264034765, QUANTITY_IN_100KG 61678
  2. Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
    Quoted lines
    • Figure 8DS-045409, reporter DE, product 90278990, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 734487088
  3. Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)
    Quoted lines
    • Figure 9sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs ENT_NR, 2023, 63227
    • Figure 10sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs NETTUR_MEUR, 2021, 105308
    • Figure 11sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs EMP_NR, 2023, 600000
  4. U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 334516, 2025 (2026-11-04)
    Quoted lines
    • Figure 12QCEW 2025 annual, US000, private, NAICS 334516, annual_avg_estabs 1326
    • Figure 13QCEW 2025 annual, US000, private, NAICS 334516, annual_avg_emplvl 42896
    • Figure 14QCEW 2020 annual_avg_emplvl 39065; 2025 annual_avg_emplvl 42896
    • Figure 15QCEW 2025 annual, US000, private, NAICS 334516, avg_annual_pay 121324
  5. U.S. Food and Drug Administration: openFDA 510(k) clearances, device_name "automated hematology analyzer" (2026-11-04)
    Quoted lines
    • Figure 16openFDA device/510k device_name:"automated hematology analyzer", sum of counts by decision_date = 25
    • Figure 17openFDA device/510k decision_date 2021-2025 count = 4
  6. U.S. Food and Drug Administration: openFDA 510(k) clearances by applicant, device_name "automated hematology analyzer" (2026-11-04)
    Quoted lines
    • Figure 18applicant.exact "Sysmex America, Inc." count 16
    • Figure 19applicant.exact "Abbott Laboratories" count 3
    • Figure 20applicant.exact "Abx Diagnostics" count 2
    • Figure 21applicant.exact "Abbott Diagnostics" count 1
    • Figure 22applicant.exact "CellaVision AB" count 1
    • Figure 23applicant.exact "Sysmex Corp." count 1
  7. U.S. National Library of Medicine: PubMed search "hematology analyzer"[tiab] AND 2025[dp] (2026-11-04)
    Quoted lines
    • Figure 24esearch count 132

Buyers and suppliers

Who buys

  • Hospital laboratories
  • Diagnostic chains
  • Physician offices

Large non-EU suppliers to the EU

  1. United States469.3 EUR million
  2. Switzerland224.5 EUR million
  3. China164.1 EUR million
  4. Japan135.1 EUR million
  5. United Kingdom99.5 EUR million
  6. Singapore42.0 EUR million

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

  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 European Union 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

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
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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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