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Healthcare & Life SciencesEuropean UnionUpdated 4 Nov 2026

Biopsy guidance systems Market 2026: trade data and key figures

The EU imported €1.03 billion of biopsy guidance systems and related goods (CN 90181200) from outside the EU in 2025. That was 19% more than in 2020. China was the largest outside supplier.

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Edited by the Stratum Market Research editorial team. Updated 4 Nov 2026.

Headline figure

1.03EUR billion

EU imports from outside the EU, 2025

Extra-EU imports of CN 90181200, EUR million20202025 Eurostat, 4 Nov 2026

+19 % change

Extra-EU imports of CN 90181200 were up 19% in 2025 compared with 2020 (€862.6 million), calculated from Eurostat values.

Eurostat

723.4 EUR million

EU exports of CN 90181200 to countries outside the EU were worth €723.4 million in 2025.

Eurostat

838.8 EUR million

Trade between EU member states in CN 90181200 (intra-EU arrivals) came to €838.8 million in 2025.

Eurostat
ChartExtra-EU imports of CN 90181200, EUR million
Extra-EU imports of CN 90181200, EUR million03006009001,2002020: 863 EUR million86320202021: 845 EUR million20212022: 995 EUR million20222023: 996 EUR million20232024: 981 EUR million20242025: 1,026 EUR million1,0262025

Source: Eurostat

Why this market is moving now

  • Extra-EU import value moved +19% from 2020 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.
  • US employment in the core industry shifted -1% since 2020.

What this market covers

Imaging and navigation systems that steer a biopsy needle to a target in the body. Hospitals, cancer centres and radiology groups buy them.

Typical segments

  • Ultrasound guided systems
  • MRI fusion systems
  • Stereotactic systems
  • CT guided systems

Who buys

  • Hospitals
  • Cancer centres
  • Radiology groups

Largest non-EU suppliers to the EU

CountryImport value
China267.5 EUR million
United States from 1995 -> 2000)227.4 EUR million
Korea, Republic of222.6 EUR million
Japan143.9 EUR million
Norway64.1 EUR million
Malaysia26.4 EUR million

Key figures

Each figure links to the page it came from.

FigureValueYearSource
The EU imported €1.03 billion of products under CN code 90181200 (Ultrasonic scanning apparatus) from outside the EU in 2025.1.03 EUR billion2025Eurostat
Extra-EU imports of CN 90181200 were up 19% in 2025 compared with 2020 (€862.6 million), calculated from Eurostat values.+19 % change2025Eurostat
EU exports of CN 90181200 to countries outside the EU were worth €723.4 million in 2025.723.4 EUR million2025Eurostat
Trade between EU member states in CN 90181200 (intra-EU arrivals) came to €838.8 million in 2025.838.8 EUR million2025Eurostat
China was the largest non-EU supplier of CN 90181200 to the EU in 2025, with €267.5 million, or 26% of extra-EU imports.267.5 EUR million2025Eurostat
EU exports of CN 90181200 to the United States were €158.0 million in 2025.158.0 EUR million2025Eurostat
The average value of extra-EU imports of CN 90181200 was €221.10 per kilogram in 2025, calculated from Eurostat value and weight.221.10 EUR per kg2025Eurostat
Germany was the largest EU exporter of CN 90181200 to non-EU countries in 2025, at €168.6 million.168.6 EUR million2025Eurostat
The EU had 1,791 enterprises in NACE class C2660 (Manufacture of irradiation, electromedical and electrotherapeutic equipment) in 2023.1,791 enterprises2023Eurostat
EU enterprises in NACE class C2660 had net turnover of €30.54 billion in 2023.30.54 EUR billion2023Eurostat
NACE class C2660 employed 74,126 people across the EU in 2021.74,126 persons employed2021Eurostat
The US had 2,220 private establishments in NAICS 334510 (Electromedical and electrotherapeutic apparatus manufacturing) in 2025.2,220 establishments2025U.S. Bureau of Labor Statistics
NAICS 334510 employed an average of 72,575 people in US private industry in 2025.72,575 jobs2025U.S. Bureau of Labor Statistics
US employment in NAICS 334510 changed by -1% between 2020 (73,147 jobs) and 2025, calculated from BLS figures.-1 % change2025U.S. Bureau of Labor Statistics
Average annual pay in US NAICS 334510 was $140,429 in 2025.140,429 USD per year2025U.S. Bureau of Labor Statistics
The FDA has recorded 3 510(k) clearances for devices named "biopsy guidance".3 510(k) clearances2026U.S. Food and Drug Administration (openFDA)
Hologic, Inc. holds 1 510(k) clearances for devices named "biopsy guidance".1 510(k) clearances2026U.S. Food and Drug Administration (openFDA)
Lorad, A Hologic Co. holds 1 510(k) clearances for devices named "biopsy guidance".1 510(k) clearances2026U.S. Food and Drug Administration (openFDA)
Qlarity Imaging holds 1 510(k) clearances for devices named "biopsy guidance".1 510(k) clearances2026U.S. Food and Drug Administration (openFDA)

Companies to watch

Hologic, Inc.

1 FDA 510(k) clearances for devices named "biopsy guidance".

Lorad, A Hologic Co.

1 FDA 510(k) clearances for devices named "biopsy guidance".

Qlarity Imaging

1 FDA 510(k) clearances for devices named "biopsy guidance".

What the full report covers

Illustration of a report page with its five main parts numbered12345
  1. 1

    Executive summary

    The answer on two pages: size, growth and what drives it.

  2. 2

    Market size and outlook

    History, the current year and a five-year view with base, low and high cases.

  3. 3

    Segments and regions

    Splits by product, buyer and geography across the US, Europe and MEA.

  4. 4

    Company profiles

    The main players, how they compete and where they are investing.

  5. 5

    Data and method

    Every figure in Excel, with the sources and assumptions behind it.

  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

Frequently asked questions

How big is the EU biopsy guidance systems market?

There is no single official market total. Eurostat trade data shows the EU imported €1.03 billion of goods under CN 90181200 from outside the EU in 2025 and exported €723.4 million.

Where does the EU import biopsy guidance systems from?

China was the largest non-EU supplier in 2025. The next largest were United States from 1995 -> 2000), Korea, Republic of, Japan.

What is the average import price of biopsy guidance systems in the EU?

Dividing Eurostat import value by weight gives about €221.10 per kilogram for CN 90181200 in 2025.

Which EU countries export the most biopsy guidance systems?

Germany led EU exports to non-EU countries in 2025, followed by Austria, Netherlands.

How many biopsy guidance systems devices are cleared by the FDA?

openFDA lists 3 510(k) clearances for devices named biopsy guidance.

Which companies hold the most FDA clearances for biopsy guidance systems?

By 510(k) count: Hologic, Inc., Lorad, A Hologic Co., Qlarity Imaging.

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)DS-045409, reporter EU27_2020, product 90181200, partner EXT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 1026140792
  2. Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)DS-045409, reporter EU27_2020, product 90181200, flow import, 2020 VALUE_IN_EUROS 862608968; 2025 VALUE_IN_EUROS 1026140792
  3. Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)DS-045409, reporter EU27_2020, product 90181200, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 723423697
  4. Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)DS-045409, reporter EU27_2020, product 90181200, partner INT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 838810958
  5. Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)DS-045409, reporter EU27_2020, product 90181200, partner CN, flow import, 2025, VALUE_IN_EUROS 267516302
  6. Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)DS-045409, reporter EU27_2020, product 90181200, partner US, flow export, 2025, VALUE_IN_EUROS 157991215
  7. Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)DS-045409, reporter EU27_2020, product 90181200, flow import, 2025, VALUE_IN_EUROS 1026140792, QUANTITY_IN_100KG 46410
  8. Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)DS-045409, reporter DE, product 90181200, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 168589924
  9. Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)sbs_ovw_act, geo EU27_2020, nace_r2 C2660, indic_sbs ENT_NR, 2023, 1791
  10. Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)sbs_ovw_act, geo EU27_2020, nace_r2 C2660, indic_sbs NETTUR_MEUR, 2023, 30540
  11. Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)sbs_ovw_act, geo EU27_2020, nace_r2 C2660, indic_sbs EMP_NR, 2021, 74126
  12. U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 334510, 2025 (2026-11-04)QCEW 2025 annual, US000, private, NAICS 334510, annual_avg_estabs 2220
  13. U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 334510, 2025 (2026-11-04)QCEW 2025 annual, US000, private, NAICS 334510, annual_avg_emplvl 72575
  14. U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 334510, 2025 (2026-11-04)QCEW 2020 annual_avg_emplvl 73147; 2025 annual_avg_emplvl 72575
  15. U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 334510, 2025 (2026-11-04)QCEW 2025 annual, US000, private, NAICS 334510, avg_annual_pay 140429
  16. U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances, device_name "biopsy guidance" (2026-11-04)openFDA device/510k device_name:"biopsy guidance", sum of counts by decision_date = 3
  17. U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "biopsy guidance" (2026-11-04)applicant.exact "Hologic, Inc." count 1
  18. U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "biopsy guidance" (2026-11-04)applicant.exact "Lorad, A Hologic Co." count 1
  19. U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "biopsy guidance" (2026-11-04)applicant.exact "Qlarity Imaging" count 1

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