-36 % change
Extra-EU imports of CN 38221900 were down 36% in 2025 compared with 2022 (€8.60 billion), calculated from Eurostat values.
Eurostat10.38 EUR billion
EU exports of CN 38221900 to countries outside the EU were worth €10.38 billion in 2025.
Eurostat9.74 EUR billion
Trade between EU member states in CN 38221900 (intra-EU arrivals) came to €9.74 billion in 2025.
EurostatSource: Eurostat
Why this market is moving now
- Extra-EU import value moved -36% 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.
- US employment in the core industry shifted -2% since 2020.
- Clinical research is active, with studies recruiting now.
What this market covers
A blood test that measures the CA 125 protein, used to monitor ovarian cancer treatment and recurrence. Hospitals and laboratories buy the reagents and analyzers.
Typical segments
- Immunoassay kits
- Laboratory analyzers
- Point of care tests
- Monitoring panels
Who buys
- Hospital laboratories
- Oncology clinics
- Reference laboratories
Largest non-EU suppliers to the EU
| Country | Import value |
|---|---|
| United States from 1995 -> 2000) | 3,299.2 EUR million |
| United Kingdom | 570.5 EUR million |
| Singapore | 353.0 EUR million |
| Japan | 314.3 EUR million |
| China | 270.2 EUR million |
| Korea, Republic of | 172.1 EUR million |
Key figures
Each figure links to the page it came from.
| Figure | Value | Year | Source |
|---|---|---|---|
| The EU imported €5.49 billion of products under CN code 38221900 (Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory) from outside the EU in 2025. | 5.49 EUR billion | 2025 | Eurostat |
| Extra-EU imports of CN 38221900 were down 36% in 2025 compared with 2022 (€8.60 billion), calculated from Eurostat values. | -36 % change | 2025 | Eurostat |
| EU exports of CN 38221900 to countries outside the EU were worth €10.38 billion in 2025. | 10.38 EUR billion | 2025 | Eurostat |
| Trade between EU member states in CN 38221900 (intra-EU arrivals) came to €9.74 billion in 2025. | 9.74 EUR billion | 2025 | Eurostat |
| United States from 1995 -> 2000) was the largest non-EU supplier of CN 38221900 to the EU in 2025, with €3.30 billion, or 60% of extra-EU imports. | 3.30 EUR billion | 2025 | Eurostat |
| EU exports of CN 38221900 to the United States were €2.31 billion in 2025. | 2.31 EUR billion | 2025 | Eurostat |
| The average value of extra-EU imports of CN 38221900 was €123.36 per kilogram in 2025, calculated from Eurostat value and weight. | 123.36 EUR per kg | 2025 | Eurostat |
| Germany was the largest EU exporter of CN 38221900 to non-EU countries in 2025, at €4.62 billion. | 4.62 EUR billion | 2025 | Eurostat |
| The EU had 3,116 enterprises in NACE class C2120 (Manufacture of pharmaceutical preparations) in 2023. | 3,116 enterprises | 2023 | Eurostat |
| EU enterprises in NACE class C2120 had net turnover of €428.65 billion in 2023. | 428.65 EUR billion | 2023 | Eurostat |
| NACE class C2120 employed 600,730 people across the EU in 2023. | 600,730 persons employed | 2023 | Eurostat |
| The US had 500 private establishments in NAICS 325413 (In-vitro diagnostic substance manufacturing) in 2025. | 500 establishments | 2025 | U.S. Bureau of Labor Statistics |
| NAICS 325413 employed an average of 28,101 people in US private industry in 2025. | 28,101 jobs | 2025 | U.S. Bureau of Labor Statistics |
| US employment in NAICS 325413 changed by -2% between 2020 (28,792 jobs) and 2025, calculated from BLS figures. | -2 % change | 2025 | U.S. Bureau of Labor Statistics |
| Average annual pay in US NAICS 325413 was $118,381 in 2025. | 118,381 USD per year | 2025 | U.S. Bureau of Labor Statistics |
| The FDA has recorded 19 510(k) clearances for devices named "CA-125". | 19 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| 1 of those clearances were issued from 2021 to 2025. | 1 510(k) clearances | 2025 | U.S. Food and Drug Administration (openFDA) |
| Bayer Corp. holds 2 510(k) clearances for devices named "CA-125". | 2 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| Fujirebio Diagnostics,Inc. holds 2 510(k) clearances for devices named "CA-125". | 2 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| Roche Diagnostics holds 2 510(k) clearances for devices named "CA-125". | 2 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| Roche Diagnostics Corp. holds 2 510(k) clearances for devices named "CA-125". | 2 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| Tosoh Medics, Inc. holds 2 510(k) clearances for devices named "CA-125". | 2 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| Abbott Diagnostics holds 1 510(k) clearances for devices named "CA-125". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration (openFDA) |
| ClinicalTrials.gov lists 5,337 registered studies for the condition "ovarian cancer". | 5,337 registered studies | 2026 | U.S. National Library of Medicine (ClinicalTrials.gov) |
| 774 of those studies were recruiting participants when checked in November 2026. | 774 recruiting studies | 2026 | U.S. National Library of Medicine (ClinicalTrials.gov) |
Companies to watch
Bayer Corp.
2 FDA 510(k) clearances for devices named "CA-125".
Fujirebio Diagnostics,Inc.
2 FDA 510(k) clearances for devices named "CA-125".
Roche Diagnostics
2 FDA 510(k) clearances for devices named "CA-125".
Roche Diagnostics Corp.
2 FDA 510(k) clearances for devices named "CA-125".
Tosoh Medics, Inc.
2 FDA 510(k) clearances for devices named "CA-125".
Abbott Diagnostics
1 FDA 510(k) clearances for devices named "CA-125".
What the full report covers
- 1
Executive summary
The answer on two pages: size, growth and what drives it.
- 2
Market size and outlook
History, the current year and a five-year view with base, low and high cases.
- 3
Segments and regions
Splits by product, buyer and geography across the US, Europe and MEA.
- 4
Company profiles
The main players, how they compete and where they are investing.
- 5
Data and method
Every figure in Excel, with the sources and assumptions behind it.
- 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 cA 125 test market?
There is no single official market total. Eurostat trade data shows the EU imported €5.49 billion of goods under CN 38221900 from outside the EU in 2025 and exported €10.38 billion.
Where does the EU import cA 125 test from?
United States from 1995 -> 2000) was the largest non-EU supplier in 2025. The next largest were United Kingdom, Singapore, Japan.
What is the average import price of cA 125 test in the EU?
Dividing Eurostat import value by weight gives about €123.36 per kilogram for CN 38221900 in 2025.
Which EU countries export the most cA 125 test?
Germany led EU exports to non-EU countries in 2025, followed by Netherlands, Sweden.
How many cA 125 test devices are cleared by the FDA?
openFDA lists 19 510(k) clearances for devices named CA-125.
Which companies hold the most FDA clearances for cA 125 test?
By 510(k) count: Bayer Corp., Fujirebio Diagnostics,Inc., Roche Diagnostics, Roche Diagnostics Corp..
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)
DS-045409, reporter EU27_2020, product 38221900, partner EXT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 5494247512
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 38221900, flow import, 2022 VALUE_IN_EUROS 8597502879; 2025 VALUE_IN_EUROS 5494247512
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 38221900, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 10381369868
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 38221900, partner INT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 9737396680
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 38221900, partner US, flow import, 2025, VALUE_IN_EUROS 3299232386
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 38221900, partner US, flow export, 2025, VALUE_IN_EUROS 2307556427
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter EU27_2020, product 38221900, flow import, 2025, VALUE_IN_EUROS 5494247512, QUANTITY_IN_100KG 445398
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
DS-045409, reporter DE, product 38221900, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 4616768801
- 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 C2120, indic_sbs ENT_NR, 2023, 3116
- 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 C2120, indic_sbs NETTUR_MEUR, 2023, 428651
- 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 C2120, indic_sbs EMP_NR, 2023, 600730
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 325413, 2025 (2026-11-04)
QCEW 2025 annual, US000, private, NAICS 325413, annual_avg_estabs 500
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 325413, 2025 (2026-11-04)
QCEW 2025 annual, US000, private, NAICS 325413, annual_avg_emplvl 28101
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 325413, 2025 (2026-11-04)
QCEW 2020 annual_avg_emplvl 28792; 2025 annual_avg_emplvl 28101
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 325413, 2025 (2026-11-04)
QCEW 2025 annual, US000, private, NAICS 325413, avg_annual_pay 118381
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances, device_name "CA-125" (2026-11-04)
openFDA device/510k device_name:"CA-125", sum of counts by decision_date = 19
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances, device_name "CA-125" (2026-11-04)
openFDA device/510k decision_date 2021-2025 count = 1
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "CA-125" (2026-11-04)
applicant.exact "Bayer Corp." count 2
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "CA-125" (2026-11-04)
applicant.exact "Fujirebio Diagnostics,Inc." count 2
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "CA-125" (2026-11-04)
applicant.exact "Roche Diagnostics" count 2
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "CA-125" (2026-11-04)
applicant.exact "Roche Diagnostics Corp." count 2
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "CA-125" (2026-11-04)
applicant.exact "Tosoh Medics, Inc." count 2
- U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "CA-125" (2026-11-04)
applicant.exact "Abbott Diagnostics" count 1
- U.S. National Library of Medicine (ClinicalTrials.gov): ClinicalTrials.gov API v2, condition "ovarian cancer" (2026-11-04)
query.cond=ovarian cancer totalCount 5337
- U.S. National Library of Medicine (ClinicalTrials.gov): ClinicalTrials.gov API v2, condition "ovarian cancer", status recruiting (2026-11-04)
filter.overallStatus=RECRUITING totalCount 774
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