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Healthcare & Life SciencesUnited StatesUpdated 4 Nov 2026

Circulating tumor cell Market 2026: trade data and key figures

The FDA has 6 510(k) clearances on record for circulating tumor cell devices. ClinicalTrials.gov lists 124,514 registered studies for cancer. In the US, the core industry (In-vitro diagnostic substance manufacturing) had 500 establishments in 2025.

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

Headline figure

6510(k) clearances

FDA 510(k) clearances on record

Illustrative
U.S. Food and Drug Administration, 4 Nov 2026

3,116 enterprises

The EU had 3,116 enterprises in NACE class C2120 (Manufacture of pharmaceutical preparations) in 2023.

Eurostat

428.65 EUR billion

EU enterprises in NACE class C2120 had net turnover of €428.65 billion in 2023.

Eurostat

600,730 persons employed

NACE class C2120 employed 600,730 people across the EU in 2023.

Eurostat

Why this market is moving now

  • US employment in the core industry shifted -2% since 2020.
  • Clinical research is active, with studies recruiting now.

What this market covers

Blood tests that find and count cancer cells shed from tumors into the bloodstream. Used to follow cancer progression and treatment response.

Typical segments

  • Cell enrichment systems
  • Detection and counting assays
  • Molecular analysis of captured cells
  • Research kits

Who buys

  • Cancer centers
  • Diagnostic laboratories
  • Pharmaceutical developers

Key figures

Each figure links to the page it came from.

FigureValueYearSource
The EU had 3,116 enterprises in NACE class C2120 (Manufacture of pharmaceutical preparations) in 2023.3,116 enterprises2023Eurostat
EU enterprises in NACE class C2120 had net turnover of €428.65 billion in 2023.428.65 EUR billion2023Eurostat
NACE class C2120 employed 600,730 people across the EU in 2023.600,730 persons employed2023Eurostat
The US had 500 private establishments in NAICS 325413 (In-vitro diagnostic substance manufacturing) in 2025.500 establishments2025U.S. Bureau of Labor Statistics
NAICS 325413 employed an average of 28,101 people in US private industry in 2025.28,101 jobs2025U.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 % change2025U.S. Bureau of Labor Statistics
Average annual pay in US NAICS 325413 was $118,381 in 2025.118,381 USD per year2025U.S. Bureau of Labor Statistics
The FDA has recorded 6 510(k) clearances for devices named "circulating tumor cell".6 510(k) clearances2026U.S. Food and Drug Administration (openFDA)
Veridex, Llc holds 6 510(k) clearances for devices named "circulating tumor cell".6 510(k) clearances2026U.S. Food and Drug Administration (openFDA)
ClinicalTrials.gov lists 124,514 registered studies for the condition "cancer".124,514 registered studies2026U.S. National Library of Medicine (ClinicalTrials.gov)
18,775 of those studies were recruiting participants when checked in November 2026.18,775 recruiting studies2026U.S. National Library of Medicine (ClinicalTrials.gov)

Companies to watch

Veridex, Llc

6 FDA 510(k) clearances for devices named "circulating tumor cell".

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 United States 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

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Frequently asked questions

How many circulating tumor cell devices are cleared by the FDA?

openFDA lists 6 510(k) clearances for devices named circulating tumor cell.

Which companies hold the most FDA clearances for circulating tumor cell?

By 510(k) count: Veridex, Llc.

How many clinical trials study cancer?

ClinicalTrials.gov lists 124,514 registered studies.

How many US companies are in the circulating tumor cell industry?

BLS counts 500 private establishments in NAICS 325413 (In-vitro diagnostic substance manufacturing), the closest official industry.

How many EU companies are in the circulating tumor cell industry?

Eurostat counts 3,116 enterprises in NACE class C2120 (Manufacture of pharmaceutical preparations).

Sources and method

The figures on this page come from the public sources listed below. Read how we work.

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances, device_name "circulating tumor cell" (2026-11-04)openFDA device/510k device_name:"circulating tumor cell", sum of counts by decision_date = 6
  9. U.S. Food and Drug Administration (openFDA): openFDA 510(k) clearances by applicant, device_name "circulating tumor cell" (2026-11-04)applicant.exact "Veridex, LLC" count 6
  10. U.S. National Library of Medicine (ClinicalTrials.gov): ClinicalTrials.gov API v2, condition "cancer" (2026-11-04)query.cond=cancer totalCount 124514
  11. U.S. National Library of Medicine (ClinicalTrials.gov): ClinicalTrials.gov API v2, condition "cancer", status recruiting (2026-11-04)filter.overallStatus=RECRUITING totalCount 18775

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