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Healthcare & Life SciencesUnited StatesUpdated 4 Nov 2026

Antimicrobial regenerative wound matrix Market 2026: trade data and key figures

The FDA has 369 510(k) clearances on record for antimicrobial regenerative wound matrix devices. In the US, the core industry (Surgical appliance and supplies manufacturing) had 3,528 establishments in 2025. The EU counted 63,227 enterprises in the related industry class.

Region
United States
Evidence
15 sourced figures from 4 sources
Last checked
4 Nov 2026
FDA 510(k) clearances per year, antimicrobial regenerative wound matrix20162025

369510(k) clearances

FDA 510(k) clearances on record

63,227enterprises

The EU had 63,227 enterprises in NACE class C3250 (Manufacture of medical and dental instruments and supplies) in 2023.

105.31EUR billion

EU enterprises in NACE class C3250 had net turnover of €105.31 billion in 2021.

600,000persons employed

NACE class C3250 employed 600,000 people across the EU in 2023.

What this market covers

Biologic or synthetic scaffolds that support tissue regrowth in chronic and surgical wounds while limiting infection. Buyers are hospitals, wound care centres and surgeons.

Typical segments

  • Collagen matrices
  • Silver impregnated matrices
  • Synthetic matrices
  • Biologic skin substitutes
ChartFDA 510(k) clearances per year, antimicrobial regenerative wound matrix
FDA 510(k) clearances per year, antimicrobial regenerative wound matrix024682016: 3 clearances320162017: 6 clearances2018: 7 clearances20182019: 7 clearances2020: 1 clearances20202021: 2 clearances2022: 3 clearances20222023: 8 clearances2024: 5 clearances2025: 6 clearances62025

Source: U.S. Food and Drug Administration

Why this market is moving now

  • US employment in the core industry shifted +3% since 2020.

Key figures

Each figure names the source it came from. Open the source list below to read the quoted line.

FigureValueYearSource
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 3,528 private establishments in NAICS 339113 (Surgical appliance and supplies manufacturing) in 2025.3,528 establishments2025U.S. Bureau of Labor Statistics
NAICS 339113 employed an average of 105,116 people in US private industry in 2025.105,116 jobs2025U.S. Bureau of Labor Statistics
US employment in NAICS 339113 changed by +3% between 2020 (102,053 jobs) and 2025, calculated from BLS figures.+3 % change2025U.S. Bureau of Labor Statistics
Average annual pay in US NAICS 339113 was $102,311 in 2025.102,311 USD per year2025U.S. Bureau of Labor Statistics
The FDA has recorded 369 510(k) clearances for devices named "wound dressing".369 510(k) clearances2026U.S. Food and Drug Administration
24 of those clearances were issued from 2021 to 2025.24 510(k) clearances2025U.S. Food and Drug Administration
Polymedica Industries, Inc. holds 10 510(k) clearances for devices named "wound dressing".10 510(k) clearances2026U.S. Food and Drug Administration
Bioderm, Inc. holds 9 510(k) clearances for devices named "wound dressing".9 510(k) clearances2026U.S. Food and Drug Administration
Acrymed, Inc. holds 8 510(k) clearances for devices named "wound dressing".8 510(k) clearances2026U.S. Food and Drug Administration
Calgon Vestal Div. holds 8 510(k) clearances for devices named "wound dressing".8 510(k) clearances2026U.S. Food and Drug Administration
Carrington Laboratories, Inc. holds 7 510(k) clearances for devices named "wound dressing".7 510(k) clearances2026U.S. Food and Drug Administration
Dermaphylyx, Inc. holds 6 510(k) clearances for devices named "wound dressing".6 510(k) clearances2026U.S. Food and Drug Administration

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)
    Quoted lines
    • Figure 1sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs ENT_NR, 2023, 63227
    • Figure 2sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs NETTUR_MEUR, 2021, 105308
    • Figure 3sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs EMP_NR, 2023, 600000
  2. U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339113, 2025 (2026-11-04)
    Quoted lines
    • Figure 4QCEW 2025 annual, US000, private, NAICS 339113, annual_avg_estabs 3528
    • Figure 5QCEW 2025 annual, US000, private, NAICS 339113, annual_avg_emplvl 105116
    • Figure 6QCEW 2020 annual_avg_emplvl 102053; 2025 annual_avg_emplvl 105116
    • Figure 7QCEW 2025 annual, US000, private, NAICS 339113, avg_annual_pay 102311
  3. U.S. Food and Drug Administration: openFDA 510(k) clearances, device_name "wound dressing" (2026-11-04)
    Quoted lines
    • Figure 8openFDA device/510k device_name:"wound dressing", sum of counts by decision_date = 369
    • Figure 9openFDA device/510k decision_date 2021-2025 count = 24
  4. U.S. Food and Drug Administration: openFDA 510(k) clearances by applicant, device_name "wound dressing" (2026-11-04)
    Quoted lines
    • Figure 10applicant.exact "Polymedica Industries, Inc." count 10
    • Figure 11applicant.exact "Bioderm, Inc." count 9
    • Figure 12applicant.exact "Acrymed, Inc." count 8
    • Figure 13applicant.exact "Calgon Vestal Div." count 8
    • Figure 14applicant.exact "Carrington Laboratories, Inc." count 7
    • Figure 15applicant.exact "Dermaphylyx, Inc." count 6

Buyers and suppliers

Who buys

  • Hospitals
  • Wound care centres
  • Surgical practices

Companies to watch

Polymedica Industries, Inc.

10 FDA 510(k) clearances for devices named "wound dressing".

Bioderm, Inc.

9 FDA 510(k) clearances for devices named "wound dressing".

Acrymed, Inc.

8 FDA 510(k) clearances for devices named "wound dressing".

Calgon Vestal Div.

8 FDA 510(k) clearances for devices named "wound dressing".

Carrington Laboratories, Inc.

7 FDA 510(k) clearances for devices named "wound dressing".

Dermaphylyx, Inc.

6 FDA 510(k) clearances for devices named "wound dressing".

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 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

Included with the full report

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  • 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 many antimicrobial regenerative wound matrix devices are cleared by the FDA?

openFDA lists 369 510(k) clearances for devices named wound dressing.

Which companies hold the most FDA clearances for antimicrobial regenerative wound matrix?

By 510(k) count: Polymedica Industries, Inc., Bioderm, Inc., Acrymed, Inc., Calgon Vestal Div..

How many US companies are in the antimicrobial regenerative wound matrix industry?

BLS counts 3,528 private establishments in NAICS 339113 (Surgical appliance and supplies manufacturing), the closest official industry.

How many EU companies are in the antimicrobial regenerative wound matrix industry?

Eurostat counts 63,227 enterprises in NACE class C3250 (Manufacture of medical and dental instruments and supplies).

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