Top HHS in-vitro diagnostic substance manufacturing contractors
In the 12 months ending Oct 5, 2026, the Department of Health and Human Services obligated $12.0M in net prime contract dollars under NAICS 325413, up 22.4% from $9.8M in the preceding 12 months. 52 prime contractors received positive obligations, and 15 of them accounted for 80% of that spend.
Prime contracts funded by the Department of Health and Human Services. Latest 12 months: Oct 6, 2025 to Oct 5, 2026. Source: USAspending.gov.
Obligations by fiscal year
Net prime contract obligations by federal fiscal year (October to September).
Top HHS contractors for NAICS 325413
Ranked by positive obligations in the latest 12 months. Share is of all positive obligations in this market.
| # | Contractor | Latest 12 mo | Prior 12 mo | Share | Rank change |
|---|---|---|---|---|---|
| 1 | Cepheid | $4.2M | $4.7M | 30.7% | — |
| 2 | Illumina, Inc. | $1.7M | $2.3M | 12.2% | — |
| 3 | Biomerieux Inc | $727K | $1.6M | 5.3% | — |
| 4 | Werfen USA LLC | $534K | $464K | 3.9% | ▲ 4 |
| 5 | 10x Genomics, Inc. | $465K | $1.2M | 3.4% | ▼ 1 |
| 6 | Fisher Scientific Company L.L.C. | $443K | −$372K | 3.3% | New |
| 7 | Remel Inc. | $364K | $323K | 2.7% | ▲ 4 |
| 8 | Beacon Scientific Inc | $357K | $0 | 2.6% | New |
| 9 | Quidelortho Sales Company, LLC | $354K | $0 | 2.6% | New |
| 10 | Roche Diabetes Care Inc | $343K | $718K | 2.5% | ▼ 4 |
| 11 | National Environmental Inc | $336K | $29K | 2.5% | ▲ 35 |
| 12 | Orasure Technologies Inc | $335K | $239K | 2.5% | ▲ 3 |
| 13 | Roche Diagnostics Corporation | $283K | $578K | 2.1% | ▼ 6 |
| 14 | Abbott Laboratories Inc. | $262K | $123K | 1.9% | ▲ 14 |
| 15 | Oxford Nanopore Technologies, Inc. | $253K | $95K | 1.8% | ▲ 17 |
What changed in the last 12 months
Contractors with the largest change in reported obligations versus the preceding 12 months.
Largest gains
- Watmind USA, Inc−$2.4M → $0 (+$2.4M) · no latest-period obligations
- Becton, Dickinson and Company−$2.2M → −$273K (+$2.0M) · no latest-period obligations
- Bioteke USA, LLC−$1.6M → $0 (+$1.6M) · no latest-period obligations
Largest declines
- Siemens Healthcare Diagnostics Inc.$1.1M → −$231K (−$1.3M) · no latest-period obligations
- Biomerieux Inc$1.6M → $727K (−$915K) · now #3
- 10x Genomics, Inc.$1.2M → $465K (−$753K) · now #5
New to this market
10 contractors received their first obligations in this market (since FY2022) during the latest 12 months. The largest:
| Contractor | First obligation | Latest 12 mo |
|---|---|---|
| Beacon Scientific Inc | Sep 2, 2026 | $357K |
| Quidelortho Sales Company, LLC | Apr 10, 2026 | $354K |
| Cerus Corporation | Mar 3, 2026 | $225K |
| Cancer Diagnostics, Inc. | Sep 17, 2026 | $90K |
| Trustees of the University of Pennsylvania, the | May 7, 2026 | $60K |
| Phadia US Inc | Apr 29, 2026 | $41K |
| American Research Products, Inc | Apr 16, 2026 | $25K |
| Immudex USA, LLC | Jul 22, 2026 | $25K |
Where the money comes from
Funding sub-agencies within the Department of Health and Human Services, latest 12 months. The funding organization can differ from the office that runs the requirement.
| Funding sub-agency | Latest 12 mo | Prior 12 mo | Change |
|---|---|---|---|
| Indian Health Service | $5.8M | $5.2M | Up $580K (11.1%) |
| National Institutes of Health | $2.8M | $5.2M | Down $2.5M (47.1%) |
| Food and Drug Administration | $2.0M | $2.7M | Down $669K (25.0%) |
| Centers for Disease Control and Prevention | $1.1M | $483K | Up $634K (131.3%) |
| Office of Assistant Secretary for Preparedness and Response | $335K | −$3.8M | Up $4.1M (108.9%) |
Potential recompetes
Large awards in this market whose current period of performance ends in the next 18 months. Treat these as research leads: options, extensions, and follow-on vehicles often change the timing.
| Award | Incumbent | Obligated | Current end |
|---|---|---|---|
| 75A50424C00006 | Atlantic Trading LLC OVER THE COUNTER (OTC) COVID-19 TESTS - GAO CORRECTIVE ACTION | $26.5M | Oct 29, 2026 |
| 75H70722P00094 | Cepheid ZSU CEPHEID GENEXPERT REQUIRES GROUP B REAGENTS KITS | $2.8M | Feb 28, 2027 |
| 75A50123C00036 | Siro Diagnostics, Inc. ADVANCED DEVELOPMENT OF A NAAT MULTIPLEX RESPIRATORY PATHOGEN TEST FOR PROFESSIONAL POINT-OF- CARE (CLIA WAIVED) AND AT-HOME OTC USE WITH THE CUE HEALTH MONITORING SYSTEM… | $28.3M | May 1, 2027 |
| 75H71226F28007 | Biomerieux Inc BPA, BIOMERIEUX, BIOFIRE PANEL REAGENTS, PIMC LABORATORY DEPT, BPA CALL 26F28007 | $1.2M | May 5, 2027 |
| 75H71226F28028 | Cepheid NEW BPA CALL FOR CEPHEID SUPPLIES | $1.8M | May 13, 2027 |
| 75A50122P00014 | Orasure Technologies Inc THE PURPOSE OF THIS PURCHASE ORDER IS TO PROCURE ANTIBODY AND DIAGNOSTIC TESTS TO DETECT EBOLA VIRUS IN CADAVERS. | $1.2M | Jun 22, 2027 |
| 75H70722P00226 | Cepheid MSU CEPHEID TESTING KITS | $1.6M | Aug 31, 2027 |
Common questions
Who are the top HHS contractors for NAICS 325413?
In the latest 12 months, Cepheid ($4.2M), Illumina, Inc. ($1.7M), Biomerieux Inc ($727K) received the most HHS obligations for in-vitro diagnostic substance manufacturing.
How concentrated is this market?
The eight largest primes held 64.1% of positive obligations, and Cepheid alone held 30.7%. 10 contractors won their first obligations in this market during the latest 12 months.
Are any large HHS NAICS 325413 contracts ending soon?
7 of the largest awards in this market reach their current end date in the next 18 months. The first is 75A50424C00006 (Atlantic Trading LLC, $26.5M obligated), ending Oct 29, 2026. An end date is a research lead, not a confirmed recompete: options and extensions often move it.
Related markets
NAICS 325413 across all agencies
VA · NAICS 325413
$105.5MDoD · NAICS 325413
$50.8MFigures are net obligations on prime contracts (award types A–D) from USAspending.gov, grouped by funding agency and the NAICS code on each award. Net obligations include deobligations and corrections, so they can differ from positive-obligation totals. See methodology.
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