Health

Diagnostic tests and lab supplies

PCR reagents, rapid antigen tests, lab analyzers, and sample collection kits for clinical and public health testing.

Why it matters · Longer diagnostic turnaround times, deferred diagnoses, and public health blindspots when testing supplies are constrained.

9

Inputs

25

Companies

23

Facilities

10

Source countries

How it's made

The process

  1. 01

    Antigen/Antibody Development & Production

    Monoclonal antibodies specific to the target analyte are generated via hybridoma technology or recombinant expression systems, then purified. For antigen-based tests, recombinant antigens are expressed in E. coli or mammalian cell lines. This step sets the assay sensitivity and specificity ceiling and cannot be substituted mid-production without revalidation.

  2. 02

    Label/Conjugate Preparation

    Detection labels — colloidal gold nanoparticles (40–80 nm) for lateral flow, or fluorescent dyes for immunofluorescence — are conjugated to the capture antibody. For PCR kits, fluorescent reporter probes (FAM, HEX, ROX) are synthesized and attached to oligonucleotide primers. Critical inputs: tetrachloroauric acid reduced to colloidal particles, or NHS-ester fluorescent dyes.

  3. 03

    Membrane & Substrate Preparation

    For lateral flow assays: nitrocellulose membrane rolls are quality-tested for pore size (8–12 µm) and capillary flow rate. For PCR: silica-membrane spin columns are prepared. For immunoassay analyzers: microtiter plates or paramagnetic bead suspensions are coated with capture antibody in blocking buffer.

  4. 04

    Reagent Striping & Coating

    For lateral flow: test-line and control-line antibodies are dispensed onto NC membrane in precise 1 mm bands using XY-table dispensers. For ELISA/immunoassay: capture antibody is coated onto microplate wells, then blocked. For PCR kits: master mix (polymerase, dNTPs, buffer salts) is formulated and aliquoted into single tubes.

  5. 05

    Lamination & Assembly

    Lateral flow strips: NC membrane, conjugate pad, sample pad, and absorbent wicking pad are laminated onto a polyester backing card. Strips are cut to width (4–6 mm) with precision guillotine cutters. For PCR kits: lyophilization of master mix with primers/probes, then filling into single-use polypropylene tubes or sealed foil pouches.

  6. 06

    Cassette Housing & Packaging

    Individual test strips are placed into injection-molded polystyrene cassette housings with sample wells and result windows. Desiccant pouches are added and each cassette is heat-sealed in a foil moisture-barrier pouch. PCR kits: tubes, buffers, and controls are assembled into kit boxes with cold-chain packaging.

  7. 07

    Quality Control & Lot Release Testing

    Each batch undergoes analytical validation: sensitivity/specificity testing against positive/negative panels, stability testing (accelerated aging), cross-reactivity testing, and instrument compatibility checks. FDA-cleared IVDs require 21 CFR Part 820 QSR compliance. Lot-release testing takes 5–15 business days and constitutes a significant production bottleneck.

  8. 08

    Cold-Chain Distribution

    Finished tests are shipped with specified temperature ranges (most lateral flow: 2–30°C; PCR enzymes: -20°C frozen). Validation of shipping conditions via logged temperature data recorders is required for regulated markets. International air freight dominates — relying on commercial passenger cargo holds for speed and temperature control.

Where it comes from

Country dependencies

Weighted share of upstream inputs sourced from each country.

CountryWeighted shareInputs supplied to diagnostic tests and lab supplies
ITItaly50%Nasopharyngeal Flocked Nylon Swabs
USUnited States35%Colloidal Gold Nanoparticles (AuNPs) · Diagnostic-Grade Monoclonal Antibodies (mAbs) · Fluorescent Reporter Dyes & Oligonucleotide Probes +6
DEGermany27%Diagnostic-Grade Monoclonal Antibodies (mAbs) · Fluorescent Reporter Dyes & Oligonucleotide Probes · Glass Fiber Conjugate Pads & Borosilicate Fiber Membranes +3
GBUnited Kingdom26%Colloidal Gold Nanoparticles (AuNPs) · Glass Fiber Conjugate Pads & Borosilicate Fiber Membranes
IEIreland25%Nitrocellulose (NC) Membrane for Lateral Flow
CNChina21%Colloidal Gold Nanoparticles (AuNPs) · Diagnostic-Grade Monoclonal Antibodies (mAbs) · Fluorescent Reporter Dyes & Oligonucleotide Probes +6
JPJapan17%Fluorescent Reporter Dyes & Oligonucleotide Probes · PDMS (Polydimethylsiloxane) Sylgard 184 for Microfluidic Chips
FIFinland12%Glass Fiber Conjugate Pads & Borosilicate Fiber Membranes
INIndia11%Glass Fiber Conjugate Pads & Borosilicate Fiber Membranes · Nitrocellulose (NC) Membrane for Lateral Flow
CHSwitzerland10%RNA Extraction Kit Components (Silica Columns, Chaotropic Salts)

Who makes it

Supplier companies

25 companies in this supply chain, sorted by market share.

Brescia, Lombardy-based manufacturer that invented and patented flocked nasopharyngeal swab technology (FLOQSwab, 2003). Pre-COVID held ~50% of global NP swab supply. Located in the Lombardy region — the first European COVID epicenter — creating a catastrophic supply chain disruption when their workers were among the first hospitalized.

Supplies these inputs

Nasopharyngeal Flocked Nylon Swabs

Replaceability

Substitutability 20% · 12 mo to replace

Business segments

  • FLOQSwab® Flocked Nasopharyngeal & Specimen Swabs55% rev
  • Transport Media (UTM / VTM / ESwab)25% rev
  • WASPLab® Automated Microbiology (Robotics)15% rev
  • Specialty Diagnostics & Forensics5% rev
Cytiva (Danaher Corporation)
HQ US45% shareSOLE SUPPLIER

Life sciences tools and services business of Danaher Corporation (NYSE: DHR); formed from the 2019 GE Healthcare Life Sciences acquisition; produces Vivid® lateral flow nitrocellulose membranes (formerly Whatman/GE brand); market leader in lateral flow assay membranes for diagnostics; also owns the Pall filtration business; Cytiva Vivid membranes are the reference standard used in most FDA-cleared lateral flow diagnostic assays including COVID-19, pregnancy tests, and flu diagnostics; Marlborough MA headquarters

Supplies these inputs

Fluorescent Reporter Dyes & Oligonucleotide Probes · Glass Fiber Conjugate Pads & Borosilicate Fiber Membranes · Nitrocellulose (NC) Membrane for Lateral Flow

Replaceability

Substitutability 20% · 18 mo to replace

Business segments

  • Lateral Flow Nitrocellulose Membranes (Vivid/Whatman)30% rev
  • Pall Filtration (Industrial & Pharmaceutical)35% rev
  • Bioprocessing Tools & Resins25% rev
  • Cell Biology & Analytical10% rev

Family-owned manufacturer in Guilford and Pittsfield, Maine. Pre-COVID the only significant US domestic producer of flocked NP swabs. Received >$250M in combined US DoD and HHS funding to rapidly scale COVID swab production. Output scaled to millions of swabs/week during pandemic.

Supplies these inputs

Nasopharyngeal Flocked Nylon Swabs

Replaceability

Substitutability 25% · 12 mo to replace

Business segments

  • Flocked Diagnostic Swabs (NP/OP/Nasal)55% rev
  • Traditional Cotton & Foam Applicators30% rev
  • Forensic & Law Enforcement Collection10% rev
  • Veterinary & Environmental Testing5% rev
QIAGEN NV (QGEN)
HQ NL40% share

QIAGEN NV (Venlo, Netherlands; operational HQ Hilden, Germany); market leader in DNA/RNA extraction kits with 22-26% global share; flagship QIAamp Viral RNA Mini Kit is the WHO-recommended standard for respiratory virus testing including SARS-CoV-2; manufacturing in Hilden (Germany), Barcelona (Spain), Germantown MD (USA), and Suzhou (China); in March 2020 Qiagen operated 3 shifts/7 days to meet COVID demand at Hilden and Barcelona; Thermo Fisher attempted $11.5B acquisition in 2020 but withdrew in August 2020; Qiagen remains independent with a partial stake held by Danaher

Supplies these inputs

RNA Extraction Kit Components (Silica Columns, Chaotropic Salts) · Taq DNA Polymerase & Reverse Transcriptase (RT) Enzymes

Replaceability

Substitutability 30% · 6 mo to replace

Business segments

  • Sample Technologies — DNA/RNA Extraction Kits45% rev
  • Molecular Diagnostics & PCR30% rev
  • Forensic Genomics12% rev
  • Bioinformatics & Clinical Interpretation13% rev

Washington DC-based conglomerate that owns Cytiva (Whatman brand — nitrocellulose membranes, glass fiber pads), IDT (oligonucleotide probes), and Pall Corporation (filtration). Controls an extraordinary concentration of IVD supply chain chokepoints through acquisitions across multiple independent critical nodes.

Supplies these inputs

Glass Fiber Conjugate Pads & Borosilicate Fiber Membranes · Nitrocellulose (NC) Membrane for Lateral Flow

Business segments

  • Cytiva (GE Healthcare Life Sciences) — Bioprocess35% rev
  • Pall Corporation (Industrial & Lab Filtration)25% rev
  • IDT (Integrated DNA Technologies) — Oligonucleotides & CRISPR15% rev
  • Diagnostics (Beckman Coulter, Cepheid)25% rev
Sartorius AG (SRT)
HQ DE30% share

German life sciences company that manufactured the world's first industrial nitrocellulose membrane in 1960 in Göttingen. Its Unisart® CN series is one of the two dominant global LFA membrane brands. Key OEM supplier to virtually every major rapid test manufacturer.

Supplies these inputs

Nitrocellulose (NC) Membrane for Lateral Flow

Replaceability

Substitutability 25% · 18 mo to replace

Business segments

  • Bioprocess Solutions (Single-Use Bioreactors & Filtration)58% rev
  • Nitrocellulose Membranes (Lateral Flow Assay)12% rev
  • Lab Products & Precision Instruments30% rev

Thermo Fisher Scientific (Waltham MA; NYSE: TMO; ~$43B revenue 2024) is the world's largest manufacturer of cell culture media through its Gibco brand — the dominant label in CHO (Chinese Hamster Ovary) cell culture media for biopharmaceutical manufacturing. Gibco CHO-S Serum-Free Medium, GlutaMAX supplement, CD CHO medium, and EX-CELL Advanced CHO media series supply the majority of global monoclonal antibody manufacturing processes. Thermo Fisher's cell culture media is manufactured primarily at its Grand Island, NY facility (acquired from Life Technologies, itself formerly GIBCO BRL), which is the single most important cell culture media manufacturing site in North America. Thermo Fisher also operates a major media production site in Paisley, Scotland (UK) that serves European biopharmaceutical manufacturing. Gibco media formulations are validated into more FDA-approved biologics manufacturing processes than any other supplier — creating regulatory lock-in equivalent to Cytiva's position in chromatography resins. The 2014 Thermo Fisher merger with Life Technologies (which itself had acquired Invitrogen in 2008 and GIBCO BRL in 2000) consolidated what were once multiple competing cell culture brands into a single dominant supplier.

Supplies these inputs

Fluorescent Reporter Dyes & Oligonucleotide Probes · RNA Extraction Kit Components (Silica Columns, Chaotropic Salts) · Taq DNA Polymerase & Reverse Transcriptase (RT) Enzymes

Replaceability

Substitutability 30% · 6 mo to replace

Business segments

  • Life Sciences Solutions40% rev
  • Analytical Instruments25% rev
  • Laboratory Products & Services25% rev
  • Specialty Diagnostics10% rev

German multinational producing the Hi-Flow Plus nitrocellulose membrane — one of the two industry-standard LFA membranes globally. Received a €121M US DoD/HHS contract to build the first US lateral flow membrane facility in Sheboygan, WI (2022) to reduce concentration risk in Cork, Ireland.

Supplies these inputs

Fluorescent Reporter Dyes & Oligonucleotide Probes · Glass Fiber Conjugate Pads & Borosilicate Fiber Membranes · Nitrocellulose (NC) Membrane for Lateral Flow

Replaceability

Substitutability 25% · 4 mo to replace

Business segments

  • Life Science (MilliporeSigma — US Brand)42% rev
  • Healthcare (Pharma — Small Relative to Life Science)22% rev
  • Electronics / Performance Materials (Liquid Crystals & OLED)28% rev
  • Surface Solutions & Specialty Chemicals8% rev
BBI Solutions
HQ GB20% share

UK-based manufacturer of gold colloid and lateral flow assay reagents; headquartered in Crumlin, South Wales; ISO 13485:2015 certified; supplies gold nanoparticles used in over 500 million diagnostic assays globally per year; pioneer in commercial colloidal gold production for 30+ years; offers proprietary large-batch manufacturing with high particle uniformity; acquired IBEX Technologies (Canada) in 2024 and Biotez GmbH (Germany) to expand biochemistry capabilities; key supplier to Roche, Abbott, Siemens Healthineers and other major IVD manufacturers

Supplies these inputs

Colloidal Gold Nanoparticles (AuNPs)

Replaceability

Substitutability 35% · 12 mo to replace

Business segments

  • Colloidal Gold (Diagnostic Grade)55% rev
  • Lateral Flow Assay Components30% rev
  • Biochemistry (IBEX, Biotez)

Danaher subsidiary (acquired 2020 as part of the $21.4B GE Healthcare Life Sciences deal); world's largest custom oligonucleotide manufacturer; makes fluorescent-labeled TaqMan-compatible probes using proprietary Freedom Dyes portfolio (patent-free Cy dye alternatives); Coralville IA HQ; expanded GMP therapeutic oligo manufacturing 2023

Supplies these inputs

Fluorescent Reporter Dyes & Oligonucleotide Probes

Replaceability

Substitutability 45% · 6 mo to replace

Business segments

  • Custom DNA Oligonucleotides (Research)40% rev
  • CRISPR & Gene Editing Tools25% rev
  • NGS & Library Prep20% rev
  • RNA & Functional Oligos15% rev

Cincinnati, Ohio-based company and one of the world's largest OEM suppliers of diagnostic enzymes and antibodies. Offers 3,000+ antigens and antibodies covering 500+ diseases plus comprehensive PCR enzyme portfolio. Many IVD manufacturers depend on Meridian as a hidden sole-source OEM supplier — a chokepoint invisible to end users.

Supplies these inputs

Taq DNA Polymerase & Reverse Transcriptase (RT) Enzymes

Replaceability

Substitutability 40% · 9 mo to replace

Business segments

  • PCR Enzymes (OEM Backbone of Molecular Diagnostics)35% rev
  • Diagnostic Antibodies & Antigens (IVD OEM)40% rev
  • Finished Diagnostic Tests (Internal Brand)20% rev
  • Maravai / Meridian Overlap & Structure5% rev
HyTest Ltd.
HQ FI18% shareSOLE SUPPLIER

Finnish biotechnology company (Turku, Finland); specialist manufacturer of diagnostic monoclonal antibodies for cardiac biomarkers; introduced the first anti-cardiac troponin I (cTnI) monoclonal antibodies to market in 1994; supplier to virtually every major cardiac diagnostic test maker (Abbott, Roche, Siemens Healthineers, Beckman Coulter); acquired by Mindray Medical (China's largest medical device company) in 2016 for an undisclosed sum; Mindray ownership means Chinese corporate control of the dominant non-Chinese supplier of troponin I capture antibodies — the gold standard biomarker for myocardial infarction diagnosis

Supplies these inputs

Diagnostic-Grade Monoclonal Antibodies (mAbs)

Replaceability

Substitutability 20% · 24 mo to replace

Business segments

  • Cardiac Biomarker Antibodies65% rev
  • Infectious Disease Antibodies20% rev
  • Other Diagnostic Components15% rev
Roche Diagnostics
HQ CH15% share

Diagnostic division of F. Hoffmann-La Roche (Basel, Switzerland); manufactures viral RNA extraction kits including the High Pure Viral RNA Kit and MagNA Pure series; integrated with Roche cobas PCR system for automated end-to-end COVID testing; ~10-12% of RNA extraction kit market; manufacturing in Mannheim, Germany (primary) and Penzberg, Bavaria; FDA approved the Roche extraction kit as an alternative to Qiagen during COVID, but Roche was also on backorder simultaneously

Supplies these inputs

RNA Extraction Kit Components (Silica Columns, Chaotropic Salts) · Taq DNA Polymerase & Reverse Transcriptase (RT) Enzymes

Replaceability

Substitutability 35% · 8 mo to replace

Business segments

  • Molecular Diagnostics (PCR, NGS)35% rev
  • Tissue Diagnostics (Pathology)20% rev
  • Clinical Chemistry & Immunoassay25% rev
  • Point of Care10% rev

Chinese biotechnology CRO/manufacturer (Beijing); specializes in recombinant protein production and monoclonal antibody development for diagnostic use; one of the world's largest suppliers of diagnostic-grade SARS-CoV-2 antibodies (spike, RBD, nucleocapsid); supplied capture and detection antibodies for COVID-19 rapid antigen tests manufactured by Western companies in 2020-2021; rapid protein and antibody development capability (weeks vs months for Western competitors) made Sino Biological the fastest-to-market supplier for novel pathogen antibodies; exports to 100+ countries

Supplies these inputs

Diagnostic-Grade Monoclonal Antibodies (mAbs)

Replaceability

Substitutability 40% · 6 mo to replace

Business segments

  • Diagnostic Antigens & Antibodies (COVID + Other Pathogens)45% rev
  • Research Proteins (Cytokines, Growth Factors, Checkpoints)38% rev
  • CRO / Custom Development Services17% rev

Finnish specialty fiber and filtration materials company; merged with Munksjö 2017; produces ReliaFlow™ conjugate pads (8980, 6614) for lateral flow immunoassays; serves infectious disease, pregnancy, drugs-of-abuse, food safety, veterinary, and environmental LFA markets; major European alternative to Whatman/Cytiva glass fiber pads

Supplies these inputs

Glass Fiber Conjugate Pads & Borosilicate Fiber Membranes

Replaceability

Substitutability 50% · 4 mo to replace

Business segments

  • Medical & Diagnostics Fiber Materials30% rev
  • Filtration Materials30% rev
  • Food & Beverage Filtration20% rev
  • Industrial & Other Specialty20% rev

Finnish diagnostic reagent company (Kauniainen, near Helsinki, Finland); produces monoclonal and polyclonal antibodies for cardiac markers (troponin, CK-MB, myoglobin), fertility hormones (hCG, LH, FSH), infectious disease (HIV, HCV), and other IVD applications; key OEM supplier to global diagnostic companies; alongside HyTest, one of the two Finnish firms that supply the antibody backbone for most of the world's cardiac rapid tests; exports to 100+ countries

Supplies these inputs

Diagnostic-Grade Monoclonal Antibodies (mAbs)

Replaceability

Substitutability 25% · 18 mo to replace

Business segments

  • Cardiac Biomarker Antibodies40% rev
  • Fertility & Hormone Antibodies30% rev
  • Infectious Disease & Inflammation30% rev

Indian manufacturer of nitrocellulose membranes for lateral flow diagnostics; headquartered in Ambala, Haryana, India; a major contributor to India's ~15% global NC membrane production share; supplies membrane to global rapid test manufacturers at competitive prices; one of the few non-Western qualified NC membrane suppliers; capacity expansion driven by COVID-19 demand and Indian government ambitions in global diagnostics supply chain

Supplies these inputs

Nitrocellulose (NC) Membrane for Lateral Flow

Replaceability

Substitutability 50% · 12 mo to replace

Business segments

  • Nitrocellulose Membranes (Lateral Flow)80% rev
  • Other Diagnostic Membranes20% rev

San Diego, California-based gold and silver nanoparticle manufacturer; acquired by Fortis Life Sciences (~2020); produces highly monodisperse gold nanoparticles for lateral flow assays, immunodiagnostics, and research; reference manufacturer for many gold NP characterization standards; known for ultra-uniform particle sizing critical for consistent assay performance; supplies to diagnostic kit developers and OEM test manufacturers globally

Supplies these inputs

Colloidal Gold Nanoparticles (AuNPs)

Replaceability

Substitutability 40% · 9 mo to replace

Business segments

  • Gold Nanoparticles (Diagnostic)60% rev
  • Silver Nanoparticles20% rev
  • Research & Custom NPs20% rev

Where it's made

Facilities

23 facilities producing inputs that feed diagnostic tests and lab supplies.

AMD Ambala Cantt India

IN

Advanced Microdevices Pvt. Ltd. (AMD) · Haryana · processing

Advanced Microdevices main manufacturing campus in Ambala Cantt, Haryana; produces glass fiber conjugate pads, nitrocellulose membranes, absorbent pads, and LFA starter kits; key supplier for Asia-Pacific diagnostic developers seeking cost-effective alternatives to Western suppliers; growing role as India scales domestic IVD manufacturing

ATTO-TEC Siegen Germany

DE

ATTO-TEC GmbH · North Rhine-Westphalia · processing

University of Siegen campus spin-off; sole manufacturing location for ATTO dye portfolio; ATTO 647N and ATTO 655 have up to 100x better ozone photostability than Cy5/Alexa647; exports globally to oligo synthesis labs as Cy dye alternatives for diagnostic probes and super-resolution imaging

Ahlstrom Helsinki Finland (HQ & Medical Division)

FI

Ahlstrom (Ahlstrom-Munksjö) · Uusimaa · processing

Ahlstrom headquarters and medical/life sciences division management; company operates distributed manufacturing across Europe; ReliaFlow conjugate pads for lateral flow diagnostics; primary market: infectious disease POC testing, pregnancy tests, drug screening, food safety; offers glass and polyester conjugate pad options with pre-treatment capabilities

BBI Solutions Crumlin Manufacturing Facility

GB

BBI Solutions · South Wales · processing

Primary BBI gold colloid manufacturing site; ISO 13485:2015 certified; 30+ year production history; supplies gold nanoparticles used in 500M+ assays/year globally; proprietary batch synthesis achieves high size uniformity across large volumes; key European supply hub for diagnostic gold reagents

Copan Group Brescia Facility

IT

Copan Diagnostics / Copan Group · manufacturing

Primary global NP swab manufacturing. Located in Lombardy, Italy — the first European COVID-19 hotspot (February-March 2020), directly disrupting global swab supply at the moment of peak demand.

Cytiva Little Chalfont UK (Historic Amersham Site)

GB

Cytiva (Danaher Corporation) · Buckinghamshire · processing

Original Amersham Biosciences site (GE Healthcare Life Sciences → Cytiva); birthplace of the Cy3/Cy5 CyDye fluorescent nucleotide product line; Cytiva holds the Cy and CyDye trademarks; commercial diagnostic manufacturers must obtain a separate trademark license from Cytiva to name their products Cy3/Cy5; nucleotide labeling hub serving genomics and FISH diagnostic markets

Cytiva Whatman Maidstone UK Membrane Plant

GB

Cytiva (Danaher Corporation) · Kent · processing

Historic Whatman nitrocellulose membrane manufacturing site in Maidstone, Kent; Whatman was acquired by GE Healthcare then Danaher/Cytiva; produces Vivid lateral flow NC membranes that are the reference standard in diagnostic assay development; key UK production asset supplying European and global markets

HyTest Turku Antibody Manufacturing

FI

HyTest Ltd. · Southwest Finland · processing

HyTest's primary antibody production facility; hybridoma cell culture and antibody purification; 30+ years of cardiac marker antibody production; supplies troponin I, troponin T, CK-MB, and BNP antibodies to global IVD manufacturers; owned by Mindray (China) since 2016

IDT Coralville Iowa Main Campus

US

Integrated DNA Technologies (IDT) · Iowa · processing

IDT headquarters and primary oligo synthesis campus; largest custom oligonucleotide synthesis facility in North America by volume; synthesizes FAM, HEX, ROX, and Freedom Dye-labeled TaqMan probes at diagnostic and GMP scale; 2023 expansion added therapeutic oligo manufacturing for cell & gene therapy

Medix Biochemica Kauniainen Facility

FI

Medix Biochemica Group · Uusimaa · processing

Medix Biochemica primary manufacturing site; produces cardiac, fertility, and infectious disease monoclonal antibodies for OEM supply; alongside HyTest Turku, forms a Finnish antibody manufacturing cluster that supplies the backbone of global cardiac rapid testing

Merck MilliporeSigma Cork Facility

IE

Merck KGaA (MilliporeSigma in US) · manufacturing

Primary Hi-Flow Plus nitrocellulose membrane production (two casting lines). Pre-2022 essentially the only significant Hi-Flow production capacity globally, creating geographic concentration risk.

Meridian Bioscience Cincinnati HQ & Manufacturing

US

Meridian Bioscience Inc. · manufacturing

Primary site for ISO 13485-certified diagnostic enzyme and antibody production. Serves as hidden OEM supplier for dozens of competing IVD kit brands simultaneously.

New England Biolabs Ipswich MA HQ & Manufacturing

US

New England Biolabs (NEB) · Massachusetts · processing

NEB primary enzyme manufacturing and R&D campus; produces research-grade Taq polymerase, Q5, LongAmp, and RT enzymes; reference-standard enzyme quality widely used in clinical assay validation; NEB also operates a production facility in Hitchin, UK and Ipswich UK for European supply

Puritan Medical Products Guilford, ME

US

Puritan Medical Products · manufacturing

Primary family-owned facility. Pre-COVID producing ~800K swabs/week. Received $75M DoD contract (April 2020) then additional HHS funding totaling >$250M to expand. Visited by President Trump June 2020.

QIAGEN Hilden Manufacturing

DE

QIAGEN NV · manufacturing

Primary global production site for RNA extraction kits. During COVID-19, ran 24/7 triple shifts. Scaled from 1.5M to 20M extractions/month (13x) in approximately 6 months.

Qiagen Barcelona Manufacturing Site

ES

QIAGEN NV · Catalonia · processing

Secondary Qiagen manufacturing hub; operated 3 shifts/7 days alongside Hilden during COVID surge demand in 2020; key capacity buffer for European supply; produces QIAamp extraction kits and silica column components

Roche Diagnostics Mannheim Manufacturing

DE

Roche Diagnostics · Baden-Württemberg · processing

Primary Roche Diagnostics manufacturing site; produces cobas PCR reagents, MagNA Pure RNA extraction kits, High Pure Viral RNA kits; the FDA-approved Roche RNA extraction alternative to Qiagen during COVID-19 was manufactured here; also on backorder in March 2020 alongside Qiagen

Sartorius Göttingen Manufacturing Campus

DE

Sartorius AG · manufacturing

Site of world's first industrial nitrocellulose membrane production (1960). All Unisart® membranes produced here. Single-site manufacturing of a global supply chain critical input.

Sino Biological Beijing HQ & Production

CN

Sino Biological Inc. · manufacturing

Primary production site for recombinant antigens and monoclonal antibodies. Supplies diagnostic-grade SARS-CoV-2 proteins to Western IVD manufacturers; can produce mg to kg scale in ~2 weeks.

Takara Bio Kusatsu Shiga Manufacturing

JP

Takara Bio Inc. · Shiga · processing

Takara Bio primary manufacturing site; produces PrimeScript RT enzymes, Ex Taq polymerase, and PCR master mixes; key supplier for Asia-Pacific COVID-19 RT-PCR testing; provides Japanese quality-certified enzyme supply for clinical diagnostics

Thermo Fisher Carlsbad CA Genomics Manufacturing

US

Thermo Fisher Scientific · California · processing

Thermo Fisher Carlsbad site (former Invitrogen headquarters); produces TRIzol reagent, Applied Biosystems PCR reagents, MagMAX RNA purification kits; key US source of RNA extraction components for clinical and research labs

mdi Membrane Technologies Ambala Facility

IN

mdi Membrane Technologies (Advanced Microdevices) · Haryana · processing

Primary mdi membrane manufacturing facility; produces porous nitrocellulose membranes for lateral flow diagnostics; supplies to global diagnostic kit manufacturers; India's NC membrane production capacity expanded significantly post-COVID to serve diversification demand from Western diagnostic companies

nanoComposix San Diego Manufacturing

US

nanoComposix (Fortis Life Sciences) · California · processing

nanoComposix San Diego HQ and manufacturing; produces research-grade and diagnostic-grade gold nanoparticles; reference supplier for many ISO-traceable gold NP standards; acquired by Fortis Life Sciences; key US supply source for lateral flow conjugate gold