Report Details Over 30 Top IVD Contract Manufacturers

Press Release
Sep 14, 2018
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Rockville (MD), September 14, 2018 — There is a large market for tests used in clinical decisions, and there is also a large market for manufacturers that make those IVD tests that are then marketed by others. Valued at more than $12 billion in 2017, the global contract in vitro diagnostic (IVD) manufacturing segment is well positioned for long-term growth. Several trends and factors will boost the revenue potential of this business. Most leading worldwide of producers of proprietary IVD systems will increase their reliance on outside contractors as a cost-effective means to expand product lines, broaden manufacturing capacity and capabilities, and serve selected customers. Contract IVD companies will also derive significant demand from the production of private label and non-branded reagents, test kits, and instruments for medical supply wholesalers and retailers.

Kalorama’s new report, which analyzes the market opportunity and competitive situation for OEM IVD, Kalorama said these firms are among the top in vitro diagnostics contract manufacturers in each major category of testing:

Top Clinical Chemistry IVD Manufacturing Companies

Kalorama says that among the upwards of 300 global competitors in the contract clinical chemistry segment are Denka Seiken, Dutch Diagnostics, KMC Systems, Medicon and Wako Diagnostics. Denka Seiken produces a line of clinical chemistry reagents that are compatible with general-purpose analyzers and include substances for the direct measurement of HDL and LDL cholesterol. Dutch Diagnostics makes approximately 50 clinical chemistry reagents, calibrators, and controls as well a benchtop analyzer and fully automated, high-throughput floor model system.

EKF Diagnostics offers a broad line of clinical chemistry reagents, assays, calibrators, controls, and standards through fermentation. Specific substances include enzymes, proteins, and procalcitonin. KMC Systems produces automated clinical chemistry analyzers, nuclear magnetic resonance clinical chemistry systems, and high-performance liquid chromatography drug analyzers. Medicon makes clinical chemistry agents for about 40 analytes, including the measurement of cholesterol, glucose, and total protein.

For OEM markets, Sclavo Diagnostics International offers a variety of general purpose and specialty clinical chemistry reagents, specializing in proteins for urinary and serum/plasma testing. Contract clinical chemistry products available from Thermo Fisher Scientific include analyzers and reagents for the routine blood and urine testing of glucose, cholesterol and other common substances. The company also offers advanced testing systems for specific proteins, therapeutic drugs, and drugs-of-abuse. Wako Diagnostics produces clinical chemistry reagents, calibrators, and controls for measuring HDL and LDL cholesterol, microalbumin, and non-esterified fatty acids, and total complement activity.

Top Point of Care Diagnostics Manufacturing Companies

Because of the expertise involved with mini numerous companies that make near-patient systems. Contract manufacturers of POC IVD products for global markets include AgaMatrix, Auer Precision, Cone Bioproducts, EKF Diagnostics, Guilin Royalyze Medical, Innovize, Inteprod, KMC Systems, LRE Medical, Natech Plastics, Nova Biomedical, SAFC (MilliporeSigma), Sensirion, and Teco Diagnostics. Worldwide, this segment includes upwards of 300 competitors. AgaMatrix makes private label blood glucose monitors. Auer Precision and Guilin Royalyze Medical Instrument produce blood and urine test strips for POC devices. Cone Bioproducts, EKF Diagnostics, and SAFC manufacture clinical chemistry and immunoassay reagents for handheld and benchtop POC instruments.

Among other products, Innovize makes test strips and sensors for home pregnancy test kits. Inteprod and LRE Medical produce benchtop blood analyzers for POC and other applications. Inteprod also manufacturers handheld blood glucose and coagulation devices. KMC makes desktop immunoassay and hematology analyzers for POC markets. Natech Plastics produces test cassettes adaptable to POC analyzers and readers.

Nova Biomedical manufactures blood glucose and coagulation meters and test strips. Sensirion makes sensor components for POC devices. Teco Diagnostics products urine test strips, kits, and readers for pregnancy, ovulation, and fecal occult blood detection. The company also makes reagents, calibrators, and controls for POC clinical chemistry instruments.

Histology IVD Manufacturers

Histology is one of the fastest-growing areas of the in vitro diagnostics market. Agilent Technologies, BIT Group, MilliporeSigma, and TCS Biosciences are among the contract manufacturers of histology/cytology IVD products.

Coagulation IVD Manufacturers

Sclavo Diagnostics International and Sekisui Diagnostics are among the leading contract manufacturers of coagulation reagents and instruments. Sclavo Diagnostics International offers a handheld coagulation device and desktop coagulation system, liquid reagents and kits for measuring prothrombin time, a D-dimer kit, and chromogenic and clotting assays.

Blood Grouping Contract Manufacturing Companies

MilliporeSigma is the leading global contract producer of blood grouping products, offering a full line of reagents based on human or murine monoclonal antibodies. Other competitors active in this segment include Alpha Laboratories and TCS Biosciences.

Top Microbiology IVD Contract Manufacturing Companies

Essential for combating infectious disease, blood culture, resistance and pathogen ID tests have long been one of the top growth fields. Thermo Fisher Scientific is among the leading producers of microbiology IVD products for OEM markets, specializing in antibiotic susceptibility tests and blood culture systems. Other competitors in this segment include Affinity Life Sciences, Collagen Solutions, Hardy Diagnostics, Lampire Biological Laboratories, Meridian Life Science, and Tulip Diagnostics. All of these companies offer custom-formulated culture media.

Top Molecular Diagnostics Contract Manufacturing Companies

DiaCarta, LRE Medical, Maxim Biomedical, Promega, and SurModics IVD are among the contract producers of molecular diagnostic products, according to Kalorama’s report. Agilent also competes in this market. Offerings from Agilent Technologies include competent cells, PCR enzymes, QPCR and RT-QPCR Master Mixes, AffinityScript and AccuScript reverse transcriptases, reference RNAs, DNA labeling and hybridization kits, modifying enzymes, and GeneJammer transfection reagent. DiaCarta makes PCR reagents and test kits for the detection of colon cancer, fusion genes, and gene mutations for outside partners.

Eurogentec (Kaneka) manufactures GMP oligonucleotide-based components and GMP Taq DNA polymerases for molecular diagnostic kits and companion diagnostics. LRE Medical makes real-time PCR and microarray instruments. Maxim Biomedical produces real-time qPCR, isothermal amplification, and genetic detection systems. Promega offers contract molecular diagnostic products for DNA amplification, genetic identity testing, nucleic acid purification and detection, and protein analysis. SurModics IVD makes microarray slides and surfaces for IVD applications.

Kalorama Information’s The Market for In Vitro Diagnostic Test Contract Manufacturing (OEM) is available on its website:

About Kalorama Information

Kalorama Information, a division of, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama’s website and are also available on and

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