Description
What is The Market for Outsourced Manufacturing of IVD Products?
Valued at more than $12 billion in 2017, the global OEM 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.
IVD marketers rely on outsourcing to help create the products that fulfill the global demand for clinical tests. Kalorama’s Contract Manufacturing in IVD: Market Analysis looks at contract manufacturing in in vitro diagnostics, providing a market guide for the industry. IVD firms also earn additional revenues from servicing OEM tasks for other firms. Yet the market is not well-documented.
This is the most current and informative report on the IVD OEM industry.
For 2017-2022, the report examines the contracting market for IVD products, providing market sizing and regional trends for each major market segment (POC, Immunoassay, Clinical Chemistry, Microbiology, Molecular, Hematology, Histology/Cytology, Coagulation, Blood Grouping), including global contract IVD manufacturing demand by country/region, by product group, by technology, and by type.
Biokit, EKF Diagnostic Holdings, Meridian Life Science, MilliporeSigma, Polymed Therapeutics, and Sekisui Diagnostics are among the companies reviewed in Contract Manufacturing in IVD: Market Analysis , companies in this industry that builds IVD devices, reagents, antibodies, and other accessories for major IVD companies.
Reliable Market Data and Forecasts for the IVD OEM Market
For each major market segment, the report breaks out the contracting market for IVD products, including market sizing and regional trends for 2017 with forecasts to 2022 for the following:
- Global Contract IVD Manufacturing Demand by Technology, 2017-2022 (Global IVD Demand, % contract manufacturing, Global Contract IVD Mfg Demand, POC, Immunoassay, Clinical Chem, Microbiology, Molecular, Hematology, Histology/Cytology, Coagulation, Blood Grouping)
- Global Contract IVD Manufacturing Demand by Country/Region, 2017-2022 (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
- Global Contract IVD Manufacturing Demand by Product Group, 2017-2022 (Global Contract IVD Mfg Demand, Reagents & Consumables, Instruments & Systems, Supplies & Accessories)
- Global Contract Point of Care (POC) IVD Product Demand by Type, 2017-2022 (Total POC IVD Product Revenues; % contract; Contract POC IVD Product Revenues; Reagents & Consumables: Glucose, Antibodies, Other Reagents, Standards & Controls; Instruments & Systems: Full, Components; Accessories)
- Global Contract Immunoassay Product Demand by Type (Total Immunoassay Product Revenues; % contract; Contract Immunoassay Product Revenues; Reagents & Consumables: Antibodies, Enzymes, Other; Instruments & Systems: Full, Components; Accessories)
- Global Contract Clinical Chemistry Product Demand by Type (Total Clinical Chemistry Product Revenues; % contract; Contract Clinical Chemistry Product Revenues; Reagents & Consumables: Glucose, Lipids, Enzymes, Electrolytes, Proteins, Toxicology, Other Reagents, Standards & Controls; Instruments & Systems: Full, Components; Accessories)
- Global Contract Microbiology IVD Product Demand by Type (Total Microbiology IVD Product Revenues; % contract; Contract Microbiology IVD Product Revenues; Reagents & Consumables: ID/STAT, Media, Other; Instruments & Systems: Full, Components; Accessories)
- Global Contract Molecular Diagnostics Demand by Type (Total Molecular Diagnostic Product Revenues; % contract; Contract Molecular Diagnostic Product Revenues; Reagents & Consumables: Amplified Probes, Direct Probes, Other; Instruments & Systems: Full, Components, Accessories)
- Global Contract Hematology IVD Product Demand by Type, 2017-2022 (Total Hematology IVD Product Revenues; % contract; Contract Hematology IVD Product Revenues; Reagents & Consumables: Enzymes, Other; Instruments & Systems: Full, Components; Accessories)
- Global Histology/Cytology IVD Product Demand by Type (Total Histology/ Cytology IVD Product Revenues; % contract; Contract Histology/ Cytology IVD Product Revenues; Reagents & Consumables: DNA Probes, Antibodies, Other; Instruments & Systems: Full, Components; Accessories)
- Global Contract Coagulation IVD Product Demand by Type (Total Coagulation IVD Product Revenues; % contract; Contract Coagulation IVD Product Revenues; Reagents & Consumables; Instruments & Systems: Full, Components; Accessories)
- Global Contract Blood Grouping IVD Product Demand by Type (Total Blood Grouping IVD Product Revenues; % contract; Contract Blood Grouping IVD Product Revenues; Reagents & Consumables; Instruments & Systems: Full, Components; Accessories)
Top IVD Manufacturers in Each Category Listed
In its report, Kalormaa Information details the top manufacturers in each market:
Top Molecular Diagnostics Contract Manufacturing Companies
Agilent Technologies, DiaCarta, Eurogentec (Kaneka), LRE Medical, Maxim Biomedical, Promega, and SurModics IVD are among the contract producers of molecular diagnostic products. 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.
Top Clinical Chemistry IVD Manufacturing Companies
Among the upwards of 300 global competitors in the contract clinical chemistry segment are Denka Seiken, Dutch Diagnostics, EKF Diagnostics, KMC Systems, Medicon, Sclavo Diagnostics International, Thermo Fisher Scientific, 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
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
Agilent Technologies, BIT Group, MilliporeSigma, and TCS Biosciences are among the contract manufacturers of histology/cytology IVD products.
Coagulation 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.
Top 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
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.
Table of Contents
1: EXECUTIVE SUMMARY
GLOBAL MARKET OUTLOOK – CONTRACT IVD MANUFACTURING
Table 1-1: Summary Table – Global Contract IVD Manufacturing Market, 2017-2022 (million dollars)
SCOPE AND METHODOLOGY
2: MARKET ENVIRONMENT
GENERAL
ECONOMIC FACTORS
Table 2-1: Gross Domestic Product by Country/Region, 2017-2022 (billion dollars) (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
Table 2-2: Per Capita Gross Domestic Product by Country/Region, 2017-2022 (dollars) (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
DEMOGRAPHIC TRENDS
Total Population
Table 2-3: Population by Country/Region, 2017-2022 (million persons) (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
Age Distribution
Table 2-4: Population 50 Years & Older by Country/Region, 2017-2022 (million persons) (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
Table 2-5: Population 65 Years & Older by Country/Region, 2017-2022 (million persons) (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
Table 2-6: % of Population 65 Years & Older by Country/Region, 2017-2022 (million persons) (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
GLOBAL HEALTHCARE TRENDS
Medical Conditions
Health Expenditures
Table 2-7: Health Expenditures by Country/Region, 2017-2022 (billion dollars) (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
Table 2-8: Per Capita Health Expenditures by Country/Region, 2017-2022 (dollars) (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
Hospital Beds
Table 2-9: Number of Acute Care Hospital Beds by Country/Region, 2017-2022 (thousands) (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
Table 2-10: Number of Acute Care Hospital Beds per Thousand Capita by Country/Region, 2017-2022 (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
Physicians
Table 2-11: Number of Practicing Physicians by Country/Region, 2017-2022 (thousands) (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
Table 2-12: Number of Practicing Physicians per Thousand Capita by Country/Region, 2017-2022 (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
Patient Activity
Table 2-13: Number of Acute Care Hospital Admissions by Country/Region, 2017-2022 (thousands) (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
Table 2-14: Number of Acute Care Hospital Admissions per Thousand Capita by Country/Region, 2017-2022 (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
Table 2-15: Number of Surgical Procedures by Country/Region, 2017-2022 (thousands) (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
Table 2-16: Number of Physicians’ Consultations by Country/Region, 2017-2022 (million) (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
Table 2-17: Number of Physicians’ Consultations Per Capita by Country/Region, 2017-2022 (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
Table 2-18: Number of Professional IVD Tests by Country/Region, 2017-2022 (million) (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
Table 2-19: Number of Professional IVD Tests Per Capita by Country/Region, 2017-2022 (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
3: IVD PRODUCTS
INDUSTRY OVERVIEW
Table 3-1: Global IVD Product Demand by Technology & Product Segment, 2017-2022 (million dollars) (Global IVD Tests (mil), $ IVD/test, Global IVD Demand, POC, Immunoassay, Clinical Chem, Molecular, Microbiology, Hematology, Histology/Cytology, Coagulation, Blood Grouping; By Product Segment: Reagents & Consumables, Instruments & Systems)
PRODUCTION BY REGION
Table 3-2: Global IVD Production Value by Country/Region, 2017-2022 (million dollars) (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
PRODUCT GROUPS
Reagents & Consumables
Table 3-3: Global IVD Reagent & Consumable Demand by Product Group, 2017-2022 (million dollars) (Global IVD Demand, % reagents & consumables, Global IVD Reagents & Consumables, POC, Immunoassay, Clinical Chem, Molecular, Microbiology, Hematology, Histology/Cytology, Coagulation, Blood Grouping)
Instruments & Systems
Table 3-4: Global IVD Instrument & System Demand by Product Group, 2017-2022 (million dollars) (Global IVD Demand, % instruments & systems, Global IVD Instrument & Systems, POC, Immunoassay, Clinical Chem, Molecular, Microbiology, Hematology, Histology/Cytology, Coagulation, Blood Grouping)
4: CONTRACT IVD MANUFACTURING
MARKET OVERVIEW
Table 4-1: Global Contract IVD Manufacturing Demand by Technology, 2017-2022 (million dollars) (Global IVD Demand, % contract manufacturing, Global Contract IVD Mfg Demand, POC, Immunoassay, Clinical Chem, Microbiology, Molecular, Hematology, Histology/Cytology, Coagulation, Blood Grouping)
REGIONAL TRENDS
Table 4-2: Global Contract IVD Manufacturing Demand by Country/Region, 2017-2022 (million dollars) (World; N America: US, Canada, Mexico; W Europe: France, Germany, Italy, Spain, UK, Other; Asia/Pacific: Australia, China, India, Japan, S. Korea, Other; C & S America; E Europe; Afr/Mideast)
PRODUCT GROUPS
Table 4-3: Global Contract IVD Manufacturing Demand by Product Group, 2017-2022 (million dollars) (Global Contract IVD Mfg Demand, Reagents & Consumables, Instruments & Systems, Supplies & Accessories)
Contract POC IVD Products
Table 4-4: Global Contract Point of Care (POC) IVD Product Demand by Type, 2017-2022 (million dollars) (Total POC IVD Product Revenues; % contract; Contract POC IVD Product Revenues; Reagents & Consumables: Glucose, Antibodies, Other Reagents, Standards & Controls; Instruments & Systems: Full, Components; Accessories)
Contract Immunoassay Products
Contract Manufacturing in IVD
Table 4-5: Global Contract Immunoassay Product Demand by Type (million dollars) (Total Immunoassay Product Revenues; % contract; Contract Immunoassay Product Revenues; Reagents & Consumables: Antibodies, Enzymes, Other; Instruments & Systems: Full, Components; Accessories)
Contract Clinical Chemistry Products
Table 4-6: Global Contract Clinical Chemistry Product Demand by Type (million dollars) (Total Clinical Chemistry Product Revenues; % contract; Contract Clinical Chemistry Product Revenues; Reagents & Consumables: Glucose, Lipids, Enzymes, Electrolytes, Proteins, Toxicology, Other Reagents, Standards & Controls; Instruments & Systems: Full, Components; Accessories)
Contract Microbiology IVD Products
Table 4-7: Global Contract Microbiology IVD Product Demand by Type (million dollars) (Total Microbiology IVD Product Revenues; % contract; Contract Microbiology IVD Product Revenues; Reagents & Consumables: ID/STAT, Media, Other; Instruments & Systems: Full, Components; Accessories)
Contract Molecular Diagnostic Products
Table 4-8: Global Contract Molecular Diagnostics Demand by Type (million dollars) (Total Molecular Diagnostic Product Revenues; % contract; Contract Molecular Diagnostic Product Revenues; Reagents & Consumables: Amplified Probes, Direct Probes, Other; Instruments & Systems: Full, Components, Accessories)
Contract Hematology Products
Table 4-9: Global Contract Hematology IVD Product Demand by Type, 2017-2022 (million dollars) (Total Hematology IVD Product Revenues; % contract; Contract Hematology IVD Product Revenues; Reagents & Consumables: Enzymes, Other; Instruments & Systems: Full, Components; Accessories)
Contract Histology/Cytology Products
Table 4-10: Global Histology/Cytology IVD Product Demand by Type (million dollars) (Total Histology/ Cytology IVD Product Revenues; % contract; Contract Histology/ Cytology IVD Product Revenues; Reagents & Consumables: DNA Probes, Antibodies, Other; Instruments & Systems: Full, Components; Accessories)
Contract Coagulation IVD Products
Table 4-11: Global Contract Coagulation IVD Product Demand by Type (million dollars) (Total Coagulation IVD Product Revenues; % contract; Contract Coagulation IVD Product Revenues; Reagents & Consumables; Instruments & Systems: Full, Components; Accessories)
Contract Blood Grouping IVD Products
Table 4-12: Global Contract Blood Grouping IVD Product Demand by Type (million dollars) (Total Blood Grouping IVD Product Revenues; % contract; Contract Blood Grouping IVD Product Revenues; Reagents & Consumables; Instruments & Systems: Full, Components; Accessories)
5: INDUSTRY STRUCTURE
INDUSTRY CONCENTRATION
REGULATION
COMPETITIVE STRATEGIES
COMPANY BRIEFS
Affinity Biologicals, Inc.
Antibodies Incorporated
Biokit S.A.
BIT Group
Cenogenics Corporation
Collagen Solutions plc
Coris Bioconcept
Custom Diagnostics
DiaCarta Inc.
EKF Diagnostic Holdings plc
Guilin Royalyze Medical Co. Ltd.
IDxDI
KMC Systems Inc.
Maxim Biomedical Inc.
Meridian Life Science Inc.
MilliporeSigma
Polymed Therapeutics, Inc.
Promega Corporation
Savyon Diagnostics
Sekisui Diagnostics LLC
Other Contract Producers of IVD Reagents and Test Kits
Table 5-1: Other Producers of Contract IVD Reagents and Test Kits
