While the COVID-19 pandemic will have a negative impact on the US IVD market in the near term, the market will nonetheless exhibit moderate growth over the forecast period, driven by the aging US population and the shift toward value-based health care, which will fuel uptake of newer tests with improved diagnostic accuracy and reduced turnaround time.
This Medtech 360 Report provides comprehensive data and analysis on the current state of the market for IVDs in the US across a 10-year period.
The COVID-19 pandemic will negatively impact the US IVD market to some extent.
- Which test types and segments will be most impacted?
- At what pace will the IVD market recover?
The use of MDx tests will expand rapidly over the forecast period.
- Which MDx tests will experience the highest growth throughout the forecast period?
- How will adoption of MDx tests affect the other test segments in the IVD market?
The PAMA reimbursement revision will promote widespread pricing pressures and increasing laboratory consolidation in the US.
- How must vendors adjust their strategies to adapt to this trend?
- How will the growth prospects of the market be affected?
- How will test volumes between the different facility types be affected?
The IVD competitive landscape consists of large MNCs as well as smaller niche competitors specializing in specific segments and diseases.
- How do strategies differ between MNCs and smaller companies in this space?
- What are the key purchasing criteria laboratories consider when selecting an IVD manufacturer?
Table of Contents
United States
Abstract
Executive Summary
- COVID-19 Updates
- Market Highlights
- Competitive Highlights
- Market Developments
- Procedures Covered
- Products Covered
Key Report Updates
COVID-19 Analysis
- Market Impact
- Guidance and Recommendations
- Major Market Forecast Changes and Assumptions
- Competitive Impact
In Vitro Diagnostics Market
- Market Highlights
- Market Definitions
- Market Forecast Data
- Competitive Highlights
- Market Shares
- Competitive Factors and Strategies
- Clinical Data
- Product Improvements and Innovations
- Mergers, Acquisitions, and Partnerships
- Product Portfolio Management
- Market Developments
Clinical Chemistry Test Market
- Market Highlights
- Market Definitions
- Market Forecast Data
- General Chemistry Tests
- Diabetes Tests
- Therapeutic Drug Monitoring Tests
- Drug of Abuse Testing
- Specific Protein Tests
- Cardiac Marker
- Blood Gas
- Competitive Highlights
- Market Shares
- Competitive Factors and Strategies
Immunoassay Test Market
- Market Highlights
- Market Definitions
- Market Forecast Data
- Allergy Tests
- Anemia Tests
- Bone Metabolism Tests
- Cardiac Marker Tests
- Fertility/Hormone Tests
- Infectious Disease Tests
- Specific Protein
- Thyroid Tests
- Tumor Marker Tests
- Competitive Highlights
- Market Shares
- Competitive Factors and Strategies
Microbiology Test Market
- Market Highlights
- Market Definitions
- Market Forecast Data
- Pathological Culture Tests
- Blood Culture Tests
- Identification/Antibiotic Susceptibility Testing
- Competitive Highlights
- Market Shares
- Competitive Factors and Strategies
Hematology and Coagulation Test Market
- Market Highlights
- Market Definitions
- Market Forecast Data
- General Screening and Anticoagulation Monitoring Tests
- Prothrombin Time Tests
- D-Dimer Tests
- Fibrin Formation and Degradation Tests
- Competitive Highlights
- Market Shares
- Competitive Factors and Strategies
Molecular Diagnostic Test Market
- Market Highlights
- Market Definitions
- Market Forecast Data
- Infectious Disease Tests
- Competitive Highlights
- Competitive Factors and Strategies
- Market Shares
Appendix
- Abbreviations
- Bibliography
Methodology
- Core Country Coverage Methodology
- Research Methodology
- Marketrack Methodology
- PriceTrack Methodology
- Forecast Methodology
- Supplemental Country Coverage Methodology
- Base-Year Ratio Analysis
- Market Forecasting
Tables and Figures
- Factors Impacting the IVD Market, by Application, US
- IVD Market, by Application, US (USD), 2019-2029
- IVD Market Landscape, US (USD), 2019 and 2029
- Competitive Factors and Strategies, by Product Type, US
- IVD Test Revenue Market Share Rankings, by Application, US, 2018 (market share rankings di...
- Companies Mentioned
- Recent Events in the IVD Market, US
- IVD Procedures Covered, US
- IVD Products Covered, US
- COVID-19 Impact Assessment Summary, IVD Market, US
- Guidance and Recommendations for IVD Procedures
- IVD Market, by Application, US (USD), 2019-2029 (Excluding COVID-19 Impact)
- IVD Market, by Application, US (USD), 2019-2029 (Including COVID-19 Impact)
- COVID-19 Competitive Factors and Strategies, IVD Market, US
- COVID-19 Impact by Competitor, IVD Market, US
- Factors Impacting the IVD Market, by Application, US
- IVD Market, by Application, US (USD), 2019-2029
- IVD Market, by Product Type, US (USD), 2019-2029
- IVD Market, by Setting, US (USD), 2019-2029
- IVD Market, by Application, US (USD), 2019-2029
- IVD Test Market, by Application, US (USD), 2019-2029
- IVD Instrumentation Market, by Application, US (USD), 2019-2029
- IVD Test Revenue Market Shares, US, 2018 (market share rankings displayed are from the pre...
- IVD Test Revenue Market Shares, by Application, US, 2018 (market share rankings displayed ...
- Competitive Factors and Strategies, by Product Type, US
- Recent Events in the IVD Market, US
- Clinical Chemistry Test Market, by Product Type, US (USD), 2019-2029
- Clinical Chemistry Test Market, by Product Type, US (USD), 2019-2029
- Clinical Chemistry Test Market, by Setting, US (USD), 2019-2029
- Clinical Chemistry Test Market, by Test Type, US (USD), 2019-2029
- Alanine Aminotransferase Tests, by Setting, US, 2019-2029
- Alkaline Phosphatase Tests, by Setting, US, 2019-2029
- Aspartate Aminotransferase Tests, by Setting, US, 2019-2029
- Bilirubin Tests, by Setting, US, 2019-2029
- Calcium Tests, by Setting, US, 2019-2029
- Comprehensive Metabolic Panel Tests, by Setting, US, 2019-2029
- Creatinine Tests, by Setting, US, 2019-2029
- Electrolyte Panel Tests, by Setting, US, 2019-2029
- Hepatic Panel Tests, by Setting, US, 2019-2029
- Human Chorionic Gonadotropin Tests, by Setting, US, 2019-2029
- Lactate Tests, by Setting, US, 2019-2029
- Lactate Dehydrogenase Tests, by Setting, US, 2019-2029
- Lipase Tests, by Setting, US, 2019-2029
- Lipid Panel Tests, by Setting, US, 2019-2029
- Magnesium Tests, by Setting, US, 2019-2029
- Metabolic Panel including Total Calcium Tests, by Setting, US, 2019-2029
- Phosphorus Tests, by Setting, US, 2019-2029
- Potassium Tests, by Setting, US, 2019-2029
- Total Protein Tests, by Setting, US, 2019-2029
- Uric Acid Tests, by Setting, US, 2019-2029
- Other General Chemistry Tests, by Setting, US, 2019-2029
- Blood Glucose (Non-Reagent-Strip) Tests, by Setting, US, 2019-2029
- Blood Glucose Reagent Strip Tests, by Setting, US, 2019-2029
- Glucose Tolerance Tests, by Setting, US, 2019-2029
- HbA1c Tests, by Setting, US, 2019-2029
- Insulin Tests, by Setting, US, 2019-2029
- Microalbumin Quantitative Tests, by Setting, US, 2019-2029
- Urine Glucose Tests, by Setting, US, 2019-2029
- Other Diabetes Tests, by Setting, US, 2019-2029
- Carbamazepine Tests, by Setting, US, 2019-2029
- Cyclosporine Tests, by Setting, US, 2019-2029
- Digoxin Tests, by Setting, US, 2019-2029
- Phenobarbital Tests, by Setting, US, 2019-2029
- Phenytoin (Total) Tests, by Setting, US, 2019-2029
- Tacrolimusl Tests, by Setting, US, 2019-2029
- Theophylline Tests, by Setting, US, 2019-2029
- Valproic Acid (Total) Tests, by Setting, US, 2019-2029
- Vancomycin Tests, by Setting, US, 2019-2029
- Other TDM Tests, by Setting, US, 2019-2029
- Ethanol Tests, by Setting, US, 2019-2029
- Acetaminophen Tests, by Setting, US, 2019-2029
- Salicylate Tests, by Setting, US, 2019-2029
- Antinuclear Antibody Tests, by Setting, US, 2019-2029
- Haptoglobin Tests, by Setting, US, 2019-2029
- Homocysteine Tests, by Setting, US, 2019-2029
- Prealbumin Tests, by Setting, US, 2019-2029
- Rheumatoid Factor Tests, by Setting, US, 2019-2029
- Somatomedin Tests, by Setting, US, 2019-2029
- Other Specific Protein Tests, by Setting, US, 2019-2029
- Apolipoprotein Tests, by Setting, US, 2019-2029
- Cholesterol Tests, by Setting, US, 2019-2029
- C-Reactive Protein Tests, by Setting, US, 2019-2029
- High Sensitivity C-Reactive Protein Tests, by Setting, US, 2019-2029
- Low Density Lipoprotein Tests, by Setting, US, 2019-2029
- Triglyceride Tests, by Setting, US, 2019-2029
- Other Cardiac Marker Tests, by Setting, US, 2019-2029
- Arterial Blood Gas Tests, by Setting, US, 2019-2029
- Chloride Tests, by Setting, US, 2019-2029
- Urea Nitrogen Tests, by Setting, US, 2019-2029
- Other Blood Gas Tests, by Setting, US, 2019-2029
- Clinical Chemistry Test Revenue Market Shares, US, 2018 (market share rankings displayed a...
- Clinical Chemistry Test Revenue Market Shares, by Product Type, US, 2018 (market share ran...
- Competitive Factors and Strategies, US
- Immunoassay Test Market, by Product Type, US (USD), 2019-2029
- Immunoassay Test Market, by Product Type, US (USD), 2019-2029
- Immunoassay Test Market, by Setting, US (USD), 2019-2029
- Immunoassay Test Market, by Test Type, US (USD), 2019-2029
- Allergy IgA, IgD, IgG, IgM Tests, by Setting, US, 2019-2029
- Allergy IgE Tests, by Setting, US, 2019-2029
- Immunoglobulin Subclasses Tests, by Setting, US, 2019-2029
- Erythropoietin Tests, by Setting, US, 2019-2029
- Ferritin Tests, by Setting, US, 2019-2029
- Intrinsic Factor Antibody Tests, by Setting, US, 2019-2029
- Iron Tests, by Setting, US, 2019-2029
- Iron Binding Capacity Tests, by Setting, US, 2019-2029
- Vitamin B-12 Tests, by Setting, US, 2019-2029
- HGH Tests, by Setting, US, 2019-2029
- Parathormone Tests, by Setting, US, 2019-2029
- Vitamin D 25 Hydroxy Tests, by Setting, US, 2019-2029
- Creatine Kinase Tests, by Setting, US, 2019-2029
- CK-MB Tests, by Setting, US, 2019-2029
- BNP Tests, by Setting, US, 2019-2029
- Troponin Tests, by Setting, US, 2019-2029
- ACTH Tests, by Setting, US, 2019-2029
- Estradiol Tests, by Setting, US, 2019-2029
- FSH Tests, by Setting, US, 2019-2029
- LH Tests, by Setting, US, 2019-2029
- Progesterone Tests, by Setting, US, 2019-2029
- Prolactin Tests, by Setting, US, 2019-2029
- Testosterone Tests, by Setting, US, 2019-2029
- Other Fertility/Hormone Tests, by Setting, US, 2019-2029
- Acute Hepatitis Tests, by Setting, US, 2019-2029
- CMV Tests, by Setting, US, 2019-2029
- Epstein-Barr Virus Tests, by Setting, US, 2019-2029
- Hepatitis A Tests, by Setting, US, 2019-2029
- Hepatitis B Tests, by Setting, US, 2019-2029
- Hepatitis C Tests, by Setting, US, 2019-2029
- HIV-1/HIV-2 Tests, by Setting, US, 2019-2029
- HSV Tests, by Setting, US, 2019-2029
- HSV Type 2 Tests, by Setting, US, 2019-2029
- HTLV or HIV Tests, by Setting, US, 2019-2029
- Influenza A/B Tests, by Setting, US, 2019-2029
- Lyme Disease Tests, by Setting, US, 2019-2029
- Microsomal Antibodies Tests, by Setting, US, 2019-2029
- Nephelometry Tests, by Setting, US, 2019-2029
- Parvovirus Tests, by Setting, US, 2019-2029
- Respiratory Syncytial Virus Tests, by Setting, US, 2019-2029
- Rotavirus Tests, by Setting, US, 2019-2029
- Rubella Tests, by Setting, US, 2019-2029
- Treponema Pallidum Tests, by Setting, US, 2019-2029
- Varicella-Zoster Virus Tests, by Setting, US, 2019-2029
- Other Infectious Disease Tests, by Setting, US, 2019-2029
- Albumin Tests, by Setting, US, 2019-2029
- Alpha-1 Antitrypsin Tests, by Setting, US, 2019-2029
- Gamma-Glutamyl Transferase Tests, by Setting, US, 2019-2029
- Thyroxine (Free) Tests, by Setting, US, 2019-2029
- Thyroglobulin Tests, by Setting, US, 2019-2029
- Thyroid (T3) Tests, by Setting, US, 2019-2029
- Thyroid (T3 or T4) Tests, by Setting, US, 2019-2029
- Thyroxine (Total) Tests, by Setting, US, 2019-2029
- TSH Tests, by Setting, US, 2019-2029
- Alpha-Fetoprotein Serum Tests, by Setting, US, 2019-2029
- Beta-2 Microglobulin Tests, by Setting, US, 2019-2029
- CA 125 Tests, by Setting, US, 2019-2029
- CA 15-3 Tests, by Setting, US, 2019-2029
- CA 19-9 Tests, by Setting, US, 2019-2029
- Carcinoembryonic Antigen Tests, by Setting, US, 2019-2029
- PSA (Free) Tests, by Setting, US, 2019-2029
- PSA (Total) Tests, by Setting, US, 2019-2029
- Other Tumor Marker Tests, by Setting, US, 2019-2029
- Immunoassay Test Revenue Market Shares, US, 2018 (market share rankings displayed are from...
- Immunoassay Test Revenue Market Shares, by Product Type, US, 2018 (market share rankings d...
- Competitive Factors and Strategies, US
- Microbiology Test Market, by Product Type, US (USD), 2019-2029
- Microbiology Test Market, by Product Type, US (USD), 2019-2029
- Microbiology Test Market, by Setting, US (USD), 2019-2029
- Microbiology Test Market, by Test Type, US (USD), 2019-2029
- Salmonella and Shigella (Stool Culture) Tests, by Setting, US, 2019-2029
- Other Pathogen (Stool Culture) Tests, by Setting, US, 2019-2029
- Mycobacteria Culture Tests, by Setting, US, 2019-2029
- Aerobic Bacterial Culture (Non-Urine, -Blood, -Stool) Tests, by Setting, US, 2019-2029
- Anaerobic Bacterial Culture (Non-Urine, -Blood, -Stool) Tests, by Setting, US, 2019-2029
- Urine Bacteria Culture Tests, by Setting, US, 2019-2029
- Blood Culture Tests, by Setting, US, 2019-2029
- Aerobic Culture Identification Tests, by Setting, US, 2019-2029
- Anaerobic Culture Identification Tests, by Setting, US, 2019-2029
- Immunologic Culture Identification Tests, by Setting, US, 2019-2029
- MIC Tests, by Setting, US, 2019-2029
- Microbe Susceptible Disk Tests, by Setting, US, 2019-2029
- Presumptive Pathogenic Organisms Culture Tests, by Setting, US, 2019-2029
- Yeast Identification Tests, by Setting, US, 2019-2029
- Other ID/AST Tests, by Setting, US, 2019-2029
- Microbiology Test Revenue Market Shares, US, 2018 (market share rankings displayed are fro...
- Microbiology Test Revenue Market Shares, US, 2018 (market share rankings displayed are fro...
- Competitive Factors and Strategies, US
- Hematology and Coagulation Test Market, by Product Type, US (USD), 2019-2029
- Hematology and Coagulation Test Market, by Product Type, US (USD), 2019-2029
- Hematology and Coagulation Test Market, by Setting, US (USD), 2019-2029
- Hematology and Coagulation Test Market, by Test Type, US (USD), 2019-2029
- Automated Platelet Count Tests, by Setting, US, 2019-2029
- Blood Smear with Differential White Blood Cell Count Tests, by Setting, US, 2019-2029
- Complete CBC Automated Tests, by Setting, US, 2019-2029
- Complete CBC with Automated White Blood Cell Count Tests, by Setting, US, 2019-2029
- Erythrocyte Sedimentation Rate Tests, by Setting, US, 2019-2029
- Hematocrit Tests, by Setting, US, 2019-2029
- Hemoglobin Tests, by Setting, US, 2019-2029
- Leukocyte Tests, by Setting, US, 2019-2029
- Red Blood Cell Count Tests, by Setting, US, 2019-2029
- Reticulocyte Tests, by Setting, US, 2019-2029
- Sickle Cell Screen Tests, by Setting, US, 2019-2029
- Transferrin Tests, by Setting, US, 2019-2029
- Other General Screening and Anticoagulation Monitoring Tests, by Setting, US, 2019-2029
- Prothrombin Time Tests, by Setting, US, 2019-2029
- D-Dimer Tests, by Setting, US, 2019-2029
- aPTT Tests, by Setting, US, 2019-2029
- Fibrinogen Tests, by Setting, US, 2019-2029
- Hematology and Coagulation Test Revenue Market Shares, US, 2018 (market share rankings dis...
- Hematology and Coagulation Test Revenue Market Shares, by Product Type, US, 2018 (market s...
- Competitive Factors and Strategies, US
- MDx Test Market, by Product Type, US (USD), 2019-2029
- MDx Test Market, by Product Type, US (USD), 2019-2029
- MDx Test Market, by Setting, US (USD), 2019-2029
- Chlamydia Tests, by Setting, US, 2019-2029
- Clostridium Difficile Tests, by Setting, US, 2019-2029
- Gonorrhea Tests, by Setting, US, 2019-2029
- Hepatitis C Tests, by Setting, US, 2019-2029
- HIV-1 Tests, by Setting, US, 2019-2029
- HPV Tests, by Setting, US, 2019-2029
- HSV Tests, by Setting, US, 2019-2029
- Staphylococcus Aureus Tests, by Setting, US, 2019-2029
- Streptococcus Group A Tests, by Setting, US, 2019-2029
- Unspecified Infectious Agent Tests, by Setting, US, 2019-2029
- Other Infectious Disease Tests, by Setting, US, 2019-2029
- Competitive Factors and Strategies, US
- MDx Test Revenue Market Shares, US, 2018 (market share rankings displayed are from the pre...
- MDx Test Revenue Market Shares, by Product Type, US, 2018 (market share rankings displayed...
- Abbreviations