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

  • In Vitro Diagnostics - Market Insights - United States
    • Abstract
    • Executive Summary
      • COVID-19 Updates
        • Market Highlights
          • 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 Highlights
          • Competitive Factors and Strategies, by Product Type, US
          • IVD Test Revenue Market Share Rankings, by Application, US, 2018 (market share rankings displayed are from the previous iteration of the report)
          • Companies Mentioned
        • Market Developments
          • Recent Events in the IVD Market, US
        • Procedures Covered
          • IVD Procedures Covered, US
        • Products Covered
          • IVD Products Covered, US
      • Key Report Updates
        • COVID-19 Analysis
          • Market Impact
            • COVID-19 Impact Assessment Summary, IVD Market, US
          • Guidance and Recommendations
            • Guidance and Recommendations for IVD Procedures
          • Major Market Forecast Changes and Assumptions
            • IVD Market, by Application, US (USD), 2019–2029 (Excluding COVID-19 Impact)
            • IVD Market, by Application, US (USD), 2019–2029 (Including COVID-19 Impact)
          • Competitive Impact
            • COVID-19 Competitive Factors and Strategies, IVD Market, US
            • COVID-19 Impact by Competitor, IVD Market, US
        • In Vitro Diagnostics Market
          • Market Highlights
            • Factors Impacting the IVD Market, by Application, US
            • IVD Market, by Application, US (USD), 2019–2029
          • Market Definitions
            • Market Forecast Data
              • 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
            • Competitive Highlights
              • Market Shares
                • IVD Test Revenue Market Shares, US, 2018 (market share rankings displayed are from the previous iteration of the report)
                • IVD Test Revenue Market Shares, by Application, US, 2018 (market share rankings displayed are from the previous iteration of the report)
              • Competitive Factors and Strategies
                • Competitive Factors and Strategies, by Product Type, US
              • Market Developments
                • Recent Events in the IVD Market, US
            • Clinical Chemistry Test Market
              • Market Highlights
                • Clinical Chemistry Test Market, by Product Type, US (USD), 2019–2029
              • Market Definitions
                • Market Forecast Data
                  • 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
                • Competitive Highlights
                  • Market Shares
                    • Clinical Chemistry Test Revenue Market Shares, US, 2018 (market share rankings displayed are from the previous iteration of the report)
                    • Clinical Chemistry Test Revenue Market Shares, by Product Type, US, 2018 (market share rankings displayed are from the previous iteration of the report)
                  • Competitive Factors and Strategies
                    • Competitive Factors and Strategies, US
                • Immunoassay Test Market
                  • Market Highlights
                    • Immunoassay Test Market, by Product Type, US (USD), 2019–2029
                  • Market Definitions
                    • Market Forecast Data
                      • 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
                    • Competitive Highlights
                      • Market Shares
                        • Immunoassay Test Revenue Market Shares, US, 2018 (market share rankings displayed are from the previous iteration of the report)
                        • Immunoassay Test Revenue Market Shares, by Product Type, US, 2018 (market share rankings displayed are from the previous iteration of the report)
                      • Competitive Factors and Strategies
                        • Competitive Factors and Strategies, US
                    • Microbiology Test Market
                      • Market Highlights
                        • Microbiology Test Market, by Product Type, US (USD), 2019–2029
                      • Market Definitions
                        • Market Forecast Data
                          • 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
                        • Competitive Highlights
                          • Market Shares
                            • Microbiology Test Revenue Market Shares, US, 2018 (market share rankings displayed are from the previous iteration of the report)
                            • Microbiology Test Revenue Market Shares, US, 2018 (market share rankings displayed are from the previous iteration of the report)
                          • Competitive Factors and Strategies
                            • Competitive Factors and Strategies, US
                        • Hematology and Coagulation Test Market
                          • Market Highlights
                            • Hematology and Coagulation Test Market, by Product Type, US (USD), 2019–2029
                          • Market Definitions
                            • Market Forecast Data
                              • 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
                            • Competitive Highlights
                              • Market Shares
                                • Hematology and Coagulation Test Revenue Market Shares, US, 2018 (market share rankings displayed are from the previous iteration of the report)
                                • Hematology and Coagulation Test Revenue Market Shares, by Product Type, US, 2018 (market share rankings displayed are from the previous iteration of the report)
                              • Competitive Factors and Strategies
                                • Competitive Factors and Strategies, US
                            • Molecular Diagnostic Test Market
                              • Market Highlights
                                • MDx Test Market, by Product Type, US (USD), 2019–2029
                              • Market Definitions
                                • Market Forecast Data
                                  • 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 Highlights
                                  • Competitive Factors and Strategies
                                    • Competitive Factors and Strategies, US
                                  • Market Shares
                                    • MDx Test Revenue Market Shares, US, 2018 (market share rankings displayed are from the previous iteration of the report)
                                    • MDx Test Revenue Market Shares, by Product Type, US, 2018 (market share rankings displayed are from the previous iteration of the report)
                                • Appendix
                                  • Abbreviations
                                    • Bibliography

                                  Author(s): Sophia Quraishi, BA

                                  Sophia Quraishi is an analyst on the Medtech Insights team at Decision Resources Group and currently serves as the in-house expert in gastroenterology, open surgery, and liquid biopsy markets. Sophia has been instrumental in leveraging medical claims and hospital purchase order data for expanded new areas of investigation within her fields of expertise. Sophia holds a Bachelor's degree in Psychology with a specialization in Neuroscience from Columbia University in the City of New York.