United States Market for In Vitro Diagnostic Tests (Molecular Assays, Microbiology, Histology, Chemistry, Hematology, Blood Banking, POC and Other Tests)

  • ID: 3816871
  • Report
  • Region: United States
  • 210 Pages
  • Kalorama Information
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United States Market for In Vitro Diagnostic Tests

United States Market for In Vitro Diagnostic Tests takes a considered look at the U.S. in vitro diagnostics (IVD) market and examines what current market trends mean for diagnostic manufacturers and investors. This report includes important tools for business planners. Included are market size estimates and forecasts for the following U.S. IVD segments:
  • Clinical Chemistry Market (2015/2020)
  • Identification and Antibiotic Susceptibility Testing (ID/AST) Microbiology (Traditional) Market – Automated ID/AST, Manual/Semi‐Auto ID/AST, Blood Culture, Chromogenic Media, Rapid Micro (2015/2020)
  • Molecular Microbiology / Virology Market – HAIs/BSIs, HIV, Hepatitis, CT/NG, HPV, Respiratory, Mycobacteria/TB, Other (2015/2020)
  • Point-of-Care (POC) Diagnostics Markets – Professional (Drugs of Abuse, Infectious Disease, Pregnancy, Glucose, HbA1c, Lipids, Cardiac Markers, FOB, Critical Care, Coagulation, Hematology, Other), OTC Diabetes, OTC Other (2015/2020)
  • Immunoassays Market – Non Infectious (Cardiac Markers, Tumor Markers, HbA1c, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D) (2015/2020)
  • Immunoassays Market – Infectious (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis, Parasitology, Mycology, Others) (2015/2020)
  • Urinalysis Lab Diagnostics Market (2015/2020)
  • Molecular Diagnostics Market (2015/2020)
  • Coagulation Diagnostics Market (2015/2020)
  • Histology and Cytology Diagnostics Market (2015/2020)
  • Hematology Diagnostics Market (2015/2020)
  • Blood Testing and Typing Diagnostics Market (2015/2020)
  • Clinical Flow Cytometry Market (2015/2020)
The United States represents the world’s largest in vitro diagnostics (IVD) market, projected to outpace other IVD markets in the developed world such as Western Europe and Japan. The report discusses market factors and trends, including:
  • continued expansion of the insured population under the ACA and increased healthcare utilization baselines;
  • demographic aging that increases demand for clinical testing paid for through the country’s leading vehicle for lab payments (Medicare);
  • relatively optimistic macroeconomic indicators vis-à-vis the domestic outlook five years ago or other developed markets in the world;
  • continued product innovation and industry responsiveness to clients’ needs in the world’s largest IVD market.
The report tracks developments, both challenging and positive, in the United States IVD market. Conclusions about the market are made concerning issues such as distribution of market share in IVD market segments, future U.S. IVD market growth, anticipated market obstacles, the growth of the molecular diagnostics market, and core lab IVD market growth.

United States Market for In Vitro Diagnostic Tests profiles in-depth the top tier U.S. IVD market participants. The total combined IVD sales of these top tier companies are estimated by Kalorama to represent nearly 70% of the total U.S. IVD market. The report ranks these firms and notes the IVD strengths of each. Companies discussed include:
  • Danaher Corporation
  • Roche Diagnostics
  • Siemens Healthcare Diagnostics
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1: Executive Summary Introduction Market Metrics – Utilization Market Metrics – Aging Market Metrics – Disease Market Metrics – U.S. Total Health and Clinical Lab Expenditures and Payers Market Metrics – U.S. Clinical Testing by Channel Impacts of the Affordable Care Act Impacts of PAMA and LDT Reform U.S. IVD Market Top Tier U.S. IVD Market Participants and Rankings Conclusions 2: Introduction to U.S. Health Care The United States and In Vitro Diagnostics U.S. Patient Population Healthcare System Utilization Aging Disease Prevalence and Incidence Health Insurance in the United States and the Affordable Care Act U.S. Health Expenditure U.S. Clinical Lab Expenditure Affordable Care Act (ACA) Clinical Testing under Medicare – Reimbursement Cuts and Market-Based Pricing 55 Protecting Access to Medicare Act of 2014 (PAMA) Molecular Diagnostics and Medicare Policy Laboratory-Developed Tests (LDTs) Invigorate Market, Challenge Regulators U.S. Healthcare Infrastructure and Testing Channels Hospitals Independent Labs Physician Office Laboratories Self-Testing Retail Clinics Conclusions 3: U.S. IVD Market Analysis Clinical Chemistry Microbiology and Virology – ID/AST and Molecular Point-of-Care Testing Immunoassays Urinalysis Molecular Diagnostics Coagulation Histology Hematology Blood Testing and Typing Flow Cytometry Total U.S. IVD Market 4: Top Tier U.S. IVD Market Players Abbott Diagnostics Core Lab Hematology Molecular Blood Testing Mass Spectrometry ID/AST Diabetes Testing Point-of-Care (POC) Diagnostics Alere Critical Care Lipids and Cardiac Markers Diabetes Testing Coagulation Toxicology / Drugs of Abuse Infectious Diseases Beckman Coulter (Danaher) Immunoassays Clinical Chemistry Hematology Microbiology Urinalysis Flow Cytometry Molecular Becton, Dickinson and Company (BD) Microbiology Mass Spectrometry Immunoassays Molecular Histology/Cytology Flow Cytometry bioMérieux Microbiology Mass Spectrometry Immunoassays Molecular Sequencing Bio-Rad Laboratories Microbiology Hemoglobinopathy and Diabetes Testing Immunoassays Blood Typing and Testing Tissue Typing Sequencing Cepheid Molecular Hospital-Acquired Infection (HAI) Testing Molecular Sexual Health and Women’s Health Testing Molecular Critical Infectious Disease Testing Molecular Oncology Testing Danaher Corporation Histology Point-of-Care Testing Hologic Molecular Cytology / Histology (HPV) Other Molecular (STIs, HIV, HCV, TB, Respiratory) Microbiology (AccuProbe Molecular Culture ID Tests) Blood Testing (Molecular PROCLEIX Tests) Johnson & Johnson (Incl. Janssen Diagnostics) Ortho-Clinical Diagnostics Core Lab Blood Testing and Typing QIAGEN Molecular Infectious Disease Companion Diagnostics Immunoassays Next-Generation Sequencing Roche Diagnostics Professional Diagnostics Immunoassays Point-of-Care Diagnostics Diabetes Care Tissue Diagnostics Molecular Diagnostics Blood Testing Sequencing Microbiology (GeneWeave) Siemens Healthcare Diagnostics Clinical Chemistry Immunoassays Hematology Molecular Diagnostics and Histology Urinalysis Coagulation Point-of-Care Diagnostics Sysmex Corporation Hematology Coagulation Urinalysis Thermo Fisher Scientific Immunoassays Drug Testing Histology Mass Spectrometry Microbiology Molecular Sequencing

L I S T   O F   E X H I B I T S

CHAPTER ONE: EXECUTIVE SUMMARY

- Table 1-1: U.S. Commercially Insured Members’ Encounters with Ambulatory Physicians (per 1,000 Members) (2005-2014)
- Table 1-2: Historical and Projected U.S. Aged Populations (60+) (% Share of Total Population, Population in Millions) (1950-2050)

- Table 1-3: U.S. IVD Market by Segment (2015/2020)
- Table 1-4: U.S. IVD Market Rankings by Estimated 2015 Revenue – Top 15 Companies

CHAPTER TWO: INTRODUCTION

- Figure 2-1: U.S. IVD Market (2015/2020)
- Table 2-1: U.S. Hospital Inpatient Admissions and Outpatient Visits Per 1,000 Persons (1994-2013)

- Table 2-2: U.S. Commercially Insured Members’ Encounters with Ambulatory Physicians (per 1,000 Members) (2005-2014)
- Table 2-3: Historical and Projected U.S. Aged Populations (60+) (% Share of Total Population, Population in Millions) (1950-2050)
- Table 2-4: U.S. Cancer Incidence – Aggregate, Lung, Colon, Prostate, Breast (per 100,000 persons) (2002-2012)
- Table 2-5: Selected Notifiable Infectious Disease Incidences in the United States (per 100,000 persons) (2003-2013)
- Table 2-6: U.S. National Health Expenditure by Payer (Out-of-Pocket, Private Health Insurance, Medicare, Medicaid) (2013-2020)
- Table 2-7: U.S. Clinical Laboratory Market by Segment - Hospital, Independent, Physician Office (2013-2020)
- Figure 3-1: U.S. Clinical Chemistry Market (2015/2020)
- Figure 3-2: U.S. ID/AST Microbiology Market (2015/2020)
- Figure 3-3: U.S. Molecular Microbiology / Virology Market (2015/2020)

CHAPTER THREE: MARKET ANALYSIS

- Table 3-1: U.S. ID/AST Microbiology Market – Automated ID/AST, Manual/Semi-Auto ID/AST, Blood Culture, Chromogenic Media, Rapid Micro (2015/2020)
- Table 3-2: U.S. Molecular Microbiology / Virology Market – HAIs/BSIs, HIV, Hepatitis, CT/NG, HPV, Respiratory, Mycobacteria/TB, Other (2015/2020)
- Figure 3-4: U.S. Point-of-Care (POC) Diagnostics Markets – Professional, OTC Diabetes, OTC Other (2015/2020)

- Table 3-3: U.S. Point-of-Care (POC) Diagnostics Markets – Professional (Drugs of Abuse, Infectious Disease, Pregnancy, Glucose, HbA1c, Lipids, Cardiac Markers, FOB, Critical Care, Coagulation, Hematology, Other), OTC Diabetes, OTC Other (2015/2020)
- Figure 3-5: U.S. Immunoassays Markets – Infectious and Non-Infectious (2015/2020)
- Table 3-4a: U.S. Immunoassays Market – Non Infectious (Cardiac Markers, Tumor Markers, HbA1c, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D) (2015/2020)
- Table 3-4b: U.S. Immunoassays Market – Infectious (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis, Parasitology, Mycology, Others)
- Figure 3-6: U.S. Urinalysis Lab Diagnostics Market (2015/2020)
- Figure 3-7: U.S. Molecular Diagnostics Market (2015/2020)
- Figure 3-8: U.S. Coagulation Diagnostics Market (2015/2020)
- Figure 3-9: U.S. Histology and Cytology Diagnostics Market (2015/2020)
- Figure 3-10: U.S. Hematology Diagnostics Market (2015/2020)
- Figure 3-11: U.S. Blood Testing and Typing Diagnostics Market (2015/2020)
- Figure 3-12: U.S. Clinical Flow Cytometry Market (2015/2020)
- Table 3-5: U.S. IVD Market by Segment (2015/2020)

CHAPTER FOUR: COMPANY PROFILES

- Table 4-1: Abbott Diagnostics Revenue (2012-2015)
- Table 4-2: Alere Revenue (2012-2015)
- Table 4-3: Beckman Coulter Revenue (2012-2015)
- Table 4-4: BD Revenue (FY 2012-FY 2015)
- Table 4-5: bioMérieux Revenue (2012-2015)
- Table 4-6: Bio-Rad Laboratories Revenue (2012-2015)
- Table 4-7: Cepheid Revenue (2012-2015)
- Table 4-8: Danaher Diagnostics Group Subsidiary Revenue (Beckman Coulter, Radiometer, Leica Biosystems) (2012-2015)
- Table 4-9: Hologic Revenue (FY 2012-FY 2015)
- Table 4-10: Johnson & Johnson Diagnostics Revenue (2012-2015)
- Table 4-11: QIAGEN Revenue (2012-2015)
- Table 4-12: Roche Diagnostics Revenue (2012-2015)
- Table 4-13: Siemens Healthcare Diagnostics Revenue (FY 2012-FY 2015)
- Table 4-14: Sysmex Corporation Revenue (FY 2012-FY 2015)
- Table 4-15: Thermo Fisher Scientific Revenue (2012-2015)
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