Description
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
Table of Contents
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)
