The United States Market for In Vitro Diagnostic Tests

Mar 18, 2014
130 Pages - Pub ID: KLI5217921
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The United States is the world’s largest in vitro diagnostics and nearly half of the global IVD market. While companies seek emerging markets for growth, most healthcare business is generated in the United States and its volume is still a strong advantage of this market.  Most recently the U.S. IVD market weathered interrupted lab and healthcare sector investment in anticipation of the Affordable Care Act and several regulatory and austerity measures on the part of government payers that constricted payments for clinical testing. 

In this report, The United States Market for In Vitro Diagnostic Tests, Kalorama Information analyst Emil Salazar takes a considered look into these trends and what they mean for diagnostic manufacturers and investors. 

As the report notes, there are both challenging developments and postiive trends which make the United States a stable IVD market: The expansion of the insured population under the ACA; demographic aging that increases demand for clinical testing and a medical program that serves as a leading, stable vehicle for payment (Medicare); relatively optimistic macroeconomic indicators vis-à-vis the domestic outlook five years ago or other developed markets in the world; and continued product innovation and industry responsiveness to clients’ needs in the world’s largest IVD market. 

This report includes important tools for business planners, including market size estimates and forecasts for the following IVD segments:
  • Point of Care  (Glucose, Professional, OTC)
  • Histology and Cytology 
  • Clinical Chemistry 
  • Immunoassays (Infectious Disease, Non-Infectious Disease)
  • Molecular Assays (Non-Infectious Disease)
  • Hematology
  • Urinalysis
  • Flow Cytometry
  • Coagulation 
  • Microbiology and Virology (ID/AST, Molecular)
  • Blood Testing
Market sizes, forecasts and shares are provided, as well as a geographic breakdown of the segments, where possible. Changes in technology development, regulatory and reimbursement issues, clinical care, and business environments are discussed. Current market numbers are presented for 2011, with projections given through 2016. The following data points are included in this report:

  • U.S. Health Expenditure
  • U.S. Clinical Lab Expenditure
  • U.S. Infectious Disease Market Opportunities
  • Affordable Care Act (ACA)
  • Clinical Testing under Medicare – Reimbursement Cuts and “Revaluation”
  • Molecular Diagnostics and Medicare Policy
  • Patient Population
  • Healthcare System Utilization
  • Aging
  • Disease Prevalence and Incidence
  • Analyst Conclusions About the Market
Many of the top IVD companies use Kalorama Information products for business planning, which means that this volume can provide a uniform standard for in vitro diagnostic market numbers. This edition greatly expands coverage of the field and tracks the most important developments. See aspects of the industry that might not be available in your company's internal resources. View the market from an independent point of view. Learn about competitors in away that may be invisible to internal personnel. Know the market players - your competitors and potential partners, in proper context and classification. Save countless hours of staff time and other research expenses with the authoritative guide for IVD market estimates and forecasts.

As part of the reports, the following companies are covered:

  • Abbott Diagnostics
  • Alere
  • Beckman Coulter
  • Becton Dickinson
  • Danaher Corporation
  • Hologic
  • Ortho-Clinical Diagnostics / J&J Diabetes Care
  • QIAGEN
  • Roche Diagnostics
  • Siemens Healthcare Diagnostics
  • Sysmex Corporation
  • Thermo Fisher Scientific
CHAPTER ONE: EXECUTIVE SUMMARY
Introduction
Market Metrics – System Utilization
U.S. Hospital Inpatient Admissions and Outpatient Visits Per 1,000 Persons (1991-2011)
Market Metrics – Aging
Historical and Projected U.S. Aged Populations (% Share of Total Population, Population in Millions) (1950-2050)
Market Metrics – Disease
U.S. Infectious Disease Market Opportunities Ranked
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 CLFS Cuts and Molecular Reimbursement Reform
U.S. IVD Market
U.S. IVD Market by Segment
Top Tier U.S. IVD Market Participants and Rankings
U.S. IVD Market Rankings by Estimated 2013 Revenue – Top 12 Companies
Conclusions
CHAPTER TWO: 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 (ACA)
U.S. Health Expenditure
U.S. Clinical Lab Expenditure
Affordable Care Act (ACA)
Clinical Testing under Medicare – Reimbursement Cuts and “Revaluation”
Molecular Diagnostics and Medicare Policy
U.S. Healthcare Infrastructure and Testing Channels
Hospitals
Independent Labs
Physician Office Laboratories (POLs)
Self-Testing
Retail Clinics
Other Labs
Conclusions
CHAPTER THREE: 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
CHAPTER FOUR: TOP TIER U.S. IVD MARKET PLAYERS
Abbott Diagnostics
Core Lab
Molecular
Diabetes
Alere
Critical Care
Infectious Disease
Consumer Diagnostics
Beckman Coulter
Clinical Chemistry
Immunoassays
Hematology
Flow Cytometry
Becton Dickinson
Molecular
Rapid Tests
Flow Cytometry
Danaher Corporation
Histology
Point-of-Care Testing
Hologic
Molecular Diagnostics / Histology
Ortho-Clinical Diagnostics / J&J Diabetes Care
Blood Banking
QIAGEN
Companion Diagnostics / Cancer Markers
Infectious Disease
Immunoassays
Roche Diagnostics
Professional Diagnostics
Diabetes Care
Molecular Diagnostics
Siemens Healthcare Diagnostics
Clinical Chemistry/Immunoassays
Immunoassays
Microbiology
Companion Diagnostics
Urinalysis
Coagulation
Point-of-Care Diagnostics
Sysmex Corporation
Hematology
Coagulation
Thermo Fisher Scientific
Immunoassays
Microbiology
Molecular Diagnostics
LIST OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1: U.S. Hospital Inpatient Admissions and Outpatient Visits Per 1,000 Persons
(1991-2011)
Table 1-2: Historical and Projected U.S. Aged Populations, % Share of Total Population,
Population in Millions (1950-2050)
Table 1-3: U.S. Infectious Disease Market Opportunities Ranked
Table 1-4: U.S. IVD Market by Segment
Table 1-5: U.S. IVD Market Rankings by Estimated 2013 Revenue – Top 12 Companies
CHAPTER TWO: INTRODUCTION TO U.S. HEALTH CARE
Figure 2-1: US IVD Market, 2013 and 2018
Table 2-1: U.S. Hospital Inpatient Admissions and Outpatient Visits Per 1,000 Persons (1991-2011)
Table 2-2: Historical and Projected U.S. Aged Populations(1950-2050)
Table 2-3: U.S. Adult Diabetes Prevalence – Age-Adjusted and Crude Rates(2002-2012)
Table 2-4: U.S. Cancer Incidence – Aggregate, Lung, Colon, Prostate, Breast(per 100,000 persons) (2000-2010)
Table 2-5: Selected Notifiable Infectious Disease Incidences in the United States(per 100,000 persons) (2001-2011)
Table 2-6: U.S. Infectious Disease Market Opportunities Ranked
Table 2-7: U.S. National Health Expenditure by Payer (Out-of-Pocket, Private Health
Insurance, Medicare, Medicaid) (2002-2022)
Table 2-8: U.S. Clinical Laboratory Market by Segment - Hospital, Independent,
Physician Office ($ millions) (2008-2018)
CHAPTER THREE: U.S. IVD MARKET ANALYSIS
Figure 3-1: US Clinical Chemistry Market
Figure 3-2: US Microbiology and Virology, ID/AST and Molecular Market
Figure 3-3: US Point of Care Testing Market
Figure 3-4: US Immunoassays Market
Figure 3-5: US Urinalysis Market
Figure 3-6: US Molecular Diagnostics Market
Figure 3-7: US Coagulation Market
Figure 3-8 US Histology Market
Figure 3-9 US Hematology Market
Figure 3-10 US Blood Testing and Typing Market
Figure 3-11: US Flow Cytometry Market
Table 3-1: U.S. IVD Market by Segment
CHAPTER FOUR: TOP TIER U.S. IVD MARKET PLAYERS
Table 4-1: Abbott Diagnostics Estimated Global Revenue by IVD Segment – (Core Lab,
Hematology, POC, Molecular, Diabetes) (2011-2013)
Table 4-2: Alere Global Revenue by IVD Segment – (Professional POC, Infectious Disease,
Toxicology, Diabetes, Other; Consumer [OTC] Diagnostics) (2011-2013)
Table 4-3: Beckman Coulter Global Estimated Revenue by IVD Segment – (Clinical Chemistry,
Immunoassays, Hematolgy, Flow Cytometry) (2011-2013)
Table 4-4: Becton Dickinson Global Estimated Revenue by IVD Segment – (Histology, Molecular,
Microbiology [ID/AST, Media, Rapid Tests, Blood Culture], Flow Cytometry)(2011-2013)
Table 4-5: Danaher Corporation Global Estimated Revenue by Subsidiary Group – (Beckman Coulter,
Radiometer, Leica Biosystems, Leica Microsystems, AB Sciex, Molecular Diagnostics)(FY 2011-2013)
Table 4-6 Hologic Estimated Global Revenue by Product Group – (HPV, ThinPrep, Gen-Probe
Clinical Molecular, Gen-Probe Blood Banking) (FY 2011-2013)
Table 4-7: Ortho-Clinical Diagnostics / J&J Diabetes Care Estimated Global Revenue by Product
Group – (OTC Diabetes [SMBG], Immunoassays, Chemistry, Blood Banking)(2011-2013)
Table 4-8: QIAGEN Estimated Global Revenue by Segment – (HPV, Other Molecular Clinical
Applied Testing, Pharma, Academia) (2011-2013)
Table 4-9: Roche Diagnostics Estimated Global Revenue by Segment – (Professional Diagnostics,
Diabetes Care, Molecular Diagnostics, Tissue Diagnostics) (2011-2013)
Table 4-10 Siemens Healthcare Diagnostics Estimated Global Revenue by Segment – (Hematology,
Coagulation, Chemistry/Immunoassays, Microbiology, Urinalysis, Blood Gases)(2011-2013)
Table 4-11: Sysmex Corporation Estimated Global Revenue by Segment – (Hematology, Coagulation,
Urinalysis, Chemistry/Immuno, Other IVD) (2011-2013)
Table 4-12 Thermo Fisher Scientific Estimated Global Revenue by Segment – (Clinical Products,
Immunoassays [Phadia], Microbiology, Histology, Transplant Diagnostics)(2011-2013)

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