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

$3,196.00 – $6,720.00

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SKU: KLI15035998 Categories: Clinical Chemistry, Diagnostics Market Research, Immunoassays Pages: 210
  • Description
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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)

 

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