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)