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In Vitro Diagnostic Products - Demand and Sales Forecasts, Market Share, Market Size, Market Leaders

  • Study #: 2923
  • Published: 07/2012
  • Pages: 365
  • Full Study Price: US$ 5,100

In Vitro Diagnostic Products - Industry Market Research, Market Share, Market Size, Sales, Demand Forecast, Market Leaders, Company Profiles, Industry Trends

US demand for in vitro diagnostic (IVD) products will rise 6.1 percent annually to $24.7 billion in 2016. Molecular diagnostic products will grow the fastest due to their advantages in the detection of infectious diseases, tumors and genetic disorders. Hospital labs will continue to comprise the largest and most diverse market.

This study analyzes the $18.4 billion US IVD products industry, with forecasts for 2016 and 2021 by product type (e.g., clinical chemistry, immunoassay, molecular diagnostic, blood testing, cellular analysis, anatomical pathology, microbiology), application (e.g., infectious disease testing, cancer testing, diabetes testing, heart disease testing, blood grouping and screening, drug testing) and market (e.g., hospitals, independent clinical laboratories).

The study also considers market environment factors, details industry structure, evaluates company market share and profiles 27 industry players, including Roche, Johnson & Johnson and Danahar).

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Table of Contents

INTRODUCTION

EXECUTIVE SUMMARY

MARKET ENVIRONMENT

General

Macroeconomic Outlook

Population & Age Distribution

Trends in Health Care

Medical Conditions

Acute Conditions

Chronic Conditions

Health Insurance Coverage

National Health Expenditures

Spending Categories

Funding Sources

Medical Providers

Hospitals

Outpatient Facilities

Physicians & Physicians' Offices

Home Health Care Providers

Other Medical Providers

Patient Activity

Hospital Activity

Surgical Procedures

Outpatient Activity

IVD Market Composition

Regulation

510(k) Pre-Market Notification

Pre-Market Approval (PMA)

Current Good Manufacturing Practices (cGMPs)

Packaging

Post-Marketing Surveillance

Laboratory Regulations

Medicare & Medicaid

Technology

Trends in IVD Testing

IVD Tests by Technology

IVD Testing Sites

Historical Market Trends

US Trade

World IVD Demand

PRODUCTS

General

Product Segments

Reagents & Consumables

Instruments & Systems

Clinical Chemistry Products

Reagents & Consumables

Blood Glucose

Lipids

Electrolytes & Blood Gases

Proteins

Enzymes

Toxicology Reagents

Other Reagents

Standards & Controls

Instruments & Systems

Clinical Chemistry Analyzers

Blood Glucose Monitors

Applications

Producers

Immunoassay Products

Reagents & Consumables

Enzyme Immunoassays

Chemiluminescent Immunoassays

Fluorescent Immunoassays

Radioimmunoassays

Instruments & Systems

Applications

Producers

Molecular Diagnostic Products

Technology Overview

Polymerase Chain Reaction (PCR)

Microarrays

DNA Sequencing

In Situ Hybridization

Restriction Fragment Length Polymorphisms (RFLPs)

Reagents & Consumables

Amplified DNA Probe Assays

Direct DNA Probes

Microarrays

Other Reagents & Consumables

Instruments & Systems

PCR Systems

Other Molecular Diagnostic Systems

Applications

Producers

Blood Testing Products

Hematology Products

Reagents & Consumables

Instruments & Systems

Applications

Producers

Blood Bank Products

Reagents & Consumables

Instruments & Systems

Applications

Producers

Hemostasis Products

Reagents & Consumables

Instruments & Systems

Applications

Producers

Cellular Analysis Products

Flow Cytometry Products

Reagents & Consumables

Instruments & Systems

Applications

Producers

Other Cellular Analysis Products

Reagents & Consumables

Instruments & Systems

Applications

Producers

Anatomical Pathology Products

Reagents & Consumables

Instruments & Systems

Applications

Producers

Microbiology Products

Reagents & Consumables

Instruments & Systems

Applications

Producers

Other IVD Products

Effusion & Visual Inspection Products

Reagents & Consumables

Instruments & Systems

Applications

Producers

Cytology Products

Reagents & Consumables

Instruments & Systems

Applications

Producers

APPLICATIONS

General

Infectious Disease Testing

Sexually Transmitted Diseases

AIDS/HIV

Chlamydia

Herpes Simplex (HSV)

Gonorrhea

Other Sexually Transmitted Diseases

Other Infectious Diseases

Hepatitis

All Other Infectious Diseases

Cancer Testing

Cervical Cancer

Breast Cancer

Prostate Cancer

Colorectal Cancer

Other Cancers

Producers

Diabetes Testing

Reagents & Consumables

Blood Glucose Test Strips & Related Consumables

Other Reagents & Consumables

Instruments & Systems

Heart Disease Testing

Lipid Profiling

Cardiac Markers

Blood Proteins

Blood Grouping & Screening

Blood Typing & Matching

Blood & Bleeding Disorders

Drug Testing

Therapeutic Drug Monitoring

Drugs-of-Abuse Testing

Forensic Medicine

DNA Analysis

Identity Testing

Other Applications

Other IVD Applications

Disease Detection

General Health Screening

Pregnancy & Ovulation Testing

MARKETS

General

Hospitals

Independent Clinical Laboratories

Outpatient Facilities

Home Health Care Market

Physicians' Offices

Other Markets

INDUSTRY STRUCTURE

General

Market Share

Competitive Strategies

Mergers & Acquisitions

Cooperative Agreements

Research & Development

Marketing & Distribution

Manufacturing

Company Profiles

Abbott Laboratories

Affymetrix Incorporated

Agilent Technologies Incorporated

Alere Incorporated

ARKRAY Incorporated

Axis-Shield, see Alere

Bayer AG

BD Diagnostics Infectious Disease, see Becton Dickinson

Beckman Coulter, see Danaher

Becton, Dickinson and Company

Bioline, see Meridian Bioscience

bioMerieux SA

Bio-Rad Laboratories Incorporated

Caliper Life Sciences, see PerkinElmer

Celera, see Quest Diagnostics

chemagen Biopolymer-Technologie, see PerkinElmer

CombiMatrix Corporation

Danaher Corporation

Focus Diagnostics, see Quest Diagnostics

Gen-Probe Incorporated

HemoCue, see Quest Diagnostics

Hologic Incorporated

Illumina Incorporated

Inverness Medical Innovations, see Alere

Johnson & Johnson

Leica Microsystems, see Danaher

LifeScan, see Johnson & Johnson

Life Technologies Corporation

Lumigen, see Danaher

Meridian Bioscience Incorporated

Myriad Genetics Incorporated

Ortho-Clinical Diagnostics, see Johnson & Johnson

PerkinElmer Incorporated

Phoenix Bio-Tech, see Trinity Biotech

QIAGEN NV

Quest Diagnostics Incorporated

Roche Holding Limited

Sequenom Incorporated

Siemens AG

Sysmex Corporation

Thermo Fisher Scientific Incorporated

Third Wave Technologies, see Hologic

Trinity Biotech plc

TriPath Imaging, see Becton Dickinson

Veridex, see Johnson & Johnson


List of Tables

EXECUTIVE SUMMARY

Summary Table

MARKET ENVIRONMENT

Macroeconomic Indicators

Resident Population by Age Group

Acute Conditions by Type

Chronic Conditions by Type

Health Insurance Coverage of the US Population

National Health Expenditures by Category

National Health Expenditures by Source

Hospitals & Hospital Beds

Number of Outpatient Facilities by Type

Physicians & Physicians' Offices

Home Health Care Indicators

Number of Other Medical Providers by Type

Hospital Activity

Surgical Procedures by Site

Outpatient Episodes by Type

IVD Tests by Technology

IVD Testing Sites

IVD Product Market, 2001-2011

US Trade in IVD Products

World IVD Product Demand by Region

PRODUCTS

IVD Product Demand by Type

IVD Product Demand by Technology

IVD Reagent & Consumable Demand by Technology

IVD Instrument & System Demand by Technology

Clinical Chemistry Product Demand by Type

Clinical Chemistry Reagent & Consumable Demand by Type

Clinical Chemistry Instrument & System Demand by Type

Clinical Chemistry Product Demand by Application

Immunoassay Product Demand by Type

Immunoassay Reagent & Consumable Demand by Type

Immunoassay Instrument & System Demand by Type

Immunoassay Product Demand by Application

Molecular Diagnostic Product Demand by Type

Molecular Diagnostic Reagent & Consumable Demand by Type

Molecular Diagnostic Instrument & System Demand by Type

Molecular Diagnostic Product Demand by Application

Blood Testing Product Demand by Technology

Hematology Product Demand by Type

Hematology Product Demand by Application

Blood Bank Product Demand by Type

Blood Bank Product Demand by Application

Hemostasis Product Demand by Type

Hemostasis Product Demand by Application

Cellular Analysis Product Demand by Technology

Flow Cytometry Product Demand by Type

Flow Cytometry Product Demand by Application

Other Cellular Analysis Product Demand by Type

Other Cellular Analysis Product Demand by Application

Anatomical Pathology Product Demand by Type

Anatomical Pathology Product Demand by Application

Microbiology Product Demand by Type

Microbiology Product Demand by Application

Other IVD Product Demand by Technology

Effusion & Visual Inspection Product Demand by Type

Effusion & Visual Inspection Product Demand by Application

Cytology Product Demand by Type

Cytology Product Demand by Application

APPLICATIONS

IVD Product Demand by Application

Infectious Disease Testing IVD Product Demand by Type, Technology, & Condition

Sexually Transmitted Disease (STD) Testing IVD Product Demand by Type, Technology, & Condition

Other Infectious Disease Testing IVD Product Demand by Type, Technology, & Condition

Cancer Testing IVD Product Demand by Type, Technology, & Condition

Diabetes Testing IVD Product Demand by Type

Heart Disease Testing IVD Product Demand by Type, Technology, & Condition

Blood Grouping & Screening IVD Product Demand by Type, Technology, & Application

Drug Testing IVD Product Demand by Type, Technology, & Function

Forensic Medicine IVD Product Demand by Type, Technology, & Function

Other Applications IVD Product Demand by Type, Technology, & Function

MARKETS

IVD Product Demand by Market

Hospital IVD Product Demand by Type & Technology

Independent Clinical Laboratory IVD Product Demand by Type & Technology

Outpatient Facility IVD Product Demand by Type & Technology

Home Health Care IVD Product Demand by Type & Technology

Physicians' Office IVD Product Demand by Type & Technology

Other Markets IVD Product Demand by Type & Technology

INDUSTRY STRUCTURE

IVD Product Sales by Company, 2011

Selected Acquisitions & Divestitures

Selected Cooperative Agreements


List of Charts

MARKET ENVIRONMENT

National Health Expenditures by Category, 2011

PRODUCTS

IVD Product Demand by Type, 2001-2021

IVD Product Demand by Technology, 2011

APPLICATIONS

IVD Product Demand by Application, 2011

MARKETS

IVD Product Demand by Market, 2011

INDUSTRY STRUCTURE

IVD Product Market Share, 2011


© by The Freedonia Group, Inc.


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