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U.S. In Vitro Diagnostics (IVD) Market by Technology (Immunoassay, Clinical Chemistry, Molecular Diagnostics, Microbiology), Application (Infectious Diseases, Diabetes, Cancer, Cardiology), End User (Hospitals & Laboratories) & by Region - Forecast to 2020

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Date: 17-Mar-2016
No. of pages: 178
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In vitro diagnostics testing is an indispensable tool in the modern medical practice. IVD tests are conducted with the help of various medical devices for the diagnosis of a number of diseases. With evolution in biotechnology, there has been a drastic change in the type of tests conducted for diagnosing various diseases, thus helping physicians to diagnose and treat diseases promptly and effectively. The most important trend witnessed recently in the U.S. IVD industry is the trend of self-testing as opposed to patients visiting hospitals. This is a key factor driving the growth of point-of-care testing, as patients prefer self-testing to avoid hospital visits. IVD tests have a significant role in the prevention, monitoring, diagnosis, and treatment of diseases. Common IVD tests include blood tests for glucose, tests for detection of electrolytes (calcium, sodium, and potassium), liver enzymes, and drug tests.

The U.S. IVD market is projected to reach USD 25.99 billion by 2020 at a CAGR of 4.7% from 2015 to 2020. The rising incidence of chronic and infectious diseases, rapidly aging population, growing preference for point-of-care testing and personalized medicine, implementation of the Affordable Care Act (ACA), increasing demand for automated instruments, and automation in laboratories are key factors driving the IVD market in the U.S. In this report, the market is segmented by product & service, technology, application, end user, and region.

The U.S. IVD product & services market is broadly segmented into reagents, instruments, services, and data management system/software. The instruments market is further segmented into fully automated instruments, semi-automated instruments, and other instruments. The fully automated instruments segment accounted for the largest share of the U.S IVD instruments market in 2014. The increasing number and complexity of tests, coupled with a shortage in laboratory staff, is driving the greater adoption of fully automated instruments in laboratories.

On the basis of end user, the U.S. IVD market is segmented into hospital laboratories, clinical/independent laboratories, and others. In 2014, the hospital laboratories segment accounted for the largest share of the U.S. IVD market in the U.S. The high inpatient flow and ancillary outpatient flow in hospitals, growing prevalence of chronic and infectious diseases, and increasing number of accredited laboratories are key factors driving market growth in this end-user segment.

The major players in the U.S. IVD market are Roche Diagnostics Limited (Switzerland), Abbott Laboratories, Inc. (U.S.), Becton, Dickson and Company (U.S.), Johnson & Johnson (U.S.), Danaher Corporation (U.S.), Thermo Fisher Scientific, Inc. (U.S.), Siemens Healthcare (Germany), Bio-Rad Laboratories, Inc. (U.S.), Sysmex Corporation (Japan), QIAGEN N.V. (Netherlands), Alere Inc. (U.S.), Ortho-Clinical Diagnostics Inc. (U.S.), and bioMérieux (France).

Reasons to Buy the Report

The report will enrich established firms as well as new entrants/smaller firms to gauge the pulse of the market, which in turn would help them, garner a greater market share. Firms purchasing the report could use one or any combination of the below-mentioned five strategies (market penetration, product development/innovation, market development, market diversification, and competitive assessment) for reaping greater market shares.

This report provides insights on the following pointers:


  • Market Penetration: Comprehensive information on product portfolios offered by top players in the U.S. IVD market. The report analyzes the U.S. IVD market by product, technology, end user, and application across all regions

  • Product Development/Innovation: Detailed insights on upcoming trends, R&D activities, and new product launches in the U.S. IVD market

  • Market Development: Comprehensive information on the lucrative emerging markets by product, technology, end user, application, and region

  • Market Diversification: Exhaustive information about new products, growing regions, recent developments, and investments in the U.S. IVD market

  • Competitive Assessment: In-depth assessment of market shares, growth strategies, products, distribution networks, manufacturing capabilities, and SWOT analyses of leading players in the U.S. IVD market

U.S. In Vitro Diagnostics (IVD) Market by Technology (Immunoassay, Clinical Chemistry, Molecular Diagnostics, Microbiology), Application (Infectious Diseases, Diabetes, Cancer, Cardiology), End User (Hospitals & Laboratories) & by Region - Forecast to 2020

Table of Contents

1 Introduction
1.1 Objectives of The Study
1.2 Market Definition
1.3 Market Scope
1.3.1 Markets Covered
1.3.2 Years Considered for The Study
1.4 Currency
1.5 Limitations
1.6 Stakeholders

2 Research Methodology
2.1 Research Data
2.1.1 Secondary Data
2.1.1.1 Key Data From Secondary Sources
2.1.2 Primary Data
2.1.2.1 Key Data From Primary Sources
2.1.2.2 Key Industry Insights
2.2 Market Size Estimation
2.3 Market Breakdown and Data Triangulation
2.4 Market Share Estimation
2.5 Assumptions for The Study

3 Executive Summary

4 Premium Insights
4.1 Growth Potential of The U.S. in Vitro Diagnostics Market
4.2 U.S. in Vitro Diagnostics Market, By End User (2014)
4.3 U.S. in Vitro Diagnostics Market, Regional Mix

5 Market Overview
5.1 Introduction
5.2 Market Segmentation
5.2.1 By Product
5.2.2 By Technology
5.2.3 By Application
5.2.4 By End User
5.3 Market Dynamics
5.3.1 Drivers
5.3.1.1 Rapid Growth in Geriatric Population and Increasing Incidence of Chronic Diseases in The U.S.
5.3.1.2 Increasing Adoption of Point-Of-Care (POC) Testing
5.3.1.3 Growing Awareness on Personalized Medicine
5.3.1.4 Rise in Reagent Rental Agreements
5.3.1.5 Implementation of The Affordable Care Act (ACA)
5.3.1.6 Increasing Adoption of Automated Instruments and Automation in Laboratories
5.3.2 Restraints
5.3.2.1 Unfavorable Reimbursement Scenario
5.3.2.2 Rising Healthcare Costs and Low Budgets
5.3.3 Opportunities
5.3.3.1 Condition-Specific Markers and Tests With Advances in Genomics and Proteomics
5.3.4 Challenges
5.3.4.1 Stringent Regulatory Framework

6 U.S. in Vitro Diagnostics Market, By Product & Service
6.1 Introduction
6.2 Reagents
6.3 Instruments
6.3.1 Fully Automated Instruments
6.3.2 Semi-Automated Instruments
6.3.3 Others
6.4 Data Management Software
6.5 Services

7 U.S. in Vitro Diagnostics Market, By Technology
7.1 Introduction
7.2 Clinical Chemistry
7.3 Immunochemistry/Immunoassays
7.4 Microbiology
7.5 Molecular Diagnostics (MDX)
7.6 Hematology
7.7 Coagulation/Hemostasis
7.8 Other IVD Technologies

8 U.S. in Vitro Diagnostics Market, By Application
8.1 Introduction
8.2 Infectious Diseases
8.3 Diabetes
8.4 Oncology/Cancer
8.5 Cardiovascular Disorders
8.6 Endocrine Disorders
8.7 Autoimmune Diseases
8.8 Bone & Mineral-Related Diseases
8.9 Pulmonary Diseases
8.10 Other Applications

9 U.S. in Vitro Diagnostics Market, By End User
9.1 Introduction
9.2 Hospital Laboratories
9.3 Clinical/Independent Laboratories
9.3.1 Large Laboratories/Reference Laboratories
9.3.2 Medium-Sized Laboratories
9.3.3 Small Laboratories
9.4 Other End Users

10 Competitive Landscape
10.1 Overview
10.2 Market Share Analysis
10.3 Competitive Situation and Trends
10.3.1 New Product Launches
10.3.2 Collaborations, Agreements, & Partnerships
10.3.3 Approvals
10.3.4 Mergers & Acquisitions
10.3.5 Others

11 Company Profiles
(Overview, Financials, Products & Services, Strategy, & Developments)*
11.1 Abbott Laboratories, Inc.
11.2 Danaher Corporation
11.3 Johnson and Johnson
11.4 Roche Diagnostics
11.5 Siemens Healthcare
11.6 Becton, Dickinson and Company
11.7 Biom¨¦rieux
11.8 Bio-Rad Laboratories, Inc.
11.9 Sysmex Corporation
11.10 Thermo Fisher Scientific, Inc.
11.11 Qiagen N.V.

12 Appendix
12.1 Insights of Industry Experts
12.2 Discussion Guide
12.3 Other Developments
12.4 Knowledge Store: Marketsandmarkets¡¯ Subscription Portal
12.5 Introducing RT: Real-Time Market Intelligence
12.6 Available Customizations
12.7 Related Reports

List of Tables

Table 1 Increased Incidence of Chronic Diseases and Rapid Growth in Geriatric Population Will Drive The Market Growth
Table 2 Unfavorable Reimbursement and Rising Healthcare Costs to Restrain Market Growth
Table 3 Condition Specific Markers, an Area of Opportunity
Table 4 Stringent & Uncertain Regulations, A Key Challenge for The IVD Market
Table 5 U.S. IVD Market Size, By Product & Service, 2013¨C2020 (USD Million)
Table 6 U.S.: IVD Market Size, By Region, 2013¨C2020 (USD Million)
Table 7 U.S. IVD Reagents Market Size, By End User, 2013¨C2020 (USD Million)
Table 8 U.S. IVD Instruments Market Size, By Type, 2013¨C2020 (USD Million)
Table 9 U.S. IVD Instruments Market Size, By End User, 2013¨C2020 (USD Million)
Table 10 U.S. IVD Data Management Software Market Size, By End User, 2013¨C2020 (USD Million)
Table 11 U.S. IVD Services Market Size, By End User, 2013¨C2020 (USD Million)
Table 12 U.S. IVD Market Size, By Technology, 2013¨C2020 (USD Million)
Table 13 U.S. Clinical Chemistry Market Size, By End User, 2013¨C2020 (USD Million)
Table 14 U.S. Immunochemistry/Immunoassys Market Size, By End User, 2013¨C2020 (USD Million)
Table 15 U.S. Microbiology Market Size, By End User, 2013¨C2020 (USD Million)
Table 16 U.S. Molecular Diagnostics Market Size, By End User, 2013¨C2020 (USD Million)
Table 17 U.S. Hematology Market Size, By End User, 2013¨C2020 (USD Million)
Table 18 U.S. Coagulation/Hemostasis Market Size, By End User, 2013¨C2020 (USD Million)
Table 19 U.S. Other IVD Technologies Market Size, By End User, 2013¨C2020 (USD Million)
Table 20 U.S. IVD Market Size, By Application, 2013¨C2020 (USD Million)
Table 21 Infectious Disease Incidence in The U.S., 2008¨C2012
Table 22 Human Immunodeficiency Virus (HIV) Prevalence in The U.S., By Region
Table 23 U.S. IVD Market Size, for Infectious Diseases By End User, 2013¨C2020 (USD Million)
Table 24 Diabetes Incidence in The U.S., By Region, 2008¨C2012
Table 25 U.S. IVD Market Size, for Diabetes By End User, 2013¨C2020 (USD Million)
Table 26 Cancer Incidence Rate in The U.S., By Region (Per 100,000 Individuals), 2008¨C2012
Table 27 U.S. IVD Market Size, for Oncology/Cancer By End User, 2013¨C2020 (USD Million)
Table 28 U.S. IVD Market Size, for Cardiovascular Disorders By End User, 2013¨C2020 (USD Million)
Table 29 Obesity Incidence Rate in The U.S., By Region (Per 100,000 Individuals), 2008¨C2012
Table 30 U.S. IVD Market Size, for Endocrine Disorders By End User, 2013¨C2020 (USD Million)
Table 31 Arthritis Incidence in The U.S., By Region, 2011 & 2013
Table 32 U.S. IVD Market Size, for Autoimmune Diseases By End User, 2013¨C2020 (USD Million)
Table 33 U.S. IVD Market Size, for Bone & Mineral-Related Diseases By End User, 2013¨C2020 (USD Million)
Table 34 Asthma Prevalence in The U.S., By Age, 2007-2011
Table 35 U.S. IVD Market Size, for Pulmonary Diseases By End User, 2013¨C2020 (USD Million)
Table 36 U.S. IVD Market Size, for Other Applications By End User, 2013¨C2020 (USD Million)
Table 37 U.S.: IVD Market Size, By End User, 2013¨C2020 (USD Million)
Table 38 U.S.: IVD Market Size for Hospital Laboratories, By Region, 2013¨C2020 (USD Million)
Table 39 U.S.: IVD Market Size for Hospital Laboratories, By Application, 2013¨C2020 (USD Million)
Table 40 U.S.: IVD Market Size for Clinical Laboratories, By Region, 2013¨C2020 (USD Million)
Table 41 U.S.: IVD Market Size for Clinical Laboratories, By Application, 2013¨C2020 (USD Million)
Table 42 U.S.: IVD Market Size for Clinical Laboratories, By Laboratory Size, 2013¨C2020 (USD Million)
Table 43 U.S.: IVD Market Size for Other End User, By Region, 2013¨C2020 (USD Million)
Table 44 U.S.: IVD Market Size for Other End Users, By Application, 2013¨C2020 (USD Million)
Table 45 Growth Strategy Matrix, 2012¨C2015
Table 46 New Product Launches, 2014¨C2015
Table 47 Collaborations, Agreements, & Partnerships, 2014¨C2016
Table 48 Approvals, 2015
Table 49 Mergers & Acquisitions, 2014¨C2016
Table 50 Others, 2014¨C2015

List of Figures

Figure 1 U.S. in Vitro Diagnostics Market
Figure 2 Research Design
Figure 3 Bottom-Up Approach
Figure 4 Top-Down Approach
Figure 5 Data Triangulation Methodology
Figure 6 U.S. IVD Market Size, By Products & Services, 2015 vs 2020 (USD Million)
Figure 7 U.S. IVD Instruments Market Size, By Type, 2015 vs 2020 (USD Million)
Figure 8 U.S. IVD Market Size, By Technology, 2015 vs 2020 (USD Million)
Figure 9 U.S. IVD Market Size, By Application, 2015 vs 2020 (USD Million)
Figure 10 U.S. IVD Market Size, By End User, 2015 vs 2020 (USD Million)
Figure 11 U.S. IVD Market Size, By Region, 2015 vs 2020 (USD Million)
Figure 12 Growing Prevalence of Chronic Diseases and Increasing Demand for Automated Instruments to Drive Market Growth
Figure 13 Hospital Laboratories Accounted for The Largest Share of The U.S. IVD End-Users Market in 2014
Figure 14 South Region to Dominate The U.S. IVD Market During 2015 to 2020
Figure 15 U.S. in Vitro Diagnostics Market Segmentation, By Product
Figure 16 U.S. in Vitro Diagnostics Market Segmentation, By Technology
Figure 17 U.S. in Vitro Diagnostics Market Segmentation, By Application
Figure 18 U.S. in Vitro Diagnostics Market Segmentation, By End User
Figure 19 U.S. IVD Market: Drivers, Restraints, Opportunities, & Challenges
Figure 20 Number of Patients With Chronic Condition in The U.S. (In Million)
Figure 21 Reagents, The Fastest Growing Segment of The U.S. IVD Market During 2015-2020
Figure 22 The Molecular Diagnostics Segment to Register The Highest Growth During The Forecast Period
Figure 23 Oncology Segment to Register The Highest Growth During The Forecast Period
Figure 24 Prevalence of Cardiovascular Diseases in Adults AGED ¡Ý20 Years
Figure 25 U.S. IVD Market Size, By End User, 2015 vs 2020 (USD Million)
Figure 26 U.S. Clinical Laboratories Market Size, By Type, 2015 vs 2020 (USD Million)
Figure 27 Market Players Actively Adopted New Product Launches as A Key Growth Strategy Between 2012 and 2015
Figure 28 U.S. in Vitro Diagnostics Market Share Analysis, 2014
Figure 29 Battle for Market Share: New Product Launches Was The Key Strategy
Figure 30 Geographic Revenue Mix of The Top 5 Market Players
Figure 31 Company Snapshot: Abbott Laboratories, Inc.
Figure 32 Company Snapshot: Danaher Corporation
Figure 33 Company Snapshot: Johnson and Johnson
Figure 34 Company Snapshot: F. Hoffmann-La Roche Ltd.
Figure 35 Company Snapshot: Siemens Ag
Figure 36 Company Snapshot: Becton, Dickinson and Company
Figure 37 Company Snapshot: Biom¨¦rieux
Figure 38 Company Snapshot: Bio-Rad Laboratories, Inc.
Figure 39 Company Snapshot: Sysmex Corporation
Figure 40 Company Snapshot: Thermo Fisher Scientific, Inc.
Figure 41 Company Snapshot: Qiagen N.V.

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