HOME Top Market Reports 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

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

By: marketsandmarkets.com
Publishing Date: March 2016
Report Code: MD 4174

 

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The U.S. IVD market is projected to reach USD 25.99 Billion by 2020 at a CAGR of 4.7% during the forecast period of 2015 to 2020. Some of the key factors driving the growth of this market are the rising incidence of chronic and infectious diseases in the U.S., rapidly aging population, growing preference for point-of-care testing and personalized medicine, implementation of the Affordable Care Act (ACA), increasing adoption of automated instruments, and automation in laboratories. The extending reach of molecular diagnostics and new range of condition-specific markers and tests with advances in genomics and proteomics are creating new opportunities for this market. However, the unfavorable reimbursement and lack of sufficient budget is hampering the growth of the U.S. IVD industry. Stringent regulatory framework presents a significant challenge to the market growth.

Over the past few years, the U.S. in vitro diagnostics market has witnessed steady growth owing to the increasing demand for high-performance products. Increasing urbanization and changing lifestyles have resulted in the growing incidence of chronic ailments such as diabetes, blood pressure, and cardiovascular diseases. This is further fueling the demand of innovative in-vitro diagnostic products for the early detection and diagnosis of these diseases. As a result, currently, most of the leading players in the in vitro diagnostics market are focusing on acquisitions as a major strategy to capture market share and sustain their leadership position in this market. Acquisition of similar or smaller players has enabled these companies to achieve greater competitiveness through the expansion of their product portfolio and technological expertise in a short period of time.

Geographically, the U.S. is the largest regional segment of the global IVD market. The large share of this region can be attributed to the accessibility to technologies, superlative opportunities for molecular diagnostics in genetic testing and cancer screening, established distribution channels, and the presence of a large number of market players such as Abbott Laboratories, Inc., Johnson & Johnson, Becton, Dickson and Company, Danaher Corporation, Thermo Fisher Scientific, Inc., Bio-Rad Laboratories, Inc., and Alere, Inc. Roche Diagnostics Limited (Switzerland), Danaher Corporation (U.S.), Siemens Healthcare (Germany), Thermo Fisher Scientific Inc. (U.S.), and Abbott Laboratories, Inc. (U.S.) are the leading companies, which accounted for ~50-55% of the market in 2014. However, new local players are intensifying competition and thereby threatening the market share of existing players. In order to maintain their shares, leading players are continuously adopting various strategies. This increased competitiveness is expected to drive innovation in the market, thereby driving market growth.

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Stakeholders of the Report:

  • IVD Product Manufacturers
  • Group Purchase Organizations (GPOs)
  • OEM Manufacturers
  • Clinical Laboratories
  • Distributors of IVD Products
  • Hospitals and Clinics
  • Healthcare Institutions
  • Research Institutes
  • Market Research and Consulting Firms
  • Venture Capitalists and Investors

Scope of the Report

This research report categorizes the U.S. IVD market on the basis of products & services, technologies, applications, and end users. These markets are further segmented, providing value analysis for 2013, 2014, and 2015, as well as forecast up to 2020. The end user market is comprehensively analyzed by region (South, Midwest, West, and Northeast) to provide in-depth information on the U.S. scenario.

U.S. In Vitro Diagnostics Market

This research report categorizes the U.S. in-vitro diagnostics market into the following segments:

U.S. In Vitro Diagnostics Market, by Products & Services

  • Reagents
  • Instrument
    • Fully Automated Instruments
    • Semi-automated Instruments
    • Others
  • Data Management Systems/Software
  • Services

U.S. In Vitro Diagnostics Market, by Technology

  • Clinical Chemistry
  • Immunochemistry/Immunoassay
  • Hematology
  • Coagulation & Hemostasis
  • Microbiology
  • Molecular Diagnostics (MDx)
  • Other Instruments

U.S. In Vitro Diagnostics Market, by Application

  • Infectious Diseases
  • Diabetes
  • Oncology/Cancer
  • Cardiology
  • Endocrine Disorders
  • Autoimmune Diseases
  • Bone & Mineral Disorders
  • Pulmonary Disorders
  • Others

U.S. In Vitro Diagnostics Market, by End User

  • Hospital Laboratories
  • Clinical/Independent Laboratories
    • Large Laboratories
    • Medium-sized Laboratories
    • Small Laboratories
  • Others

U.S. In Vitro Diagnostics End User Market, by Region

  • Hospital Laboratories Market
    • South
    • Midwest
    • West
    • Northeast
  • Clinical/Independent Laboratories
    • South
    • Midwest
    • West
    • Northeast
  • Others
    • South
    • Midwest
    • West
    • Northeast

Available Customizations

With the given market data, MarketsandMarkets offers customizations as per the company*s specific needs. The following customization options are available for the report:

  • Product Analysis

Product matrix, which gives a detailed comparison of the product portfolios of each company

  • Company Information

Detailed analysis and profiling of additional market players (Up to 5)

Table of Contents

1 Introduction (Page No. - 14)
    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 (Page No. - 17)
    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 (Page No. - 24)

4 Premium Insights (Page No. - 29)
    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 (Page No. - 32)
    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 (Page No. - 43)
    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 (Page No. - 52)
    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 (Page No. - 61)
    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 (Page No. - 74)
    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 (Page No. - 83)
     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 (Page No. - 92)
(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谷rieux
     11.8 Bio-Rad Laboratories, Inc.
     11.9 Sysmex Corporation
     11.10 Thermo Fisher Scientific, Inc.
     11.11 Qiagen N.V.

12 Appendix (Page No. - 149)
     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 (50 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每2020 (USD Million)
Table 6 U.S.: IVD Market Size, By Region, 2013每2020 (USD Million)
Table 7 U.S. IVD Reagents Market Size, By End User, 2013每2020 (USD Million)
Table 8 U.S. IVD Instruments Market Size, By Type, 2013每2020 (USD Million)
Table 9 U.S. IVD Instruments Market Size, By End User, 2013每2020 (USD Million)
Table 10 U.S. IVD Data Management Software Market Size, By End User, 2013每2020 (USD Million)
Table 11 U.S. IVD Services Market Size, By End User, 2013每2020 (USD Million)
Table 12 U.S. IVD Market Size, By Technology, 2013每2020 (USD Million)
Table 13 U.S. Clinical Chemistry Market Size, By End User, 2013每2020 (USD Million)
Table 14 U.S. Immunochemistry/Immunoassys Market Size, By End User, 2013每2020 (USD Million)
Table 15 U.S. Microbiology Market Size, By End User, 2013每2020 (USD Million)
Table 16 U.S. Molecular Diagnostics Market Size, By End User, 2013每2020 (USD Million)
Table 17 U.S. Hematology Market Size, By End User, 2013每2020 (USD Million)
Table 18 U.S. Coagulation/Hemostasis Market Size, By End User, 2013每2020 (USD Million)
Table 19 U.S. Other IVD Technologies Market Size, By End User, 2013每2020 (USD Million)
Table 20 U.S. IVD Market Size, By Application, 2013每2020 (USD Million)
Table 21 Infectious Disease Incidence in The U.S., 2008每2012
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每2020 (USD Million)
Table 24 Diabetes Incidence in The U.S., By Region, 2008每2012
Table 25 U.S. IVD Market Size, for Diabetes By End User, 2013每2020 (USD Million)
Table 26 Cancer Incidence Rate in The U.S., By Region (Per 100,000 Individuals), 2008每2012
Table 27 U.S. IVD Market Size, for Oncology/Cancer By End User, 2013每2020 (USD Million)
Table 28 U.S. IVD Market Size, for Cardiovascular Disorders By End User, 2013每2020 (USD Million)
Table 29 Obesity Incidence Rate in The U.S., By Region (Per 100,000 Individuals), 2008每2012
Table 30 U.S. IVD Market Size, for Endocrine Disorders By End User, 2013每2020 (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每2020 (USD Million)
Table 33 U.S. IVD Market Size, for Bone & Mineral-Related Diseases By End User, 2013每2020 (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每2020 (USD Million)
Table 36 U.S. IVD Market Size, for Other Applications By End User, 2013每2020 (USD Million)
Table 37 U.S.: IVD Market Size, By End User, 2013每2020 (USD Million)
Table 38 U.S.: IVD Market Size for Hospital Laboratories, By Region, 2013每2020 (USD Million)
Table 39 U.S.: IVD Market Size for Hospital Laboratories, By Application, 2013每2020 (USD Million)
Table 40 U.S.: IVD Market Size for Clinical Laboratories, By Region, 2013每2020 (USD Million)
Table 41 U.S.: IVD Market Size for Clinical Laboratories, By Application, 2013每2020 (USD Million)
Table 42 U.S.: IVD Market Size for Clinical Laboratories, By Laboratory Size, 2013每2020 (USD Million)
Table 43 U.S.: IVD Market Size for Other End User, By Region, 2013每2020 (USD Million)
Table 44 U.S.: IVD Market Size for Other End Users, By Application, 2013每2020 (USD Million)
Table 45 Growth Strategy Matrix, 2012每2015
Table 46 New Product Launches, 2014每2015
Table 47 Collaborations, Agreements, & Partnerships, 2014每2016
Table 48 Approvals, 2015
Table 49 Mergers & Acquisitions, 2014每2016
Table 50 Others, 2014每2015


List of Figures (41 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 ≡20 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谷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.

The U.S. is a prime market due to the availability of government funds, expansion of molecular diagnostics for genetic disorders and cancer screening, and easy access to IVD tests through diagnostic service providers and major leading companies headquartered in the U.S. The U.S. in vitro diagnostics market is estimated to reach USD 25.99 Billion by 2020, growing at a CAGR of 4.7% during the forecast period. This market is primarily driven by the rising incidence of chronic and infectious diseases, rapidly aging population, increasing demand for automated high-throughput instruments, increasing automation in laboratories, implementation of Affordable Care Act (ACA), and rise in point-of-care testing and personalized medicine. Additionally, extending reach of molecular diagnostics and new range of condition-specific markers and tests with advances in genomics and proteomics are creating new opportunities for this market. However, stringent regulatory framework presents significant challenges to market growth.

In this report, the market is segmented on the basis of products & services, technologies, applications, end users, and regions. The research report discusses key market drivers, restraints, opportunities, and challenges in the U.S. IVD market and its submarkets.

The U.S. IVD product & services market is broadly segmented into reagents, instruments, services, and data management system/software. The reagents segment accounted for the largest share of the U.S IVD product & service market in 2014, and is expected to grow at a highest CAGR during the forecast period of 2015 to 2020. The accessibility of a wide range of reagents and the need for reliable, specific, and faster detection of chronic diseases and genetic disorders at early stages are driving the market growth in this product segment.

On the basis of technology, the U.S. IVD market is broadly segmented into immunoassays/immunochemistry, clinical chemistry, molecular diagnostics, hematology, microbiology, coagulation/hemostasis, and others. Of these, the immunoassays/immunochemistry segment accounted for the largest share of the U.S. market in 2014. The ability of immunoassay/immunochemistry technologies to offer faster results with high sensitivity and accuracy is one of the key factors contributing to the growth of this market over other technologies.

The U.S. IVD market by region is segmented into South, Midwest, West, and Northeast region. In 2014, the South region commanded the largest share of the U.S. IVD market, followed by West. However, the Midwest region is expected to witness the highest growth largely driven by the increasing number of accredited laboratories, reimbursement by the Medicare, growing demand for technologically advanced diagnosis devices, and increased spending capabilities of consumers on healthcare.

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 bioM谷rieux (France).

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