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  5. > U.S. In Vitro Diagnostics Market by Technology, Application, End User & by Region - Forecast to 2020

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

Table Of Contents

U.S. In Vitro Diagnostics Market by Technology, Application, End User and by Region - Forecast to 2020
TABLE OF CONTENTS

1 INTRODUCTION 14
1.1 OBJECTIVES OF THE STUDY 14
1.2 MARKET DEFINITION 14
1.3 MARKET SCOPE 14
1.3.1 MARKETS COVERED 15
1.3.2 YEARS CONSIDERED FOR THE STUDY 16
1.4 CURRENCY 16
1.5 LIMITATIONS 16
1.6 STAKEHOLDERS 16
2 RESEARCH METHODOLOGY 17
2.1 RESEARCH DATA 17
2.1.1 SECONDARY DATA 18
2.1.1.1 Key data from secondary sources 18
2.1.2 PRIMARY DATA 19
2.1.2.1 Key data from primary sources 19
2.1.2.2 Key industry insights 20
2.2 MARKET SIZE ESTIMATION 20
2.3 MARKET BREAKDOWN AND DATA TRIANGULATION 22
2.4 MARKET SHARE ESTIMATION 23
2.5 ASSUMPTIONS FOR THE STUDY 23
3 EXECUTIVE SUMMARY 24
4 PREMIUM INSIGHTS 29
4.1 GROWTH POTENTIAL OF THE U.S. IN VITRO DIAGNOSTICS MARKET 29
4.2 U.S. IN VITRO DIAGNOSTICS MARKET, BY END USER (2014) 30
4.3 U.S. IN VITRO DIAGNOSTICS MARKET, REGIONAL MIX 31
5 MARKET OVERVIEW 32
5.1 INTRODUCTION 33
5.2 MARKET SEGMENTATION 34
5.2.1 BY PRODUCT 34
5.2.2 BY TECHNOLOGY 34
5.2.3 BY APPLICATION 35
5.2.4 BY END USER 35

5.3 MARKET DYNAMICS 36
5.3.1 DRIVERS 37
5.3.1.1 Rapid growth in geriatric population and increasing incidence of chronic diseases in the U.S. 37
5.3.1.2 Increasing adoption of point-of-care (POC) testing 37
5.3.1.3 Growing awareness on personalized medicine 38
5.3.1.4 Rise in reagent rental agreements 38
5.3.1.5 Implementation of the Affordable care Act (ACA) 39
5.3.1.6 Increasing adoption of automated instruments and automation in laboratories 39
5.3.2 RESTRAINTS 40
5.3.2.1 Unfavorable reimbursement scenario 40
5.3.2.2 Rising healthcare costs and low budgets 40
5.3.3 OPPORTUNITIES 41
5.3.3.1 Condition-specific markers and tests with advances in genomics and proteomics 41
5.3.4 CHALLENGES 41
5.3.4.1 Stringent regulatory framework 41
6 U.S. IN VITRO DIAGNOSTICS MARKET, BY PRODUCT and SERVICE 43
6.1 INTRODUCTION 44
6.2 REAGENTS 46
6.3 INSTRUMENTS 47
6.3.1 FULLY AUTOMATED INSTRUMENTS 48
6.3.2 SEMI-AUTOMATED INSTRUMENTS 49
6.3.3 OTHERS 49
6.4 DATA MANAGEMENT SOFTWARE 50
6.5 SERVICES 51
7 U.S. IN VITRO DIAGNOSTICS MARKET, BY TECHNOLOGY 52
7.1 INTRODUCTION 53
7.2 CLINICAL CHEMISTRY 54
7.3 IMMUNOCHEMISTRY/IMMUNOASSAYS 55
7.4 MICROBIOLOGY 56
7.5 MOLECULAR DIAGNOSTICS (MDX) 57
7.6 HEMATOLOGY 58
7.7 COAGULATION/HEMOSTASIS 59
7.8 OTHER IVD TECHNOLOGIES 60

8 U.S. IN VITRO DIAGNOSTICS MARKET, BY APPLICATION 61
8.1 INTRODUCTION 62
8.2 INFECTIOUS DISEASES 63
8.3 DIABETES 65
8.4 ONCOLOGY/CANCER 66
8.5 CARDIOVASCULAR DISORDERS 67
8.6 ENDOCRINE DISORDERS 68
8.7 AUTOIMMUNE DISEASES 70
8.8 BONE and MINERAL-RELATED DISEASES 71
8.9 PULMONARY DISEASES 72
8.10 OTHER APPLICATIONS 73
9 U.S. IN VITRO DIAGNOSTICS MARKET, BY END USER 74
9.1 INTRODUCTION 75
9.2 HOSPITAL LABORATORIES 76
9.3 CLINICAL/INDEPENDENT LABORATORIES 77
9.3.1 LARGE LABORATORIES/REFERENCE LABORATORIES 80
9.3.2 MEDIUM-SIZED LABORATORIES 80
9.3.3 SMALL LABORATORIES 80
9.4 OTHER END USERS 81
10 COMPETITIVE LANDSCAPE 83
10.1 OVERVIEW 83
10.2 MARKET SHARE ANALYSIS 85
10.3 COMPETITIVE SITUATION AND TRENDS 87
10.3.1 NEW PRODUCT LAUNCHES 87
10.3.2 COLLABORATIONS, AGREEMENTS, and PARTNERSHIPS 88
10.3.3 APPROVALS 89
10.3.4 MERGERS and ACQUISITIONS 90
10.3.5 OTHERS 91
11 COMPANY PROFILES 92
(Overview, Financials, Products and Services, Strategy, and Developments)*
11.1 ABBOTT LABORATORIES, INC. 93
11.2 DANAHER CORPORATION 97
11.3 JOHNSON AND JOHNSON 103
11.4 ROCHE DIAGNOSTICS 106
11.5 SIEMENS HEALTHCARE 112
11.6 BECTON, DICKINSON AND COMPANY 118
11.7 BIOMÉRIEUX 123
11.8 BIO-RAD LABORATORIES, INC. 128
11.9 SYSMEX CORPORATION 133
11.10 THERMO FISHER SCIENTIFIC, INC. 139
11.11 QIAGEN N.V. 145
*Details on Financials, Product and Services, Strategy, and Developments might not be captured in case of unlisted companies.
12 APPENDIX 149
12.1 INSIGHTS OF INDUSTRY EXPERTS 149
12.2 DISCUSSION GUIDE 150
12.3 OTHER DEVELOPMENTS 153
12.4 KNOWLEDGE STORE: MARKETSANDMARKETS' SUBSCRIPTION PORTAL 174
12.5 INTRODUCING RT: REAL-TIME MARKET INTELLIGENCE 176
12.6 AVAILABLE CUSTOMIZATIONS 177
12.7 RELATED REPORTS 178



LIST OF TABLES

TABLE 1 INCREASED INCIDENCE OF CHRONIC DISEASES AND RAPID GROWTH IN GERIATRIC POPULATION WILL DRIVE THE MARKET GROWTH 40
TABLE 2 UNFAVORABLE REIMBURSEMENT AND RISING HEALTHCARE COSTS TO RESTRAIN MARKET GROWTH 41
TABLE 3 CONDITION SPECIFIC MARKERS, AN AREA OF OPPORTUNITY 41
TABLE 4 STRINGENT and UNCERTAIN REGULATIONS, A KEY CHALLENGE FOR THE IVD MARKET 42
TABLE 5 U.S. IVD MARKET SIZE, BY PRODUCT and SERVICE, 2013-2020 (USD MILLION) 45
TABLE 6 U.S.: IVD MARKET SIZE, BY REGION, 2013-2020 (USD MILLION) 45
TABLE 7 U.S. IVD REAGENTS MARKET SIZE, BY END USER, 2013-2020 (USD MILLION) 46
TABLE 8 U.S. IVD INSTRUMENTS MARKET SIZE, BY TYPE, 2013-2020 (USD MILLION) 47
TABLE 9 U.S. IVD INSTRUMENTS MARKET SIZE, BY END USER, 2013-2020 (USD MILLION) 48
TABLE 10 U.S. IVD DATA MANAGEMENT SOFTWARE MARKET SIZE, BY END USER,
2013-2020 (USD MILLION) 50
TABLE 11 U.S. IVD SERVICES MARKET SIZE, BY END USER, 2013-2020 (USD MILLION) 51
TABLE 12 U.S. IVD MARKET SIZE, BY TECHNOLOGY, 2013-2020 (USD MILLION) 53
TABLE 13 U.S. CLINICAL CHEMISTRY MARKET SIZE, BY END USER, 2013-2020 (USD MILLION) 54
TABLE 14 U.S. IMMUNOCHEMISTRY/IMMUNOASSYS MARKET SIZE, BY END USER,
2013-2020 (USD MILLION) 55
TABLE 15 U.S. MICROBIOLOGY MARKET SIZE, BY END USER, 2013-2020 (USD MILLION) 56
TABLE 16 U.S. MOLECULAR DIAGNOSTICS MARKET SIZE, BY END USER,
2013-2020 (USD MILLION) 57
TABLE 17 U.S. HEMATOLOGY MARKET SIZE, BY END USER, 2013-2020 (USD MILLION) 58
TABLE 18 U.S. COAGULATION/HEMOSTASIS MARKET SIZE, BY END USER,
2013-2020 (USD MILLION) 59
TABLE 19 U.S. OTHER IVD TECHNOLOGIES MARKET SIZE, BY END USER,
2013-2020 (USD MILLION) 60
TABLE 20 U.S. IVD MARKET SIZE, BY APPLICATION, 2013-2020 (USD MILLION) 62
TABLE 21 INFECTIOUS DISEASE INCIDENCE IN THE U.S., 2008-2012 63
TABLE 22 HUMAN IMMUNODEFICIENCY VIRUS (HIV) PREVALENCE IN THE U.S., BY REGION 63
TABLE 23 U.S. IVD MARKET SIZE, FOR INFECTIOUS DISEASES BY END USER,
2013-2020 (USD MILLION) 64
TABLE 24 DIABETES INCIDENCE IN THE U.S., BY REGION, 2008-2012 65
TABLE 25 U.S. IVD MARKET SIZE, FOR DIABETES BY END USER, 2013-2020 (USD MILLION) 65
TABLE 26 CANCER INCIDENCE RATE IN THE U.S., BY REGION (PER 100,000 INDIVIDUALS), 2008-2012 66
TABLE 27 U.S. IVD MARKET SIZE, FOR ONCOLOGY/CANCER BY END USER,
2013-2020 (USD MILLION) 66
TABLE 28 U.S. IVD MARKET SIZE, FOR CARDIOVASCULAR DISORDERS BY END USER,
2013-2020 (USD MILLION) 68
TABLE 29 OBESITY INCIDENCE RATE IN THE U.S., BY REGION (PER 100,000 INDIVIDUALS), 2008-2012 69
TABLE 30 U.S. IVD MARKET SIZE, FOR ENDOCRINE DISORDERS BY END USER,
2013-2020 (USD MILLION) 69
TABLE 31 ARTHRITIS INCIDENCE IN THE U.S., BY REGION, 2011 and 2013 70
TABLE 32 U.S. IVD MARKET SIZE, FOR AUTOIMMUNE DISEASES BY END USER,
2013-2020 (USD MILLION) 70
TABLE 33 U.S. IVD MARKET SIZE, FOR BONE and MINERAL-RELATED DISEASES BY END USER, 2013-2020 (USD MILLION) 71
TABLE 34 ASTHMA PREVALENCE IN THE U.S., BY AGE, 2007-2011 72
TABLE 35 U.S. IVD MARKET SIZE, FOR PULMONARY DISEASES BY END USER,
2013-2020 (USD MILLION) 72
TABLE 36 U.S. IVD MARKET SIZE, FOR OTHER APPLICATIONS BY END USER,
2013-2020 (USD MILLION) 73
TABLE 37 U.S.: IVD MARKET SIZE, BY END USER, 2013-2020 (USD MILLION) 75
TABLE 38 U.S.: IVD MARKET SIZE FOR HOSPITAL LABORATORIES, BY REGION,
2013-2020 (USD MILLION) 76
TABLE 39 U.S.: IVD MARKET SIZE FOR HOSPITAL LABORATORIES, BY APPLICATION,
2013-2020 (USD MILLION) 77
TABLE 40 U.S.: IVD MARKET SIZE FOR CLINICAL LABORATORIES, BY REGION,
2013-2020 (USD MILLION) 78
TABLE 41 U.S.: IVD MARKET SIZE FOR CLINICAL LABORATORIES, BY APPLICATION,
2013-2020 (USD MILLION) 79
TABLE 42 U.S.: IVD MARKET SIZE FOR CLINICAL LABORATORIES, BY LABORATORY SIZE, 2013-2020 (USD MILLION) 79
TABLE 43 U.S.: IVD MARKET SIZE FOR OTHER END USER, BY REGION,
2013-2020 (USD MILLION) 81
TABLE 44 U.S.: IVD MARKET SIZE FOR OTHER END USERS, BY APPLICATION,
2013-2020 (USD MILLION) 82
TABLE 45 GROWTH STRATEGY MATRIX, 2012-2015 84
TABLE 46 NEW PRODUCT LAUNCHES, 2014-2015 87
TABLE 47 COLLABORATIONS, AGREEMENTS, and PARTNERSHIPS, 2014-2016 88
TABLE 48 APPROVALS, 2015 89
TABLE 49 MERGERS and ACQUISITIONS, 2014-2016 90
TABLE 50 OTHERS, 2014-2015 91


LIST OF FIGURES

FIGURE 1 U.S. IN VITRO DIAGNOSTICS MARKET 15
FIGURE 2 RESEARCH DESIGN 17
FIGURE 3 BOTTOM-UP APPROACH 21
FIGURE 4 TOP-DOWN APPROACH 21
FIGURE 5 DATA TRIANGULATION METHODOLOGY 22
FIGURE 6 U.S. IVD MARKET SIZE, BY PRODUCTS and SERVICES, 2015 VS. 2020 (USD MILLION) 24
FIGURE 7 U.S. IVD INSTRUMENTS MARKET SIZE, BY TYPE, 2015 VS. 2020 (USD MILLION) 25
FIGURE 8 U.S. IVD MARKET SIZE, BY TECHNOLOGY, 2015 VS. 2020 (USD MILLION) 26
FIGURE 9 U.S. IVD MARKET SIZE, BY APPLICATION, 2015 VS. 2020 (USD MILLION) 27
FIGURE 10 U.S. IVD MARKET SIZE, BY END USER, 2015 VS. 2020 (USD MILLION) 27
FIGURE 11 U.S. IVD MARKET SIZE, BY REGION, 2015 VS. 2020 (USD MILLION) 28
FIGURE 12 GROWING PREVALENCE OF CHRONIC DISEASES AND INCREASING DEMAND FOR AUTOMATED INSTRUMENTS TO DRIVE MARKET GROWTH 29
FIGURE 13 HOSPITAL LABORATORIES ACCOUNTED FOR THE LARGEST SHARE OF THE U.S. IVD END-USERS MARKET IN 2014 30
FIGURE 14 SOUTH REGION TO DOMINATE THE U.S. IVD MARKET DURING 2015 TO 2020 31
FIGURE 15 U.S. IN VITRO DIAGNOSTICS MARKET SEGMENTATION, BY PRODUCT 34
FIGURE 16 U.S. IN VITRO DIAGNOSTICS MARKET SEGMENTATION, BY TECHNOLOGY 34
FIGURE 17 U.S. IN VITRO DIAGNOSTICS MARKET SEGMENTATION, BY APPLICATION 35
FIGURE 18 U.S. IN VITRO DIAGNOSTICS MARKET SEGMENTATION, BY END USER 35
FIGURE 19 U.S. IVD MARKET: DRIVERS, RESTRAINTS, OPPORTUNITIES, and CHALLENGES 36
FIGURE 20 NUMBER OF PATIENTS WITH CHRONIC CONDITION IN THE U.S. (IN MILLION) 37
FIGURE 21 REAGENTS, THE FASTEST GROWING SEGMENT OF THE U.S. IVD MARKET DURING 2015-2020 44
FIGURE 22 THE MOLECULAR DIAGNOSTICS SEGMENT TO REGISTER THE HIGHEST GROWTH DURING THE FORECAST PERIOD 53
FIGURE 23 ONCOLOGY SEGMENT TO REGISTER THE HIGHEST GROWTH DURING THE FORECAST PERIOD 62
FIGURE 24 PREVALENCE OF CARDIOVASCULAR DISEASES IN ADULTS AGED ?20 YEARS 67
FIGURE 25 U.S. IVD MARKET SIZE, BY END USER, 2015 VS. 2020 (USD MILLION) 75
FIGURE 26 U.S. CLINICAL LABORATORIES MARKET SIZE, BY TYPE,
2015 VS. 2020 (USD MILLION) 78
FIGURE 27 MARKET PLAYERS ACTIVELY ADOPTED NEW PRODUCT LAUNCHES AS A KEY GROWTH STRATEGY BETWEEN 2012 AND 2015 83
FIGURE 28 U.S. IN VITRO DIAGNOSTICS MARKET SHARE ANALYSIS, 2014 85
FIGURE 29 BATTLE FOR MARKET SHARE: NEW PRODUCT LAUNCHES WAS THE KEY STRATEGY 87
FIGURE 30 GEOGRAPHIC REVENUE MIX OF THE TOP 5 MARKET PLAYERS 92
FIGURE 31 COMPANY SNAPSHOT: ABBOTT LABORATORIES, INC. 93
FIGURE 32 COMPANY SNAPSHOT: DANAHER CORPORATION 97
FIGURE 33 COMPANY SNAPSHOT: JOHNSON AND JOHNSON 103
FIGURE 34 COMPANY SNAPSHOT: F. HOFFMANN-LA ROCHE LTD. 106
FIGURE 35 COMPANY SNAPSHOT: SIEMENS AG 112

FIGURE 36 COMPANY SNAPSHOT: BECTON, DICKINSON AND COMPANY 118
FIGURE 37 COMPANY SNAPSHOT: BIOMÉRIEUX 123
FIGURE 38 COMPANY SNAPSHOT: BIO-RAD LABORATORIES, INC. 128
FIGURE 39 COMPANY SNAPSHOT: SYSMEX CORPORATION 133
FIGURE 40 COMPANY SNAPSHOT: THERMO FISHER SCIENTIFIC, INC. 139
FIGURE 41 COMPANY SNAPSHOT: QIAGEN N.V. 145

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