US In Vitro Diagnostics Market by Technology (Immunoassay, Clinical Chemistry, Molecular Diagnostics, Microbiology), Application (Infectious Diseases, Diabetes, Cancer, Cardiology), End User (Hospitals & Laboratories) & Region
The US In Vitro Diagnostics Market size is projected to grow 4.7%. The growth of the market can be attributed to the rising incidence of chronic and infectious diseases in the US, 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. IVD technologies being used in many applications such as infectious diseases, diabetes, oncology, cardiology, endocrine disorders, autoimmune diseases, bone & mineral disorders, pulmonary disorders, and others.
Market Dynamics
Drivers
- Rapid growth in geriatric population and increasing incidence of chronic diseases
- Increasing adoption of point-of-care (POC) testing
- Growing awareness on personalized medicine
- Implementation of the Affordable Care Act (ACA)
- Increasing adoption of automated instruments and automation in laboratories
Restraints
- Unfavorable reimbursement scenario
- Rising healthcare cost and low budgets
Opportunities
- Condition-specific markers and tests
Challenges
- Stringent regulatory framework
Growing Awareness On Personalized Medicine Drive The Us IVD Market
Growing patient awareness for personalized medicine is one of the key factors resulting in the increased use of molecular diagnostics and IVD technologies. Diagnostic tests, especially those that provide rapid or real-time results are an essential part of individualized treatment regimens for many chronic diseases and conditions. These tests enable physicians to make an informed clinical decision and reduce the likelihood of unnecessary adverse events. Some of the most widely used personalized treatment regimens include HbA1c tests (glycated hemoglobin) for monitoring diabetes; therapeutic drug monitoring tests to select drugs for resistant HIV strains; cholesterol (and other lipid) testing to monitor the effectiveness of lipid lowering therapy; and so on. Personalized medicine also involves pharmacogenomics testing. In a March 2012 survey conducted by the United Health Center for Health Reform & Modernization, more than 75% respondents agreed that genetic testing allowed physicians to offer personalized treatment. The survey also stated that the U.S. currently spends USD 5 billion on genetic tests, which could reach USD 25 billion by 2021. Hence, an increase in the uptake of personalized medicine approach is expected to drive the growth of the IVD technologies market in the U.S. in the coming years.
Increasing Adoption Of Automated Instruments And Automation In Laboratories- Opening New Avenues For Growth In Us Ivd Market
The market is gaining traction due to the increasing adoption of fully automated instruments in diagnostic laboratories. As compared to manual and semi-automated instruments, automated instruments are more scalable, meet high performance levels, help in decreasing the hands-on time of technologists, eliminate batch testing, and deliver faster results to physicians. Due to these advantages, market players are increasingly focusing on developing automated instruments. Moreover, automation in laboratories enables, expedites, and increases the efficiency and effectiveness of diagnostic tests in laboratories. Total lab automation system is capable of handling all aspects of the testing process, from the loading of specimen tubes to generating results for all major lab disciplines. The advancement of lab automation in the clinical diagnostics industry is continuing to expand as more manufacturers are entering the market with expanded automation options. A shortage of lab personnel and increase in test volumes in the industry require labs to perform more tests with fewer personnel; this has fueled the necessity for the increased adoption and use of laboratory automation in the U.S.
In vitro diagnostics (IVD) are laboratory tests that are performed to diagnose diseases and medical conditions, and to monitor the clinical status of a patient. IVD tests are performed in an artificial environment on various samples, such as blood, urine, and cells or other tissues collected from a patient. The IVD technologies market covering various products and services instruments, reagents, data management software, and services (including support and maintenance services)
The U.S. IVD market has been segmented, on the basis of products & services. The instruments segment is subsegmented into fully automated, semi-automated, and other instruments. The market for fully automated instruments segment is expected to grow at the highest CAGR between 2015 and 2020. The increasing need for faster and accurate test results with minimal human intervention is driving the greater adoption of fully automated IVD instruments among various end users.
The U.S. IVD market in Midwest region is expected to grow at the highest CAGR during the forecast period. The growth of this region is primarily 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. As a result, Midwest region holds a significant share of the overall U.S. IVD market
Applications such as infectious diseases, bone and mineral-related diseases, endocrine diseases, cardiovascular disorders, pulmonary disorders, cancer, diabetes, autoimmune diseases, and other diseases drive the growth of U.S. IVD market
Infectious Diseases
The rising incidence of various infectious diseases, such as TB, hepatitis, and AIDS, coupled with the growing rate of hospital-acquired infections, have fueled the demand for IVD tests over the last few years. According to the CDC, in 2013, an estimated 47,352 individuals were diagnosed with HIV infection in the US. In the same year, an estimated 26,688 individuals were diagnosed with AIDS. Moreover, according to a Healthline Media article, about 1,155,792 people in the US have been diagnosed with AIDS till date.
Critical questions the report answers:
- Where will all these developments take the industry in the mid to long term?
- What are the upcoming industry applications for IVD products?
Unfavorable reimbursement scenario and rising healthcare costs and low budgets are major factor restraining the growth of the market. The reimbursement scenario in the US is a major factor restricting the growth of the IVD market. Medicare revised its reimbursement mechanism for some IVD tests, including molecular pathology tests, in 2012. Some of these molecular pathology tests do not have their own Healthcare Common Procedure Coding System (HCPCS) codes and are instead billed using unlisted codes for which Medicare Administrative Contractors (MACs) establish a payment amount for their local jurisdictions. This will adversely affect the US nucleic acid testing (NAT) market, which will in turn hinder growth in the IVD market.
The U.S. IVD market comprises a network of players involved in the research and product development; raw material supply; component manufacturing; distribution and sale; and post-sales services. Key players considered in the analysis of the computer assisted coding market are Roche Diagnostics (Switzerland), Abbott Laboratories (US), Siemens Healthineers (Germany), Danaher Corporation (US), and Thermo Fisher Scientific (US). Some of the other major players in this market include Johnson & Johnson (US), Ortho-Clinical Diagnostics (US), Sysmex Corporation (Japan), Bio-Rad Laboratories (US), bioMérieux (France), QIAGEN (Netherlands), and Becton, Dickinson and Company (US).
Major Market Developments
- In October 2017, Abbott Laboratories (US) acquired Alere Inc. (US). This acquisition is expected to leverage Abbott’s point-of-care testing business and significantly strengthen its diagnostics presence across the globe, including the US.
- In November 2015, Roche (Switzerland) launched the VENTANA HE 600 system, the latest fully automated hematoxylin and eosin (H&E) tissue staining system that enhances patient and technician safety and produces exceptional staining quality.
- In March 2015, Siemens Healthineers launched three new scalable hematology systems—the ADVIA 360, 560, and 560 AL. These systems helped enhance the company’s product portfolio.
- In March 2015, Siemens Healthineers introduced two new advanced urine-testing solutions for US central laboratories—the CLINITEK Novus Automated Urine Chemistry Analyzer and the CLINITEK AUWi PRO Automated Urine Workstation. These product launches helped expand the company’s automated chemistry analyzers portfolio and gain a market share.
Target Audience
- IVD Product Manufacturers
- Group Purchase Organizations (GPOs)
- OEM Manufacturers
- Independent Reference Laboratories
- Pathology Laboratories
- Distributors of IVD Products
- Hospitals and Clinics
- Healthcare Institutions
- Research Institutes
- Market research and consulting firms
- Venture capitalists and investors
US In Vitro Diagnostics Market Report Scope
By Products & Services
- Reagents
-
Instrument
- Fully Automated Instruments
- Semi-automated Instruments
- Others
- Data Management Systems/Software
- Services
By Technology
- Clinical Chemistry
- Immunochemistry/Immunoassay
- Hematology
- Coagulation & Hemostasis
- Microbiology
- Molecular Diagnostics (MDx)
- Other Instruments
By Application
- Infectious Diseases
- Diabetes
- Oncology/Cancer
- Cardiology
- Endocrine Disorders
- Autoimmune Diseases
- Bone & Mineral Disorders
- Pulmonary Disorders
- Others
By End User
- Hospital Laboratories
-
Clinical/Independent Laboratories
- Large Laboratories
- Medium-sized Laboratories
- Small Laboratories
- Others
By Region
-
Hospital Laboratories Market
- South
- Midwest
- West
- Northeast
-
Clinical/Independent Laboratories
- South
- Midwest
- West
- Northeast
-
Others
- South
- Midwest
- West
- Northeast
Critical questions which the report answers
- What are new application areas which the IVD companies are exploring?
- Which are the key players in the market and how intense is the competition?
Frequently Asked Questions (FAQ):
What is the size of US In Vitro Diagnostics Market ?
The global US In Vitro Diagnostics Market size is growing at a CAGR of 4.7%
What are the major growth factors of US In Vitro Diagnostics Market ?
The growth of the market can be attributed to the rising incidence of chronic and infectious diseases in the US, 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.
Who all are the prominent players of US In Vitro Diagnostics Market ?
Key players considered in the analysis of the computer assisted coding market are Roche Diagnostics (Switzerland), Abbott Laboratories (US), Siemens Healthineers (Germany), Danaher Corporation (US), and Thermo Fisher Scientific (US). Some of the other major players in this market include Johnson & Johnson (US), Ortho-Clinical Diagnostics (US), Sysmex Corporation (Japan), Bio-Rad Laboratories (US), bioMérieux (France), QIAGEN (Netherlands), and Becton, Dickinson and Company (US). .
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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¨¦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¨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 (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 ¡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.
The following are the major objectives of the study.
- To define, describe, and forecast the U.S. in vitro diagnostics (IVD) market on the basis of products & services, technologies, applications, and end users
- To provide detailed information regarding major factors influencing growth of the U.S. IVD market (drivers, restraints, opportunities, challenges, and industry trends)
- To strategically analyze various segments and subsegments covered in the study with respect to individual growth trends, future prospects, and contributions to the overall market
- To analyze opportunities in the U.S. IVD market for stakeholders and provide details of the competitive landscape for market leaders
- To strategically profile the key players in this market and comprehensively analyze their market shares and core competencies
- To forecast the market size of the U.S. IVD market
- To track and analyze competitive developments such as expansions, joint ventures, mergers and acquisitions, new product developments, agreements and partnerships, and research and development activities of the leading players in the market.
During this research study, major players operating in the U.S. IVD market in various regions have been identified, and their offerings, regional presence, and distribution channels have been analyzed through in-depth discussions. Top-down and bottom-up approaches have been used to determine the overall market size. Sizes of the other individual markets have been estimated using the percentage splits obtained through secondary sources such as Hoovers, Bloomberg BusinessWeek, and Factiva, along with primary respondents. The entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews with industry experts such as CEOs, VPs, directors, and marketing executives for key insights (both qualitative and quantitative) pertaining to the market. The figure below shows the breakdown of the primaries on the basis of the company type, designation, and region considered during the research study.
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Growth opportunities and latent adjacency in US In Vitro Diagnostics Market