The US IVD Market is valued at USD 20.7 billion in 2015 and is expected to register a CAGR of 4.7% to reach to USD 26.0 billion by 2020. 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. The base year considered for the study is 2014, and the forecast has been provided for the period between 2015 and 2020.

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

Challenge

Stringent regulatory framework

Growing Awareness On Personalised 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.

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.

To know about the assumptions considered for the study, download the pdf brochure

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), bioM�rieux (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

Report Scope

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



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?

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. The growth of the market can be attributed to 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.

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.

Key players in the US IVD Market include Roche Diagnostics (Switzerland), Abbott Laboratories (US), Siemens Healthineers (Germany), Danaher Corporation (US), and Thermo Fisher Scientific (US). Other players include Johnson & Johnson (US), Sysmex Corporation (Japan), Bio-Rad Laboratories (US), bioM�rieux (France), QIAGEN (Netherlands), and Becton, Dickinson and Company (US) among others. These players are increasingly undertaking mergers and acquisitions, and product launches to develop and introduce new IVD products in the market.

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