In-Vitro Diagnostics Market Report Suite | United States | 2016-2022 | MedSuite

  • Year: 2016
  • Scope: 2012-2022
  • Region: United States
  • Pages: 245
  • Published Date: 11/1/2015
  • Type: MedSuite

The fastest-growing segment in 2015 was molecular diagnostics, which increased by 3.6% over the previous year. Growth in the molecular diagnostics market will be driven by increases in the number of Food and Drug Administration (FDA) approved tests and higher penetration of molecular testing in medium and small volume labs due to the decreasing costs. In addition, testing is expected to shift from other methods, such as microbiology and immunoassay, to molecular techniques due to their higher sensitivity and specificity.

Although the total POC market will witness a steady growth, a significant increase in POC test volumes is expected. This can be partly attributed to the cost containment provisions of the ACA, which introduced outcome-based reimbursements for accountable care organizations (ACOs), moving away from the fee-for-service reimbursement models held earlier. This is expected to result in decentralization of testing as hospitals try to save costs by decreasing the number of tests done in core labs and performing more tests during patient visits for early detection of diseases and to provide timely treatment.

This report also includes an analysis of other factors and trends that have positively and negatively impacted the market.

The U.S. in vitro diagnostics market includes analyzers and reagents used for performing assays in vitro, (Latin for “in glass”), which can be interpreted as a controlled environment outside of the living organism. In the context of medicine, in vitro diagnostics involves testing of bodily fluids for diseases, conditions or infections. Test results are then used for monitoring disease progress and effects of treatment, or aiding in the diagnosis of disease. In vitro diagnostic testing can be performed in a variety of different environments, ranging from hospital laboratories and commercial reference laboratories care to physician offices, imaging centers, non-laboratory health institution testing sites, blood banks and health maintenance organizations (HMOs).

In vitro diagnostics involves the testing of specimens such as blood, urine or other bodily fluids, along with analysis of specimen reactions with reagents. They are aimed at effectively, accurately and quickly obtaining readings that allow healthcare professionals to make appropriate decisions for patient care. In many cases, in vitro diagnostics plays a key role in influencing treatments and patient outcomes.
Sales of analyzer systems often involve some form of reagent rental agreement or contracts. As part of these contracts, manufacturers either give the analyzers to the customers for free or charge them a substantially low price, while locking them into a binding agreement for the purchase of reagents over a period of 2 to 7 years. The cost of the analyzer is recovered through the sales of reagents. At the end of the contract, the analyzer is either returned back to the manufacturer, or the contract is further extended or it is sold to the customer at lower price. More than 75 – 80% of the analyzers are placed in hospital labs and in independent commercial labs through these types of contracts. The rest of the analyzers are purchased directly from refurbished sellers. Due to inherent complexity and variability associated with these contracts from one customer to another, calculating the ASPs or market values for analyzers becomes challenging. Consequently, only units and growth rates are reported for the analyzer systems, while ASPs and market values are reported for the reagents, which also represent the ASPs and market sizing for a given segment. The only exception to this practice is found in the point of care (POC) testing, where the analyzers are usually purchased due to the relatively low cost of these instruments.

In Vitro Market Report Data Types Included

  • Unit Sales, Average Selling Prices, Market Value & Growth Trends
  • Forecasts Until 2022, and Historical Data to 2012
  • Market Drivers & Limiters for Each Device Segment
  • Competitive Analysis with Market Shares for Each Segment
  • Recent Mergers & Acquisitions
  • Disease Overviews and Demographic Information
  • Company Profiles, Product Portfolios and SWOT for Top Competitors
  • Related Press Releases from Top Competitors

In Vitro Companies Analyzed

The leading competitor in the IVD market was Roche Diagnostics, especially in the molecular diagnostics markets. They were also the second-leading competitor in the immunochemistry, POC testing and blood donor screening markets. Within the molecular diagnostics market, they dominated the blood-borne virus assay and thrombophilia assay segments. In 2014, FDA approved Roche’s Cobas®HPV Test for primary screening of cervical cancer. This development is expected to significantly boost Roche’s share in the future and pose a threat to Qiagen’s dominance in HPV market.

In 2015, the second-leading competitor in the IVD market was Siemens Healthcare Diagnostics. They competed in five of the six segments, leading the immunochemistry and hemostasis markets. Siemens offers a broad spectrum of products that can be used in conjunction with their solutions for automation and informatics.

Companies also researched in this report includes Siemens Healthcare Diagnostics, Abbott Diagnostics, Hologic, Myriad Genetics, Genomic Health, Ortho Clinical Diagnostics, Sysmex America, Cephied, Becton Dickinson, Diagnostica Stago, Diamond Diagnostics, Dynex Technologies, Hycor Biomedical, Inova Diagnostics, Luminex, MDxHealth, Mindray North America, Nova Biomedical, Quest Diagnostics, Quidel Corproation, Randox Laboratories, Tosoh Bioscience and various others.

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The "US Market Report Suite for In-Vitro Diagnostic Devices 2016 - MedSuite" includes analysis on the following companies currently active in this market:
Alfa Wasserman
Aurora Biomed
AutoGenomics Inc.
Awareness Technology
Becton Dickinson
Bio/Data Corporation
Carolina Liquid Chemistry
Chrono-Log Corporation
Diagnostica Stago
Diamond Diagnostics
Drucker Diagnostics
Dynex Technologies
Elitech Group
Focus Diagnostics
GenMark Diagnostics
Grifols USA
HTG Molecular Diagnostics
Illumina Inc.
Immunodiagnostic Systems
Inova Diagnostics
Jant Pharmacal Corporation
Medica Corporation
Meridian Bioscience
Mindray North America
Nanostring Technologies
National Genetics Institute
Nova Biomedical
OPTI Medical
Pathwork Diagnostics
Plasma Services
Quest Diagnostics
Quidel Corporation
Randox Laboratories
ThermoFisher Scientific
Third Wave Technologies Inc.

*Not all companies are currently active in every segment or sub-report from this suite. For more details contact an iData Research Product Advisor.

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