U.S. IVD Market to Exceed $9.5 Billion by 2017
This calendar year, IVD Technology readers clicked on this story —about the potentially very lucrative future of IVD —more than any other.
Molecular diagnostics, POC diagnostics, and hematology are expected to see continued growth.
The current IVD market includes immunochemistry, molecular diagnostics, blood donor screening, hematology, hemostasis, and point-of-care testing. As the IVD market evolves to become more efficient and less costly, a shift from manual testing to automated methods is essential. Furthermore, as patient care shifts from the hospital to the alternate care setting, IVD is likely to follow.
Overall market growth will be driven by the increasing prevalence of chronic diseases in the U.S. population, many of which require IVD testing. Therefore, over the forecast period, the market is expected to grow at a compound annual growth rate (CAGR) of 2.5% by 2017.
High Specificity of Molecular Testing Drives Market Growth. The molecular diagnostics market is expected to grow as more assays become FDA approved and testing shifts to molecular methods from microbiology or immunoassay disciplines. (See Figure 1.) Molecular diagnostics involves tests for the detection of nucleic acids, including DNA, RNA, and related proteins. The main areas of molecular diagnostic testing include infectious disease, genetic disease, and oncology testing.
Traditional testing methods to detect proteins lack the sensitivity necessary to detect minute amounts of protein that may be present in the early stages of the disease. Current methods include chemiluminescence and enzyme-linked immunosorbent assay (ELISA), which require higher concentrations of protein biomarkers. Thus these methods are only effective once the disease has progressed. As early detection of disease becomes more important, more sensitive methods, such as molecular testing, will gain popularity. Molecular testing methods can detect protein at concentration levels hundreds’ less than current immunoassay techniques, thus enabling earlier detection of disease and more-accurate monitoring of disease progression.
The infectious-disease assay market will be driven by the development of new assays for different diseases and conditions. The growth experienced a spike in 2010 due to the introduction of an FDA-approved assay for Herpes Simplex Virus (HSV; see Figure 2). Therefore the market for molecular diagnostics will grow at a CAGR of 2% to exceed $2.38 billion by 2017.
Point-of-Care Testing Continues to Grow Despite Uncertainty from Healthcare Reform. Point-of-care (POC) testing is defined as medical testing at or near the site of patient care. POC testing may also be done in alternate care settings including radiology/imaging centers, surgical centers and primary care and allows the physician to receive and deliver results in a shorter period of time than traditional laboratory testing.

The market for molecular diagnostics experienced a spike in 2010 due to the introduction of an FDA-approved assay for the Herpes Simplex Virus.
In 2010 healthcare reform legislation was implemented in the United States. Uncertainty as to the scope and changes that might result in healthcare caused many hospitals and physician office labs to delay equipment purchases. An annual excise tax on the sale of medical devices is expected to start in 2013. This may result in manufacturers getting customers to absorb the extra cost, thus increases in ASP and delays in new purchases are anticipated. However, strong growth in unit sales is expected at a CAGR of 6.1% over the forecast period, as physicians become more aware of the many benefits of POC testing.
Global Powerhouses Siemens and Roche lead U.S. Market. The IVD market is highly segmented, as many niche players hold market share in market sub-segments. (See Figure 1.) However, large international players such as Siemens, Roche, Beckman Coulter, and Abbott held significant shares due to their brand recognition and comprehensive portfolios.
In 2010 the leading competitor in the IVD market was Siemens Healthcare Diagnostics. It competed in five of the six market segments and was also the leader in the immunochemistry and hemostasis markets. Siemens offers a broad spectrum of products that can be used in conjunction with its solutions for automation and informatics.
In October 2010, Siemens announced a new three-year agreement with Premier Purchasing Partners, LP, the group purchasing unit of Premier Inc., for hemostasis, urinalysis, and microbiology systems and reagents. They are responsible for device purchases for more than 2400 member hospitals and nearly 70,000 additional healthcare sites in the United States. This contract will further increase Siemens' penetration in the hemostasis and urinalysis markets.
The second leading competitor was Roche Diagnostics. It was the leading competitor in the POC testing and molecular diagnostics markets, as well as the second leading competitor in the blood donor screening and immunochemistry markets.
In the POC testing market, Roche launched the Cobas b 123 POC system multi-parameter blood-gas analyzer for use at the point of care and in laboratories last year. Roche also launched several new products in 2010 within the molecular-diagnostics bloodborne virus assay market segment.
The information contained in this story is taken from a comprehensive report published by iData Research (, “U.S. In Vitro Diagnostics.” For more information and a free synopsis of the report, readers can contact iData Research at
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