IVD Industry Overview
A report by Kalorama Information (New York), “The Worldwide Market for In Vitro Diagnostic Tests,” concluded that the future for immunoassays is a mixed bag. In the clinical laboratory, mature assays will show moderate growth while emerging assays will fuel most of the growth in this IVD segment. However, all immunoassays will have to pass the test of medical research to demonstrate their contributions to improving patient outcomes. For example, increased knowledge of disease...
“Unfair,” “counterproductive,” and “onerous” were some of the choice words used to express the IVD industry's reactions to and feelings about the potentially devastating bomb that was dropped on its doorstep last fall. In September, Senator Max Baucus (D-MT), chairman of the Senate Finance Committee, introduced the committee's healthcare reform legislation. Among the various methods proposed in the bill to pay for the healthcare reforms was a $4 billion tax...
Life sciences had a solid third quarter of 2009 in venture capital (VC) investment relative to other industry sectors. A late-October report by PriceWaterhouseCoopers indicates that the biotech industry received the highest level of funding for all industries in the quarter with $905 million going into 104 deals. (The report includes private, emerging companies only.) This level of investment reflects a 4% decrease in dollars but a 16% increase in deals compared to the previous quarter, when...
A report issued in September by the Lewin Group and cofunded by AdvaMed and ACLA finds the contributions of clinical lab screening and diagnostic tests to overall healthcare quality and outcomes “substantial.” The authors state that “innovation, demonstrated clinical benefit, and appropriate use of laboratory screening and diagnostic tests are essential for achieving the goals of health system reform.” They also cite the importance of clinical lab testing in making...
          The market for infectious disease diagnostics in the United States makes up a significant part of the IVD market. In 2005, the total market size for infectious disease diagnostics was more than $6 billion, increasing at a compound annual growth rate of 9% at that time. Molecular testing has seen the most significant rate of growth. In 2008, the market for infectious disease diagnostics was $8.4 billion, and it is expected to increase to $12.4 billion by 2013...
          While the underlying theme in the IVD industry during the past few years had been consolidation, this year's theme has been surviving the global recession. Nonetheless, some industry analysts believe that the IVD market will not be stalled by economic conditions for a variety of reasons. For example, Kalorama Information (New York City) says it sees no reason to revise its forecast of a $56 billion industry by 2012.   “The economic conditions have...
        Photo by Jeffrey A. Davis Photography. IVD manufacturers might well be forgiven if they do not have ready answers to questions right now about what their product-development challenges will be during the next six to twelve months. The uncertainty in the global economy during the past couple of years has made a shambles of corporate planning in many business sectors. And despite slight improvements in economic conditions, IVD manufacturers continue to feel...
                    The American Civil Liberties Union (ACLU; New York City) and the Public Patent Foundation (New York City) filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer not only stifle research that could lead to cures but also limit women's options regarding their medical care.   ACLU filed the lawsuit in the U.S. District Court for the Southern District of New York on...
      Photo by iStockPhoto. Senators Edward M. Kennedy (D-MA) and Kay Bailey Hutchison (R-TX) introduced the 21st Century Cancer Access to Lifesaving Early Detection, Research, and Treatment (ALERT) Act (S. 717), which comprehensively addresses the challenges in battling cancer. This bill is the first sweeping cancer legislation introduced since the 1971 National Cancer Act, which was also authored by Kennedy.   The bill aims to provide critical funding for...
    TRENDS & PERSPECTIVES     Estimated to grow from $3.4 billion in 2007 to $4.7 billion in 2013, with a compound annual growth rate of 5.4%, the liquid chromatography (LC) market is seeing plenty of technological advances, according to a report from Kalorama Information (New York City). Although the market has been mature for quite awhile, companies have continued to introduce new systems that perform fast LC and ultra-high-pressure LC (UHPLC). The industry's goals are...