Spurred by new technologies and growth in emerging regions, the world market for in-vitro diagnostics (IVD), estimated at $42 billion in 2007, is expected to grow 6 percent annually through 2012, according to a report by market research firm Kalorama Information.
After tremendous consolidation in the IVD industry, just 16 top-tier companies own 86 percent of the market. Compartively, 18 top-tier companies held 72 percent of the market in 2005, according to the report.
Of particular significance, the report noted the 2007 Siemens Medical Diagnostics’ acquisition of DPC, Dade Behring and Bayer Diagnostics. While the top companies will continue to reign, they will experience single-digit growth, driven by the second-tier niche players, according to the report.
Technologically, the report said that IVD market has also changed dramatically due to advances in functional genomics, bioinformatics, microelectronics, test device miniaturization and new features, such as wireless capability. Also, the publication of the human genome project makes it possible to link specific genes to disease risks, creating a significant opportunity for IVD makers.
“Technological advances, specifically those in device miniaturization, data digitization and the internet, form a technical synergy that will permit IVD tests and devices to maintain a central role in disease management,” said Shara Rosen, a Kalorama analyst. “By 2015, many IVD analyses, both lab-based and those designed for point-of-care testing, will use some variation of miniaturization and ‘chip’ techniques.”
Kalorama reported that IVD product development is being influenced by several factors, including the increasing need for accurate data and rapid test results, rising healthcare costs and managed care’s obsession with cost reductions, which is pushing the need for decentralized near patient testing. An emphasis on outcomes-based disease management dictates that new tests must prove their added value to patient care, affecting how many and which tests are recommended and thus, reimbursed.
“Healthcare today is driven by data,” Rosen said. “Regardless of how novel an approach may be, there must be data to support its use.”