Hundreds of millions of formalin-fixed, paraffin-embedded (FFPE) archive specimens available globally have piqued tremendous interest for biomarker validation studies, generating a surge in demand for FFPE sample prep solutions. FFPE archive specimens from patients with known clinical outcomes provide an economic and readily available source for the biomarker validation needed to develop clinical molecular cancer tests.
Analysis from Frost & Sullivan's (clinicaldiagnostics.frost.com) Demand Analysis of U.S. Cancer Sample Prep Market research finds that automated sample prep systems developed specifically for FFPE provide greater sample throughput and satisfy the requirements of various end users.
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Archived tissues are Institutional Review Board (IRB) exempt and are a feasible alternative to validating biomarkers when compared to costly prospective clinical trials. Therefore, pharmaceutical companies and research institutes are employing FFPE services for their pharmacogenomics programs.
"Translational research using FFPE archive specimens is helping to produce an expanding menu of future molecular-based cancer testing," said Frost & Sullivan Industry Analyst Winny Tan. "A Frost & Sullivan survey of molecular pathology labs in the United States reveals that nucleic acid extraction from FFPE specimens is poised for more than 20 percent volume growth in the next three years."
Molecular sample prep vendors have offered kits for FFPE specimens for the last three to five years. Process automation signals the brink of a market expansion fueled by the increased throughput. Additionally, clinical molecular tests for serine/threonine-protein kinase B-Raf (BRAF) and GTPase Kras (KRAS) gene biomarkers, as well as for epidermal growth factor receptor (EGFR), are driving the demand for the FFPE sample preps.
Sample prep for FFPE specimens that produce nucleic acid extractions of high purity and yield will become even more critical for downstream molecular testing. The clinical labs surveyed by Frost & Sullivan anticipate an inevitable integration of molecular extraction techniques with the long FFPE legacy that exists in solid tumor diagnostics.
However, growth of this market is hindered by the limited number of sites where molecular pathology is performed as well as the slow adoption of FFPE sample prep automation by hospital laboratories. Further, hospital budgets are restricted, and investments for FFPE sample prep automation compete with other top priorities, such as the implementation of electronic medical records. Despite these factors, the hospital segment is far from saturation, as it has long-term potential.
The FFPE sample prep automation market targets a variety of end user segments with different needs, applications, and perceptions; therefore, a strong understanding of relevant product specifications is critical for capitalizing on the market opportunity. Vendors must remain attentive to genomic analysis trends and emerging applications to keep pace with changing customer needs in specimen types, protocol customization and throughput.
"Since the larger application segment for the FFPE sample prep automation market is research on FFPE archival specimens, FFPE sample prep vendors should align their products with the pricing and technological needs of customers in this segment," said Tan. "Vendors could serve more customer segments by offering multiple automation systems that vary in batch size and options. Such choices would also provide multiple price points to match customers' budgets."
Demand Analysis of U.S. Cancer Sample Prep Market is part of the Life Sciences Growth Partnership Services program, which also includes research in the following markets: U.S. Tissue Diagnostics Market, U.S. Nucleic Acid Purification and Isolation Market, and U.S. MicroRNA Market and Strategic Analysis of U.S. MicroRNA Services Market. All research services included in subscriptions provide detailed market opportunities and industry trends evaluated following extensive interviews with market participants.
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Demand Analysis of U.S. Cancer Sample Prep Market / N9BB-55