The expiration of the Polymerase Chain Reaction (PCR) patent is set to offer growth opportunities for nucleic acid purification and amplification technologies, particularly for small companies, who can offer tests without developing a novel nucleic acid technology, which normally requires heavy R&D investment.
The expiry of the PCR patent is expected to have a dramatic effect on the market, especially academic research, which is highly price sensitive. Not only will the patent expiry lead to a rise in competition to reduce the PCR reagent cost and instrumentation, the segment will also see enhanced competition from cheaper products.
There is no doubt that the popularity of traditional nucleic acid separation methods such as plasmid isolation will threaten the dominance of nucleic amplification technologies (NATs) that are based on polymerase chain reaction (PCR).
This technique is so popular because manufacturers are not able to keep up with product line diversity caused by the number of organisms researched increasing exponentially.
The research community is finding itself relying on traditional nucleic acid separation methods, such as phenol-chloroform extraction.
Frost and Sullivan's latest report also takes into account funding resources becoming ever scarcer as researchers are looking for viable alternatives to meet their growing need for inexpensive sample preparation.
Most automated sample preparation instrumentation products cost more than $70,000 (€59,000) inhibiting widespread adoption of this technology. Although most academic budgets can cover this cost, maintenance contracts and consumable/reagent costs also need to be considered.
"Through the development of more sophisticated systems, the time currently spent on manual sample preparation and detection could be significantly reduced," said S. Ravi Shankar, Frost and Sullivan's industry analyst.
"A major trend in instrumentation systems is an increase in the number of manufacturers that are focusing on low-throughput isolation instrumentation," he added.
Despite the challenges faced the future of this technology is secure because of the intrinsic paradigm shift in research. As the scientific community transitions from sequencing to functional genomics, the report predicted there would be a greater need for consistently pure nucleic acid samples, which will drive demand for automated instrumentation products.
Low-throughput products are ideal for clinical laboratories where space and time are limited, but quality is essential.
In Europe, there is a move towards the smaller and medium throughput instruments. This is due to more European countries operating smaller and medium-sized laboratories, which do not process as large a number of samples as the United States.
The demand for nucleic acid-based amplification kits has boomed and is anticipated to continue over the next decade. This is mainly due to the completion of the human genome project and growing interest in molecular diagnostics.
The report also focused on amplification kits, all-in-one kits that reduce labour costs and molecular-based kits, which are far more efficient than earlier technologies.
All-in-one kits enable even regular laboratory technicians to carry out the experiments easily. Molecular kits also have emerged as highly attractive alternatives to serology- and immunology-based assays, due to their cost effectiveness.
Also, the need for quantitative assays due to Europe's increasing unmonitored population and EU's In Vitro Diagnostic Directive (IVDD) that requires approval will convince end users to favour commercial kits.
Overall, NAT's cost and the expected shift from genomics to proteomics may restrain the market a bit but its multiple benefits of cost-effectiveness and reduction in time as well as external factors such as EU directives and PCR patent expiry are expected to hoist this technology to new heights.
More information on the report: "European Advances in Nucleic Acid Purification and Amplification Technologies," is available here.