Surge in nucleic acid-based amplification

Burgeoning growth in the uptake of nucleic acid-based amplification test (NAT) kits is sweeping both the clinical and the research sector, fuelled by the technology's ability to supply increasingly early and accurate diagnosis.

Already playing an integral role in today's life sciences, ground-breaking inroads projected to be made into amplification techniques will provide yet further evidence of the market's continuing importance.

The associated benefit of reduced therapeutic outlay will boost penetration of NAT kits.

More crucially, the employment of NATs in the determination of chlamydia trachomatis (CT) infections, highly prevalent across Europe, has powered sales momentum in the market.

Quantitative monitoring tests are expected to be deployed more widely in the detection of Hepatitis C (HCV), following the recent encouraging results obtained from costly combination therapy drug treatment of sufferers, further adding lustre to the overall market.

An upbeat forecast issued by Frost and Sullivan, the international marketing consulting company, this week, values revenues amassed in the European nucleic acid-based amplification kits market at over $330 million in 2001, forecast to reach $715 million by 2008.

Almost on a par with the clinical kits segment, the market for research kits amassed approximately $170 million, just over 50% of total market sales.

"For the time being," emphasises Alex Wong, research analyst at Frost and Sullivan, "mainly virology-based quantitative NATs have been developed, permitting viral load monitoring - essential to cost-effective therapeutic management of virus-borne diseases.

Tests based on disease markers yet to be comprehensively catered for, coupled with the impact of emerging technologies such as microchips, are expected to stimulate market growth in the future." The saturated and highly fragmented research kits market is nearing maturity, with growth being vigorously sustained by sales of kits based on quantitative real-time technology.

Greater advancements driving the biotechnology and pharmaceutical industries will further accelerate growth in the research kits sector.

Polymerase chain reaction (PCR) kits required for microchip and single nucleotide polymorphisms (SNP) analysis are expected to be a key contributor to the research sector's buoyancy.

Growing demand for quantitation indicates that real-time PCR kits, in particular, are driving the growth of the research kits market.

"In the wake of the completion of the Human Genome Project, and indeed in the lead up to it, the number of reactions carried out have been steadily rising," Mr Wong points out.

"Prompted by the rich rewards of possible patents, there has been a rush to analyse genes and their functions.

Consequently, the demand for nucleic acid-based amplification kits has boomed and will continue to outstrip expectations." In light of the surge in nucleic acid-based amplification reactions carried out in Europe, the number of kits and reagents required to statisfy the growing level of high-throughput techniques performed by the biotechnology and pharmaceutical industries, is poised to soar. Owing to curtailed budgets, researchers have become increasingly inclined to create their own in-house home-brew assays, especially for repeated basic routine experiments.

With limited expenditure on consumables, a large proportion of end-users aims to identify the most competitively-priced supplier.

This trend will continue to have an adverse effect on sales growth over the forecast period.

The performance of the HIV market has been crucial to the success of clinical kits and continues to entice sales.

The study underlines the substantially greater magnitude of the market for stand-alone consumables in comparison with individual PCR-based kits.

"The rising uptake of nucleic acid-based amplification tests across Europe accentuates the market's attractive growth prospects," Mr Wong reports. "Conventional serology-based tests are now second choice behind the more sensitive and specific NATs.

Since these molecular tests are significantly more expensive than immunoassays, their increased consumption will result in remarkable market revenue growth." Molecular kits have emerged as an increasingly popular alternative to serology- and immunology-based assays, for virus-borne diseases such as HIV and hepatitis, as well as for chlamydia.

With some molecular tests for pathogen detection now considered as the 'gold standard', such as Roche's PCR for HCV, consumption of nucleic acid-based amplification kits is set to expand.

Frost and Sullivan attributes a large share of the clinical sector's fortunes to the high cost of therapeutics, which necessitates tighter monitoring of patient reactions to the treatment, in order to institute necessary changes in therapy.

Mr Wong explains: "Combination therapies for HCV via the use of pegylated interferon, alpha-2a and ribavirin, are showing encouraging results, however, treatment remains very expensive. Monitoring kits have allowed the progress of treatment to be followed, giving early indications of therapy efficacy.

Thus, treament of a disease is becoming more individualised and tailor-made, resulting in more cost-efficient disease management. With viral load assays being implemented throughout Europe, this will provide the market with a long-term fillip." Despite the clinical sector's rosy growth prospects, Frost and Sullivan cautions that endeavours among new arrivals on the clinical kits stage to deepen their market penetration are being hampered by the established players' existent technology patents.

This is reflected by the lack of competition in this market, giving rise to consistently high prices for kits.

The Taq polymerase case still remains unresolved, but at the time of writing, it appears that the European Patents Office is likely to uphold the patents.

Following appeals by Hoffman-La Roche, the current patent holder, the PCR kits market is not anticipated to experience major changes to the present market situation.

There are currently 20 main companies in the total European nucleic acid-based amplification kits market.

The research kits market is highly fragmented, composed of 16 companies, while only six are currently present in the clinical kits market.

Only two multinational heavyweights, Roche Diagnostics and BD Diagnostic Systems, are active in both clinical and research markets, with Roche ranking in top position as the dominant force across the competitive environment.

In terms of competitors, the clinical kits market is scarcely populated, due to the patents to the amplification technologies employed in disease diagnostics being owned by the six different companies.

However, bearing in mind that the patent for the PCR technique is expected to expire towards the end of the forecast period, the number of new entrants to the NAT market is likely to heighten, particularly in the research sector.

Abbott Diagnostics, BioMérieux, Bayer Diagnostics and Gen-Probe count amongst the remaining four major contenders in the NAT arena, the study concludes.