4 min readInsight into the European PCR market

Several procedures such as culture techniques, Immunoassays/Serology and Fluorescent In Situ Hybridisation (FISH) have been used to detect disease agents for many years. However amplification technologies such as polymerase chain reaction (PCR) have been shown to be very popular amongst end users and are creating a great amount of interest in the market place.

The history of PCR dates back to 1983, when it was developed by Kary Muller. PCR is a technique that can be used to amplify DNA fragments exponentially without using any living organisms. Due to the technological advances and increasing use of genomics and proteomics, PCR has become one of the most common techniques used in medical, biological research labs and for clinical purposes.

There has been a tremendous advancement in technology with regards to PCR. According to recent Frost & Sullivan analysis, the total European PCR reagent market for research applications was worth $302 million in 2007. Roche was the first to acquire rights to the PCR technology in 1991. The company also acquired rights to the use of Taq polymerase, a thermostable polymerase used in the synthesis of DNA copy. In the beginning Taq was the only enzyme that was used to carry out PCR. Nowadays thermostable DNA polymerase comes in different types, each having a unique benefit. Some are optimized for fast reactions, some have a lower error rate than Taq due to their proof reading capacity and some only become active at very high temperatures (95oC), thereby reducing the chances of mispriming. Some of the major players in the PCR reagents market for research purposes are Roche, Applied Biosystems, Qiagen, Invitrogen, Promega, Agilent Technologies, ThermoFischer, Bio-Rad and GE.

Similarly there has also been great advancement in the thermal cycler technologies. Roche’s LightCycler is a popular machine that can run a PCR in 16-30 minutes. Similarly Applied Biosystem’s 9800 Fast Thermal Cycler is a high speed instrument used for high throughput applications, whereas Cepheid’s SmartCycler and Bio-Rad’s iCycler IQ can perform four-colour real time PCR.

Feedback has shown that conventional PCR has been in the market for several years and is now heading towards a mature stage, while the benefits of qPCR are being realized and its market is in a growth stage. There are increasing price pressures from Eastern European and South American companies in the PCR reagents market. There are in fact many competitors selling very similar products. An increasing number of alliances and acquisitions between companies manufacturing PCR instrumentation and PCR reagents are therefore taking place in order to extend product lines and sell specialized and niche products. In 2006 Qiagen acquired Eppendorf’s reagents business, which included PCR reagents, and in 2007 Agilent Technology acquired Strategene, which had a pipeline of PCR reagents.

In relation to clinical diagnostics, PCR allows the highly specific detection and quantification of extremely low levels of disease agents. Subsequently, therapeutic management via monitoring of patients can be carried out. Viral-borne infectious diseases such as Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Human Papilloma Virus (HPV) and bacterial borne diseases such as Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and Mycobacteria tuberculosis (MTB) are receiving a lot of clinical attention. Tests to screen for hospital acquired infections such as Methicillin-resistant Staphylococcus aureus (MRSA) are also emerging as an important market. Similarly PCR used for genetic testing and transplant diagnostics are also increasing interest in the market.

Apart from PCR some of the other nucleic acid-based amplification technologies (NAT) are Branched DNA Technology (bDNA), Nucleic Acid Sequence Based Amplification (NASBA), Strand Displacement Amplification (SDA) and Transcription Mediated Amplification (TMA). The top 6 players in the NAT market are Roche Diagnostics, Abbott Diagnostics, Siemens Medical Solutions, Biomerieux, Becton, Dickinson and Gen-Probe, with the majority of their revenues being generated in the infectious disease segment. The NAT reagents market for clinical applications generated revenues of $432 in 2007, excluding blood screening. Frost & Sullivan believes it will grow at a CAGR of 15% in the period 2007-2014.

The fact that the NAT technology gives more accurate and sensitive results has made end-users realize its benefits. The increase in automation technology and the use of quantitative PCR (qPCR) and multiplexing gives a more user-friendly and fast method to diagnose disease states and medical disorders early on and gives a reliable tool for fast therapy decisions.

The use of NAT, which includes PCR for screening purposes, can increase the market size significantly. As an example, the incorporation of HPV tests in the healthcare system was a massive driver, and Frost & Sullivan’s research has indicated that the use of NAT reagents for HPV was growing at around 30% in 2007.

It is anticipated that due to the completion of the human genome project and the increasing number of biomarkers being identified, the number of tests that will be launched in the market will increase, especially for genetic testing and oncology.

Research has shown that regulatory bodies are opting for CE marked reagents as opposed to home brewed assays and non-approved kits. Hence launching CE marked PCR reagent kits can also drive this market.

Lastly, due to the expiry of the patent, the PCR technology is available in the public domain. This has increased the amount of innovation carried out by smaller companies. Companies no longer have to pay high license fees to Roche and hence many smaller companies are coming up with specialized diagnostic products that use PCR reagents and technology. This is leading to an increase in the market size of NAT reagents.

Despite the fact that the NAT reagents market is showing significant growth, market participants face several challenges. Firstly, the price for NAT reagents is still high. The alternative methods for clinical applications such as home brewed assays, Immunoassays, Fluorescence In Situ Hybridization and culture techniques are still less expensive than using NAT reagents. Many small laboratories therefore find these less expensive alternatives more attractive. ELISA, for example, is still used in many laboratories for the detection of HIV and culture techniques for GC and MTB are also still widely used.

Similarly, indirect costs associated with using NAT reagents are also high. The use of NAT technology requires highly skilled labour. Additionally the cost for instrumentation and the need for increased floor space also add to the budget. The reagent and material costs for commercial PCR assays are two to five times the cost of bacterial culture. Finally, reimbursement is also a major issue. Companies need to push hard to get their products reimbursed due to strict budgetary constraints in the healthcare environment.

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