6 min readSmall Things Getting Big Importance

Size is becoming one of the key success factors today across many industries in this shrinking world. From cars to iPods, we see size and opportunity becoming more inversely proportional. Healthcare sector is no different in this trend. When it comes to instruments used in research/ diagnostics laboratories or even in point-of-care setting, reducing the foot print is given a top priority. Advancements in the development of micro total analysis systems (uTAS or mTAS) or lab-on-chip has slowly gained importance in various fields of which lifesciences is one of the major application areas.

The European lab-on-chip and microfluidics market generated revenues of $660 million in 2008, with an annual growth rate of 12 per cent. This article aims to understand and analyse some of the major factors that is impacting the growth of this market.

Driving Factors in the Market

A. Inherent Advantages of Microfluidics Drive Adoption

The adoption of microfluidics by pharmaceutical companies provides them multiple benefits such as improved data quality, economical reagent consumption and cost reduction and speeding up of drug discovery processes, ultimately shortening the time-to-market of a drug. Microfluidics significantly reduces the time and cost of producing large amounts of biological material, such as proteins or enzymes for drug screening, by reducing the amount of material required. This helps drug developing companies to cut down on initial expenses of drug development, but at the same time gain speed for bringing a drug into the market. Its meritorious features such as increased sensitivity, mobility and efficiency are likely to favour the technology’s deployment by private and public health sectors. For end users, both in the research and medical sector, the functional superiority of this technology is likely to outweigh the cost issues.

B. Mass Producibility of BioMEMS Devices Facilitates Cost Reduction and Disposability

BioMEMS devices have been applied to a variety of steps in the drug discovery pathway. Through the use of MEMS technology it is currently possible to integrate multiple functional units together in a single chip. This facilitates multiple and complex analytical protocols to be conducted in a rapid and inexpensive manner, most of which traditionally were done using different bulky instruments. The compact nature of the MEMS technology, thus, allows mass production of such micro sized devices ultimately leading to reduction in costs of single unit components. In addition to this, it also allows effective sample mixing and separation by permitting highly accurate and repeatable dimensional control. The cost reduction in turn will pave way for single-use disposable devices, which is likely to aid in preventing risks arising from cross-contamination due to reuse.

The above chart depicts the market size of major application areas of lab-on-chip and microfluidics in the lifesciences market, Europe 2008. Source: Frost & Sullivan

C. Flexibility and Applicability Benefits Enhances Uptake

The adoption rate of a technology increases with its flexibility to be interfaced with multiple methods and related biological research experiments. This is achieved by the use of and microfluidics. For example, microfluidics enables the integration of multiple processes such as sample preparation, DNA extraction and detection of a gene mutation in a single chip. This ultimately leads to significant reduction in processing time, reduces the risk of sample loss or contamination and eliminates the need for costly and bulky laboratory instruments. Additionally, microfluidics technology has a wide range of applications especially in fields of point-of-care diagnostics, high-throughput screening, DNA analysis, protein analysis, cell-based assays and bioterrorism efforts.

D. Simplification of Tedious Protein Assays Makes Microfluidic Technologies Particularly Attractive to the Biotechnology Sector

The trend that has been witnessed over the last decade is that protein therapeutics is gaining greater traction and is a major driver in itself for all the core proteomic technologies and enabling technologies such as microfluidics. Having said that, the increasingly stringent regulatory demands placed on very early toxicity testing is another indirect driver for microfluidics. These toxicity testing procedures are very tedious if performed using conventional techniques such as animal testing and enzyme-linked immunosorbent assay (ELISA). On a microfluidic scale, these tests and assays are performed much more easily and quickly saving the biotechnology companies’ several months of project time. Although microfluidics cannot completely replace animal testing, it definitely does complement it very well, as a plethora of assays can be performed by using blood from just one animal due to small sample requirement. It also improves the standard of testing as opposed to many different animals. Time savings also ensue from the fact that waiting time for the same animal to recover between one blood sample drawing and the subsequent one is slashed several fold as all the tests can be performed with just one blood sample if the microfluidic platform is used.

E. Some High-throughput Laboratories are Reaching their Limits with Existing Instruments

In certain companies such as those in biotechnology and pharmaceutical sectors, which have been using automation technologies extensively, some labs are reaching the point where new bottlenecks can no longer be solved with existing products. The main reason for this relates to the liquid handling capabilities of most automation products, which are limited beyond small volumes in the low nanolitre range or below. This need is being met to some extent with the introduction of certain new liquid handling products with lower sensitivities. It is also well known by experienced end users in these segments that proportional efficiency gains are not always achieved by automation to the full extent against what is anticipated before implementation. In other words, bottlenecks tend to move around rather than disappear. As laboratories continue to upgrade their automated systems, they are finding that certain bottlenecks can no longer be eliminated, moved, decreased or the like. An increasing number of these laboratories are expected to look at adding microfluidics technology as the most appealing solution. As automated laboratories tend to be more technically advanced and forward thinking, they are more prone to adopt a novel technology. At the same time, open technologies and standards will play a major role in driving the acceptance rate.

Restraining Factors in the Market

A. Interoperability with Existing Laboratory Equipment is a Major Stumbling Block to Ready Uptake of Microfluidics

Considering the fact that existing laboratory equipment will operate at a much larger scale than the microfluidics instruments, comparing results from these two different platforms is likely to prove a major challenge. Besides, on the same lines, incorporating microfluidic devices into existing workflows is a major stumble block to the adoption of microfluidics into regularised drug screening and discovery workflows. Considering drug screening and discovery is a decade long process, it is likely to pose significant challenges on scientists to incorporate lab-on-chip devices into on-going programmes. That leaves people wondering how long it is likely to take before microfluidic devices are adopted for mainstream screening processes. The first lab-on-chip screening equipment entered the market about five years ago. Therefore, if assumed that from then on, all new drug screening programmes started using microfluidic platforms, it is likely to take about 10 to 15 more years before this technology is expected to potentially completely replace conventional macro-scale research instrumentation. Until such a scenario presents itself, the lab-on-chip manufacturers are likely to witness sporadic instalments due to which they will be side-lined by conventional technology-providers.

B. Automation of Established Technologies Restrains the Growth of the Emerging Lab-on-chip Technology

The main competitors for microfluidics manufacturers are the automation and instrument manufacturers, more so than the companies in the microfluidics market. This is due to the fact that providers of conventional drug discovery and diagnostic technologies are infusing greater levels of automation and miniaturisation into their products. The lab-on-chip industry participants have been cautious enough to steer clear of the applications developed by others in the industry. In addition to the automated instruments that the vendors of conventional technologies offer, they are also offering increasingly high-density microplates. Microplates such as 384, and 1536 are being offered in addition to the pre-existing 96 well microplates, which addresses quite effectively the throughput issue surrounding these technologies. Ultimately limits will be reached due to evaporation and other issues but this will not trickle through to the mid and late adopters for a few years yet. Auto samplers, fraction collectors and similar products are not very new but what is new is the convergence of instrument features, robotic capabilities and other new auxiliary equipment that allow more choice in incremental advances in efficiency.

C. Hostile Intellectual Property (IP) Environment Hinders Growth

This mainly refers to the patenting of genes and proteins. Although the microfluidics market has experienced a large amount of IP litigation, most of those cases have been settled. Nonetheless, companies must be aware of the IP environment in their respective niches. The more nebulous issue involves the question of gene or protein function, structure their role in determining the patent ownership. Many lab-on-chip devices incorporate biomolecules for separation, detection or other functions, which are likely to be vulnerable to IP issues.

Lab-on-chip companies in the diagnostic segment are expected to be impacted the most by this uncertainty due to the additional product development associated with regulatory requirements. A separate but related question that remains unresolved is the management of genetic and other medical records. Highly dense biochips, whether microfluidics or microarrays, can rapidly produce huge volumes of data about a person, not only about gene sequences but also networks and expression levels (which are witnessed as more important at present due to the low number of genes). The research segments, which rely increasingly on clinical data, for example, morbidity, SNPs etc., will also be affected in more ways than one. In the broad sense, content is increasingly important and are likely to be limited depending on how these matters play out (unclear). Genetic content of targeted analyses tools such as various DNA and protein arrays will undoubtedly be influenced by the IP issues.

Although the merits of the lab-on-chip technology platform over traditional technology implementations are apparent to the pharmaceutical and biotechnology industry, it is nevertheless still in the realms of being an emerging technology. In addition the global financial meltdown has largely impacted the investment on capital equipment. Most lab-on-chip equipment being capital expenditure, will therefore, take a back-seat in the laboratory supplies purchase lists of pharmaceutical companies, biotechnology companies and academic laboratories for the year 2009 and 2010. Depending on the recovery of the financial market, this scenario is likely to play out to 2011 as well. However, research indicates that companies that already have a significant installed base will continue to witness revenues from consumables required for the functioning of those equipment.

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