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The Reagent/Research Tool Market

Managing Editor

Reagent market helps account for fast start of the general RNAi market

The RNAi reagent/research materials industry is an established market, fully capable of supplying the research needs of the relative biotechnology drug development market.

Conveyance of drugs to target cellular areas is a fundamental element in the discovery and administration of therapeutics, and RNAi research is effectively using intelligence obtained from the study of the successes and limitations of genomics, small molecule, antisense and ribozyme platforms to expand and manage an operative method to identify and validate a broad base of drug targets.

Current undertakings that imply a proactive posture of the reagent sector to continue to be a driver of the overall RNAi market are the efforts that are focusing on expanding the number of human genes targeted by existing and forthcoming gene silencing libraries.

Any stagnation in the reagent segment would have a direct and immediate effect on the RNAi drug development market given the latter's dependence of the former.

The existence and resultant accomplishment of the research tools sector eliminates the need and expense for therapeutics companies to develop their own gene libraries and maintain their own programs and even offers a contract research source.

The reagents used in gene silencing have proven themselves effective beyond earlier technologies by showing an ability to degrade or knock out function in any gene once the sequence for that gene is known; as a result, the demand for RNAi laboratory kits and related tools that facilitate research has risen, along with the number of researchers who are using the mechanism to classify gene function and control gene expression.

The market is led by Dharmacon Inc., of Lafayette, CO, the number one reagent company with respect to sales and target applications, which maintains a diverse collection of genome-wide libraries of siRNA reagents targeting any unique human, mouse or rat gene.

Dharmacon's position, and future, were further bolstered in April 2004 when the company was acquired as a wholly-owned subsidiary by Fisher Scientific International for $80 million.

Other primary players supplying the market and poised to grow in accordance with the fortunes of the industry include Ambion Inc., Qiagen Inc. and Cenix BioScience GmbH.

Big pharma test-drives the market through reagent collaborations

The biggest impact the reagent industry may have contributed to the overall RNAi market is the trailblazing it has accomplished in establishing an increasing relationship with big pharma, with several reagent providers having brokered supply, licensing or research agreements over the past two years with pharmaceutical giants such as Bayer Corporation, Merck & Co. Inc., Eli Lilly & Co. and Abbott Laboratories Inc.

Such deals involving reagent businesses almost certainly portend the eventual collaboration of big pharma-biotech in comparative RNAi therapeutic development applications that would have the potential and proclivity to cultivate relationships with blockbuster implications in areas such as drug pipeline schedule acceleration, license fees and R&D sponsorship.

Pharmaceutical companies have begun to dabble in RNAi research by slightly infusing siRNA experimentation into some of their drug discovery agendas, but should be ready to get more involved as the technology takes off.

Their current involvement consists primarily of modifying some internal R&D programs to accommodate RNAi drug discovery, giving a boost to the reagent market in the form of a steady increase in orders for related research products.

Big pharma has traditionally adopted a similar wait-and-see approach for such emerging technologies, jumping in by means of participation in agreements that exact substantial compensatory arrangements, but also allow it to exploit the know-how of companies already ensconced in the technology, rather than trying to use its resources to build a program from the ground up, thus eschewing the time-consuming process of catching up to the competition.

An additional opportunity for growth in this market will become possible with the expected increase in the number of companies that abandon rival antisense and ribozyme programs once they consider the advantages of efficiency and reliability RNAi technology is proving to offer over the two mechanisms.

Further growth is directly linked to the growth of overall market

The reagent/research materials market is profoundly acknowledged and accountable for its contribution to the successful start of the RNAi general market, supplying the majority of the industry with reliable, guaranteed life science tools that are necessary for the laboratory, and soon-to-be clinical application of research work.

The progression of the overall RNAi market has never been hampered by the need to wait on the research materials supply segment to draw level to the drug development technology, and now, as the therapeutic clinical drug development race heats up, the research tools market is ready for human trials, with applicable products on the market to address relative trials for every human gene in the National Center for Biotechnology Information Reference Sequence database (NCBI RefSeq).

Capitalizing, in part, on the successful mapping of the human genome, these reagent companies have quickly produced a stable of experiment-ready products that address effective target validation, gene silencing and drug delivery methods.

It is estimated that an additional 10,000-15,000 new drug targets for several diseases will be identified as a result of the sequencing of the human genome, opening a window of opportunity for the reagent market to grow in target validation applications.

The reagent segment does not rely solely on the RNAi market for revenue, but siRNA and related processes do account for the fastest growth in this robust sector, as more companies acknowledge the value and advantage of the technology with respect to its stability, specificity, durability and efficacy in research environments.

siRNA and its related RNAi technologies, based on a record of assiduous progress with nominal setbacks, are gaining wider recognition for their efficacies and are projected to become the definitive mechanisms to induce clinical target validation and to support research in drug discovery environments.

The RNAi reagent development and supply market, like its therapeutic/drug discovery counterpart, is primarily rooted in the United States, where approximately 90 per cent of the companies that are involved with manufacturing and furnishing RNAi-related tools and services for laboratory and clinical applications are chartered.

The reagent industry outside the U.S. is small, but participants are nonetheless able to thrive, due to the increasing recognition of the technology and the consequent multiplication in the amount of scientists engaging it as the preferred research approach.

Growth outside the U.S. market is led by stable companies such as Cenix BioScience GmbH, of Dresden, Germany, and, in a trend that is expected to continue for the duration of the drugs-to-market chase, a host of branches and divisions opened in European and Asian countries by mid-level and large pharma and biotech companies, such as Isis Pharmaceuticals Inc., which recently announced a planned branch opening in Singapore, that seek to benefit from incentive-laden business offers and cost-effective labor rates that are not as prevalent in the American business climate.

Additional opportunities in the reagent market will arise as the limitations of more disciplines, such as small molecule development, are exposed and if RNAi can be expanded to experiment with additional classes of drugs, such as antibiotics, that are not yet being as aggressively and expressly targeted by the technology as diseases such as age-related macular degeneration (AMD), cancer, Lou Gehrig's Disease and hepatitis C virus (HCV).

Interest in RNAi technology is high and the field is competitive, with more than 50 companies having either stake in the reagent market or a dedicated agenda for RNAi research and therapeutic development.

That number is up from single digits as recently as three or four years ago, when the technology was still largely defined by its hype, and had no viable track record in the laboratory yet.

The effective evolvement of the reagent market has helped to bring the overall RNAi market into viability and legitimacy, and it is literally impossible for the overall market to thrive without taking the reagent segment along for the ride, given that it is on the front-end of the industry and its products provide the fuel to drive any research.

As more researchers look to the technology to accomplish their goals, the demand for more reliable reagents and relative kits will increase, further stimulating an already invigorated market.

BioWorld projects the number of researchers using siRNA in research applications will double within the next four years, as scientists come to regard RNAi as a most dependable method of target validation across a broad range of applications.

Once the genome of an organism is sequenced, RNAi can be customized to address every gene in that genome and target for specificity, thereby rendering an unlimited number of applications to concentrate on and develop appropriate products for.

Gene function evaluation, target identification and custom kit design are some of a growing number of applications that will help to advance this market as it incorporates drug discovery and therapeutic development in the clinic to its list of revenue-generating subjects.

The demand for the technology is apparent when considering the proliferation of conferences related to the technology and the increasing number of researchers in attendance.

A survey of attendees at some of these events indicates that companies are budgeting more for laboratory personnel to accompany, or supplant, traditional executive attendees, underscoring the importance of those doing research to better understand the market and the parameters and consequences associated with issues of intellectual property, competitive research and available new reagent products for an expanding list of drug targets.

The reagent market is not projected to grow in dollars on a scale with the pace of the potential therapeutics market, inasmuch as new drugs carry intrinsic individual blockbuster potential with their introduction to the market, while research tools and accessories don't garner that appeal of directly "curing" anything; however, reagents and research tools are necessary for continued development of any RNAi drug discovery pipeline and that industry will have to experience steady growth throughout the successful advancement of any relative drug development clinical trial.