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June 23, 2016

Race to Find Better Tests Fuels miRNA Detection Market

Constant Innovation and Translation of Scientific Knowledge to Clinical Applications Is Driving the Market

Race to Find Better Tests Fuels miRNA Detection Market

miRNAs are a class of small, noncoding RNA molecules involved in the regulation of gene expression at the post-transcriptional level. [Shunyu Fan/Getty]

  • Today, most assays for diseases or pathogens use an immunologic premise—they find a target antigen using a specific antibody. But this approach makes test development a long process, and obtaining a product that provides the accuracy needed for medical practice can be tricky. Clearly there is a clinical need for functioning tests and faster development of such assays. Enter microRNAs (miRNAs) and the hopes of speeding development up.

  • Utility of miRNAs

    miRNAs are a class of small, noncoding RNA molecules involved in the regulation of gene expression at the post-transcriptional level.  They influence a wide range of biological processes, including cell cycle control (progression, migration, and apoptosis), stem cell differentiation, immune modulation, metabolic control, neuronal development, and viral replication. These processes are directly connected to the pathology of various diseases. Thus, tests based on miRNAs could represent a huge advance for disease treatment, largely because RNA is so much easier to manipulate than protein.

    With researchers seeking to understand the function and biological role of miRNA and to identify and develop miRNA-based biomarkers and therapeutics for a variety of diseases, there should be no reduction in interest or growth in this market, at least not over the five-year period that might be considered a reasonable prediction range.  The usability of these molecules helps.  miRNAs have been found in many types of tissues and in serum, plasma, saliva, and urine.  miRNAs are highly stable, making them useful in biomarker development. miRNA’s roles in various diseases, including cancer, neurodegenerative disorders, and cardiovascular and autoimmune diseases, has prompted their investigation for potential clinical diagnostics and therapeutics applications. Furthermore, miRNAs show higher tissue and organ specificity than other biomolecules and can also cross the blood–brain barrier, potentially constituting suitable biomarkers of brain health in various neurological diseases, such as multiple sclerosis, Alzheimer’s, and Parkinson’s disease.

    These advances have, not surprisingly, fueled a market for equipment that can detect miRNA and companies that can perform detection services.  The global market for miRNA tools and services had estimated revenues of approximately $407 million in 2015, according to Kalorama Information’s latest research report on the industry.

  • Detection and Measurement of miRNAs

    There are several technologies used to detect and measure miRNA. Real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) can measure amplification of nucleic acids produced during each cycle of the PCR. That’s useful, but it has certain limitations in terms of multiplexing and throughput.    

    Hybridization-based expression profiling though microarrays—a well-established research technique in biomedical research for gene expression studies that has adapted well to the miRNA field—is another approach. Microarrays are reliable, easy to use, and cost-effective.    Their cost and high-throughput capabilities have rendered this technique very useful in miRNA research, particularly in large-scale studies, such as cancer biomarker validation. They are less sensitive than other techniques, however, and hybridization through microarrays will not reveal previously uncharacterized miRNAs or isomiRs (miRNA variants).  Nonetheless there are many manufacturers of hybridization-based technologies for miRNA expression profiling, including Affymetrix, Agilent, Thermo Fisher Scientific, Illumina, and others.

    In addition to these techniques, next-generation sequencing (NGS) recently has been  adopted and employed more frequently in the profiling and quantification of miRNA as the sequencing technologies have advanced rapidly and become more affordable and easier to perform. The adoption of NGS for miRNA analysis has been also facilitated by the introduction of more affordable benchtop sequencers, such as Illumina’s MiSeq and Thermo Fisher Scientific’s Ion Personal Genome Analyzer and Ion S5 systems, which have made the technology available to a larger base of users. 

    NGS has several advantages, including higher throughput and sensitivity, greater accuracy, broader dynamic range, increased reproducibility, and the ability to discover novel molecules and deliver “quant and qual” results. Nonetheless, NGS has had several limitations that have hindered its use in miRNA research thus far. These include its extensive sample preparation requirements, inaccuracies in quantitation, higher costs, greater complexity, and fragmented workflow requiring instrumentation, reagents, and data analysis software from various vendors. The preparation of samples in the case of miRNA imposes the use of particular strategies to reduce the formation of adapter dimers and necessitates a final library purification step.

  • miRNA Functional Tools

    Functional tools are another important miRNA technology. “Mimics and inhibitors” are oligonucleotides modified with various chemical functions that increase their stability and specificity, reduce toxicity to cells, and augment their potency. Mimics and inhibitors can be used together in the same experiment to determine the particular function of a miRNA. Several companies are involved in the development of miRNA functional tools, including Thermo Fisher Scientific, Dharmacon, Exiqon, Integrated DNA Technologies, Qiagen, and MilliporeSigma.

  • A Dynamic miRNA Market

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    The overall market for miRNA analysis tools and services is a dynamic market driven by constant innovation and translation of scientific knowledge to clinical applications.  Numerous life science instrumentation and reagent companies participate in this market with different capabilities, developing and commercializing a large variety of products, such as miRNA-specific qRT-PCR reagents, microarrays, labeling reagents, library preparation kits for NGS, and mimics and inhibitors for the functional analysis of miRNA.

    Competition is based primarily on the quality and performance of products. In this market, it is essential that products and technologies meet their performance specifications for the purpose of publication and clinical applications. Leading companies in the overall market include Thermo Fisher Scientific, Exiqon, Dharmacon, Qiagen, and Illumina. For example, Thermo Fisher Scientific, a large multinational company, offers numerous products and services across each segment of the market, including reagents and instrumentation for qRT-PCR, NGS, microarrays, and tools for the analysis of miRNA’s function. It has established its leading position in this market by recently acquiring two key players, Life Technologies and Affymetrix, in 2014 and 2016, respectively.

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