Microarrays – A long way to go

In the future, microarray technologies have the potential to help medical professionals select the most effective drugs, or those with the fewest side effects, for individual patients. But the road from gene identification to effective treatments is long and fraught with challenges.

Particular proteomic-individualities of patients have recently driven the initiation of personalized medicine and these particularities can be thoroughly done only with advanced technologies. The Human Genome Project has shown that there are multiple players in human disease development where the transcriptome, proteome, and metabolome entered this field. However, the project would never have been accomplished without the aid of several high-throughput proteomic technologies, one of these being antibody-based protein microarrays. New formats were constantly evolving to tackle the personalized proteome analysis. With these new formats of microarrays, parallel analysis can be carried out, investigating variations in protein structure and moreover protein interaction particular to each biological sample.

As cancer has a complex multifactorial trait and it is the result of acquired dysregulation at various levels (genomic, epigenomic, proteomic, and metabolomics), complex multi-molecular signatures obtained from these domains would bring new information on cancer diagnosis, prognosis and personalized treatment. Platforms combining protein microarrays with bioinformatics, are bringing new tools for the further development of personalized medicine to medical and scientific communities. Protein microarrays are involved in oncology for identifying and validating new biomarkers, depicting molecules for early detection, and can monitor disease and select optimal therapeutic strategies. These platforms can intervene in all fields of oncology, as this proteomics technology can screen a multitude of parameters and encumbers tremendous future potential for applications in diagnostic and personalized medicine.

Global market dynamics
The global microarray market was valued at USD 3.90 billion in 2018 and is anticipated to grow at a CAGR of 8.7 percent during 2019 to 2026. Microarrays have a wide range of applications and have found increasing usage in basic molecular biology, toxicological response profiling, pharmaceutical target screening, and biomarker identification. The ability of microarrays to facilitate analysis of thousands of genes at the same time has resulted in the success of this technology in the past few years.

Global rise in the incidence of cancer is one of the key factors propelling market growth. According to a report published by WHO in 2018, global cancer was estimated to have risen by 18.1 million new cases during this year leading to 9.6 million deaths. Rise in healthcare R&D is also anticipated to be one of the factors boosting market potential in coming years.
The rise in the usage of microarrays in various applications is another factor anticipated to propel the market growth over the next 7 years. For instance, the use of microarray analysis has proven to be effective in antibiotic treatment as bacterial genomic DNA in most cases outlasts the viability of bacteria. DNA microarray is usually used in such cases as diagnosis can be made using a small amount of the DNA instead of larger amount of bacteria needed for culturing. In the recent past, the usage of DNA-based microarrays has become the method of choice for assaying of gene expression. This is mainly attributed to factors, such as complexity and cost reduction, facilitating the technology to be more accessible and standardized.

However, rapid advances in NGS have facilitated NGS to be a highly cost-effective, specific, and accurate alternative that can hinder market growth. Other factors that are expected to restrain market potential include strict government regulations, standardization of microarray data, and lack of skilled professionals.
Repeat and bulk purchase of consumables for various research applications is the dominant factor attributing to its large market share in 2018. This product segment is anticipated to continue its dominance over the next 7 years with its incessant usage in research procedures.

A wide range of instruments has been developed by leading market players, facilitating their increased adoption. Thermo Fisher Scientific Inc. offers products, such as GeneChip Scanner, that aid in scanning next-generation high-density arrays for transcription and all-exon arrays. Another such product offered by the company consists of a gene-chip hybridization oven, which provides precise temperature and rotation of samples, thereby enabling successful hybridization.

A rising number of product launches with regard to the software and services segment is also anticipated to boost market potential.

According to a research study published by the Royal Society of Chemistry in 2019, a portable fluorescence microarray imaging system that connects to a smartphone has been used for the detection of breast cancer gene expression. The technique is based on an interactive binding of Cy3-target DNA to probe DNA. Such technological advances are anticipated to facilitate easy diagnosis of cancer, thereby boosting market growth.

Based on microarray type, DNA microarray held the largest market share in 2018 with its wide range of applications in gene expression analysis, transcription factor binding analysis, and genotyping, among others.
Protein microarrays are typically constituted of various support surfaces, such as nitrocellulose membranes, slides, microtiter plates, and beads, causing binding of proteins. Rise in the adoption of protein microarrays by leading pharmaceutical and biopharmaceutical companies for drug discovery and toxicology studies is anticipated to further fuel market growth.

Based on application, research held the largest market share in 2018 owing to rise in private as well as government funding for research in genomics and proteomics. For instance, in 2018, UVic-Genome BC Proteomics Centre, a central hub of the Canadian proteomics centers, received funding of USD 18 million from Genome Canada and Genome British Columbia to facilitate improved diagnosis of a wide range of diseases, such as cancer and Alzheimer’s disease. The funding is also expected to aid rising research in the rapidly developing field of personalized medicines.

Research and academic institutions held the largest market share in 2018 with rise in the use of microarrays in drug discovery and research applications, based on end users. For instance, in a report published by NIH in 2018, it was observed that microarrays are used in the process of discovery of a drug used in cancer treatment. The hospital and diagnostic centers segment in India attracted foreign direct investment (FDI) worth USD 6 billion between the years 2000 and 2018. Increasing R&D investments in the healthcare sector are further anticipated to fuel market growth.

Diagnostic laboratories are anticipated to increase the demand for various products offered by leading companies used to diagnose infectious diseases, cancers, diet-related, and autoimmune disorders, and other diseases. For instance, Applied Microarrays Inc. offers custom arrays to diagnose cancer, infectious diseases, such as influenza, Ebola, sepsis, among other diseases. Some of the other diseases detected by these products consist of diet-related disorders such as dysbiosis and general food intolerance and autoimmune disorders such as celiac.

Based on region, North America held the largest revenue share in 2018 with rise in the number of cancer patients in the US. According to the European Commission, the government of Europe will be funding USD 7.5 billion for R&D in the field of biotechnology, facilitating a rise in the use of microarrays for various genomic and proteomic research in the European region. Similarly, the Government of Denmark intends to spend USD 14.94 million by 2020 for a new genomic research center, further facilitating increasing usage of microarrays. The Asia-Pacific region is also anticipated to witness a significant growth with rising funding from the government in the healthcare sector.

Some major players catering to the market are Bio-Rad Laboratories, Agilent Technologies, Inc., Thermo Fisher Scientific Inc., Illumina, Inc., PerkinElmer Inc., Merck KGaA, GE Healthcare, Molecular Devices, LLC, Arrayit Corporation, and Microarrays, Inc.

New product launches by leading companies are expected to propel market growth. Mergers and acquisitions are another major strategy applied by various leading companies to gain maximum revenue share.

Vendors update
In September 2019, GE Healthcare launched Cell Dive multiplexed imaging, an anti-body-based solution that builds on years of research and development to transform immuno-oncology. This multiplexed imaging can reveal up to 60 biomarkers in one sample with hyperplexed immunofluorescence imaging, compared to multispectral imaging tools typically capable of analyzing six to eight. It also combines the speed and image quality of the IN cell analyzer 2500HS with the flexible Cell Dive workflow as well as supports whole slide, region of interest, and tissue microarray imaging.

In August 2019, PerkinElmer launched CGX Oligo microarray, specifically designed, developed, and verified by Signature Genomics for the detection of small genetic aberrations associated with learning disability and dysmorphic features in research applications.

In June 2019, US Food and Drug Administration (FDA) offered 510(k) clearance to Akonni Biosystems Inc. for its TruDiagnosis System. The system is a compact point-of-service molecular diagnostic device, which includes a TruDx 2000 imager and a TruArray consumable test kit, both unique and patented technologies developed at Akonni.

In May 2019, Bio-Rad Laboratories Inc. launched Bio-Plex 200 system, a suspension array system, which offers protein and nucleic acid researchers a reliable multiplex assay solution that permits analysis of up to 100 biomolecules in a single sample.

In April 2019, Agilent Technologies Inc. and SomaLogic, Inc. (a privately held biotechnology company) entered into a multi-year supply agreement, whereby Agilent will supply customized high-fidelity oligo microarrays for use in the nucleic acid detection step within SomaLogic’s novel SOMAscan assay, a protein measurement platform with applications across basic and clinical research, diagnostics, and pharmaceutical discovery and development.

In February 2019, Roche NimbleGen launched the NimbleGen MS 200 microarray scanner, which is the first scanner optimized to unleash the full potential and capture the complete picture from NimbleGen DNA microarrays. The MS 200 offers 2-micron resolution and heightened sensitivity to achieve high data quality and confident results from high-density NimbleGen microarrays. Critical to the workflow, NimbleScan and SignalMap software are included to analyze and view the high-quality data from MS 200.

In December 2018, Illumina, Inc. launched a high-density genotyping array, the Infinium Global Diversity Array. This new array was developed for and inspired by the All of Us Research Program. The All of Us Research Program is a historic effort to gather data from one million or more people living in the US to accelerate human disease research and improve health.

In November 2018, Molecular Devices launched the GenePix 4300A and GenePix 4400A scanners that deliver maximum imaging quality with optimal resolution and highly configurable platforms. The configurations include maximum scan resolutions of 5 μm or 2.5 μm per pixel, a choice of up to four excitation lasers, and sixteen emission-wavelength filters. These options allow the system to detect a variety of fluorophores. Together with GenePix Pro Microarray Image Analysis software and Acuity Microarray Informatics software, GenePix systems provide powerful, flexible, and easy-to-use solutions for capturing and analyzing data from all types of arrays including nucleic acids, proteins, tissues, and cells.

Outlook
Microarrays have made a significant contribution to science both because they can survey a large number of genes quickly or study a small sample size. Microarrays have been used to assay gene expression within a single sample or to compare gene expression in two different cell types or tissue samples, such as in healthy and diseased tissues. However, this technology is branching out into many different applications, including genotyping, sequence analysis, and many different types of microarrays, including carbohydrates, peptides, RNAi, microRNA, proteins, and antibodies. In the future, microarray technologies have the potential to help medical professionals select the most effective drugs, or those with the fewest side effects, for individual patients. Since microarray technology can also help identify individuals with similar biological patterns, microarray analysis can assist drug companies in choosing the most appropriate candidates for participating in clinical trials of new drugs. The ultimate goal is to use this genetic information to develop new ways to treat, cure, or even prevent thousands of diseases that afflict humankind. But the road from gene identification to effective treatment is long and fraught with challenges.