Microarray is a powerful tool used widely to characterize tumors and over the years it has greatly improved the ability to subalignify tumors according to shared molecular characteristics and clinical behavior. It is now being used to measure the expression of a large number of genes in any specimen simultaneously. Such profiling has uncovered molecular signatures that could influence clinical care. Biomarker discovery has been made possible with the availability of microarray systems. Prognostic, diagnostic, and therapeutic biomarkers are still a hot pursuit. The quest for finding these biomarkers is making researchers and manufacturers appreciate the individualistic nature of each patient and hence reinforcing the concept of personalized medicine.

Advancing breakthroughs in high-throughput microarray technologies have equipped related solutions to produce results with high efficiency, accuracy, specificity, and reproducibility in target identification, primary screening, and toxicity study in drug discovery and cancer research. The technological advances have also enabled solutions to be applied in clinics, commercial laboratories and research institutions, and hospitals to detect DNA and proteins with the motive of early disease identification, significantly increasing the acceptance and adoption of these solutions. Furthermore, this technology also enables researchers to analyze critical biological complications such as genomic variations and the nature of inherited syndromes that cause cardiovascular diseases and cancer.

According to the National Cancer Registry Program of the India Council of Medical Research (ICMR), the estimated mortality rate due to cancer saw an increase of about six percent between 2012 and 2014. It is estimated that there are nearly 15–20 lakh cancer cases at any given point of time. Over seven lakh new cases of cancer and three lakh deaths occur annually due to cancer. Over the last 10 years or so, breast cancer has been rising steadily and it is estimated that for every two women newly diagnosed with breast cancer, one woman dies of it. Early prognosis of this disease is vital in breast surgery. Cervical cancer is the second most common cancer in Indian women accounting for 22.86 percent of all cancer cases in women and 12 percent of all cancer cases in both men and women. One woman dies of cervical cancer every eight minutes in the country.

India has prepared and adopted a National Action Plan and Monitoring Framework for Non Communicable Diseases with 10 targets and 21 indicators. At present, National Program for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) being implemented to generate awareness for cancer prevention, screening, early detection, and referral to an appropriate level institution for treatment. The focus is on three areas namely breast, cervical, and oral cancer.

Government of India is also implementing a scheme for enhancing the tertiary care facilities for cancer in the country. Under the said scheme, the government is assisting to set up/establish 20 state cancer institutes (SCI) and 50 Tertiary Care Cancer Centers (TCCC) in different parts of the country. The SCI and TCCC shall mentor all cancer related activities including research and treatment inter alia. Setting up of 11 SCI and 13 TCC has been approved till date.

In the government sector, research activities for detection and treatment of cancer are mostly carried out by institutions/departments such as the Indian Council of Medical Research, Department of Science and Technology, and Department of Atomic Energy (DAE). National Cancer Institute at Jhajjar, Haryana and a second campus of Chittaranjan National Cancer Institute, Kolkata are being set up. The implementation of the projects is at the initial stage. These institutes will be apex institutes for activities related to cancer including research and treatment.

The microarray systems market in the country is thus expected to witness an era of unprecedented growth with the increasing adoption of microarray technologies in cancer research. Over the years the demand of the systems will be affected by factors like the rising popularity of personalized medicines for cancer treatment and increasing research institutes. Moreover, growing population and better economic conditions, increasing awareness among the people about cancer, education, government initiatives, and modern and advanced technology are expected to propel the market in the country.

Global Market

The global microarray market is expected to witness tremendous growth and will post a staggering CAGR of more than 14 percent from 2017 to 2020, predicts Technavio. Increasing government spending, rise in research and development activities, need for early cancer detection, increasing healthcare expenditure, and diagnosis and large-scale DNA/gene chip initiatives are expected to drive the market.

Industry Speak

 A Paradigm Shift in Genetic Screening with Microarray Technology

Microarray has been a gold standard technology since many years for applications like gene expression profiling, miRNA analysis, and SNP genotyping. However, new applications like pharmacogenomics and molecular cytogenetics have recently brought a paradigm shift in the utility of microarray technology. The application of microarray in genetic testing has improved doctors' ability to diagnose and treat certain illnesses.Due to high resolution, cytogenetic microarray (CMA) is moving to replace the traditional karyotyping for the evaluation of individuals with intellectual disability, autism, and congenital malformations. The diagnostic yield of CMA adds extra 15–20 percent to the existing information and is more than any other investigation for evaluation of developmental disabilities. Several studies showed that compared to conventional karyotyping, prenatal diagnosis with Cytosure and CytoPrime microarray solutions from Genes2Me reveals 8–35 percent extra diagnoses in abnormal ultrasound pregnancies. Also, these solutions have empowered the evaluation of genetic anomalies in product of conception (POC) samples.

Confirming the above findings, The American College of Medical Genetics has recently published guidelines that support the use of chromosomal microarrays as the first-tier cytogenetic diagnostic test for patients with DD/ID, ASD, or multiple congenital anomalies (MCA). Also, ACOG guidelines recommend prenatal microarray testing to be used for confirmation of NIPS once an invasive procedure is offered.

The use of CMA has improved diagnostic yield and the turnaround time to results in prenatal genetic analysis. The revolutionizing CytoSure assay offers balanced whole-genome coverage for both prenatal and postnatal screening with ability to check gains/losses as low as 100 kb. It enables high-resolution DNA copy number analysis with precise breakpoint accuracy as well as high-density SNP coverage for LOH, and uniparental isodisomy (UPD) detection. The CytoPrime assay is a dedicated product for POC and prenatal samples. It overcomes the inherent issues of POC sample culturing leading to failed karyotyping. Also, it could be a cost effective replacement for Karyotyping and FISH for certain indications as the TAT could be brought down to 4–6 days, which is crucial in the prenatal scenario.

Neeraj Gupta
Director,
Genes2Me LLP

In addition, adoption of personalized medicines in the field of oncology, wide range of application areas, and technological advancements are expected to drive the market for microarrays. However, standardization in microarray data and lack of skilled professionals are some of the major factors restraining growth of the global microarrays market.

Based on modalities, the popularity of DNA microarray technology will increase significantly as it helps in the early detection of diseases and selection of accurate treatment methods, which reduces mortality rates. DNA microarrays can be used for single nucleotide polymorphism-based diagnostics, forensic detection, gene expression profiling, etc. Large number of applications of DNA microarrays makes it a major segment of the microarray market.

The consumables segment dominates the market and is expected to lead the market over the next three years. The growth of this segment is attributed to the increase in the number of applications that use a variety of consumables such as reagents and buffers on a regular basis for testing. The consumables segment comprises reaction buffer, primers, reagent kits, DNA chips, and other consumables used in various microarray-based applications. In the recent years, there is an augmented demand for consumables as they are used in various applications in in-vitro diagnostics, academics, drug discovery, agri-genomics, and personalized medicines, significantly increasing the sales of these consumables.

The global microarray market is highly diversified owing to the presence of several well-established international and regional vendors. The market is growing rapidly with the increasing adoption of microarray technology in the medical field through transcriptome studies, as well as the diagnosis of infectious diseases. Increasing number of mergers and acquisitions, rise in the number of collaborations and partnerships, and product launches are some of the latest trends.

The vendors compete on the basis of various factors including price, availability, brand, and variety. Key vendors in this market are – Agilent Technologies, Illumina, Thermo Fisher Scientific, and Merck. Other prominent vendors in the market include Affymetrix, Applied Microarrays, bioMrieux, Luminex Corporation, NextGen Sciences, Arrayit, AXO Science, BioCat, BioGenex, Biometrix Technology, Cepheid, GE Healthcare, InDevR, LC Sciences, Perkin Elmer, Phalanx Biotech, and Qiagen.

Outlook

Gene expression in breast cancer by microarray is fast gaining popularity in providing better prognostic and predictive information on the disease. Breast cancer is the leading cause of cancer-related deaths in women worldwide. The molecular mechanism for human breast cancer is unknown, making it more difficult to detect early. However, in addition to improving tumor alignification using microarray technologies, gene expression signatures have been identified recently which are related to BRCA1 and BRCA2 mutation status, ER status, and patient prognosis. During the past 20 years, DNA microarray technology has been developed and combined as a mundane tool in research laboratories and is now transitioning to the clinic.

For a complex disease like cancer, microarray is a valuable tool in understanding the causal molecular genetics. There is an ongoing quest to find causal determinants of cancer in different settings in India which is one of the few developing countries that has formulated a National Cancer Control Program (NCCP) to reduce the number of cancer cases and deaths and improve quality of life of cancer patients through implementing systematic, equitable, and evidence-based strategies for prevention, early detection, diagnosis, and treatment. In addition, several research activities for research on cancer prevention and control are taken up by various Indian institutes/departments.

The Union Cabinet has also approved to take over Dr. B. Borooah Cancer Institute, Guwahati by DAE and bring it under the administrative control of Tata Memorial Centre, an aided institution of DAE. Tata Memorial hospital under DAE is a premier research institution in the field of cancer research and treatment. The decision comes in the wake of the increasing instances of cancer, limited cancer treatment facilities, and the need for a hospital support to carry out further research in the North Eastern region.

The importance of microarray technology in therapeutics has helped shape the future of diagnostics and pharmaceutical industries. The key driver of microarray consumption in cancer research is the need for its early detection and targeted treatment options. The popularity of these solutions can be attributed to their capability of rapid identification of targets for therapeutic intervention. Changing government policies related to healthcare will positively impact the consumption of DNA microarrays in the country. Although microarray is an expensive technology, its extensive applications in the healthcare sector due to its portability, rapid assay times, and fewer sample requirements will lead to its augmented adoption in the future.


 

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