Global Enzyme Linked Immunosorbent Assay (ELISA) Market – Creating Substantial Growth in Medical Diagnostics
Enzyme Linked Immunosorbent Assay (ELISA) is immunoassay used to identify proteins, peptides, antibodies, and hormones. ELISA assay has application in biotechnology medicine, as a diagnostic tool, which detects color change to identify a target substance and measures its concentration in the test sample. The common diagnostic applications of ELISA are HIV infection, pregnancy tests, and measurement of cytokines, soluble proteins, and others. Various antigen-antibody combinations are used in the immunoassay that include an enzyme-labeled antigen or antibody and enzyme activity is measured.
On the basis of antigen-antibody combination, the assay is segmented in to direct ELISA, indirect ELISA, sandwich ELISA, and competitive ELISA. Increasing prevalence of infectious disease such as HIV and increasing awareness regarding diagnosis of cancer and autoimmune diseases are major factors propelling demand for ELISA to reduce the burden of chronic diseases with early and accurate disease diagnosis. For instance, According to Centers of Disease Control & Prevention (CDC), 2014, number of patients infected with HIV in the U.S. was 37,600. The CDC also reported a decline of 10% in the incidence rate of HIV as compared to 2010, owing to early detection and advanced diagnostic.
The global Enzyme Linked Immunosorbent Assay (ELISA) Market was valued at US$ 1,583.4 million in 2017 and is expected to witness a robust CAGR of 5.1% over the forecast period (2017 - 2025).
Figure 1. Global Enzyme Linked Immunosorbent Assay (ELISA) Market in (US$ Mn), by Region, 2017
Factors such as increasing incidence of infectious diseases and cancer coupled with increasing demand for cost-effective diagnostic tools are expected to drive growth of the Enzyme Linked Immunosorbent Assay (ELISA) market. According to the Centers of Disease Control & Prevention (CDC), 2015, the number of visits to physician offices for infectious and parasitic diseases in the U.S. was 16.8 million. Furthermore, vector borne diseases comprise a major percentage of infectious diseases and affects a wide population. According to the World Health Organization (WHO), 2017, annually vector borne diseases accounts for over 17% of all infectious diseases causing over 700,000 deaths worldwide. Dengue is most commonly occurring vector borne disease with around 96 million new cases diagnosed annually. Moreover, advancements in the technology of ELISA are also fueling the market growth. For instance, in August 2017, researchers at University of Illinois, Urbana Campaign, developed a portable spectral analyzer based on ELISA assay that enables a smartphone to perform lab grade medical diagnostic tests, which usually requires expensive instruments. This test includes detection and measurement of variety of proteins and antibodies in blood, urine, and saliva samples that is commonly used for wide range of clinical diagnostic tests. Apart from the conventional medical applications such as disease diagnosis and transplantation, ELISA can also be used in the field of toxicology for determination of certain classes of drugs that is expected to aid the market growth in near future. However, cross reactivity leading to false positive and false negative results exhibited by the tests leading to incorrect diagnosis can obstruct the market growth. For instance, according to study report published by American Medical Association 2011, the preliminary health department data identified 32 pregnant women with HIV positive through ELISA assays. However, after a confirmatory test, 17 of these women were confirmed to be negative for HIV virus.
In terms of region, North America dominated the global Enzyme Linked Immunosorbent Assay (ELISA) Market. This is attributed to development of innovative products by manufacturers in the region. For instance, in January 2018, Eagle Biosciences, Inc. introduced a novel intact FGF23 ELISA kit assay, which is a 96 well Sandwich ELISA assay. It measures the full length active form of Human Intact FGF23 used for the detection of Mineral Bone Disorder, Chronic Kidney Disease, Tumor induced Osteomalacia, and hyperphosphatemia. Moreover, various private and public sectors carrying out research and development in Immunoassay-based clinical diagnostics are commercializing their research inventions by collaborating with existing market players to introduce new products in the market. For instance, in March 2018, BARD1 Life Sciences, U.S-based Science Research Company is expected to commercialize its BARD1-Ovarian blood based ELISA test to identify ovarian cancer in early stages. Furthermore, Asia Pacific is projected to be the fastest growing region in ELISA market, owing to geographical expansion of regional players along with introduction of novel enzyme-based test kits at affordable prices. For instance, in January 2017, Fujirebio, a Japan-based IVD diagnostic testing company introduced Lumipulse G β-Amyloid 1-42 ELISA assay in Europe that facilitates quantitative measurement of β-amyloid1-42 in human cerebrospinal fluid within of 30 minutes.
Market players are engaged in development of innovative products to maintain leading position in global Enzyme Linked Immunosorbent Assay (ELISA) Market
The key players are developing novel, innovative, and smart products to maintain leading position in the Enzyme Linked Immunosorbent Assay (ELISA) Market. For instance, in January 2017 Illumina, Inc. and Bio?Rad Laboratories, Inc. introduced the Illumina Bio-Rad Single-Cell Sequencing Solution at the J.P. Morgan Healthcare Conference, San Francisco. The comprehensive solution is the first next-generation sequencing (NGS) workflow for single-cell analysis, providing researchers the ability to investigate the coordinated contribution of individual cells in tissue function, disease progression, and therapeutic responses. Moreover, in 2015, Enzo Life Sciences introduced new VEGF ELISA Kit, an ultra-sensitive assay as competitive detection method for measuring VEGF in serum, plasma, and cell culture supernatants that measures as little as 4 pg /ml of VEGF and provide quantitative results.
Key players operating the global Enzyme Linked Immunosorbent Assay (ELISA) Market include Bio-Rad Laboratories, Inc., Enzo Life Sciences, Inc., Thermo Fisher Scientific, Inc., Biomerieux S.A., Alpco, BioLegand, Inc., Zeus Scientific, Inc., and Shenzhen YHLO Biotech Co., Ltd.
Enzyme Linked Immunosorbent Assay (ELISA) is one of the promising techniques used for the detection and quantification of biological analytes such as peptides, proteins, antibodies, and hormones. This technique can be useful to provide a quick and cost-effective assay to measure the concentration of unknown antigen or antibody in a specific analyte. ELISA finds its extensive application as a diagnostic tool in medicines as well as to monitor and quality check-up procedures in drug development processes at various industries. ELISA can be performed by different type of methods that include direct ELISA, Indirect ELISA, Sandwich ELISA and Competitive ELISA. The high sensitivity, flexibility and cost effectiveness of indirect ELISA makes it an ideal choice of most of the test kit manufacturers and thus possess the highest market share.
The Enzyme Linked Immunosorbent Assay (ELISA) Market is expanding owing to the increasing incidence of chronic diseases mainly in case of infectious diseases, vector borne diseases and cancer. According to the National Cancer Institute, cancer has a major impact on the population of U.S. and across the world. The NCI reports approximately 1,685,210 new cases of cancer were diagnosed in 2016. Also, reports demand for efficient detection tests that can be sufficed with the help of ELISA test kits. Moreover, increasing demand for cost-effective diagnostic tool is one of the factor aiding the growth of ELISA market, especially in the low and middle income economies. For instance, in October 2017, the Nigerian government and World Health Organization (WHO) launched a campaign to vaccinate around 874,000 people against yellow fever in two states of the country Kwara and Kogi in alliance with the International Coordination Group. The samples of the patients suspected with yellow fever were further tested with the help of ELISA test at the Pasteur Institute in Dakar. However, availability of alternate immunoassays and cross reactivity projected by these tests can hinder the market growth. Development of cost-effective ELISA tests with improved reliability and accuracy can provide potential opportunity for market players to strategize their growth in the global ELISA market.
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