May 2020 | Report Format: Electronic (PDF)
The global blood screening market is expected to reach a value of USD 3.9 billion by 2024, based on a new report by Grand View Research, Inc. The growth of the market is attributed to the increase in screening of donor and continuous technological advancement by the market players. Demand for blood screening tests is increasing continuously due to increasing donation, rising awareness about transfusion-transmitted diseases, and technological developments in the industry. Furthermore, governments of various countries are in process to mandates testing all donated blood for several viruses.
Thorough screening is necessary for all donated blood to ensure that recipients receive the safest products. As of 2015, such testing consists of screening for red cell antibodies, and the infectious diseases agents: HIV-1, HIV-2, hepatitis virus, West Nile Virus (WNV), Human T-Lymphotropic Virus (HTLV) T. Cruzi, and T. pallidum (syphilis). The result of all these assays must be negative for blood donation.
Technological developments increase the sensitivity and efficiency of the tests. For instance, in 2016, the U.S. FDA approved the Procleix Zika virus assay from Hologic, Inc. and Grifols to screen donated blood. Furthermore, the U.S. FDA approved next-generation sequencing (NGS) technology in 2013. The technology is cheaper and faster than previous DNA analysis methods.
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Further Key Findings from the Study Suggest:
Nucleic acid amplification test or nucleic acid test (NAT) is expected to be the fastest growing segment during the forecast period. It comprises transcription mediated amplification (TMA) tests and polymerase chain reaction. Increasing demand of NAT over ELISA test due to high sensitivity and specificity for viral nucleic acid is contributing to the fastest growth during the forecast period. The American Red Cross implemented automated triplex NAT for HCV, HIV, and HBV in 2009. This would further boost the industry.
In 2015, reagent dominated the product segment. Introduction of new assays for the detection of various diseases is expected to enable the segment to gain the maximum share in the coming years. For instance, in January 2015 the FDA approved Roche’s blood screening assay COBAS TaqScreen MPX Test for the detection and identification of HCV, HIV, and HBV.
In 2015, regionally North America dominated with a revenue share of more than 40%. Government initiatives, presence of major players, and more patient affordability are the major factors that contributed toward its dominance. The U.S. FDA strengthens regulations that protect patients from unsuitable products.
Recently, the FDA published a guidance document proposing regulations for laboratory developed tests. In addition, In February 2015, the U.S. FDA conducted a workshop to discuss the oversight of NGS. All these factors increase awareness, which would further increase the growth of the industry.
In August 2016, the FDA recommended the testing of all the donated blood in the U.S. and its territories for Zika virus in order to prevent transmission of this virus through the blood supply.
Asia Pacific is expected to be the fastest growing region due to increasing investment of industry players, government initiatives, and rising awareness about transmission of diseases during its transfusion.
The Red Cross in Japan entered into a contract with Grifols for nucleic acid testing (NAT) for a donation camp in Japan in 2014. This agreement is anticipated to propel the NAT during the forecast period. However, low donation as compared to requirement and high cost of kits and instruments are likely to restrain the growth in low-income countries during the forecast period.
In June 2015, India launched a National Blood Donor Vigilance Programme (NBDVP) to undertake donor vigilance activity. Such initiatives from emerging countries improve the donor safety and satisfaction and thereby drives the market in coming years.
Some of the players operating in the industry are Abbott Laboratories; Danaher Corporation (Beckman Coulter); Becton Dickinson and Company; Bio-Rad Laboratories, Inc.; F. Hoffmann-La Roche Ltd.; Grifols; Ortho-Clinical Diagnostics, Inc.; Siemens AG; and Thermo Fisher Scientific. Partnerships and acquisitions play an important role in capturing the market. Competition between the industry players is rigorous due to the presence of advanced instruments and assays.