This testing (NAT) or nucleic acid amplification test (NAAT) is one of the advanced diagnostic test increasingly gaining traction over conventional culture methods, owing to high efficiency and accuracy. Furthermore, This testing has potential application in various life threating diseases including cancer, infectious disease, genetic and mitochondrial disorders, and also in development of personalized and precision medicine. NAT is an efficient diagnostic method, which significantly reduces the procedural time and consumption of reagents. Moreover, this testing is increasingly being used for screening blood donation samples to reduce the risk of transfusion transmitted infections (TTIs), thus aiding in growth of the nucleic acid testing market.
Nucleic Acid Testing Market – Driver
These tests are extensively used for screening and diagnosis of various infectious diseases. Moreover, growing prevalence of infectious diseases and management of epidemics of new diseases has led to increasing demand for advanced diagnostic tests such as nucleic acid testing. For instance, according to the World Health Organization (WHO), in 2015, around 32,000 estimated deaths from tuberculosis and around 3, 23,000 new cases of TB were registered in the European region. Furthermore, according to the Centers for Disease Control and Prevention (CDC), around 5,251 deaths due to influenza infection were registered in 2015, in the U.S. According to the National Ambulatory Medical Care Survey: 2015 data findings, 16.8 million visits to physician offices for infectious and parasitic diseases were registered in the U.S. Nucleic acid testing (NAT) enables to examine various changes in gene sequence and copy number, and provides information regarding disease recurrence and possible condition of patient to likely respond to a particular treatment. Moreover, NAT can identify, which patient have undergone inherited mutations, which eventually helps to identify whether the patient is at increased risk of developing cancer or not. Increasing incidence of cancer in various geographical areas is a major driving factor for growing adoption of nucleic acid testing. For instance, according to the Cancer Atlas: 2017, there were an estimated 14.1 million new cancer cases in 2012. Moreover, India, China, and other East and Central Asian countries accounted for nearly half of world’s new cancer cases and deaths, in 2017. Furthermore, according to the same source, by 2025, there will be an estimated 19.3 million new cancer cases and 11.4 million cancer deaths, in less developed regions.
Moreover, research funding by various government and private organizations for cancer treatment and increasing adoption of molecular and nucleic acid testing in cancer research programs, to detect molecular genetic changes in single or multiple sequence of DNA or mutations is expected to aid in growth of the nucleic acid testing market, in the near future. In 2016, National Cancer Institute (NCI) invested US$ 3.9 billion for cancer research activities, which accounts for 70.8% of overall NCI 2016 budget. Among which NCI invested around US$ 533 million on cancer detection and diagnostic research activities. Moreover, in 2016, NCI allocated 40.4% of its funds for Research Project Grants (RPGs). Furthermore, in 2017, NCI budget increased by US$ 454 million (8.7%) from previous year (2016) for research activities.
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Market – Restraint
The inability or difficulty of nucleic acid testing in obtaining quantitative results from a large pool of clinical sample, difficulty of using NAT test for susceptibility testing, and higher cost of nucleic acid testing devices is expected to hamper growth of the nucleic acid testing market. According to the data published in Asian Journal of Transfusion Science, in February 2014, NAT is highly sensitive and advanced technique, however, it is associated with high cost and requires dedicated infrastructure facility, equipment, consumables, and technical expertise.
Market – Regional Analysis
Geographically, global nucleic acid testing market is segmented into North America, Latin America, Europe, Middle East, Asia Pacific, and Africa. North America holds dominant position in nucleic acid testing market, followed by Europe. This is owing to increasing research and development studies by various government and pharmaceutical organizations in infectious disease and cancer diagnosis in North America. For instance, in January 2018, University of Glasgow-led project received US$ 1.85 million funding, which is a part of Global Challenges Research Fund (GCRF). This project will develop new tests for parasitic diseases and rapid testing in remote locations to help enable rapid diagnosis, and rapid treatment of infectious disease. Furthermore, high prevalence and awareness of cancer among people, in turn opting for early detection of cancer, is expected to aid in growth of the nucleic acid testing market in this region. For instance, according to American Cancer Society, data findings, North America registered higher incidence of cancer in children compared to any other region, in 2012. Moreover, North America accounted for 13.1% of total estimated cases of cancer, in 2012, globally, according to the same source.
Asia Pacific is expected to witness fastest growth in the nucleic acid testing market over the forecast period. This is due to growing demand for efficient and quick diagnostic testing and increasing focus of major market players to expand their geographical reach in this region. For instance, in March 2013, Qiagen N.V. launched its careHPV test in China. careHPV is molecular diagnostic test designed to screen for high risk human papillomavirus (HPV) for low-resource settings such as areas lacking electricity, water or laboratories. Qiagen also gained the approval from China’s State Food and Drug Administration (SFDA) for careHPV in 2012.
Market – Competitive Analysis
Key market players in nucleic acid testing market are Abbott Laboratories, Beckman Coulter, Inc., Becton, Dickinson and Company, BioMérieux SA, Bio-Rad Laboratories, Inc., F. Hoffmann-La Roche Ltd., Grifols, S.A., Illumina, Inc., Novartis Ag, Qiagen N.V., Quest Diagnostics Incorporated, Siemens Ag, and Tecan Group Ltd., among others. Players in the market are focusing on inorganic growth strategies, in order to enhance its market share and remain competitive in the market. For instance, in January 2017, Grifols, S.A. acquired the NAT (Nucleic Acid Testing) donor screening unit from Hologic, Inc. for US$ 1,850 million. The acquisition enabled Grifols to strengthen its position in transfusion medicine through NAT technology.
Market – Taxonomy
By Product Type
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Test Kits
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Polymerase Chain Reaction(PCR)
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Ligase Chain Reaction(LCR)
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Transcription-mediated Amplification (TMA)
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Whole Genome Sequencing
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Consumables
By Indication
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Infectious Disease
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Cancer
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Forensic Testing
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Personalized Medicine
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Others
By End User
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Hospitals & Clinics
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Pathology Laboratories
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Academic & Research Organization
By Geography:
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North America
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Latin America
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Europe
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Asia Pacific
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Middle East
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Africa
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