In June, 2021, HTG Molecular Diagnostics, Inc. which is a life science company has a goal to advance in precision medicine field, announced that its HTG EdgeSeq technology is highlighted in several posters being presented at the American Society of Clinical Oncology (ASCO) conference Presently, nucleic acid detection?based techniques and rapid diagnostic tests that detect antigens or antibodies specific to 2019?nCoV infections are the primary diagnostic tools. China National Medical Products Administration has opened a special channel for approval of new pharmaceuticals owing to urgent clinical needs, with 18 nucleic acid detection kits, 11 protein detection kits and 1 sequencing?related equipment and supporting software. Owing to the large number of suspected 2019-nCoV patients in epidemic areas, it is important to shorten diagnosis & treatment time, improve the accuracy and detection speed, promote the screening, isolation and treatment of epidemic conditions and develop innovative rapid molecular diagnostic techniques in vitro. Nucleic acid detection is an crucial diagnostic tool for the clinical diagnosis, segregation, rehabilitation and discharge of patients, and was also the ‘gold standard’ for the detection of 2019-nCoV infection in the early stage of the epidemic.
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Current nucleic acid detection methods include RT-PCR, isothermal amplification and high-throughput sequencing. At present, specimens tested by commercial nucleic acid kits mainly comprise throat swabs, oropharyngeal swabs, nasopharyngeal swabs, sputum and alveolar lavage fluid amongst others. Since the development of the 2019-nCoV epidemic, China has recommended RT-PCR technology test as a guideline for the COVID-19 diagnosis and treatment program. The Chinese Center for Disease Control and Prevention recommends the use of primers and fluorescent probes (FAM, BHQ1 and TAMRA) targeting 2019-nCoV ORF1ab and nucleocapsid protein (N) gene regions. However, restraining factors such as tedious and time-consuming operation is expected to critically impact the global molecular diagnostics market over the next eight years (2021 to 2029). In addition, recent research on patients infected with 2019-nCoV demonstrated that the positive rates of early stage nucleic acid detections of oropharyngeal swabs, anal swabs and blood were 53.3, 26.7 and 40%, respectively, while the positive rate of anal swabs was even higher than oral swabs in the late stage of infection.
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Notably, the actual positive rate is only 30-50% when collecting suspected patient samples through routine throat swabs at the outpatient fever clinic, with many of the samples producing false-negative results, despite the considerable pressure to prevent the 2019-nCoV. Gene sequencing is the most accurate and reliable technology for the detection of viruses and other pathogenic ‘emergency’ infectious diseases. Additionally, it is the only method to dynamically track genome variation in pathogens. In the early stages of the epidemic, the Chinese Center for Disease Control and Prevention identified and analyzed the genome of 2019-nCoV based on second-generation sequencing metagenomics technology (mNGS) within five days and reported that the similarity between the nucleotide sequence of 2019-nCoV and SARS or bat-derived strains were 79 and 96%, respectively. The China National Medical Products Administration has approved a gene sequencing system (ultra-high-throughput sequencer DNBSEQ-T7), supporting analysis software and nucleic acid detection kits, which can identify and diagnose coronaviruses, including 2019-nCoV and other infectious respiratory pathogens and enable rapid detection of viral sequences. Such factors are expected to assist the market growth over the forecast period.
The detailed research study provides qualitative and quantitative analysis of the global molecular diagnostics market. The molecular diagnostics market has been analyzed from demand as well as supply side. The demand side analysis covers market revenue across regions and further across all the major countries. The supply side analysis covers the major market players and their regional and global presence and strategies. The geographical analysis done emphasizes on each of the major countries across North America, Europe, Asia Pacific, Middle East & Africa and Latin America
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Global Molecular Diagnostics Market
- By Product & Services
- Reagents and Kits
- Instruments
- Software and Services
- By Application
- Genetic Tests
- Infectious Diseases
- Oncology
- Others
- By Technology
- PCR
- INAAT
- DNA Sequencing & NGS
- In Situ Hybridization
- DNA Microarrays
- Others
- By End-User
- Diagnostic Laboratories
- Hospitals
- Others
- By Region
- North America
- U.S.
- Canada
- Mexico
- Rest of North America
- Europe
- France
- The UK
- Spain
- Germany
- Italy
- Nordic Countries
- Denmark
- Finland
- Iceland
- Sweden
- Norway
- Benelux Union
- Belgium
- The Netherlands
- Luxembourg
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- New Zealand
- Australia
- South Korea
- Southeast Asia
- Indonesia
- Thailand
- Malaysia
- Singapore
- Rest of Southeast Asia
- Rest of Asia Pacific
- Middle East & Africa
- Saudi Arabia
- UAE
- Egypt
- Kuwait
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Argentina
- Rest of Latin America
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