The global Isothermal Nucleic Acid Amplification Technology (INAAT) market size was valued at USD 1.6 billion in 2016. Increasing demand for INAAT as a molecular testing technique and rising prevalence of infectious diseases are expected to drive the market over the forecast period.
According to NCBI, there are over 9.5 million deaths due to infectious diseases every year, of which majority occur in developing nations. Respiratory viral infections, diarrhea, and pneumonia are some of the leading causes of mortality, mostly in infants. Rise in aging population across the globe and increase in adoption of INAAT over other molecular diagnostic techniques are few key factors driving the market. Furthermore, increasing demand for user-friendly, rapid, and disease-specific kits is also anticipated to boost adoption of this technology.
Global INAAT market, by application, 2014 - 2025, (USD Billion)
INAAT is widely used in the U.S., primarily for diagnosis of infectious diseases such as HIV-AIDS, H. influenzae, S. pneumonia (respiratory tract infections), N. gonorrhoeae, C. trachomatis (genital infections), and TB. According to CDC, over 2.8 million new cases of chlamydia occur in the U.S. each year and more than 2% of young population already suffers from the infection.
Continuous improvements in existing amplification products along with introduction of new technologies such as Strand Displacement Amplification (SDA), Single Primer Isothermal Amplification (SPIA), & Recombinase Polymerase Amplification (RPA), and changing regulatory scenarios for the same are expected to boost the market. The SMART2 technique is one of the major technological advancements from 2010 to 2013. There is an increase in number of strategic partnerships between companies that manufacture kits and manufacturers of isothermal NAAT diagnostics for development of novel techniques, and this is likely to boost growth of this segment.
The products segment comprises of instruments and reagents. The reagents segment held the largest share in 2016 owing to extensive usage in hospitals and primary healthcare settings, and are also expected to witness substantial growth over the forecast period.
Consumables and reagents are used more extensively as compared to instruments and witness regular demand owing to increasing R&D. However, the instruments segment is expected to grow at a significant rate due to introduction of devices that are advanced in terms of accuracy, speed, and portability.
Some of the technologies in the market include SPIA, SDA, Nucleic Acid Sequence Based Amplification (NASBA), Helicase-Dependent Amplification (HDA), Loop-Mediated Isothermal Amplification (LAMP), and Transcription-Mediated Amplification (TMA). Global demand for INAAT has increased due to rising awareness among customers. TMA was the largest revenue-generating technology segment in the diagnostic market in 2016, as it is the first INAAT introduced in the market. It was developed by Hologic (Gen probe).
Increasing population suffering from cancer and infectious diseases has boosted demand for low-cost diagnostics such as INAAT. Other amplification technologies such as Polymerase Chain Reaction (PCR) are not able to fulfill the need for low-cost diagnosis. Novel technologies, which include LAMP and HDA, are anticipated to exhibit steady growth over the forecast period. Non-PCR technologies such as INAAT are gaining significance due to customization features offered by them.
Global Isothermal Nucleic Acid Amplification Technology (INAAT) market, by technology, 2016 (%)
Isothermal amplification is mostly used for detection of infectious diseases. This, along with introduction of more specific kits, increasing incidence of diseases such as HIV, hepatitis A & B, & STDs that include chlamydia and gonorrhea are key factors expected to drive the market. Moreover, increasing need for rapid testing for detection of infectious diseases to prevent them from spreading, especially in low income countries, is expected to propel growth.
Blood screening is also an important application segment owing to increasing number of blood transfusions across the globe. INAAT is widely used for screening of transfused blood for infectious organisms to limit their dissemination and prevent epidemics. Several companies have been undertaking extensive R&D for usage of INAAT in detection of cancer specific molecular biomarkers and development of drugs specific to these biomarkers.
End Use Insights
Hospitals dominated the segment with the largest market share in 2016. Development of wireless communication and miniaturized point of care INAAT instruments aids hospital-based analysis by providing single-level access to diagnostic results throughout the hospital. Automation, large number of samples for detection of infectious diseases, and demand for accurate results are factors expected to boost dominance.
As per end user analysis, the reference labs segment is expected to exhibit growth due to increasing number of reference laboratories and high adoption of novel & accurate molecular diagnostic techniques. Various public funding bodies such as CDC, NIH, as well as private investors, such as Wellcome Trust and Bill & Melinda Gates Foundation, encourage development of advanced technologies for rapid analysis of specific infectious diseases.
North America dominated the regional segment for INAAT market with highest revenue in 2016. Economies in the region, including the U.S. and Canada, have exhibited high growth owing to established research infrastructure and rising research initiatives. Growth in the isothermal diagnostics market can be attributed to growing demand and investments from foreign players, which has led to increased competitive rivalry.
Asia Pacific is anticipated to be the fastest growing region over the forecast period. China has witnessed rapid urbanization owing to strong economic growth. Increase in disposable income in developing economies, large population, increase in investments in healthcare facilities, and unmet clinical needs are factors anticipated to drive adoption of INAAT devices. Demand for cost-effective diagnosis and preventive medicine is also expected to boost the market.
INAAT market is highly competitive and concentrated. Some of the key players accounting for the largest share in 2016 are Alere, Inc.; bioMerieux SA; Eiken Chemical Co. Ltd.; Hologic, Inc. (Gen-Probe); Lucigen; QIAGEN; Quidel Corporation; Thermo Fisher Scientific; and Becton, Dickinson & Company.
Customized products and applications are expected to boost competitiveness. Players are likely to undertake mergers & acquisitions to diversify their product portfolios and gain market share.
Base year for estimation
Actual estimates/Historical data
2014 - 2016
2017 - 2025
Revenue in USD Million and CAGR from 2017 to 2025
North America, Europe, Asia Pacific, Central & South America, Middle East & Africa
U.S., Canada, UK, Germany, China, Japan, India, Brazil, Mexico, South Africa
Revenue forecast, company share, competitive landscape, growth factors and trends
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Segments covered in the report
This report forecasts revenue growth at global, regional & country levels and provides an analysis of the industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global Isothermal Nucleic Acid Amplification (INAAT) market on the basis of product, technology, application, end-use, and region:
By Product Outlook (Revenue, USD Million, 2014 - 2025)
By Technology Outlook, (Revenue, USD Million, 2014 - 2025)
By Application Outlook (Revenue, USD Million, 2014 - 2025)
Infectious disease diagnostics
By End-use Outlook (Revenue, USD Million, 2014 - 2025)
Central and reference labs
Regional Outlook (Revenue, USD Million, 2014 - 2025)
Central & South America
Middle East & Africa
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