Strand Displacement Amplification Market Size, Share, and COVID-19 Impact Analysis, By Product Type (Instruments and Reagents & Consumables), By Application (Tuberculosis, Hepatitis, Malaria, Cancer, and Others), By End User (Hospitals & Clinics, Diagnostic Centers, and Others), and Regional Forecast, 2025-2032

Strand displacement amplification (SDA) is an isothermal process and is a molecular technique used for the amplification of nucleic acids such as deoxyribonucleic acid (DNA) or ribonucleic acid (RNA). The technique is an alternative amplification method to polymerase chain reaction (PCR). This requires two inner and outer primers which include nicking endonucleases, nucleotides, exonucleases, and strand displacement DNA polymerase.

The prevalence of diseases such as hepatitis, tuberculosis, cancer, and many more are rising as well as the diagnosis rate for these diseases is also increasing leading to fuel the demand for these techniques.

• For instance, as per an article published by Plos One in 2022, around 71 million people worldwide are affected by the hepatitis C virus (HCV), but chronic HCV infections are frequently asymptomatic, and thus 80% of those infected are unaware of their illness.

Various amplification assays are being used apart from the PCR-based amplification method such as loop-mediated isothermal amplification, transcription-mediated amplification, ligase chain reaction, rolling circle amplification, and strand displacement amplification. Among these techniques, strand displacement amplification offers various benefits such as it is a simple, fast, sensitive, specific, and inexpensive method that influences its adoption rate as a preferred point-of-care diagnostics, eventually leading to market growth.

Moreover, this technique provides an important potential in the field of genetic analysis, in which disease predisposition and therapeutic efficacy are frequently determined by multiple nucleic acid markers that are expected to generate excellent opportunities for market growth.

However, the rising use of alternative techniques such as polymerase chain reactions (PCR) for the diagnosis of diseases may limit its adoption rate leading to limiting the market growth, owing to certain limitations of this technique such as the inability to efficiently amplify long target sequence, may influence its preference in the diagnostic market leading to slower market growth.

Impact of COVID-19 on the Strand Displacement Amplification Market

The outbreak of the COVID-19 pandemic has impacted the global market positively as it has imposed a huge burden on healthcare systems worldwide. The pandemic escalated testing, isolation, and contact tracing efforts through large-scale testing which allows health services to quickly identify positive cases and prevent the spread. For the rapid detection of COVID-19, a non-enzymatic whole-genome detection method based on a simple isothermal signal amplification approach was used which is termed non-enzymatic isothermal strand displacement and amplification (NISDA), with the ability to quantify 10 RNA copies.

• For instance, according to an article published by Nature Communications in 2021, in 164 clinical oropharyngeal RNA samples, the NISDA assay was 100% specific, and it was 96.7% and 100% sensitive when setting up in the laboratory and hospital, respectively.

However, these methods perform well when the target gene is short and are yet to function efficiently to detect whole genomes like long DNA or RNA targets. The companies operating in the market are exploring different approaches for detecting different pathogens and developing a point-of-care diagnostic device for multiple disease diagnostics.

The market recovered to its pre-pandemic growth level in terms of patient visits and is anticipated to grow at a pre-pandemic growth rate during the forecast period 2023-2030.

Key Insights

• Prevalence of Key Infectious Diseases, By Key Countries, 2022.
• Key Industry Developments - Mergers, Acquisitions, and Partnerships.
• New Product Launches, By Key Players.
• Overview of R&D initiatives, By Key Players.
• Impact of COVID-19 on the Global Strand Displacement Amplification Market.

Analysis by Application:

Based on the application, the market is segmented into tuberculosis, hepatitis, malaria, cancers, and others. The hepatitis segment is expected to account for a significant share due to the robust usage of this technique to detect hepatitis. Hepatitis B virus (HBV) is one of the critical global health problems and in the last few years, the field for its diagnosis has evolved rapidly with advancement in molecular biology. A number of isothermal amplification assays such as strand displacement amplification have been utilized for HBV diagnosis. These isothermal amplification techniques are comparatively sensitive, and specific, and require less instrumentation and automation. The prevalence of hepatitis is increasing and timely treatment can be addressed if diagnosed early. Hence as the diagnosis rate for HBV with this method will drive market growth.

• According to the data of the Hepatitis B Foundation, globally 2 billion people have been infected with Hepatitis B virus which is one out of three people. Further, it stated that 1.5 million people become newly infected each year out of which 300 million are chronically infected.

Similarly, the usage of this technique for the diagnosis of other infectious diseases is projected to augment the segment’s growth.

• According to an article published by Frontiers in 2021, several isothermal nucleic amplification technologies (INATs) are being used for the detection of various pathogenic microbial infections like Hepatitis B Virus (HBV), African Swine Fever Virus, human papillomaviruses (HPV), etc., that have been successfully used to detect DNA sequences in real-life samples in labs with basic facilities.

Regional Analysis:

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Among regions, North America accounted for a significant share in the global market. The dominant share is attributed to the increasing demand for DNA-based diagnostics and the incorporation of novel technologies for identifying and targeting specific gene mutation that causes diseases such as cancer is contributing to regional growth. According to the American Cancer Society in 2023, over 1.9 million new cancer cases are expected to be diagnosed in the US in 2023. Such a scenario fuels the adoption rate of this method across the region leading to global market growth.

Key Players Covered

The report will include the profiles of key players such as NuProbe, Bio-Rad Laboratories, Inc., New England Biolabs, Yeasen Biotechnology (Shanghai) Co., Ltd, Geno Technology Inc., Lucigen Corporation (LGB Biosearch Technologies), NIPPON Genetics Co, Ltd., highQu GmbH, and others.

Segmentation

Key Industry Developments

• December 2022: ArcticZymes Technologies ASA launched AZscript Reverse Transcriptase (RT) that supports RT-qPCR and RT-LAMP (Loop-mediated isothermal amplification) workflows in molecular research and diagnostics.
• November 2022: Bio-Rad Laboratories, Inc., and NuProbe entered into an exclusive licensing agreement. In this agreement, Bio-Rad will apply the blocker displacement amplification technology of NuProbe to its Droplet Digital PCR.
• September 2021: TransGen Biotech Co., Ltd., launched Bst II DNA Polymerase with application in strand displacement DNA synthesis.