The nucleic acid amplification, detection, and diagnostics market was valued at approximately US$ 14,014.59 million in 2019 and is anticipated to grow to US$ 38,162.68 million by 2027, reflecting a compound annual growth rate (CAGR) of 13.4% from 2020 to 2027.
This market expansion is primarily driven by the increasing incidence of infectious diseases and the growing demand for sophisticated diagnostic systems. However, the lack of sufficient infrastructure in developing nations is expected to hinder market growth during the forecast period.
Nucleic acid amplification serves as a crucial component in various life science technologies, including the development of clinical medicine, the diagnosis of infectious diseases, and gene cloning. The rising prevalence of both chronic and infectious diseases is propelling the need for advanced diagnostic systems. Ongoing research and development efforts, along with significant investments, are focused on creating innovative reagents and kits for nucleic acid amplification technologies, which offer rapid and reliable diagnostic capabilities compared to traditional in-vitro diagnostics (IVD) tests. Furthermore, numerous companies have introduced integrated, portable, and microfluidics-based platforms aimed at enhancing the functionality of diagnostic analysis and sensing. Notable examples include bioMerieux's NucliSENS easyQ tests and Enigma Diagnostics's MiniLab, both of which provide cost-effective and user-friendly microfluidics-based solutions.
The surge in investments and partnerships is crucial for the advancement of cutting-edge diagnostic kits and instruments. Pharmaceutical companies and research institutions are increasingly adopting nucleic acid amplification technologies due to their high precision in disease diagnosis. For instance, in June 2020, Shionogi & Co., Ltd., a prominent player in the Japanese pharmaceutical sector, formed a strategic alliance with Gunma University, Nihon University, and Tokyo Medical University to develop a modern diagnostic system for detecting infectious diseases. This collaboration focuses on signal amplification methods to create rapid testing products.
The COVID-19 pandemic has further highlighted the effectiveness of nucleic acid amplification technology, leading to its wider acceptance among healthcare professionals. This growing recognition has resulted in an increase in product launches. For example, in April 2020, Hologic, Inc. introduced the Aptima molecular assay for COVID-19 diagnosis, utilizing transcription-mediated amplification (TMA) techniques. Such innovations underscore the rising demand for nucleic acid amplification detection and diagnostics, which is expected to significantly contribute to market growth in the coming years.
The nucleic acid amplification, detection, and diagnostics market is categorized based on the type of nucleic acid into deoxyribonucleic acid (DNA) and ribonucleic acid (RNA). In 2019, the DNA segment dominated the market share and is projected to experience the fastest growth during the forecast period.
In terms of process, the market is divided into diagnostics, amplification, and detection. The amplification segment is further classified into transcription-mediated amplification (TMA), loop-mediated isothermal amplification (LMIA), strand displacement amplification (SDA), helicase-dependent amplification (HDA), nucleic acid sequence-based amplification (NASBA), among others. The diagnostics segment held the largest market share in 2019 and is expected to grow at the fastest rate during the forecast period.
Regarding product types, the market is segmented into kits & reagents, assays, and systems. The kits & reagents segment was the largest in 2019 and is projected to see the most rapid growth in the upcoming years.
From a technological perspective, the market is categorized into polymerase chain reaction (PCR), next-generation sequencing (NGS), isothermal amplification technology, direct nucleic acid detection, and CRISPR-Cas9. The PCR segment, which includes sub-segments such as quantitative PCR (qPCR), reverse-transcriptase (RT-PCR), multiplex PCR, nested PCR, and in-situ PCR, held the largest market share in 2019 and is anticipated to grow the fastest during the forecast period.
In terms of applications, the market is divided into infectious diseases, genetic disorders, oncology, forensic testing, paternity testing, and others. The infectious diseases segment was the largest in 2019, while the oncology segment is expected to register the fastest growth in the forecast period.
Finally, based on end users, the market is segmented into hospitals & clinics, diagnostic centers, research institutes, and others. The hospitals & clinics segment held the largest market share in 2019, whereas research institutes are projected to experience the fastest growth during the forecast period.
This report has utilized primary and secondary sources, including the World Health Organization (WHO), Food and Drug Administration (FDA), National Health Service (NHS), and Centers for Disease Control and Prevention, to compile comprehensive insights into the nucleic acid amplification, detection, and diagnostics market.