Nucleic Acid Testing Market Size, Share, Industry, Forecast and Outlook (2024-2031)

Nucleic Acid Testing Market is segmented By Product Type (Nucleic Acid Test Kits, Consumables), By Indication (Infectious Disease, Cancer, Forensic Testing, Genetic Disorders, Others), By End User (Hospitals, Pathology Laboratories, Research Institutes, Others), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031 

Nucleic Acid Testing Market Overview

The Nucleic Acid Testing Market report analyzes the global market size, shares, recent trends, competitive intelligence, and future market outlook. Nucleic acid testing involves the detection and analysis of genetic material to diagnose and monitor various diseases. It is widely used in molecular diagnostics, infectious disease testing, and genetic screening. The market is driven by factors such as the increasing prevalence of infectious diseases, advancements in nucleic acid testing technologies, and growing demand for personalized medicine. The Nucleic Acid Testing Market is witnessing significant growth in the Asia Pacific region. Key players in the market include Roche Diagnostics, Abbott Laboratories, Thermo Fisher Scientific Inc., and other prominent players operating in the market.

A nucleic acid test (NAT) is a method applied to detect a specific nucleic acid, bacteria, or virus which acts as a pathogen in blood, urine, tissue, etc. The nucleic acid tests differ from other tests in that it detects genetic materials rather than antigens or antibodies. Detection of genetic elements allows an early diagnosis of disease as for the detection of antigens; they require time to appear in the bloodstream. NAT significantly reduces the procedural time and consumption of reagents and the risk of transfusion-transmitted infections with its increased use for screening blood donation samples. 

Nucleic Acid Testing Market Summary

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Nucleic Acid Testing Market Dynamics

• The global market for the Nucleic Acid Testing Market is primarily driven by the growing occurrence of infectious diseases like cancer and genetic disorders and rising demand for technological advancements in testing methods globally.

• For instance, according to the World Health Organization (WHO), in 2017, 10 million people fell ill with Tuberculosis (TB), and 1.6 million died from the disease. Growing end-user acceptance and favorable regulatory mechanisms globally along with the increasing need for new & improved testing methods that utilize new reagent systems in an extensive range of applications will also give the market with lucrative opportunities.

• Nucleic acid tests aid in identifying the problem and also offer an additional layer of blood screening. Its advantage of early detection and ability to provide accurate analysis makes the nucleic acid testing market attractive as it can help narrow down the infectious period.

• Moreover, research funding by government and private organizations for cancer treatment and increased adoption of nucleic acid testing in cancer research programs is expected to aid in the growth of the nucleic acid testing market.

• However, the difficulty of nucleic acid testing in attaining quantitative results from a big pool of clinical samples and the high cost of the testing devices and reagents may hinder the market progress.

Nucleic Acid Testing Market Segment Analysis

• Based on Product Type, the global nucleic acid testing market is segmented into nucleic acid test kits and consumables. Nucleic acid test kits are sub-segmented into Polymerase chain reaction (PCR), Ligase chain reaction (LCR), Transcription-mediated amplification (TMA), Whole Genome Sequencing, and others. Nucleic acid test kits hold the most significant segment is owing to it to their ability to detect infectious donations faster than current tests with accuracy.

• The polymerase chain reaction is expected to be the primary revenue-generating share as it is a lower-cost technique with various applications in disease detection, DNA typing, cloning, structural analysis, mutation analysis, sequencing, and mapping.

• Based on Indication Type, the global nucleic acid testing market is segmented infectious diseases, cancer, genetic disorders, forensic testing, and others.

• Infectious diseases hold the most significant market share is owing it to nucleic acid testing capability to identify genotypes and subtypes, which help in identifying viral load.

• Unique factors such as identifying fastidious bacteria, determining resistance to certain antibiotics, and bacterial resistance testing increase the demand for nucleic acid testing in the identification of infectious diseases. It is expected to play a vital role in personalized medicine in the future to avoid adverse reactions to drugs.

• Cancer is supposed to be the fastest-growing share in the indication type segment owing to its increasing prevalence and the nucleic acid testing ability for early diagnosis of genetic variations and prevention of cancer.

• According to Cancer Statistics 2018, a scientific paper published in the American Cancer Society journal, there will be an estimated 1,735,350 new cancer cases diagnosed and 609,640 cancer deaths in the United States.

Nucleic Acid Testing Market Geographical Share

• North America is the dominant share in the global Nucleic Acid Testing Market, and it is primarily attributed to factors such as the rise in infectious diseases and cancer cases along with technological advancement, broad adoption of genetic engineering and driving the market growth of the nucleic acid testing market in North America.

• Moreover, its broad base of the patient population and the established healthcare infrastructure and the rising disposable income, and higher investment in R&D activities contribute to the growth of North America’s share.

• Asia-Pacific region is expected to be the fastest-growing market during the forecast period, owing to the region’s rapidly improving healthcare infrastructure and the presence of a broad base of the target population. The high economic growth, geographic business expansions of market players, and the increasing government initiatives also boost the Nucleic Acid Testing Market in the Asia Pacific region.

Nucleic Acid Testing Market Companies and Competitive Landscape

• Key players are adopting strategies such as mergers and acquisitions, partnerships, and regional expansion to stand out as strong competitors in the market. New product launches along with increased focus on R&D are other ways the leading players improve their market presence. Key players are also bolstering their networks of distribution to expand the geographical scope of their products.

• February 2019, Hologic received two CE-Marks for its Aptima HIV-1 Quant Dx Assay in early infant diagnosis and to test dried blood spots in Europe. The assay is an in-vitro nucleic acid amplification test designed to detect and quantitate HIV type 1 on the company’s Panther system. The Aptima HIV-1 Quant Dx Assay has been designed to aid in HIV-1 diagnosis, as a confirmation of the infection, and as an aid in the clinical management of infected patients.

• February 2019, SGS expanded its Glasgow facility’s testing capabilities and capacity. The investment has been supported in part by a Scottish Enterprise Research and Development grant award of £1.7 million. The new laboratory increased the ability of all existing biosafety services and enhanced real-time polymerase chain reaction (PCR) platforms, to support viral safety and genetic stability assessment of cell banks for vaccines, gene, and cell therapies.

• February 2019, Grifols announced that the U.S. Food and Drug Administration (FDA) approved the Procleix Babesia assay, a qualitative test for the detection of the ribosomal RNA from Babesia species (B. microti, B. Duncan, B. divergens, B. venatorum) in individual samples or up to 16 pooled lysed specimens from human donors, including donors of whole blood and blood components for transfusion. The assay runs on the Procleix Panther system, a fully automated platform utilizing Nucleic Acid Testing (NAT) for blood screening.

• August 2018, Grifols announced that the U.S. Food and Drug Administration (FDA) approved the Procleix Zika Virus assay for the detection of the virus in individual or pooled plasma specimens from human donors, including volunteer donors of whole blood and blood components for transfusion.

• January 2017, Grifols, S.A. acquired the Nucleic Acid Testing donor screening unit from Hologic. The acquisition enabled Grifols to strengthen its position in transfusion medicine through NAT technology.

• Key players are Abbott Laboratories, Becton, Dickinson and Company, Beckman Coulter, Inc., Bio-Rad Laboratories, Illumina, Inc., Siemens Healthcare, bioMérieux SA, F. Hoffmann-La Roche Ltd.,, Novartis International AG, Grifols, S.A.